Government Gazette

Page 1

Government Gazette £10.00, €11.00 ISSN 2042-4168

March 2016

Exclusive health report

Expert voices for change

Living on the edge , migration climate change and crime


human trafficking UNICRI’s new director speaks out

labour exploitation European Union Agency for Fundamental Rights measures EU-wide severity

democracy rebooted Looking at the future of technology in elections

save the date

PCa Europe 2017 Tuesday, 24th January 2017

Brussels, Belgium A high-level meeting bringing together key healthcare policy makers and stakeholders to reach an EU-wide consensus for improved diagnostic accuracy, effective management and care in Prostate Cancer. Get involved in the discussion and have your say

Government Gazette

Government Gazette

Government Gazette £10.00, €11.00 ISSN 2042-4168

March 2016

Exclusive health report

Expert voices for change

Living on the edge , migration climate change and crime


human trafficking UNICRI’s new director speaks out

labour exploitation European Union Agency for Fundamental Rights measures EU-wide severity

democracy rebooted Looking at the future of technology in elections

Migration, Climate change & integration 38

The business of climate change 15

Government Gazette March 2016 ISSN: 2042-4169

Editor Jonathan Lloyd (+44) 020 3137 8612 Commissioning Editor Janani Krishnaswamy (+44) 020 3137 8653 Publisher Matt Gokhool (+44) 020 3137 8611 Subscriptions (+44) 020 7878 1008 © 2015 CPS Printed by The Magazine Printing Company plc, Mollison Avenue, Brimsdown, Enfield, Middlesex, EN3 7NT. The acceptance of advertising does not necessarily indicate endorsement. Photographs and other material sent for publication are submitted at the owner’s risk. The Government Gazette does not accept responsibility for any material lost or damaged.



climate action


editorial view

2 Jonathan Lloyd, Editor, Government Gazette

eu news bulletin 3 Andrea Tivoli, Public Policy Exchange 5 John Halloran, European Social Network 5 Alfonso Lara Montero, European Social Network


6 Interview with Cindy Smith, UNICRI 8 Marlene Mizzi MEP 10 Catherine Bearder MEP

labour exploitation 12 Michael O’Flaherty, EU Agency for Fundamental Rights

climate change 15 Jos Delbeke, Directorate for Climate Action & Energy, European Commission 17 Mark Radka, United Nations Environment Programme 20 Miriam Dalli MEP 22 Fabrice Leveque and Imke Lübbeke, WWF Europe 24 Torgny Holmgren, Stockholm International Water Institute 25 Magda Stoczkiewicz, Friends of Earth Europe 27 Paul McAleavey, European Environment Agency 29 Hanne Knaepen, European Centre for Development Policy Management

climate change adaptation

30 Anna Leidreiter, World Future Council

climate & security 31 Major General A N M Muniruzzaman, (Retd.), GMACCC

climate & jobs

33 Sharon Burrow, International Trade Union Confederation

climate finance

34 Gabriela Ramos, OECD Chief of Staff and Sherpa to the G20 36 Erik Solheim, OECD DAC

climate induced migration

38 Dr Bettini Giovanni, Lancaster Environmental Centre climate action


migration & public health 39 Santonio Severoni, World Health Organization

climate displacement

41 Alice Thomas, Refugees International

migration & development 44 Magdy Martínez-Solimán, United Nations Development Programme 46 Demetrios G. Papademetriou, Migration Policy Institute Europe

migration & integration 48 Dr Alex Mesoudi, Durham University

elections & democracy

health report 52

88 Ann Ravel, US Federal Election Commission 89 Thomas Hicks, US Election Assisstance Commission 90 John Fortier, The Democracy Project at Bipartisan Policy Center 92 Antonio Mugica, Smartmatic 93 Rachel DeLevie-Orey, Atlantic Council 94 Lefterije Luzi, CEC Albania 95 Vasu Mohan, International Foundation for Electoral Systems

European health


editorial view

Europe, living on the edge


he new year started on a rather depressing note, with a renewed stream of ISIS engineered terrorist attacks, the escalating number of human trafficking victims, extreme forms of labour exploitation, and a sudden influx of refugees. The Schengen area, which allows free movement, is currently under threat as border controls have been reintroduced. The March edition of Government Gazette reflects upon these internal and external crises, identifies the causes, provides an insight into who is affected and finally, identifies suggestive policy action. Human trafficking is an abysmal phenomenon that’s growing at a frightening rate across the globe. In our extended focus on crime, human trafficking and labour exploitation, we evaluate the current nature and intensity of trafficking in Europe and assess the impact of the present policy options to tackle this hideous crime. Fully committed to fight human trafficking, MEPs Marlene Mizzi and Catherine Bearder take a closer look at this modern form of slavery, and point towards the importance of the gender dimension. Dr Cindy J Smith, Director, UNICRI, speaks to Government Gazette on the kind of efforts European countries should take to destroy the criminal gangs of human traffickers, who are particularly exploiting the ongoing migrant crisis. Taking stock of severe forms of labour exploitation within Europe, Michael O’Flaherty, Director, EU Agency for Fundamental Rights makes suggestions for policy action. Migration, climate change and environment are interrelated. In our current edition, we take a look at this complex nexus and analyse their serious ramifications in several other areas including jobs, security, justice, water, finance and public health. Our extended focus on the subject features interesting narratives from prominent policy advocates, academics and experts who look at how climate is inextricably linked to several other global challenges and what world leaders are doing to


tackle climate change. While the Paris agreement can be considered a real breakthrough on several accounts, our climate experts and exclusive voices from the European Parliament and European Commission take a look at the ambitious goals of the deal and analyse how they can be best implemented. Will 2016 be a better year for migrants? In our section on migration, development and integration, we take a look at the broken promises and lack of aspiration in the approach to migration and identify what urgent action is required to stop Europe from falling apart. Demetrios G. Papademetriou, Founder and President of Migration Policy Institute Europe, offers a five-point-cluster which when acted upon in an integrated manner can bring us back to normality. Moving beyond the confines of Europe’s existential threats, the current edition of Government Gazette also includes an exclusive health report featuring well-known voices from the world of oncology, diabetes and eHealth. With an exclusive interview of Vytenis Andriukaitis, European Commissioner for Health and Food Safety and updates from the European Parliament, the health report analyses policies that promote the prevention, treatment and care of prostate cancer, bladder cancer and diabetes. Featuring perspectives from practitioners, pharmaceutical companies and academics, the report also makes recommendations regarding current EU-wide policies relating to screening, diagnostic accuracy, treatment, patient support, preventative measures and research. While a number of international democracies have chosen not to go down the path of adopting technological changes to transform how governments interact with citizens, a few European countries have already gone digital. Continuing our theme on digital democracy and electoral technology, the current edition takes a look at how the United States is revolutionising elections and evaluates the need for international guidelines for electoral technology

Government Gazette


eu news bulletin

Refugee crisis threatens EU’s Internal Market


he reintroduction of borders might destroy the Euro and put EU’s single market under threat, warns European Commission President Jean-Claude Juncker. With an unprecedented number of migrants arriving at Europe’s shores, several EU countries, including Germany, Sweden, Denmark and Austria decided to reintroduce border controls to better control the influx of migrants. But the future of Europe’s passport-free zone is now under threat. Juncker recently warned that without free movement of workers - the EU’s passport-free Schengen zone - would lose its main raison d’être. According to Juncker, the EU would endure a consistent loss of growth that could eventually lead to the collapse of the European internal market. Recently speaking to MEPs in Strasbourg he noted that Europeans no longer have many borders, but a common border and a shared responsibility to protect it. The European Commission’s internal estimates have already illustrated the extra costs deriving from reinstating border controls. For instance, the ID checks reintroduced at the beginning of this year by Sweden and Denmark on the Öresund Bridge have already generated over €300 million costs. With respectively over 47 and 24 million cases of road transport and business trips per year in the European

single market, the loss in terms of growth would be immeasurable. Nonetheless, with several EU Member States still showing reticence to assume their legal and political commitments, the EU might be moving towards a crisis in terms of credibility. This is particularly true in the case of the agreed relocation scheme of 160,000 migrants from Greece and Italy, which has so far succeeded to relocate less than 300 people. Juncker has also announced that the current version of the Dublin system will be reformed with plans to rebuild the bloc’s asylum policy on the core principle of redistribution, a measure on which European officials expect to face resistance from EU governments

New EU data protection regulation affects everyone


fter more than three years of negotiations, European policymakers have finally reached a political agreement on EU data protection reform on December 2015. This new regulation - which will come into effect by 2018 - is intended to reinforce Europeans’ privacy rights. The reform package will consist of two instruments: (1) the General Data Protection Regulation (GDPR), which will allow European citizens to have a greater say over how their digital information is collected and managed and (2) the Data Protection Directive (DPD), which will serve the police and criminal justice sector in order to facilitate cross-border cooperation of police and prosecutors to fight crime and terrorism in Europe. Some of the most notable innovations included in the GPDR proposals include new individual rights to access information, a right to data portability and a clarified ‘right to be forgotten.’ The new policies also encompass the obligation for popular social services such as Facebook, Snapchat or Instagram to obtain parental consent for anyone under 16 unless any national government lowers the age limit to 13. Additionally, companies and businesses will also be required to report to national

regulators any data breach within three days. The new regulations will apply to any company that has customers in European Union, regardless of the fact that the company is based outside of the region. To ensure the respect of the GPDR, EU policy makers have agreed upon including provisions for fining non-complying companies up to four per cent of their global revenues, a measure that can potentially result in fines amounting to billions of euros. The threat of considerable fines has triggered negative reactions over the fact that Europe’s data protection overhaul will mostly target large American tech companies and not their smaller European rivals. For EU officials, this new regulation is a major step towards a Digital Single Market that will benefit both citizens and businesses by creating one single common data protection standard across Europe. This will also imply cutting red tape and improving legal certainty and chances for competition for all businesses on the European market. However, according to data protection experts, various areas of policy privacy will still remain unresolved. Amongst these, it is still unclear which of Europe’s many national data protection regulators will have the final say in determining if a company has breached the region’s privacy rules, thus leaving a certain degree of uncertainty on how to implement the rules. Several European business associations have also raised concerns, claiming that the new legislation risks harming European consumers and businesses by overburdening European SME’s and scaring off potential investors towards other markets, elements which could seriously damage Europe’s digital growth. The reform package is expected to be approved by the EU Parliament when it meets later this year

Government Gazette


eu news bulletin


he European Union Council of Ministers recently adopted a directive aimed at enhancing transparency on tax rulings given by member states to companies.

With an estimated £730bn lost by EU member states in tax evasion and avoidance each year, triggered by the ‘Luxleaks’ revelations about Luxembourg’s dubious tax deals with multinationals, European authorities decided to act to counter aggressive corporate tax planning and evasion in Europe. The proposed measures aim to ensure that where one member state issues a tax ruling or transfer pricing arrangement, any other affected member state will be able to monitor the situation and the possible impact on its tax revenue. According to EU officials, this mechanism will contribute to considerably reduce rulings concerning tax-driven structures, which have led to low levels of taxation of high amounts of income in the country issuing the

ruling and left low amounts of income to be taxed in any other countries involved. The new directive will demand member states to automatically exchange information on cross-border tax rulings, as well as advance pricing arrangements, therefore eliminating the discretion members states previously had on the information they shared concerning their tax rulings. The European Commission will also develop a central directory where the information exchanged will be stored. Access to this directory will be guaranteed to all member states as well as to the Commission in order to monitor the implementation of the directive. The new rules will be adopted in January 2017, while existing obligations will stay in place in the meantime. The European Parliament has also agreed on a new six-month mandate for the Special Committee on Tax Rulings (TAXE), designated to monitor legal initiatives related to corporate taxation and further fact-finding. The European Commission plans to continue investigating into tax ruling practices in all EU member states, reserving its right to open new enquiries where evidence indicates that rules are not being complied with


EU adopts new cross-border tax transparency rules

Netherlands takes over EU presidency


he Netherlands has taken over the rotating presidency of the Council of the EU during a time when the European Union is both internally and externally threatened by crises and instability. For the next six months, the country will have to face several tests and challenges that have contributed to undermine the European Union over recent months. Along with the Slovakians and the Maltese, the Dutch diplomats will focus on developing a comprehensive approach to migration and international security, reinforcing the role of Europe as an innovator and job creator, maintaining financial stability in the Eurozone as well as stimulating EU policies on climate and energy. Tackling the influx of migrants, the Dutch aim to improve the future developments of the Common European Asylum System, uphold the EU’s refugee relocation programme and implement the agreements on the exchange of data and cooperation between national security services, a measure that pushes for further harmonization between internal and external policies of the EU. Apart from the above listed four main core challenges, innovation and job creation in Europe has also emerged as a major priority for the Dutch. The Netherlands will pursue an innovative union founded on structural growth and employment, a goal that will require a more active stimulation of entrepreneurs as well as boosting the service and innovation sectors of the EU economy.

reforming European finances, mainly through a revision of the EU multiannual budget. Furthermore, the Dutch also wish to support the transition to a circular economy that uses natural resources in a sustainable manner, and present a proposal for achieving the Sustainable Development Goals (SDGs) within the EU. The Dutch will also focus on strengthening the internal market and international trade

Another pillar of the newly appointed presidency will be to concentrate efforts on achieving financial stability in the Eurozone while supporting economic growth. To achieve this, the Dutch plan to focus on following through the path of structural reforms and coordinated economic policies in order to guarantee healthy public finances in member states. The Dutch are also expected to launch a debate on the possibility of


Government Gazette

eu news bulletin

Integrated services: (how) does it work? Local public social services rise to the integration challenge. John Halloran, CEO and Alfonso Lara Montero, Policy Director, The European Social Network share their experiences from a recent seminar on integrated services

health services and a third sector partner are working collaboratively to establish an accessible garden space where adults with learning disabilities can have training and employment opportunities through a social enterprise.

From left to right: Luc Claessens, Senior Advisor, Education Policy Division, Municipality of Antwep Lise Burgade, Deputy Head of Health and Social Care Unit, National Solidarity Fund for Autonomy (CNSA), Dr Nicholas Goodwin, CEO, International Foundation for Integrated Care (IFIC), Martin Duggan, Director, Strategy and Market Development, IBM


n 5-6 November, more than 100 participants from 24 European countries joined our annual seminar in Manchester, which looked at how local public social services are addressing the concept of integrated care in their countries. Across Europe, when people talk about “integration” they may refer to structural reorganisation and improved governance; for instance, having a single accountable agency responsible for commissioning services. Others mean improving cooperation between professionals from different sectors working with the same client. There are yet more who refer to integrating various strands of finance by pooling budgets or creating specific integrated funds to support specific groups with complex needs. They are all important and in some form or another they are all integration, but do they improve people’s outcomes? That’s why, if we are to use the word “integration”, we ought to have some common definition. In the European Social Network (ESN), we have defined the term “integrated services” as the range of activities, (depending on sectors, target groups and governance contexts), implemented to achieve more efficient coordination between services and improved outcomes for service users. At the seminar we listened to various experiences, which highlighted how changes in the care landscape may benefit service users as support becomes more holistic. New integrated support requires new skills and new ways of working. Therefore, new roles are emerging, new career paths are being developed, joint training is taking place to enhance mutual understanding as public social services, education, health and employment rise to the

In many jobcentres in Germany, several organisations have been merged into one single agency for service delivery, including traditional job-seekers’ support such as advice, counselling and training, but also housing support, mental health and childcare support. In addition, there is a network of cooperation with a variety of organisations, including schools, immigration offices, housing organisations, youth welfare services, employers’ associations and thirdsector organisations.

The Finnish service integrator –Kotitorigathers all older people’s services from public and private providers that are available in challenge of integrated services. Tampere, and provides guidance for service In Manchester, public service reform revolves users so that they can choose the most suitable. around integrated, co-ordinated and sequenced This is a public-private partnership where bespoke support packages; family based a private company provides the software approaches to changing behaviour; and whilst the municipality covers costs for needs choosing interventions on assessment and advice. strength of the evidence. An According to self-reported The European Social evaluation following the first evaluations, service users Network (ESN) promotes phase of the Troubled Families are highly satisfied as the the exchange of knowledge (TF) programme demonstrated integrator helps them access and expertise of professionals that 67% of the children all necessary services through working in public social assessed as children in need, had a single point. services across Europe to that status removed within 6 shape policy and practice at These examples show that months of the end of their key national and European levels. integration is certainly about worker intervention (compared ESN has been working with making organisational, with an estimated 50% without Vilans, the National Centre governance, budgetary, TF intervention). of Expertise for Long-term structural or cultural changes Care in the Netherlands In Andalucía, Spain, the but most importantly to review current literature network of early intervention the ‘i’-word is about the and practice on integrated for young children with individual, whose needs services in Europe. The developmental problems has are placed squarely at the seminar was organised to developed a software that is centre of their support. collate the inputs of the available for all professionals There is a need to invest in members of the European from education, health and the organisations’ learning Social Network. A report social services working with environment, joint training summarising the findings these children. This tool allows and skills development but has been published recently all professionals working in also in the human side of and can be accessed at the region to access the unique professionals’ relationships, records of each child to ensure such as trust-building, php?page=files&id=1910 continuity of care and prevent common understanding the need for individuals to have and assessment. Ultimately, to repeat their story to other the aim is to ensure that professionals. the move to integration improves people’s outcomes and their quality of life In Renfrewshire, Scotland, the co-location of the day services for adults with learning disabilities has been a collaborative effort between social and leisure services to develop facilities that provide a platform for the promotion of healthy lifestyles, integration and inclusion in the community. Social services,

Government Gazette



Europe, living on the edge


oday, Europe is facing several threats and challenges ranging from transnational terrorism to human trafficking and the migrant crisis. Over the past year, an unprecedented number of migrants have made their way to Europe leading several countries to temporarily reintroduce border controls within the Schengen zone. Fears abound that terrorists could make the most of migration to slip into Europe. Fears of attacks in Europe have grown ever since Islamic militants carried out a spate of massacres in Paris in November last year. The number of victims of human trafficking has also been growing, with the victim rate rising by more than a fifth last year in the UK alone. Increasingly these human traffickers are changing their illegal trafficking routes to Europe. Overall, the UK Home Office has estimated that there are between 10,000 and 13,000 victims of modern-day slavery just in the UK. Migrants and refugees fleeing wars or natural disasters are becoming more and more vulnerable. In an interview with Janani Krishnaswamy, Commissioning Editor, Government Gazette, the newly appointed Director of the United Nations Interregional Crime and Justice Research Institute, Dr Cindy J Smith discusses her goals in relation to implementing improved policies in the field of crime prevention and criminal justice.


The unprecedented influx of migrants, fear of terrorist attacks and the increasing number of human trafficking victims have widened the scope of organisations created to advance policy and practice in prevention and control of crime. In an exclusive interview with Janani Krishnaswamy, Commissioning Editor, Government Gazette, Dr Cindy J Smith, Director, United Nations Interregional Crime and Justice discusses the organisation’s priorities in tackling these existential threats and implementing efficient policies to establish social peace and stability

As the newly appointed Director of UNICRI, what would be some of your immediate priorities in tackling criminal threats to social peace, development and political stability? We are an independent Institute and our efforts are aimed at advising and informing governments, the private sector and the civil society about emerging risks and problems to be urgently addressed. In this respect, we play an active role in raising their awareness, promoting actions and enhancing capabilities to tackle current and potential threats. UNICRI supports the international community in assessing the magnitude of criminal threats, designing new policies and strategies, providing training and developing platforms for cooperation. We are addressing several critical issues; all of them require urgent intervention. That is why we operate in roughly a dozen different areas at the same level of priority, from mitigating the potential risks related of advances in technologies - such as the improper use of

Government Gazette

chemical, biological, radiological and nuclear material (CBRN) - to preventing many other phenomena including cyber crimes, environmental crimes, violent extremism, human trafficking, counterfeiting and illicit trafficking of precious metals. My vision of UNICRI is to provide a rapid response to the changing nature of all types of crimes that threatens peace and security. What I do consider as a priority is to address all these current or potential threats by taking in due consideration their impact on people. This is to say that I put victims at the forefront of our agenda and an inclusive and citizens centered approach as a pillar of our strategy. In all the thematic fields UNICRI operates, we address factors that result in criminal threats to social peace, development and political stability, by reducing the vulnerabilities of people to crime. In addition, I do believe that promoting people’s rights, equality and dignity is the best strategy to tackle the threats posed by organised crime and violent extremism. We may recognise that the most effective ally in the fight against crime and extremism is civil

human trafficking

society. Our priority is therefore to promote just and resilient societies. This is the most important sustainable response to guarantee peace, development and stability. UNICRI will support the fulfilment of the United Nations post-2015 agenda, and in particular help in promoting peaceful, inclusive societies and access to justice. We assist in building effective, accountable and inclusive institutions at all levels. What kind of efforts should European countries take to destroy criminal gangs of human traffickers exploiting the migrant crisis? What are some of the “My vision is to provide good practices you advise countries in this regard? a rapid response to the First of all, I think it is important we consider migration as a structural and permanent phenomenon of our modern society. A positive one, since it is usually associated with economic growth in the origin and destination countries. Of course migration crises can happen, especially those linked to major adverse events such as wars or natural disasters. Their tragic consequences are under everyone’s eyes.

changing nature of all types of crimes that threatens peace and security. What I do consider as a priority is to address all these current or potential threats by taking in due consideration their impact on people. This is to say that I put victims at the forefront of our agenda.”

In the future, we will continue to experience migration and humanitarian crises impacting different regions, especially those affected by climate change. Europe is experiencing an unprecedented emergency due to the Middle East situation. The 28 countries of the EU are addressing the crises in different ways, but the current situation should be viewed as an opportunity to harmonise European policies and actions on asylum seekers and economic migrants. It is also an important opportunity to join efforts in countering traffickers and smugglers. I think these opportunities will be missed if the problem is confined as an issue of border security only.

On the other hand, we cannot deny that the global economic crises and the fear of terrorism are interfering with the current European debate on migration. However, having an agreed policy at regional level is fundamental and this is valid for Europe as well as for other regions of the world. In future, I think we should improve our capacities to develop policies and implement actions to prevent crises especially in origin countries and regions. When a situation is addressed as an emergency, there is a high probability of lacking consensus and putting in place interventions which mitigate the adverse impact of the crises but do not address the root causes. Organised crime is taking advantage of our weaknesses in preventing and managing such crises in a timely manner. Thus, we should bring all actors – health professionals,

criminal justice system actors, policy makers, environmentalists, foreign affairs actors, the economic experts, etc. to the table. We should provide them with real examples of what has occurred elsewhere and help them practice a response. It is within this context that they can identify their gaps in the process and develop a plan to close the gaps. We have to recognise that human traffickers have remained in operation over several decades. Once a criminal group is dismantled, another one is ready to take its place. Over the past few decades, criminal organisations have increased their sphere of action, perpetuating a vicious and inseparable cycle between the management of illegal activities and the reinvestment of capital in the legal economy. Criminal organisations are very dynamic, they are able to rapidly adapt to new political and economic scenarios, change routes and exploit new victims. Like any other commodity, organised crime groups displace people and goods where there is demand, by taking advantage of unstable contexts, the absence of the rule of law and the routes crossing the weakest countries. We do believe it is crucial to enhance capabilities, cooperation and sharing of information on transnational criminal syndicates. It is crucial that the law enforcement and the judiciary of different countries work together. In parallel, we must address the root-causes of trafficking in human beings by doubling peace making and development efforts. It is crucial to establish

Government Gazette

coherent frameworks, finding long-term solutions, whenever is possible with the involvement of the countries of origin, transit and destination. We also have to improve the legal frameworks and operational protocols for refugees and economic migrants. Much more should be done to support victims and give them concrete alternatives in their origin or destination countries. Tackling corruption is also a fundamental part of the process, we have to end impunity. Criminal groups rely on corrupt officials, avoid border controls and take advantage of the lack of strong normative regimes, capabilities and cooperation. We must tackle the problem from a regional and global perspective. Crime displacement is a serious concern. When we assist only one country to close their gaps, crime moves to the next weakest link in the chain of countries. In addition, we should not underestimate the negative effect that criminalisation and stigmatisation of migrants produce on social cohesion. Migrants who commit offences have to be brought to justice, but too often their crimes - the crimes of a limited segment of the migrant population - encourage prejudice and criminal labelling of religious or ethnic minority groups. Despite long-standing efforts made by governments, real integration of migrants in hosting societies has not yet reached a satisfactory level. Living in deteriorated neighbourhoods, faced with discrimination, difficulties in finding or keeping a cultural identity accepted by the hosting society and lack of a real dialogue may lead to unemployment, alienation and frustration and consequently create the conditions for social conflicts, extremism and delinquency among immigrants, especially among youth people.


human trafficking

We have to rethink our present to shape our future and ask ourselves what we have created for future generations, how much we are investing in them. Many current situations are challenging the principles of a united globalized community. We have to pass this test and defend these principles. The principles of the United Nations Charter, that starts with We the people.

Over the past decade, UNICRI has been strongly involved in the implementation of many applied-research and technical assistance projects in the field of counter-trafficking in persons and child exploitation in various areas of the world. The activities have been carried out in the Czech Republic, Costa Rica, Germany, Italy, Nigeria, Poland, Thailand, the Philippines and Ukraine.

There is no security if the basic rights of people, the rights to leave in peace and prosperity are violated.

Our programmes seek on the one hand to strengthen institutional capacities to curb trafficking flows and on the other to rehabilitate trafficked victims and decrease the vulnerability of potential trafficking victims, especially women and children. Activities are carried out in close cooperation with governments as well as with international organisations and civil society members involved in preventing and combating trafficking in persons, especially women and children.

The UN estimates that more than 700,000 people have crossed to Europe by boat so far this year Roughly 13 percent of refugees travelling toward Europe are women. Of those, some 4,200 are estimated to be pregnant and another 1,400 “at risk of sexual violence.� What are some of your priorities in preventing and eradicating trafficking and exploitation? Can you detail the present work of UNICRI in tackling human trafficking and migrant smuggling in Europe?

In 2016, UNICRI will implement a new project aimed at promoting a comprehensive coordination mechanism to deal with migratory

flows in North Africa and counter organized crime in human trafficking and smuggling of migrants. The project represents the inception component of a broader programme aimed at enhancing regional and national rapid response mechanisms to tackle the challenges posed by irregular migration, human trafficking and smuggling of migrants in North Africa. It will enhance coordination of existing initiatives and cooperation among key stakeholders at national and regional level in North African countries. Today more than ever we must support development and the rule of law in the fight against trafficking in persons. Our efforts to counter this scourge have to be comprehensive. None can play in isolation since the most powerful weapon we have is our capacity to address the phenomenon comprehensively and collectively

Europe needs a forceful response and a victimcentred approach Human trafficking is a complex crime that is constantly evolving, with traffickers adopting newer methods and routes. Strasbourg


MEP Marlene Mizzi discusses the current state of human trafficking in Europe, evaluates the tools used to tackle the crime and calls for a strong stance to eradicate the hideous crime

here is no doubt that trafficking in human beings is a modern form of slavery that ruthlessly exploits the most vulnerable members of society by tricking or forcing victims into prostitution, forced labour or other forms of exploitation.


a serious form of organised crime that affects women, men, girls and boys generating billions of euros in profits for traffickers. Therefore, it comes as no surprise that human trafficking brings the biggest source of illicit earnings after drug-related crimes.

Trafficking in human beings is a widespread crime and a global phenomenon. It is a severe violation of fundamental human rights and

Human trafficking is unacceptable in every sense of the word and it must be stopped. It is unacceptable that in the 21st century, this


Government Gazette

modern form of slavery still exists and affects millions of people around the world. We must never give up and make sure that we do everything possible to eradicate this hideous crime. Despite constant interest in addressing the problem and keeping it high on the international policy agenda, the extent and severity of human trafficking remains alarming.

human trafficking

Just within the EU alone, several thousands are trafficked every year for various reasons, such as forced labour, prostitution, illegal trade in human organs and illegal adoptions among others.

We know the most vulnerable parts of society often become victims to trafficking. We know the main channels and practices used by the traffickers. We know the reasons and different forms of exploitation.

assess the new trends in trafficking in particular when it comes to migrant, women and children smuggling, and last but not least measure the impacts and results of the current antitrafficking actions.

The very nature of this crime makes it difficult to obtain information on the offenders, the victims, and the traffic flows. Nevertheless, current estimates show that women and girls form the vast majority of human trafficking victims, both in and outside the EU.

We have broad knowledge on the subject, but somehow we still lack the determination to break the circle of impunity. We have the why, but we are missing the how... How are we going to fight and stop this mistreatment, abuse and exploitation?

In addition, the Commission also has to ensure that the current EU Strategy towards the Eradication of Trafficking in Human Beings that expires in 2016 is extended beyond 2020.

Trafficking of women for sexual exploitation has not only sharply increased in recent years, but has become the most commonly identified form of human trafficking.

We are all concerned and we all agree that the issue should be treated with urgency by each and every Member State. But despite our knowledge and our willingness to eradicate this modern plague, the severity of the problem remains a challenge and still many of the criminals walk free as conviction rates in Member States remain low.

According to Eurostat, 80% of the victims are female and 70% of traffickers are male. The data clearly demonstrates that trafficking in persons remains a crime with a strong gender connotation. The gender dimension of trafficking in human beings is a serious issue. Every day, hundreds of women and girls across the world and within the EU lose their lives at the hands of traffickers to become sex slaves. Alarmingly, another worrying trend is the increase in child victims. 27% of all victims detected globally are children. Of every three child victims, two are girls and one is a boy. Children are clearly more vulnerable than adults and easier targets for criminals due to the low risk of detection. Children lack experience and maturity and are more prone to trust others who obviously do not a have their best interest at heart and see them as money making objects. Another vulnerable group, besides women and children, are migrants and refugees fleeing wars or natural disasters. The irregular status of migrants and asylum seekers further aggravates their vulnerability to traffickers. There are many other potentially vulnerable persons, including adolescents, who may become easy targets for exploitation in the sex industry. What do we know about this illegal activity? We know that trafficking in persons is a serious problem with a cross-border dimension affecting all countries in the world and imposing severe harm on the victims. We know that victims are trafficked through countries and between countries using intra- and interregional trafficking routes.

Although much has been achieved at the European level, with the adoption of a comprehensive legal and policy framework guided by the European Union’s Antitrafficking Directive and the EU Strategy towards the Eradication of Trafficking in Human Beings 2012-2016, gaps in implementation, enforcement and coordination of EU and national policies still exist. Trafficking in persons is a complex crime that is constantly changing. Traffickers are constantly adopting and mastering different trafficking methods and routes, creating a complex and evolving web of trafficking flows worldwide. Individual member states are not able to fight cross-border trafficking networks and the right way forward is only through a common European response. Overall, the European Union has the tools to tackle this crime. The widespread ratification of the Anti-trafficking Directive is a success story not only for Europe but globally. The directive is considered to be the global gold standard for protection of victims. The directive is a stepping stone in the right direction, but it has its shortcomings, which sooner or later need to be addressed. Therefore, I call on the EU and its member states to do more. The Commission needs to present, as soon as possible, a report on compliance of the Directive, which must ensure a clear gender perspective in fighting human-trafficking,

Government Gazette

Human trafficking at the European level requires a forceful response and a holistic victim-centred approach based on respect of human rights and protection of victims and focused on preventive measures to combat trafficking and reduce future demand and supply. We need to improve law enforcement and fine tune the criminal justice system to ensure that traffickers are investigated, prosecuted and convicted. We need to ensure a comprehensive legal framework to respond to the constant changes ensuring that the Member States have appropriate measures to counter new practices connected to trafficking, such as cybercrime and the spread use of the digital and social media tools. We need to expand police and judiciary cooperation to help better identify the victims and increase knowledge and awareness about this problem which will help detect and punish criminal activities. Furthermore, we need to give priority to the rights of victims and their specific needs and ensure that a support system is in place to address their traumas. We also need special provisions concerning children that will always take into consideration what is best for the child. Last but not least, we need to collect more and better information on victims, traffickers, and trafficking at the national level in order to facilitate improved analysis at the European and international levels respectively. Furthermore, we need a cross-border intelligence sharing system for the identification of traffickers and to facilitate each member state to come down on these criminals by adopting harsh legislation which would allow the judiciary to deliver sentences fit for such a heinous crime, which goes against basic human rights and dignity


human trafficking

Time to take the gender dimension more seriously Women and girls are inherently more vulnerable to trafficking because they are disproportionally affected by some factors which make them easy prey to traffickers. Liberal


MEP Catherine Bearder sheds light on current perspectives on the gender dimensions of human trafficking and says why the European Commission must take it more seriously


o coincide with the European Commission’s assessment of the implementation of the 2011 AntiTrafficking Directive, I am writing a report which will suggest that the EU must identify gender as one of the main causes of human trafficking and offer solutions to deal with the problem. According to the Eurostat report produced this year, 80% of registered victims of human trafficking between 2010 and 2012 were female. Although this horrible crime affects women, men, girls and boys, the statistics show that the gender dimension of human trafficking is clear and undeniable. Since gender equality is at the heart of the founding treaties of the EU it should also be at the heart of this Directive. Women are inherently more vulnerable due to the structural inequalities between women and men all over the world. For women, the gender based vulnerability can be attributed to barriers of access to education, the gender pay gap, unequal access to decent work opportunities and gender-based violence. A key example of how gender leads to women becoming victims of human trafficking is prostitution. The European Commission’s 2014 report states that 69% of all registered victims of trafficking were trafficked for the purposes of sexual exploitation, and of that number, 95% were women. Although this report is not intended to stigmatise sex workers or debate different models of prostitution, we cannot deny the prevalence of prostitution in human trafficking. Of course human trafficking statistics are not always a perfect representation of the real situation, and there is likely to be a big difference between the number of victims registered and the real figures. I will be proposing that EU countries provide gender specific data in order to better assess the gender


dimension of trafficking. While the focus of my report is on gender, it is very important to ensure that we do not put different types of human trafficking in competition with each other. The legal definition of trafficking in this Directive and in other international law makes no distinction between the different forms of trafficking and qualifies all as serious crimes. Labour exploitation for example is often considered a lesser crime than sexual exploitation, as it more likely to be seen as illegal work and breach of employment regulations rather than a crime. In the UK, the common experience of men who come to complain to the police about abuse at the workplace (such as withheld wages) is that

Government Gazette

they are turned away and sent to a citizens’ advice centre. We must treat labour exploitation as a form of human trafficking and authorities need to deal with it accordingly. We must also consider the scale of abuse and trafficking of children. The 2014 Eurostat report states that 16% of the total number of registered victims of trafficking were under 18, of which 13% were girls and 3% were boys. Children at risk include child victims of war and crisis, so-called orphans of European labour migration, children in care, child victims of family violence and children from marginalised communities. The implementation of this directive must also consider how poverty

gender dimension

and lack of opportunities influence human trafficking. Prevention is an essential plank to the strategy of addressing human trafficking, and we must ensure that EU countries are doing all that they can in order to prevent people from becoming victims as well as dealing with the aftermath of the crime. EU member states have an obligation to set up systems for early detection, identification and assistance to victims.

The EU Anti-trafficking Directive is generally held to be the gold standard in trafficking legislation due to its victim-centred and gender-sensitive an essential approach. Despite

“Prevention is plank to the strategy of addressing human trafficking, but we also need proper and effective services for victims of human trafficking. Victims with special needs (e.g. pregnancy, poor health, disability) should receive additional help.�

this, victims of human trafficking in the EU continue to struggle with access to justice and fair treatment as outlined in the directive. It is hugely important that the Commission and member states take action to recognise and take into account the gender dimension of human trafficking

However, the identification of victims is consistently flagged as an issue in dealing with human trafficking. According to the directive, a person should be provided with assistance and support as soon as there is a reasonable-grounds indication for believing that he or she might have been trafficked and irrespective of his or her willingness to act as a witness. We also need proper and effective services for victims of human trafficking. The Directive itself stresses that victims have the right to certain things and certain types of services. The services for victims should include appropriate and safe accommodation, material assistance, medical treatment, including psychological assistance, counselling and information, and translation and interpretation services where appropriate. Victims with special needs (e.g. pregnancy, poor health, disability) should receive additional help. The nature of trafficking means that victims are unlikely to have the resources to pay for this kind of assistance, therefore this should be free to all victims.

Government Gazette


labour exploitation

Europe needs to promote a climate of zero tolerance Labour exploitation is not an isolated phenomena. Despite its pervasivness, it has received little attention from researchers. The EU Agency for Fundamental Rights has recently investigated labour exploitation, from the perspective of experts in the field and examined areas of law that to date have not been utilised sufficiently.

Michael O’Flaherty, Director, EU Agency for Fundamental Rights

(FRA) explains why Europe has to promote a climate of zero tolerance towards labour exploitation


s the drownings in the Mediterranean continue and new walls – both physical and metaphorical – go up around Europe for the first time since the end of the Cold War, migration is a word set to remain on everybody’s lips in 2016. But migration is far broader an issue than one of border control. In order to meet the challenges we are facing in the EU, we need a more holistic approach to human rights protection that accompanies migrants from arrival through to their full participation in democratic society. Labour exploitation is one such aspect of migration that does not generally receive much attention, either from researchers or policy makers. The EU Agency for Fundamental Rights (FRA) recently investigated severe forms of labour exploitation in the EU, defined as forms of labour exploitation that are criminal under the legislation of the EU Member State where the exploitation occurs. The results are available in the report ‘Severe labour exploitation: workers moving within or into the European Union.’ Although the phenomenon of severe labour exploitation is widespread, it often remains invisible to the public: consumers remain blithely unaware that the wine they drink, the potatoes they eat, the shirts they wear or the services they receive in hotels or restaurants may well be the product of exploitation. One example of this was a case in Greece where 119 migrants from Bangladesh worked on a strawberry farm in inhumane conditions. They had been promised payment of €22 a day, but when the workers asked for their wages, the three supervisors opened fire on them. The owner of the enterprise was acquitted unanimously of charges of serious assault and labour trafficking. As a result, the verdict cannot be appealed by prosecutors. This is just one of the 217 case studies collected by FRA in the course of its research. These studies, alongside in-depth interviews with 616 professionals working in the area, led us to conclude that severe labour exploitation is


an endemic problem that we must take urgent action to end. FRA spoke to a range of professionals including labour inspectors, victim support staff and the police. One in five of them said they came across cases of severe labour exploitation at least twice a week. Such exploitation is particularly rife in several sectors, ranging from agriculture through domestic work and manufacturing to the entertainment industry. We found that the biggest risk factors for becoming a victim of labour exploitation include lack of inspections, targeted monitoring, extreme poverty, racial backgrounds and enforced isolations in which many exploited workers live.

Government Gazette

The situation of exploitation itself often makes it difficult for victims to report their experiences. Very often, forceful migration, a lack of knowledge of workers’ rights and support services and a fear of retaliation against themselves or their families are the main reasons behind reduced reportage of labour exploitation. Why do we need to take action on this? Firstly because it is breaking the law: While certain forms of labour exploitation are covered by EU criminal legislation, Article 5 of the Charter of Fundamental Rights of the EU prohibits slavery and forced labour, and Article

migration & human rights

31 stipulates that all workers have the right to “fair and just” working conditions. Secondly, because labour exploitation not only harms the victims themselves, but also undermines labour standards in a broader sense. Allowing severe labour exploitation to spread across entire swathes of the economy will not only tolerate serious violations of fundamental rights, but in the long run, also have a negative impact on the labour standards of all workers. Last but not least, integration into the labour market and the prospect of fair work for fair pay as well as a real chance of career advancement is crucial if the EU is to incorporate the newly arrived refugees and other migrants into the European society. What action should we take? To begin with, EU member states should ensure that a comprehensive and well-resourced system of inspections of working conditions is in place. Unfortunately, some EU countries have recently gone in the opposite direction and cut resources for labour inspectorates. In addition, labour inspectors and police officers should be trained to deal with cases of severe labour exploitation. Close links should also be established between the police, public prosecutors and monitoring authorities such as labour inspectorates. Wherever possible, we should create specialist police units that have experience in handling trafficking, in order to respond to migrants more effectively. Consumers can and should be assured when goods or services are not products of severe labour exploitation – a “fair work” label, so to speak. This could be complemented by a public register of employers and recruiters convicted of labour exploitation. As one employers’ association representative FRA interviewed said: “By making honest employment practices visible in the market you provide added value … If you want to get at someone you can give them a fine, which helps. But it helps much more if they cannot sell their product any more.” While legislation to protect workers from labour exploitation does exist at national and EU level, implementation often lags behind.

migrants arriving on its soil, the issue of severe labour exploitation continues to grow. Greater efforts must be made to monitor the situation more effectively, sanction perpetrators, and above all, promote a climate of zero tolerance for exploitation

Today, the shocking photos and film footage of people who have escaped Syria, Iraq or Eritrea, are sure to make the migrants ever so vulnerable. Potential exploiters are highly likely to think that those who have successfully reached Europe’s shores should be grateful for surviving and not complain about the conditions they face at work. As the EU and its member states seek appropriate policies to ensure respect for the fundamental rights of the refugees and other

Government Gazette


Government Gazette

climate action

Europe will continue to lead the global clean energy revolution The European Union has played a key role in brokering the historic agreement in Paris, where 195 countries adopted the first-ever universal, legally binding global climate deal. In an exclusive interview with Government Gazette, Jos Delbeke, Director-General, European Commission’s Directorate for Climate Action & Energy explains the European Commission’s priorities in the new agreement


ollowing limited participation in the Kyoto Protocol and the lack of agreement in Copenhagen in 2009, the EU has been building a broad coalition of developed and developing countries in favour of high ambition that shaped the successful outcome of the Paris conference. One of the aims of the agreement is to make financial flows consistent with the global goal towards low greenhouse gas emissions and climate resilient development. Shifting private and public investment towards low-emission and climate resilient technologies over the coming decade will be key to reducing emissions and adapting to climate change. In an exclusive interview with Janani Krishnaswamy, Commissioning Editor, Government Gazette, Director-General Jos Delbeke discusses the next steps of the European Commission in implementing the deal. With regard to the Paris negotiations, can you elaborate on the Commission’s priorities and ambitious objectives in the new agreement, and tell us how different this is from the Kyoto Protocol? The Paris agreement is the world’s first

universal, legally binding climate deal, which makes it a critical turning point in the fight against climate change.

How do you think Europeans can contribute to the change? How can Europe lead the global fight against climate change?

Going to Paris, the European Union wanted an ambitious, transparent and fair agreement that is legally binding and applicable to all parties – and that is what we got. The agreement includes an operational, long-term emissions reduction goal, a review mechanism to strengthen ambition over time, and a common transparency and accountability system to track progress. It also ensures support for vulnerable countries.

Europe has long been at the forefront of international efforts to fight climate change, and we can be proud of the active and constructive role the European Union played to reach a good outcome in Paris.

A key achievement of the Paris conference is that we are moving from “action by few” to “action by all.” The focus is shifting from ideological debates about which countries should bear the burden of fighting climate change towards cooperation and collective efforts. More than 180 countries, representing more than 95% of global emissions, have submitted national climate action plans as their contribution to the agreement. This can be considered major progress compared to what we had before.

Government Gazette

The EU has the most ambitious climate policies in the world. What’s more, we have shown that climate protection and economic growth go hand in hand. Between 1990 and 2014, our emissions fell by 23% while our GDP increased by 46%. We are making good progress, but we know we need to do much more. This is reflected in our target of reducing emissions by at least 40% by 2030 – part of our contribution to the Paris agreement. We have already started to put measures in place to implement this pledge and accelerate the transition to clean energy and a low-carbon economy. For example, we already made a proposal on the revision of the EU emissions trading system for the period after 2020 to ensure it delivers the required greenhouse gas emission reductions to reach


cop21 delegation

our 2030 target. Surveys show that European citizens are on board for climate action. In a recent EU-wide Eurobarometer survey, 91% of them have said they see climate change as a serious problem. People are also taking action in their daily lives: 93% said they had already taken some action against climate change, such as reducing and recycling waste and trying to cut their use of disposable items. The Paris accord claims to accelerate a shift in capital spent on adapting to the effects of climate change. Can you elaborate on some of Europe’s immediate plans? The importance of strengthening the ability of societies in coping with negative impacts of climate change is reflected in the Paris agreement. The EU is the largest contributor of international climate finance and has committed to further scale up support. Financial and technical support for adaptation action comes via a number of different channels, including bilateral government agreements, non-governmental organisations and the private sector, as well as a range of multilateral institutions and funds. The most significant source of public adaptation finance from the EU and its member states to developing countries comes through bilateral assistance programmes. Furthermore, it is important to integrate adaptation to climate change into private and public sector investments in all countries. Adaptation action is also needed in Europe. The European Commission has adopted an EU strategy on adaptation to climate change, and many countries have national strategies.

Adaptation is also tackled at local and regional level in Europe – it is a key part of initiatives such as the Covenant of Mayors, which brings together thousands of local and regional authorities across Europe for climate action and sustainable energy. While representatives from the vast majority of countries party to the agreement walked away satisfied, some of them have criticized the deal as too weak and for not providing enough support for developing countries. What do you have to say about this? Despite any such differences, one of the aims of the Paris agreement is to make financial flows consistent with our goal towards low greenhouse gas emissions and climate resilient development. Shifting private and public investment towards low-emission and climate resilient technologies over the coming decade will be key to reducing emissions and adapting to climate change. Moreover, the Paris deal includes a solidarity package which ensures support for vulnerable countries. Developed countries committed to a goal of mobilising USD 100 billion per year from 2020 to 2025 in the context of meaningful and transparent mitigation actions. The EU is committed to delivering its fair share of this goal. In 2014 alone, the EU and its member states provided EUR 14.5 billion to support climate action in developing countries. Between now and 2020, at least 20% of the EU budget will be spent on climate action. This means that the EU budget alone will provide an average of EUR 2 billion of grants per year to support climate action in developing countries – more than double compared to the average

level in 2012-2013. A new goal for international support will be set before 2025, widening the donor base. This makes clear sense: all those who can participate in the overall effort should do so. This also means unlocking more private finance, which will be key to scaling up investments in climatesmart development across the world. What role will technology play in achieving global climate goals? In Paris, governments agreed to limit global temperature rise to “well below 2°C” and make efforts to limit the rise to 1.5°C. These are ambitious goals. Keeping the rise below 1.5°C will require a trajectory of full decarbonisation and accelerated strategies and pathways to achieve this goal. Research, innovation and investment in low-carbon technologies will be essential to find the ground-breaking solutions needed to tackle this challenge. The International Energy Agency estimates that the implementation of the national climate plans submitted by countries – the intended nationally determined contributions, or INDCs – will mean 13.5 trillion dollars of investment in low-carbon technologies, renewables and energy efficiency over the next 15 years. Crucially much of this replaces investments that might otherwise be made in fossil fuels, while many, especially in energy efficiency, can ultimately pay for themselves.

However, keeping temperature rise below 2°C means going beyond the INDCs, and for this we need to develop and deploy innovative technologies across the global economy, the most obvious example being carbon capture and storage (CCS). The EU is well placed to take a share of these new opportunities. We are among world leaders in areas such as “Adaptation action is also low-carbon industry process needed in Europe. The European technologies and renewable Commission has adopted an EU energy technologies – but we need to keep innovating to strategy on adaptation to climate stay in the lead change, and many countries have

national strategies. Adaptation is also tackled at local and regional level in Europe – it is a key part of initiatives such as the Covenant of Mayors, which brings together thousands of local and regional authorities across Europe for climate action and sustainable energy.”


Government Gazette

climate action

UNEP’s role in Paris was to help countries make a bridge between climate science and policy, identify and analyse options, and gain confidence to move on their climate commitments.

Mark Radka, Head,

Bridging climate science and policy making


ccording to the US National Oceanic and Atmospheric Administration, 2015 was the hottest year on record, but it is also the year in which nations finally agreed on a comprehensive approach to address the growing threat posed by climate change. The Paris agreement is not perfect, but it is a much needed victory for multilateralism and creates a good foundation on which to build progressively stronger action to reduce emission of greenhouse gases and adapt to a changing climate. As some observers have noted, Paris is the “end of the beginning”; attention must now turn to the actions needed to make the Paris promise a reality. Despite the claims of an increasingly isolated fringe, climate science is well established and is getting more robust. The growing evidence of greater climate variability is increasingly shaping public opinion, and most negotiators went to Paris knowing their citizens wanted an agreement. Many governments drew confidence from the growing number of efforts to reduce greenhouse gas emissions already

underway. By the time the COP finished, cities, states and regional governments, the private sector, and other non-state actors had registered almost 11,000 climate change commitments with the UN’s Non-State Actor Zone for Climate Action (NAZCA) database. The importance of this action at the state, city, and individual level is hard to overstate; it is particularly crucial in motivating additional effort to reduce emissions in the roughly four year period before the Paris agreement enters into force. The record-breaking investments into renewable energy and low-carbon technologies worldwide – almost $270 billion in 2014 – are sending powerful signals to governments that technologies to reduce emissions in the energy sector exist and have moved beyond being merely affordable to a point where they are less expensive than fossil fuel alternatives in many locations. In recent years, over half of capacity additions globally have been from renewable sources, driven by falling prices that have made utility-scale solar PV and onshore

Government Gazette

UNEP’s Climate and Technology Branch discusses the organisation’s role in launching the Africa Renewable Energy Initiative (AREI)

wind cost competitive with fossil fuel-based power generation. Over the last five years, the cost of solar PV modules has fallen by about 75% and both wind and solar power increasingly beat fossil fuel options in head-tohead competitions. Decentralised renewable energy hybrid systems are also coming of age and are particularly attractive for rural energisation. Good renewable energy resources in many countries, declining technology and project costs, and the fast speed of renewables deployment make a “renewables rich” energy future both feasible and logical. The bottom-up approach to commitments of Paris worked in favour of an agreement. By the midpoint of the two-week negotiations, 185 countries had submitted so-called Intended Nationally Determined Contributions (INDC), their commitment to take mitigation and adaptation measures that “represent a progression beyond the current undertaking of that Party.” INDCs will now be turned into NDCs, and will be ratcheted upward every five years through a review mechanism. Pledging,


cop21 delegation

reporting, and the review form the heart of the new approach.

up the harnessing of the continent’s huge renewable energy potential.

The INDCs are certainly not sufficient to keep the world below a 2°C rise in temperature, but it is significant that going into the Paris COP almost all countries made commitments to reduce greenhouse gas emissions. Some INDCs are outcome-based – that is they specify actual levels of greenhouse gas reductions – while others are action-based and take the form of commitments to enact policies or undertake projects.

UNEP helped developed the Initiative, which aims to put in place at least 10 GW of new and additional renewable energy generation capacity by 2020 and mobilize the African potential to install at least 300 GW of capacity by 2030. The AREI was not formally part of the deal but with over $10 billion in funding committed at Paris it is indicative of the spirit of finding common agendas that characterized the negotiations, in this case one linking developed countries’ commitment to help poorer countries reduce emissions with African countries’ priority for more – and in this case cleaner – energy.

Many include both mitigation and adaptation components, and more than 100 countries have included adaptation in their INDCs. Fifteen countries included so-called shortlived climate pollutants or made reference to reducing air pollution or other benefits in their INDC submissions, evidence that they are now putting climate actions in a broader sustainable development context. That said, many INDCs are aspirational, and the poorest countries in particular will require help to make them a reality. UNEP’s role in Paris was to help countries make a bridge between climate science and policy, identify and analyse options, and gain confidence to move on their climate commitments. As an example, at COP21, world leaders launched the Africa Renewable Energy Initiative, a transformative, Africaowned and led effort to accelerate and scale-


Half of the African population lacks access to modern energy – rising to nine out of ten people in rural areas – and yet the continent has immense renewable energy resources. Poor infrastructure, insufficient investment, fragmented approaches, weak institutions, a low human skill base have so far kept much of Africa un-electrified. Africa needs more energy, and decisions made today in terms of the mix of fossil or renewable energy will determine its future emissions. African countries have a rare opportunity for technology leapfrogging and moving onto a modern energy path that brings energy independence and reduces their carbon footprint, decoupling growth in electricity

Government Gazette

supply from GHG emissions. The AREI’s goal, then, is to develop efficient, reliable, cost effective, and environmentally friendly energy infrastructure that reduces poverty and drives vigorous sustainable development of the continent. It’s a good example of what the Paris agreement can accomplish going forward. As the countries of the world left le Bourget there was cause for optimism that the Paris agreement will forestall the worst impacts of climate change and preserve our earth for future generations. But it will require much hard work, and each of us will have to do our part to bring about the better future that lies within our grasp Mark Radka heads the UN Environment Programme’s Energy, Climate, and Technology Branch, where he is responsible for managing UNEP’s efforts to link the global energy and environment agendas. UNEP’s work in this area focuses on reducing emission of greenhouse gases through greater use of renewable energy and improved energy efficiency.

Government Gazette


Š Climate Council of Australia Ltd 2015

cop21 delegation

Post-COP21 ... Will we stop our climate from changing? The Paris deal signals progress on a number of fronts, but perhaps, the most significant one is the signal that it sends to investors. MEP Miriam Dalli, Member of EP’s COP21 delegation discusses the urgent priorities of the climate change agreement and says we have to reach a new level of partnership among heads of states, undertake more research to develop newer sources of clean energy and introduce climate change as a topic in primary schools


he United Nations agreement on climate change can truly be considered a historic turning point as it embeds climate action in the heart of the political agreement. More than ever before, this ambitious Paris deal is a clear and much-needed sign that there is still hope and that a better greener world is still an attainable goal. Among progressive European leaders, there was a pronounced sense of urgency and a strong need for a global deal. It is to the merit of such leaders that we are filled with confidence that the escalating climate crisis can be tackled. If nothing else, we owe this to our children and grandchildren so that they may inherit a liveable planet with a cleaner future. The Paris agreement is a real breakthrough. It is the first global deal on climate change, the first time that 195 countries managed to agree on the long-term goal of decarbonisation whilst decoupling their economic growth from fossil


fuels. Moreover this deal goes much further than the world would have expected a couple of years ago. COP21 was successful in that it was an unprecedented political recognition of the risks that climate change brings about. Moreover COP21 managed to unite all countries to take action together. Elements of the climate agreement are legally binding and manage to set the road towards limiting global warming to well below 2°C above the pre-industrial levels and to further work towards 1.5°C. This is a much more ambitious goal than many would have thought. In many procedural ways, too, the Paris climate agreement exceeded what was initially anticipated. There was a huge step towards moving from the previous hard line on differentiation. For the first time ever, it was agreed that all countries in the world must participate in this global effort by resubmitting

Government Gazette

their greenhouse gas emissions reduction plans every five years. The reporting and monitoring system is to be more transparent and comprehensive, meaning that ambitions of the national contributions will be revisited after a stocktaking exercise every five years. The fact that all nations have agreed to make contributions makes the agreement universal in nature. Furthermore, as the rich, more developed countries are invited to help the less developed ones meet their decarbonisation objectives, it can be stated that this is also a fair and ambitious agreement. These points show that the Paris deal signals progress on a number of fronts, but perhaps, the most significant one is the signal that it sends to investors. I hope that this agreement will be the strongest indicator that fossil fuels are a thing of the past and that the future lies in renewables and the technologies that support them. However, the success of this

climate action

global climate agreement depends on what will geographical borders. No nation and no region happen in the near future. What happened in can afford to be inward-looking. Countries’ Paris back in December 2015 must serve as the individual initiatives are virtually ineffective if beginning of a revolution taken in isolation. in policy-making, in There is a strong making investment need to shift the “More needs to be done. The decisions, in the financial environmental hope is that a bottom-up markets and in energy focus away from processes, rather than strict UN technologies. the national to mandates, will drive up the the international We need to undertake and from the level of action in the decades to more research to develop individual to the come. Governments will need to further new sources of collective. clean energy. Innovative structure their power markets, solutions must be As climate and re-plan their growth, but supported so that they change poses an the nature of climate change is can be rolled out on a unprecedented such that new policies need to commercial scale. The threat to the future transcend geographical borders.” world needs new patterns of our planet, of investment and new equity, solidarity sources of finance. We need and responsibility to change our emphasis on are the main what technologies we incentivise by focusing principles that should guide our actions. We on greener and more sustainable technology. have a moral duty towards ourselves, our Providing better and cheaper technology children and grandchildren, to take urgent and a greater flow of climate finance towards action at a global level because ultimately, this developing countries would help individual is our common responsibility. national ambitions for greenhouse gas We have to reach a new level of partnership reduction grow faster. between heads of governments from every More needs to be done. The hope is that a region, working constructively alongside the bottom-up processes, rather than strict UN private sector and civil society to address an mandates, will drive up the level of action in enormous challenge that no one nation or the decades to come. Governments will need indeed region is capable of solving alone. to structure their power markets, and re-plan We have to act together. All of us, both their growth, but the nature of climate change individually and collectively, both at national is such that new policies need to transcend and at international level, today’s and future

Government Gazette

generations together. We need to seriously consider the introduction of climate change as a topic in our primary schools. Our children are agents of change and they are pivotal to start changing attitudes and behaviours. Teaching our children about climate change from a very early age will help us change our citizens’ mentality because the impact our kids have on their parents is simply amazing and many times underrated. Most importantly, we need ambitious policies, a proper roadmap, which can lead to a shift in the mentality of people, organisations and policy-makers. However, this is not an issue for governments alone to deal with. Each and every one of us has the power to start changing things. We can all contribute in concrete ways to address climate change. The Paris climate change summit was one small step for our mankind. Although the nations of the world know that they cannot all of a sudden impose themselves on one another to stop emitting greenhouse gases, because fossil fuels are fundamental to the way some economies work and grow, they also know that they need to find ways and means to work together towards a better future. The Paris agreement offers a range of mechanisms to make this happen; and we, as individuals and communities have to make it work


cop21 delegation

Is the UK Government living up to its Paris rhetoric?

The UK Government is committed to the Paris climate accord, yet last year’s General Election illustrates the difficulties that lie ahead. Will the UK deliver on climate change?


Leveque, Energy & Climate Specialist and Imke Lübbeke, Head of Unit, Climate &

Energy, WWF European Policy Office analyse the energy-efficiency improvements undertaken by the UK Government so far and discuss how it has been moving in “the opposite direction”


he outcome of the UN climate summit in Paris last December surprised many by the ambition of the agreed long term goal: moving global ambition to limiting climate change to ‘well below’ two degrees of warming and keeping in sight the target of 1.5 degrees. However, with no enforceable mechanism to hold countries to account over their emission reduction pledges, the success of the agreement will depend on Governments around the world turning lofty rhetoric into action. Despite playing a constructive role at the talks, the UK Government’s track record since last year’s General Election illustrates the difficulties ahead, as the desire to cut spending has often taken priority over the chronic impacts (and related costs) of climate change. This is particularly apparent in its approach to energy efficiency, which has suffered repeated cut-backs to policy.


Using energy efficiently should be the first step in reducing carbon emissions, and it is often the most economic. Buildings, responsible for around a third of the UK’s carbon emissions, are a particularly pressing priority, as the UK has one of the least efficient building stocks in Europe. As a result, and despite having some of the lowest consumer energy prices in Europe, the UK suffers some of the highest rates of fuel poverty, ranking 13th in a recent assessment of fuel poverty in 16 major EU economies. Improving the energy efficiency of buildings, for example through improved insulation to roofs and walls, has been a priority of successive Governments, with good results: a combination of regulations and incentives achieved a 25% reduction in domestic energy use between 2004 and 2011. Yet the Committee on Climate Change, the official adviser to Government on climate targets, has advised that the UK’s homes and buildings must continue to be

Government Gazette

significantly improved to meet both near and long term climate targets. As well as providing low cost emissions reductions and tackling fuel poverty, energy efficiency will reduce the estimated £1.3 billion spent every year by the NHS on illnesses caused by cold homes, and can boost economic productivity by freeing capital and energy system capacity for more productive uses. Unfortunately the number of energy efficiency improvements delivered to UK households fell by approximately 80% over the course of the last Parliament, reflecting successive cuts to support from Government. Little of the remaining support has survived the first ten months of this Government: several hundred million pounds of annual funding was cut in the Spending Review, followed by the cancellation of a building code for new-build homes, the Zero Carbon Homes standard. The Energy Company Obligation scheme,

© WWF Infographic summary: The Economics of Climate Change Policy in the UK

climate action

one of two flagship policies, has recently been extended by five years, but its annual budget has been reduced to £650 million, down from £1.3 billion in 2012. The other flagship policy, the Green Deal, a finance mechanism intended to stimulate uptake across all households, was cancelled after disappointing uptake caused by poor policy design and high interest rates, which failed to interest consumers. As a result, activity to improve the UK’s homes is now well below levels recommended by the Committee on Climate Change to meet the UK’s carbon targets. Although the Conservatives are likely to meet their election pledge to insulate one million homes over this Parliament, advice from the Committee suggests that approximately five million homes will need to be insulated over the same period to ensure that the UK’s climate targets are met cost effectively, at the minimum level of ambition required to avoid the worst economic impacts of climate change. This puts delivery of future carbon budgets at risk. Government estimates suggest that emissions will exceed the fourth carbon budget period (covering 2023 to 2027) by around 10%; this gap will increase as new homes continue to be built at today’s inadequate efficiency standards, and improvements to existing buildings continue to slow.

The UK needs a long-term programme that recognises the need to decarbonise its buildings by 2050. This could be achieved with an annual investment of around £4 billion per year, for the next twenty years. The value for money of such expenditure should be compared to the £15 billion that UK households spend every year on gas for heating, and the £100 billion of infrastructure projects to be invested in by Government over the course of this Parliament, before the manifest economic benefits of such investment are even counted.

which will now look into what higher energy efficiency targets for the EU would mean, as it plans revisions to directives on the subject later this year. Indeed EU Climate Action & Energy Commissioner Miguel Arias Cañete has publicly voiced his support for greater ambition, aware that a low, 27% target could undermine the environmental integrity of European climate ambition as a whole. With support from Member States in the European Council, the Commission and Parliament may succeed in increasing this ambition.

This programme would provide similar value for money to the HS2 rail link and new roads, reducing gas imports in 2030 by 26% and creating an additional 100,000 jobs. Government has a key role in making this happen, by using its powers to address the market failures that hold back investment in efficiency.

The UK Government has been moving in the opposite direction, although there is still time to arrest the decline in efficiency policy. It is currently exploring options to replace one of the flagship policies, the Green Deal. Doing this effectively will ensure that the UK is not left behind as the rest of Europe wakes up to the economic, energy security and climate benefits of energy efficiency.

This UK slowdown also runs contrary to activity at EU level. While the current EU proposal is for an unambitious and nonbinding 27% efficiency target by 2030, the European Parliament has repeatedly voted in support of a 40% target, which would bring Europe in line with the international climate deal reached in Paris in December. The European Parliament’s stance has resonated within the walls of the European Commission,

Government Gazette


climate change & water

Amplifying the voice of water in COP21 climate talks

Hydro-climate disasters account for nearly 95% of all people affected by disasters, and have caused over 60% of all damage incurred worldwide by such disasters.

Torgny Holmgren, Executive Director, Stocholm

International Water Institute (SIWI), says there are significant commercial opportunities both in the mitigation and adaptation to climate change, especially when viewed through a water lens


ate last year, I travelled to Paris for COP-21, the climate change conference – where one of the world’s most inclusive agreements (195 countries) providing a framework for the global response to climate change, was signed.

incurred worldwide by such disasters (UNISDR 2012).

My colleagues and I were in Paris to raise awareness among actors at all levels about the centrality of water to climate change adaptation and mitigation. An increase in global temperatures of 2 degrees or more will dramatically impact the hydrological cycle leading to the increased melt-off of glaciers, decreased permafrost, more intense rainfall, floods, droughts, and changing water quantity and quality.

Things have changed since COP-15 in 2009. Unlike the process leading up to the Copenhagen Accord, business, cities and civil society are no longer waiting for direction from national governments. While the Paris Agreement helps to provide the necessary level playing field upon which progress can be made, these actors are now taking the lead towards becoming carbon-neutral.

Hydro-climate disasters already account for nearly 95% of all people affected by disasters, and have caused over 60% of all damage


In Paris, I observed two things: Actors beyond national governments are not just engaged, they are leading the way

A major part of this shift is consumer-driven There are significant commercial opportunities both in the mitigation and adaptation to climate change, especially when viewed through

Government Gazette

a water lens. The Paris Agreement sets the global direction for (1) emission targets to keep the temperature increase below 2 degrees and (2) resilience building by 2030, including adaptation to climate change impacts. Many efforts to reduce greenhouse gas emissions will depend on reliable access to water resources, and the expansion of renewable energy will also, to a large extent, depend on access to water at all levels. Even without the increased risk imposed by climate change, global water demand is expected to increase by some 55% by 2050 (OECD). This is largely due to additional water requirements for manufacturing and electricity generation due to the growing world population and increased income levels in many countries.


Huge investments in infrastructure for water provision and treatment will be required to accommodate this growth. However, since freshwater resources are finite, we will need to be better at managing what we have – and all parts of society, including business, will need to contribute. The financial markets are key for change to take place A great deal of finance will be needed for both supplying water and treating waste water.

with the Climate Bonds Initiative to label water standards for green bonds. In fact, the World Economic Forum’s 2015 Global Risk Report stated that of all the risks facing the globe in the next ten years, water crises would have the most damaging impact on countries and industries. Water scarcity and variability pose significant risks to all economic activity, and in many cases, water stress actually implies a considerable financial risk. Looking forward: local-level implementation

Beyond international financial mechanisms like the recently established Green Climate Fund, consideration should be given to how existing investment funds can be redirected towards more green (blue) investments. According to the World Economic Forum, some USD 5 trillion per year needs to be invested in global infrastructure over the next two decades to support the growing population. Redirection towards green investments would change the game dramatically.

To achieve the targets set out in the Paris agreement, climate change adaptation and mitigation strategies will need to be implemented at the local level. In this process, water should be viewed as a connector - not a sector - joining policy areas, economic sectors, ecosystems, and societies. Its importance to both climate adaptation and mitigation cannot be underestimated. It is also a key channel through which opportunities for cooperation can grow.

A good example is the significant increase in the use of green bonds in recent years, with some USD 36 billion worth being issued in 2014, and some USD 100 billion in the next few years (CBI, 2015). SIWI is currently working

Government leaders and policy makers can use water to drive local level engagement by illustrating the impact climate change can have at the local level. This is especially true for already vulnerable communities that face an

increased risk of floods and coastal inundation. It was encouraging to see water being discussed more intensely among business, civil society, and governments in Paris, than at earlier climate change conferences - especially by the COP 20-22 presidencies of Peru, France, and Morocco. However in order for the Paris Agreement to really leave its mark, local level decision-makers, such as mayors, CEOs and civil society leaders around the world are most crucial and will need to take even more action. The implementation strategies outlined in the Intended Nationally Determined Contributions (INDCs) will serve as a good starting point for this to happen. As a truly local resource, water can help to engage a broad range of actors, connecting the global agreement to the local level actions needed to tackle the impacts of climate change that we will all face. Torgny Holmgren is the Executive Director of SIWI. He is a former Ambassador at the Swedish Ministry for Foreign Affairs heading the Department for Development Policy. He is an economist from the Stockholm School of Economics, having served at the World Bank in Washington DC, and the Swedish Embassy in Nairobi

The effects of climate change are not always environmental Climate change is the ‘threat multiplier’ that is linked to other global challenges and injustices. Though it may not be the root cause of migration, “it affects people in a very disproportionate manner.” Magda

Stoczkiewicz, Director, Friends of the Earth Europe looks at climate change from an environmental justice angle


he scale of the climate challenge facing humanity cannot be underestimated. Large areas of our world are already experiencing man-made climate change. It can be seen in the form of rising sea levels, crop failures, wild fires, extreme weather events, and increasingly severe floods and droughts.

But it would be a gross oversimplification to think that the effects of climate change are only environmental. The difficult truth is that the effects of climate change are highly complex and go far beyond the natural world. Climate change is inextricably linked to other global challenges and injustices. With this understanding, Friends of the Earth

Government Gazette

International together with a coalition of other non-government organisations established the Bali Principles of Climate Justice in 2002. These define climate change from a human rights and environmental justice perspective. Their starting point is that the effects of climate change are felt – and will increasingly be felt in the future – unequally by people around the world. Some countries bear the overwhelming


climate justice

rich industrialised polluters. It allows them to avoid being held accountable for the climate crisis they have caused. It allows them to ignore climate justice. The soaring rhetoric we heard from political world leaders in Paris is not matched by the details of the deal. The overall agreement has nothing in the way of fair, equity and sciencebased binding targets for developed countries, only countries’ self-determined piecemeal pledges to ‘pursue efforts’ to keep global warming below 1.5 degrees. Combined with this, the provision of finance and technology from rich to poor countries for an energy shift is weak. Without the required financial flow, emissions reductions targets are nothing more than empty words and the burden for achieving them falls unfairly on the poor.

historical responsibility for having caused the climate crisis but, perversely, it is other parts of the world which will disproportionately have to deal with its impacts. Industrialised nations – predominantly the United States and Europe – have historically emitted about 80% of greenhouse gases globally, while it is developing nations from the Global South which face the direst consequences, affecting their lives, dignity, and basic human rights. On average, 27 million people are displaced by climate and weather-related disasters each year – more than the entire population of Australia, according to the Environmental Justice Foundation. The United Nations Refugee Agency predicts that up to 250 million people will be displaced by 2050 as a result of extreme weather conditions, dwindling water reserves, degradation of agricultural land, and conflicts over resources. Though climate change may not be the root cause of migration, it is likely to exacerbate other conflicts and crises which push people to flee their homes. Climate change is known as a ‘threat multiplier’. Places with ethnic, religious, political and other divides coincide with the regions that will be first and worst affected by climate change. Without more urgent, drastic action to tackle the climate crisis more people from these places on the frontline of climate change impacts will undeniably seek to move in search of safety and a better life. Climate change affects people disproportionately within countries as well.


Everywhere, including here in Europe, marginalised

“Viewed from an environmental justice perspective, it is only possible to judge the Paris Agreement on climate change, adopted by nearly 200 countries in December 2015, as a failure”

communities bear the brunt of its impacts. Climate change contributes to food insecurity and food price rises which affect more people in low-income communities. In Europe we are witnessing an increase in fuel poverty with more and more families unable to adequately heat their homes. Studies have shown that black communities around the globe are more affected by pollution and extractive industries than white people. For example, although African-Americans have a smaller carbon footprint on average, they are more vulnerable to the effects of climate change. So climate change is also a racial justice issue. Further, climate change isn’t gender neutral, with women more exposed to its impacts. Women are on the forefront of climate change all around the world. Women make up most of the world’s poor and are more likely to be climate refugees. They are often the last to leave disaster affected areas, and are more likely to die when natural disasters hit. Viewed from this justice perspective, it is only possible to judge the Paris Agreement on climate change, adopted by nearly 200 countries in December 2015, as a failure. The Paris agreement is in fact a great escape by

Government Gazette

The Paris Agreement recognises more funding is needed for frontline communities to adapt to climate change but does not include any solid steps or figures to help make this happen, and importantly no urgency. There is no compensation mechanism for irreparable damage so the most vulnerable countries will be left alone to pick up the pieces. Because of the way climate change is linked to and deepens existing social inequalities, it cannot be tackled in isolation. Emissions reduction targets cannot suffice unless they are matched with a fair distribution of the effort to achieve them, and much greater solidarity for those vulnerable to the impacts of climate change. We stand with those who are least responsible for causing climate change, who will suffer most and whose voices are most overlooked in the negotiating halls, and in 2016 people around the world will be fighting more than ever against the interconnected causes and effects of climate change and injustice

climate change

Understanding and adapting to climate change in Europe

The Paris climate deal constitutes a promising step towards building a climate-resilient world. However, an effective approach to climate change requires “a wider perspective with the integration of climate change into different public policies around sustainability.” Paul McAleavey, Head of Air & Climate Change Programme, European Environment Agency, says adaptation policies can reduce the impacts and damage costs of climate change, and prepare societies to thrive and develop in a changed climate


limate change is already impacting our health, natural environment and economy. Even with substantial and immediate reductions in greenhouse gas emissions, the emissions already released into the atmosphere are expected to continue changing our climate. Their impacts will be felt across the world in the form of more frequent and severe extreme weather events as well as gradual changes in the climate — such as rising sea levels and warming oceans.

2050, heatwaves are projected to cause 120 000 excess deaths per year in the European Union, and to have an economic cost of EUR 150 billion if no further measures are taken. This higher estimate is not only due to more frequent and higher temperatures, but also due to Europe’s changing demographics.

In many parts of Europe, increased intensity and frequency of rainfall will result in frequent and serious flooding events, destroying homes and affecting other infrastructure such as transport and energy in areas at risk. Elsewhere in Europe, in southern Europe in particular, higher temperatures and reduced rainfall will increase the risk of drought, intensifying the competition between agriculture, industry and households for scarce water resources.

Climate change will also affect ecosystems across Europe. Many economic sectors depend on healthy and stable ecosystems to provide a variety of products and services to humans. Changes to the balance of species and habitats in ecosystems could have wide-reaching effects. A reduction in rainfall in southern Europe could make it impossible to grow certain crops, while higher temperatures might allow alien invasive species and species that carry diseases to migrate northwards. Warmer oceans are already forcing various fish species to move northward, which in turn puts further pressure on the fisheries sector.

Climate change could also exacerbate heatrelated health problems across Europe, and especially in southern Europe and the Mediterranean. According to World Health Organisation estimates, the heatwave of 2003 caused 70 000 excess deaths in 12 European countries, mostly among older people. By

Most of the damage from extreme weather events in recent decades cannot be attributed to climate change alone. Socio-economic developments and decisions such as expanding cities towards floodplains, are the main causes of the increased damage. But without adaptation actions, damage costs and other

Government Gazette

adverse effects are projected to increase as our climate continues to change. The costs of future climate change are potentially very large. Recent research estimates that without adaptation actions, heat-related deaths could reach about 200 000 per year in Europe by 2100, and the cost of river flood damages could be more than EUR 10 billion a year. In the case of extensive climate change and no adaptation actions, forest fires could affect an area of roughly 800 000 hectares every year. The number of people affected by droughts could also increase by a factor of seven to about 150 million per year, and economic losses due to sea-level rise would more than triple to EUR 42 billion a year. Whatever the projected impacts are, European countries need to adapt their rural landscape, cities, and economy to a changing climate and reduce our vulnerability to climate change. A European Union-level adaptation strategy is already in place to help countries plan their adaptation activities, and more than 20 European countries have adopted national adaptation strategies. Adaptation policies can reduce the impacts and damage costs of climate change, and prepare


environmental justice

societies to thrive and develop in a changed climate. Some adaptation measures involve using natural methods to increase an area’s resilience to climate change, such as restoring sand-dunes to prevent erosion or planting trees on river banks to reduce flooding. Other adaptation measures consist of using laws, taxes, financial incentives and information campaigns to enhance resilience to climate change. Extreme weather events in particular show that not adapting is a very costly decision and is not a viable option in the medium and long term.

The latest projections by EU Member States, included in the European Environment Agency’s report ‘Trends and projections in Europe 2015’, show that the European Union is heading for a 24% reduction in greenhouse gas emissions by 2020 with current measures in place, and a 25% reduction with additional measures already being planned in Member States. However, the EEA analysis also shows that new policies need to be put in place to meet the target of a 40% reduction by 2030. An effective approach to climate change requires a longer-term and wider perspective with the integration of climate change into different public policies around sustainability. This raises questions about how to build cities, how to transport people and products, how to supply energy to homes and factories, how to produce food, and how to manage the natural environment. The challenge is to make sure

that all current and future investments put us one step closer to greening the economy and do not lock us into an unsustainable path of development. It is clear that an effective combination of adaptation and mitigation measures are needed to ensure that impacts of climate change are limited, and that when they occur, Europe is better prepared and more resilient. The climate deal agreed in Paris in December constitutes a promising step towards building a low-carbon and climate-resilient world. A key component of this agreement is the transition towards clean energy, which calls for investments to be channelled away from polluting fossil fuels towards clean energy sources, worldwide and also in Europe. Making the right investments today can reduce the overall costs of climate change

© European Environment Agency

The severity of climate change will depend on how much and how quickly we can cut greenhouse-gas emissions released into the atmosphere. The scientific community strongly recommends limiting the rise in global average temperatures and reducing greenhouse-gas emissions to avoid adverse impacts of climate change. Within the United Nations Framework Convention on Climate Change, the international community has agreed to limit

the global average temperature increase to 2°C above pre-industrial times and to drive efforts to limit this to 1.5°C.


Government Gazette

climate change

A Europe-Africa marriage in Paris? The EU-Africa rapprochement culminated in the creation of a “high-ambition coalition” during COP21. Before the end of negotiations, this coalition had been joined by the US, Canada, Japan and Brazil, among several others. Hanne Knaepen, Policy Officer on Climate Change, European Centre for Development Policy, discusses how EU-Africa relations could add value to the international climate policy process two years earlier.


isagreements between Europe and Africa on how to tackle climate change have delayed progress at global climate conferences. The difference in their positions predominantly owed to the principles of equity and fairness. Europe’s economy could blossom for decades thanks to gravely polluting industries, causing temperatures to increase in Africa, animals to die, crops to perish and people to flee their worn-out lands. Africa, on the contrary, could only but adapt to these adverse climate impacts. Europe would work mostly on mitigating its own emissions. The Kyoto Protocol, signed in 1997, was based on this divide. By now, developing countries, including some African ones, have climbed the socioeconomic ladder. Some emit more than European countries. Global dynamics have changed. And, responses from politicians, companies and civil society have changed alike. The Paris Agreement, signed by nearly 200 countries at the closure of COP21, is evidence of new forms of global climate action with all countries agreeing to progressively increase the ambition to decarbonise and build climate resilience. First signs towards an engagement In 2011, in Durban (COP17), an AfricaEurope coalition broke some of the deadlocks that plagued the COP. Both probably understood that joining hands would lead to more success instead of replicating the antagonistic positions taken in Copenhagen,

In April 2014, during the 4th EU-Africa Summit, the EU and the African Union expressed their willingness to fight climate change together. Since then, diplomatic efforts, numerous travels and inter-ministerial meetings led to an even closer alignment. They did however not agree on all fronts: while Africa lobbied in favour of adaptation at the previous climate conferences, Europe maintained that adaptation measures in countries’ intended post-2020 climate actions (the Intended Nationally Determined Contributions, INDCs) should be a voluntary choice. A wedding with many guests The EU-Africa rapprochement culminated in the creation of a high-ambition coalition during COP21 to marry disagreements and agreements. The EU teamed up with 79 African, Caribbean and Pacific countries in calling for an ambitious deal and agreed on the core elements of the envisioned Paris deal. Before the end of negotiations, this coalition had been joined by the US, Canada, Japan and Brazil, among others. This informal coalition put the necessary pressure on China and India. The success in Paris is partly thanks to multilateral diplomacy. Building up a solid relationship Ultimately, the Paris Agreement aims to hold the increase in the global average temperature to well below 2 degrees above pre-industrial levels and to pursue efforts to limit it to 1.5 degrees. The heart of the Agreement is the ambitious mechanism by which progress towards meeting the 2 degrees limit is reviewed every 5 years. This creates a global “political moment” where countries can be encouraged to do more. As the key advocate

Government Gazette

of this mechanism, the EU must ensure this dynamic logic is reflected in its own legislative framework implementing its 2030 targets. Agriculture has been high on the African climate agenda. This is because it constitutes almost 40 percent of Africa’s GDP and about 80 percent of Africans rely on it. Shocks to its production could have damaging effects. Although the Paris Agreement does not mention “agriculture”, it opens the door to food security. It also places adaptation (which is especially relevant in the agricultural sector), resilience and response to climate impacts at the heart of the new regime. Insurance will be provided to 400 million people in vulnerable countries by 2020. This will address the many problems of environmental refugees. Can Europe-Africa relations add value to international climate policy processes? Certainly, they can jointly contribute to the effective implementation of the Paris Agreement. Intensive work is needed. Once the honeymoon period wears off, the climate agreement will need what all solid marriages need: commitment, dedication and keeping one’s promises. There are a number of promising initiatives, setting the pathway towards a carbon neutral world by 2050. During COP21, the Africa Renewable Energy Initiative was launched to help Africa leapfrog into lowcarbon development. The EU and separate EU countries signed a declaration to ensure Sustainable Energy for All in Africa with African partners. The EU and Africa can also cooperate towards the elaboration of adaptation techniques, design indicators to measure the level of adaptation, and to find out whether adaptation methods contribute to the reduction of greenhouse gases. The two blocs can also intensify their advocacy efforts to ensure that ‘agriculture’ can take an even more prominent place during the COP22 discussions in Marrakesh at the end of this year


climate change adaptation

Can national governments keep up with the change in the world? By Anna Leidreiter, Policy Officer, Climate and Energy, World Future Council renewables is completely different. It starts in the fundamental way our energy system is structured. The current fossil fuel based energy system is characterized by complex centralized infrastructures where a) the fuel is transported to the power plant, and b) energy production and distribution is controlled by some entities. The supply chain is vertical, and the benefits are shared only among a few stakeholders. In the necessary transformation towards 100% renewable energy, this is changing.


he UN Climate Conference in Paris was a test to see whether national politicians could keep up with the change we are seeing in the real world. While nations brokered the climate deal, mayors from around the world have already shown in recent years what’s working in the fight against climate change. In fact, especially the growing global movement for 100% renewable energy (RE) proves that climate action is not only a moral obligation but socially and economically the most beneficial path. The City of Frankfurt is one example that shows how local economies can be strengthened by transitioning to 100% RE. By 2050, the City will produce 100% of its energy consumption with local and regional renewable sources. Hereby, the City brings down its current energy import costs of €2 billion a year to zero. Thanks to its public local utility which drives this transition, the city of Frankfurt not only benefits from these savings but also generates additional income in the form of revenues and tax incomes. By prioritizing energy production from within the city and from the surrounding region – while still being connected to the larger national grid – the money will stay in the region. Energy efficiency measures have saved Frankfurt €100 million in energy costs, a number that is projected to rise. Finally, the city has reduced emissions by 15% since


1990, while its economy grew by 50% for its approximately 715.000 inhabitants. Looking at North America, one city that leads this movement is Vancouver. Widely recognized as the most livable city in the world, its environmental footprint is currently three times larger than it can sustain. Mayor Robertson and his team are committed to changing this by putting the city on track to meet all its energy needs via 100% renewable sources as part of a grand plan to make Vancouver the greenest city in the world. By 2050, Vancouver will obtain 100% of the energy it uses from renewable sources and emit 80% fewer GHGs than in 2007. But it is not only the climate and environment that motivates the government to take this action: The city of Vancouver is a great example on how climate and environmental protection on the one hand and economic growth on the other hand can complement each other. A study by Brand Finance estimates that Vancouver’s brand is valued at $31 billion due to its reputation as a “green, clean and sustainable” city. Additionally, by steering the city towards 100% renewable energy and focusing on local sustainability, the City has helped create more than 3,000 new local green jobs in only 5 years. In fact, both cities prove that converting our energy system is about more than replacing fossil resources with sun and wind as new sources. The business model for

Government Gazette

As Tony Seba puts it, renewable energy will flip the architecture of energy and bring abundant, cheap and participatory energy to everyone. The technologies are based on a decentralized way of energy production and consumption, embody a horizontal supply chain, and require innovation in infrastructure and energy markets. New stakeholders, including citizens, farmers and small businesses, are entering the system; claim ownership rights, and have direct impacts on the implementation. New ownership models are required and are being developed as different stakeholders become directly involved in the transformation. A pioneer of this movement is Denmark. The country is well on its way to achieving its 100% renewable energy target for electricity, heat and transport by 2050 thanks to the success of the co-operative enterprise model that places people, local communities and regions firmly in the driver’s seat. Over 100 wind turbine cooperatives have a combined ownership of threequarters of the country’s turbines and hereby drive local development in rural communities. One example is Hvide Sande – “White Sand” – on the west coast of Denmark. The three turbines at the Hvide Sande harbour were set up in December 2011. As per Danish law, 80% of the turbines is owned by a local business fund from the Holmsland Klit Tourist Association which initiated and financed the project. Hvide Sande’s North Harbour Turbine Society I/S pays an annual rent of €644,000 to the local harbour. The other 20% is owned by local residents living within a 4.5 km radius, again according to guidelines set out by the Danish Renewable Energy Act. This wind co-operative has 400 local stakeholders, and with an annual return of 9 to 11% the turbines are expected to pay for themselves in 7 to 10 years. The fund is used to initiate new business initiatives for the benefit of the harbor and local municipality. While many energy experts and governments see citizen participation and the involvement of

climate & security

communities as a necessity to ensure acceptance and avoid nimbyism, the benefits go much beyond this. In fact, adopting a people-centered approach and empowering citizens, farmers and small businesses to invest in renewable energy projects, is a tool for socio-economic development and wealth distribution. Last September, a German study revealed that some 5.4 billion € were generated in Germany in 2012 through renewable energy projects that were partially or fully owned by local investors – including citizens. Local private investments created a total of about 100,000 jobs that year in both the construction sector and operation.

Hold leaders to account, for urgent implementation of Paris Agreement

So, have national politicians actually passed the test in Paris? Can they keep up with the change we are seeing in the real world? Looking at the final agreement, one could say: Indeed, the Paris Agreement marks a fundamental paradigm shift as for the first time, 195 countries have agreed to keep the earth hospitable for human beings. However, it lacks any clear figures or measures on phasing out greenhouse gas emissions but still tries to manage them. This is well reflected by the fact that parties could only agree upon the goal of “achieving a balance between anthropogenic emissions by sources and removals by sinks of greenhouse gases”. It is an illusion to think that we can continue with “business-as-usual” and burn fossil fuels and emit carbon, as long as the emissions are off-set by sequestration through negative emissions technologies (like nuclear energy and carbon capture and storage), afforestation (planting trees), or geoengineering techniques of ocean fertilization. Likewise, it is an illusion to think that simply fueling the same system with different resources will lead us to more equal wealth distribution, social well-being, or keep the planet habitable for future generations. With the international community starting to implement the Paris Agreement as well as the new Post-2015 Development Agenda with the Sustainable Development Goals, there is the urgent need for standards and indicators that allow measuring and assessing policies and implementation. For this, we must learn from pioneers of the global 100% RE movement as they are the most shining example on how to mitigate climate change and boost socioeconomic development. Therefore, members of the Global 100% RE campaign have initiated a consultation process to develop guidelines that support policy makers on how to reach a sustainable 100% RE vision

The security impacts of climate change show how the consequences might slip beyond our control and understanding. It therefore becomes vital for civil society groups to hold national leaders to account to urgently implement the agreements made during the historic Paris climate change accord. Major General A N M Muniruzzaman, (Retd.), Chairman, Global Military Advisory Council on Climate Change discusses both the physical impacts of climate change and their repercussions for national and international security


he whole world must hold leaders to account, to urgently implement the agreements made during the Paris accord on climate change, to head off a civilisational threat, which transcends borders and governments. In December last year, countries agreed to address the problem of climate change for the long term, rather than a stop-gap measure, to eliminate greenhouse gas emissions in the second half of this century. We must celebrate their effort. However, the security impacts of climate change show how the consequences of climate change can slip beyond our control and understanding, by spilling across borders, creating new consequences which wildly run out of control. It is vital, therefore, that civil society groups including my own, the Global Military Advisory Council on Climate Change, hold governments fast to their targets, and explain the consequences of failure.

Government Gazette

Climate change has both direct impacts and indirect consequences, which together present a new challenge for which we have no training. Direct climate impacts include more frequent extreme weather, from the poles to the tropics, from the coasts to the small island states, like Tuvalu, to the ceiling of the world, in Nepal. No country is too big or small, or isolated from the problem. To illustrate, in recent times, we have seen costly floods, especially devastating and deadly in India, but also in Britain. While climate change may reserve its worst pain for developing countries, it will impact everybody. And that global, systemic risk becomes clearer when we consider the indirect effects. Where people are unsafe, they will seek shelter, and move, as the tramp of troubled peoples across Europe this year shows. It is not speculation to implicate climate change in the Syrian civil war, and a subsequent mass


climate & security

migration across Europe. Syria experienced its worst recorded drought from 2006 to 2011, in turn displacing farmers from scorched fields to over-crowded cities, stirring unemployment and unrest, and ultimately civil war. A recent study showed how a long-term drying trend in the eastern Mediterranean, caused by climate change, had made the Syrian drought twice as likely. Neither is it speculation to draw a further link to the rise of ISIS. We know that marginalised people, in this case uprooted by extreme drought, are a recruitment opportunity for extremist and terrorist groups. We have seen how these groups reach the victims of natural disasters first, before the state, first responding to, then exploiting their plight. We have seen the impacts: regional conflict, and mass migration. There are now almost 3 million Syrian migrants in Turkey, or 4% of the population, while a further million are making their way to or are already in Europe. Such migration is not only a problem of human security, but threatens the stability of bordering countries, including Turkey, Lebanon and Jordan, which are becoming overwhelmed. Similar examples abound, where local, climaterelated disasters have unravelled on a global scale. Scholars calculate that the Russian heat wave of 2010 was made more acute by climate change. By destroying the nation’s wheat


harvest, it triggered an export ban and higher global food prices, which in turn saw street protests on the other side of the globe, and provided a catalyst for the Arab Spring. By inflicting social and economic shocks, climate change can also spawn disease, especially in weakened, fragile states, where problems so easily escalate. Water shortages may illustrate best how climate change threatens our most basic needs. At present, we are at risk of water-related conflicts in 50 countries on five continents, according to the Global Policy Forum. Scientists tell us that the number of city dwellers facing water shortages will grow to almost 1 billion by 2050, from 150 million today, partly as a result of climate change. And then there is sea level rise. One metre of sea level rise would submerge about a fifth of the territory of my home country, Bangladesh. The government last week declared that some 40 million people were threatened, risking climate migration on a biblical scale. These examples show how the impacts of climate change are non-linear, a complex web of consequences and new consequences. It is myopic, therefore, for a country to think that the problem does not affect them, because they are not a victim, directly. Climate change calls for a deeper understanding, a wider vision

Government Gazette

of leadership which understands the wider nature of the problem. These are problems not just for leaders, but for all our civilisation. Military leaders increasingly get it. In its latest global strategic outlook to 2045, Britain’s Ministry of Defence warned that some 60 million people would move from desertified areas of sub-Saharan Africa to northern Africa and Europe, by 2020, a figure that it said would thereafter increase. The military will see an evolving, humanitarian role, and must work with the wider security community to respond to climate impacts, and be prepared. The Global Military Advisory Council on Climate Change (GMACC) has called on leaders for urgent action to implement the Paris agreement, to save the earth from catastrophic consequences. Politicians are struggling to join the dots on climate change, given these new, unchartered demands. All people, including experts, activists and individuals must therefore hold them to account, to ensure that they take the next step, to implementation, and the Paris agreement turns from process to success

climate & jobs

Zero carbon, zero poverty Climate change impacts working people first. Leading the worker’s fight on climate change, Sharan Burrow, General Secretary, International Trade Union Confederation talks about why we should act now to secure a stable climate with development and inclusive growth


he year 2015 marked a turning point in global ambitions. The UN Sustainable Development Goals were born from the recognition that a model of development relying on the trickle down theory of benefit from corporate growth had not only failed but also set the world on a course of greater inequality, historic unemployment, escalating conflict and mass migration. And the Paris agreement on climate was born of necessity to end our dependency on fossil fuels if we are to mitigate the social and economic ravishes of climate change. Together these decisions can chart a course for a world where zero carbon, zero poverty is realised but it requires planning and investment on a global scale not seen before. There are no jobs on a dead planet. This is much more than a slogan for us. We are already witnessing the loss of lives and livelihoods. Climate impacts hit working people first and with extreme weather events, changing seasons and rising sea levels whole communities stand on the frontlines. In order to stabilise the climate, we need to make profound changes to energy systems – and therefore to all economic sectors. This means workers are again on the frontlines in both vulnerable industries and with their families in vulnerable communities. However, they are also on the frontline of opportunity with the possibilities for investment and jobs. The challenge of industrial transformation is an opportunity for unions to demand dialogue, to organise, to bargain for and to lead the changes to work and skills acquisition that will be required. It is also an opportunity to ensure our pension funds work for sustainability on our terms. We know there are jobs, millions of jobs. With infrastructure investment projected to be US

$50 trillion by 2030 and $90 trillion by 2050, we certainly know this means more jobs. There are more jobs in construction, manufacturing, transport and services as we green every industry and build those mega cities. There are more jobs in sustainable agriculture and forest and land restoration. Our own research shows us there are jobs in existing industries. A 2012 study by the Millennium Institute for the International Trade Union Confederation (ITUC) showed that if just 12 countries invested 2% of GDP each year for five years in existing industries this would generate around 48 million jobs. The ILO has similarly found that policies facilitating climate transition are employment generators. Combining economic growth with environmental improvement can lead to net gains of up to 60 million jobs. Energy is critical to the transformation so energy workers are at the centre of the transition. In renewable energy the U.S. solar industry is creating jobs twenty times faster than the overall economy while the world’s largest renewable energy job market is in China, with 3.4 million working in the industry. And in Germany, 370,000 people are employed in renewable energy, the largest number in Europe. Germany is one of the few countries with a comprehensive nationwide energy plan.

Government Gazette

All nations and all sectors must plan for the future. And the urgency to go further, ensure a circular economy to live within planetary boundaries will spawn new technologies, businesses and jobs. For unions our members are involved in every aspect of this challenge - from activists campaigning for action on climate to workers in new industries to workers in fossil fuel production. We know that our sons and daughters may work in energy in the future but they probably won’t work in fossil fuels. Yet, we demand that the workers who have brought us the prosperity of today have to be given their due respect and that the transition be a just and equitable one. Workers and unions want to see the dialogue that will ensure that there are plans at national, industry and enterprise level for transition. Workers and their unions both demand and accept responsibility for the dialogue necessary to develop and implement just transition plans. Success needs governments to show leadership when setting ambitious climate goals but it also requires all of us – businesses, workers and their unions, civil society and communities to support change. The transition requires dialogue and understanding of different needs at all levels. It requires an integrated approach to both climate action and the UN Sustainable Development Goals for inclusive


climate & jobs

development, with investment consistent with these objectives.

• guarantee social protection and human rights;

It was heartening to see massive support for the call to dialogue for just transition evident at the Paris Climate Summit, with representatives of 1,000 businesses and 500,000 civil society activists signing up with the ITUC to a Joint Declaration.

• invest in community renewal to gain the hope and trust of regions and townships at the forefront of the energy transition, industrial transformation or climate impacts;

The consensus is that a just transition will: • invest in decent work opportunities in sectors which reduce emissions and help communities adapt to climate change; • respect the contribution that workers in fossilfuel industries have made to today’s prosperity and provide them with income support, retraining and redeployment opportunities, as well as secure pensions for older workers;

• support innovation and technology sharing to enable a rapid transformation of energy and manufacturing companies along with all other economic sectors and the involvement of workers and communities in the sectoral plans for transforming megacities;

their unions for workplace change, resource productivity and skills development with the monitoring of agreements which are public and legally enforceable. This is the most significant challenge the world will face in the next 30 years, but we must start now. We can lose the battle on climate change with horrendous consequences for all working people and their communities, or we can act now to secure a stable climate with development and inclusive growth

• formalise jobs associated with rescue, restoring communities and building resilience to climate disasters; • be based on social dialogue with all relevant parties, collective bargaining with workers and

The Paris Accord: From agreement to implementation The COP21 has brought us the much-needed global commitment to tackle climate change. It’s now time to deliver on these commitments.

Gabriela Ramos, Special

Counsellor to the Secretary General, Chief of Staff and Sherpa, OECD, discusses everything from agreement to implementation


he Paris Agreement at COP21 marks a decisive turning point in our response to climate change. Under the guidance of its President, Minister Fabius, the COP21 upheld a transparent and inclusive process for all Parties, resulting in 195 countries agreeing to strive for an ambitious temperature goal “well below” 2°C, with efforts to limit the global temperature increase to 1.5°C.


The successful outcome of the Paris Agreement would not have been possible without all the preparatory groundwork carried out by the French and Peruvian Presidencies, by the UNFCCC and other key stakeholders. The momentum was reinforced by strong support from Heads of State early in the COP, and boosted by society as well as the enthusiasm of business leaders to move ahead with marketbased actions, such as putting a price on carbon, accelerating the phasing out of fossil

Government Gazette

fuel subsidies, and ramping up investment in clean energy. The Paris Agreement includes several milestones for when and how this is to be achieved and each country must spell out a credible roadmap for action. The agreed support to be provided by developed countries will be paramount; while a framework to track progress for all countries, but “with built-in flexibility that takes into account Parties’ different capacities”

climate finance

will help enhance transparency. Nationally Determined Contributions (NDCs) to 2025 or 2030 will be formalised with the ratification of a 5-year review cycle and facilitative dialogue in 2018. This will be a key mechanism for attempting to make bottom-up NDCs consistent with the longterm goal, while support will need to be provided to developing country Parties for implementation. All Parties are meant to report regularly on emissions and progress toward NDCs, adaptation actions, and on means of implementation, for example, finance, technology, and capacity building. The OECD worked on several fronts leading up to and at the COP to support the negotiations and provide targeted assistance to the COP Presidencies of France and Peru. We put a great effort to prepare an up-to-date estimate of climate finance in the context of the commitment by developed countries to mobilise 100bn US Dollars per year by 2020. In 2015, the OECD report on climate finance, in a difficult field was referred by many as a defining contribution in the climate effort. It was presented to Sherpas and Finance Ministers in Lima and I personally travelled to Bonne to discuss it with participants in the climate discussions. In addition, the G20 Climate finance Study Group mandated the OECD in 2015, to work on both an adaptation toolkit, in order to help policy makers in DC navigate and seize opportunities for accessing finance for adaptation; as well as on an inventory of existing climate funds. This work has helped to increase transparency on methodological and data issues involved in making such estimates. Counting climate finance remains a contentious area, but it is vitally important to achieving our goals. In addition, following on from the work on “Climate change mitigation: policies and progress”, the OECD’s data and policy analysis is well-placed to underpin implementation efforts. While agreements may make the headlines, it is effective implementation that makes the difference. Strong and coherent domestic policy is essential

to drive the changes we need. Building further on our work conducted in 2015 on “Aligning Policies for a Low-Carbon Economy,” the OECD can support cost-effective action and policy alignment to implement countries’ own emissions reduction commitments and adaptation actions. We strongly encourage countries to conduct their own diagnosis of policy misalignments and strike the balance between multiple policy objectives. This can help to pave the way for governments to envision a more coherent way in their policydesign by involving multiple portfolios such as the SDGs. The world can keep growing and emit less CO2, while at the same time enjoying cleaner air, better cities and reduce the risks to the natural systems on whose services we all depend. The recent OECD report on “The Economic Consequences of Climate Change” projected that with no further action the combined effect of selected impacts on global annual GDP are projected to rise over time to likely levels of 1.0% to 3.3% by 2060. These levels are expected to reach up to 6% in Africa, South Asia, South East Asia. (1) Looking ahead, we need to try our best to craft new approaches to meeting the complex, crosscutting challenges facing the world economy. The OECD’s New Approaches to Economic Challenges (NAEC) initiative – launched in 2012, and that I am proud to oversee– has spurred us to take a closer look at the green growth-productivity growth axis, a process which started under the OECD’s Green Growth Strategy in 2011. NAEC has played an important part in expanding traditional growth models by focussing on different non-income dimensions (including environment) and distributional implications. We have extended our current capabilities to assess the binding nature of environmental policies and the potential burdens that such policies might impose. In the years ahead, measurement and quantification will remain critical for tracking progress towards economic growth that is less energy and materials-intensive.

mobilising private investment in renewable energy. G20 countries host 80% of existing renewable power capacity around the world. The IEA estimates that annual renewable energy investment would need to increase from USD 270 billion in 2014 to around USD 400 billion in 2030 to peak global energy-related emissions by 2020. (2) Recent OECD work presented at COP21 focuses on green investment banks and green bonds, which have the potential to provide low cost, long-term sources of debt capital needed by infrastructure projects. For example, the issuances of green bonds trebled in 2014 to around USD 37 billion and grew further in 2015. (3) Ultimately, we must invest in reducing emissions and adapt to the climate change that is already locked-in. Even a world that is 2°C warmer will require costly adaptation, and there will be some residual effects that we will have to cope with. The Paris Agreement brought us the muchneeded global commitment to tackle climate change. We now need to deliver on these commitments. Experience has shown us that for developed and developing nations alike, the uncertainty of climate risks can wreak havoc – with the most vulnerable often being on the frontlines. Let’s ensure that policies are proactively geared towards a low-carbon and climate-resilient world References: 1. OECD, The Economic Consequences of Climate Change, 2015 2. IEA, Energy and Climate Change, World Energy Outlook Special Report, 2015 3. IEA, 2015, World Energy Outlook Special Report: Energy and Climate Change, OECD/IEA Publishing, Paris

Governments have a central role to play in

Government Gazette


climate & jobs

Why climate financing matters to real people Although most of the focus at COP21 was on the emission reductions required to achieve the global targets, the real issue on the table was climate finance.

Erik Solheim, Chair, OECD Development

Assistance Committee discusses why equitable financing has been at the forefront of all international climate negotiations


magine your country being hit by a hurricane, and the damages are so big that your government has to spend every dollar on repairing the damages the next two years. No money is left for schools, hospitals or roads. This has already happened to the small island state Grenada in the Caribbean. Perhaps, this could happen to other poor countries in the future. While rich countries are mainly responsible for the climate changes, the poorest countries and the small developing island states are those who will suffer the most from the changes.

understanding of the common threat we are all facing. And contrary to the popular belief, the least developed countries and the small islands developing states do not simply seek free finance from the developed world. They also recognise the importance of taking firm climate action themselves as well as engaging private capital. We need to support these initiatives through both policies and aid money.

A few years ago, Grenada experienced two hurricanes that wiped out 200 percent of their gross domestic product and destroyed nine out of ten dwellings. This compares to the US, where even the worst hurricanes result in damage amounting to only a most limited part of their national budget.

In this context, it is thus important to say that a lot of good things are already happening. And we need to look at the success stories which now are being told from all over the world and be inspired by them:

The rich countries have a responsibility to share the cost of the climate changes and support countries to adapt and mitigate to these changes. I am both happy and proud that the climate agreement in Paris last December closed with an ambitious agreement that will put us on track to cut emissions in order to maintain global temperatures below two degrees. And with the ambition to reach lower than 1.5 degrees. The agreement also included the goal of achieving 100 billion dollars by 2020 to finance climate changes in countries which are highly dependable on aid money, having difficulties with attracting private capital and acute economic vulnerability to shocks. These countries also often face challenges in mobilising finance effectively, and some have high debt levels. At the same time, it is important to emphasise that this is not framed in terms of poor countries asking for money from rich yet again, but in terms of partnership. There is an


A main concern is to support adaption. The recent OECD report on climate finance recognises that finance for adaption is a small proportion of the overall climate finance flows. Most poor people depend on agriculture for their livelihoods. And this makes them extremely reliant on environmental conditions, and therefore vulnerable to climate change. Stepping up efforts in the food security, nutrition and agricultural sector has thus become imperative. An example of good work on this is how farmers in Ethiopia now can insure their crops. Increased climate variability has led to more uncertainty from year-to-year for many, putting their crops and livelihood in jeopardy. Now Oxfam has made insurance possible, and thus the farmers can receive payments for crops being harmed by the weather. Another great concern is how countries can have best access to both finance and technology. Experience shows that some countries have difficulty accessing resources from these funds to adapt to climate changes due to the complexity of the procedures. So

Government Gazette

another important issue is to facilitate and ease the access for the countries which need this finance and technology. Rwanda is one country which has received money from one of these funds, The Green Climate Fund. 30 innovative projects for both private and public institutions in climate resilience have been approved. For instance, 30 million trees were planted last year. When I attended the Paris climate convention, I met representatives from the government of Rwanda who told me how they now prepare for above normal rain using technology. To cope with and minimise effects of disasters due to climate change, Rwanda is using SMS sending automatic messages to people and different rescue stakeholders in early disaster warning. This will be extremely useful for the people of Rwanda during this year’s El Nino weather phenomenon, which the US National Aeronautics and Space Administration (NASA) has warned could be the strongest ever. And experiences from Rwanda might be useful in other countries as well. El Niùo is responsible for flooding across big parts of the world. In East Africa, Somalia is expected to displace at least 900,000 people due to flooding and drought in Ethiopia might leave eight million people in need of food aid. There are also many good ongoing initiatives by people in the private sector. One example is on energy, where a collection of billionaires, including Bill Gates, Mark Zuckerberg and Jeff Bezos have launched a new global initiative, the Breakthrough Energy Coalition. They aim at accelerating private sector investment in clean energy. Last year’s investment flows

climate finance

to renewables such as solar and wind raked a record of $329.3 billion. This resulted in 121 gigawatts added, more than ever before, according to new data by Bloomberg New Energy Finance. Back to Grenada and other small Islands Developing States, their experiences show how hurricanes tend to contribute to the vulnerability. Climate change is a serious threat even though they have a low contribution to global greenhouse gas emissions. Due to their size and location, small islands are especially susceptible. As developing economies, they are relying on various sectors that are vulnerable to the climate, like tourism, agriculture and fishing. They will also be detrimentally affected by a continued rise in sea levels, changes in rainfall and temperatures, and increasing weather changes and natural disasters. In sum, more and better climate-related development finance is needed for the most vulnerable developing states. The need of the moment, of course is more development assistance to countries in need and better utilisation of such assistance to help transform these economies.

Š World Resources Institute

All development needs to be sustainable, and this is not possible without tackling climate change. We must work in partnership to bring about robust and lasting action to protect the most vulnerable from climate change

Government Gazette


climate & migration

Climate change and migration – reflections from the Paris summit Though it is important that migration was mentioned at the Paris Summit,

Dr Giovanni Bettini, Lecturer in

Global Climate Politics and International Development says relying on the UN’s climate policy to solve migration means “hoping for a silver bullet that does not exist”


he question of how climate change will influence human migration has become a source of growing concern - not surprisingly, considering the centrality that global warming has gained in international politics and the frequency with which mobility is in the spotlight (most often a negative light) of media and policy debates. Indeed, even the best-case scenario following the new climate agreement (signed last December in Paris) will still lead to rising sea levels, harsher droughts and more destructive storms – all of which will hit those with least protection the hardest, and add to existing factors of political instability. So, is the current “refugee crisis” only an anticipation of what will happen when climate change kicks in? Are we going to see waves of “climate refugees” pushing on Europe’s gates and jeopardise our security? One would think so, at least judging from the way the media talks about the issue. Time after time, the figure of ‘climate refugees’ is mobilised to provide dangerous global warming with a human face. Usually, to highlight the security implications of climate change. Recently, this narrative has surfaced in relation to the Syrian tragedy and the way that the conflict and the related displacements have been attributed to climate change by research papers – and even Prince Charles. Such alarmism might be appealing to media outlets, and the spectre of an invasion by the victims of climate change resonates with the “moral panic” that, as sociologist Zygmunt Bauman recently pointed out, surrounds migration in these turbulent times. But these alarmist framings are at odds with most of the research on how climate change will interact with migration.


Against alarmism The figures of hundreds of millions of so called climate refugees have been widely echoed in the media but the headline numbers are at the least controversial if not outright scientifically unsound. The entire concept of “climate refugees” is evocative but misleading. Let’s begin with the obvious: people migrate for lots of different reasons and, in most cases, it is impossible to single out environmental degradation. When people do move in response to a sudden storm or flooding, they usually stay in the same region and return home as soon as they can. A growing number of interventions point out that migration, in presence of the right conditions, can also represent a proactive strategy to cope with stress or adapt to change. Finally, there’s no simple link between climate change, displacement and security. Environmental stress can exacerbate tensions, but also increase cooperation. And we should not conflate things playing out at different scales: the idea that food stress (and the poor) causes war is very problematic – a quarrel over a loaf of bread is not the same as an armed conflict between states. None of this means the issue is unimportant. Climate change will have the biggest impact on the weakest and most exposed – whether they are migrants or those without the means to move. Indeed, (im)mobility will be one of the currencies through which vulnerable people will pay the price of the international community’s failure to avoid climate change. How does climate policy deal with migration? The Paris agreement establishes a “task force” to “develop recommendations” on displacement. Some hoped for stronger wording – an earlier

Government Gazette

draft included the creation of a “coordination facility”, presumably with more powers. This was only removed in the last days of the summit. Yet in order to keep the issue on the table, a mention in the treaty is a step in the right direction. However, I am not sure we can expect too much from the UN’s climate process. An emissions deal was clearly the highest priority for this phase of diplomacy. With a “refugee crisis” shaking European institutions and the reaction to the terror attacks in Paris adding to the international tension over migration, the topic was just too controversial. In this context, it wasn’t exactly realistic to expect states in Paris to accept any legally-binding obligations to facilitate the movement of vulnerable people. But, on top of the question of political feasibility, it is also worth asking whether UN climate policy should even be addressing migration at all. Migration isn’t a problem to be solved The idea we should “solve” climate migration is rooted in a view of mobility as pathological as the result of a failure to develop, to adapt to climate change, or to be more resilient. But in reality, contrarily to the anxiety and fears that currently surround it, migration is an ordinary social, economic, and political process. Of course, it would be naive to overlook the divisive questions that migration brings to the surface. And we should always remember that people on the move (or stuck somewhere they don’t want to be) are often exposed to many wrongs and suffering. But relying on the UN’s climate policy to sort these matters out means hoping for a silver bullet that does not exist – it is an illusory shortcut that obfuscates the inherently political

climate management

character of migration and will lead to poor policies. To make a provocative comparison: would we ever expect the UNFCCC (or any single policy) to “solve poverty”? Yes, it is important that migration was mentioned in the Paris agreement, and we should talk more about the links between climate change and mobility. But more as a matter of climate justice than one of security. And not as a contingent problem to be solved (or that can be solved) – rather as one of the ways in which we deal with the highly political question of the kind of mobility and society we want for the decades to come An earlier version of this article appeared in The Conversation.

Refugee and migrant health tops agenda at WHO Europe Following the changing paths of migration routes, the Public Health Aspects of Migration in Europe (PHAME) project of the World Health Organisation has evolved.

Dr Santino Severoni and Sara Barragan Montes from WHO discuss

how best the project addresses the major health challenges, needs and priorities of migrants


arge-scale migration is a global phenomenon that has occurred throughout the history of mankind. History shows that large-scale population movements may arise rapidly and continue for lengthy periods of time. Today, four years after the start of the Civil War in the Syrian Arab Republic, European Member States are facing the undeniable need to manage a situation that hasn’t caught anyone by surprise. The number of refugees and migrants arriving to European shores and borders has been increasing since 2011. In 2015, however, this number has more than doubled, reaching over 1.000.000 arrivals by sea so far. (1) Conscious of the potential implications that

war, instability and extreme poverty in Middle Eastern and African countries may have for European Member States, the WHO Regional Office for Europe established in 2012 the project ‘Public Health Aspects of Migration in Europe’ (PHAME) with the financial support of the Ministry of Health of Italy. During the past three years, the project has provided continuous support to Ministries of Health, through health-system assessments, provision of on-site technical assistance and policy advice. Following the changing paths of migration routes, these activities focused first on southern European countries across the Mediterranean and later expanded to the South Eastern part of the Region. Furthermore, WHO established a

Government Gazette

field presence in Gaziantep, Turkey, in October 2013, and has worked closely with the Ministry of Health and its partners since then to scale up the capacity and respond to the health needs of the almost 2 million refugees living in the country. (2) On 31 August 2015, a WHO interdivisional Migration and Health Task Force was formed at the Regional Office for Europe to respond quickly and efficiently to the increase of arrivals and requests for assistance. As a result, our efforts are focusing on the preparation of additional health-system assessment missions, the delivery of medical supplies, the provision of training on refugee and migrant health for health and non-health professionals, and the


public health & migration

development of information products to defuse misconceptions linked to public health and migration. 90% of the refugees and migrants arriving by Sea to the European Region come from the Syrian Arab Republic, Afghanistan, Eritrea, Iraq, Nigeria, Pakistan, Somalia, Sudan, Gambia and Bangladesh. (3)

around appropriate target interventions. Appropriate immunisation programmes for refugees, asylum seekers and other migrants should be ensured. Systems should be set in place for these and other relevant health data and records to be available as appropriate, as an individual moves around.

They comprise a heterogeneous group with diverse health needs, risks and beliefs linked to their cultural background as well as the conditions in their home country, during the journey, in transit and destination countries. Some have been exposed to violence, including gender-based violence, sexual violence and forced prostitution. Other requirements are linked to sexual reproductive health and rights, mother and child health, diabetes, cardiovascular diseases, mental health, emergency care and protection against vaccinepreventable diseases.

Large-scale migration is a recurrent phenomenon in the European Region with short-, medium- and long-term direct and indirect health implications, ranging from emergency health care to the role of the health sector in ensuring adequate integration into receiving societies. The public health interventions and policies put in place in all these stages must be supported by robust scientific research.

European health systems must respond to the wide diversity of needs and WHO stands by their side to assist in the provision of adequate care for all. The provision of adequate care, ensuring universal health coverage and leaving no one behind are central tenets in connection with the influx of refugees, asylum seekers and other migrants arriving in the WHO European Region. Migrants, asylum seekers and refugees do not pose an additional health security threat to the host communities. However, adequate capacity is essential to address communicable diseases and all other hazards, to ensure effective health protection in transit and destination countries. Epidemiological surveillance capacities need to be strengthened to include migrant-sensitive data, particularly in health districts with greater presence of refugees and migrants, and should be able to identify the most vulnerable. Systems that collect data in respect of migrant health also need to be reinforced so that outcomes and access issues may inform further planning


To promote and strengthen the evidence available on migrant and refugee health for public health decision-making, the WHO European Advisory Committee on Health Research (EACHR) was formed in July 2014 a Sub-group on Migration and Health. Three Health Evidence Network (HEN) reports were commissioned, each focusing on a particular population group: refugees and asylum seekers; labour migrants; and undocumented migrants. They address the following policy question: which policies and interventions work to improve health care access and delivery for each population group? These reports have been recently published and are available in the WHO/Europe website. (4) Other relevant topics identified for policy formation, and for which additional HEN reports are being prepared, include migrant and refugee mental health and maternal health. At the WHO Regional Committee for Europe held in September 2015 in Vilnius, Lithuania, senior government officials of the 53 European Member States supported the role of the Regional Office in this refugee and migrant crisis, and called for continued involvement and

Government Gazette

assistance. Given the urgency of the situation, a High-level Meeting on Migration and Health was held on 23-24 November 2015, which was hosted by the Ministry of Health of Italy. The aim of this meeting was to agree on a common public health understanding to large-scale migration in the Region, identifying priority areas in which the future work of the Regional Office for Europe will focus. We commit to ensure that this approach – and the activities that will follow in the areas of research, policy formulation and technical assistance – reflects our belief that each and every person on the move must be granted full access to a hospital environment, to prevention and, when needed, to high-quality care, without discrimination on the basis of gender, age, religion, nationality or race. We have a precious opportunity to respond to this crisis with humanity and solidarity; an opportunity we cannot afford missing to translate the modern values and principles of our health policy framework, Health 2020, into action References: 1. Europe’s Refugee Emergency Response Update #3 17-24 September 2015 [website]. The Office of the United Nations High Commissioner for Refugees: http://data.unhcr. org/mediterranean/regional.php 2. 2015 UNHCR country operations profile – Turkey [website]. The Office of the United Nations High Commissioner for Refugees: 3. Refugees/Migrants Emergency Response – Mediterranean [website]. The Office of the United Nations High Commissioner for Refugees: regional.php

climate & migration

© Refugees International: Powerful flood waters toppled this home in Kalay Township, Sagaing Region, Myanmar

Climate displacement: The next wave?

Experts anticipate that the vast majority of displacement stemming from climate change effects will be internal, leaving the most climate-vulnerable countries with the burden of responding to displacement due to the actions of the developed ones. Alice Thomas, Climate Displacement - Program Manager, Refugees International says we may be overwhelmed by the next wave of displacement and migration “far sooner than we think”


s record numbers of people continue to flee war and persecution, there is growing public concern regarding whether the world is ready to protect millions more who will be uprooted by more extreme weather, sea level rise, and other effects brought on by climate change. This includes not only forced displacement from major floods, storms, and other disasters that already displace tens of millions of people each year (1), but also increased migration resulting from growing food insecurity and loss of livelihoods. Low-lying islands and other coastal populations are particularly vulnerable to inundation and sea level rise, as are indigenous populations whose lives and cultures are closely tied to land and natural resources. Tragically, this is already happening to Native Alaskan communities who, due to increased storm surge, permafrost melt, and loss of arctic sea ice, are already being forced to retreat inland. (2) Unfortunately, the international refugee and

migration regimes offer little in the way of solutions. While often referred to as “climate refugees,” those uprooted by climate change do not fall neatly within the 1951 Refugee Convention, which affords international protection to those fleeing their countries due to a “well-founded fear of persecution … for reasons of race, religion, nationality, membership of a particular social group or political opinion.” (3) Meanwhile, proposals to revise the Refugee Convention, or for a new international convention, to protect those displaced by climate change have fallen flat. In a world that is failing miserably to protect the 60 million people fleeing conflict, the reluctance among governments to grant asylum to potentially millions of vulnerable people who may be displaced by global warming is hardly surprising. But it is definitely disappointing given the fact that in most cases neither they nor their governments will have contributed

Government Gazette

much in the way of greenhouse gas emissions. Lack of political will aside, many complex questions remain regarding the link between climate change and human mobility that the current refugee and migration regimes are ill-suited to address. Chief among them is the issue of causation – in other words, the reason a person is forced to flee and in need of protection. In the case of sudden-onset events like typhoons and floods, not all of these hazards can be attributed to climate change as opposed to naturally-occurring weather events (despite recent progress in climate attribution science (4), for example, assertions that climate change played a role in unprecedented flooding in the UK. (5)) In addition, evidence shows that man-made factors such as deforestation, land degradation, and lack of coastal protection serve to compound the extent of damage and drive up the numbers of people who are rendered


climate & migration

below” 2°C which, if achieved, would go a long way toward allowing people to remain where they are. The Agreement also commits developing and fast developing countries to ramp up financial assistance to help the most climate-vulnerable countries adapt to climate change. Going forward, climate finance must be put toward measures specifically aimed at minimizing displacement. But that is not all. The Paris outcome goes further by calling for the establishment of a “task force” to develop recommendations for integrated approaches to “avert, minimize and address displacement related to the adverse effects of climate change.” (8) Its establishment represents a new forum under the UNFCCC for building consensus on how to address the issue and recognizes displacement as a form of loss and damage to affected countries and communities that requires redress.

Alice Thomas, Climate Displacement Program Manager, Refugees International

homeless by these disasters. In the case of more slowly unfolding, climate change-related phenomena like recurrent drought, erratic rainfall, and increased temperatures that undermine traditional livelihoods, it remains difficult to determine the extent to which other socio-economic factors contributed to the decision to move and how to distinguish “climate migration” from ordinary, economic migration. Moreover, experts anticipate that the vast majority of displacement stemming from climate change effects will be internal, meaning that neither the international refugee nor migration regimes would apply. This means leaving the most climate-vulnerable countries themselves – most of which are poor and underdeveloped to begin with – with the burden of responding to displacement due to the actions of richer, more developed countries. The good news is that important groundwork was laid in 2015 that promises to move us closer to international consensus on how to address the issue. In October, 109 governments endorsed an “Agenda for the Protection of Cross-Border Displaced Persons in the Context of Disasters and Climate Change.” (6) The Protection Agenda is the culmination of a two-year consultative process with governments known as the Nansen Initiative led by the Swiss and Norwegian governments. As the title indicates, the Nansen Initiative Protection Agenda applies to those displaced “in the context of disasters and climate change” thereby taking a more holistic approach to the complex causation questions. Moreover, rather than proposing a new global arrangement, the Protection Agenda proposes that solutions be pursued on a regional level and build upon a broad set of existing displacement, migration, and refugee policies and practices that have


been employed by governments to protect people in such crises (e.g., humanitarian visas, temporary protection status) which can serve as a “tool box” for countries to build upon. The regional approach is likely to prove more effective since how climate change acts to drive population movement, and how certain countries and their neighbors decide to address the issue, is likely to vary from region to region. For example, in the case of small-island nations who want to do everything possible to keep their populations and territory, the Agenda specifies that the relocation of communities be pursued only as a last resort. Where adaptation is no longer sufficient to protect people in place, and planned movement of populations becomes necessary, the Agenda calls for “migration with dignity” to avoid the particular risks that migration presents such as discrimination, exploitation, and trafficking. Moreover, although the Nansen Initiative was initially aimed at protecting those already on the move, the Protection Agenda goes further to identify priority action areas to prevent displacement. These include scaling up investments in reducing disaster risk and building resilience of vulnerable populations to climate stress. In doing so, the Protection Agenda takes a proactive approach often absent from refugee and migration laws and policies while linking climate-related displacement to the broader disaster risk reduction, resilience, and climate change adaptation agendas from which it, to date, has been largely absent. A second breakthrough came in Paris in December when 195 governments signed an historic agreement to combat climate change as part of the UN Framework Convention on Climate Change (UNFCCC) (7). The agreement has been lauded for putting the world on a path to keep temperatures “well

Government Gazette

Neither the Nansen Protection Agenda nor the new task force under the UNFCCC is a silver bullet, however. Left unanswered are important questions regarding how to ensure that migration or relocation programs are sufficiently funded, whether countries have an obligation to assist and protect those displaced by climate change, and whether those whose homelands are rendered uninhabitable will be remunerated for their losses. But with scientific evidence mounting that the world is warming and sea levels rising far more quickly than previously anticipated (9), finding solutions must be prioritized. We may be overwhelmed by the next wave of displacement and migration far sooner than we think References: 1. IDMC (2015). Global Estimates 2015: People Displaced by Disasters. Available at: assets/library/Media/201507-globalEstimates-2015/20150713global-estimates-2015-en-v1.pdf [Accessed 13 January 2016]. 2. Bronen, R (2013). Climate-Induced Displacement of Alaska Native Communities. Available at: research/papers/2013/01/30-arctic-alaska-bronen [Accessed 13 January 2016]. 3. United Nations Human Rights (1951). Convention relating to the Status of Refugees. Available at: ProfessionalInterest/Pages/StatusOfRefugees.aspx [Accessed 13 January 2016]. 4. Earth System Research Laboratory (2015). Interpreting Climate Conditions: Why Attribution? Available at: http://www. [Accessed 13 January 2016]. 5. Cookston, C (2016), “Climate Change Strongly Linked to UK Flooding”, Financial Times 8 January. Available at: http:// html#axzz3x95BThO4 [Accessed 13 January 2016]. 6. The Nansen Initiative (2015). Global Consultation Report. Available at: [Accessed 13 January 2016]. 7. UNFCC (2015). The Paris Agreement. Available at: http:// [Accessed 13 January 2016]. 8. UNFCC (2015). The Paris Agreement. Available at: http:// paragraph 50[Accessed 13 January 2016]. 9. Hansen, J. et al (2015). Ice melt, sea level rise and superstorms: evidence from paleoclimate data, climate modeling, and modern observations that 2 C global warming is highly dangerous. Available at: http://www.atmos-chem-phys-discuss. net/15/20059/2015/acpd-15-20059-2015.pdf [Accessed 13 January 2016].

Bladder Cancer Europe 2016

Tuesday, 21st June 2016 Brussels, Belgium

A high-level meeting bringing together key healthcare policy makers and stakeholders to reach an EU-wide consensus for improved diagnostic accuracy, effective management and care in Bladder Cancer.

Topics include

* The need for a comprehensive EU-wide Bladder Cancer policy * Raising EU-wide awareness: education, research and policy * Screening: Issues, opportunities and challenges * The need for innovative approaches and future technologies * Treatment costs: Bringing it down without compromising quality

Get involved in the discussion and have your say

Government Gazette

© UNHCR: Amina’s hands—she fled the conflict in Nigeria by running to Niger.

migration & development

‘No forced migrant left behind’ The mounting migration crisis in Europe cannot be resolved by short-term solutions. To tackle this urgent humanitarian priority, we need a four-pronged approach with an emphasis on resilience building and sustainable development. Magdy Martinez-Soliman, Assistant Secretary-General, United Nations and Assistant Administrator, United Nations Development Programme presents solutions that address the root causes of the problem


he images of lifeless three-yearold Syrian boy, Aylan Kurdi, who drowned tragically with eleven others while attempting the sea crossing from Turkey to the Greek island of Kos, have become the symbol of today’s human tragedy: a mix of war, despair, flight, death and a call on the rich world’s conscience. We watch as Syrian refugees trail across our TV screens, walking miles in the wintry cold through Eastern European countries to reach Germany. We read about the large numbers of minors from Central America trying to make it to the United States to live a better life with their parents. And we read – a lot lesser - about the ethnic Royingya people, who leave Myanmar to seek safe haven in Thailand, Indonesia, and Malaysia. Migration is today a combined humanitarian and a development priority. Around the world, people are on the move, looking for safer and better environments in which to live, find work and gain employment. This is not a short-term crisis, but a long-term


trend. The journey is risky, and puts forced migrants in harm’s way. Hence there is a need for a humanitarian response, to save lives; and a human rights approach, to protect them from abuse and uphold their rights. The number of people fleeing war and conflict is at a historically high level. Sixty million individuals are displaced; 95% within their respective region of origin. Beyond those forced to move, many people also cross international borders for economic reasons, to join their families or to study. Today, 232 million people are international migrants. (1) Ad hoc and short-term solutions to cope with refugees and migrants are no longer viable – or at least, they will not solve the problem. Only resilience-building and sustainable development will tackle the root causes. This approach depends on four key points: Bridging humanitarian assistance and development

Government Gazette

When dealing with refugees and migrants, there is an understandable tendency to focus international efforts on emergency humanitarian assistance. However, the majority of the events we are witnessing today are not short-term crises that can be resolved tomorrow. On average, a refugee or an internally displaced person spends more than 17 years in displacement. For this reason, it is essential to establish early recovery mechanisms that promote humanitarian assistance as part of an over-arching long-term development strategy from the outset. This means that, in the event of crisis such as in Syria, peace-building and relief efforts must bridge development interventions from the start. An integrated and robust international response to displacement, bringing together humanitarian and development actors, is the only way forward. The international response must empower refugees and migrants by helping them access economic, labor, and human rights so that they can contribute positively to their host country, or country of origin upon their return.

migration & development

Addressing the root causes of migration and displacement While helping refugees, migrants, displaced persons and the communities that host them, we must also ask what prompts large-scale migration and address the root causes and drivers. It is important to recognize that migration is not an evil that needs to be limited—human mobility is a positive driver of sustainable development. However, people are often forced to leave their homes and search for safer, better places for themselves and their children. Migration should be a choice, not a necessity, and the international community must address the most pressing drivers of migration and displacement. Four key root causes that drive the increased levels of migration and displacement are: i) insufficient development gains; ii) protracted conflicts and violent extremism; iii) governance challenges; and iv) the negative effects of climate change. The solutions to these challenges reflect these root causes: i) more effective and democratic governance; ii) economic opportunity, especially for young women and men; iii) action to prevent and mitigate the effects of environmental degradation and climate change; and iv) conflict prevention and more effective recovery after economic, social, environmental and political shocks. For this reason, development actors—including the United Nations—must redouble their efforts to tackle poverty, improve governance and support the rule of law, prevent conflict and support recovery, and protect the environment and reduce disaster risk. These interventions are critical to addressing the push factors driving migration flows today. The United Nations Development Programme (UNDP) has stepped up efforts to deal with these issues by adopting a resilience-based development approach in Syria and other crisis afflicted countries. This aims to help people cope, recover and sustain their development gains in the short, medium and long term. It includes emergency employment schemes for displaced women and youth, and providing support to local governments in countries neighbouring Syria to provide refugees and host communities with essential services.

skills and establish new business. In addition, migrants bring new expertise and knowledge to their country of destination. They support the local labour force and address the effects of population aging. It should not be forgotten that migrants don’t move from poor to rich countries alone. Today, countries in the Global South host 41% of all international migrants (2) and over 86% of the world’s refugees. (3) For this reason, we must also focus our attention on developing our countries as countries of settlement and transit, and support local and national governments in developing regions to harness the positive potential of such inflows. Facilitating comprehensive migration management The newly adopted ‘2030 Agenda for Sustainable Development’ recognizes the positive contributions of migrants for inclusive growth and sustainable development. It states that: “migration is a multi-dimensional reality of major relevance for the development of countries of origin, transit and destination, which requires coherent and comprehensive responses.” Recognizing the shared responsibilities of countries origin, transit, and destination, it is important to formulate and implement comprehensive national and regional policy and institutional frameworks that promote people-focused migration management. Such migration management needs to involve local and national authorities, migrants and refugees, regional organizations, as well as global level institutions, such as the United Nations (UN). Only then can we maximize the gains and minimize the risks associated with migration and displacement, and support medium and long-term development solutions. The Sustainable Development Goals (SDGs) adopted in September by UN Member States urges parties to protect migrant workers, in particular women migrants labour rights, to implement planned and well-managed

migration policies, and to reduce the transaction costs of migrant remittances. The SDGs present a framework for taking collective action to develop and implement long-term development solutions for the most vulnerable people, including refugees. The new ‘2030 Agenda for Sustainable Development’ applies to all countries, at all stages of development, and aims to help shape the response to the migration and refugee crisis by developing comprehensive policy frameworks for migration, and harnessing the long-term positive development impacts of migration. The key challenges for the next decade lies in the implementation of these SDGs and mobilizing the resources to support implementation. At the recent Valetta Summit on migration, countries agreed to the creation of a EUR 1.8 billion EU Emergency Trust Fund for Africa. This will fund initiatives aimed at rekindling the hope of African youth through poverty reduction, youth employment, promotion of peace, good governance, rule of law, and respect for human rights. At the same time, the fund will enable countries to include migration into development planning and facilitate the positive contributions of migrants to sustainable development. We need the commitment of actors in all parts of the world to reach the ambitious Sustainable Development Goals. No one, including migrants or refugees, can be left behind References 1. United Nations (2013). International Migration Report 2013, United Nations Department of Economic and Social Affairs, Population Division. 2. United Nations (2013) 3. UNHCR (2015) Global Facts and Figures in the social values they hold.

Harnessing the positive contributions of migration

© UNDP-supported projects in Jordan

The current focus on the ‘refugee crisis’ overshadows other important development aspects of migration. Migration can be a successful adaptation strategy, enabling people to find better and more sustainable lives by moving away from difficult living conditions. Migrants often send home remittances, which provide an important boost to the economies in their countries of origin. For example, in 2014, international migrants sent back US$ 583 billion to support their families and communities. Diasporas can also facilitate exports from countries of their origin, while returning migrants can bring back home

Government Gazette


migration & development

Europe must take control of the migration crisis Will 2016 be a better year for migrants? It will be, if we take urgent action to stop Europe from falling apart. Demetrios


Papademetriou, Founder

and President, Migration Policy Institute Europe, offers a five-pointcluster which when acted upon in an integrated manner will bring us back to normality ‘reintegration’ assistance (which can be used to attempt to re-enter Europe), those who are not bona fide refugees are all elements of what is needed to regain control.


wenty fifteen was a year in which both the European institutions and EU member states proved decidedly unequal to two of the biggest tests Europe faced — the border and migration crisis, and the asylum crisis. That failure has set the stage for a massive challenge that must be addressed in 2016. If not, the damage to the very idea of Europe will be difficult to contain, let alone repair. Here is a roadmap that holds the key to a better 2016 for Europe. It requires coordinated action on five policy clusters if the policy whole is to be much larger than the sum of its parts. There is evidence that Europe, pushed by Germany and probably without the consensus that it craves, is moving toward the goals outlined below. Restoring Europe’s mediterranean borders Europe’s Central and Eastern Mediterranean borders have been disappearing for a while now. In fact, the Mediterranean search-andrescue operations, however legally required and morally responsible, have amounted to a unilateral suspension of borders by bringing


those rescued to Europe and virtually allowing all of them to stay almost indefinitely. Europe must thus make border controls both a first priority, as Council President Turk has insisted, and a truly collective responsibility. That means, inter alia, Europe must provide all funds necessary for controlling the Union’s external borders and care for, vet claims, and relocate those who merit asylum to the rest of Europe, and increasingly to other safe countries. It must acknowledge that policies of individual member states, by fueling additional flows and/or taking stark, ‘beggar-thy-neighbor’ initiatives, make solutions more difficult. Many of these ideas are now on the agenda, but implementation is where Europe fails consistently. One is thus forced to ask the hardest of questions: Does Europe fully understand that if it cannot solve the border/ migration/asylum challenge, its other accomplishments will be deeply imperiled? If it does, re-instituting border controls, vetting (not just registering) entrants at the point of entry, detaining and removing, quickly, systematically and without undue process or elaborate

Government Gazette

Stopping deteriorating conditions in Syria Syrians make up the largest group of entrants. Virtually all of them are likely to receive some form of protection. Addressing the Syria issue is thus absolutely essential. After Assad was allowed to turn parts of Syria into killing fields (lately with active Russian engagement), there now seems to be an opening for a possible deal whose outlines are becoming clearer but whose outcome remains uncertain. It all starts with stopping the deterioration of conditions in Syria and gradually reversing them so that hope can begin to return and, with it, the exodus can slow and returns can become a reality. Progress on this will require a global response. Turkey at the controls Even if the first two policy clusters are pursued with extreme diligence, they will not be nearly enough to diminish dramatically the spontaneous flows through the Greek islands without the fullest cooperation of the one country that holds the key to managing the crisis: Turkey. Only Turkey can change the calculus that now leads migrants to get to Europe regardless of cost and by any means, by

migration & development

To begin to turn things around, three things are paramount: educating Syrian children (twothirds of whom, well over 400,000 —are not in school, virtually guaranteeing that they will be a ‘lost generation’) regardless of the outcome of the crisis; offering adults the opportunity to work legally; and assisting them with starting their own businesses. In order to avoid inevitable frictions, the same assistance must be offered to the host population, and Jordan and Lebanon must be included in this effort. This will require massive resources; but it will also create powerful virtuous cycles for the local economies that can benefit everyone. Turkey must do more difficult things Defeat the criminal networks and smugglers that move would-be ISIS fighters and arms to Syria, as well as waves of migrants to Europe, with complete impunity. No doubt, smugglers will not disappear. They will move underground and charge more. However, another outcome is equally certain: the numbers that can be moved will only be a fraction of the 2015 total. All this will require large sums of money— making the 3 billion euros Europe has promised a mere downpayment. Turkey is already asking for 6 billion euros and is likely to get it because investing ‘over there’ can translate into a return to order and social peace in Europe while meeting humanitarian obligations; because it is much more cost efficient to take care of Syrians

in countries of first asylum versus doing so in Europe; and because doing so dramatically increases the probability for Syrians to return to their country and begin its reconstruction. Large-scale resettlement A commitment to large-scale resettlement will give Europe the spine and moral high ground to do the things the first three policy clusters require for success. It also addresses the security and related concerns that have enormously gained in importance by vetting would-be refugees through well-developed and constantly updated security protocols, returning order to migration and protection systems, creating opportunities for first-world employers to develop specialised training programs so refugees can hit the ground running when resettled or upon their return to Syria, and generally give Europe the breathing space to do things more smartly than it has to date. Integration Only if analogous progress is made in the four clusters above will the relentless flows shrink markedly. However, it is the fifth cluster — integration — that will determine whether Europe avoids a scenario where the handful of member states that absorb virtually all newcomers struggle with long-term burdens of dependency, un-and underemployment, social marginalisation and even exclusion — as well as a culture of self-isolation — that create the conditions for anomie and worse. The successful integration of such large numbers, however, requires a fundamental rethinking of

how to deliver large-scale programs and will necessitate a deep adaptation of labour market, educational, and civic engagement institutions. None of this will be easy. Furthermore, it will be extremely expensive in terms of the political and financial capital, patience, and the required expenses that will most likely be borne as unequally as the effects of the migration crisis have been. We have spent a year watching the alternatives unfold. Heart-wrenching deaths and human suffering; the disappearance of solidarity in responding to the crisis; the erosion of the rule of law all along the migration arc; the rise of political opportunism in the form of growing support for populist parties, right and left; deepening divisions between citizens willing to open their hearts, wallets, and even homes to newcomers and those who have withdrawn their initial welcome as the social and economic costs became clearer; and perhaps most significantly, the ascendancy of fear and the massive loss of confidence and trust toward government and the political elites that seemed to have no strategy other than ‘taking them all in’ or ‘keeping them all out.’ It is now time to pull together, even if the burdens are shared unequally. Demetrios G. Papademetriou is also President Emeritus and co-founder of the Migration Policy Institute.

© Syrian refugee camp in Turkey

creating hope and opportunity for the nearly 3 million Syrian refugees spread throughout Turkey.

Government Gazette


migration & development

© Street logo sign of Brick Lane in English and Bengali, in London

Do immigrants really think differently?

While immigrants to the European Union may show different psychological characteristics compared to the mainstream majority population, Dr Alex Mesoudi, Associate Professor in Cultural Evolution, University of Exeter, UK says “these differences substantially reduce in just a single generation, allaying fears that immigrants will inevitably fail to integrate.”


nternational migration is increasing. The Mediterranean migrant crisis saw over 430,000 migrants arrive in Europe by sea between January and August 2015, already double the number of migrants who crossed the Mediterranean in all of 2014 [1]. Beyond this crisis, many EU member states are receiving the largest numbers of long-term international immigrants in decades. 636,000 people migrated to the UK in the year ending June 2015, up from 574,000 the previous year [2]. Germany received 1,465,000 immigrants in 2014, up 19% on 2013 [3]. While many people celebrate the economic prosperity and cultural enrichment that is brought by immigrants, there are also many voices of concern. An oft-cited fear is that immigrants will fail to integrate with mainstream European society due to differences in the way people from different cultural backgrounds think, or differences in the social values they hold. According to the 2013 British Social Attitudes survey [4], 77% of the UK public want immigration levels reduced. 45% said immigrants undermined Britain’s cultural life, versus 35% who said they enriched it. Half of them agreed that one cannot be “truly British” unless one has British ancestry (51% agree) and shares British customs and values (50% agree). Similar survey results can be found across Europe, and the success of political parties such as UKIP or the Danish People’s


Party, who received 12.6% and 21.1% of votes in the 2015 British and Danish general elections respectively, are indicators of these concerns over immigration. But is there any scientific evidence for the idea that people from different cultural backgrounds think differently and hold different social values and attitudes? And if so, are such differences in thinking styles fixed, such that immigrants remain permanently different? Recent research in the behavioural sciences shows that the answer to the first question is ‘yes’ and the second is ‘no.’ Not everyone is W.E.I.R.D. Until recently, psychologists assumed that everyone everywhere had the same fundamental ways of perceiving the world, themselves, and other people. The problem with this was that until recently, virtually all psychological research had been conducted on people from what Joseph Henrich, Steven Heine and Ara Norenzayan of the University of British Columbia have labelled Western, Educated, Industrialised, Rich and Democratic – or “WEIRD” - countries [5]. When psychologists started measuring the psychological attributes of people from less WEIRD, non-Western countries - primarily East Asian countries like China, Japan and Korea - surprising cultural

Government Gazette

variation emerged [6,7]. Take object categorisation. When given a set of objects – say cow, chicken and grass - Westerners typically use formal rules to categorise them, grouping cow and chicken (because both are farm animals), while East Asians typically categorise based on relationship, grouping cow and grass (because cows eat grass). When explaining other people’s actions, Westerners typically appeal to people’s internal dispositions or motivations – for example, explaining poor exam performance as due to a student’s low intelligence or their laziness – while East Asians typically appeal to wider situational factors, such as a lack of educational support. People from WEIRD countries are typically more individualistic: they are motivated more by their individual goals and agree more with statements such as “It is important that I do my job better than others.” People from less WEIRD countries are typically more collectivistic: they are motivated more by

migration & development

What about immigrants? At first sight, this seems to support concerns that immigrants – particularly those from nonWestern, less-WEIRD countries - may struggle to integrate into European society due to a mismatch between different thinking styles. Indeed, research into workplace satisfaction and performance suggests that while neither Western-typical traits (e.g. individualism) nor non-Western typical traits (e.g. collectivism) are more or less effective in absolute terms, there must be a match between person and context. Managers in the U.S. perform better on workplace tasks when training emphasises personal performance, matching their individualistic social orientation, while Chinese managers do better on the same tasks when training emphasises group performance, matching their collectivistic social orientation [8]. This suggests that a collectivistic person – say, an immigrant from South or East Asia – might struggle in a Western, individualistic workplace environment. The thinking styles of East London British Bangladeshis This leads to the second question. Are these thinking styles and social values fixed, or can they change? And if so, how quickly? To find out, Kesson Magid, Delwar Hussain and myself, recently examined the psychological profiles of British Bangladeshis living in East London [9]. This group is notable in being highly geographically concentrated and culturally cohesive compared to many other ethnic minorities. Indeed, British Bangladeshis constitute 32% of the population of Tower Hamlets, the borough where our study was conducted. We found that 1st generation British Bangladeshis, born and raised in Bangladesh before migrating to the UK aged 14 or older, show many of the same psychological attributes as other non-Westerners. For example, 1st generation British Bangladeshis on average use more situational and less dispositional explanations for other people’s actions, as shown in Figure 1. Crucially, however, Figure 1 also shows that 2nd generation British Bangladeshis, who were born and raised in the UK, are intermediate between their 1st generation parents and nonmigrants. We found the same one-generation shift for other measures such as individualism and collectivism.

Our results indicate that psychological characteristics are not fixed, and can rapidly and substantially shift from heritage values to values typical of wider society. Similar onegeneration shifts have been found in Asian Americans [6].



3. Federal Statistical Office (Destatis) (2014) https:// PE15_321_12711.html.

We can draw several conclusions from this research. First, there are differences in the way people from different parts of the world think

6 ●


● ●



2. Office for National Statistics (2015) http://www. html.

4. Ormston, R. & Curtice, J. (2015) British Social Attitudes: The 32nd Report. London, UK: NatCen Social Research. 5. Henrich, J., Heine, S. J. & Norenzayan, A. (2010) Most people are not WEIRD. Nature 466, 29–29.

Dispositional attribution

Mean Score

group goals and agree more with statements such as “Family members should stick together, no matter what sacrifices are required.” Cultural variation has also been found in people’s sense of fairness, morality, responses to aggression, susceptibility to visual illusions and personality [6,7]. In sum, people everywhere do not think, reason and perceive in the same way; there is substantial cultural variation in psychological processes.

● ●

Situational attribution

Non−migrant 2nd gen

6. Heine, S. J. (2011) Cultural psychology. New York: WW Norton.

1st gen

British Bangladeshi

Figure 1: 1st generation British Bangladeshis in East London are more likely to explain other people’s actions in terms of situations (‘situational attribution’) and less likely to explain other people’s actions in terms of internal dispositions (‘dispositional attribution’) than non-migrants. For both measures, 2nd generation British Bangladeshis fall in between their 1st generation parents and non-migrants. (Data points are mean values, error bars show 95% confidence intervals.)

and in their social values. These differences are neither ‘good’ nor ‘bad’, but are simply different ways of perceiving our physical and social environments. Second, fears that immigrant communities will fail to integrate due to fixed and intrinsic psychological or social differences are unfounded. All the evidence suggests that people are extremely adept at absorbing the local thinking styles and social values of their wider society. This is seen even in culturally cohesive migrant communities such as British Bangladeshis in East London.

7. Henrich, J., Heine, S. J. & Norenzayan, A. (2010) The weirdest people in the world? Behavioral and Brain Sciences 33, 61–135. 8. Earley, P. C. (1994) Self or group? Cultural effects of training on self-efficacy and performance. Administrative Science Quarterly 39, 89–117.

9. Mesoudi, A., Magid, K. & Hussain, D. (in press) How do people become W.E.I.R.D.? Migration reveals the cultural transmission mechanisms underlying variation in psychological processes.

Finally, immigrants need not shed their cultural identity in order to facilitate successful integration. The 2nd generation British Bangladeshis in our study were almost all Muslim and fluent Bengali speakers. Yet they still show substantial shifts in psychological attributes towards typically “British” values. It is easy, perhaps natural, to see immigrants as fundamentally different to “us”, but our and others’ research shows that “they” become part of “us” surprisingly quickly and easily Alex Mesoudi’s research is funded by the UK Economic and Social Research Council ( For more details of the research mentioned in this article, please visit www.

References 1. International Organization for Migration (2015)

Government Gazette


Government Gazette

Health REport Recommendations to reshape policy making

european commission

Exclusive interview with European Commissioner for Health & Food Safety

urological guidelines European Association of Urology on developing an evidence-based database


Prof. Dr. Sehnaz Karadeniz, Chair, IDF Europe takes a critical look

coping with prostate cancer

Towards better treatment, prevention and care Five faces of prostate cancer Dr Alastair Lamb outlines research identifying genetic subtypes

Government Gazette

european commission 52 Interview: Vytenis Andriukaitas, Commissioner for Health & Food Safety

policy action 54 Piernicola Pedicini MEP 55 Nessa Childers MEP

latest research

56 Dr. Alastair Lamb

diagnosis, care & treatment 57 Prof. Jonathan Waxman, Professor of Oncology, Imperial College London 59 Randy AuCoin, President and CEO, Exact Imaging

urological guidelines

60 Prof. Dr. Hein Van Poppel, Professor of Urology, University Hospital in Leuven 60 Prof. Dr. Nicolas Mottet, Chair, EAU Prostate Cancer Guidelines Panel

holistic management 61 Gary Steele, Chairman Leighton Hospital 62 Prof. Dr. Bertrand Tombal, Consultant Urologist 63 Dr. Laurent Fossion, Urologist, FeBU 64 Jane Griffiths, Group Chairman, Janssen Europe, Middle East and Africa 65 Dr. Riccardo Valdagni, Director of Radiotherapy, European School of Oncology 66 Prof. Jelle Barentsz, Professor of Radiology 68 Prof. Ronald Van Velthoven, Head of Urology, Institut Jules Bordet 69 Prof. Dr. Louis Denis, Director, Oncology Centre Antwerp 70 Dr. Anjali Zarkar, Consultant Clinical Oncologist, University Hospital Birmingham 71 Leslie Wise, Vice President of Global Healthcare Economics, AngioDynamics 73 Andrew Gilliver, Community Involvement Manger, LGBT Foundation 74 Gissoo Decotiis, Oncology Advocacy Relations, Pharmaceuticals Division, Bayer 75 Angela Culhane, Chief Executive, Prostate Cancer UK 76 Mihaela Militaru, Director, European Cancer Patient Coalition 77 Dr. Ben Pais, Vice President Medical Affairs, Elekta 78 Dr. Chris Booth, Member of Clinical Advisory Board, Tackle Prostate Cancer 80 Dr. Howard Urnovitz, Dr. Nick Plowman, and Prof. Dr. Ekkehard Sch端tz, Chronix Biomedical 81 Dr Riccardo Belli, Medical Director, AstraZeneca 82 Arvind Venkataramana, Research Director, ICPS

diabetes challenge 84 Prof. Dr. Sehnaz Karadeniz, Chair, IDF Europe 85 Dr. Andrew JM Boulton, President, Worldwide Initiative for Diabetes Education

Government Gazette


Commission’s action on health priorities within Europe In an exclusive interview with Government Gazette, Vytenis Andriukaitis, European Commissioner for Health and Food Safety, discusses the EU action on cancer, diabetes and healthcare technology


he incidence of prostate cancer and diabetes has significantly increased over the past two decades and continued growth is expected, due to an aging population. While greater awareness of the causes and earlier diagnosis can provide hope for these two major non communicable diseases, they continue to impose a heavy financial burden on our health services. Government Gazette interviews the European Commissioner for Health and Food Safety to find out more about the European Commission’s action on the deadly diseases. Commissioner Andriukaitis, it is often said that the EU action on cancer is one of its earliest policies in the field of health. After thirty years of EU action in the field of cancer can you tell us where we are at the moment? As European Commissioner for health, contributing to cancer prevention, screening and care, is a major concern for me. I personally lost family members to this terrible disease, and I am not alone – most of us have been affected by cancer in some way. This year, we celebrate thirty Against Cancer” which provides user friendly years of EU action in the field of cancer. Since the advice to avoid cancer. It also includes action on European Community leaders first met in 1985 cancer risk factors, in particular laws on tobacco and committed to take action to fight against products and on their marketing, on pesticides, cancer, EU policy has helped save lives through air quality, and protecting its four pillars of action: early workers against exposure to diagnosis, prevention, research carcinogens, as well as action “In the past seven and partnership. on alcohol, nutrition and years, the EU has First, the EU has, since 2003, physical activity. invested nearly € 1.44 recommended population-based Third, during the past seven cancer screening for breast, billion notably in years, the EU has invested cervical and colorectal cancer, international nearly € 1.44 billion notably and has produced European collaborative research in international collaborative Guidelines for all three types of research and coordination and coordination cancer screening. Now a quality of national cancer research of national cancer assurance scheme for breast efforts. This funding aims to cancer units is underway to research efforts.” find new ways to understand recognise the best places where and fight cancer, and to help women in Europe can get high patients. quality care. Early detection of cancer is vital as it gives patients the chance to receive timely and Lastly, a new Joint action was launched in often life-saving treatment. This is true for all 2014 on Comprehensive Cancer Control types of cancer – prostate, lung, skin, etc. – and I (“CANCON”) to deliver a European Guide on urge anyone who suspects symptoms to promptly Quality Improvement in Cancer Control. By consult their physician. presenting evidence-based recommendations for Second, addressing the risk factors is the Commission’s first line of attack to help reduce the burden of cancer. Actions in the past thirty years include supporting the “European Code


all stages of cancer control and care, this guide aims to reduce inequalities in cancer between EU countries. Commissioner, you indicated in several

Government Gazette

occasions that your priorities in public health could be summed up by the three words: “promotion, prevention, and protection”. What is the EU action doing on obesity and diabetes, for instance? With an estimated thirty-two million adults aged 20-79 living with diabetes in the EU, we are facing one of the biggest healthcare challenges of our time. If left untreated, diabetes can lead to heart disease, kidney failure, nerve damage and eye complications. Some forms of diabetes are lifestyle-related and obesity is a key risk factor. This is why we must put our efforts into preventing diabetes, starting with our youngest citizens. We must also help people who are living with diabetes. In 2008, one in four children aged six to nine were overweight or obese. By 2010 this figure rose to one in three children. In 2013, this worrying trend forced several European countries to jointly develop a European action plan targeting childhood obesity. The action plan puts forward initiatives to: support a healthy start in life, promote healthier environments - especially in schools and preschools, restrict marketing and advertising for children, encourage physical activity and increase research. In addition, we are also working with Member States through a Joint action (“CHRODIS”)

health report

on chronic diseases launched in 2014 and co-financed by the EU Health Programme. It promotes healthy ageing across the life cycle and aims to help EU countries and regions to exchange good practices in tackling chronic diseases. A special focus will be given to health promotion and disease prevention, multimorbidity (people with more than one long-term condition) and diabetes. Beyond public health, I understand that one of your priorities is healthcare technology assessment. Could you explain how you see the development of EU action in this field? A rapid increase in health technology is a sign of our times. There are more innovative medicines, medical devices and cutting-edge diagnostic tools than ever, and patients’ expectations are rising in parallel. This is challenging as it increases the pressure on national healthcare budgets, already under intense strain. Decision-makers are seeking answers to essential questions: is this innovative new medicine worth the money, or will an existing, cheaper medicine be as effective? Will buying this new machine save my hospital money in the long-run? Will it be more or less labour intensive? This is where Health technology assessment (HTA) comes into the picture. HTA informs decision makers on comparative effectiveness and efficiency of treatments. Cooperation on HTA at EU level will benefit patients by providing them with better access to innovative technologies. This is a challenging and important task on which the Commission will be concentrating its work in 2016, under my request and guidance. The EU support of HTA cooperation over the past twenty years has delivered tangible results on methodologies and information exchange. It has now paved the way for efficient use of HTA resources in Europe and the creation of a sustainable system of HTA knowledge sharing. In the coming months, I want to harness the commitment of EU countries and stakeholders to accelerate progress in this area, which will pay dividends for all of us.

The concrete building of the links between the technology, I am convinced that the right eHealth countries is now starting, supported by the EU tools that offer safe and efficient care can also help funds from the Connecting Europe Facility alleviate the burden on our healthcare systems. programme. I call upon EU countries to embrace Of course, the EU is made up of twenty-eight the opportunity and join the real work of separate health systems, which themselves are providing citizens and patients easier and better not uniform. This is why interoperability within health services when travelling. and between the countries is vital. The latter is a key aim of the eHealth Action plan 2012Interoperability 2020, which sets out a long is also vital in the term vision for eHealth in establishment of “The EU support of Health Europe. The eHealth Network European Reference plays a central role in solving Technology Assessment Networks (ERNs) interoperability challenges (HTA) cooperation over which should constitute between electronic health a major step forward the past twenty years has systems. for patients and health delivered tangible results professionals. By the Since it was launched in on methodologies and end of next year, ERNs 2011, the Network has for information exchange and will be operational instance adopted ePrescription now enables to envisage an and will bring together guidelines in 2014, laying out highly specialised the type of data needed for efficient use of HTA resources healthcare providers sharing prescriptions across in Europe and the creation of from different EU borders and giving patients a sustainable system of HTA countries in areas where the possibility to get the knowledge sharing.� expertise is rare, thereby medication they need anywhere pooling knowledge in the EU, which is particularly on rare diseases. They important for people with will be an additional chronic medical conditions. example of the importance of eHealth as their In addition, the Network also produced patient functioning will involve the use of an integrated summary guidelines in 2013, giving patients the IT platform (e.g. exchanging electronically clinical possibility to have, on request, a summary of their information, tests and diagnostic tools between electronic health record when visiting another professionals). Indeed, it is the application of Member State. The benefit is that for unplanned interoperable eHealth solutions which will allow or emergency care, the doctor in the country of the Networks to interact and fulfil their objectives treatment will have an electronic overview of for the benefit of patients in the EU the patient, and a set of basic administrative and medical information, which will improve patient safety.

We live in a connected world, especially in the area of health. I understand that the Commission is preparing the EU for future developments in the field of electronic health notably. Can you elaborate please? Speaking of chronic diseases and healthcare

Government Gazette


health report

Improving patient safety and embracing technology Canvassing for innovative mobile solutions in disease management and improving patient safety, MEP

Piernicola Pedicini,

Member of EP’s Committee on the Environment, Public Health and Food Safety explores measures that could potentially boost the uptake of eHealth and provides an overview of European healthcare


ould you ever want to find that you had a terminal prostate cancer through a smartphone application? Most certainly not. Technology will never replace doctors, but they must embrace it. In fact, telemedicine integrated with healthcare at home would contribute towards the rationalisation of costs and increase the humanisation of care. A patient-centred approach is essential in health treatments, however, unfortunately, sometimes such an approach is not given the right priority. It is essential to promote the humanisation of treatments, for instance, providing home-care medical treatments, which can help patients psychologically and result in better healthcare performance. eHealth and mobile health have a great potential in increasing the efficiency of healthcare treatments and reducing costs. I welcome the identification by the Commission of eHealth as a priority area of activity in the Digital Single Market strategy.

the uptake of eHealth in Europe include establishing online and publicly available patient waiting lists; establishing information points where medical examinations can be booked online; setting audio-visual telecommunications healthcare consultation where the doctor can visit the patient from the institute; guaranteeing free data access to enhance de-hospitalisation, and finally providing home care treatment and telemedicine, which would improve the quality of the treatment and also reduce costs. Pedicini’s initiative report I was rapporteur of the initiative report on “Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance,” adopted by a large majority of the European Parliament in May 2015. In the report, we identified some key actions which the various member states and the European Commission should take as a matter of urgency in order to increase patient safety and reduce antimicrobial resistance. There is also a need to adopt a patient-centred approach as well as a multidisciplinary strategy when doctors decide on best medical treatments.

eHealth can contribute to the empowerment of patients with key information, making them able to take informed decisions. However, we should make sure that patients and their organisations are actively involved in healthcare treatment decision-making as they have a pivotal role in the uptake of eHealth.

The indiscriminate application of austerity measures, that some member states have applied to the health sector, have a negative impact on patient safety, for example the reduction of medical personnel or of hygiene specialists increases the patient’s risk in getting associated infections. This eventually results in higher expenses for the healthcare sector.

Other measures that could potentially boost

The upstream cause of threat to patient safety


Government Gazette

is the political interference in appointment of managers and other health professionals, which implies lower healthcare quality standards. That is the primary reason why the report stresses that member states should “ensure that health managers are appointed on the basis of their merit and not of political affiliation.” Nowadays we are facing a major threat to human healthcare which is antimicrobial resistance. Every year 25,000 European citizens die due to increased resistance to antimicrobial agents and, in 2050, the deaths caused by antibiotic resistance is estimated to be about 10 million: more than the number of deaths caused by cancer. Urgent measures are needed, particularly from the pharmaceutical industry in “real development” of new antimicrobial drugs and, at the same time, to research alternative natural methods to fight drug resistance. Furthermore, we need more appropriate microbiological diagnosis before prescribing any antibiotics; prohibition of sales without prescription; awareness-raising campaigns targeting all population groups to promote an appropriate and responsible use of antibiotics; limit the use of antibiotics in veterinary medicine; eliminating the prophylactic use, as well as strongly restrict the metaphylactic use of antibiotics in animals. Innovative healthcare method to detect prostate cancer The EU health policy should address not only traditional research but also look at innovative healthcare methods which could have an important impact on reducing healthcare costs. For instance, a study published last April on the Journal of Urology showed an alternative method to detect prostate cancer. It showed that a trained canine olfactory system can detect prostate cancer specific volatile organic compounds in urine samples with high estimated sensitivity and specificity. This study can lead to the development of a highly innovative procedure to identify prostate cancer with a highest predictive value compared to traditional methodologies, which have shown scarce specificity and sensitivity. The discovery is particularly relevant considering that prostate cancer represents the fifth most frequent cancer in the world and given the increasing mortality rates within Europe

policy action

Reducing mortality rates tops MAC’s latest agenda The MEPs Against Cancer (MAC) group strives to reduce cancer incidence by promoting prevention, reducing mortality through equitable access to high-quality care and ensuring good quality of life for cancer patients. MEP Nessa Childers, Vice President, MEPs Against Cancer Group talks about the European Parliament’s fight against cancer


ancer is an ever growing public health concern. In 2012, cancer was the second most common cause of death in the EU: around 708,000 men and 555,000 women died from it, the main causes being lung, colorectal, prostate, pancreatic, stomach and liver cancer among men, and breast, lung, colorectal, pancreatic, ovarian and stomach cancer among women. Aside from this killer’s human toll, from an economic point of view, cancer is a major burden, costing EU Member States a total of €126 billion in 2009. The main risk factors for cancer are smoking and drinking, an unbalanced diet, excess weight, lack of physical activity as well as environmental and work-related exposure to cancer-causing substances (carcinogens). More than 30% of cancer deaths could be prevented, mainly by avoiding risk factors and adopting a healthy lifestyle. Whilst the provision of health care services ultimately lies within the competencies of each Member State, the EU can still complement the efforts carried out at national level, by sharing best practises and fostering cooperation. Within the European Parliament, in 2005, an informal group was set up by my colleague Alojz Peterle, the standing President. Together with Alojz Peterle, Pavel Poc and myself,

as Vice-Presidents, and other cross-party colleagues, we work on policies against cancer in the belief that European cooperation adds value to Member State actions. The MEPs Against Cancer (MAC) group is a forum where we gather input and exchange views with MEPs, scientific experts, European Commission officials, researchers, Member State representatives and patients. In the current parliamentary term (2014-2019), the group’s strategic goal is to reduce cancer incidence by promoting prevention, reducing mortality through equitable access to highquality care and ensuring good quality of life for cancer patients. The group collaborates with other relevant organisations in order to achieve the goal of reducing cancer by 15% by 2020. Furthermore, in order to establish stronger links with cross-party groups in European national parliaments, MAC has set up an Ambassador scheme.

In order to address the challenges faced by the EU, MAC is working together with other organisations to help further the policy goal of reducing cancer incidence by 15% by the year 2020. Some of the ways in which we are trying to achieve this goal are by addressing the risk factors through legislation on pesticides, tobacco products and through campaigns to raise awareness such as ‘Ex-smokers are unstoppable’. The EU invests a total of €1.5 billion in the fight against cancer– mostly for international collaborative research projects, but also for public-private partnerships and the coordination of national cancer research. Most of the research work is within the field of rare cancers, which are linked to an ever increasing mortality rate in the European Union

Since the economic crisis has hit many EU countries, and that governments have implemented harsh cuts to health budgets as part of their austerity plans, we are also focussing on safeguarding public health in austerity policies to ensure, among other goals cancer patients have access to the medicines they need and that economic policies do not block access to the provision of life saving care.

Government Gazette


health report

The five faces of prostate cancer

Prostate cancer can no longer be treated as one disease.

Dr. Alastair Lamb,

Clinical Lecturer in Urology, Cambridge Biomedical Campus, UK, outlines some recent work identifying genetic subtypes of prostate cancer and how this could alter future care


he question that often arises from the patient is “When will this prostate cancer kill me, doctor?”. The question may take a softer form than this but the point is the same: men want to know whether this new diagnosis they have just received is going to shorten their life; whether it means they can no longer go on the long-planned family trip to Australia next year; or whether they’ll see their first grandchild born. Risk stratification And really this is a question about risk stratification. The thing is, as often discussed with men in clinic (or with someone at a dinner party), that it doesn’t necessarily matter if you get prostate cancer; half of all men are going to get it if they live beyond the age of 80. No, the problem isn’t having prostate cancer; it’s what type you have. We already divide men into subgroups in prostate cancer which we believe have different outcomes. Currently we do this on the basis of three things: a blood test (the prostate specific antigen or PSA test), the appearance of tissue under the microscope (the Gleason score), and the size and extent of the tumour based on MRI scanning and digital examination of the prostate (the TNM score). Based on these three things, we divide men into low, intermediate or high risk. (1)But the problem is that we often come across men in the lower risk groups who, contrary to expectations, do very poorly in terms of outcome. Conversely we also have men in the high risk group who actually do unexpectedly well. So, there must be some additional information about the behaviour of such cancers that we are missing with our current approach.


Genetic information in each cancer cell An important answer to this problem could be the genetic information stored within the prostate tissue itself. Tissue architecture, tumour growth and, to an extent, release of PSA are all downstream indicators of something that is happening in the DNA of the cancer cells within the tumour. DNA is the library code which contains the information that tells a cell what to do. The machinery within each cell nucleus turns DNA into RNA (Ribonucleic acid) which in turn determines the sequence of amino acids to form a protein which acts out the function of a cell. It’s these ‘molecules’ – DNA, RNA and protein – which are the key to a cell’s behaviour. Protein is notoriously difficult to measure accurately and so DNA and RNA (a surrogate for protein levels) can together be measured to give a molecular impression of current and future cell activity. The five faces of prostate cancer In our study recently published in EBioMedicine (a new open-access journal from The Lancet and Cell Press) we looked at prostates from 259 men from Cambridge, UK and Stockholm, Sweden and measured the DNA and RNA in the tissue looking for mutations in the DNA library code and whether RNA levels had been turned up or down. Based on this, we grouped men with prostate cancer into five distinct groups, each with a characteristic genetic fingerprint, coining the name the “five faces of prostate cancer” in Aine McCarthy’s CRUK blog. Two of these groups had dramatic changes in the number of ‘copies’ of each gene due to mutations in the DNA and these were linked to

Government Gazette

marked increase or decrease in RNA levels. By contrast, the two groups had very little change compared to normal prostate tissue. A fifth group was somewhere in between. (2) We were very interested to see that the two groups with dramatic molecular changes did far worse in terms of prostate cancer relapse compared to the other groups. In fact, membership of one of these two groups was a much stronger predictor of poor outcome than current clinical parameters such as PSA, Gleason score or T stage. The future of prostate cancer care Future decision-making in prostate cancer could look very different to current practice. Although we don’t currently screen for prostate cancer (thus lagging behind breast, ovarian and gut cancer) “next-generation screening” based on a composite algorithm of PSA-related tests will soon be available (Lamb & Bratt, Lancet Oncology 2015 in press – details to follow). Having identified a population of ‘at-risk’ men, we will then proceed to diagnosis with a biopsy. We then have to apply the molecular stratification techniques described above to biopsy tissue – the EBioMedicine study looked at prostate removed at prostatectomy which gives larger samples of tissue than biopsy – or even to small amounts of circulating DNA in the blood. An important step here will be to make sure that the right bit of the prostate is sampled and it is likely that high resolution “multi-parametric” MRI scanning will play an important role in selecting the key target in the prostate. The molecular information received from selectively targeted biopsies, alongside the current clinical parameters will inform a more

policy debate

comprehensive risk stratification which will permit a far more intelligent approach to treatment decision making and subsequent follow-up regimens. The precise form of molecular score is yet to be decided. Two commercial scores are already available (Prolaris and Oncotype Dx) and it is likely that further approaches will soon follow.

clinical benefit, helping men to avoid the sideeffects of treatment including incontinence, impotence and bowel dysfunction, and ultimately saving lives

For these to be used alongside the trio of PSA, Gleason and TNM staging, much rigorous testing will be needed in larger cohorts of men to prove that they really can provide large-scale


Alastair Lamb, Clinical Lecturer in Urology, Addenbrooke’s Hospital, Cambridge & Cancer Research UK Cambridge Institute, Cambridge Biomedical Campus, UK.

1. D’Amico, A. V., Whittington, R., Malkowicz, S. B., Schultz, D., Blank, K., Broderick, G. A., Tomaszewski, J. E., Renshaw, A. A., Kaplan, I.,

Beard, C. J., and Wein, A. (1998). Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. Jama 280, 969-974. 2. Ross-Adams, H., Lamb, A. D., Dunning, M. J., Halim, S., Lindberg, J., Massie, C. M., Egevad, L. A., Russell, R., Ramos-Montoya, A., Vowler, S. L., et al. (2015). Integration of copy number and transcriptomics provides risk stratification in prostate cancer: A discovery and validation cohort study. EBioMedicine 2, 1133-1144.

It’s time to take action, or it could be you...


he Government Gazette is distributed through the United Kingdom Houses of Parliament, and the European Parliament. There are 459 male MP’s, 609 male Lords and Bishops, and 473 male MEP’s. Prostate cancer is now the commonest cancer in men, affecting one in nine men. So, the chances are that 51 MP’s and 67 members of the House of Lords, and 52 MEP’s have or will develop prostate cancer. So it could indeed be you, and you of course do have a vested interest in understanding prostate cancer and encouraging advances in research and treatment into this very common disease at a UK national and European level. What do you know about prostate cancer? It’s surprising that almost less than 20% of

Considering that prostate cancer is affecting one in nine men, there are chances that 51 MPs, 67 members of House of Lords and 52 MEPs already have or will develop the commonest cancer of men if policy makers don’t take immediate action. Prof. Jonathan Waxman, Professor of Oncology, Imperial College London gives a complete lowdown on the deadly disease and discusses what needs to be done from a policy perspective men and women only know where the prostate is and what it does. The prostate is a gland at the base of the bladder, and because of the gland’s location, enlargement of the prostate by any benign or malignant growth of the prostate can cause difficulty with urination. The prostate makes a fluid that mixes with sperm to form the seminal fluid which contains high concentrations of fructose, a sugar that nourishes the sperm in its perilous voyages in foreign parts. The number of people affected by prostate cancer has increased incredibly over the last 50 years. In the UK, in the mid

Government Gazette

1960’s, around 6000 men were diagnosed with prostate cancer per annum. The latest available figures show that 41,736 men were diagnosed with prostate cancer in the UK in 2012. This increase is replicated around Western Europe where currently 343,174 men were diagnosed. Mortality rates are around 30% both in the UK and in the rest of the EU. What is the cause of prostate cancer? Prostate cancer is generally a disease of older men, increasing in incidence with age so that it is found in some form in up 80% of 80 year


health report

olds.. As the average age of death in the UK has increased by ten years over the last fifty years it might be thought that the change in prostate cancer incidence reflects the changes in the demographics of our society. But not so, because when age is factored in the massive change in incidence is not explained. There is no obvious genetic cause. No single genes have been found to be altered and cause prostate cancer. However multiple genetic abnormalities are seen and are likely to be a secondary event, reflecting the impact of environmental factors on the genome. The evidence showing this has been available from the 1960’s. Entire galaxies of studies have shown that the increase in incidence of prostate cancer is likely to be due to changes in diet, with the star dust firmly sprinkled on meat and dairy products, and in particular on to processed and smoked foods. How is prostate cancer treated? Prostate cancer can be divided into two main types, a mild form that requires no treatment and a more aggressive form that can be confined to the prostate or have spread to involve other organs. Mild prostate cancer looks only slightly different from normal tissue when examined microscopically and is generally associated with low PSA levels. This is a ‘cancer’ that has an excellent outlook and can usually be managed without treatment merely requiring regular follow up blood testing and clinical monitoring. When the more aggressive form is found, and is confined to the prostate, the patient is offered treatment with radiotherapy or surgery. The results of treatment are exactly the same and radiotherapy has much less side effects. The addition of hormone treatment and chemotherapy provides a survival benefit for some subgroups of patients treated with radiotherapy. For patients whose cancer has spread, treatment is with hormonal therapy that blocks the effect of the male hormone, and with chemotherapy. In the UK, doctors are unable to use all the drugs that they would like to use to treat their patients because of the restrictions applied by the National Institutes of Clinical and Health Care Excellence (NICE). What to do about prostate cancer? So how do we act to decrease mortality? We do so by developing national preventive strategies, by encouraging screening, by stimulating basic science research, improved patient care, and through facilitating and making available treatment advances so that new drugs can be given to patients. In some cancers public health campaigns have been effective in reducing cancer incidence. For lung cancer for example, public health campaigns have reduced smoking levels to under 20% of the population, and this has led to decreases in death rates. In many cancers national screening programmes have led to fabulous falls in death rates for common cancers. Cervical cancer screening has led to a decrease in mortality rates by over 50%. Breast cancer screening is associated with a fall of 30%


in death rates, and there is very strong evidence that colonoscopic screening for large bowel cancer is effective in reducing death rates but faecal occult blood testing which is cheaper, is relatively less effective. How about national prevention strategies? In prostate cancer public health campaigns would need to focus on dietary educational campaigns, battling against vested interests, as a very long term strategy to reduce prostate cancer incidence. We need you as our national representatives to campaign on such important public health matters. But, what about prostate cancer screening? Why is there no national screening programme for the early detection of prostate cancer? Firstly it is still not clear that early detection and treatment does lead to a fall in death rates. Secondly we do not have good diagnostic tests. Current screening is based on the PSA blood test. PSA is an enzyme that is produced in the prostate where it acts like biological washing powder to keep the tiny internal tubes clear of gunk, as we clinical scientists call it! PSA spills over into the blood stream and can be measured. Unfortunately, the PSA test is not specific and where blood levels are raised to double the normal range, the chance of a patient having prostate cancer is around 25 – 40%. As a result, if PSA is used to screen normal populations a lot of unnecessary further tests are done. In a recent analysis of over 350,000 men involved in PSA screening campaigns, no benefit was found for screening. So, should you as our national representatives, be calling for investment in new tests for the development of national screening programmes in prostate cancer? Yes! We need a better test that distinguishes between the two different forms of prostate cancer. And basic science research? In the UK in 1996 around £46,000 of public money was allocated to prostate cancer research, a hundredth of the allocation to breast cancer. As a result of a national campaign led by the Daily Mail, I met with Yvette Cooper who was the Minister of Public Health. The minister then announced that central funding for prostate cancer research would be increased to a par with breast cancer, to around £4million pa. A great step forward, but inconsiderable in the context of the cost of developing a new drug for cancer which is around £1.3billion. Basic science research is left to charity, where the major funder in the UK is Prostate Cancer UK, an organisation that I founded to remedy the lack of funding for information, clinical services and for research. But we cannot leave matters of such importance to charity alone. So please focus on targeting national research in this area of great public concern. Improving patient care Breast cancer was taken as a campaigning issue

Government Gazette

by women, and led by the glorious radicals of the 1960’s. As a result of feminist campaigns, the care of breast cancer patients has been taken from paternalistic surgeons and into the realms of the multi-disciplinary teams, led by oncologists. Care in breast cancer has been transformed. This standard has not been applied to prostate cancer, where the cancer specialists unfortunately remain distanced by the surgeons, who fail to refer on to their colleagues. As a direct result, in a recent survey we found out that just 1 in seven men who would be considered for chemotherapy for prostate cancer receive treatment, denying these men additional time with their families. In a further survey that I carried out some time ago less than 50% of men with prostate cancer got referred on for radiotherapy to palliate pain, or to Macmillan services. So, we need help in applying the standard for breast cancer care to men with prostate cancer. Making treatment advances available. The survival time for of men with advanced prostate cancer has almost doubled over the last 20 years. This is due entirely to the introduction of new drugs for prostate cancer. But not all the available new drugs are given to men with prostate cancer, and this is for two reasons. The armies of the drug companies marched late into the battlefield of prostate cancer. Some time was spent in realising that there was a significant ‘market’ for prostate cancer drugs. The battle has been engaged and new drugs have been developed, but once developed not all the drugs that could have been given to men with prostate cancer in the UK have been allowed by NICE, on the basis of wonky cost calculations. This is because NICE uses an appraisal system that applies a universal model for judging cancer drugs that is not relevant to cancer. The subjective scoring system calculates cost as judged by the addition of a year of quality added life and is based on the cost of a drug given to 100% of patients for one year. Now, generally 40 – 50% of cancer patients will benefit from a new drug and take that drug for around 6 or 9 months. 50 – 60% stop the drug after a couple of months as it is not working. So the equation comes out of the back of bovines. The bizarre cost formulae championed by NICE and based on research in the 1950’s needs to be reformed. In summary You -- as our national representatives, have a vested interest in making things better for prostate cancer patients. It could be you, it could be, but there is a chance that it might not be you if you do something for prostate cancer

coping with prostate cancer

Targeted prostate biopsy gets cost-effective Exact Imaging’s breakthrough ExactVu™ micro-ultrasound system enables a 300% improvement in resolution over the current ultrasound systems. Urologists can now accurately visualise suspicious regions in the prostate and better target biopsies for better and more cost-effective prostate cancer detection


Randy AuCoin, President and CEO, Exact Imaging

rostate cancer is the most common cancer in Europe for males. In 2012, around 417,000 new cases of prostate cancer were diagnosed in Europe, and approximately 92,300 deaths were attributed to prostate cancer (1). The cost associated with detection and treatment of this disease is very significant to health care systems throughout Europe. Current standard of care Prostate cancer is diagnosed by a pathologist analysing tissue samples taken from a man’s prostate via ultrasound-guided biopsy. When a man is determined to have elevated risk factors or symptoms commonly associated with prostate cancer, a urologist orders a prostate biopsy procedure. During this routine procedure, between 10 and 14 separate tissue samples are collected and subsequently sent to pathology for analysis. Ultrasound is the standard of care worldwide for guiding prostate biopsies. Using a transrectal ultrasound probe, the prostate is imaged and the operator guides the biopsy needle to the various locations he or she would like to collect the tissue samples from. Unfortunately, the resolution on conventional ultrasound systems used for prostate biopsy procedures is inadequate to distinguish between cancerous tissue and benign tissue. As a result, prostate biopsies are collected systematically, simply following a needle placement and spacing protocol with the hope of hitting the cancer if it is present. This “blind biopsy” approach results in a 30%-40% false negative rate (missed cancer). During a recent section meeting for urological imaging (2) organized by the European Association of Urology (EAU), distinguished speaker Dr. Hashim Ahmed from University College London referred to the current standard for performing prostate biopsies as “rubbish.” Existing alternative In an attempt to overcome the lack of adequate resolution on conventional ultrasound systems, some larger institutions throughout Europe

and North America have been experimenting with adding MRI into the workflow for guiding prostate biopsies. This does not eliminate the need for the ultrasound-guided prostate biopsy procedure; rather it adds on a process called MRI/Ultrasound “fusion” whereby suspicious areas identified on MRI can be targeted with the hopes of missing fewer serious prostate cancers. There is a growing body of evidence that if an institution can successfully modify its workflow to add on an MRI procedure and can develop the expertise necessary to master the fusion approach, improved clinical outcomes can be obtained for the patient. Published clinical studies seem to be demonstrating that there are some improvements in clinical outcomes when the MRI/ US fusion workflow is implemented properly and the required techniques mastered. However, an active debate continues regarding the practicality of implementing this approach given the significant increase in total procedure cost, the steep learning curve to get improved results, the considerable change to the standard clinical workflow, and the increased procedure time, just to name a few of the issues. With significant downward cost pressure on healthcare systems worldwide, experts question the practicality of implementing such techniques that dramatically change clinical workflow and significantly increase overall procedure cost. Solution: Using much better ultrasound The lack of resolution on conventional ultrasound systems is the root-cause of the problem of not being able to visualise and distinguish suspicious tissue so that those areas can be “targeted” for biopsy. Exact Imaging has developed a high resolution micro-ultrasound system for urology that addresses the problem of inadequate ultrasound resolution. This micro-ultrasound system was originally commercialised for small animal imaging in the field of pre-clinical research, in which researchers study human disease models in mice and require much higher resolution due to the small structures they are imaging. This proven technology is the gold-standard for small animal ultrasound imaging with over 2,000 systems installed worldwide. Exact Imaging has adapted this revolutionary technology and taken it from mouse to man. The ExactVu™ micro-ultrasound

Government Gazette

system offers a 300% increase in resolution and this allows for targeted prostate biopsies to be performed without requiring the add-on of MRI. A 2,000 patient randomized-controlled clinical trial is currently underway at five sites across North America. The trial should conclude in May 2016 and is expected to demonstrate that improved clinical outcomes are possible in an “ultrasound-only” prostate biopsy setting. Approval to market the ExactVu™ microultrasound system in Europe is expected in June 2016. Recommendation

A solution to a clinical problem is only a solution if the healthcare system can afford to implement it. Cost-effectiveness has several components including appropriate patient care, physician expertise required, availability of necessary imaging equipment, procedure cost, and procedure time. Conventional ultrasound is the standard of care for guiding prostate biopsies. It meets all measures of cost-effectiveness with only one exception: it has inadequate resolution. ExactVu™ solves the problem by providing targeted prostate biopsy capability in a cost effective manner within existing clinical work flow. The adoption of this technology will be an important step for dealing with Europe’s high incidence and prevalence of prostate cancer The article is authored by Randy AuCoin, President and CEO, Exact Imaging. References:: 1. Cancer Research UK, accessed at www. cancer-statistics/statistics-by-cancer-type/ prostatecancer 2. ESUI 2015 (November 12, 2015: Barcelona)


health report

Improving European healthcare with evidence-based information Prof. Dr. Nicolas Mottet

For almost 40 years, the European Association of Urology has addressed the most pressing concerns of urological diseases.

Prof. Dr. Nicolas Mottet and Prof. Dr. Hein Van Poppel -- on behalf of the EAU -- elaborate on how it strives to assist medical professionals and researchers in developing reliable patient information on 11 urological diseases in 16 European languages


rological diseases represent a collection of various symptoms and conditions, most of them predominantly related to age. Furthermore, with the rise in the elderly population within Europe, we expect an increase in urological problems. Among urological cancers, prostate cancer is the first malignancy in men, the third cause of death from cancer in men, and leading cause of health expenses.

needed. That’s why the European Association of Urology’s (EAU) Guidelines exist and are continuously developed.

Initially considered a simple disease, prostate cancer is now considered a very heterogeneous disease. This heterogeneity implies that its management can no longer be considered a “one size fits all.” It must be individualized and therefore becomes more complex, requiring a close collaboration of multiple specialists in addition to urologists, such as pathologists, radiologists, biologists, radiotherapists, and medical oncologists. On top of this, the individual patient demands, personal objectives, quality of life, priorities and individual life expectancy are also key decision drivers.

The EAU Guidelines cover all urological problems, including chapters on urological cancers (prostate, bladder, upper urinary tract, kidney, urethra, testis and penile) and chapters on non-oncological situations such as kidney and bladder stones, infections, lower urinary tract symptoms, pelvic pain, infertility, male sexual dysfunction, neuro-urology, paediatric urology, among others. They all share the same multidisciplinary approach, rules and methodologies and are regularly updated.

Major progress has been made, such as the recognition that 50% of the situations are almost indolent, while others are at risk of evolving in the following years, and a minority will have a rapid progression. The recent development of new technologies, new drugs and new approaches requires clarification between experimental and evidence-based data. The latter is the cornerstone of any decision. The amount of published information makes it an impossible challenge for any individual to be fully informed. The same applies for every urological disease. Most urologists take care of all urological situations with a mission to offer the highest possible level of care. To achieve this, help is


Urological Guidelines for clinical practice Guidelines must fulfil some criteria: they must be evidence-based, unbiased and independent; they must be up to date, multidisciplinary when different specialties are involved, and they must involve patients. The EAU Guidelines fulfil all these prerequisites.

An illustration: The prostate cancer guideline panel is composed of 6 urologists, 4 radiotherapists, 2 medical oncologists, 1 radiologist, 1 pathologist and 1 patient representative. The prostate cancer guidelines are now fully endorsed by the International Society of Geriatric Oncology (SIOG), the European Society of Uro-Radiology (ESUR) and the European Society of Radiation Oncology (ESTRO). They are implemented and updated annually, based on structured literature searches, and on systematic reviews (SR). Each SR represents almost one year’s work, including 1 senior member leading the work, 1 librarian, 1 methodologist, and 2 to 4 associates for data extraction. These SRs are the only way to perform an extensive impartial and unbiased summary, leading to practical guidance. The prostate cancer panel is running 5 SRs to be finalized between 2016 and 2017.

Government Gazette

A new one devoted to long-term side-effects and quality of life of each treatment has just started, with a patient representative in the leading group. Each year new literature searches will be added. The EAU Guidelines represent a major effort of Europe’s urological and medical communities in order to improve the delivery of care. They are available for free from the EAU’s website ( and are published as detailed summaries in the EAU’s journal European Urology. The Guidelines are recognized as an important source of guidance for practicing urologists, and clinicians from bordering specialties, all around the world. They are often used as resource for national guidelines. A formalised endorsement by other associations was achieved in December 2015 for almost all 28 European Union member states, and 14 countries outside Europe including China, Russia, Indonesia, Australia and New Zealand among many others. Endorsement implies support or general approval of its content, acknowledging the value and quality of these documents. EAU Guidelines cannot replace the need for national guidelines. These often exist alongside the EAU Guidelines, adapted to some specific national situations. Educational activities The EAU Guidelines also form the basis of the European School of Urology (ESU). The ESU’s aim is to coordinate and organize all postgraduate teaching and education activities of the EAU at the highest possible level. These activities exist in various forms. The annual European Urology Residents Education Program (EUREP) is one of the ESU’s flagship teaching programmes: it lasts 1 week, and is devised for final-year urology residents. A wide variety of ESU Courses are scheduled during the Annual EAU Congress, at EAU Section

coping with prostate cancer

Patient Information Not only medical specialists require unbiased, evidence-based information. More and more patients are looking for information about their condition and possible treatments. As well-informed patients are better-equipped to talk about issues that worry them, the EAU develops patient information for several urological diseases. It provides reliable information on 11 urological diseases in 16 European languages, which takes into account the latest scientific evidence, expert recommendations, and the needs of patients. On prostate cancer, the patient information leaflets that have been produced, explain what needs to be understood concerning screening, early detection, diagnosis, different management modalities including active surveillance, surgery (open and robot), radiotherapy (external and brachytherapy), hormonal treatment, chemotherapy and novel treatments. This information is in line with the EAU Guidelines to guarantee consistency in content and quality throughout all of its translations and relevant to patients living in different countries. This truly European collaboration encourages a meaningful dialogue between the doctor and the patient, leading to better care. The confirmation of the EAU Guidelines’ impact on healthcare delivery is an ongoing process. It should hopefully confirm that all these major efforts from a multidisciplinary medical community are worth undertaking and reach its objectives: improving patients care by improving medical specialists’ knowledge Prof. Dr. Nicolas Mottet is Professor and Chairman of the Department of Urology at the CHU in SaintEtienne, France, and chairman of the EAU Prostate Cancer Guidelines Panel. Prof. Dr. Hein Van Poppel is Professor of Urology at the University Hospital in Leuven, Belgium, and is EAU Executive, responsible for Education.

Calling for a compulsory screening mechanism in UK By Gary Steele, M.B.E, Chairman, Leighton Hospital PCSG


rostate cancer is the most common cancer in men and is the biggest killer in men with cancer, second only to lung cancer. However, prostate cancer continues to have the lowest public awareness of all the major cancers in UK. The statistics surrounding this so called “silent-killer” are quite astounding. In the UK, only 8% of eligible men are tested for prostate cancer compared to over 60% across the rest of Europe and 28% of men seen for the first time by an oncologist are unable to be treated as the cancer is diagnosed at advanced stages where there is no treatment. Moreover, nearly 80% of all men diagnosed with prostate cancer don’t show any symptoms. Furthermore, as the government generally recommends screening only men over 50 years of age, it is no wonder the diagnosis and mortality rates in the UK from this type of cancer is considerably more than others in the so called modern countries with over 42,000 diagnosed and some 12,000 dying every year from this disease. A few years back, the Leighton Hospital Prostate Cancer Support Group joined forces with the Graham Fulford Trust and some other groups to arrange PSA (Prostate-Specific Antigen) blood testing for Early Detection Prostate Cancer in local and convenient locations. Over the years, we have tested some 50,000 men finding many cancers that could not have been found either due to men not visiting their GP’s or at instances where they have been refused to be tested or treated. We use the normal method of the venous draw to extract a small sample of blood using experienced and qualified phlebotomists. Under the careful direction of our urologists, the samples are taken to The Doctors Laboratory, Salford/London where the blood sample results are analysed and sent to our urologists to be posted on to the patients using the

Government Gazette

Medical Detection Dogs

and Regional meetings, and during individual National Societies’ meetings. They are UEMS/ EACCME-accredited. In recent years, e-courses and webinars have also been introduced.

traffic light signal system - green for good, amber for borderline, and red for abnormal with information regarding next steps. The Laboratory also provides a further test on those samples at 1.4 or over by using “free-tototal” which provides further accuracy to the outcome. All men who are tested and treated have been recorded, thereby providing us with the largest database in Europe regarding age, family history and PSA related results for prostate cancer providing statistics in assisting in diagnosing prostate cancer. Currently, we work in association with the charity Medical Detection Dogs where we train dogs to “sniff-out” prostate cancer from urine samples taken from those men attending our testing events. Soon after, the blood and urine samples are laboratory compared using the Medical Detection Dogs based in Milton Keynes, which are able to provide second line screening for cancers that are currently very difficult to diagnose reliably, such as prostate cancer. We are quite excited with this innovative training, which is currently showing a 92% success rate in finding the comparison between abnormal samples and detecting prostate cancer in urine samples. These results are truly spectacular. All cancers are required to be diagnosed sufficiently early if treatment should to be successful and prostate cancer appears to be the most difficult as patients often show no early symptoms. Therefore, we believe a compulsory “screening” programme should be considered which we are sure would reduce mortality rates in the UK and Europe. We know screening for men for prostate cancer is a taboo issue in the UK, however, the recent screening trials completed across Europe showed a considerable and significant fall in mortality in some instances as much as 42%, therefore if screening was introduced in the UK some 5000 men’s lives could be saved annually


health report

From therapeutic nihilism to diversity in treatment options - what can be added? Despite extensive use of radical treatments, such as surgery and radiotherapy, and constant technical innovations, mortality rates remain high. Prof Bertand Tombal, Consultant Urologist, Brussels Saint-Luc University Hospital lists out what’s missing in the battle against prostate cancer


ccording to the International Agency for Research on Cancer (IARC), prostate cancer is the second most common cancer in men. An estimated 420,000 men were diagnosed with prostate cancer in Europe in 2012, accounting for 15% of the cancers diagnosed in men. Despite extensive use of radical treatments, i.e. surgery and radiotherapy, and constant technical innovations, mortality rates remain high. IARC reported 101,000 deaths in Europe in 2012. Patients presenting upfront with disseminated metastases still uniformly die from the disease after a few years. Radical treatments fail to cure up to 30% of the patients diagnosed with a high-risk, undifferentiated, localized or locally advance disease. Ultimately most of them develop metastases and die from the disease. Castration-resistant prostate cancer, an embarrassment of riches? Since the seminal work of Charles Huggins, 1966 Nobel Prize’s laureate, suppressing testosterone, the male hormone, is the reference treatment for advanced metastatic prostate cancer. Hormone therapy induces dramatic responses but of short duration. In most cases, the tumour progresses in a stage of resistance. Complications, especially skeletal, occur rapidly and the issue is usually fatal within two to four years. In 2004, two drugs brought the first hope of cure. Docetaxel, a widely used chemotherapy, extends overall survival by three months and zoledronic acid, a bone targeting agent, delays the onset of


bone complications by several months. Many patients, however, will never receive chemotherapy, being already in their late seventies or eighties when they develop CRPC. Hopefully, four new drugs have entered the market since 2010. Enzalutamide and abiraterone are new hormones that increase overall survival and preserve quality of life in metastatic CRPC patients. Radium 223 is an injectable radionuclide that directly targets bone metastases, delays bone complications, and increase overall survival. Cabazitaxel is a taxane chemotherapy that is active in docetaxelresistant patients. Finally, denosumab is a monoclonal antibody with slightly improved efficacy over zoledronic acid in preventing skeletal complications. What seems an embarrassment of choices on paper is in fact a conundrum for the physicians. Each of these drugs reduces the risk of death by 20 to 30%. This looks appreciable at first sight, but, because the trials have been conducted at an advanced stage of progression, it translates into a survival benefit of merely 3 to 4 months. The late-stage disease niche was chosen because the purpose of the trials was to quickly register, and ultimately market, the new drugs. In addition, the benefit of these drugs is not synergic. For example, abiraterone and enzalutamide modes of action are similar resulting in “cross-resistance”. The patient progressing on a drug is very unlikely to benefit from the other. Finally, these drugs have not been tested against each other’s and physicians are left with no clue about the optimal timing for starting and stopping them and about the best sequence or combination of drugs. What’s missing in the battle against prostate

Government Gazette

cancer? Three factors, at least, are keys. First of all, we need massive investment in large international academic platforms that independently study early use of drugs, sequence and combinations. Stampede and Chaarted are academic trials that have evaluated the benefit of docetaxel chemotherapy immediately at diagnosis in metastatic patients and not when the cancer was already resistant to castration. At that earlier stage, docetaxel confers an unprecedented increase in overall survival of 21 months; seven times longer than the benefit seen at the time of resistance to castration. The benefit is impressive for the patient, practice changing, for a cost and a toxicity that is similar to a later use of the drug. Because these studies span over a decade, they challenge the conventional framework of industry’s patent protection. Docetaxel is generic now and the return for Sanofi, the original patent owner of docetaxel, is now negligible. This creates an obvious imbalance between industry sponsored studies proving that a drugs work and academic studies proving when a drug is the most efficient from an individual and a societal perspective. That is why new private-public-academic partnerships must be developed and conditional patent prolonging scenarios must be designed. This is crucial to support trial in cancer with long survival. We need to fill the “translation gap” to understand who dies from cancer and what treatment is most likely to prevent this from happening. In the last decade, we have learned that prostate cancer is an extremely heterogeneous disease. Scientists understand much better the genetic and physiological determinants of this heterogeneity but very

coping with prostate cancer

little of that knowledge is used by clinicians. Patients received broadly validated treatments merely taking into account their individual genetic characteristics. Achieving this will prove crucial in two situations. Firstly, to better identify the 30% of patients with high-risk localized cancer that die from the disease. It is a prerequisite to an early testing of the new drugs in that population. Secondly, to better select patients receiving expansive or toxic drugs to optimize the benefit and cost-efficiency and reduce inappropriate prescriptions. International precision medicine platforms are key initiatives to achieve that goal.

We need to normalize the quality of the delivery of care and include patients reported outcome in the treatment equations. Outside the strict framework of clinical trial, there is no pressure or incentive on clinicians to collect, analyse and report their results. Patients coping with the disease have no reference frame to decide where and how to be treated and what exactly they can expect from treatment. Healthcare providers, including governments, are mostly paying for prescriptions with no or little clue of performance. Considering the gigantic investment that will have to be made to treat cancer, is it still acceptable? The first

and more important step is to secure robust acquisition of quality of indicators by every physician. Initiative conducted by ICHOM needs to be applauded since it provides the first set of consensually accepted indicators ready to be deployed. Proven that we fulfil these three challenges the future of prostate cancer is bright Prof Tombal is Chairman, Division of Urology, Cliniques universitaires Saint Luc, Brussels, Belgium and Chairman Clinical Trial Division, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.

Symptoms, treatment, follow-up and everything you need to know about PCa By Dr. Laurent Fossion, M.D., Urologist, FeBU


xact causes for prostate cancer are still unknown, but dietary habits (Western feeding pattern) and genetic mutations seem to be related to the development of prostate cancer (PCa). In patients with two first line relatives ( <55 year) in their family with PCa, screening is advised. Screening for PCa can reduce PCa mortality (cfr. infra ERSPC-study) Diagnosis and care Serum markers, mainly PSA, still play the most important role in diagnosing PCa disease. Physical digital rectal examination (DRE), ultrasound guided prostate biopsies and multiparametric MRI (mpMRI) are the main tools for local evaluation of prostate cancer. The ERSPC-study showed 27% reduction in prostate cancer mortality among those men who participated in screening (PSAmeasurement and DRE). Screening consists of a single PSA-test at the age of 40 years. If PSA < 1 ug/L, lifetime chance of development of PCa is minimal. For older patients, PSAmeasurement every 2-5 years till the age of 70 years is advised. In men with normal findings on mpMRI, the risk of clinically significant PCa is very low. mpMRI has a detection rate of 44-87% of clinically significant disease (that has influence on life expectancy). It can thus avoid over treatment. Probably only 30% of the patients will need an MRI to improve sensitivity and specificity in PCa screening. The quality of mpMRI interpretation remains very important and should be centralised or supervised by experienced cancer centers (quality control). In this stage the interdisciplinary interface between the oncologic trained urologist, the uro-radiologist and uro-pathologist plays an important role.

Treatment The goal of PCa treatment is to cure patients from their (significant) prostate cancer or to delay/postpone metastases and their impact on health and survival. Active surveillance should be offered to all low risk PCa patients. This will help us to reduce over treatment and the accompanying costs and consequences for the patient. Focal treatment is still under investigation but can be seen an alternative for surgery or external radiotherapy for localised (intermediate risk) disease, but it still has the chance to miss lymph node involvement. Localised, significant PCa disease can be cured by open or minimal invasive surgery (laparoscopic or robotic assisted radical prostatectomy (RP)) or by radiation therapy (RT); the latter in combination with androgen deprivation hormonal treatment (ADT) for 2-3 years. The advantage of the surgical RP approach lies in the ability to perform both the lymph node staging and the treatment with curative intention in one operation and does not necessitate ADT. The rationality for lymph node dissection remains adequate lymph node / disease staging, but the impact on survival is unknown. Risk prediction tools help us to predict the chance of lymph node involvement and confirm the need for certain intermediate and all high risk PCa patients. The ideal number of lymph nodes removed is yet to be determined, but lies around 18-20 lymph nodes. Overall lymph node involvement varies from 1-17%. Quality control and definition of postoperative success is known as pentafecta (free surgical margins, no peri-and postoperative complications, continence, potency, survival). These quality parameters are measured in most

Government Gazette

European cancer centers and aid to optimise the quality of care. So it is clear that the surgeon does matter. Recently even locally advanced prostate cancer seem to benefit from surgical treatment (RP + lymph node dissection), but often necessitate multimodal treatment, using (salvage) radiotherapy to be able to cure these patients. Metastatic disease treatments consist of ADT hormonal treatment to suppress tumour progression and reduce the consequences of metastases. Focal radiotherapy (stereotactic RT) can help to control symptomatic bone metastasis. New insights in early adoption of chemotherapy in aggressive PCa show promising results on prolonged survival. Follow-up Standard follow up after local treatment with curative intention consists of 5 year follow up to evaluate oncologic outcome (immeasurable PSA) and treat functional and psychological consequences of local treatment. In metastatic disease or in case of biochemical recurrence (measurable PSA suiting remaining PCa) the follow-up is at least 10 years to lifetime long. Cost effectiveness Costs in PCa health care are caused by investigational aspects (PSA-test, biopsies, mpMRI, bone scan), treatment costs (operation or radiation therapy + lymph node operation + ADT) and the costs for the purchase of e.g. the operation robot (in contrast to laparoscopic and open surgery) or radiation device and finally the follow up costs and treatment costs for complications and consequences of treatment (early costs after surgery and late costs after radiation therapy)


health report

Innovative therapies must be made accessible to all

Access pathways must foster innovation to address unmet needs, align evidence requirements as treatment options move earlier in the disease course, and remove barriers to access for patients. Jane Griffiths, Group Chairman, Janssen Europe, Middle East and Africa, Janssen Pharmaceutical Companies of Johnson & Johnson writes on enhancing patient access to innovative therapies


he three million European citizens living with prostate cancer stand to benefit from significant improvements in health as a result of new, targeted medicines. As these innovative treatments become available, access pathways must adjust accordingly by fostering innovation to address unmet needs. Evidence requirements must be aligned as treatment options move earlier in the disease course and barriers to access for patients removed when the value of new interventions is clear. Innovation must be fostered to meet unmet medical needs in prostate cancer Innovative, targeted therapies are needed for castration-resistant prostate cancer (CRPC). Research into the genomic alterations present in CRPC has revealed new drug targets as well as novel biomarkers, which present major opportunities for molecular targeting of patient subgroups. New agents have the potential to be effective earlier in the course of disease, slow disease progression and improve health-related quality of life (HRQoL). Maintaining the pace of pharmaceutical research will require parallel innovation in the approach to regulation and appraisal. Recommendations: • Promote early, transparent dialogue among decision-makers and industry throughout the clinical development and life-cycle of medicines, to better identify appropriate regulatory and appraisal requirements. • Encourage the EU Commission to allocate more funds for research through investment in research centres, advanced databases and


patients’ data registries. Patient access is increasingly fragmented in Europe Most countries have a formal Health Technology Appraisal (HTA) process to evaluate the clinical (and sometimes cost-) effectiveness and the broader impact of a health technology on patients and the healthcare system. The evaluation is often used to inform pricing and reimbursement decisions and in some countries, to provide prescribing guidance. There is currently a climate where cost is affecting the up-take of new medications. Countries are adding additional hurdles beyond national HTA at the regional and hospital levels, which focus on cost and price. These processes lack transparency, include limited dialogue with industry, and the patient perspective is not explicitly taken into account. Some processes restrict prescribers to a limited use of new therapies and limit the choice of medicines. These additional processes delay or deny access to treatments that would bring the most value to patients and society. Recommendations: • If a national HTA assessment considers a medicine value for money, it should be made available to appropriate patients without additional hurdles or unnecessary delays. • HTA evaluations should be exclusively based on evidence, including real-world evidence and outcomes of particular relevance to patients. • Collaboration should be encouraged between the pharmaceutical industry, patient groups, physicians, payers, and representatives of the EMA and the EU Health Commission to

Government Gazette

develop standardised tools for HTA assessment Surrogate endpoints and patient-reported outcomes are becoming increasingly important Overall survival (OS) remains the gold standard measure of benefit for regulators. This is most useful in very late-stage disease, as the data will not be affected by patients switching to other effective treatments. As we become better at understanding and diagnosing prostate cancer, and are able to intervene earlier in the course of disease, it may not be realistic to have OS as the gold standard. In pre-metastatic or even local disease, where survival could be up to 10 years, other clinically relevant outcomes, such as overall response rate, progression-free survival, metastasis-free survival and HRQoL should be acknowledged as they offer feasible options to measure clinical benefit. Recommendations: • HTA evaluations should include clinically relevant surrogate endpoints that can address a broad definition of value of early disease stages relevant to patients. • Where OS data are required, HTA should accept adjustments for patients switching drug therapies, and acknowledge the uncertainty of limited long-term data at launch in the evaluation. The patient voice is not always being heard Patients live with the consequences of their condition every day, and have their own individual expectations from treatment. Janssen’s recent collaboration with European prostate cancer patient associations on the Prostate Cancer: Living, not Just Surviving survey highlighted the importance of HRQoL issues, with 66% of patients concerned about fatigue and 85% reporting intimacy problems with their partner. HTA and access discussions should therefore put the patient at the centre of their processes. At present, the degree of patient involvement in national HTA evaluation processes varies by country. For example, patients are not involved formally in France and Italy, whereas England and Scotland have formal processes for patient input. Well-informed patients are vital to this process and Janssen is supporting the efforts of EUPATI to empower patients to engage more effectively in the development and approval of new treatments. Recommendations: Prostate cancer patient representatives should be included in all HTA appraisal processes to provide perspectives on the burden of disease and treatment outcomes. Janssen is including patient perspectives in clinical studies and measuring patient outcome in real life. This patient-centric data should be taken into account in HTA evaluation

coping with prostate cancer

Active surveillance a great alternative to curative therapies The ‘Active surveillance’ protocol has become an alternative to curative therapy for prostate cancer that is unlikely to be biologically or clinically significant. However, Dr Riccardo Valdagni, Director, Radiation Oncology at European School of Oncology says men who choose to be monitored under Active Surveillance need to be thoroughly informed of their disease and the observational program


rostate cancer is the most common malignancy among men, with estimated 1,446,483 new cases and 715,257 deaths in 2012. The number of diagnoses has increased since the introduction of PSA as a routine exam in the early Nineties. The good thing is that up to 50% of the new prostate cancers detected can be considered clinically insignificant or indolent. This is a relatively new concept in oncology and means that these very well localised, small and non aggressive tumors, which are diagnosed with a biopsy following PSA rises, would not cause symptoms and/or cause death during one’s life. Despite this non aggressive behaviour, most of these tumors are still treated with curative standard therapies, i.e. prostatectomy, external radiotherapy and brachytherapy, equally effective treatment options, burdened though by potentially severe side effects. At the same time, we should consider the other side of the coin: there is no way to entirely distinguish upfront, before as well as after the biopsy, non aggressive, clinically insignificant, indolent tumors from aggressive, potentially lethal cancers that need to be treated immediately. In this context of overdiagnosis (cases of early prostate cancer diagnosed following a suspicious PSA, in absence of symptoms) and overtreatment (cases of prostate cancer treated despite their non aggressive and potentially non lethal behavior) active surveillance should be routinely proposed in alternative to radical treatment to very selected men with favourable disease characteristics (in general, PSA < 10 ng/mL, limited disease burden, Gleason score 3+3). Active surveillance is an observational program which monitors the disease by PSA (usually every 3 months), digital rectal examination (usually every 3-6 months) and follow up biopsy (the frequency of the procedures differs according to protocols, with the first rebiopsy usually after 12 months since diagnosis). An

extra biopsy could be prescribed if the PSA Doubling Time, which evaluates the PSA trend over time, is less than 10 years and causes worries. Another exam that has recently gained a new emerging role is the multiparametric Magnetic Resonance Imaging, a very sophisticated procedure which is able to identify areas of more aggressive disease and thus be helpful in addressing and targeting biopsy. Considering the slow evolution of low and very low risk prostate tumors and the possibility of maintaining the chances of curability if treatment becomes necessary, active surveillance permits to avoid or delay treatment and therapy induced side effects until the eventual change of the tumor initial characteristics. It is therefore clear that follow up plays a crucial role since it enables us to monitor the tumor behaviour and potentially detect the more aggressive forms, which may benefit from treatment. It is for this reason that active surveillance protocols need to have well defined criteria for inclusion, follow up and discontinuation. This helps in the selection and monitoring of patients, ready to switch to treatment if the tumor behavior changes. Reasons to discontinue the active surveillance program are usually related to the reclassification of the disease at the rebiopsy. Data coming from the pathologic results shows the upsizing, that is the increase in the number of positive cores over the limit stated in the protocol, and the upgrading, that is the change of the Gleason score, i.e higher than 3+3. Reclassification at biopsy more often happens in the first two years of active surveillance. If this is the case, it most likely does not mean the initially diagnosed tumor is evolved in a more aggressive form, rather the second biopsy enabled to better sample the prostate. Until a few years ago another cause to discontinue active surveillance was PSA Doubling Time if less than 3 years. Since active surveillance studies showed that PSA Doubling Time is not reliable enough to predict an

Government Gazette

aggressive tumor, it is now considered a warning to be paid attention to, which might induce the prescription of an extra biopsy or a multiparametric Magnetic Resonance Imaging when available, rather than the immediate discontinuation of the active surveillance program. Although active surveillance is included as an option for low and very low risk prostate cancer in the most important international guidelines, further research is urgently needed to better understand the nature of the tumor and trying to take benefit from non-invasive indicators of its progression or reclassification. Research is currently focused on finding genetic signatures of positive biopsy and adjacent normal tissue and on studying biomolecular markers possibly present in urine and blood (the so called liquid biopsy). Until then, even if AS is part of the most important international guidelines, we believe that active surveillance should be proposed within protocols authorized by the institutional Ethical Committee. What is more, men with prostate cancer who choose to be monitored in active surveillance protocols need to be thoroughly informed of their disease and the observational program. It is important that these patients understand that active surveillance is proposed as an alternative to curative therapies and should be considered in the same way as a treatment. Men need to accept and be compliant to the follow up program, which includes periodic biopsies, a procedure with potential side effects they have to be made aware of. After being well informed on active surveillance, men with prostate cancer should sign an informed consent and thus share with their clinicians the responsibility of being on surveillance


health report

The role of MRI in prostate cancer expands

The role of imaging techniques such as multiparametric MRI (mpMRI) in prostate cancer is set to expand in the coming years, particularly in cases where technology is more integrated with treatment. Prof Jelle Barentsz, Professor of Radiology, Radboud Prostate MR-Reference Center discusses the details


he main disadvantages of the current diagnostic pathway in men with an elevated risk of prostate cancer (PCa) are that: (a) systematic transrectal ultrasound (TRUS) prostate biopsy (PB) misses a substantial proportion (20%) of significant PCa because of inherent systematic sampling errors, especially in the anterior prostate [1,2]; (b) misclassifies pathologic status including Gleason score (GS) and tumour stage [3]; and (c) detects a high proportion of men with disease that is unlikely to be harmful (clinically insignificant), with subsequently overtreatments resulting in unintended harm [4]. The latter was the main reason for the U.S. Preventive Services Task Force recommendation against prostate-specific antigen- based screening for prostate cancer in 2012 [5]. Can multi-parametric MRI solve these problems? There is increasing evidence, such as two Level 1a systematic reviews [6,7], a Level 1a prospective clinical randomised trial [8], and multiple Level 1b studies [9,10], that multi-parametric magnetic resonance imaging (mpMRI) is the best method of visualising primary significant PCa. It is, therefore, widely accepted that mpMRI has the performance characteristics to help manage men with suspected or proven PCa [11,12]. The clinical utility in terms of the ability to ‘‘rule in’’ and ‘‘rule out’’ the presence of significant disease depends on using the mpMRI approach, image quality, reading system, and reporter expertise [13–16]. The cancer detection ability of mpMRI is dependent on the anatomic location, tumour volume, and aggressiveness (GS) of the underlying cancer [3]. mpMRI detected lesions


are not always significant malignant lesions [17]; false positive cancer/non-cancer cases do occur, thus adequate biopsy sampling is mandated for each lesion detected [18]. What type of cancers does mpMRI-TB detect? Literature indicates an improved ability of mpMRI-PB is to detect clinically significant cancers. A recent systematic review showed that the detection rate of clinical significant cancer is higher (44–87%) than the rates reported for TRUS-PB [7], depending on the definition of clinical significance used for targeted biopsy; this ability applies equally to biopsy naıve and men with prior negative biopsies. Histologic grades on mpMRI-TB show high concordance (88%) with final pathology after prostatectomy, which is a sharp contrast to TRUS-PB (55% concordance rate) [3]. Does mpMRI-PB systematic miss clinically significant disease? The key questions are: (1) what proportion of men with negative mpMRI harbour cancers that would require radical therapy if detected; and (2) what proportion of patients with significant disease would be detected by an additional backup TRUS-PB? The reported negative predictive value (NPV) of mpMRIPB for significant disease has been reported to be high: 63-98% [7]. The central issue is the balance between benefits and limitations of mpMRI- targeted biopsy (TB) when used alone compared with the strategy of combined mpMRI-TB with backup TRUS-PB in men with positive mpMRI findings. This was recently addressed in a very large prospective trial [9]. In 1003 men, there were additional

Government Gazette

cancers detected when mpMRI-TB was combined with TRUS-PB. However, of the 103 additional cancers detected, the majority were low risk (83% low risk; 5% high risk). Importantly, 200 combined biopsies yielded only one additional high-risk cancer, but overdiagnosed 17 low risk cancers. Also, there was no change in risk stratification in the majority of patients (857 patients; 85%), with only 19 men (2%) converting from no-cancer or low risk disease to intermediate or high risk with the combined approach. Taken together, these and other data strongly argue against the strategy of combining mpMRI-PB with systematic TRUS-TB in order to improve biopsy yields. Is there a performance difference of mpMRITB in biopsy naive patients compared with those with previous negative TRUS-PB? In previous negative biopsy patients, mpMRIPB greatly increased detection rates (+54%) of significant cancers and markedly reduced (-49% and -18% respectively) insignificant cancers detection, rendering the mpMRI-TB approach clinically effective. Thus both the European Association of Urology 2015 and the UK National Institute of Clinical and Care Excellence 2014 guidelines recommend mpMRI before repeat TRUS biopsy. UK National Institute of Clinical and Care Excellence 2014 additionally recommends against a second biopsy if mpMRI is negative, unless high-risk features are present [11]. Challenges To enhance interdisciplinary communications between radiologists and referring clinicians, it is essential that uniform, understandable terminology and content of radiology reports be used. Reports should include assessment categories of suspicion for clinically significant disease to facilitate the use of targeted biopsy. The Prostate Imaging Reporting and Data System (PI-RADS) of the European Society of Urogenital Radiology (ESUR) has been widely accepted and validated [19]. A new PI-RADS version 2 was recently adopted by the American College of Radiology and ESUR, but has yet to be validated [20,21]. To incorporate mpMRI findings using the PI-RADS system with biopsy strategies new pathways should be developed [22]. Training and quality controls Furthermore, to achieve and maintain good mpMRI diagnostic performance, adequate training, supervision, and quality-control of the acquisition of the images, the PI-RADS assessment, and the targeted biopsy procedure are needed. This is particularly true when complex image registration procedures are needed to enable small lesions to be sampled. Importantly, histology feedback is required with continuous audit checks within the multi disciplinary care teams. An important consideration for these teams is, what to do

coping with prostate cancer

when a negative biopsy is obtained from a highly suspicious region on imaging. Extensive training programs by Specialised Prostate MRI Centres must be developed in order to fulfil the rapidly increasing demand of mpMRI. These Specialised Centres will train and certify multiple Diagnostic Centres of Excellence throughout Europe, where diagnosis of prostate cancer is optimized. To ensure continuous high quality, the training and certification should be followed by a quality control program. In this way, a European prostate diagnostic network of Specialised Prostate MRI Centres (for training and QC) and Diagnostic Centres of Excellence (to provide best quality care) will be created. The potential advantages of such a prostate network are: a) better quality through double reading and inter-collegial consultation, b) faster implementation of newly validated techniques, c) will allow sharing knowledge, and d) create large scientific databases to speed up the validation process. For double reading of prostate mpMRI already tools are available and in some places implemented, being internet connected PI-RADS workstations. Costs The upfront cost per cancer diagnosed is greater using mpMRI-PB methods, in part because of the need for capacity building and tooling up. This may be counterbalanced by changes in the risk stratification of diagnosed patients towards those requiring radical treatments. Modelling studies in the Netherlands and the United Kingdom suggested that an mpMRI-PB strategy can be cost-effective while maintaining the benefits of reduced overdiagnosis and overtreatment together, with improvements in quality of life [23,24]. To get health service provider buy-in, the therapeutic consequences of mpMRI-PB also need to be considered [25]. Conclusions mpMRI-PB changes the risk stratification of men diagnosed with prostate cancer towards improved detection of men with cancers requiring radical treatments. To realise the clinical benefits of mpMRI-PB without overwhelming current resources, appropriate patient selection and investments in diagnostic and communication tools are needed. Imaging interpretation should be aligned with clinical management plans. Effective communication of imaging findings and improved urologic understanding of imaging uncertainties will improve the outcomes for men with suspected prostate cancer. To meet the increasing demand of mpMRI a prostate network of Specialised Prostate MR Centers for training and QC, and Diagnostic Centers of Excellence to provide optimal care should be established as soon as possible * This paper is based on Barentsz et al [26] and Padhani et al [22].


Prof Jelle Barentsz, Professor of Radiology

[1] Djavan B, Ravery V, Zlott A, et al. Prospective evaluation of prostate cancer detected on biopsies 1, 2, 3 and 4: when should we stop? J Urol 2001;166:1679–83. [2] Guichard G, Larre´ S, Gallina A, et al. Extended 21-sample needle biopsy protocol for diagnosis of prostate cancer in 1000 consecutive patients. Eur Urol 2007;52:430–5. [3] Hambrock T, Hoeks C, Hulsbergen-van de Kaa C, et al. Prospective assessment of prostate cancer aggressiveness using 3-T diffusion-weighted magnetic resonance imaging-guided biopsies versus a systematic 10-core transrectal ultrasound prostate biopsy cohort. Eur Urol 2012;61:177–84. [4] Bul M, van den Bergh RC, Zhu X, et al. Outcomes of initially expectantly manged patients with low or intermediate risk screen- detected localized prostate cancer. BJU Int 2012;110:1672–7. [5] Moyer V. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2012;157: 120–34. [6] Schoots IG, Roobol MJ, Nieboer D, et al. Magnetic resonance imaging– targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultra- soundguided biopsy: A systematic review and meta-analysis. Eur Urol 2015. eururo.2014.11.037 [7] Futterer JJ, Briganti A, De Visschere P, et al. Can clinically significant prostate cancer be detected with multiparametric magnetic reso-nance imaging?. A systematic review of the literature. Eur Urol 2015. eururo.2015.01.013 [8] Panebianco V, Barchetti F, Sciarra A, et al. Multiparametric MRI vs. standard care in men being evaluated for prostate cancer: A ran-domised study. Urol Oncol 2015;33, 17.e1–7. [9] Siddiqui MM, Rais-Bahrami S, Baris Turkbey B, et al. Comparison of MR/Ultrasound Fusion–Guided Biopsy With Ultrasound-Guided Biopsy for the Diagnosis of Prostate Cancer. JAMA 2015;313: 390–7. [10] Pokorny MR, de Rooij M, Duncan E, et al. Prospective study of diagnostic accuracy comparing prostate cancer detection by trans-rectal ultrasound-guided biopsy versus magnetic resonance (MR) imaging with subsequent MRguided biopsy in men without pre-vious prostate biopsies. Eur Urol 2014;66:22–9. [11] National Institute for Health and Care Excellence 2014 recom- mendations. chapter/ 1-recommendations [12] European Association of Urology 2015 Guidelines for prostate cancer. LR.pdf [13] Vache T, Bratan F, Mege-Lechevallier F, et al. Characterization of prostate lesions as benign or malignant at multiparametric MR imaging: comparison of three scoring systems in patients treated with radical prostatectomy. Radiology 2014;272:446–55. [14] Gaziev G, Wadhwa K, Barret T, et al. Defining the learning curve for mutliparametric MRI of the prostate using MRI-TRUS fusion-guided transperineal prostate biopsies as a validation tool. BJU Int 2015. bju.12892, [15] Muller BG, Shih JH, Sankineni S, et al. Prostate cancer: interobserver agreement and accuracy with the revised prostate imaging report-ing and data system at mp MRI. Radiology 2015. 10.1148/radiol.2015142818, In press.

Government Gazette

[16] De Rooij M, Hamoen EHJ, Futterer JJ, et al. AJR. Accuracy of multi-parametric MRI for prostate cancer detection: a Meta-Analysis. AJR 2014;202:343–51. [17] Bour L, Schull A, Delongchamps NB, et al. Multiparametric MRI. features of granulomatous prostatitis and tubercular prostate ab-scess. Diagn Interv Imaging 2013;94:84–90. [18] Willis SR, Ahmed HU, Moore CM, et al. Multiparametric MRI followed by targeted prostate biopsy for men with suspected prostate cancer: a clinical decision analysis. BMJ Open 2015. bmjopen-2014-004895, In press. [19] Barentsz JO, Richenberg J, Clements R, et al. ESUR prostate MR guidelines 2012. Eur Radiol 2012;22:746–57. [21] Barentsz JO, Weinreb, Verma S, et al. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. European Urology 2016;69:41-9. [22] Weinreb J, Barentsz JO, Choyke PL. PI-RADS Prostate Imaging- Reporting and Data System: 2015 version 2. European Urology 2016;69:16-40. [22] Padhani AW, Petralia G, Sanguedolce F. Magnetic Resonance Imaging Before Prostate Biopsy: Time to Talk. European Urology 2016;69:1-3. [23] De Rooij M, Crienen SJ, Witjes JA, et al. Costeffectiveness of magnetic resonance (MR) imaging and MR-guided targeted biopsy versus systematic transrectal ultrasound–guided biopsy in diag-nosing prostate cancer: A modelling study from a health care perspective. Eur Urol 2014;66:430–6. [24] Mowatt G, Scotland G, Boachie C, et al. The diagnostic accuracy and cost-effectiveness of magnetic resonance spectroscopy and enhanced magnetic resonance imaging techniques in aiding the localisation of prostate abnormalities for biopsy: a systematic review and economic evaluation. Health Technol Assess 2013; 17:vii–xix, 1–281. [25] Willis SR, Ahmed HU, Moore CM, et al. Multiparametric MRI followed by targeted prostate biopsy for men with suspected prostate cancer: a clinical decision analysis. BMJ Open 2014;4: e004895.


health report

Towards a paradigm shift in diagnosis and management Over the past years, there has been a fundamental change in the way prostate cancer has been diagnosed and treated, with patients having a greater variety of options to choose from. Prof


Van Velthoven, Head of Urology,


he last few decades were marked by a widespread use of PSA-based prostate cancer screening and hence by an exponential rise in the number of prostate biopsies, in terms of patients and of biopsies per patient. Some of these biopsies were unnecessarily performed while others missed significant prostate cancers. In addition, more men with low-risk prostate cancer were diagnosed and some were thus unnecessarily treated. The limited specificity of PSA and the low detection rate of prostate cancer on TRUS-guided biopsy generated much of the controversy existing about prostate cancer screening. Furthermore, the poor sampling of cancers under 2D TRUS and the underestimation of Gleason score widely opened the door for the development of more accurate strategies for the diagnosis of prostate cancer. In this context, we had already reported, in a previous study of biopsy-na誰ve men, higher detection rate using the 3D system of Koelis Urostation速 without MRI fusion compared to standard protocol (50% vs. 33%, p < 0.05) ) (1). Our results reflected a wider distribution of prostate cores inside the prostate and thus better sampling. Afterwards, we integrated MRI-targeted biopsy using the same system into our practice. This yielded an overall cancer detection rate of 62.7%, which is higher than most of the studies reporting on standard biopsy (2). In addition, in our study, TAR protocol improved prostate cancer detection rate compared to STD protocol and


Institut Jules Bordet, says the trend is set to continue and the future appears even brighter, particularly in molecular and genetic understandings of tumors

demonstrated higher detection rate of clinically significant disease with fewer tissue samples removed from lesions. In addition, we have used a combined localisation strategy based on a complete match between multiparametric MRI and transrectal ultrasound (TRUS) guided systematic biopsy to assess feasibility, safety, and short-to-mediumterm oncological and functional outcomes of hemiablation HIFU. Results were promising as hemi-ablation HIFU of an entire lobe, delivered with the intention to treat, was a feasible and safe procedure.(3) Functional and oncological outcomes were also encouraging at 3-years of follow up as demonstrated in our recently published updated series.(4) This is a timely issue given the recent concerns about the quality of life of prostate cancer survivors. The principal rationale of such an approach is harm reduction without compromising cancer control: early self-resolving LUTS were the most common complications but no rectal toxicities were reported and the strategy was well tolerated in the genitourinary functional domains. The procedure can also be delivered in an ambulatory care setting. This treatment strategy was associated with a good mediumterm cancer control in well-selected patients (unilateral low- to Intermediate-risk prostate cancer). Furthermore, patients with bilateral significant prostate cancer can also be safely treated by whole gland ablation with good outcomes (5). In our match cohort analysis, functional and oncologic outcomes were similar

Government Gazette

between patients treated by brachytherapy and those offered whole gland HIFU (6). However, the earlier decrease of PSA in the HIFU group compared to the brachytherapy group allowed better stratification of responders. In parallel, recent developments of molecular and clinical imaging with better specificity and sensitivity than anatomic imaging provided clinicians with the opportunity to detect lymphatic and/or haematogenous prostatic metastases at an earlier point in the disease progression, resulting in a treatment window for what was called oligo-metastatic disease(7). Since then, a paradigm shift toward more aggressive local control of primary tumor and/ or small number of metastatic lesions has gained interest in the oncologic centres of excellence. In our institution, we have implemented such an approach based on the most accurate metabolic imaging for prostate cancer that is PSMA- PET. In our experience, inherited from our routine practice of large cohorts of robot assisted laparoscopic prostatectomy for organ confined prostate cancer, radical prostatectomy remains safe, feasible and offers good local control in well-selected oligometastatic patients. Apart from the debatable oncologic effect of local control - at present the primary endpoint was to delay ADT - the main advantage is the symptomatic locoregional improvement. Several complications encountered in the late stages of metastatic prostate cancer could be avoided. This could

coping with prostate cancer

translate into an improvement in the quality of life of many patients. Actually, one should bear in mind that treating the primary tumor in such patients remains outside of all urologic guidelines and should be preferably offered under the umbrella of clinical trials. Of note, some of the patients already treated with primary radiation therapy are accurately diagnosed with PSMA-PET showing an isolated organ confined recurrence. In the same way, these patients are offered a curative treatment instead of palliative ADT, a common mistake in the current practice of urology. These patients were treated by salvage whole gland HIFU or hemiablation according to the results of MRI and MRI targeted biopsies. Our

results with both strategies are encouraging, keeping in mind the morbidity of salvage radical prostatectomy in this setting.

3. van Velthoven et al., Prostate Cancer 2014

Finally, we are witnessing at the moment, a paradigm shift in the diagnosis and management of prostate cancer. The future appears even brighter when we see the enormous efforts and advances in molecular and genetic understanding of prostate cancer tumors. The development of new accurate biomarkers will lead cancer revolution and personalized care in men with prostate cancer

5. Limani et al., Prostate Cancer 2014

4. van Velthoven et al., Prostate Cancer Prostate Disease 2015

6. Aoun et al., Advances in Urology 2015 7. Aoun et al, BioMed Research International 2015

References: 1. Peltier et al., Prostate Cancer 2014 2. Peltier et al., BioMed Research International 2015

Rethinking doctorpatient relationships in a digital era By Prof. Louis Denis, M.D. FACS


hough we live in a digital era, most patients reportedly leave their oncologists’ clinics with several questions unanswered.

A great deal of patient dissatisfaction and several complaints are due to breakdown in the doctor-patient relationship. The age old bond between the treating physician and his patient, aptly called ‘le colloque singulier’ is simply lost in the explosion of our oncological knowledge and the proven subsequent need to multidisciplinary medical treatment and multiprofessionality in providing holistic solutions. Should the oncologist be blamed? With the evolving complexity of cancer at different levels, communication and collaboration between doctors and patients become extremely essential in treating any cancer according to evidence based criteria. Guidelines and monograms ease the direction of the treatment but apply to cohorts of cancer patients and not necessarily to individual

patients with unique genetic make-ups and specific psychological, social, financial and spiritual needs. Should the patient take the blame instead? The question of who is to be blamed is often unrequited. It might be extremely difficult – both for the patient and the doctor – to handle the initial phases of diagnosis of cancer. To the patient, it might often read like a death sentence or at the least a drastic change in lifestyle. In the current healthcare climate, both doctors and patients have very little time to communicate and recover from the initial shock. The patient never gets sufficient time to fully come to terms with the medical situation and is often forced to quickly learn the nitty-gritty’s, initiate a dialogue with the treating crew and express their autonomy in a shared decision to initiate the cancer treatment and survivorship. Holistic cancer management unquestionably requires a well-established balance between tumor-centered treatment and patient-

Government Gazette

centered care. The tumor-centered treatment is multidisciplinary in nature, essentially based on evidence and forms the scientific base of cancer treatment. Patient-centered care, on the other hand is the multiprofessional aspect involving psycho-social, financial and spiritual expertise and is focused on the patient. Often, the patient comes first before his cancer. The doctor-patient relationship itself is a strong drug! Furthermore, personalised medicine and individualised treatment routines are particularly crucial in successfully diagnosing and treating cancer, as treatments often differ based on the characteristics of the tumour and its genetics. We are entering a new era of cancer treatment with unlimited expectations. Without any doubts, it will take many years to see this tailored treatment become mainstream. We should be aware of this evolution, move into clinical trials and support further research


health report

Latest advances in prostate cancer research and clinical practice

Prostate cancer treatment and care is enjoying great times in terms of expanding available treatment options, such as DC vaccine as well as improving technology in managing early prostate cancer such as robotic surgery. However, more research has to translated into clinical practice fairly quickly, in order to provide patients with better quality of life, says Dr Anjali Zarkar, Consultant Clinical Oncologist, University Hospital Birmingham


n management of prostate cancer, it remains challenging as on one hand there is evidence that the disease is over diagnosed and the men are put through interventions which affect their quality of life (incontinence and impotence) in spite of indolent disease, while on the other extreme it is the third commonest cause of death amongst men in Europe and fourth commonest cause of death in the UK (1, 2). Fortunately, recent data suggests that more and more men with early prostate cancer have been offered active surveillance as an option with the hope that unnecessary morbidity of the treatment is either delayed or avoided.


Dr Charles Huggins in 1941 first published in scientific journal, the relationship of the endocrine gland and prostate gland for which he received Nobel prize. His scientific discovery leads to androgen suppression treatment through removal of the testicles for men with advanced prostate cancer. Over the decades, this has been the most important advancement. Late 20th century, medical/ non surgical castration was the only treatment option for men with advanced disease. Androgen suppression treatment (ADT) alone has offered elderly men with advanced prostate cancer, providing enormous relief and alleviation of pain occurring due to shrinkage of cancer in bones within days. But we had to wait

Government Gazette

until 21st century for further advances in management of advanced prostate cancer. Fortunately, in the 5 years we have seen many therapeutic developments such as newer agents (Abiraterone, Enzalutamide, ARN 509, Cabazitaxel, radium 223) as well as benefit of using chemotherapy in early/ hormone sensitive stage of advanced prostate cancer. Last year we saw publication of 2 large clinical trials showing addition of 6 cycles of Docetaxel chemotherapy in men who are commencing on long term androgen deprivation treatment for metastatic disease have extension in life over 10 to 17 months (3,4). This is great news for our patients. The change in the clinical practice is

coping with prostate cancer

likely to provide better quality of life for these men as they are likely to spend less time in castration resistant phase of the disease. Licensing of the newer androgen directed treatments through either inhibition of androgen synthesis or direct inhibition of androgen receptor, has shown improved survival for patients in large phase III trials (7, 8, 9, 10). These patients were previously thought to be refractory to hormonal manipulation (metastatic castration resistant prostate cancer). These results have been practice changing and have provided expansion of systemic therapy in the disease. We need more research and trials looking into AR signaling, mechanism of its resistance to manipulate and expand the treatment options. The next development in treatment of metastatic castration resistant prostate cancer with bony metastatic disease was the new radioisotope, Radium 223. The large phase III trial published in 2013, showed very well tolerated treatment which offers not only improvement in pain but extension of survival (6). While we have more information on using older agents such as ‘Docetaxel’ early in the management of advanced prostate cancer (3, 4), we need more research into sequencing of the newer agents in the management of the high risk and advanced prostate cancer. There is exciting research looking into resistance to newer treatments such as Enzalutamide or Abiraterone due to a splice variant of the androgen receptor. As we speak, patients have been recruited into clinical trials to try newer agents who are likely to be effective in patients who are likely to be resistant to the newer androgen directed treatments due to variant androgen receptor. Attitudes of the clinicians have changed in management of advanced prostate cancer due to expanding treatment options. Patients are offered active treatments with minimal side effects rather than being managed as end of life/ palliative treatment. In spite of improvements in the available treatment options, supportive care and improving attitudes towards treating men with advanced metastatic prostate cancer, survival in these men remains poor without additional treatments (5). Prostate cancer treatment and care is enjoying great times in terms of expanding available newer treatment options such as DC vaccine, gene therapy as well as improving technology in managing early prostate cancer such as robotic surgery or stereotactic radiotherapy. However, we need more research being translated into clinical practice fairly quickly so our patients can enjoy long and better quality of life

References: 1. Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Available from: (link is external), accessed December 2013. 2. Data were provided by the Office for National Statistics on request, July 2014. Similar data can be found here: http://www. (link is external). 3. Chemohormonal therapy in metastatic hormone sensitive prostate cancer; NEJM 373(8):737-746, August 2015. 4. Addition of docetaxel, zoledronic acid, or both to fi rst-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial; ND James et al, The Lancet, published on line on 21st December 2015.

5. Survival in newly diagnosed metastatic prostate cancer in the ‘Docetaxel era’: Data from 917 patients in the control arm of STAMPEDE trial (MRC PRO8, CRUK/06/019) ND James, Matthew sydes et al; European urology 67(2015)1028-1038. 6. Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer: C Parker et al, NEJM, 2013; 369:213-223. 7. Abiraterone in metastatic prostate cancer without previous chemotherapy: Charles Ryan et al: NEJM 2013 8. Abiraterone and increased survival in metastatic prostate cancer,: Johann S De Bono et al: NEJM 2011. 9. Increased survival with enzalutamide in prostate cancer after chemotherapy: Howard Scher et al; NEJM, 367(13); 1187-1197, Sep, 2012. 10. Enzalutamide in metastatic prostate cancer before chemotherapy; Tomaz Beer et al; NEJM, 371; 424-433;July 2014.

Improved health-related quality of life A valid clinical benefit

Health policy and regulatory bodies should align themselves to improve patient access to clinically safer treatments that decrease the burden on health related quality of life. Leslie Wise, JD, Vice President of Global Healthcare Economics, AngioDynamics explains how such an improved health-related quality of life can provide clinical benefits


rostate cancer (PCa) is the most common primary site of cancer diagnosis in European men (22.8% of the total). (1) Due to aggressive screening policies globally, PCa is often diagnosed at an early stage. Improved screening with the prostate specific antigen (PSA) test and advanced imaging techniques allow most patients to be diagnosed with low- and intermediate risk local disease. (2) The early stages of PCa commonly stay symptomless for years and may never impact mortality. (3)

Using conservative treatment in low-risk Pca patients instead of radical prostatectomy or radiation therapy is a mitigation strategy for avoiding the untenable side effects of urinary incontinence (0-20%), bowel problems (2236%) and erectile dysfunction (19-74%). Nevertheless, for all patients with PCa, regardless to risk level, the psychological impact a cancer diagnosis has a serious impact on patient health related quality of life. This stress is often a compelling motive to choose active treatment over watchful waiting.

As a result, there is much debate regarding the value of PSA screening, with over diagnosis and over treatment as central themes. NIH 2011 conference statement suggested active surveillance or watchful waiting (WW) as a viable option for patients with low-risk PCa. (4)

Health policy, regulatory, and funding bodies must align to build evidence for viable alternatives from these “all or nothing” options and provide patients access to safe, innovative active treatment options which improve patient’s health related quality of life and extending overall survival.

Government Gazette


health report

Stakeholders including policy makers, funders, health technology assessment bodies, clinicians and patients are faced with a growing body of contrasting evidence which complicates treatment strategy decisions. Recent evidence from a randomized trial of RP versus WW in men with localized PCa diagnosed before the emergence of PSA screening, showed a survival benefit of RP as compared with WW of 15 years. [5] On the other hand, the PIVOT trial, initiated in the early era of PSA screening, showed that RP did not significantly reduce PCa–specific or overall mortality after 12 years. [6] And most recently, a systematic review and meta-analysis confirms that surgery improves overall survival (OS) as compared to radiotherapy. (7) The current state of the evidence seems to strongly suggest that Radical Prostatectomy (RP) provides a clinically significant survival benefit over radiotherapy across all levels of PCa risk. (7) The data on watchful waiting is less clear. In patients with medium and high risk PCa, active treatment is accepted as the appropriate course of action based upon the established evidence. In low-risk, localised PCa, the evidence on overall survival remains contestable. When the quality of life evidence is incorporated, however, clarity emerges. (5-8) Using the data generated by the cross-sectional study within the SPCG-4, with 4 years of follow up, obstructive voiding symptoms were less frequent among men treated with RP, but sexual side effects and incontinence were more common. [8] When follow-up was extended to a mean of 12 years, men in the RP group reported more distress from their symptoms, suggesting a negative psychological utility for surgical interventions. Overall quality of life (QoL) decreased in both groups through 12 years of follow-up; anxiety was more prevalent among both the RP and WW groups than the disease-free controls [8]. The clinical data


conclusively establishes improved OS with RP when compared to radiotherapy, but an OS benefit for RP vs WW is not as clear. Sadly, all three clinical strategies demonstrate a negative impact on PCa health related quality of life. Where do we go from here? NanoKnife is a CE marked medical device which may be used for the treatment of prostate cancer. It is differentiated therapy designed and proven to spare vascular and critical structures (such as the urinary sphincter, rectum and neurovascular bundles) and preserve options for re-intervention. NanoKnife is a focal therapy, offering patients a minimally invasive treatment providing the curative benefits of surgery, such as clinically proven negative margin clearance, while minimizing adverse effects which reduce HRQOL. (9,10) The body of evidence in cancer demonstrates active therapy provides better OS than WW, prostate cancer appears no different. The concept of RP is to provide a curative option to the patient in hopes of preventing death. Therefore, the increased examination of the role of innovative minimally invasive focal therapies, such as NanoKnife, is critical to providing improved care to patients References: 1. Ferlay, J., Steliarova-Foucher, E., Lortet-Tieulent, J., Rosso, S., Coebergh, J.W., Comber, H., Forman, D., Bray, F., 2013. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur. J. Cancer 49, 1374–1403 2. Bartsch G, Horninger W, Klocker H, Pelzer A, Bektic J, et al. (2008) Tyrol Prostate Cancer Demonstration Project: early detection, treatment, outcome, incidence and mortality. BJU Int 101: 809-816. 3. Cooperberg MR, Lubeck DP, Mehta SS, Carroll PR; CaPSURE (2003) Time trends in clinical risk stratification for prostate cancer: implications for outcomes (data from CaPSURE). J Urol 170: S2125.

Government Gazette

4. NIH State-of-the-Science Conference Statement on Role of Active Surveillance in the Management of Men With Localized Prostate Cancer, 2011 5. Bill-Axelson A, Holmberg L, Ruutu M, Garmo H, Stark JR, Busch C, Nordling S, Häggman M, Andersson SO, Bratell S, Spångberg A, Palmgren J, Steineck G, Adami HO, Johansson JE; SPCG-4 Investigators. 2011. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med. 364(18):1708-17. 6. Chang, Y., 2013. The Prostate Cancer Intervention Versus Observation Trial (PIVOT) in Perspective. J Clin Med Res. 2013 Aug; 5(4): 266–268 7. Wallis CJ, Saskin R, Choo R, Herschorn S, Kodama RT, Satkunasivam R, Shah PS, Danjoux C, Nam RK. 2015. Surgery Versus Radiotherapy for Clinically-localized Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2015 Nov 30. pii: S0302-2838(15)01160-4 8. Bill-Axelson A, Garmo H, Holmberg L, Johansson JE, Adami HO, Steineck G, Johansson E, Rider JR. 2013. Long-term distress after radical prostatectomy versus watchful waiting in prostate cancer: a longitudinal study from the Scandinavian Prostate Cancer Group-4 randomized clinical trial. Eur Urol. 2013 Dec; 64(6):920-8. 9. Van den Bos W, De Bruin DM, Veelo DP, Postema AW, Muller BG, Varkarakis IM, Skolarikos A, Zondervan PJ, Laguna Pes MP, SavciHeijink CD, Wijkstra H, De Reijke TM and De La Rosette JJMCH. 2015. Quality of Life and Safety Outcomes Following Irreversible Electroporation Treatment for Prostate Cancer: Results from a Phase I-Ii Stud. , J Cancer Sci Ther 2015, 7:10. 10. Valerio M1, Dickinson L2, Ali A3, Ramachandran N4, Donaldson I2, Freeman A5, Ahmed HU2, Emberton M2. 2014. A prospective development study investigating focal irreversible electroporation in men with localised prostate cancer: Nanoknife Electroporation Ablation Trial (NEAT). Contemp Clin Trials. 2014 Sep;39(1):57-65.

coping with prostate cancer

No “one size fits all” in prostate cancer

The incidence of prostate cancer in gay and bisexual men is the same as in hetrosexual men. Andrew Gilliver, Community Involvement Manger, LGBT Foundation discusses why very little is known about services for this group of men


rostate cancer is undoubtedly the most common cancer in Europe for males, and the third most common cancer overall. With over 400,000 new cases diagnosed every year it is clear that this form of cancer is affecting a wide and diverse group of people. There are more than two million people in the UK alone living with all forms of cancer and it is estimated that 40,000 of these are from LGBT communities. Although the incidence of prostate cancer in gay and bisexual men is the same as in heterosexual men, the psycho-social effects may differ and there is little or no research or resources in the UK about cancer among trans people. According to the ‘Stonewall Gay and bisexual Men’s Health Survey’ across Britain in 2012, 90% of gay and bisexual men in the UK have never talked with a healthcare professional about prostate cancer, more than two thirds – about 68% -- of gay and bisexual men aged over 50 have not had a discussion. However, in the last few years, greater awareness has been created in communities affected by prostate cancer who may be gay, bisexual or other men who have sex with men whose support needs are not being met, not to mention the invisibility of trans women who may not identify as male and may not have had a prostatectomy as part of any gender reassignment surgery. There is evidence that healthcare professionals need support in understanding and empathising with the

needs of this community. Without an improved working relationship between healthcare professional and gay, bisexual and trans (GBT) patients there is a risk that GBT people with prostate cancer may make less than ideal decisions about their treatment and care. Although there is a need to improve education and training of healthcare professionals, there are organisations that are looking specifically at the needs of LGBT people affected by all cancers. In the UK, Macmillan Cancer has recruited their first ever full time LGBT project worker to look at the needs of this community. The US has also been discussing LGBT patient’s experiences of cancer. In Europe individual organisations such as Prostate Cancer UK are including LGBT service users in their wider work by producing targeted information for gay and bisexual men. Individual LGBT organisations such as LGBT Foundation, based in Manchester have been highlighting these issues and support for groups such as Out with Prostate Cancer (OWPC) the UK support group who inform health professionals and community members alike. Community surveys suggest that gay men in general drink and smoke more than straight men, putting them at greater health risk. There is currently an absence of reliable data on the health needs of gay and bisexual men and many gay and bisexual men don’t discuss cancer with a healthcare professional. There is a need for gay and bisexual men to become more aware of the risks of health issues such as cancer, and be more open about discussing their sexual orientation with health professionals to help them understand wider health issues.

Government Gazette

The wider issue of gay and bisexual men being treated with hormone therapy for prostate cancer is of concern, especially for men who have sex with men. In some countries, chemical castration has been historically used to treat homosexuality as well as prostate cancer and this clearly needs to be taken into account by health professionals when counselling this group. Currently, little is known about the cancer risks of transgender women and hormone use and further research is needed. Transgender people experience high rates of smoking, drinking and HIV, and are at greater risk for developing cancers. Some doctors speculate that it might be better to check the prostate through the neo-vagina instead of exploring the rectum. The hormones of transgender women can lower PSA levels but this is not a reliable sign of good prostate health. Cancer organisations (and others) are beginning to realise that everyone is not the same and one size does not fit all when promoting care services. Acknowledging that there will be a sizeable group of patients and service users who are not heterosexual is important to enable the service provider to be sure that they are providing appropriate services and asking the right questions


coping with advanced prostate cancer

It’s time to speak up... against advanced prostate cancer The International Prostate Cancer Coalition (IPCC) survey found that many men with advanced prostate cancer don’t discuss symptoms like fatigue, pain or difficulty sleeping. Bayer’s newly launched ‘Men Who Speak Up’ program encourages them to do so. Gissoo Decotiis, Oncology Advocacy Relations, Pharmaceuticals Division, Bayer HealthCare Pharmaceuticals, Inc speaks about the findings of the survey change over time. Specific symptoms like fatigue, weakness, troubled sleep, pain and discomfort, difficulty walking or climbing stairs, and daily use of pain relievers may serve as a warning that prostate cancer is progressing. (2,3,4) If prostate cancer spreads, or metastasises, beyond the prostate gland, it often first grows into nearby tissues or lymph nodes before spreading to the bones.


rostate cancer represents a serious disease impacting a staggering number of people. Globally, it is the second most common cancer and the fifth leading cause of cancer-related death in men. More than 1.1 million men worldwide were diagnosed with the disease in 2012. (1) These figures do not capture the number of caregivers, spouses and family members who were also impacted by the diagnosis. When the two are combined, the impact could grow exponentially. Often, in early-stage prostate cancer, there is a significant amount of conversation at home and at doctors’ clinics about the diagnosis and individual treatment options. Unfortunately, for men who have been living with prostate cancer for several years, those important conversations sometimes stop or do not expand to help them understand how their cancer may


Approximately nine in 10 patients (90 percent) with advanced prostate cancer develop bone metastases, impacting survival and quality of life. (5,6,7,8) Therefore, diagnosing and treating bone-related symptoms at the earliest onset is critical for patients. Unfortunately, recent real-world research and insights from physicians and patients have validated the belief that men with advanced prostate cancer don’t always speak up when it comes to symptoms. Eight leading patient advocacy groups that comprise the International Prostate Cancer Coalition (IPCC) commissioned the global survey with support from Bayer. Conducted through “Harris Poll online” tool, the survey examined the perspectives of more than 1,300 men with advancing prostate cancer and caregivers across 11 countries. Findings from the 2015 IPCC Symptoms Survey, the largest conducted in advanced prostate cancer to date, revealed that nearly half of men (45%) sometimes ignore their

Government Gazette

symptoms. (4) Of those men whose cancer had already spread to their bones, 40% had experienced some sort of pain for seven months or more before they were diagnosed with metastatic disease. (4) A number of factors contributed to men failing to speak up about their symptoms. Three out of five men (56%) admit that they don’t recognise that the pain they are experiencing could be related to their cancer. (4) It’s surprising that men living with advanced prostate cancer – who should be well informed about it’s symptoms – could overlook them. But these symptoms can mimic common signs of aging or hard work, contributing to the confusion. Further results found that more than half of men (55%) often think that their pain is just something they have to live with, and one out of three (35%) report that talking about symptoms like pain makes them feel weak, supporting the notion that men are conditioned to grit their teeth through any discomfort they may experience. (4) Difficulty discussing symptoms may be culturally-driven as well. Of those surveyed, 40% in the EU region say they are not comfortable discussing how they are feeling physically with their doctor, compared to only 11% in the U.S. (4) The survey results brought to life some of the critical issues facing men with advanced disease and highlight the need to encourage more conversation, which led to the development of a global initiative from Bayer called Men Who Speak Up ( Men Who Speak Up builds upon the recognition that much more should be done to help men with prostate cancer become vocal about their disease. In the survey, men reported, that they would be motivated to speak up about symptoms if it improved quality of life (65%) or activity levels (57%), or if it prevented their cancer from getting worse (54%).4 In practical ways, the program helps men and their caregivers pinpoint the symptoms of advanced prostate cancer and empowers them to have important conversations with their healthcare providers to get the help they need. Bayer is proud to support the prostate cancer community, with these efforts to make a

health report

meaningful difference in the lives of patients by giving them the tools they need to better navigate important discussions about their symptoms with their loved ones and physicians. Opening the lines of communication for discussions about symptoms is not always easy, but it is critically important. Men Who Speak Up provides useful resources including a symptoms tracker, a doctor discussion guide, informational fact sheets and helpful statistics to facilitate those conversations Led by U.S. advocacy organization CancerCare, the IPCC is comprised of Europa Uomo, the Spanish Group of Cancer Patients (GEPAC), Patient Advocates for Advanced Cancer Treatments (PAACT), Prostate Health Education Network (PHEN), Prostate Cancer Research Institute (PCRI), Us TOO International and ZERO – The End of Prostate Cancer. References: 1. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. http:// Accessed on January 23, 2016; 2. Autio KA, Bennett AV, Jia X, et al. Prevalence of pain and analgesic use in men with metavstatic prostate cancer using a patient-reported outcome measure. J Oncol Pract. 2013;9(5):223-229 3. Farrell C. Bone metastases: assessment, management and treatment options. Br J Nurs. 2013;22(10):S4, S6, S8-S11 4. Prostate Cancer Symptoms Survey: IPCC data in file. Global Results, 2015 5. Petrylak DP, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351:1513-1520 6. Goh et al. New Multidisciplinary Prostate Bone Metastases Clinic: First of Its Kind in Canada. Current Oncology. Volume 14, Number 1

New hope for prostate cancer sufferers in UK Today, we know more about prostate cancer than we could have imagined a few years ago. However, better outcomes will only be achieved through a radical “shift in the science” around diagnosis, treatment, support and prevention, says

Angela Culhane, Chief Executive, Prostate Cancer UK


t is unacceptable that men living in the UK have a lower likelihood of surviving prostate cancer than men in most of Europe.

There are various factors which may be behind this. The extent of PSA testing could be one. Unlike the UK, some European countries have implemented a population-wide screening programme using the PSA test. In the UK, the National UK Screening Committee believes there is insufficient evidence to use the PSA test in this way, citing false positives and false negatives associated with the test as resulting in more harm than benefit. At Prostate Cancer UK, we know the PSA test is weak but until we and our research partners develop a better test, it is the best means of achieving early detection of prostate cancer in men without symptoms, especially those at higher than average risk of the disease.

longer alone in struggling with the high cost of new medicines and it may be that in time we will see a shift in European survival rates as a result. What’s needed is an EU-wide solution that can incentivise the pharmaceutical industry to make their new treatments more affordable. Without this, survival outcomes across the continent will very likely suffer. These initiatives will certainly help more men survive this disease, but, at Prostate Cancer UK, we are convinced that better outcomes for men with prostate cancer will only be achieved through a radical shift in the science around prostate cancer diagnosis, treatment, support and prevention.

Today, we know more about prostate cancer than we could have imagined a few years ago. We’re getting to grips with how it evolves, what it looks like at a molecular level, and how it can vary between one man and another. There are new life-prolonging treatments for advanced Variation in access to new treatments could also disease and in the last year alone, we’ve seen be a factor, as high prices lead to treatments research reveal unprecedented survival benefits being rejected by health technology assessment by introducing an existing treatment earlier or systems and therefore denied to patients. But using it in a more targeted, concentrated way. there is evidence to suggest that the UK is no

7. Tannock IF, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512 8. Jin, Dayyani, and Gallick. Steps in Prostate Cancer Progression that Lead to Bone Metastasis. International Journal of Cancer.

Government Gazette


health report

Prostate Cancer UK will play our part by investing as much as we can in research, focusing on three concrete areas; better diagnosis, better treatments and better prevention. We’ll target a better diagnostic test. We’ll harness our better understanding of prostate cancer to enable precision medicine and identify what men can do to prevent ever getting the disease. But we’re just a charity and we need other more powerful players to step up too. The UK government and the EU Commission

must sustain investment in medical research, while establishing cost-effective means for trial results to be easily translated into practice. They must also make sure there are effective ways to accelerate the adoption of these innovations into the health systems and ultimately, getting them to men. At the same time, we need more research pioneers to come forward, whether they’re in Europe or elsewhere in the world. Investment in prostate cancer research can only happen if there are researchers to invest in and it’s critical

that more of these scientific innovators make shifting the science for prostate cancer their goal. And in the meantime, we’ll map those areas where there is variation in the treatment and care men receive – from gold standard to worst case. We’ll highlight and target what needs to change, sharing the good-practice models and solutions that we’ve already identified - or developed ourselves - and we’ll empower men to get what’s best for them

Bladder cancer: So expensive to treat, but almost forgotten The alarming truth is that bladder cancer is the most expensive to treat, however very little policy action has been taken to prevent this urological disease. Furthermore, there are large gaps in our knowledge and understanding about treatment options.

Mihaela Militaru, Director, European Cancer Patient

Coalition discusses the current state of awareness


e know and it seems redundant, that the best way to control cancer is by lowering the chances of contracting cancer. As with many other genitourinary cancers (prostate, kidney or bladder cancer), it is not always possible to prevent bladder cancer, but we can combat some of its risk factors such as smoking or professional exposure to carcinogenic substances. As an organisation representing patients, our first concern rests with informing patients. Over the years we have conducted a number of surveys and studies. Yet, it is still surprising to see that people are not adequately informed about the major risk factors for developing cancer and in particular bladder cancer and the symptoms that could reveal bladder cancer. The European Cancer Patient Coalition (ECPC), the largest cancer patients’ umbrella organisation in Europe, works to ensure that all European cancer patients have timely and affordable access to the best treatment and care available, throughout their life. While we work across all cancer groups, this year we aim to focus on some cancers that receive less attention such as bladder cancer, which is also often known as “the forgotten cancer.” Bladder cancer is actually the fifth most common cancer in the western world and the second most frequent urological cancer after prostate cancer. However, bladder cancer is highly overlooked by policy-makers and investment in research from public and private sources are barely sufficient.


In March this year, the ECPC will launch a White Paper on bladder cancer in the European Parliament, a work coordinated by our organisation with the support of international specialists in the field. The document lists various treatments, novel opportunities, prevention and diagnosis solutions and guidelines, in the hope to raise public awareness, better educate policymakers and fine-tune bladder cancer policies in the interest of current and future patients and the society in general. We see a positive development in prevention policies. For example, both the European Commission and EU member states have developed policies tackling major health determinants and the main risk factors that increase the burden of cancer. Also, governments, based on scientific evidence, have developed legislations to ban the use of dangerous residues or to limit the exposure to carcinogens at work. More such efforts have to be pursued in the future. In addition to this, educating primary care physicians and the public about the key risks and symptoms of bladder cancer should be a priority. Since some of the risk factors for

Government Gazette

bladder cancer are the same or similar to kidney or prostate cancer, doctors should inform patients and tailor the information to the profile of the patient, about the risk factors of cancer also looking at patient’s family history or genetic factors. Due to high recurrence rates, intensive surveillance strategies, and expensive treatment costs, the management of bladder cancer contributes significantly to medical costs. As such, bladder cancer is the most expensive cancer to treat per patient. Despite its economic and human cost, unfortunately there is no new major development within the realm of bladder cancer research and treatment. Therefore, prevention at this point becomes extremely important. Our organisation and the patients that work with us encourage us to continue promoting the role of patients in this fight. From prevention to diagnosis to treatment and recovery, patients need to be kept well informed about the options of treatment and the impact a treatment can have on the patients’ quality of life

coping with prostate cancer

Delivering state-of-the-art radiotherapy for all


n the year 2011, the UN General Assembly committed to the prevention and control of Non-Communicable Diseases (NCDs) and in 2013 the WHO member states committed to reducing premature mortality from NCDs with 25% by 2025 (baseline 2010). This implies that 1.5 million cancer deaths have to be prevented each year in order to achieve this so-called “25-by25 target.” Prostate cancer has the fifth highest incidence of cancer deaths with 1.1 million deaths worldwide annually, and approximately 50-60% of these patients would require some type of radiotherapy. Radiotherapy has been used for more than a century for the treatment of cancer, but also benign diseases. In the last 2-3 decades new radiotherapy techniques have resulted in improved clinical outcomes in prostate cancer. As a result all international treatment guidelines clearly recommend the use of radiotherapy for the treatment of patients with prostate cancer. Recent evidence demonstrates that the efficacy of radiotherapy in the treatment of patients with low, intermediate and high-risk prostate cancer is comparable with surgery, whilst adverse events tend to be advantageous for radiotherapy, especially with regard to the patients’ sexual function after treatment. There are various types of radiotherapy that can be used and the decision for a certain type usually depends on the type of prostate cancer. For low-risk prostate cancer brachytherapy, either with low dose rate (LDR; also known as treatment with “seeds”) or high dose rate (HDR), is a good treatment option. External beam radiotherapy treatment (EBRT) is also a frequently used technique for low-risk prostate cancer. EBRT has evolved over time and use of modern EBRT like 3-Dimensional Conformal Radiotherapy (3D-CRT) and especially Intensity Modulated Radiotherapy (IMRT) have resulted in very good clinical outcomes. In intermediate and high-risk prostate cancer patients, the combination of EBRT with a brachytherapy boost has proven to be an excellent, cost-effective treatment option.

Radiotherapy is indispensable in the treatment of patients with prostate cancer. Over the years, new techniques have resulted in improved clinical outcomes. However, providing access to state-of-the-art radiotherapy to all requires continuous investments in radiotherapy facilities and training of radiotherapy staff, says Ben President Medical Affairs, Elekta of the radioactive beam. It can also play an important role in optimising radiotherapy of individual patients. All radiotherapy treatment parameters are stored in databases. This implies that the treatment results of all patients could be relatively easily analysed and used to define patient cohorts in these databases that could then have a predictive value for the response of comparable patients to a certain type of radiotherapy. Millions of patients have already been treated with radiotherapy, so the connection of all these data could mean a big step forward in supporting the process of “personalised” radiotherapy. This process of connecting data will of course require support from healthcare authorities. Support on a legal and regulatory level, but of course also financially. Delivering state-of-the-art facilities to all

Enabling personalised radiotherapy

There is no solid data describing the global RT treatment resources and there are large variations in the deployment of the treatment units, but estimations are that only about 40-60% of cancer patients have access to RT services. Lack of investment is the main cause of limitations in access driven by a fear of high operational costs in addition to large upfront investments.

The optimal use of radiotherapy is directly associated with good quality imaging and treatment planning software. Software plays an important role in radiotherapy anyway: besides its central role in treatment planning, it is a prerequisite for the alignment of the images showing the tumour and the targeting

As a consequence of insufficient access to radiotherapy, high-risk prostate cancer patients are, sometimes treated with hormone therapy alone. Randomised controlled research has demonstrated that this leads to dramatically worse overall survival within 5 years of diagnosis. Underinvestment is not only

Government Gazette

Pais, MD, Vice

happening in low-income countries, but also in middle-and-high-income ones, including several European countries, preventing upgrades of “old fashioned” radiotherapy services. It has been demonstrated that image guided radiotherapy substantially helps improve treatment results. More patients survive. At the same time, toxicity and adverse events as a result of radiotherapy treatment decrease. These favourable clinical characteristics of radiotherapy provide the strong basis for its cost-effectiveness that has been demonstrated in several health economic models, amongst others also in the treatment of prostate cancer. Knowing that the elderly population, over 65 years of age, will continue growing in the next 1-2 decades, the number of cancer patients will grow accordingly. Proper investments in RT, both in facilities and human resources, will enable treatment of large numbers of cancer cases to save lives, and also bring positive economic benefits. Prostate cancer accounts for a large number of deaths, almost 100.000 in Europe annually. Improved access to radiotherapy will support reaching the targets defined by the UN General Assembly and the WHO Member States to prevent death from (prostate) cancer


health report

Navigating through the maze of prostate cancer

The Melbourne Consensus Statement (2013) A group of international experts reviewed the latest information and the above conflicting guidelines. (6) They stated the following: • Randomised trials have confirmed that PSA screening reduces deaths from PCa for men age 50-69. • Healthy men aged 50-69 should be informed of the pros and cons of screening. • PSA screening should be part of an overall risk assessment for PCa and, as in the EAU guidelines, can be commenced in a man’s 40s to help predict future risk. • Men over 70 with more than 10 years life expectancy should not be denied screening, once counselled. • To avoid overtreatment, screening should be uncoupled from treatment.

Medical practices are increasingly based on well established guidelines produced by a group of experts in the field. Trying to navigate one’s way through these guidelines can be akin to walking through a maze and the ongoing advances can make it more difficult. Dr. Chris Booth, Member of Clinical Advisory Board, Tackle Prostate Cancer, tries to make sense of the multiple guidelines on prostate cancer


lthough early diagnosis and treatment of prostate cancer is usually curative, screening of men with no symptoms using the blood test Prostate Specific Antigen (PSA) remains controversial. (1) Though its use has clearly reduced the death rate, (2,3) it has also led to unnecessary and potentially harmful invasive prostatic biopsies and overtreatment of small, non-aggressive cancers leading to serious complications such as impotence and incontinence. Best medical practice is increasingly based on application and adherence to best practice guidelines produced by panels of “experts.” (4) However, the problem with prostate cancer is that there are multiple guidelines and, worse, they conflict. This synopsis provides a summary of the current major guidelines and hopefully permits a clearer understanding for both men and doctors considering screening. United States Preventive Services Task Force (2012) The task force recommends against screening for men of all ages on the basis that 1,000 would need to be screened to save one life, but 30-40 men would suffer complications due to overtreatment. This opinion was strongly criticised by the American Urological Association (AUA), mainly for failing to highlight the particular risk for men with a


family history of PCa and especially black African-American men who carry a 1 in 4 lifetime risk of developing PCa. American Urological Association (2013) The AUA suggests screening for AfricanAmerican men and those with a family history. For men aged 55-69, it recommends shared decision making with a clinician to achieve an informed choice. A baseline PSA could then be used to help quantify future risk. The association also recommends against screening for men over age 70 with less than 10-15 years life expectancy. American College of Physicians (2013) For men aged 50-69, the ACP recommendeds letting men make an informed choice ultimately based on their own preference. In particular, it discourages screening below 50 and above 69. European Association of Urology (EAU) (2013) Based on two current randomised clinical trials, the guideline states that screening clearly reduces mortality from PCa. The EAU recommends a baseline PSA at age 40-45 to predict future risk and in the majority of cases to reduce the frequency of future PSA screening. It also advocates the use of “risk calculators.”(5)

Government Gazette

In summary, the majority of international expert panels advise screening for men with a family history of PCa and black African and African Caribbean men from age 40. They recommend that clinicians obtain a baseline PSA in a man’s 40s to predict future risk and further link PSA to a “risk calculator” to assess need for and frequency of future PSA screening. It is anticipated this will reduce the overall number of PSA tests for both individuals and nationally. They also suggest not screening men with less than 10 years life expectancy. UK clinical practice UK mortality for PCa lags behind most of our European neighbours (7) and only a minority of UK men seek screening. For those men who do, NICE guidelines are crude while Public Health England’s “Prostate Cancer Risk Management Programme” is complex for patients and apparently unknown to 50% of GPs. (8) Consequently many men requesting a PSA in Primary Care are put off screening. Regarding the management of early curable PCa, the National Prostate Cancer Audit (9) suggests nearly a third of UK men have received unnecessary aggressive, invasive treatment with radiotherapy or radical prostatectomy for small, non-aggressive cancers. However, this audit relates to clinical practice between 2006-2008. Not surprisingly best practice specialist care has changed since then. Firstly PSA sensitivity and specificity can be improved by measuring free PSA, the free to total PSA ratio and utilising the variant human kallikrein2 (hK2), leading potentially to far fewer negative prostate biopsies. (10) Secondly, men under consideration for prostatic biopsy are now increasingly undergoing an MRI scan first. Only those with an abnormality on MRI then proceed to biopsy and the biopsy itself is no longer random but is

coping with prostate cancer

targeted upon the MRI abnormality.

5. European Urology: 2014: 63: 627-633

Thirdly treatment decisions for biopsy positive men are reviewed by specialist MultiDisciplinary Teams.

6. British Journal of Urology International 2014: 113(3) 186-188

Finally UK men with PCa are now taken through an informed decision making process with at least one consultant and a specialist nurse before a final treatment decision is made. The consequence of this has been a consistent increase in the proportion of UK men with early stage, low grade PCa (stage T1/T2; Gleason Score ≤6) who avoid radical treatment and opt instead for active surveillance.

8. Journal of Clinical Urology: 2014: 7(1): 45-54

7. World Life Expectancy: WHO 2011 9. National Prostate Cancer Audit, Royal College of Surgeons of England, 2014 10. British Journal of Cancer: 2010: 103(5): 708-14 11. British Journal of Medical and Surgical Urology; 2012: 5: 4-10

Conclusion UK medical students and GPs receive little formal urological training (11). Further, men themselves remain largely unaware of prostatic disease and messages from both specialists and public health are, to say the least, mixed. This calls for better education on both sides.


How outdated references can be misleading


cience fails to face the limitations of statistics. As a result, flawed statistics in scientific literature is increasingly worrying clinicians as it might often lead to negative and highly biased outcomes. Very often, newspapers and scientists, in an attempt to create maximum impact for their articles, tend to publish relative statistics, which in turn misguide GPs relying on such literature. An editorial published in the the British Medical Journal (BMJ), entitled “Full disclosure about cancer screening” (1) and a related analysis entitled “Cancer screening has never been shown to save lives” (2) are particularly highly misleading due to outdated references used by the authors to support their case.

If we are to reduce significantly the current UK death rate from PCa, Primary Care PSA screening should be provided for appropriately informed men and linked to risk calculation. This is best achieved through collaboration between Public Health, Commissioners, GPs and Specialists together promoting a consistent message to both men and the medical profession

In the above mentioned articles, emphasis is given to the differences between cancer specific and overall mortality, however it is unacceptable to use a reference that is 13 years old. (3) It is equally misleading to quote references comparing PCa mortality statistics from the pre-PSA era and present these as if the data was current. (4) Regarding death from either metastatic PCa or locally advanced PCa, this is almost always thoroughly unpleasant and to be avoided if at all possible; screening almost always achieves this.

References: 1. European Urology 2014: 65: 1046-1055 2. Lancet Oncology: 2010: 11: 725-732 3. European Urology 2014: 65: 329-336 4. British Journal of Urology International 2014: 114(3): 323-5

So far as PCa and PSA screening is concerned, these BMJ articles from foreign authors, who are not urologists, are outdated, unbalanced, do not reflect current UK practice, do not reflect the international consensus (5) that advocates PCa screening based on an individual assessment of risk and informed decision making and do nothing to help men at risk, particularly those with a family history and black African and African Caribbean men, from this serious and frequently fatal disease References: 1.Gigerenzer G, BMJ, 2016; 352, 8 2.Prasad V et al, BMJ, 2016; 352, 22-23 3.Black C W et al, J.Natnl Cancer Inst, 2002; 94(3), 167-73 4.Fang F et al, J.Natnl Cancer Inst, 2010, 102(5), 307-14 5.Murphy D G et al, BJU International, 2013, 113, 186-188

Government Gazette


health report

Genes, mutations and cancer risk While 7% of all cancer is hereditary, changes to genes -- called mutations can play an important role in the development of cancer. Dr. Howard Urnovitz, Dr. Nick

Plowman and Prof. Dr. Ekkehard Schütz from

Chronix Biomedical outline the differences between tests for hereditary and somatic cell mutations

Testing for somatic or acquired cell mutations (real time detection of cancer)


lot of attention is being focused on gene tests and cancer. Cancer gene tests started out in the 1990’s as a single marker that estimated your risk of getting cancer. Today, tests measure actual cancer dynamics in real-time. The human body is composed of 50 to 100 trillion cells starting from one fertilized egg that differentiates into almost 200 different types of cells. These trillion of cells, when working in harmony, create a healthy individual. So, what is cancer? Cancer occurs when a cell no longer listens to the body’s signals and grows uncontrollably. The blueprints for life are stored in a chemical in the nucleus of a cell known as deoxyribonucleic acid (DNA). The DNA is organised into sequences that are known as genes. The DNA blueprint, or genome, can become altered called a mutation. Mutations lead to the cancer’s independence from homeostatic controls that normally stop relentless/cancerous cell divisions. Mutations carried from generation to generation are known as hereditary mutations. Hereditary mutations rarely cause cancer alone, but when acquired or somatic mutations occur, the cells are more easily ‘tipped over’ into the cancer state; therefore, people carrying these hereditary mutations are predisposed to cancer. We will outline here the difference between tests for hereditary and somatic cell mutations. Testing for Predisposition to Hereditary Cancer (Assessment of risk of developing cancer by pedigree) Approximately 7% of all cancers are hereditary (i.e. the person has inherited a faulty (mutated)


gene which facilitates cancer initiation). From your family tree, one can get an idea as to an individual’s risk. For example, an inherited gene mutation linked to breast or ovarian cancer is more likely if several other women in the family have developed breast or ovarian cancer – particularly at a younger age (e.g. < 50 years) or where those relatives developed cancer in both breasts or a near male relative has developed prostate cancer (or cancer of the gastrointestinal tract or the otherwise rare male breast cancer) – again particularly at young age. From this vignette, it can be appreciated that family history gives a clue as to hereditary risk predisposition. Some risk mutations are associated with ethnicity (for example on important faulty/mutated gene predisposing to breast/ovarian cancer runs more strongly in people of Ashkenazi Jewish descent). Nowadays, it is possible to screen for these faulty/mutated genes in a well-person screen – if your family history suggests a risk. It is recommended to screen for the common gene mutations (associated with a particular cancer) in such persons. The list is not exhaustive but includes the most common gene mutations. The advantages of such gene testing for an individual is that more frequent screening (e.g. colonoscopy for colorectal cancers) may be employed or even pre-emptive surgical procedures to forestall or cure early cancer, where there is a proven familial/genetic predisposition. Again, all these hereditary tests measure future risk and not real-time. Hereditary mutation tests can be performed on a blood draw.

Government Gazette

Cancer is caused by mutations in DNA that lead to a “triggering” of cell multiplication, outwith the needs of the body signals. This last phrase is important as cells are dividing all the time in the body and increase this rate in response to stimuli (e.g. wound repair), but all this cell multiplication is regulated to the body’s requirements. Cancer occurs when the cell multiplication is relentless and without the body’s requirements. The genomic revolution has created Next Generation Sequencing (NGS) whereby the entire genome can be mapped within hours. Much has been learnt concerning genetic mutations and how best to measure them. This year will see a shift in emphasis from measuring the single point mutations (SNPs) to using NGS to track genome instability through measuring copy number instabilities (CNIs). CNIs are a hallmark of all cancer cells with gains and losses of genetic material. These gains and losses can range from alterations spanning large chromosome regions to smaller duplications or deletions. Importantly, cell-free DNA fragments from cancer cells appear in the blood carrying this hallmark of cancer, which can be detected with a simple blood test. Although on a more “macro” level than individual gene mapping, the correlation with cancer is very strong and there are indeed identifiable certain patterns (“hot spots”) which seem to uniquely correlate with cancers arising in different organs. This year, Chronix Biomedical will be presenting results from prospective, blinded studies on the power of measuring CNIs. CNI blood detection has a variety of applications from a pan-cancer screening blood test for all cancers to predicting treatment outcomes after one cycle of therapy. All these tests are available to physicians today on peripheral blood draws

coping with prostate cancer

Canvassing for a European network of national cancer institutes With advances in understanding of the molecular mechanisms of cancer, we have witnessed unprecedented progress in developing new forms of targeted therapy. However, Dr Riccardo Belli, Medical Director, Immunooncology, Global Medicines Development, AstraZeneca says building a European network of cancer institutes and developing dedicated patient databases are crucial in helping identify new predictive biomarkers and accelerate the launch of new therapy


rostate cancer is nowadays considered one of the most common cancers in men, in part as a result of introduction of PSA (Prostate-Specific Antigen) screening that lead to a consistent increased diagnosis of early stage prostate cancers. Since the advent of PSA evaluation, fewer than 3% of men have metastases at the time of diagnosis, and 75% of men have non palpable cancer. (1) However, early detection and treatment that have no effect on life expectancy, often increases side effects without improvement of quality of life and health care expense, while decreasing the value of PSA and rectal examintation. (2) Population-based screening of men aged between 55 and 69 years, using PSA testing, has been evaluated in randomised trials. After a median follow-up of 13 years, the European screening trial demonstrated a relative reduction in the risk of prostate cancer mortality of 21% (29% if adjusted for non-compliance). However, 781 men needed to be invited for screening and 27 patients needed to be treated to prevent one death from prostate cancer. Risk-adapted early detection of prostate cancer using a baseline PSA level has also been evaluated in retrospective cohort studies. The baseline PSA at or before the age of 50 years is associated with the risk of prostate cancer mortality over the subsequent 25 years. (3) Widespread population PSA screening for prostate cancer reduces prostate cancer mortality at the expense of over diagnosis and overtreatment and is not recommended by different group of experts. (1,2,3,4,5) Therefore, there is a need for new methods of using

noninvasive biomarker to inform patients and the physician about detection of prostate cancer at an early stage, to determine cancer aggressiveness, treating aggressive cancers and actively monitoring indolent (slow-growing) cancers. The ultimate goal would be to treat more patients who are at risk, and reduce the number of patients who aren’t. Moreover, most prostate cancer–related deaths are due to advanced levels of the disease. The current standard of care consists of prostatectomy and radiation therapy, which may be supplemented with hormonal therapies. Recurrence is common, and many develop metastatic prostate cancer for which chemotherapy is only moderately effective. It is clear that novel therapies are needed for the treatment of the malignant forms of prostate cancer that recur after initial therapies, such as hormone refractory or castration resistant prostate cancer. With advances in understanding of the molecular mechanisms of cancer, we have witnessed unprecedented progress in developing new forms of targeted therapy. Several targeted therapeutic agents have been developed and clinically used for the treatment of solid tumors such as breast cancer, non-small cell lung cancer, and renal cancer. Some of these reagents modulate growth factors and/ or their receptors, which are abundant in cancer cells. Other reagents target the downstream signal transduction, survival pathways, and angiogenesis pathways that are abnormally activated in transformed cells or metastatic tumors. In this setting, the building of a European network of national cancer institutes and the availability of a dedicated European patient database could

Government Gazette

be considered to help identify new predictive biomarkers, anticipate the launch of new target therapy and accelerate the time to access new drugs and target experimental therapies References 1. SA Brosman Prostate-Specific Antigen Testing Medscape Jan 13, 2015 2. NCCN clinical practice guideline in oncology Version I 2016 3. C. Parker, S. Gillessen, A. Heidenreich, A. Horwich Cancer pf prostate: ESMO clinical practice guidelines Ann Oncol (2015) 26 (suppl 5): v69-v77. 4. Moyer VA, US Preventive Services Task Force (2012) Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 157:120–134. 5. N. Mottet, J. Bellmunt, E. Briers, R.C.N. van den Bergh, M. Bolla, N.J. van Casteren, P. Cornford, S. Culine, S. Joniau, T. Lam, M.D. Mason, V. Matveev, H. van der Poel, T.H. van der Kwast, O. Rouvière, T. Wiegel. Guidelines on Prostate Cancer, European Association of Urology 2015. Riccardo Belli is Medical doctor, DAAD (Deutscher Akademischer Austauschdienst), Guest Fellow - Tumor Immunology at Charite Campus mitte, Berlin, Germany. ECPM (European center of pharmaceutical medicine) training held by the university of Basel, Switzerland.


health report

6th EU Prostate Cancer Roundtable: An Overview


he 6th edition of the EU Prostate Cancer Roundtable took place in Brussels on the 26th of January 2016. It brought together MEPs, senior representatives from the European Commission, leading urologists, oncologists, radiologists, representatives from interest groups as well as charity organisations to examine the ongoing challenges in managing prostate cancer more effectively, explore practical solutions to reach an EU-wide consensus and implement a forward action plan. The objective of this meeting was to discuss important developments in the diagnosis, treatment and cure for the cancer as well as analyse current EU policy in the sector with a view to put forward recommendations to policy makers and other key stakeholders. Arvind Venkataramana, Research Director at the International Centre for Parliamentary Studies, provides an overview of the discussion as well as key policy and other recommendations that were put forward over the course of the roundtable. Current EU policy Alojz Peterle, MEP, Former Prime Minister of Slovenia and current President of the MEPs Against Cancer (MAC) Group began the discussion on important technological advancements in the treatment of prostate cancer and the role it has played in the development of current policy. The MAC Group has been in existence for the last 10 years and it’s objective has been to consider


every key technological, social, demographic and medical development before putting forward any policy recommendation in the area of cancer. The discussion then moved to healthcare policy in general and the consensus was that healthcare, as a whole, needed a similar approach where policy isn’t largely influenced by clinical inputs. Instead, it should also consider patient feedback. Policy recommendations should move beyond statistics and take into account the qualitative aspect of treating prostate cancer, rather than just prolonging a patient’s life. The importance of early detection There was a general agreement that early detection is key to successfully tackling prostate cancer. The knock on effects of late detection has proven to be catastrophic. Research has shown that PSA tests done at early stages have significantly reduced mortality rates and should be the norm across the EU. Incidentally, three of the participants were diagnosed with prostate cancer and were unanimous in pledging their support for PSA testing and the key role it played in ensuring that cancer didn’t spread and was treated appropriately. Quality and transparency of data Interestingly, data and information sharing in the area of breast cancer has significantly reduced the number of deaths as a result of it. The same needs to be done in the EU for prostate cancer. A clear framework has to

Government Gazette

be developed for the smooth, efficient and real-time flow of information across member states. In addition, more robust population based data collection has to be initiated for long term research purposes such as studies on how certain ethnicities are more prone to prostate cancer than others. Big Data is another very interesting development that has transformed other industries. The group felt that it can help combat prostate cancer by ensuring data is used for better, multi-modal, multi-disciplinary and combination approaches in the diagnosis and treatment of prostate cancer. The discussion then moved to important developments in imaging and the role it has played in detection. The good news is that the quality of MRIs has improved significantly in the EU. However, there is no EU standard in place to ensure consistency in the quality of scans. More EU funding for research The current economic climate isn’t ideal but a conscious effort has to be made from all quarters to ensure that there are no cuts to funding in cancer research - more specifically, prostate cancer, according to a majority of the participants. Further, there is a need to conduct in-depth research in preventative measures at the same time as treatment, as cuts in funding at this point could seriously derail current efforts. The last five years have seen an increase in funding and studies have found a direct link between funding and reduction in deaths due to prostate cancer.

coping with prostate cancer

Although PSA testing is the most widely used and successful tool to detect the cancer, research funds should go into alternate testing methods including more evidence based testing. In the meantime, the EU should not encourage the use of other tools unless it has been tested and researched thoroughly. A multi disciplinary approach The EU should set up a Centre for Excellence where a multi-disciplinary approach to the treatment of prostate cancer is carried out. This has to go beyond just radiologists, urologists and other clinicians exchanging information. There should be technological inputs, patient care perspectives as well as any policy changes included within this multi disciplinary system. We should move away from the current “one-size-fits-all” approach. There has to be a systemic change to how long it takes for new technologies, breakthroughs and developments to become available to patients. Key policy makers have to do more to ensure there is a ‘fast-track’ route for genuine breakthroughs to quickly move from trials to being approved as delays can cost lives. Key recommendations - Better quality of MRIs, imaging and screening must become a legal norm rather than just a recommendation. - EU needs to do more to ensure guidelines are followed and should play a bigger role in shaping them. - Research funding should not stagnate and policy makers should ensure it grows year on year. - There needs to be a set budget in place to ensure there is an education programme across the EU. - PSA should be the only recommended test until we find proven alternatives. - Clinical trials and the approach towards it needs to be more efficient. - There has to be a greater consensus on the treatment of the cancer across the EU. A Centre of Excellence is a good starting point. - Labelling laws need to be revisited. - More research on the cause of deaths is important so that future research parameters can be accurately defined. - Apart from EU-wide initiatives, there is scope for exchanging information from other countries that have had better success rates. - The EU should implement a standard on less invasive procedures unless absolutely necessary. - Patient satisfaction measures should be put in place to measure the effectiveness of treatment. - The EU should ensure there is wider access to trademarks. - The EU should ensure newer technologies are implemented before they become obsolete. Fast tracking leading breakthroughs can be very effective. - Screening should go beyond just being population based. - In addition to treatment, future policy should focus more on patient rehabilitation and care.

Participants of the Roundtable included: Director, Association of European Cancer Leagues, President, Austrian Association of Urology, Head of Urology, Algemeen Stedelijk Ziekenhuis, President and Managing Director of Diagnostics, Almac Diagnostics, Vice President, Medical Director of Diagnostics, Almac Diagnostics, Vice President, Global Healthcare Economics, Angiodynamics, Senior MD, Immuno-oncology, Angiodynamics, Senior MD Immuno-oncology, AstraZeneca, Health Policy & Public Affairs Europe, Bayer HealthCare, Chair, Belgian Society for Sexual Medicine, Consultant Urologist, Brussels Saint-Luc University Hospital, Head of Urology, BUPA, Director, CHAPS - The Men’s Health charity, Chief Executive Officer, Chronix Biomedical, Chief Medical Officer, Chronix Biomedical, Vice Chairman, European Cancer Patient Coalition, E-Health Manager, European Coordination Committee of The Radiological, Electromedical And Healthcare IT Industry (COCIR), Director & Member, Steering Committee, European Network of Cancer Registries, Ex-officio Board Member, Europa Uomo - The European Prostate Cancer Coalition, Secretary General, European Association of Urology, Director, European Cancer Patient Coalition, Policy Officer on Cancer and Rare Diseases, European Commission, Scientific and Policy Officer, DG Research & Innovation, European Commission, MAC President and Rapporteur, European Parliament, Vice President Medical Affairs, Elekta, President and Chief Executive Officer, Exact Imaging, Head of Urology, Institut Jules Bordet, Chairman, University Hospital Gasthuisberg, Katholieke Universiteit (KU) Leuven, Urologist, Maxima Medisch Centrum, Veldoven, Assistant Professor of Public Health-Head of the Centre for Health Care, National Institute of Public Health of Slovenia, Director, NHS European Office, Chief Executive (Interim), Prostate Cancer UK, Professor of Radiology and Chair, Prostate MRI Reference Centre of Radboud, Medical Director - Oncology, Sanofi, EU Commerical Lead, Sanofi, Public Health Officer, World Health Organisation Europe, Oncologist, Ziekenhuisnetwerk Antwerpen (ZNA) Middelheim. The next edition of the prostate cancer roundtable will take place on January 24, 2017. If you wish to attend, please contact

Government Gazette


tackling the diabetes challenge

Taking a critical look at the diabetes challenge To reverse the diabetes epidemic and related challenges, we need a paradigm shift, a coordinated and comprehensive approach at every stage, integrated health care, alignment of sectoral policies for health, a multi-stakeholder involvement, a greater responsibility and contribution from NGOs and civil society. Prof. Dr. Sehnaz Karadeniz, Chair, IDF Europe takes a look at the worrying issues around the European health priority


iabetes is a multi-faceted issue. A person with diabetes can live a life in very good health, or may have to deal with multiple organ damages leading, for example, to visual loss or renal insufficiency. In this case diabetes is not only a health concern for the person, but also an important social and economic issue for the family, the community and the country itself. Today we have a large evidence base on how to prevent type 2 diabetes, which accounts for roughly 90% of all diabetes cases, and on how to maintain the quality of life in people with diabetes through early diagnosis and timely treatment. To what extent, however, is current knowledge translated into real life? Unfortunately, the answer is not that promising. Current estimates show that diabetes increases beyond predictions. According to the recently released Diabetes Atlas, 7th ed (IDF, 2015), the prevalence of diabetes in the European adult population has increased from 4.9% in 2000 to 9.1% in 2015, rising to an estimated 10.7% for 2040 if we cannot halt or reverse trends.


This means nearly 60 million people aged 20 and over living with diabetes in Europe: a population larger than those of many European countries! And over 23 million are not even aware of their condition. Other worrying issues are the 60 million adults at high risk of developing diabetes, as well as increasing rates of type 2 diabetes in childhood. With 1 in 3 11-year olds overweight or obese, there is much cause for concern. National prevalence rates for diabetes show a wide variation from 13.9% in Malta, to around 4.5% in Tajikistan (IDF, 2015). In absolute terms, the Russian Federation holds the European record with 12 million people with diabetes, followed by Germany with 6.5 million. Diabetes is a costly disease. There is a large disparity in health spending on diabetes between and within world regions, which may -to some extent- also reflect expenditure policy priorities of individual countries. Only 19% of the global health expenditure on diabetes was made in low- and middle-income countries, where 75.4% of people with diabetes live.

Government Gazette

In 2015, nearly 156 billion USD were spent on diabetes in the European region. The average diabetes-related expenditure per person with diabetes was 2,609 USD in Europe (1,622 USD in the world), with over 10,000 USD in Luxembourg, Norway and Switzerland, but less than 300 USD in Armenia, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan. These are both direct and indirect costs, mainly due to diabetes related long-term complications which entail increased use of health services, loss of productivity and disability. In other words, if we were to invest in prevention, raising awareness, diabetes education, good care and management, we would have the opportunity to prevent or avoid advanced cases needing dialysis, eye surgery, amputations and other costly interventions which also negatively affect the quality of life of people with this condition. Our healthcare systems, however, have traditionally been organized to address acute problems and patients’ urgent needs, rather than respond to chronic conditions such as diabetes.

health report

To reverse the diabetes epidemic and related challenges, we need a paradigm shift, a coordinated and comprehensive approach at every stage, integrated health care, alignment of sectoral policies for health, a multi-stakeholder involvement, a greater responsibility and contribution from NGOs and civil society. Several declarations, resolutions and recommendations exist at the global and European levels, inviting Member States to take action against diabetes. A European Parliament resolution addressing the EU diabetes epidemic was adopted in March 2012 by the European Parliament. A meaningful result, however, can only be achieved through national diabetes strategies, their successful implementation and close monitoring. According to the last all-Europe audit (Diabetes Policy Puzzle, 2014), 30 out of 47 European countries have a national plan covering diabetes, and 10 plan or are

in the process of developing such a strategy. What is important though is their scope and implementation in order to make a change in real life. According to the audit, these plans vary with regard to their content and scope, some focusing more on diabetes prevention, others more targeted at tackling complications in people with diabetes. Over 95% of European countries report diabetes prevention policies and campaigns targeting obesity and overweight, promoting healthy eating, physical activity, smoking cessation or tackling harmful use of alcohol. Monitoring and evaluation, nevertheless, remain a major weakness in most of these plans. These gaps in scope, inclusiveness, implementation, monitoring and evaluation need to be addressed in order to generate a positive response to the challenges created by diabetes. The International Diabetes Federation European Region (IDF Europe, the

European chapter of the International Diabetes Federation) will continue to actively contribute in this respect. We are an umbrella organisation of 70 diabetes organisations in 47 European countries, representing both people living with diabetes and healthcare professionals. Through our activities, we aim to influence policy, increase public awareness and encourage health improvement; we promote the exchange of best practice and high-quality information about diabetes throughout the European region. Our main advocacy targets at the European level are EU institutions, the Council of Europe and the World Health Organisation European Region. As IDF Europe we welcome any idea, collaboration and partnership which would make a positive difference in the lives of people with diabetes.

Let’s help prevent the diabetes epidemic “Unless drastic steps are taken through national and international programmes to attenuate the increasing prevalence of diabetes, the costs to both the individual and society will be vast.” Prof


JM Boulton, MD, Prof of Medicine,

University of Manchester, UK discusses ways to prevent the 21st century epidemic


uperior doctors prevent the disease; mediocre doctors treat the disease before it is evident; inferior doctors treat the full-blown disease. - Nai Ching, 2600 BC. There is a clear and important message in this quotation from the first Chinese medical text, for all health care professionals and providers working in non-communicable diseases. I had the pleasure of listening to an inspirational speech in Bangalore earlier this

year by Narendra Modi, the Indian Prime Minister. He clearly stated that the major threat to the health of India was no longer from infectious diseases such as tuberculosis and malaria, but from non-communicable diseases including diabetes. Perhaps he had read the recently published International Diabetes Federation’s (IDF) “Diabetes Atlas” (December 2015) (1) which estimated that there are currently >415 million people with diabetes worldwide that is predicted to increase to 642 million by the year 2040. Both the IDF

Government Gazette

estimates of >70 million adults with diabetes in India and approximately 3-4 million in the UK are very conservative. Whereas the quoted figures are for adults aged 20-79 years of age, predominantly with type 2 diabetes, the figures for type 1 (insulindependent) diabetes in youngsters also make for depressing reading. Studies from Finland report an increasing incidence of type 1 diabetes (2) which are supported by more recent data from the USA that have reported


tackling the diabetes challenge

a >50% increase in diabetes in young people between 2003 and 2013, with the highest figures seen in those aged 12-18 years. (3) Thus one must ask the question: what can be done to address this global public health tsunami. (4) The answers to this question can be found in the Chinese proverb. At present, most physicians are treating the full-blown disease, diabetes. Unless drastic steps are taken through both national and international programmes to attenuate the increasing prevalence of diabetes, the costs to both the individual and society will be vast. Thus, the NHS should be focusing on prevention. Primary prevention – that is, preventing the development of diabetes, in this context in a high risk population, is practical and cost-effective. (4) Studies from both the USA and Europe have confirmed that “lifestyle intervention” (that is, better diet and more physical activity) can significantly reduce the development of diabetes in those people with “Impaired Glucose Tolerance” or “pre-diabetes” (5,6) The American study suggested that increasing activity to 150 minutes per week was sufficient exercise – that could involve taking a 45 minute walk per day, not necessarily requiring vigorous activity in a gymnasium. (5) Screening should focus on high-risk populations that might include those with a family history of diabetes in a first degree relative, the significantly obese population, those with a history of gestational diabetes and those from certain ethnic groups such as from the Indian sub-continent and African-Caribbeans. Secondary prevention implies the prevention of the late diabetic complications in subjects who are known to have diabetes. Most important of all is the achievement of good blood glucose control, and also maintaining normal blood pressure readings and cholesterol and lipids. It must be remembered that 80% of the vast cost to the NHS of treating diabetes (estimated


by Diabetes UK to be > £10 billion a few years ago), is spent on the management of complications, especially diabetic foot disease and kidney failure, with many such cases being potentially preventable. The national diabetic eye screening programme attests to the effectiveness of such screening, as following its establishment, diabetes is not now the leading cause of blindness in working age adults in the UK. Whereas the costs of treating the late complications are staggering, screening for them is inexpensive. The concept of the “annual review” for diabetes patients is not new: indeed, I wrote an editorial on this topic some 25 years ago when editor of Diabetic Medicine. (7) Thus all those with known diabetes should be screened at least annually for early signs of the long-term complications. As discussed above, an annual retinal photograph at the local optician is now the standard of care in the UK for retinopathy screening. A simple urine test together with a blood pressure check can identify early kidney disease, whereas for the feet, the most important action is to remove the shoes and socks and examine the feet.

reduced morbidity and mortality, but also to reduced health-care expenditure. In contrast to the chronic, noncommunicable diseases such as cancer and heart disease, many regard diabetes as a “mild disease” or “a touch of sugar”. Nothing could be further from the truth: the outlook for those diabetic patients on dialysis with foot problems is worse than for most cancers and heart disease. It behoves us in diabetes care, therefore, to heed the words of our Chinese ancestors – and become superior doctors. References 1 International Diabetes Federation. IDF Diabetes Atlas 7th edn, 2015. 2 Hartutsalo V, et al. Time trends in the incidence of type 1 diabetes in Finnish children: a cohort study. Lancet 2008; 371: 1777-1782. 3 Lin L, et al. Prevalence of diabetes in a large US commercially insured pediatric population 2002-2013. Diabetes Care 2016; (In press).

Simple tests of sensation in the feet (can you feel the vibration of a tuning fork, the touch of a finger, tell hot from cold, etc) can easily identify early loss of feeling in the feet (neuropathy), while examination of the foot pulses can identify vascular disease. Those found to have evidence of nephropathy (kidney disease) require appropriate therapies to prevent progression such as optimizing diabetes and blood pressure control. If foot problems are detected, education on foot self-care, regular podiatry and advice on appropriate footwear are indicated.

4 Nanditha A, et al. Diabetes in Asia and the Pacific: indications for the global epidemic. Diabetes Care 2016; (In press).

Although such screening programmes are now widespread in the UK, they should be universal. Such primary and secondary prevention programmes lead not only to

7 Boulton AJM. The annual review: here to stay. Diabetic Med 1992; 9: 887.

Government Gazette

5 Knowler WC, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002; 346; 393-403. 6 Tuomilehto J, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with Impaired Glucose Tolerance. N Engl J Med 2001; 344: 343-1350.

6 1 0

E an h c rea betes o t a ers in di d l o re keh nd ca a t s nd ent a a s m r ake anage m m cy oli ctive p e e car y, eff h t c l hea ccura y e a er k ostic h t n e tog diag g d gin ve rin mpro b i g etin us for e el m nsens v e l co gh-

p o r u E es

t e b a i D

pr A h


m u i lg

e B s,


e s s ru B 6,

1 0 2 il


2 e l ab


d n u

o R e



wi U-

Topics include • EU diabetes policy advancements & research • The cost of treatment: bringing down cost without compromising on quality • Living with diabetes: the psychological aspects • Improving preventative measures • Raising awareness of Type 1 Diabetes • Future technologies • Type 2 Diabetes: bariatric surgery vs medication For more information:

Get involved in the discussion and have your say

Government Gazette

digital democracy

The changing scene of political campaigning in United States Technology is not a solution to all democratic challenges facing the United States. However, “online campaigning is here to stay.” Ann Ravel, Commissioner, U.S. Federal Election Commission discusses the growing role of online political activity and innovative approaches on campaign spending


s Chair of the U.S. Federal Election Commission for 2015, I have had a unique opportunity to observe how rapidly evolving technology is opening up new avenues for political and civic engagement. The Internet and smart phones are making it easier for individuals to connect with campaigns and causes they believe in, and to find ways to share their views and to persuade others to also get involved in political activity. Political campaigning is changing too, as campaigns are using specially-designed apps and social media to reach out to and to register voters, and to target donors. The rapid disclosure of campaign spending online also helps the press and the public to hold candidates and officeholders more accountable. The growing role of online political activity comes at a time when unprecedented amounts of money are being spent on campaigns and elections in the United States, and technology may also be used to evade disclosure of the sources of campaign spending. We must find ways to foster innovation and civic participation online while ensuring that the sources of political spending are fully and quickly disclosed to the public. Technology can create gateways for citizens to become engaged in policy and political action merely by using their smart phones. For example, when people make charitable contributions by text message – to causes like disaster relief or the Red Cross – they are more likely to follow the issue closely, to tell their friends and family, and to become involved in some other way. The same should be true in the political arena – technology can facilitate greater involvement by making it easier to become involved. A number of recent proposals approved by the Commission in advisory opinions aim to do just that. For example, the nonpartisan organisation Crowdpac, which describes itself as a “a datadriven political marketplace,” has created an algorithm that analyses a wide array of public


data in order to determine which issues candidates prioritise, and candidates’ positions on those issues. Last year, the Federal Election Commission issued an advisory opinion approving of Crowdpac’s proposed operations. The platform’s website ( now allows visitors to use the algorithm to connect with candidates that share their political views. Along the same lines, another company, Ethiq (, has recently obtained Commission approval to release a free mobile app that would allow users to determine the political positions of candidates and corporations, allowing them to make betterinformed choices in the ballot box and while online shopping. In response to the ever-growing amount of money that is being spent in U.S. elections, Repledge, a for-profit corporation offers an alternative, which the Commission approved this fall. An individual who is planning to contribute to one of the two major party presidential candidates can make a contribution pledge to that candidate, on the condition that the contribution will be redirected to a charitable cause if a contributor to the other party’s candidate makes a similar pledge. The more individuals sign up for the service, the more money will be redirected to charitable causes instead of to the candidates. As proposed, the Repledge website would essentially become a clearing house for

Government Gazette

individuals on both sides of the partisan aisle who wish to limit the influence of money in politics. Technology is also changing the concept of the public square and how campaigns and politicians reach out to voters. Groups like Nationbuilder ( provide candidates and officeholders with inexpensive web-based tools to connect to voters and constituents. These tools allow candidates to determine whether certain individuals would be likely to support them, based on their social media activity, and provide methods for reaching out to potential supporters online and via smart phone apps. In theory, technology now permits the nearlyinstantaneous disclosure of the sources of spending on political advertising. In two of the most significant recent campaign finance decisions, the U.S. Supreme Court repeatedly affirmed the importance of prompt and full disclosure of campaign spending online. In the 2010 Citizens United v. FEC decision, the Court announced: “with the advent of the Internet, prompt disclosure of expenditures can provide shareholders and citizens with the information needed to hold corporations and elected officials accountable for their positions

electoral management in united states

and supporters.” Over four years later, in the McCutcheon v. FEC decision, the Court reiterated the importance of political spending disclosure: “with modern technology, disclosure now offers a particularly effective means of arming the voting public with information.” While the Court continues to affirm the value of political spending disclosure online, technology can be employed not only to disclose campaign spending, but also to hide it. One example is bitcoin, a privatelyissued currency that enables users to effect financial transactions without disclosing their identities. Theoretically, donors could use bitcoin contributions to anonymously spend on campaign advertising. In 2014, the Commission approved the use of bitcoin political contributions, but only up to $100 per contributor, per election. Full disclosure of the identity of the bitcoin contributor was also Technology is required. I hope that this approach permits changing the innovation without concept of how compromising the politicians and transparency of campaigns reach election-related spending. out to voters and

have helped open up elections. It also nearly permits instantaneous disclosure of public spending, through which it encourages responsive government and political accountability.

At the FEC this year, we are improving disclosure by redesigning our website and making the campaign finance data we do have easily accessible online to the public (visit the beta version of the new site at beta.fec. gov). The website is only as good as the data we have, though, and the FEC needs to do more to collect better data on the sources of political spending. Still, while we should improve our collection of campaign finance data, the Commission is harnessing the latest innovations in web design to make our data understandable and useful for the public, consistent with the Supreme Court’s directive. Technology is not a cure-all for the challenges facing the democratic process in the United States, and it raises new challenges for those seeking to ensure the public is fully informed about political spending. But online political activity is here to stay, and we should do all we can to deploy these new forms of communication to encourage responsive government and political accountability. I look forward to learning about the political technology proposals the Commission will be presented with in 2016

Bidding farewell to old equipment and democracy inaction The EAC stands ready to help states with best practices for voting and updated voluntary voting system guidelines; and make it more flexible for the use of new technologies and ballot options, while still maintaining high standards. Thomas Hicks, Vice Chair, U.S. Election Assistance Commission, discusses the need for reforming the voting machinery


n election night 2000, most people in America went to bed thinking that Vice-President Al Gore was going to be the next President of the United States, only to wake the next morning to hear that Texas Governor George W. Bush had won the election. Over the next 36 days, the world watched and waited for a clear determination of who would be the next President. The Supreme Court made the ultimate decision on December 12, 2000, in Bush v. Gore. In the 5-4 decision, the court stated that there was an equal protection violation that could not be corrected in time for the Electoral College appointments. Shortly after, Mr. Bush accepted Mr. Gore’s concession to the election, and became the 43rd President of the U.S. The controversy did not end with the ruling or the concession. Despite this process, several major questions remained regarding the outcome of the election. Two aspects that called the election into question included concerns over voting machines and ballot design.

ballots were actually going to the candidates they selected. These issues were exacerbated in Florida, but experienced across the country. The Constitution provides the States with authority to run elections, but grants Congress the power to determine “times, places and manner of holding elections” through preemption of State regulations with uniform national rules concerning federal elections. To that point, the federal government had never provided funding to states for administration of elections, let alone the purchase of billions of dollars toward new voting equipment. Congress attempted to correct these issues by crafting bipartisan legislation – Help America Vote Act of 2002 (HAVA) – two years later that authorized almost $3.9 billion for replacing voting machines and directing that all states have statewide registration databases and other mandates to improve the

For decades, many jurisdictions had used the same voting machines to cast ballots, which were now seen as antiquated, although still easy to use. Moving to newer voting machines would be expensive, and voting equipment was not seen as a top priority for most states; roads, bridges, schools, and other everyday infrastructure was seen as a bigger and more pressing need. Ballot design was seen as confusing, which was highlighted by the Florida butterfly ballot. Voters were not confident that their cast

Government Gazette


digital democracy

elections process. This legislation was signed by President Bush in October 2002. It was passed with tremendous bipartisan support in both chambers of Congress: 357-48 in the House, and 92-2 in the Senate. With the passage of HAVA, it was anticipated that if states used federal funds for new voting equipment for federal elections, these machines would also be used in state and local election as well. Voting machines replaced after the 2000 election were purchased around 2005, and many of these are coming to the end of their lifecycles. For jurisdictions not able to purchase new voting equipment, the United States Election Assistance Commission (EAC) has issued guidance on maintenance. To avoid a repeat of the issues of 2000, HAVA created the EAC to • issue guidance for voting machines, • distribute money, and • provide best practices to states on all aspects relating to elections, ranging from voter registration to ballot design and count . A positive outcome of the law is that EAC is charged with developing guidelines and best practices to make voting more accessible for people with disabilities. These benefits also serve military and overseas Americans covered by the Uniformed and Overseas Citizens Absentee Voting Act (UOCAVA). Disabled, military, and overseas voters face many of the same obstacles when voting: the ability to cast

their ballots independently, privately, and with confidence that their ballots are received and counted. The ability to cast a ballot and have it counted improved significantly for UOCAVA voters in 2009 when the Military and Overseas Voter Empowerment (MOVE) Act was signed into law. The MOVE Act requires that ballots must be transmitted to UOCAVA voters no later than 45 days before a Federal election. These voters must be given the choice to receive their ballot by at least one electronic method (email, online or fax) or by mail, and States must have a system in place for voters to determine if their voted ballot was received by their election official. The EAC is uniquely situated to help all constituencies to fully participate in the democratic process. To aid this effort, EAC has a website map where viewers can access election information in their state. Voters should also check with their local election office to ensure that they are registered in the jurisdiction where they reside. More than half the states now allow for voters to register online, which also helps military and disabled applicants to determine their eligibility more quickly and accurately. This can be done well before Election Day so that problems with applications can be corrected in time for the next election. For disabled voters, the EAC has provided millions of dollars in research grants to make voting more accessible to all disabled voters.

For example, one grant to the Research Alliance for Accessible Voting (RAAV) developed the use of technologies that provide private and independent verification of paper ballots. As a direct result, these breakthroughs are now being used by some states to improve voting in the 2016 election cycle. Over the last decade many American service members have returned to the U.S. wounded from battle and often facing the challenge of living with a disability. Additionally, the ageing of “baby boomers” is expected to result in a significant increase in the number of voters with disabilities. It is becoming all too clear that the need of truly accessible voting equipment and clear ballot design brought to light by the 2000 election can be seen as a legacy for ensuring that all voters have access to the ballot. It is my hope that whether a voter is casting a ballot in Massachusetts or Paris or in a foxhole in Afghanistan they may do so securely, privately, and independently. The EAC stands ready to help states with best practices for voting and updated voluntary voting system guidelines; and make it more flexible for the use of new technologies and ballot options, while still maintaining high standards for manufacturers and addressing security concerns, thereby giving confidence to voters and the world that the problems associated with the 2000 election remain memories of the past

Improving the American voting experience Reforming the American election administration is loaded with difficulties, especially with the republicans and democrats having opposing view on several areas. An array of issues shaping the voting experience too easily become fodder for bipartisan debates. John C. Fortier, Director of the Democracy Project, Bipartisan Policy Center elaborates on the recommendations and successes of the Presidential Commission on Election Administration in this era of extreme political polarisation


Government Gazette


n Election Day 2012, President Obama noted with concern that some Americans had been forced to wait for many hours to vote in very long lines at polling places across the country. As he famously remarked during his victory speech: “We have to fix that.” Several months later, he established the Presidential Commission on Election Administration (PCEA) to identify best practices in election administration and to make recommendations to improve the voting experience.

electoral management in united states

But reforming American-style election administration is fraught with difficulties. There are significant hot button issues where Republicans and Democrats often have diametrically opposing positions, such as photo identification laws, same day voter registration at the polls, and the prospects of voting over the Internet. Further complicating efforts for reform is the decentralised nature of American election administration. Most election law is written at the state level and differs from state to state on key issues such as voting by mail, the days and hours polling places are open both on Election Day and during early voting, felon voting eligibility, and technology standards for voting machines. And elections are administered at the local level by jurisdictions as large as Los Angeles County with over 10 million residents and as small as towns with fewer than 100 people. The decentralisation is so strong that there is not even an agreed upon number of local election jurisdictions – numbering over 8,000 jurisdictions at least. With all of these difficulties, the President wisely positioned the PCEA in ways that could make it successful. First, while the issue of long lines initially inspired the President to act, he recognised that lines are often a symptom of other problems in the voting system and, thus, directed the PCEA to consider a wide range of issues including voter registration, voting technology, and different modes of voting such as absentee and early. Second, he did not direct the PCEA to take on the most bitterly contentious issues between the two political parties. Third, he asked the Commission to direct its recommendation to state and local policymakers and administrators and not to Congress and federal agencies. Most importantly, the President emphasised the seriousness of the effort by the personnel he nominated to serve on the PCEA. To chair the Commission, the President selected Robert Bauer, who had served as the general counsel to President Obama’s two presidential campaigns and as the White House Counsel, and Benjamin Ginsberg, who had served as the general counsel for 2012 Republican presidential nominee Mitt Romney. The selection of widely respected Democratic and Republican election lawyers to chair the PCEA signaled that the Commission was to make consensus recommendations that would be accepted by both political parties. Other PCEA commissioners included five state and local election officials with practical experience running elections and three business leaders who brought their private sector management and logistical expertise to the voting process. The PCEA held extensive hearings across the country, attended by election administrators, voting groups, and interested members of the public. In January 2014, the PCEA issued its recommendations to the President and Vice

President at the White House. The Key Recommendations from the report include: 1. Modernise the Voter Registration System.

Twenty-nine states and the District of Columbia now have online registration, and two more states have passed authorising legislation to implement systems soon. Thirteen states and the District of Columbia are now engaged in voter registration data sharing through the Electronic Registration Information Center (ERIC) and more than half the states participate in the Interstate Voter Registration Crosscheck (IVRC) program. BPC is working with states who wish to modernise voter registration.

States should adopt online voter registration. States should share their state voter registration lists with other states to improve the accuracy and comprehensiveness of voter lists. States should improve the process for voter registration at the department of motor vehicles and ensure that there is regular sharing of data between motor vehicle records lists and voter The Republicans registration lists. 2. States should address the coming crisis in voting technology. Most of the voting technology in America was purchased with funds available after the 2000 election dispute. These voting machines are now reaching the end of their lifetime. America must update the standards and testing for voting technology, fund the purchase new voting machines, and develop future voting technology that is flexible, including the use of off the shelf technology. 3. States should consider forms of voting in addition to Election Day voting.

and Democrats often have opposing positions in a panoply of issues, such as photo identification laws, same day voter registration at the polls, and the prospects of voting over the Internet. Despite these differences, the PCEA has had several noteworthy accomplishments.

To spread out the flow of voters, states should adopt options to vote early at polling locations or by mail in addition to their Election Day polling locations. 4. The Commission established a standard for waiting times at polls of 30 minutes. In the normal course of voting, voters should expect to wait no longer than thirty minutes in line. States and counties should work to measure polling place waits and to address waits longer than thirty minutes. PCEA made important and practical recommendations to improve election administration in America. Its report complete, the Commissioners worried that these recommendations could simply collect dust on a shelf without serious consideration. The Commissioners asked the Bipartisan Policy Center to work with them to continue to develop and operationalise the recommendations and promote them with policymakers and administrators across the country long after the PCEA had closed its doors.

Election Day.

Following BPC’s work to promote the implementation of the PCEA best practices and recommendations, the federal United States Election Assistance Commission adopted an interim, new technology standard for voting machines, and it has begun the process to make the next generation of voting technology possible. BPC and the Massachusetts Institute of Technology are engaged in a program working with key counties from across the country to collect extensive data about Election Day lines, improve counties’ allocation of voting machines and personnel to polling locations, and to generally improve the flow and processing of voters on

More work remains to fully achieve success at improving all Americans’ voting experience, but the former commissioners of the PCEA and the staff at BPC are prepared to help implement the PCEA’s sensible, bipartisan solutions John C. Fortier is a political scientist and director of the Democracy Project at the Bipartisan Policy Center where he leads a team which is working to further the recommendations of the President’s Commission on Election Administration. He can be reached at

Today, a team of the commissioners, election officials, scholars and others knowledgeable about voting are working on the legacy of the PCEA. A few accomplishments are noteworthy.

Government Gazette


digital democracy

Technology and 21st century democracies With the advent of the information age, algorithms and powerful computer applications built on them have disintermediated several traditional businesses. However, several democracies are yet to make the best use of the wide array of technologies available to transform how government and citizens relate with each other. While biometric registers and electronic voting are only the tip of the iceberg, Antonio Mugica, CEO, Smartmatic says a much deeper transformation is awaiting remains molded after decades-old paradigms of governance.


n 1922, the noted American sociologist William F. Ogburn coined the term “culture lag” to explain how society takes time to catch up with technology innovations. Observing thousands of years of human evolution, he concluded that social problems and conflicts can be explained by this gap. His theory is detailed in his book “Social change with respect to culture and original nature.” In recent decades we have witnessed drastic technology-driven changes that have touched virtually all aspects of our daily life. With the advent of the information age, algorithms and powerful computer applications built on them have disintermediated entire industries, transforming the landscape of countless traditional businesses such as banking, stock exchange, insurance, manufacturing, transportation, distribution, wholesale and retail commerce, real estate, travel agencies, video rental providers, among many others. In spite these drastic changes, democracy has fallen behind. For some reason, perhaps explained by Dr. Ogburn’s Culture Lag theory, democracy has not adapted to the new realities. In most cases, countries are not making the best use of the wide array of technologies available to transform how government and citizens relate with each other. Internet penetration stands today around 46% of the world population and, by the end of 2016, at least 2.16 billion people around the globe will have smartphones. Yet, we are still holding elections every other year-in the best of cases-, and for the most part, the dialogue between representatives and constituents


With information, good and bad, populating the cyberspace 24 hours a day, 365 days a year, it is easy to see how and why frustration over government efficiency is pervasive. The gap between what the population expects and what public institutions deliver might explain the declining trend in election participation. The Internet and especially social media spaces give everyone, from big corporation to NGOs, small businesses and individuals, a level playing field to express their opinions. These tools can be gateways to spark movements and engage citizens in decision making processes. Yet, actions need to be taken in order to frame, organise and channel the ongoing dialogue. Otherwise, we run the risk of being run over by a cyber mob. As the leader of an organisation that has been working to improve democracies through technology-enabled solutions for over a decade, I have attested first-hand the transformative power of technology. Whether it is the Philippines, Belgium, the US or Venezuela, our technology has helped close the democratic deficit by making voting easier, increasing turnout and bringing the cost of elections down. Affordable technology allows voting methods to diversify and adapt to holding more frequent public opinion consultation events, from national referenda down to polls of lesser level or scale, e.g. about local laws or community rulings. This invites me to be optimistic about the future ahead; one in which changes in how government works, what it does and how we hold it accountable, can bring prosperity. In 2009, we helped Bolivia create its first biometric voter register. Using portable biometrics-capturing devices we reached out to every corner of the territory. Only five years later, a voter register comprised by a

Government Gazette

majority of women elected the first House of Representatives of the National Assembly in which women represent more than 50%. Although technology alone cannot be credited for this feat, it definitely played a role in making elections more inclusive. As Dr. Ogburn anticipated, technology opened a possibility and then the changes in society took the corresponding step forward. Over the last decade my company has had positive impacts in various latitudes, yet biometric registers and electronic voting –our core business– are only the tip of the iceberg of a much deeper transformation awaiting. The algorithms and digital muscle to substitute entire government offices and bureaucratic processes and bring democracies fully into the 21st century are now available. Let’s make the best use of it. Last year, we helped two communities in Chile to decide on how to allocate public resources through electronic voting. Citizens from Maipu voted online from their mobiles or in precincts equipped with electronic voting machines in order to convey their priorities to authorities. This is direct democracy working at its best. These advances are heading towards a future of constant voting. Countries such as Australia, Scotland, Germany or the UK have already adopted electronic petitioning systems to amplify the voice of citizens and press government for action. In the UK, gathering 100,000 signatures can now initiate a Parliamentary debate. As authentication technologies evolve, we are likely to see petitions move to a more direct form of democracy-- they could become mandates. It is utterly evident that technology has already done its part. It is enabling us to have a debate about the nature of democracy in the information age. But technology, as revolutionary as it may be, is no substitute for leadership. We must engage all stakeholders and promote this conversation. It is time to bridge the gap

electoral technology

The digital age has transformed media, retail and communication. There is a seismic shift underway with the ‘appification’ of everything. With the way we share and consume information and engage with others revolutionising, is it time for elections and democracy to embrace and adapt to the fast changing digital age? Rachel

DeLevie-Orey, Assistant Director,

Election technology needs international guidelines


rom booking travel to managing bank accounts to calling a taxi, it seems there is now an app for everything; yet elections—that most sacred democratic act—remains immune to this in much of the world. While consumerism and citizenry consider how to embrace the digital age, elections must keep pace while maintaining integrity and legitimacy, ensuring strong democracies. The Atlantic Council, a foreign policy think tank in Washington, DC, is hosting an initiative to consider this issue, called “Democracy Rebooted: the Future of Technology in Elections.” With events in Silicon Valley and Washington, DC, the Atlantic Council has convened thought leaders from the technology industry, electoral experts, democracy specialists, and government and international organisation representatives to

Adrienne Arsht Latin America Center,

Atlantic Council says what we need

at the moment is a set of international guidelines to guide governments considering the change

consider the most responsible implementation of technology in elections. The Atlantic Council will publish a paper on the issue this spring, authored by former LA County Registrar and electoral expert Conny McCormack. The research of the Atlantic Council makes clear the myriad components critical to a legitimate election; from a free press to strong campaign finance laws to an accessible voter registration system, much of the credibility of an election rests on what happens before election day itself. And when that day does come, there remain the critical tasks of casting and counting the ballots. Ever-advancing technology can serve to better many aspects of this process; but considerations of cost, security, and acceptance of these technologies remain prevalent concerns. It is vital that governments seek to implement technology in a way which will increase transparency and access.

Government Gazette

In order to do this, there is an immediate need to establish international guidelines on election technology. For governments considering an update to their voting systems, there is a dearth of information: there is little data on cost analysis, the impact on voter participation, or what standards election technology should abide by. The rapid advancement of technology—and the equally rapid expansion of the companies which produce it—has created an industry which remains relatively unchecked. Uncharted territory is always ripe for opportunity and riddled with challenges. Creating international guidelines for this new technology will be instrumental in determining the validity of these tools. The acquisition of new technology begins with governments looking to modernise their voting systems. A clear understanding of what makes a system transparent and legitimate will help governments select an appropriate and reliable system for their voters. With an increasing number of companies offering new election technology, it is important to find


gender equality

a way to distinguish established, legitimate operators from those less experienced or those unwilling to comply with best practices. By identifying certain voting technology systems as those which meet internationally recognized standards, governments can be confident in their selection of a reliable technology. Such confidence is also critical for earning the trust of the voters; a change in status quo can be cause for questions in any country. But if voters understand that a new system is verified by a third party this lends legitimacy to the new machinery. The importance of this cannot be over-emphasised: trust is the most important piece of any election. The electorate must trust that their votes are being counted as they were cast, and must believe that the winner is reflective of an honest process. Governance is only possible when people believe that their elected officials rightly earned a place in that office. How to create these guidelines? The notion of international standards for elections is not a new one; the Carter Center, the National Democratic Institute, and the United Nations Development Program produced international best practices for election observation. Former UN Secretary General Kofi Annan chaired a coalition which published the internationally recognised report “Deepening Democracy,” which detailed the ways in which the world must protect the integrity of elections at all phases of the process. The Atlantic Council report rightly argues that organisations such as these would be well-suited to lead a coalition to determine guidelines for electronic voting.(1) McCormack takes care to emphasise that political clout is not enough to create these standards; indeed, the involvement of third party testing to provide technical expertise is critical. “One of the most important tools in advancing the use of electronic and other automated voting systems is the use of qualified, independent testing of hardware and software,” says McCormack. “There is no greater tool to help promote the credibility of voting systems in the eyes of the voters than to have involvement in testing and certification of qualified independent testing laboratories. For testing to be most effective, there must be standards governing the various technologies.” (2) Elections are the very foundation of democracies. The ubiquitous nature of technology will only continue to grow, and, if implemented wisely, can help shape more inclusive, transparent, reliable, democratic elections. Establishing the parameters for a credible system is a critical first step References: 1. McCormack, Conny, “Democracy Rebooted: the Future of Technology in Elections” Atlantic Council, forthcoming 2016 2. McCormack, Conny


Quotas are coercive, but tend to help women participate better

The Albanian experience has shown that quotas are a crucial measure to increase women’s participation in electoral administration. Lefterije Luzi, Chairwoman, CEC Albania, discusses the current state of implementation of gender quotas in Albania and argues why a lot remains to be done to increase the participarion of women in Election Management Bodies


pecific measures have to be adopted to increase the participation of women in decision-making bodies. The application of a gender quota system is just one of them. In Albania, gender quota systems are legal and respectively provided in the Electoral Code and on the Gender Equality Law, since 2008. These measures brought significant improvement in the representation of women in decision-making bodies. The Electoral Code guarantees legislative gender quotas for parliamentary candidates, candidates for the local government bodies and management bodies of the electoral process. The Electoral Code insists that women comprise 30% of the candidates on party lists for each of the country’s 12 election districts, and that at least one woman be placed among the top three names of each list. Article 67 of the Electoral Code provides sanctions for non-

Government Gazette

compliance of this obligation of gender quotas. Currently, there exists two types of sanctions, namely administrative sanctions with fines and complimentary sanctions which replace vacancies in the subject list, wherever there is an infringement with the candidates on the list of the less represented gender. During the last Assembly elections, the Central Election Commission (CEC) found the phenomenon of non application of the law in respect of gender quotas in the multiname lists of three political parties, which are the biggest in the country, the majority parties and the opposition parties. At the end of the Parliamentary elections in 2013, the composition of the Assembly was a total of 140 MPs, out of which 25 were women. Implementation of additional sanctions provided by the Electoral Code

electoral management

increased the participation of female MPs in the legislative body where out of 140 members, 30 or nearly 21.4% were women. Towards the end of the elections in 2009, there were only 23 women or 16.43% in the Assembly. Gender quotas established in the Electoral Code only guaranteed a 30% participation of women in party lists. However, it did not ensure a 30% representation of women in the legislative body. The new provisions of the Electoral Code after legal amendments set new criteria, which actually guaranteed a greater number of women candidates to win the MP mandate. In 2015, just before the elections for Local Government Bodies, significant changes were made to the Electoral Code, particularly in relation to the definition of gender quotas for candidates for local councils. According to the new definition, multi-name lists of candidates for local councils should have one in every two consecutive names from each gender. In conclusion, women’s participation in party lists constituted 49.36% and their representation in local government bodies was 34.80%. In essence, I think gender quotas should only be considered temporary measures until we naturally avoid such imposed barriers to women’s participation in election bodies. The elections in Albania are administered by a three - level election administration, with the first level consisting of the Central Election Commission (CEC) as a permanent body (seven-members), the second level consisting of 90 Commissions of Electoral Administration Zones (720 commissioners), and the third level consisting of 5,301 Voting Center Commissions (37,107 commissioners) and 866 counting teams ( 3,464 counters).

Based on the Albanian Constitution, the quota law “On Gender Equality in Society,” enacted in July 2008, states that at least 30% of each level of election administration, should be represented by the less represented gender. Subsequently, the Electoral Code of December 2008, provided a gender criterion only for CEC membership at the second level, and weakened the “language” about quotas that appeared in the earlier legislation. These legal regulations examine the role of women as electoral commissioners in Albanian elections of 2009, 2011, 2013 and 2015.

in order to increase women’s participation within the political system.

The Electoral Code was extensively and substantively amended in July 2012, and later in April 2015. It included provisions to ensure equal gender representation in both the Assembly and local government eleections, however nothing really changed about gender representation in election administration.

Seven years after the establishment of quotas, although the election law was twice amended, the political parties which have the right to adopt laws, had “forgotten” to include quotas for all levels of election administration.

Currently, three members of the CEC are women, as opposed to two in 2008. At the second level, there were at least 24% women in local elections of 2011, 26% in 2013, and 29% in 2015. Women’s representation at the third level of election administration remains significantly lower, due to the absence of electoral law requirements of gender quotas for this level. Nonetheless, during the 2015 elections, nearly half of the Voting Centre Commissions composed of men. This reality is that equal rights are not always synonymous with equal opportunity.

The CEC strives to make the necessary efforts to improve gender representation in all levels of election administration, to be continuously in touch with political parties, citizens and other social and political actors increasing the representation of women on each level of election administration, and to design elections that are gender-sensitive and encourage women’s engagement in the political process. This year, Albania will once again undergo electoral reform. The primary focus of this reform will be to improve the procedures in the Election Commission, and to ultimately increase of the participation of women in Election Mangement Bodies

In order to assess the proper adherence to gender quotas, we should not only closely monitor party lists. Instead, we should consider monitoring the entire election administration

To be truly effective, a rights-based approach must “focus on enabling an environment in which all citizens can exercise their fundamental right to vote.” Vasu Mohan, Regional Director for Asia-Pacific, IFES elaborates on how this approach can help inform the type and scope of security planning


The Albanian experience has shown that quotas are a crucial measure to increase the participation of women in electoral administration, because unless political parties are required by law to respect “gender quotas,” they are highly unlikely to do so in a voluntary manner.

These data reinforce an important lesson.

A rights based approach to electoral security

he International Foundation for Electoral Systems (IFES) defines electoral violence as “any harm or threat of harm to any person or property involved in the election process, or the process itself, during the election period.” Electoral violence is a unique subcategory of political violence experienced in different forms, ranging from intimidation, to destruction of property, to violent clashes

I agree with the EU Justice Commissioner Viviane Reding, who said ‘I don’t like quotas, but I like what quotas do.”

resulting in loss of life. Electoral security, on the other hand, encompasses all aspects of protecting electoral stakeholders such as voters, candidates, poll workers, media and observers; electoral information such as vote results and registration data; electoral property such as campaign materials, ballot papers, results sheets and indelible ink; electoral facilities such as polling stations and counting centres; and electoral events such as campaign rallies, against

Government Gazette

disruption, damage or death. IFES approach to electoral security In many emerging and transitional democracies violence continues to challenge the integrity of elections. Given that elections are inherently competitive, the potential for violence during an electoral process can be significant. Conversely, elections often take place in environments with protracted and sustained insecurity, and can also provide an alternative to violence as an avenue to deliver a peaceful transfer of power. The context for electoral insecurity can be very different from place to place or over time, but the fundamental right to electoral security – a human right – remains the same. One of the greatest global achievements of the last half century has been the development of an international framework for the protection of human rights. Out of this framework, the concept of human security emerged – the idea that security is not simply the absence


electoral security

of conflict or the security of States, but the protection of people and their fundamental rights and freedoms. The Universal Declaration of Human Rights (UDHR) is at the core of the international human rights paradigm, and provides protections with respect to electoral security. UDHR includes articles guaranteeing all people the right to security of person (Article 3); the right to periodic and genuine elections, by universal and equal suffrage, and through secret vote (Article 21); and the right to assemble and associate peacefully (Article 20). Together, these articles underpin the right of all people to participate in the electoral process in a peaceful and safe environment. These rights are reinforced in the International Covenant on Civil and Political Rights (ICCPR), Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), Convention on the Rights of Persons with Disabilities (CRPD) and other UN/international instruments such as Security Council Resolution 1325. As part of the international framework of standards that govern elections, the right to safely participate in the electoral process is a fundamental pillar of electoral integrity. While types of electoral insecurity may change, the end result is usually the same: disenfranchised voters, loss of trust in the electoral process, and lack of electoral integrity. Electoral insecurity also represents a failure to protect the rights of citizens to take part in the electoral process. Over the past 26 years, the International Foundation for Electoral Systems (IFES) has worked closely with electoral authorities operating in challenging environments to support their efforts to create a secure environment for voters. Because insecurity can take many forms, it can also require different responses. For this reason, the responsibility to protect the rights of voters usually lies with a variety – and ideally a coalition – of stakeholders, including governments, election officials, media, security forces, law enforcement agencies, political parties, candidates, community leaders and concerned citizens. At the heart of any response, however, must be the safety of voters and candidates, whose right to participate in the electoral process is enshrined in international law. The current focus of electoral security efforts is primarily on electoral management bodies, law enforcement, military and other security entities. Peace building initiatives, women, community leaders, and robust formal and alternative dispute resolution mechanisms are not factored into plans. Reframing electoral security as human-centered, rather than event-, location- or materialcentered, allows for a more holistic approach to security that covers all phases and activities of the electoral process and that adheres to the spirit of international standards and


norms governing elections. It also avoids the dissolution of responsibility in environments of protracted insecurity, whereby attention is only given to key phases of the electoral process and not to understanding, planning for and mitigating the effects of complex, pre-existing insecurity. To be truly effective, a rights-based approach to electoral security must focus on enabling an environment in which all citizens can exercise their fundamental right to vote or be elected. This approach can help inform the type and scope of security planning undertaken. It helps crystallise exactly what must be protected, which in turn can shape how this protection should be provided. This approach demands that when we look at integrity of elections we consider the ability of people to exercise their rights to ensure that “the will of the people shall be the basis of the authority of government,” as stated in the UDHR. IFES Electoral Security study IFES has conducted systematic research on electoral security and electoral violence from a new perspective through the use of previously untapped resources: election observation reports. We have studied 175 election observer reports for 172 elections. (1) These reports are from election observation missions fielded by well-established organizations globally. (2) In a forthcoming report, we identify and categorize the most common successful violence mitigation and prevention measures that have been mentioned in these reports. While we acknowledge that the election observation reports do not necessarily include detailed information on all aspects of those elections and the political context, they nevertheless provide considerable information that is substantiated with data collected on the ground by observer missions. Also, since these reports often follow a similar structure, they provide additional advantages for comparative purposes. We have collected these reports from the Ace Project Electoral Knowledge Network’s database. We have not limited the type of elections studied and our data pool has various types of elections from national elections to local elections or referendums. This study will be completed in 2016. One key finding from this study is the critical role of the election management body in reducing election violence. Strong election management bodies play a crucial role in averting election violence. On the other hand, EMBs that are in charge of delivering free and fair elections might themselves suffer from poor decision-making, overt partisanship and/ or incompetency and thus escalate the risks for electoral violence. The end-result is electoral malpractice and impaired electoral integrity. Research demonstrates that countries suffering from electoral malpractice are more susceptible to electoral violence. The National Elections

Government Gazette

Across Democracy and Autocracy (NELDA) database from Yale University’s Department of Political Science shows that within elections that have the poorest electoral integrity scores, four out of each ten elections became the scene of fatal violence. What’s more, violent clashes occurred in nearly all of the countries with low electoral integrity scores. Death and violent clash rates are dramatically lower in countries with better electoral integrity scores and less electoral malpractice. Take Kenya’s case for example. Kenya’s 2007 presidential elections provide a case to examine the escalation of electoral violence. Among the factors that provoked violence during these elections, both electoral malpractice through the EMB’s administrative failure and inflammatory media broadcasts are commonly mentioned. The Electoral Commission of Kenya’s failure to achieve transparent and accountable vote-counting was identified as one of the most significant triggers of the violence that broke out during the presidential elections. Six years later, a newly-appointed Kenyan EMB, the Independent Electoral and Boundaries Commission, that operated under new leadership, legislation and regulations was able to conduct a far less violent presidential election. A recent study by the United States Institute for Peace has found that “sound security sector engagement and election administration, both at the heart of the state’s electoral responsibilities, demonstrate the greatest ability to mitigate violence or preventing it all together.” (1) EMB credibility plays a significant role in preventing electoral violence according to studies and observer reports. Indeed, credibility has even been named as “the most valuable asset any EMB can possess” because it can dramatically enhance electoral security. (2) References: 1. Claes J. and G. Macdonald (Forthcoming 2016). Findings and Conclusion. In Braving Troubled Elections (TBC). Washington, DC: U.S. Institute of Peace. 2. Staffan Darnolf and Almami Cyllah. (2014). “EMBs and Electoral Violence,” in Almami Cyllah (ed). Elections Worth Dying for? A Selection of Case Studies from Africa, Washington D.C.: IFES. p. 15 Vasu Mohan has managed IFES election support projects in conflict and post conflict countries. A version of this article first appeared on IFES’ website in 2015. The research referred to in this article was conducted by Vasu Mohan in collaboration with Research Consultants Dr. Ahu Yingit and Andrew McCoy, and IFES Program Coordinators Ritika Bhasker, Ryan Bennett and Sue Pang.

International Electoral Awards 2016 December 2016*

ICPS and ICEP have established an award exclusively for electoral stakeholders, in recognition of their work and to acknowledge their significant contribution to the democratic process beyond the community of electoral professionals, practitioners and experts. The nomination period will start soon. For further information, about the awards, nomination procedure and last year’s winners, please visit the International Electoral Awards website:


Venue and date to be confirmed shortly