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Government Gazette November 2016

In recognition of Lung Cancer Awareness Month

£10.00, €11.00 ISSN 2042-4168

Policy recommendations to battle lung cancer in Europe Let’s do more for children with cancer

Review of the EU Paediatric Medicines Regulation


VIVIAN HERTZ

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Government Gazette

Government Gazette November 2016

what’s inside?

Editor

Jonathan Lloyd editor@governmentgazette.co.uk (+44) 020 3137 8612

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Commissioning Editor

Janani Krishnaswamy janani.krishnaswamy@governmentgazette.co.uk (+44) 020 3137 8653

commissioner vytenis andriukaitis

European Commissioner For Health and Food Safety

Publisher

The European Commissioner addresses the key risk factors of lung cancer and details the European Commission’s current action plan against cancer

Matt Gokhool matt.gokhool@governmentgazette.co.uk (+44) 020 3137 8611

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Subscriptions

subscriptions@governmentgazette.co.uk (+44) 020 3137 8612 © 2016 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.

dr. jamie shea Deputy Assistant Secretary General, NATO

Dr.Jamie Shea analyses the intensity of the cyber threat in Europe and reiterates NATO’s new role in tackling cyber threats

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Cover Image: The London Research Institute Electron Microscopy Unit

glenis willmott mep

Member, European Parliament

In-Focus

Glenis Willmott MEP reviews the 2007 EU Peadeatric Medicines Regulation and points out what needs changing in the world of paediatric oncology

paediatric oncology

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Healthcare Stakeholders make an assessment of the challenges within paediatric oncology in Europe and explain why more needs to be done to help children with cancer

respiratory oncology

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Miriam Dalli MEP addresses the environmental risk factors of lung cancer and evaluates European Parliaments’s work on cancer

security report

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Security Experts offer key policy recommendations on how the EU and its member states can protect the homeland and tackle the challenges within the border and cyber arenas

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lunc cancer health report

campaign for cleaner air

migration report


EDITORIAL VIEW

Lung cancer is a huge challenge, but we’re facing up to it

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ung cancer is one of the most common cancers worldwide with over 300,000 deaths every year in Europe alone, accounting for approximately 28% of total cancer deaths. While survival across all cancers has doubled in the last 40 years, that progress hasn’t been equal for all types of the disease. Lung cancer has lagged behind and there has been little improvement in recent decades. Apart from delayed diagnosis, poor survival outcomes and denied or late access to innovative treatment that make lung cancer a particularly emotional disease for people to deal with, there are many negative perceptions and stigmas due to the disease’s link to smoking. This in turn has had a strong impact on funding, incentives for research, resources and media support.

within Europe and make convincing arguments for change. MEPs Glenis Willmott and Francoise Grossetete review the EU Paediatric Medicines Regulation and point out what crucially needs changing regarding current EU-wide policies on prevention, education, screening, treatment, care and research relating to childhood cancer.

For change to happen, we need policies that reduce the uncertainty around both the use and regulatory acceptance of novel clinical trial designs and drug development. Urgent action is required at the policy level and broader collaboration is required among policy makers, professional societies, healthcare professionals and patient organisations. That’s why we’ve made lung cancer a priority in the November edition of Government Gazette.

While addressing the serious challenges relating to health security, the current edition also makes an assessment of the challenges surrounding border security, migration, cyber security and other key social developments affecting the EU. Dr. Jamie Shea, Deputy Assistant Secretary General, NATO, took to the pages of Government Gazette’s exclusive Security Report, to appraise the intensity and nature of cyber crime within Europe and reiterate NATO’s new role in tackling cyber threats.

In recognition of the Lung Cancer awareness month, Members of the European Parliament, senior representatives from the European Commission, medical and clinical experts, patient groups and other key stakeholders have come together to offer policy recommendations to improve prevention, treatment and care of this devastating disease.

Policy makers and cyber security experts offer key recommendations on how the EU and its member states can learn from existing cyber breaches and prepare for the future. MEPs Afzal Khan and Victor Negrescu analyse how our economies have turned out to be more interconnected and digitalised and have as a result become more vulnerable to cyber threats.

Addressing the risk factors of cancer is the European Commission’s first line of attack in the battle against cancer. In his exclusive healthcare editorial, Vytenis Andriukaitis, European Commissioner for Health and Food Safety, focuses on the two major tools which add value to the prevention and treatment of lung cancer. MEPs Catherine Bearder and Mariam Dalli address the environmental risk factors of lung cancer and argue why we shouldn’t miss another historic opportunity to save thousands of lives each year and reduce the costs to our health services.

In our extended focus on migration and border security, Yury Fedotov, Executive Director, United Nations Office on Drugs and Crime and Magdy Martinez-Soliman, Assistant Secretary General, United Nations, review the current global security crisis, the associated migration crisis, human trafficking, terrorism and migrant smuggling to put forward recommendations to the European Parliament, the European Commission and member states to address current shortfalls and improve existing policy on border security.

Clinical experts, researchers and other stakeholders discuss the challenges within the field of respiratory oncology and argue that the right amount of coordination and encouragement from all healthcare players is required to facilitate better clinical developments and timely prevention of the deadly disease. In our extended focus on oncology, Government Gazette also takes a closer look at one other cancer that requires urgent attention. Ten years after the entry into force of the EU Paediatric Regulation 2007, cancer remains a great threat to children’s lives. Children cannot wait any longer. As tackling the present situation within paediatric oncology requires innovative solutions and unusual approaches, healthcare stakeholders make an assessment of the challenges existing

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MIGRATION REPORT

Standing up for the victims, staring down the criminals Migration, human trafficking and migrant smuggling have remained high on the UN agenda throughout history, with a view towards drafting new laws and developing comprehensive strategies to destroy criminal networks. Yury Fedotov, Executive Director, United Nations Office on Drugs and Crime, evaluates UNODC’s work in the prosecution of perpetrators

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e currently face perhaps the greatest humanitarian crisis since World War II. Across the world tens of millions of people are escaping conflict or hoping to embrace new economic opportunities. The world seems to be in perpetual motion.

Just last month, Reuters reported that police had concluded their long investigation into the deaths of 71 migrants found in an abandoned truck along a stretch of Austrian motorway. The truck’s backdoors had been wired shut. Several individuals now face prosecution in this horrifying case. But brutal and uncaring smugglers are not the only threat.

Many of those taking long perilous journeys are isolated and scared children; crossing seas, braving deserts, inching along hostile land routes. Newspaper reports reveal both the desperate nature of those trying to escape, as well as the deadly dangers.

Women, children and men fleeing their homes are vulnerable to the violence and abuse of human traffickers. Based on the UN Office on Drugs and Crime’s (UNODC) Global Report on Trafficking in Persons 2016, trafficking movements appear to follow migratory movements. The majority

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of trafficking victims are also foreigners in the countries where they are detected. Of all the victims discovered, according to the report, an overwhelming 79 per cent were women and children. The daily barrage of disturbing news reports the clear analysis showing that women and children are the most vulnerable, and the impunity that criminals enjoy is accelerating international responses. In September, the UN Summit for Refugees and Migrants brought together governments, UN agencies and civil society to commit themselves to the New York Declaration adopted at the summit and to negotiate a global compact for safe, orderly and regular migration.


UNODC is the guardian of the UN Convention against Transnational Organised Crime—also known as the Palermo Convention—along with its two protocols related to migrant smuggling and human trafficking. Viewed together, these legal instruments, adopted through domestic legislation, are a powerful tool in the hands of law enforcement bodies to chase crime across territorial borders, share information and undertake joint action.

With the international wheels turning faster, the New York Declaration contains 19 commitments, three of which are dedicated to concrete action against these crimes. UNODC is the guardian of the UN Convention against Transnational Organised Crime—also known as the Palermo Convention—along with its two protocols related to migrant smuggling and human trafficking. Viewed together, these legal instruments, adopted through domestic legislation, are a powerful tool in the hands of law enforcement bodies to chase crime across territorial borders, share information and undertake joint action. The Palermo Convention enables countries to draft new laws and to develop comprehensive national strategies to roll up the criminal networks. It promotes effective investigations and prosecutions of perpetrators and helps identify the trafficking victims among susceptible groups of migrants and refugees. International cooperation is also encouraged through the Convention, particularly in the field of

tracking the massive enormous profits from these crimes. Adoption of the Palermo Convention is almost universal, but the challenge remains in encouraging nations to fully implement the Convention and the protocols. This means applying the Convention so that criminals are removed from the streets, and successfully prosecuted. The victims of human trafficking and migrant smuggling need to know that those who abuse them cannot escape justice. These approaches are only the start. Shallow, time-limited interventions that fail to go after the real criminals risk punishing the victims, while leaving transnational networks in place to cause more harm. There needs to be a greater focus on more sustained approaches, as well as better resources. The cause of justice, after all, takes time, committed personnel and money. Thousands of police hours are expended on going after the perpetrators, tracing the money both physically and online and coordinating cross border operations.

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Every country needs to be involved in this fight. No country can afford to turn its back on the suffering and misery of the victims. The entire world should be joined in an integrated response to these crimes, and UNODC is doing everything possible to ensure that the New York Declaration remains a high priority. But the issue is also one of respect for people and their fundamental human rights. Victims of human trafficking and migrant smuggling need to be fully protected and the perpetrators punished. We must avoid any and all discrimination against these individuals. They have suffered enough. Throughout its history, the UN has worked to place these issues high on the international agenda, call countries together for support and deliver solutions where needed. In committing ourselves to the New York Declaration, we have a new starting point for turning commitments into action. This work has just begun, but it must continue until we have reached the end.


MIGRATION REPORT

Managing displacement with development solutions It’s a sad fact that the current global security crisis and the associated migration crisis is leading to the militarisation of our borders. Magdy Martinez-Soliman, Assistant Secretary General, United Nations and Assistant Administrator, United Nations Development Programme, reviews the United Nation’s recent work on migration and explains how human mobility can be better managed with development solutions Development policies need to adequately integrate and consider migration and displacement. A year and one day after the international community adopted the 2030 Agenda for Sustainable Development, the world’s political leaders have acknowledged the important links between development and people’s rights to stay where they are. Responding quickly and effectively to sudden population movements is key in keeping migrations and other forms of human mobility safe and in order to protect those on the move. The prism of crisis and emergency caters to the most urgent needs, including saving lives. But it cannot provide solutions to protracted situations of fear and need. Human mobility has to be included more comprehensively into long-term policy planning. National development strategies that aim at economic, social and rural development, the consolidation of the rule of law, climate action and peace and security, need to factor in migration and migrants, displacements and refugees.

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his September, the world’s governments came together at the United Nations General Assembly to adopt the New York Declaration for Refugees and Migrants.

General Assembly also stresses the need to address the “root causes.” It boils down to the fears and threats people are running away from, leaving behind their homes and countries, their jobs and businesses, their land and villages.

The declaration highlights the need of the international community to save lives, protect rights, share responsibility, and promote international cooperation, in particular cooperation among countries of origin or nationality, transit and destination of these displaced populations. The declaration and the discussion at the UN

Conflict, climate shocks, the lack of opportunity, repression, violation of rights, extremism and widespread poverty top the list of development and governance failures that produce forced displacements. Successful development and inclusive societies appear as two of the clearest solutions.

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In recent months, borders and walls have been a topic of discussion in several countries. Walls to keep some people out, walls to keep other people safe, it is said. The New York Declaration recognises that states have rights and responsibilities to manage and control their borders. Border management has to conform to obligations under international law, including international refugee law. The smartest policies today consider and absorb the impact of large inflows into municipalities in border areas – and beyond. A recent UNDP report highlights that local governments are at the forefront of receiving people crossing international borders, and host communities are responding with generosity and without walls, when given a chance.


MIGRATION REPORT

Human mobility has to be included more comprehensively into longterm policy planning. National development strategies that aim at economic, social and rural development, the consolidation of the rule of law, climate action and peace and security, need to factor in migration and migrants, displacements and refugees. They are, after all, some of the ones left behind by business-as-usual development – and Agenda 2030 wants us to leave no one behind.

Knowing what is happening is the first step to avoid panic reactions, populist demagoguery or simply ill-informed decision-making. UNDP and the OECD have developed a comprehensive set of indicators measuring human development of migrants and their families, in the communities of origin, transit and destination. This includes indicators on countries allowing asylum-seekers safe access to their territories. Good policies enhance the capabilities of people, promote integration and take advantage of diversity, enabling migrants

and refugees to become proactive agents of development. This includes giving the right to work, with the necessary precautions to avoid shocks to and deregulation of national labour markets. A broad range of rights and freedoms are universal and independent from any residence status – we have the right to enjoy them regardless of where we are, and the authorities of the soil where we have landed have the obligation to protect these rights of ours. Only in this way can displaced persons eventually become productive parts of the host societies and redo their lives,

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with a view to returning to their countries of origin or integrating for good. This is the only way to make human mobility work for sustainable and long-term development. The future will see human mobility increase - internally and internationally. The question is whether we will respect the right to stay where we are and make the most of it, or listen to those who want to spend taxpayers’ money in kilometers of walls, barbed wire and watch towers.


Government Gazette

SECURITY REPORT

Rethinking Security Guest Editorial: Dr. Jamie Shea, Deputy Assistant Secretary General, NATO Border Security Europe Roundtable 2016: An Update A Viewpoint by Jura Group Schengen Update: Ministry of the Interior of the Czech Republic A Viewpoint by QinetiQ A Viewpoint by OVD Kinegram AG A Viewpoint by Entrust Datacard Girding for battle in the cyber arena: Afzal Khan MEP Cyberspace, the final frontier: Victor Negrescu MEP Cyber Security Europe Roundtable 2016: An update


NATO’s new role in tackling cyber threats By Dr. Jamie Shea, Deputy Assistant Secretary General, NATO

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e may not see cyber-attacks but they are happening every day, and with increasing severity. In the UK, 90% of large organisations have reported cyber breaches over the last two years and the average cost of dealing with these attacks has risen from £600,000 in 2014 to £1.5 million this year. Hardly a day goes by without a newspaper featuring an article on the latest cyber intrusion, be it the compromise of data of 500 million individuals linked to Yahoo, or the theft of over a billion dollars from the Bangladesh national bank through a compromise of the SWIFT payment system. We have used the term cyber crime in terms of the theft of money or individual identities; but what is increasingly of concern is the use of cyber for political interference or coercion. For instance, last year the power grid in Western Ukraine was shut down for several hours, denying power to 220,000 customers. The recent US election campaign was also marked by a number of cyber attacks against the Democratic Party in order to leak compromising e-mails, and many US states reported attempts to gain access to their voter registration lists. In short, we are beginning to realise that the aggressive use of cyber space can serve multiple purposes. Not just for information or financial gain, but also for propaganda, disruption, actual physical destruction, extortion and ransom and now interference with a view to influencing political debates. Therefore, it is not just every conflict or crisis that will have a cyber dimension, but worryingly, even normal political processes will.

Given this context, the key tasks of those who believe in the positive power of cyber space to spread individual freedom and grow our economies, will be to maintain trust in the use of the Internet, to uphold privacy, to maintain competition among service providers but also to increase the security of our information systems, so that they are far less prone in the future to penetration and misuse by ill-intentioned actors. This of course will be a major challenge and many international organisations will have to follow a coordinated approach in order to be successful. NATO too has its role to play. In the first place, we have declared that Article 5, NATO’s collective defence pledge, can be invoked in response to cyber-attacks above a certain threshold. Thus, cyber defence is part of the Alliance’s core task of collective defence. We have also recognised that cyberattacks can seriously undermine NATO’s missions around the world. Our forces are increasingly likely to cooperate in environments where cyber tools are used to disrupt our command and control, manipulate our data or even paralyse our weapons systems. Thus, at their recent

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Warsaw Summit, NATO’s leaders declared that cyber is now an operational domain for the Alliance. This means that we are looking at our organisation, capabilities, and planning to ensure that we can manage the risks, recover quickly and function as smoothly in cyber space as in the more traditional areas of land, sea and air operations. Naturally, NATO’s capabilities in the cyber domain will continue to depend on what individual allies produce at home. We cannot afford any weak links in the chain of cyber defence due to some allies underinvesting in this area or not being fully interoperable. Therefore, at the Warsaw Summit, NATO’s leaders also adopted a Cyber Defence Pledge


SECURITY REPORT NATO has launched a Cyber Industry Partnership through which it is engaging industry, not just on information-sharing, but also on supply chain security, innovation and experimentation, particularly looking to reach out to those small or medium enterprises that are often at the forefront of creativity in the cyber domain.

and we are currently seeking how to best implement this by using NATO’s defence planning system to set individual Allies realistic targets and to devise a rigorous method of assessment to ensure that those targets are met. Along the way, NATO is also helping allies to improve their cyber intelligence. Our Cyber Threat Assessment Cell uses information gathered both by individual allies and the Alliance itself and we share real-time information through a dedicated malware information-sharing platform. This has also been recently established with a number of industry partners, as 90% of information technology networks are owned and operated by the private sector and private companies are often in the lead for early warning, threat assessments and analysis, and the innovative ideas that can help us achieve a more secure cyber space. For all these reasons, NATO has also launched a NATO Cyber Industry Partnership through which we are engaging

industry, not just on information-sharing, but also on supply chain security, innovation and experimentation, particularly looking to reach out to those small or medium enterprises that are often at the forefront of creativity in the cyber domain. Finally, NATO’s activities in the area of education and training are helping allies to develop the skills and techniques that are just as important for secure cyber defence as better technology. Recently we held another Cyber Coalition exercise in Estonia, an event which annually gathers over 400 operators, both from NATO and its partner countries who test their skills against the whole gamut of malware, denial of service attacks and other forms of cyber threat. Portugal is also soon to open a NATO Cyber Defence Academy, which will offer a range of advanced training courses, as well as research and development. Many of NATO’s activities within the Science for Peace and Security programme involve help with cyber training or the development of

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national cyber defence strategies for partners as diverse as Iraq, Jordan, Bosnia and Ukraine. For all that NATO is doing to adapt to a changing world, one thing will not change. NATO is a defensive Alliance and its actions will always be proportionate and in strict accordance with international law. In turn, this means that NATO will strongly support efforts to foster a more transparent and secure cyber space through the development of voluntary norms of behaviour by individual states and related confidencebuilding measures. Cyber defence depends ultimately on effective partnerships. In this respect, the ICPS Cyber Security Europe Roundtable 2016 has been an excellent forum to bring key stakeholders together and especially NATO and the EU, at a time when the EU is also significantly upgrading its efforts in cyber defence. This makes this roundtable particularly important for the Alliance and we will continue to support it.


Steps to better manage our borders By Arvind Venkataramana, Research Director, International Centre for Parliamentary Studies

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he Border Security Roundtable organised by the International Centre for Parliamentary Studies, took place on the 11th of October 2016 in Brussels. This year’s meeting brought together Members of the European Parliament, senior representatives from the European Commission, Border Security Forces, Police Forces, Human Rights Groups and NGOs to discuss the current challenges in the EU surrounding Border Security, operational weaknesses, technological developments and other key political and social developments affecting the EU. The objective of this meeting was to put forward recommendations to the European Parliament, the European Commission and member states to address current shortfalls and improve existing policy on Border Security. The European Parliament viewpoint Mr. Geoffrey Van Orden MBE, MEP, gave his appraisal of the challenges facing the EU. Of the 200 million border crossing that took place in 2016 across the EU, 2 million of them were illegal. He addressed the issue of migration and its impact on security forces. He highlighted the sensitive, but important crossover between terrorism, migration, lack of adequate security initiatives and current EU policies. He went on to stress that member states should go beyond just physical controls – more needs to be done to prevent illegal migration. The European Commission viewpoint Mr. Istvan Dobo, Policy Officer in the Border Management and Schengen Unit of the European Commission clarified that the word Frontex has been inaccurately used as the main border security agency in the EU. In fact, he noted that the organisation that manages the EU’s borders is the European Border and Coast Guard Agency (EBCGA). He highlighted the complexities involved in managing Europe’s borders. Before any new measures are adopted, it is necessary to take into account the Lisbon Treaty, which sets out clear procedures and they have to be adhered to. Although the EBCGA oversees policy in the EU, it still leaves the

policing of borders with the member states. Finally, he highlighted the need for greater cooperation between member states, police forces, border security forces and other stakeholders to ensure the EUs borders are adequately protected. Lack of a common security policy There is a lack of consensus on a common and unanimous security policy in the EU. This is allowing the current systems to be abused by criminals and illegal migrants. There are different security systems in member states and this can cause major security lapses. The EU needs to establish different policies for migrants from war-torn countries. Human rights and children There were conflicting views on the issue of curbing migration. Some participants felt it was the duty of the EU and its member states to take measures to accommodate migrants from Syria, Iraq and other countries facing civil war. While discussing ways to tackle human trafficking, some participants noted that children should not be treated in the same way as adults, especially as the number of child trafficking cases have increased over the last 18 months. There were a range of issues discussed at the roundtable including upcoming border security technologies, the need to strengthen databases, adequate training for police forces, risk management and other interesting developments. Towards the end of the roundtable, policy makers offered the following recommendations to better manage our borders. - Public Private Partnerships should be strengthened to ensure all key stakeholders have access to the same information. Eg. Police forces and the airline industry; - Cooperation between member states is important and the European Commission should facilitate better information sharing; - Digitalisation and verification should be watertight and technologies that are successful should be rolled out across

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the region; - Border security should not just be about external borders; it should encompass internal ones as well; - Security and ease of travel should go hand in hand – we cannot have tradeoffs between the two and the EU should focus on ensuring security measure do not cause delays in airports and borders; - Pilot projects should be given set dates for completion and feasibility studies should be fast tracked; - Effective Schengen border management strategies should be devised and implemented; - Border security forces should work closely with social services, educational institutions, human rights groups etc in order to put in place robust preventative measures; - Biometric technologies should be researched further and the European Commission should initiate such projects; - Legal loopholes have to be addressed as a matter of urgency especially around the lack of documentation, especially as the latter is the single most common problem faced by border security forces across the EU; - The EU should not lose sight of the most vulnerable people in its quest to improve security – this is as much a humanitarian issue as it is a security one; - Asylum applications need to have standard criteria and genuine cases have to be approved within a set time frame and - Staff training especially for border security forces should be made a priority as we are experiencing migration at unprecedented levels.


SECURITY REPORT

Delegates at Border Security Roundtable 2016 Chief Police Commissioner, Belgian Federal Police, Director of Business Development, Broadcast Microwave Services,Inc., Vice President of Security & Contingency, Brussels Airlines, Coordinator of the Centre of Thematic Expertise (CoTE) on Crisis Reaction and Security Sector Reform, Directorate-General Neighbourhood and Enlargement Negotiations (NEAR), Sr. Marketing Manager, Govt Solutions, Entrust Datacard, Liaison Officer to the EU Institutions in Brussels, European Asylum Support Office, Advisor to the EU Counter-terrorism Director, European Commission, Coordinator for Migration, European Commission, Directorate-General Justice, Director of Migration and Protection, European Commission - Directorate General for Migration and Home Affairs, Policy Advisor, European Network of Migrant Women, MEP France, European Parliament, MEP UK, European Parliament, MEP Czech Republic, European Parliament, MEP UK, European Parliament, MEP Belgium, European Parliament, MEP, Vice Chair of Security Committee, European Parliament, MEP, Chair of the Delegation for Relations with NATO, European Parliament, Junior Policy Analyst, European Policy Centre, Special Assistant to the Chairman, European Union Military Committee, Programme Manager - Home Office Biometrics Programme, UK Home Office, CEO, IDECO, Thematic Specialist, Immigration and Border Management, IOM, Liaison Officer to European Institutions, International Policy Association, Sales Director, JURA Group, Counsellor, Ministry of Defence, Head of Unit for Coordination of Schengen Cooperation and Border Control, Ministry of The Interior, Czech Republic, Secretary General, Missing Children Europe, Head of Border Security and Management Unit, Transnational Threats Department, Organization for Security and Cooperation in Europe (OSCE), General Director Sales - Africa, OVD Kinegram, Head of New Business, OVD Kinegram, Advocacy Officer for Migration Policy, Platform for International Cooperation on Undocumented Migrants, Associate, Swiss Mission to the EU, First Secretary of Embassy, Swiss Mission to the EU, Senior Liaison Officer to Frontex, UNHCR, Regional Adviser EECA Regional Office, United Nations Population Fund, Business Development Director, Government eID solutions, X INFOTECH

For more information on this year’s roundtable, please email information@parlicentre.org. For details on the next edition of the roundtable, please visit www.bordersecurity. parlicentre.org.

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Touch the future

By Janos Friss, Sales Director, Jura Group

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igital identity is a potential tool for countries to eliminate the inefficiencies and insecurities of paperbased identity systems.

Jura Group is a well-known supplier of security features for travel-document personalisation. The technology is based on a patent licensed exclusively by Jura Trade Ltd. (US Patent and Trademark Office # number 6’104’812. European Patent #: EP 1 048 168 B1.) Photo-document security in the 21st century requires biometric features. The photo (portrait, facial image) of the document holder is no doubt the number one biometric feature in these documents.

require any electric equipment; Encoding the IPI-inserted photograph: 
 The IPI software module receives the original photograph and the personal data. The module encodes the data into the image while preparing the data for printing. The encoding is fully automatic, it takes two seconds. It is implemented as a Windows® DLL, so it can be easily integrated into any personalisation system. IPI can be adapted to all major technologies 
 • Ink-jet printers
 • Dye-sublimation and re-transfer printers 
 • Digital printing machines 


• Is a visible image on the data page (eventually on an observation page). 


It is composed of personalized microtext.

• Might provide authentication also if advanced document database contains the same format data as MRZ on the passport. 


The verification Software analyzes LetterScreen++ by a full-page passport reader. The software regenerates the unique personal data structure and matches it with the structure of the scanned LetterScreen++ image. If they match: a green light shows that the document is authentic. The red light shows that the LetterScreen++ image has been forged or manipulated.

• IPI eliminates photo-substitution. 
 • Verification is simple and does not require any special 
knowledge or experience. 
 • Verification process with lens does not

• Is globally interoperable. 


It provides automatic, fast, primary verification within seconds.

Jura offers different unique graphical security features for document-issuing authorities to protect the photo, including overt and covert features:

Security Benefits of IPI

• Links documents to holders/bearers. 


Security Benefits of LetterScreen++

• Laser-engraving machines 


• LetterScreen++ is an advanced multi-level feature. It is machine verifiable, 
but ideal also for authentication without any tool, at anytime and anywhere. 


• Protects also the bio-data, such as the holder’s portrait, resulting in increased 
confidence that these key elements have not been altered after issuance. 


• Is a machine verifiable security feature that the issuing authorities may use for their own purposes in travel document authentication. 


Though the facial image is the number one biometric of the document holder, it is not protected sufficiently. As per ICAO the photo substitution is the main threat to security of travel documents. ICAO strongly recommends to include embedded (hidden) images on the data page, to be detected by suitable devices. The best solution is to incorporate personal information in the photo.

• IPI is a Level 3 feature for primary inspections using a dedicated tool
and/or document reader

holder and the existing database records. 


Each LetterScreen++ image is created along a unique wave structure, arranged by a special algorithm based on personal data.

LetterScreen++ Key Features • Protects personal data from alteration. 
 • Authenticates the travel documents at border control. 
 • Is visible to the naked eye, and ideal for automatic verification by full-page 
readers. 
 • Is suitable also for automated border clearance, it can create a link between 
the

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• Is based on mathematical algorithms that secure digital 
photos and detects the tampering of digital media. 
 • Improves border control officers’ visual confirmation. 
 Jura personalization features act in the complex security concept of the document. In order to maximize protection the Jura features should be combined with other analog and electronic features. • IPI and LetterScreen++ can be printed with UV ink to protect the document against copying. Hidden features can be verified with the normal decoding lens and UV light together. 
 • IPI is against data manipulation and can be combined with ICI® – an offset printed constant feature – against copying and can be checked with a similar simple device


SECURITY REPORT

Are we witnessing the evolution of a Schengen with checks? As the EU has allowed five states in Schengen to continue the checks for illegal migrants until February 2017, Jiri Celikovsky, Head of Unit for Coordination of Schengen Cooperation and Border Control, Department for Asylum and Migration Policy, Ministry of the Interior of the Czech Republic, elucidates the significance of Schengen

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he shocking outbreak of migration and the brutal terrorist attacks of 2015 cruelly coincided with the 20th anniversary of successful Schengen cooperation. The members of Schengen now have an opportunity to demonstrate to what extent they are willing to protect and even further develop their area of free movement. In reaction to the sharp increase in uncontrolled immigration in 2015, terms such as “Schengen crisis” were often used by European politicians and EU sceptics alike. Despite this, the European Union hesitated for months before initiating the first steps towards launching the safeguard mechanism after the Arab Spring which would enable the reintroduction of internal border controls. In the meantime, a massive influx of refugees soon exceeded politically acceptable limits. In this atmosphere, member states began to react on their own: some by applying instruments envisaged by the European legislation and others outside the legal framework. Thus, instead of implementing a unified European solution, individual countries began to take measures aimed at rerouting or stopping the flow of transiting refugees on their own. Shortly thereafter, the limits of tolerance were met even in traditionally refugee-sympathetic member states. At that moment the core attributes of proper Schengen cooperation were suppressed and Schengen’s eventual decay became imaginable. In March, the European Commission presented a bold roadmap called Back to Schengen. At this time, it was unclear whether there was a desire among member states to honour the same principles embodied in the convention of 1990. Schengen is thus undergoing a historic test, the results of which will unveil whether the original concept of a borderless area can continue to be a showcase of European integration. It seems that most internal borders will be able to function without free movement. However, in places where the societies and economies can no longer function without a border free regime, a

natural process of re-inventing regional “Schengens” might occur. Schengen rocking There is no doubt that Schengen has already changed. First, by integrating Schengen rules into the framework of the European Union, it lost an invisible but important aspect – the voluntary participation in Schengen cooperation. This change has enabled EUsceptics to shift Schengen to a product of “Brussels bureaucracy” and thus blame it for everything instead of effectively solving the migration crisis in the original framework of intergovernmental cooperation. Second, the “big bang” enlargement of 2007 led to the loss of an effective buffer zone of countries with the re-admission. Finally, after a period of enjoying unrestricted travel, Schengen has slowly shifted towards “a la carte” mentality, wherein member states can pick and choose which policies they want to enforce, while the abolishment of border checks is silently sacrificed. The loss of political support for free movement is understandable, as the unpopular queues that led to the abolishment of checks have not been around for years and the daily benefits of free movement at the borders are taken for granted. On the other hand, it is very easy to convince the public that checks at internal borders are necessary and is the right tool for protection against migration and terrorism. Contrary to the beliefs of EU sceptics, the Schengen Area has very low crime rates - thanks to its developed police and judiciary cooperation. One of those tools, the Schengen Information System, currently contains over 63 million records that helped find over 150 thousand objects and persons last year. Despite the fact that Schengen is very powerful and successful when it comes to protecting the security of over 400 million Europeans, it is still very difficult to advocate the idea of Schengen. Back to still waters Despite the current problems and dire predictions, Schengen will most likely survive the current situation. There is as much of a practical need for it today as there was in 1985 when the Schengen agreement

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was signed, at least in certain areas of Europe. Moreover, all scenarios that include ending Schengen would be politically hazardous. The Schengen safeguard mechanism is a wise concept because it doesn’t isolate the country making trouble from the rest of the area of free movement. It enables the reintroduction of border control for a time period of up to two years for recovery of the Schengen Area. In real life, implementing this measure requires the support of all Schengen member states. The EU avoided interpreting the current use of the mechanism as “punishment”. On the contrary, the country which caused the application of this mechanism plays a crucial role in solving the crisis. Unfortunately, the chosen concept lacked the attributes of a courageous approach with reference to limits set by the legal framework. It is a paradox that the route from the Central Mediterranean remains outside the scope of the safeguard mechanism. Thus Schengen did not send a clear signal that there are no doubts on its determination to enforce its own rules, and this situation causes headaches for policymakers who are responsible for deciding how to fully restore Schengen again without controls. Schengen cannot solve the migration crisis as the asylum policy lies outside its scope and immigration policy is mainly the domain of national states. Everything indicates that the Migration Agenda of the European Commission combined with the Greek Action Plan is working and that migration is slowly coming under control, however painful and fragile this process may be. It is desirable that Schengen comes out of the crisis keeping its generous approach to the free movement phenomenon which seems to be a necessary precondition for establishing and maintaining a truly border free area. Otherwise, there is a risk that external border control will gradually spread inside the whole Schengen Area and that random or even systematic checks verifying the legal status of people at internal borders would become standard. Isn’t Schengen with checks at internal borders an oxymoron?


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SECURITY REPORT

Do employees threaten your company’s security? By Simon Bowyer, Senior Consultant, Human Performance, QinetiQ adopt the desired behaviours? Are employees able to stay secure? Employees are rarely recruited because they’re good at security. Additionally, technology and systems aren’t always designed with the human in mind, e.g. the ever-increasing complexity of passwords can frustrate users when they’re unable to complete tasks because they can’t recall them. Additionally, people are required to memorise multiple passwords and change them on a regular basis.

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n 2015, an auditor from Morrisons with a grudge was jailed for leaking personal data, including bank details, of 100,000 other employees. It cost Morrisons more than £2 million to rectify. In 2016, a small hair salon in Gloucestershire was victim of a ransomware attack that left it locked out of its appointment and booking system, which contained client contact details. The salon owners decided to pay the ransom and estimated that the attack would cost them a total of £6-7,000. The common cyber risk factor all businesses face, regardless of size, is the behaviour of its employees. Impacts on small businesses can be just as big, with the attack on the hair salon threatening the existence of the business. If repeated on a wider scale (there are 35,500+ UK registered hair salons), it could potentially be as damaging to the economy as an attack on a single large enterprise. Extrapolate this situation to all the sole traders and small to medium businesses across Europe, and the potential impact to job security and the wider economy is significant. Adherence to the concepts and suggested applications of the new European-wide General Data Protection Regulation (GDPR) will assist organisations control and monitor the integrity of the personal data in their possession. ‘Training’ employees is not enough Every organisation must recognise there’s no ‘one size fits all’ solution and no silver bullet to changing employee behaviour. Simply telling employees to ‘be better’ or assuming that training alone will provide the answer is, in today’s world, too simplistic. Cyber security is a complex set of interactions

between people, technology and the organisational environment, as shown in figure above. Every organisation needs to give time and thought to the risks it faces, how it protects itself, and the vulnerabilities that exist. Understanding the people-related risks and how they link into wider technological and organisational systems is a key part of this, and something that QinetiQ is highly experienced in. Understanding employee behaviour is a critical part of this process; key questions we ask clients are: Do employees know what to do? This is about enabling employees to know what to do in critical situations. For example, do your employees know what to do if there’s a fire in your building? Do they know what to do in the event of a cyber security attack? An important aspect of enabling employees to know what to do relates to the organisation’s ability to provide a consistent coherent story as to what’s important and why. Organisations must support this story through provision of appropriate behavioural cues (e.g. signs) that subtly remind employees how they should behave when these situations arise. Key questions for organisations to explore are: • Do we communicate the message clearly enough? • Have we articulated our security values? • What are the behavioural norms of our leaders? • Is there sufficient awareness of our security requirements? • Are there appropriate artefacts and cues in the environment to encourage people to

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Writing passwords down is a behavioural issue that creates weaknesses in the security system. It’s also, in some cases, the inevitable outcome of designing a security system that most humans are unable to comply with – they don’t have the memory to enable adherence to the process. Key questions that organisations should explore when considering the ability of employees are: • Do they have the skills to stay secure? • Do our ways of working, support them in doing it? • Do they have the technology they need? Are employees willing to act securely? This is an important issue that relates to motivation and engagement of the workforce. Research on employee engagement shows that it has a positive relationship with a range of business outcomes, with security no exception. System designers also need to address the ‘line of desire’ to prevent users from developing their own unintended shortcuts when working on systems; these tend to occur where security systems make it less efficient or more difficult to complete a task. Lastly, and perhaps key, it’s important to consider how much employees share the organisation’s values. Establishing shared values is a critical aspect of developing an effective organisational culture, without which it’s unlikely employees will consistently want to behave in desired ways. Key questions to explore when considering if employees will act in a secured manner: • How aligned are your employees values to the security values of your company? • Does security (cyber or physical) add inconvenience or stop users from doing necessary tasks? • Do technology and security processes directly support what they need to do? For further information about any of the discussion points in this article, contact customercontact@QinetiQ.com


Integrating physical and digital security at our borders By Dr John A. Peters, Manager New Business Development, OVD Kinegram AG*, Zug, Switzerland

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n discussions on policies related to border security and management, this article communicates two important messages: Firstly, concomitant with progress in the use of biometrics at border crossings, it is imperative that we maintain stringent requirements for travel documents with good physical security; and secondly, there are significant benefits to be derived from integrating the physical security features with the emerging digital verification processes. With the number of travellers entering Europe or crossings at borders between countries within Europe constantly increasing, several countries are consciously exploring improved methods for efficient and secure border management. To this end, border crossing points at some airports may be equipped with Automatic Border Control gates or ABC’s to enable convenient and secure verification of the traveller’s passport or ID documents, while most still rely on manual inspection. This is because of the lack of implementation of the automatic controls or due to the absence of the necessary infrastructure to support such control systems. Due to the vast number of different travel documents, each with their own unique set of security features designed to protect against counterfeits, the task of the document examiner is becoming increasingly difficult. Even with the most sophisticated security features, how can we expect the document examiners to know which security features on each document should be checked and how each of these can be verified? Why is it important to maintain a strong physical security in the travel documents? Of course, Automatic Border Controls (ABC) using e-Gates are a key requirement in order to cope with the rapidly growing number of international travellers. Facilitated by the use of chip-based biometric documents, this technology promises increased traveller convenience

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SECURITY REPORT

The solution – called the KINEGRAM® Digital Seal - involves the use of an app to scan the document and within seconds and without on-line connectivity display a video showing the first-level security features of the KINEGRAM corresponding to that document. It is no longer essential for the document examiner to have prior knowledge of the KINEGRAM security features on all travel documents.

without compromising security. However, assuming the electronic data in the passport can be read and matched to the biometrics of the document bearer, it is imperative that the ABC system is capable of verifying the Country Signing Certificate belonging to the issuing country. This requires the availability of the corresponding public keys and access to an updated revocation list. This requirement is not always easy to fulfil, yet without this, we cannot be sure that the personalized data was not created in a substitute chip using a self-generated private key. When this level of trust in the automatic inspection process is not available, reverting to a manual inspection is necessary. Therefore, physical document designs need to be optimized for reliable manual inspection. How then can the integration of physical security with digital verification benefit document examination processes?

documents using a smartphone or another mobile device. The solution – called the KINEGRAM® Digital Seal - involves the use of an App to scan the document and within seconds and without on-line connectivity display a video showing the first-level security features of the KINEGRAM corresponding to that document. Therefore, it is no longer essential for the document examiner to have prior knowledge of the KINEGRAM security features on all travel documents. The App has additional features including basic access control of the biographic data and photo stored in the chip, as well as online access to a data-base for verification of document authenticity. In summary therefore, despite the rapid emergence of automatic border controls in Europe and the associated use of digital verification processes, it is imperative to

When a traveller approaches an automatic border control or e-gate, he is required to present his passport with the data page containing biographic information face down on the document reader. According to standard procedures defined by the International Civil Aviation Organization, selected information from the data page allows access to the biometric data such as the facial image stored on the chip. This data is then compared with a biometric live scan to confirm a match. However, if the physical security features such as the KINEGRAM are designed so that the same standard document reader at e-gates is capable of automatic inspection of these features, then the level of trust in the document authenticity will be enhanced significantly. This procedure would then be integrated into the check routines of all automatic document readers. As mentioned previously, if the e-gate is not capable of providing an adequate level of trust in the authentication of the travel document, the traveller will be directed to present his document to a border crossing guard for secondary or manual inspection. To assist the border guards in this situation, OVD Kinegram has recently introduced a simple yet very efficient solution to enable document examiners to inspect the travel

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maintain a physically secure and counterfeit resistant travel document. Furthermore, huge benefits are possible if the physical security features can be integrated with the digital verification process, as exemplified in the case of the KINEGRAM technology described above. * OVD Kinegram is based in Zug Switzerland, and is a wholly-owned subsidiary of the KURZ Group which is headquartered in Fürth, Germany. Over the past 25 years, OVD Kinegram has established itself as the most trusted provider of sophisticated optical security features based on the KINEGRAM® technology – a non-holographic process never disclosed in the public domain and thus out of the reach of counterfeiters. Over one hundred countries world-wide, and more than half of these in Europe, have placed their trust in the use of the KINEGRAM.


Creating a secure credential lifecycle to drive border security By Wayne Fletcher, Global Director Government Vertical Marketing, Entrust Datacard

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n an increasingly global market, people everywhere are moving freely across borders and around the globe at a rapid rate. International travel topped 1.1 billion in 2014 , continuing a rapid surge that will have 1.8 billion people crossing national borders by 2025. For governments and border control agencies tasked with moving these record-high numbers of travellers securely and efficiently across their borders, the challenge has never been more complex. Threats abound, from growing terrorism to escalating drug trafficking ($435B in 2015), human trafficking ($32B in 2015) and firearms trafficking ($1B in 2015). Combatting these threats becomes that much more difficult with more than 53 million lost or stolen travel documents in circulation worldwide, as well as millions of individuals arriving with unreliable or falsified credentials — or no credentials at all.

What lies at the core of this challenge? When an individual arrives at your border, how do you know that they are who they claim to be, and how do you reliably know where the individual has travelled — or where they are ultimately going? The right tools exist In fact, the technology-based solutions necessary to address this challenge already exist. These technologies range from digital security, such as public key infrastructure (PKI), to enhanced physical document security. The challenge now, as stated by Interpol president Mrs. Mireille Ballestrazzi at Interpol World 2015, is for governments to utilize the information already available to them — to consolidate information and enhance inter-state collaboration to drive better, faster and more secure border control decisions. Trusted identity in context: the elements of secure credentials

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The secure document lifecycle creates three distinct, complete histories — the credential history, the individual history and the travel history. In leveraging all three histories, the focus is not on management of a physical document, but rather on the management (i.e., integrity and validity) of individual identity. These distinct histories provide critical context that enable border agents to validate the identity of the traveller in front of them with respect to three key questions: Can we trust this credential? Can we trust this individual? And, does the travel history match the travel itinerary? Elevating trust through collaboration The security of travel credentials and the effectiveness of border control will always be partially dependent on and greatly enhanced by collaboration between countries. But by taking this first step — implementing existing technologies to consolidate powerful identity information — each individual country best positions itself for secure and efficient border control. An integrated solution for trusted identity Many governments and border control agencies looking to implement the ICAO


SECURITY REPORT

“ 9303 standards for creating trusted travel credentials are turning to Entrust Datacard for a complete, end-to-end solution. The Entrust Datacard approach combines physical document security and robust digital security technologies, including proven PKI — supported by the company’s long history with these technologies and deep understanding of the evolving challenges in the border control world. These fully integrated solutions allow Entrust Datacard government partners to align secure document production with secure document validation, which ensures trust and security throughout the entire credential lifecycle. Envisioning a better (more secure) border experience Entrust Datacard trusted identity solution deployments are already delivering proven results for nations of all sizes: • High-assurance identity: complete traceability back to the point of credential origin gives agents high confidence in validating credential authenticity. • Efficient validation and processing: overt physical document security, combined with advanced digital security, enables

Many governments and border control agencies looking to implement the ICAO 9303 standards for creating trusted travel credentials are turning to Entrust Datacard for a complete, end-to-end solution. The Entrust Datacard approach combines physical document security and robust digital security technologies, including proven PKI — supported by the company’s long history with these technologies and deep understanding of the evolving challenges in the border control world.

faster credential validation, driving faster processing and a more convenient travel experience — without compromising security. • Risk mitigation: establishing trusted identity that links a secure credential with accurate individual and travel records increases the chances of catching known threats. It’s time to make the most of the information at hand It’s daunting to consider the challenge of identifying the billions of people moving across borders today. But we’re more capable than we realize. There is a lot of information we can obtain — and a lot of information we already know. The next step is synthesizing this information in a fast, accurate and intuitive solution that drives better border control decision-making. ICAO has articulated the framework for this solution — leveraging existing technologies for physical and digital credential creation, issuance and validation. This provides governments with complete visibility to document and identity lifecycles and enables traceability throughout the entire lifecycle of a travel credential.

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The tipping point will come as more governments deploy these solutions and best practices to create trusted identities that drive security, efficiency and convenience at borders and throughout an interconnected identity ecosystem.


Girding for battle in the cyber arena The digital age has opened up new possibilities to connect, allowing people to participate actively in social, cultural and political spheres. As a result, our economies have become more vulnerable to cyber threats. Afzal Khan MEP assesses the intensity of cyber crime within Europe and offers solutions to make sure the Internet remains free, open and secure

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few years ago it would have been unthinkable to have cars that drive themselves, drones delivering products, 3D printing machines making body implants, or to store information in The Cloud. The digital revolution has opened up new possibilities to connect people, allowing them to participate actively in the social, cultural and political spheres, and has created ways to boost the economy like never before. Close to half of the world’s population is currently using the Internet and this is increasing by the day. More and more of our everyday life is moving online. However, as our economies become more interconnected and digitalised, they have also become more vulnerable to cyber threats. Every second, a cyber attack occurs somewhere around the world, someone’s computer is being hacked, someone’s personal records, financial information, or intellectual property is being stolen. The number and impact of cyber incidents continue to grow, making headlines daily in the media, such as the recently announced loss of 500 million users’ data from Yahoo accounts. The exact cost of cybercrime is unknown. It is because many cyber incidents aren’t reported and many suffer cyberattacks without knowing that they are being victims of it. However, it’s estimated that the annual cost for the global economy varies from 330 to 506 billion euro. The stakes could be even higher. Let’s say our electricity supply or air traffic control were successfully attacked online, the impact would then be in terms of lives lost. We are in the midst of a revolution of the cyber threat and an inadequate response could result in consumers losing confidence, businesses losing money and even national security being put at stake. For years EU countries considered cybersecurity as a national responsibility and they were reluctant to adopt a common approach. However, member states are now recognising that working towards cybersecurity should be a priority. After all cybercriminals do not know borders, so one country’s weakness can put the whole of

Europe in danger. Stepping up cooperation among EU countries is therefore the only way to prevent cybercrime. Cybersecurity is high on the European agenda, aiming to reduce fragmentation, increasing coordination and fighting cross-border cybercrime. The past year was particularly active given the agreements on the Network and Information Security (NIS) Directive, the General Data Protection Regulation (GDPR) and the announcement of the Digital Single Market (DSM) initiative by the European Commission. Challenges are the differences between the priorities and capabilities of individual member states and the lack of systematic cooperation and sharing of information between governments and the private sector that operates essential services such as transport, energy, health and banking. A well-established framework exists only in 5 EU member states. As the first comprehensive European piece of legislation on cybersecurity, the NIS directive will play a key role in closing the gap. If Member States can harmonise their approach and cybersecurity capabilities, it will be a significant step towards achieving a true Digital Single Market in the EU. We must also not forget about prevention. Our ability to defend ourselves in cyberspace depends upon a strong knowledge base. Nearly half of phishing attacks, carried out using fake emails, were against SMEs. Small businesses are fast becoming cyber criminals’ favoured target because they tend to have lower defence systems. Consequences for SMEs that ignore security risks can be disastrous, resulting even in a company closure. It is crucial we raise awareness and provide advice to ensure that people are better informed about potential risks and how to avoid them. These campaigns should be coordinated with other national and international organisations. Moreover, the EU has an important role to play in the field of cybersecurity by balancing security concerns with the respect for the rule of law and the protection of fundamental rights. Currently the balance has been shifted in favour of security. The

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SECURITY REPORT

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It is clear that cyber threat is one of the most serious security challenges we face. If Member States can harmonise their approach and cybersecurity capabilities, it will be a significant step towards achieving a true Digital Single Market in the European Union.

way to shift it back is to ensure that we have the checks and balances and accountability structures. The EU data protection package was a major achievement ensuring some of the highest standards in the world. Safeguarding these rights remains a major concern for the EU citizens, and we should continue to defend this. It is clear that cyber threat is one of the most serious security challenges we face. It is also clear that we have to be flexible and constantly evolve our response, as criminals develop new and more sophisticated malicious practices. A growing reliance on computer networks makes it increasingly difficult to treat cybersecurity as a distinct policy area. It needs to be mainstreamed into all our policies, especially when we think about new technologies and emerging sectors. Together we can make sure the Internet remains free, open and secure and that interconnectedness remains a strategic advantage, not a vulnerability.

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Cyberspace, the final frontier By Victor Negrescu MEP, Member, European Parliament

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he emergence of a new social environment of human practices and interaction has been apparent for quite some time. The increasing number of actions which no longer require a physical presence or a material manifestation, the number of significant interactions which take place “online”, the large prevalence of digital or automatic technologies in shaping our life and our environment from the smallest details to the largest and most consequential

events or phenomena, all point towards the emergence of cyberspace as a frontier of social life and reality. And, as any frontier space in human history, cyberspace is fraught with dangers and remarkable opportunities, an almost anarchic sense of freedom and passion for deregulation and the emergence of its own proper set of rules. It is safe to say that the transformations brought about by digital technology in the last decades are here to stay. And, contrary to what many pundits think, I believe that the transformations which have occurred

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have a deeper sense of permanence than many are willing to admit. The qualitative and quantitative dynamics of the past years will continue, at a rate faster than we would have been ready to admit ten years ago. We were born into a world where most inhabitants hadn’t seen a phone or even less had a phone call. Today, the absolute majority of the world’s inhabitants own a handheld device. Undoubtedly, this trend will continue. And just as a decade ago, its speed and width is hard to estimate. We nevertheless know that this process, which entails a speeding-up of the effects and practices of globalization, with all the identity consequences this embodies, will


SECURITY REPORT

This new environment is marked by many security challenges. On a frontier where personal identity is in the end reduced to a set of data, marking the boundaries between what constitutes the domain of private life and the private sphere constitutes a challenge.

the security of private transactions are all issues which require increased cooperation not only between governmental agencies or nation states, but also between public and private actors.

continue. Social networks will continue to be more than a fad of leisure time and have probably an even stronger influence on our lives, while the interconnectedness between devices and our social environment will intensify – the internet of things might be a project with obvious quantitative advantages, but will also mark a profound qualitative transformation of our societies, or, indeed of our emerging global society which is probably embodied the best in the global social networks. This new environment is marked by many security challenges. On a frontier where personal identity is in the end reduced to a set of data, marking the boundaries between what constitutes the domain of private life and the public sphere constitutes a challenge. Accordingly, identity theft and

Moreover, as an increasingly larger number of our vital infrastructures have a profoundly important digital component, their security, or, conversely, their vulnerability is a matter of concern for responsible power holders. The proliferation of cyber attacks raises the question as to whether the establishment of international regimes concerned with limiting the occurrence of cybercrimes should not be a priority of national diplomats. In the end, if outer space is subject to military and political rules agreed by international actors, I see no reason why cyberspace should not become the object of international agreements, perhaps modelled or based on the long experience we have in combating international crime or terrorism or in promoting arms control and disarmament. The consequences of cyber attacks on vital civilian infrastructure elements are too dire to contemplate without considering the need for international and mutually beneficial agreements. Cyberspace is also the background for a significant transformation of our political environment. We need to stop treating social networks and the virtual environment as a classical means of communication – sending messages and expecting our target public to react. The particular nature of cyberspace is that it is a “living” media, which distorts, constructs, interprets, reacts and even generates new messages. Social networks are not only a tool – they are a true medium of interaction which is beyond the control of

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the emitter as in classical communication. Given the prevalence of the virtual interaction for our youngest citizens and the avenues for self-organization, I believe that responsible European leaders need to look closer at the opportunities that cyberspace creates for enacting a more transparent and democratic political system, for enacting true and wide systems of political decision making and consultation. Much has been written about the economical challenges and potential of this new frontier of human existence. And it is true that the last years have seen an unparalleled wave of continuous improvement, development, research and innovation, a trend which requires a continuous stream of wellprepared professionals. European learning systems must deliver these professionals, ensuring that unemployment (especially amongst youth) decreases and that European companies remain competitive in the global environment. At the same time, we must balance these requirements with the reality that digitalization can lead to short-term loss of jobs and with the imperative of maintaining an adequate level of consumer satisfaction and protection. Cyberspace is the final frontier of political actions. The rules it is governed by need to be encompassed by the effort of responsible political leaders, while its opportunities need to be grasped at face value. Far from being the new Eldorado or a jungle fraught with dangers and threats, cyberspace is, to a large extent, the frontier of our reality. And it is up to us, cyber-inhabitants, to a larger or lesser degree, to decide what its future would look like.


By Arvind Venkataramana, Research Director, International Centre for Parliamentary Studies

What should Europe do differently in tackling cyber risk? By Arvind Venkataramana, Research Director, International Centre for Parliamentary Studies

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he 2016 Cyber Security Roundtable organised by the International Centre for Parliamentary Studies took place in Brussels on the 12th of October. Attendees included Members of the European Parliament, the European Commission representatives, Chief Information Officers from the public and private sectors, law enforcement agencies and other key stakeholders to discuss the ongoing challenges and threats in cyber security in the EU. Over the course of the event, policy makers and cyber security experts offered key recommendations on how the EU and its member states can learn from existing cyber breaches and prepare for the future. Here are some of the key themes that came out of the discussions at the roundtable. The European Parliament Viewpoint Mr. Afzal Khan, Member of the European Parliament, provided the MEP viewpoint. He admitted his primary objective was to

listen to everyone else’s points of view and take recommendations back to the European Parliament. He spoke about the immense opportunities that were available as a result of digitalising key functions such as banking, transportation, energy, government departments etc and the subsequent threats, which should be addressed immediately. Cyber attacks are becoming increasingly common from individual to governmental levels. The EU should be more proactive in dealing with them, as criminals are currently one step ahead of the system. What is the source? The biggest challenge in dealing with cyber threats is identifying the source. There have been multiple instances of attacks coming from countries such as Russia, China, North Korea and other parts of the world which indicate government backing. On the other hand, member states have had to deal with individuals sitting within the confines of their homes and initiating attacks on government infrastructure. The EU should,

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therefore, put in place better systems to identify and track down the source, which can then lead to improved enforcement action. Balance between privacy and security One of the biggest challenges in dealing with emerging cyber threats is gathering information and data. While data is freely available, converting it into meaningful information can be a complex operation and may involve breaching privacy laws. The EU should revisit existing legislation to ensure it continues to protect privacy but strengthens security as well – there should not be a trade off between the two. Need for further collaboration Member states should collaborate amongst themselves but should also build partnerships with governments in other regions. Collaboration is the most significant step towards identifying and eliminating cyber threats. The European Commission should initiate and fund such programmes.


Recommendations and conclusion

cyber attacks;

The following recommendations were put forward by the attendees of this roundtable to the policy makers of Europe:

- The role of biometrics in reducing cyber crime has been well documented and the EU needs to implement the consistent use of these technologies among member states;

- The EU should qualify and define the Rules of Engagement so all stakeholders are aware of the action that needs to be taken to address a threat; - Current EU policy is far too reactive so new systems, procedures and technologies need to be adopted in order to address imminent threats; - The EC should initiate innovative collaborative projects (eg. Cyber Coalition), for member states to share best practices, upcoming technologies and prepare for threats. Cyber security is a truly global phenomenon and solutions will not be effective if it is purely country-specific; - Existing business plans to procure cutting-edge technologies are not strong enough and this needs to be revisited. Procurement should have a long term focus;

- Policy has to evolve with changing threats. As it stands, policies do not cover emerging cyber threats and this can have far reaching consequences; - The EU should build and fund centralised Centres of Excellence, which can be tasked with identifying threats, developing fast responses and eliminating cyber attacks; - Recent data has shown certain marginalised groups of individuals have been the source of cyber attacks so more ‘counter education’ initiatives have to be invested into; - IT education should start very early in schools and should be included in compulsory curriculum; - Public Private Partnerships have to be established where the sharing of data and information is done with ease.

- EU policy makers seem to have a ‘fortress’ mentality in strengthening infrastructure but tend to dismiss micro-level threats that can escalate;

For more details on this year’s roundtable, please email information@parlicentre.org. For next year’s programme, please visit www. cybersecurity.parlicentre.org.

- Within Europe, there is a shortage of skills in dealing with cyber threats and more jobs should be created to attract the best talent;

Delegates at Cyber Security Europe 2016

- The private sector should be held accountable for lapses and there has to be a common code of conduct to ensure data breaches are not encouraged; - Education and creating awareness around cyber security can go a long way in reducing

Croatia’s Deputy Milrep for EU, Armed Forces Of The Republic Of Croatia, Director, Center For Cyber And Information, Security Officer Commanding, Defence Forces Headquarters Communications and Information Services Company, Defence Forces Ireland, ATM Security Specialist, Eurocontrol,

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Lieutenant-Colonel, Eurocorps, Head of Unit - Digital Policy Development and Coordination, European Commission Directorate General, Digital Economy & Society, Head of Unit - Cybersecurity and Digital Privacy, European Commission - Directorate General, Digital Economy & Society, MEP (Romania), European Parliament, MEP (UK), European Parliament, MEP (Poland), European Parliament, Special Assistant to the Chairman, European Union Military Committee, CEO, IDECO, Director of Policy and Public Affairs, Internet Watch Foundation, Research Expert Cryptography, Katholieke Universiteit Leuven, Director, Media Council, Adviser, Ministry Of Defence, CounsellorCybersecurity Policy, Ministry Of Defence, Deputy Milrep, Ministry Of Defence, Deputy Director General, Ministry of Justice, Head of NSM NorCERT, National Security Authority (Nsm), SVK MilRep, NATO, Deputy Assistant Secretary General - Emerging Security Challenges, NATO, Key Account Manager: Security, Innovation & Capability Development, QinetiQ, Principal Consultant: Advanced Cyber Threat Projects, QinetiQ, Managing Director, The Delian Project, IT Security Manager, The Foreign Intelligence Service, Manager, European Regional Affairs, The Internet Society, Research Associate, University College London


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BEATING CHILDHOOD CANCER

Why more needs to be done to help children with cancer

More than 60 types of cancer occur in children and more than 6,000 children and adolescents die of cancer within Europe every year. Professor Martin Schrappe, University Hospital Kiel, Kiel, Germany analyses the many factors that contribute to the current crisis within paediatric oncology and argues that more needs to be done to help children with cancer

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ancer is a global emergency, and we are used to the overall number of patients growing with every passing year. Most people however think that this major public health issue almost exclusively affects adults and the elderly or that, anyway, paediatric cancers are a rare disease. This is not completely true. There are more than 60 types of cancers that occur in children and adolescents: each individual type may be rare, but taken together paediatric cancers represent a death sentence for too many patients. Every year 6,000 children and adolescents die of cancer, and one out of 600 newborns will develop cancer before turning 20. If it is true that children and adolescents are more responsive to treatments and, thus, many young patients survive - 300,000 survivors in

Europe, expected to become approximately half a million in 2020 - it is also true that suffering from cancer during such a delicate phase of life can induce severe problems at a later stage (infertility, hearing loss, cardiac dysfunctions, etc.). Two-thirds of European survivors suffer indeed from late side effects of treatment, which can be severe and have an impact on the daily life of half of those affected. Last but not least, the overall level of care and the survival rates in many Eastern European countries are lower than those in Western and Northern Europe. Many factors could contribute to improve this situation. More funding would speed up the necessary research advances on these specific types of cancer, biologically different from adult cancers. Better and more structured cooperation at the European level would ensure that the mutually

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agreed European Standards of Care for Children with Cancer are used as a reference throughout the region and that high quality specialised care becomes accessible to every patient. The set-up of dedicated processes and tools to ensure a coherent follow-up after the end of treatment would contribute to better outcomes and a healthier life for survivors. This is why the European Society for Paediatric Oncology (SIOPE) undertook a major collective effort to define a structured way to tackle all the issues encountered by childhood cancer patients and professionals in Europe. SIOPE gathers the expertise and knowledge of paediatric cancer specialists from all over Europe (more than 1,500 professionals from 34 countries). Since 2013, SIOPE closely cooperated with parents, patients and survivors as well as other stakeholders


BEATING CHILDHOOD CANCER committed to improve young patients’ chances of being cured, finalising last year a consensus-based strategy to increase the cure rate and the quality of long term survival of children and young people with cancer. After its presentation to the medical community at the 2015 European Cancer Congress, we officially launched the SIOPE Strategic Plan last November at the European Parliament, where all participants agreed that childhood cancer should always be a priority for the European Union. In line with this agreement, we continue to actively engage to influence EU policies and legislation to improve patients’ access to quality research, healthcare, and follow-up across the region. A recent example of our engagement in this sense was the Conference ‘Review of the EU Paediatric Medicines Regulation: Let’s do more for children with cancer’ (7 September 2016, European Parliament, Brussels), an important event addressing the effects and potential review of the EU Paediatric Medicines Regulation to ensure a better access to innovative therapies for childhood cancer patients – in line with the SIOPE Plan’s objective ‘Innovative therapies’. This Plan is the most important development in paediatric haematology-oncology over the past decades. Our priority today is to make it a reality, with the help of everyone, and our Society took the lead in coordinating all the phases of its implementation. We already started so far several cross-tumour platforms and projects, to address for instance the need to have more and better clinical trials within the new EU Clinical Trials Regulation (via the Clinical Trial Facilitation platform), to develop innovative anticancer paediatric medicines in a timely fashion (via the ACCELERATE Platform, see article in this journal at page 32), and to ensure minimal treatment-related radiotherapy side effects (through the QUARTET project, see article in this journal at page 32). Importantly, the SIOPE community also submitted an application for a paediatric oncology European Reference Network (ERN) in the rare cancers field: building on the work performed within the project ExPO-r-Net, this ERN will establish a framework to provide cross-border healthcare for complex conditions requiring a concentration of expertise. You too can play a role in reaching the goals of our ambitious Plan. Thanks to your support, we could finance research fellows and continue to carry out all the planned projects and initiatives to improve young people’s chances of surviving this disease. If you think that children and adolescents with cancer deserve a brighter future, join the SIOPE community and contribute to what we do (www.siope.eu/donate)

The outcome of this far-reaching exercise is the comprehensive SIOPE Strategic Plan, ‘A European Cancer Plan for Children and Adolescents with Cancer’, which targets the following objectives:

1.

Innovative treatments: to introduce safe and effective innovative treatments into standard care;

cancer medicine: to use improved risk classification as 2. Precision well as biological characteristics of both the tumour and patient to

3.

help guide decisions on which therapies to use; Tumour biology: to increase knowledge of tumour biology and speed up translation from basic research to clinical care to benefit patients;

access: to bring about equal access across Europe to standard 4. Equal care, expertise and clinical research; and young adults (TYA): to address the specific needs of 5. Teenagers TYA in cooperation with adult oncology; of survivorship: to address the consequences of cancer 6. Quality treatment and to improve quality of life of childhood cancer survivors;

of cancer: to understand the causes of paediatric cancers and 7. Causes to address prevention wherever possible.

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Help us make a difference

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ven a little donation can contribute to create a brighter future for a little patient. If you think that children and adolescents with cancer deserve a brighter future, join our community and support what we do. The European Society for Paediatric Oncology (SIOPE) works to increase the cure rate of childhood cancers and improve the quality of survivors’ lives. Thanks to your donation, we can carry out and continue our projects and initiatives to address the current obstacles to better outcomes for children and adolescents with cancer.

You will contribute to quality research, which will allow us to better understand paediatric cancers’ biology and speed up its translation from bench to bedside to benefit patients. We will be able to introduce effective innovative treatments and precision medicine into standard childhood cancer care and address the long-term consequences of cancer treatment. You will also back our initiatives to reduce the existing inequalities in the quality and accessibility of the paediatric oncology care and treatment provided in Europe, address the specific needs of teenagers and young adults, and improve the overall quality of life of an increasing number of childhood cancer survivors. Discover more on what we do and on our Strategic Plan on www.siope.eu/donate.

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BEATING CHILDHOOD CANCER

Innovative treatments and quality radiotherapy are essential drug development before 2007, it didn’t represent a solution for paediatric cancers: too few drugs targeting paediatric oncology are currently under development, and it does not yet address adequately the urgent needs of children and adolescents with cancer.

Overall survival from childhood malignancies has dramatically improved, with survival rates reaching over 80%, yet some types of cancer remain a challenge. Professor Gilles Vassal, Institut Gustave Roussy, Villejuif, France, says innovative therapies could effectively target several paediatric malignancies and help save far more young lives than before

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esearch in paediatric malignancies has been quite successful over the past fifty years, allowing for the average survival rate of children and adolescents with cancer to grow to the current 80% in Europe. However, these major progresses are not equally applied all over the continent, and several problems relating to access of the best possible treatment persist. Innovation is key Innovative therapies, for instance, could effectively target several paediatric malignancies which are still refractory and, thus, save many young lives. However, while new experimental therapies are targeting adult cancer patient’s immune system and molecular tumour profiling are nowadays becoming widely available in Europe, less than 1 in 10 children in relapse with a not curable cancer has access to innovative medicines today, and investment in new drug development in paediatric oncology is insufficient. To identify new ways to accelerate new oncology drug development for the paediatric population is one of the priorities of the European Society for Paediatric

Oncology (SIOPE), as highlighted in its European Strategic Plan. In this context, and together with the Cancer Drug Development Forum (CDDF) and the European ‘Innovative Therapies for Children with Cancer’ (ITCC) academic consortium, SIOPE created the multistakeholder ACCELERATE platform which makes paediatric haemato-oncologists and scientists, parent/patient advocates, pharmaceutical companies and regulatory representatives discuss and formulate possible solutions to this complex and multifaceted problem. Paediatric drug development is currently regulated in Europe via the EU Regulation on medicinal products for paediatric use 1901/2006. Also known as the ‘Paediatric Regulation’, it came into force in 2007 and aimed to: a) facilitate the development and availability of medicines for children aged 0 to 17 years; b) ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately; and c) improve the availability of information on the use of medicines for children, all this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults. Although this Regulation did change the landscape of

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This piece of legislation allows pharmaceutical companies to derogate to the requirement to initiate a paediatric investigation plan when the target disease or condition is only present in adults and, because of these waivers, several drugs potentially beneficial for a paediatric malignancy were not investigated in children. While the way a specific drug compound works (its “mechanism of action”) in an adult type of cancer may be relevant to a malignant type that only occurs in children, the current system overlooks this potentially life-saving use of a new drug for children. Furthermore, delays in starting paediatric investigation plans and insufficient incentives to pharmaceutical companies represent potential barriers. Members of the ACCELERATE platform, including the Unite2Cure group of parents, parent organisations and patient advocates who are calling for better access to treatment for children and young people with cancer, decided this year to jointly propose some amendments to the Regulation: i) Suppress class waivers that are both scientifically and medically unjustified and run paediatric development based on drug mechanism-of-action instead of adult indication; ii) Set up an efficient system to choose and prioritise the potentially best new oncology drugs to develop in children; iii) Start early the paediatric development plans well before first marketing authorisation to speed up innovation and reduce off-label use; iv) Break the 18 years’ dogma; v) Introduce a more efficient and adapted system of rewards and sanctions. In May 2016, a few representatives from SIOPE and Unite2Cure had the opportunity to meet the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, and explain the concerns of the paediatric cancer community in this regards. More recently, the proposals for change in the regulation and its implementation were discussed and warmly welcomed at the conference ‘Review of the EU Paediatric


HEALTH REPORT Medicines Regulation – Let’s do more for children with cancer’ (7 September 2016, Brussels). Taking place at the European Parliament, the event was hosted by Elena Gentile MEP (S&D, IT), supported by Glenis Willmott MEP (S&D, UK), and co-organised by the MEPs Against Cancer (MAC) European Parliament Group, Cancer Research UK (CRUK) and SIOPE.

care but, still today, the centres delivering multidisciplinary treatments in Europe greatly vary in their capability to meet certain minimum standards of care in the delivery of the therapies and in monitoring patient outcomes.

Assuring quality and excellence in radiotherapy

To assess and improve the effectiveness of the radiotherapy treatments is an important condition to obtain better and more equitable outcomes in children and adolescents with cancer. This is why, thanks to the collaboration between SIOPE and EORTC, the QUARTET project (Quality and Excellence in Radiotherapy and Imaging for Children and Adolescents with Cancer across Europe in Clinical Trials) will investigate and assess the effectiveness of radiotherapy in paediatric cancers through an online prospective quality assurance programme.

Another aspect related to equal access to quality care in Europe is that “cure is not enough.” We should always ensure that the quality of the treatment young patients receive will only entail minimal treatment-related side effects on the long term. Reducing the risk of recurrence and long-term toxicity is an essential aspect of

Over a period of 5 years and with an estimated number of 500 patients included per year, the project will ensure a centralized review of prospective fields and radiation treatment plans for every child and adolescent before radiotherapy, in order to make necessary amendments if needed. The QUARTET group will cover children

In 2017, the Commission will publish the 10-years report of the regulation and define what is the future. It is crucial that the needs of the paediatric population with cancer are taken into account at a time when therapeutic innovations are dramatically accelerating in adults: children and adolescents should not be left apart.

and adolescents treated for neuroblastoma, rhabdomyosarcoma and brain tumours as part of 9 European prospective clinical trials. More specifically, the project will use the EORTC radiotherapy quality assurance platform with expert paediatric radiotherapists, as part of the clinical trials implemented within the SIOPE community. QUARTET will also create a database for the real-time use of such quality control data and evaluation and conduct research projects using the data collected. This important project has been funded thanks to the generosity of the Luxembourg foundation ‘Fondatioun Kriibskrank Kanner’. In conclusion, introducing safer and more innovative treatments into standard care is an essential aspect of ensuring better outcomes for all children and adolescents with cancer. Both these important projects – ACCELERATE and QUARTET – are inscribed in the wider scope of the SIOPE Strategic Plan ‘A European Cancer Plan for Children and Adolescents’, recently endorsed by the European paediatric cancer community.

Delivering harmonised paediatric oncology training By Professor Riccardo Riccardi, Università Cattolica del Sacro Cuore, Rome, Italy

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he delivery of high quality care as well as considerable progresses clinical and basic research can only be ensured via a harmonised paediatric oncology training and education programme throughout Europe. This is one of the priorities of the European Society for Paediatric Oncology (SIOPE), actively involved in several courses to develop the knowledge of health professionals on state-of-the-art therapies and allow them to gain more practical skills in the treatment of paediatric malignancies. One of these initiatives is the Masterclass in paediatric oncology, in partnership with the European School of Oncology (ESO), a society dedicated to improving the skills of all health professionals dealing with cancer patients. It is a practice-oriented training with a focus on the application of the most recent research findings to clinical practice. At its sixth edition, this educational programme is intended for young paediatric oncologists who wish to improve their practical skills in the clinical management of common childhood tumours. The Masterclass teaching sessions focus on the application of the most recent research findings in different tumour types (central nervous system tumours, neuroblastoma,

soft-tissue sarcoma, bone tumours, Wilms’ tumour, acute lymphoblastic leukaemia and rare tumours) into clinical practice. The 2016 edition of this Masterclass received 61 applications, of which 42 participants were selected from 18 countries. Particularly attractive for young professionals – the average age of participants was 34 – the course has been “an excellent experience” for Dr. Antonio Juan Ribelles (Spain). “A whole review of all paediatric malignancies was revised in five intense but entertaining days. All the topics were conducted by European specialists in the subject, and the last updates were highlighted in the presentations” continues Dr. Ribelles, who recommends this experience to other junior paediatric oncologists. Course participants had the opportunity to present a clinical case that was commented on by the staff, thus making “the rhythm of the class more fluid and educational.” Two of the patient cases presented during the Masterclass – a case on adolescent sarcoma from Dr. Luca Bergamaschi and one on refractory metastatic rhabdomyosarcoma on an adolescent at the end of life from Dr. Jessica Morgan – have already been uploaded on the ESO ePatCare platform for educational purposes, and are likely to soon be transformed in interactive ESO-SIOPE e-sessions.

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To mark its tenth year of existence, SIOPE is also preparing a brand new educational event. The SIOPE Society Day (27th January 2017, Amsterdam, the Netherlands) will bring together experts from multidisciplinary tumour boards in Europe and national societies, who will share their crucial research advances and lessons learnt in paediatric oncology on the first day of the 2017 European Cancer Congress (ECCO2017). Sessions will also illustrate the most effective approaches at the clinical and research levels. The second part of the Society Day will consist in a Policy Session – benefitting from the participation of high level representatives of the European Commission – where the importance of exchange on EU health and research policies and future initiatives of the SIOPE community will be instrumental for the implementation of the SIOPE Strategic Plan ‘A European Cancer Plan for Children and Adolescents’. Building on the existing cooperation with the adult oncology world, SIOPE is building the most relevant and complete educational programme for its community of childhood cancer professionals.


BEATING CHILDHOOD CANCER

A Paediatric Oncology Reference Network in Europe Though survival rates in childhood cancer have vastly improved, inequalities still remain in treatment and care available to different member states. Professor Ruth Ladenstein, St. Anna’s Children’s Hospital, Vienna, Austria, reviews the survival gap and details how ExPO-r-Net addresses this need, in line with the SIOPE Strategic Plan’s objective to bring about equal access to standard care

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hanks to the progress made in Europe by research over the past fifty years, survival rates for childhood cancers in Europe have greatly improved and today amount to approximately 80%. However, this is not valid in all European countries: in Eastern-European countries with low health expenditure rates (LHEAR countries) survival is on average 10 to 20% lower than in the rest of the region. Some centres in Europe have been promoting excellence and dispose of the latest diagnostic and treatment technologies, and others do not even dispose of the basic requirements to ensure standard treatments, care, and followup to all patients. Delayed diagnosis and treatment, lack of specialised centres with multidisciplinary teams, and limited drug supply might explain these inequalities. Collaborative programmes to ensure a Europe-wide cross-border healthcare can reduce the current inequalities in childhood cancer healthcare capabilities in different EU member states and thus narrow the survival gaps. ExPO-r-Net addresses this need, in line with the SIOPE Strategic Plan’s objective to bring about equal access to standard care (in both diagnosis and treatment), expertise and clinical research across Europe. To do so, this 3.5-years’ EU project is building a European Reference Network (ERN) for Paediatric Oncology. A ERN is a network connecting highly specialised healthcare providers to improve access to diagnosis, treatment and the provision of high-quality healthcare for patients with conditions requiring a particular concentration of resources or expertise in Europe. The aim of ExPO-rNet is thus to enable children and young people with cancer to receive high-quality treatment in a Member State other than the Member State of affiliation, because of a lack of expertise or specialised resources in a certain type of malignancy. ExPO-r-Net partners are therefore working to provide a clear roadmap to approved expert referral sites and virtual tumour advisory boards for healthcare providers, incorporating expertise

from all over Europe and integrating all existing information to allow advice on diagnostics and treatments for patients in need. The disease-specific clinical trial groups in Europe which were identified in a bottom up process have acted as “hubs of coordination” for special childhood cancer interventions and treatments. The project fosters virtual tumour boards that facilitate the free movement of information and knowledge. It also addresses related open reimbursement questions for virtual tumour boards when acting across the EU. On 16 March 2016 the European Commission’s Directorate for Health and Food Safety (DG SANTE) published a call to establish ERNs. This first call for ERNs published by the European Commission – in line with the EU Directive on Cross-Border Healthcare and implementing decision of 2014 – recognised paediatric oncology as a stand-alone European Reference Network (ERN) in the rare cancers field. The SIOPE community responded and committed to engage in this call and to submit an application for a paediatric cancer ERN (PaedCan ERN). The “pilot project” ExPO-r-Net increased this PaedCan ERN’s potential to become a strong network, having already prepared a clear structure for healthcare providers/patients to provide cross-border healthcare along with twinning structures for identified centres in lower income European countries. In the best interest of patients, a triage function is proposed in the decision-making process for cross-border healthcare (CBHC) through virtual tumour board advice. The PaedCan ERN strongly engages with national and clinical trial group structures. The virtual tumour board advisory function is a main theme, but will absorb considerable amounts of local expert resources at the engaging expert sites. A European compensation system similar to the already existing S2 agreements for CBHC will be needed to guarantee the sustainability of this function. As a logical extension of the ExPO-r-Net, funded by DG SANTE, Project Coordinator and SIOPE Board Member Professor Ruth

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Ladenstein and her institution CCRI took the lead in preparing the ERN application, coordinating the preparation of a list of reference centres to be included as a start in PaedCan ERN. This was possible with the support of the National Societies of Paediatric Haemato-Oncology (NaPHOS), the European Clinical Trial Groups (ECTGs) and the ExPO-r-Net partners. The PaedCan ERN will have a broader scope than envisaged at the start of ExPO-r-Net, not only concentrating on a few very rare paediatric cancer indications. It will include all types of childhood cancers but will keep the focus on special conditions requiring CBHC interventions. After two independent evaluations – one at the European level (the network defines itself and presents the partner centres chosen through a bottom up process) and one at the national level (European member states must agree with those choices) – the accepted networks are expected to kick-off at an official conference in February 2017. In summary, the creation of these patientcentred and clinically-led networks of healthcare providers aim to improve the quality, safety and access to quality expert healthcare across Europe for complex paediatric malignancies. The innovative character of the proposed PaedCan ERN is the strengthening of multidisciplinarity, its capacity to overcome fragmentation in its capacity to cover the needs for CBHC advise and care. This is a major added value to improve outcomes in young people with cancer.


HEALTH REPORT

Children with cancer can’t wait any longer The EU Paediatric Medicines Regulation has benefited a series of childhood diseases, yet only two innovative anti-cancer drugs have been authorised so far. Francoise Grossetete MEP analyses the impact of the legislation and points out what more needs to be done to offer quick and tangible results to children with cancer

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he Paediatric Regulation came into force in the European Union on 26 January 2007. In early 2017, the European Commission – the EU body that drafts and updates new laws – will decide whether to revise the law or leave it as it stands. This amending regulation was deemed necessary because the legislative framework at the time had failed to address the lack of new paediatric medicines being put on the market and the lack of innovation thereof. It had a strong impact on development of paediatric medicines, partly because it obliged companies to conduct a Paediatric Investigation Plan (PIP) for each new molecule they wanted to market. In this regard, it helped improve the situation and led to tangible benefits for a series of childhood diseases. However, we now clearly see that there is still a long way forward, especially in certain therapeutic areas such as paediatric oncology. Childhood cancer remains the first cause of death by disease in children aged one year and over, and 6,000 young people die of cancer each year in Europe. Those who are treated often suffer from treatment-related side effects. Yet, only two innovative targeted anti-cancer drugs were authorised for a paediatric malignancy since the Paediatric Medicines Regulation came into force. We

clearly see that something urgently needs to be done.

Parliament has decided to adopt a resolution to highlight its priorities.

According to my shared understanding, the obstacles are threefold. First, the legal requirement to pursue a PIP is too often waived, because the drug is being developed for an indication that does not occur in children. Second, the PIPs, conducted at a very early stage in the process, are often complex and inflexible, which leads companies trying to bypass them or to simply abandon them later in the process. Third, the current system of rewards and sanctions is not appropriate and effective enough, leaving pharmaceutical companies with little incentive to invest in a field where return on investments are far from guaranteed.

The final text is yet to be adopted but as it stands, it tries to address the main shortcomings I have mentioned above. It calls to take into consideration not only cancer-type-based paediatric development plans, but also plans based on the mechanism of action matching the tumour’s biology. It asks companies to start paediatric development as soon as possible, in order to enable early regulatory dialogue and joint development with the European Medicines Agency, allowing for more feasible PIP.

For all those reasons, I believe that the current regulation must be adapted if it is to deliver concrete results for children with cancer. A full legislative review may not be needed, as it could take time and seriously put at risk the basis of the current legislation, which I think has proved successful even if we now see its limits. Instead, I think changes could be introduced through regulatory procedures, guidelines from the EMA for example. To work in this direction and ahead of the publication of the European Commission’s implementation report on the Paediatric Medicines Regulation next year, the European

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Finally, it requires the European Commission to assess how different types of rewards could be best utilised to drive and accelerate clinical development of drugs for childhood disease, and specifically for those cancers which occur only in children. This resolution is obviously only a first step. I have high expectations for the Commission’s report due to be published in 2017, which should make a good assessment of the situation and of the existing margins of manoeuvre for adapting the current legislative framework. Whatever is the chosen solution in the end, it will have to be able to quickly deliver tangible results.


BEATING CHILDHOOD CANCER

Europe must do more to ensure children don’t miss out on life-saving treatments

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ancer remains the single biggest cause of death by disease for children in Europe, with 35,000 children and adolescents diagnosed every year. While survival rates have certainly improved, 6,000 young people will die from cancer each year. As with other rare diseases, research into paediatric cancer is often not seen as a priority because the pool of patients is relatively small and the profit margins low; so despite the progress that has been made in treating cancer, very few innovative treatments have been developed specifically for childhood cancer. Those treatments that are available cause severe side-effects in two thirds of paediatric cancer survivors. The European Union’s Paediatric Regulation was intended to address the lack of treatments for paediatric conditions by requiring developers to test all new medicines for their potential to treat children. The Regulation has certainly had some success: since 2007, more than 800 Paediatric Investigation Plans have been agreed, with 41 medicines developed with a specific paediatric indication and a further 120 where paediatric dosing has been improved. However, for oncology the impact of the regulation has been disappointing, with only two innovative targeted anti-cancer drugs authorised for paediatric indications. There are a number of reasons for this but one of the main problems is that under the legislation, waivers are granted for medicines that are intended to treat a condition that does not occur in children. Most adult cancers do not occur in children and vice versa, and so many new oncology drugs are not investigated for their potential to treat paediatric cancers. The problem with this is that, even where a type of cancer only occurs in adults, the mechanism of action of a drug may still be effective in treating a paediatric cancer. For example Crizotinib is used in the treatment of ALK+ lung cancer, which does not occur in children. The same molecular abnormalities that cause this type of cancer have been observed in a number of paediatric cancers, such as lymphoma and sarcoma. However, because the drug

The EU Paediatric Medicines Regulation has resulted in far fewer treatments being made available for children than there should be. Glenis Willmott MEP reviews the regulation and points out what crucially needs changing regarding current EU-wide policies on prevention, education, screening, treatment, care or research relating to paediatric cancer was developed for a condition that does not occur in children, the developers received a paediatric investigation waiver and children in Europe were denied access to this potentially life-saving medicine. Researchers estimate that in the first five years after the Paediatric Regulation came into force, 26 new drugs were developed for adult cancer that had potential to treat paediatric conditions, but over half received a waiver. The Commission is due to report on the success of the Paediatric Regulation in 2017 and may consider revising it. I’ve been working with Unite2Cure, which represents the parents of children with cancer, calling for the Commission to amend the legislation so that the decision to grant a waiver is not based purely on the type of condition, but also takes into account the biology of the cancer and the drug’s mechanism of action.

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There are other problems we’d like to see addressed too, such as the fact that Paediatric Investigation Plans (PIPs) for new anti-cancer drugs are often started late in a drug’s development as the investigators wait for it to show promise in adults first, meaning that some children may miss out on potentially life-saving treatments. Similarly, there’s nothing to stop investigators ending a promising paediatric trial early if they’re not getting the results they want in an adult trial. When it comes to clinical trials, cross border trials are particular important for childhood cancer, as there often aren’t enough patients in one country to make a trial viable; for many children with cancer, a clinical trial may be their only chance of survival. Another important piece of EU legislation in this regard is the new Clinical Trials Regulation, which will make it much easier to carry out cross-border trials.


HEALTH REPORT

Paediatric Oncology

The European Union’s Paediatric Regulation has certainly had some success: since 2007, more than 800 Paediatric Investigation Plans have been agreed, with 41 medicines developed with a specific paediatric indication and a further 120 where paediatric dosing has been improved. While progress is clearly being made in Paediatric Oncology, there’s more that Europe could do to facilitate it and I hope the European Commission will listen to some of these recommendations.

I was interested to read about recent research into a potential treatment for malignant rhabdoid tumours, a devastating form of cancer for which there is currently no cure. Scientists at the Institute for Cancer Research found that using existing medicines to inhibit two types of protein effectively killed the cancer cells. This is promising research and the researchers are hopeful it

may be relevant to other types of cancer too. Nevertheless, they also highlighted that it is currently too easy for pharmaceutical companies to avoid evaluating their drugs in children. So while progress is clearly being made in Paediatric Oncology, there’s more that Europe could do to facilitate it and I hope the European Commission will listen to

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some of these recommendations. The UK organisation Christopher’s Smile, who raise money for research into paediatric cancer and advocate for better policies in this area, have a vision for “every child diagnosed with childhood cancer to not only survive, but to reach adulthood enjoying a good quality of life.” I believe that should be the European Union’s aim too.


Government Gazette

Health REport Recommendations to reshape policy making

State of the fight Lung Cancer policy in Europe

Bringing together viewpoints of healthcare policy makers and stakeholders to reach an EU-wide consensus for improved diagnostic accuracy, effective management and care in lung cancer


What’s inside? European Commission

40 Vytenis Andruikatis, Commissioner for Health and Food Safety 42 Antoni Montserrat Moliner, Senior Expert for Cancer and Rare Diseases

European Parliament

44 Catherine Bearder MEP 46 Mariam Dalli MEP

Care, prevention and treatment

48 Lydia Makaroff, Director and Francesco Florindi, Policy Coordinator, European Cancer Patient Coalition 49 Stefania Vallone, Director, Lung Cancer Europe 50 Dr. Karen Noble, Head of Research Training and Fellowships, Cancer Research UK 52 Dr. Giorgio Scagliotti, President Elect, IASLC 53 Dr Ilona Rousalova, Pulmonologist & Thoracic Surgeon, Czech Lung Cancer Cooperative Group 55 A Viewpoint by Roche 56 Denis Horgan, Executive Director, European Alliance for Personalised Medicine 58 A Viewpoint by Illumina 59 A Viewpoint by GE Healthcare 60 Arvind Venkataramana, Research Director, International Centre for Parliamentary Studies


BATTLINGLUNG CANCER IN EUROPE

Arming for the European battle against lung cancer Addressing the risk factors of cancer is the European Commission’s first line of attack in the battle against cancer. In this article, Vytenis Andriukaitis, European Commissioner for Health and Food Safety, focuses on the two major tools which add value to the prevention and treatment of lung cancer

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e often speak about cancer in violent metaphors – ‘fighting’, ‘waging war’, ‘winning the battle’, etc. Is this appropriate? Significant increases in survival rates of breast cancer, for example, thanks to advances in detection and treatment, may make this sort of language outdated as we turn our focus more towards survivorship and rehabilitation. For lung cancer, on the other hand - which is responsible for the most cancer-related deaths in the EU, this type of language may

be more fitting in the sense that we need powerful tools to fight a formidable battle. In this article, I would like to focus on two EU-level tools which can add value in the prevention of lung cancer and in its treatment: EU tobacco control policy and European Reference Networks respectively. First some statistics: in 2013 alone 270 000 people in the EU died from lung cancer, representing 21% of deaths due to cancer and making it the greatest source of cancerrelated death in Europe.(1) There is a high variation between EU countries - the highest proportion of lung cancer among all cancer deaths was recorded in Hungary (26%),

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followed by Belgium, Denmark, Greece and Poland (all 24%), and the lowest in Portugal (15%) and Sweden (16%). There is also a gender gap. Lung cancer accounted for 26% of all male fatal cancer (185 600 deaths), compared with 15% for female (83 500 deaths). This can partly be explained by the greater prevalence of risk factors among men, notably smoking rates. Addressing the risk factors of cancer is the Commission’s first line of attack, and as smoking is the greatest risk factor for lung cancer, I am particularly proud of the EU Tobacco Products Directive (2), which has recently become applicable to member states


HEALTH REPORT

I sincerely believe that we are turning a corner in the fight against lung cancer, and that EU tobacco policy and ERNs are part of the solution, alongside other EU actions to support member states such as research funding and Joint Actions on rare cancers and comprehensive cancer control.

from the harmful effects of tobacco, and the Eurobarometer conducted in 2012 (3), just before the Commission put forward its proposal, illustrates this. Indeed, its results show that: “around three respondents in five support measures banning advertising at sales points (64%), banning flavours (63%), banning Internet sales of tobacco (62%) and keeping tobacco products out of sight in shops (58%)”. It seems that the anti-tobacco sentiment in the EU is gaining momentum both at individual and government level. Evidence pointing to this includes falling smoking rates, especially in the 16-25 year age group, and the introduction of plain packaging and stricter laws on smoking in public places in some Member States. I am delighted with this trend and convinced that it will continue, so that in twenty, thirty years’ time, we will see a significant reduction in lung cancer deaths in the EU thanks to lower smoking rates.

(20 May 2016). Through rules intended to make tobacco products look and taste like tobacco products – and not cosmetics, sweets or toys this piece of legislation aims to reduce smoking rates by two percentage points by 2021. Some particular rules are mandatory – large picture warnings covering the front and back of cigarette and roll-your-own packages; bans on products with characterising flavours; small packs; ‘lipstick-style’ packs and misleading elements on packaging, which entice children and teenagers into starting to smoke. Few people can argue with measures that protect young people

Another line of attack facilitated by the EU lies in bringing together expertise and maximising synergies between Member States in their common effort to fight diseases. The value of EU collaboration is especially apparent in the case of rare diseases and conditions where knowledge and resources are scarce and fragmented across individual EU countries. Lung cancer is always serious, but rare forms of lung cancer are particularly hard to treat, and patients face real challenges with diagnosis and accessing expertise and appropriate treatment. This is where future European Reference Networks (ERNs) can help. ERNs are unique and innovative crossborder networks that will help diagnose and treat rare and complex diseases, including rare forms of cancer. They will become operational in early 2017. No country alone has the knowledge and capacity to treat all these diseases, but by cooperating and exchanging life-saving knowledge at European level through ERNs, patients across the EU will have access to the best expertise available.

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I sincerely believe that we are turning a corner in the fight against lung cancer, and that EU tobacco policy and ERNs are part of the solution, alongside other EU actions to support member states such as research funding and Joint Actions on rare cancers and comprehensive cancer control. (4) I will do my utmost to ensure correct transposition of the Tobacco Products Directive by Member States so that the positive effects on public health in the EU are felt as soon as possible. With regard to ERNs, my services are developing a state-ofthe-art IT platform and tools. We will also ensure that ERNs receive adequate support via EU funding mechanisms such as the Health Programme, the Connecting Europe Facility (CEF) and Horizon 2020, so that they can reach their full potential. References: 1. Eurostat Press Release 4 February 2016: http://ec.europa.eu/eurostat/ documents/2995521/7149996/3-03022016BP-EN.pdf/0bbc3389-8c0d-44a0-9b0c2a0bff49f466 2. Directive 2014/40/EU of the European Parliament and the Council, adopted on 3 April 2014: http://ec.europa.eu/health/ tobacco/docs/dir_201440_en.pdf 3. Eurobarometer on Attitudes of Europeans towards tobacco: http://ec.europa.eu/health/ tobacco/docs/eurobaro_attitudes_towards_ tobacco_2012_en.pdf 4. See factsheet on EU action on cancer: http://ec.europa.eu/health/major_chronic_ diseases/docs/30years_euaction_cancer_ en.pdf


BATTLINGLUNG CANCER IN EUROPE

Targetting the environmental risk factors of lung cancer The European Commission addresses the environmental risk factors of lung cancer through an ambitious tobacco control policy comprising both robust laws regulating tobacco products and prohibiting the advertising and sponsorship of such products. Antoni Monsterrat Moliner, Senior Expert for Cancer and Rare Diseases, Directorate of Public Health, European Commission, elaborates on the the EU fight against lung cancer

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ung cancer causes 1.37 million deaths per year worldwide, which represents 18% of all cancer deaths. Within the European Union, lung cancer is the one of the most fatal cancers, leading to over 266,000 deaths yearly and accounting for 20.8% of all cancer deaths. Lung cancer mortality in men from the European Union peaked in the late 1980s at an age-standardised (world standard population) rate over 53 per 100,000 and declined subsequently to reach 44 per 100,000 in the early 2000s and continued to fall over recent years, to reach a value of 41.1/100,000 in 2005-2009. The fall was similar at all-ages and in middle-aged men (less than 2% per year over most recent years), but was appreciably larger in young men (aged 20-44 years, over 5% per year). A favourable trend is thus likely to be maintained in the foreseeable future, although the predicted overall EU rate in 2015 is still over 35 per 100,000, i.e., higher than the US rate in 2007 (33.7 per 100,000). This favourable trend is essentially due to the widespread measures for smoking control and cessation. Smoking can contribute to around 85% of all lung cancer cases. (1) Anti- tobacco policies, especially in middleaged European men, i.e., in the generations where smoking prevalence used to be high, would lead to appreciable reductions in male lung cancer mortality in the near future. This is particularly urgent in central and eastern European countries. According to EUROCARE-5 Study (2), lung cancer had a European average survival of 13%. The European mean age-standardised 5-year survival for lung cancer is one of the poorest and it’s better for women than for men. Geographical differences were small, varying from 9% in the UK and Ireland to 14.8% in central Europe. Age was a strong determinant of survival, ranging from 24.3% for patients aged 15–44 years, to


HEALTH REPORT

Smoking can contribute to around 85% of the lung cancer cases. Anti- tobacco policies, especially in middle-aged European men, i.e., in the generations where smoking prevalence used to be high, would lead to appreciable reductions in male lung cancer mortality in the near future.

7.9% for patients aged older than 75 years. However European 5-year survival increased significantly from 11.6% in 1999–2001 to 13.4% in 2005–07, with similar trends in each region. For the European Commission, cancer prevention constitutes one of our highest priorities. The adoption of the new version of the European Code Against Cancer permits to have a key tool for general prevention of cancer with a particular emphasis in some recommendations that could be very efficient in prevention of lung cancer. These recommendations are supported by an active policy of the EU. With one in three cancers being preventable, addressing the risk factors (or determinants) is at the forefront of the Commission’s strategy to reduce the burden of cancer. The Commission addresses all the key risk factors, e.g. through an ambitious tobacco control policy comprising both robust laws regulating tobacco products and prohibiting the advertising and sponsorship of such products; an award winning pan-EU campaign “Ex-smokers are unstoppable”; strategies and platforms for joint action on alcohol and nutrition & physical activity bringing together member states and a wide range of stakeholders including NGOs and industry. The Commission further contributes to cancer prevention by addressing environmental factors such as exposure to carcinogenic and mutagenic substances both indoors (including in the workplace) and outdoors. It does so mainly by developing and implementing legislation on air, soil and water quality and on general chemical exposure (i.e. in water, waste and organic pollutants). Lung cancer in women differs from lung cancer in men in many ways. Even though smoking is the number one cause of lung cancer, a higher percentage of women who develop lung cancer are life-long nonsmokers. Some of the causes may include exposure to radon, second hand smoke, other environmental and occupational exposures, or a genetic predisposition. Recent studies suggest infection with the human papilloma virus may also play a role.

On 30 April 2015, the European Respiratory Society (ERS) and the European Society of Radiology (ESR) published a joint white paper on lung cancer screening (3) suggesting data supporting the survival benefit for screening of individuals at high risk for early detection of lung cancer using low dose computed tomography (LDCT) including minimum requirements and recommended refinements. In the framework of the ongoing Joint Action (2014-2017) on Cancer Control, supported by the EU Health Programme, a specific work package will evaluate suggestions on possible new cancer screening programmes. On the basis of the conclusions of this Joint Action and an opinion of the European Commission Expert Group on Cancer Control, the Commission would consider whether it would support the development of screening guidelines for lung cancer. The Seventh Framework Programme for Research and Technological Development (FP7) has displayed a comprehensive approach to nurturing research and innovation on Chronic Respiratory Diseases (CRD), tuberculosis and cancer. During this programme, 194 relevant projects related to CRD from which 16% related to lung cancer. Lung cancer and infections with an impact on CRD have been funded for an amount of over €350 million. Horizon 2020, the Framework Programme for Research and Innovation (2014–2020; overall budget €80 billion), provides a wealth of opportunities to address unmet research and innovation needs in CRD within the theme “Health, demographic change and wellbeing” (budget €7.6 billion) and elsewhere in Horizon 2020. The European Commission feels fully concerned by the tremendous impact of lung cancer. We will invest, as much as possible, to contribute to towards reducing cancer prevalence and offer a better prognosis for affected patients. References: 1. Dela Cruz, Charles S., Lynn T. Tanoue, and Richard A. Matthay. “Lung Cancer: Epidemiology, Etiology, and Prevention.”

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Clinics in chest medicine 32.4 (2011): 10.1016/j.ccm.2011.09.001. PMC. Web. 8 Nov. 2016. 2. Roberta De Angelis et al, “Cancer survival in Europe 1999–2007 by country and age: results of EUROCARE-5—a populationbased study.” Lancet Oncol. 2013 3. Hans-Ulrich Kauczor et al, “ESR/ERS white paper on lung cancer screening.” European Respiratory Journal. 2015


Wake up call in the fight against pollution Despite efforts by the European Parliament and European Commission to put in place ambitious national caps on emissions to slash air pollution, individual member states have have agreed for a weak emissions control deal. Passionate about cleaning up the air, Catherine Bearder MEP writes why we shouldn’t miss another historic opportunity to save thousands of lives each year and costs to our health services

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ir pollution causes ten times more deaths each year than traffic accidents. Yet we are still not doing enough to tackle this invisible killer. Air pollution is a national health crisis that has been ignored for far too long. This year the European Parliament approved strict new national limits on major pollutants to be met by 2030. These limits are expected to halve the number of premature deaths caused by air pollution each year, estimated at 400,000 in the EU and 50,000 alone in the UK. The European Parliament voted, both in committee and the full Parliament to include ammonia and methane as pollutants; for binding interim targets for 2025 to ensure EU countries are on track to meet their 2030 goals; for 2030 targets to be in line with the European Commission’s original proposal; and to exclude mercury, which comes largely from coal-powered plants. I welcomed all of this as a lead Liberal negotiator on the National Emissions Ceiling legislation, but one of my disappointments was that our call for more ambitious 2030 targets were not adopted. During the negotiations with the European Commission, the governments in the European Council and the Parliament, the MEPs were under huge pressure from the farming sector and some of the national governments, including the UK, who pushed to exclude agricultural emissions and to water down the overall targets. In fact, in an earlier vote in the European Parliament Environment Committee, the Conservative MEPs voted against the proposals. That is why I felt it was so important that we didn’t miss an historic opportunity to put in place strong air pollution limits that will save thousands of lives each year and costs to our health services, and this is a position that the Liberal Democrats have always fought hard on.

After the Dieselgate scandal, when we were all trying to sort out what had gone wrong and how we could make sure that this deception could not be repeated, I was furious. And I am still furious when I think of the UK Government voting in favour of watering down new tests to tackle pollution from diesel cars. The Tories once again didn’t act in our country’s best interests. By voting to weaken diesel emission limits, the Conservative government gave into the money-fuelled motoring lobby, put thousands more British lives at risk and added extra burdens on our own beleaguered NHS. I am passionate about cleaning up our air. I thought the Volkswagen scandal would be a wake-up call in the fight against diesel pollution and that the government would stop turning a blind eye to this invisible killer, but evidently not. I have seen the impact of air pollution first hand and I know it will take yet more lives the longer we allow it to persist. There is no reason the public should have to wait another 5 years for cleaner air and there is no reason that justifies another life lost to illnesses caused by air pollution such as lung cancer. But what happens next in the wake of the outcome of the European Referendum on 23rd June? I will continue to lead and work hard, irrespective of external events, to keep the issue of air pollution on the agenda. We can only tackle problems like this by working together across borders. Almost half of deadly particulate pollution in the UK comes from overseas. That is why strong EU laws are needed to ensure every sector and country plays its part in improving air quality. Without these in place soon, we will not be able to include these standards in the TTIP negotiations either. The UK government must commit to meeting the 2030 targets no matter what happens in the coming years. Brexit cannot be used as an

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CAMPAIGN FOR CLEANER AIR

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BATTLINGLUNG CANCER IN EUROPE excuse to water down environmental laws and become the dirty man of Europe again. If we are to determinately strive to improve air quality, we must also look at the impact it has on member states’ health costs. Taking as much action as we can now will surely pay for itself in the long-term. I have lead on improving European legislation on air quality through the National Emissions Ceiling but when the NHS is under threat from an ever-increasing desire from this Tory government to privatise it, I find myself again being alarmed at government’s announcement to expand Heathrow Airport. There is very little desire among the people who actually live in the South East for airport expansion at either Gatwick or Heathrow. The impact on pollution would be severe and will mean London continues to breach vital European air quality standards without forgetting the impact extra road traffic expansion also brings. There is no way to describe it but as a betrayal of people.

Clinical and policy cooperation important in fight against cancer While the work done by the European Parliament’s informal group MEP’s against Cancer and the European Partnership for Action Against Cancer will continue to develop on cancer prevention in Europe and improve policy between member states, M iriam D alli MEP says cooperation is crucial in beginning a rejuvenated fight against lung cancer

The turbulence in the Conservative Party is nothing compared to the anger felt by those they have betrayed by giving up their commitment to the environment. Theresa May used to make this case, now she has ripped those words down from her website and scrubbed them from history.

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As a member of the committee on Environment, Public Health and Food Safety, the health of European families is one of my top priorities. The burden of cancer needs the support of politicians and citizens to move in a positive direction for action to be taken quickly.

HEALTH REPORT

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n 2012, cancer was the second most common cause of death in the EU. But one of the deadliest, and most common of all cancers is lung cancer. There were 353,723 deaths to lung cancer in the EU in 2012 and only around 12.6% of European patients to survive this deadly illness. Cancer is a destructive disease, which can leave traumatic lifelong effects on those who have to face it. Prevention is the strongest weapon we have in saving lives. It is foreseen that nearly 30% of cancer deaths could be prevented by adopting a healthy lifestyle and early detection through screening programmes. In order to properly implement a stronger prevention plan, we must address all the combination of risks that a person will be exposed to in various areas of their life and then adapt preventive measures that address occupational and environmental factors. This pertains directly to lung cancer as studies have shown that 8% of annual cancer deaths are caused by exposure to carcinogens in the workplace. One of the possible environmental causes of lung cancer is air pollution. Studies have suggested that air pollution from traffic and the combustion of coal, diesel fuel, and wood, has a modest association with lung cancer risk. One study looking at urban air pollution in Europe suggests that up to 10.7% of lung cancer cases considered, are related to exposure to air pollution. Our role as policy makers is to ensure that legislation aimed at reducing air pollution is enacted and enforced. Following the major steps that COP21 in Paris took last December in setting global targets to reduce emissions, I believe that it is our duty as global citizens to play an active role in implementing these targets in our everyday life. By continuing to work on improving Europe’s air quality, the EU is striving to lead the action against air pollution in efforts to have a lasting global health effect. Although prevention is better than cure, the importance of health care cannot be underestimated. The effort in improving health care services should not only reside in the member states. By fostering cooperation, the EU can contribute to research and equal access of information, which will impact the lives of all Europeans. The mobilisation of funds, incentives to encourage privatepublic investment and education about early detection are crucial. It has been proven that an efficient national cancer program can lower cancer incidence and mortality, in some cases by more than 70%. However, some cancer patients still have unequal access to medical information. Since 2009, the European Partnership for Action Against Cancer has encouraged all member states to develop national cancer plans and improve public health programmes.

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This plan has strengthened efforts and improved the quality of life for cancer patients within the EU member states. This partnership has been successful in getting member states to unite their forces but greater effort is required to develop a response that will be felt throughout Europe. Quality assurance schemes, monitoring impact assessments and support schemes will also help reduce the burden of lung cancer on governments and patients alike. The European Parliament has addressed the fact that member states could benefit from additional financial support to improve their prevention, early detection, and treatment strategies, especially states with an aging population. The work done in MAC, MEP’s against Cancer, will continue to improve and develop on cancer prevention in Europe and will improve policy between member states. In efforts to reduce the amount of new cancer patients, MAC is dedicated to collaborate with the European Commission and Council to reduce cancer incidence by 15% by 2020. The guarantee that everyone will have universal access to cancer medicine, including access to innovative medication is a target we should strive to achieve. It is also important to continue efforts in adopting standard terminology between member states to strength European-wide prevention and programmes to improve data collection. As a member of the committee on Environment, Public Health and Food Safety, the health of European families is one of my top priorities. The burden of cancer needs the support of politicians and citizens to move in a positive direction for action to be taken quickly. Cooperation is vital to begin a new effective era of fighting lung cancer. Time is crucial and lives are at stake. Action needs to be taken now.


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Policies to improve lung cancer prevention, treatment, and research in Europe

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Over the past decade, substantial improvements have been achieved in the prevention and treatment of lung cancer. However, continued efforts are required to ensure that workers are not unduly exposed to carcinogens, patients have timely and equitable access to personalised treatments.

Chromium VI, also known as hexavalent chromium, is used in textile dyes, wood preservation and anti-corrosion products. It has been associated with an increased lung cancer risk in non-smokers. European and national policies should ensure that strict binding occupational exposure limits exist for human lung carcinogens, including crystalline silica and Chromium VI, to ensure that workers are protected from the potentially carcinogenic effects of these compounds. Furthermore, any workers who are exposed to these carcinogens should have access to lifelong post-employment medical surveillance and cancer screening services.

People diagnosed with lung cancer face many challenges that include stigma, delayed diagnosis, and access to optimal treatment. Lydia Makaroff, Director and Francesco Florindi, Policy Coordinator, European Cancer Patient Coalition, assess these challenges and offer urgent solutions to policy makers

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ung cancer is one of the most common causes of death from cancer, with over 300,000 deaths every year in Europe alone, accounting for approximately 28% of total cancer deaths (2). People diagnosed with lung cancer face many challenges that include stigma, delayed diagnosis, and access to optimal treatment. While one risk factor for lung cancer is cigarette smoking, up to one third of people with lung cancer have never smoked (3). Risk factors for lung cancer also

include exposure to second-hand smoke, consumption of cured meat, sedentary activity, air pollution, genetics, and occupational exposure to carcinogens (4). Exposure to human lung carcinogens, such as crystalline silica and Chromium VI, can place people at increased risk of developing lung cancer (1). Crystalline silica is a basic component of soil, sand, and granite, and respirable crystalline silica exposure results from abrasive blasting. Over 5 million workers worldwide are potentially exposed to respirable crystalline silica, with most working in the construction sector (5).

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Within Europe there are many disparities with regards to diagnosis and access to treatment. Radiotherapy plays a leading role in treating lung cancer, however, in many regions of Europe, the utilisation of radiation therapy is sub-optimal. The estimated age-standardised rate of lung cancer mortality in the European Union is 36.5 deaths per 100,000. Hungary, Serbia and Macedonia have above-average mortality rates of over 50 deaths per 100,000. Countries with below-average mortality rates include Malta, Portugal, and Cyprus, with rates below 24 deaths per 100,000 (2). Mortality rates can be improved by speeding up diagnosis and referral to specialists, and ensuring access to effective and personalised treatments. Improved understanding of the molecular diversity of lung cancer has opened new possibilities for treatment. Personalised medicine based on biomarkers and immunotherapy has demonstrated benefits in the treatment of some kinds of lung cancer, and has been associated with longer survival as well as improved quality of life. Biomarker testing is now a critical part of the diagnostic process for lung cancer, as treatment is tailored


HEALTH REPORT to the molecular signature of the lung cancer (6). However, biomarker testing and personalised treatments can be expensive and may not be reimbursed by the health system. Furthermore, patients treated with such targeted therapies often experience unwanted side-effects, and the management of these reactions must also be incorporated into the treatment plan. In order to ensure sustainable use of innovative treatments, biomarker testing must be used to ensure that only patients with the correct type of cancer are given the treatments. Currently there are over 636 ongoing lung cancer clinical trials on the EU clinical trials register. However, it is very difficult for patients to use the interface to find out what kind of clinical trial may be suitable for them. The EU clinical trials register database should be made more accessible for the development of patient-friendly portals with information on ongoing trials and top line results of completed trials. Over the past decade, substantial improvements have been achieved in the prevention and treatment of lung cancer. However, continued efforts are required to ensure that workers are not unduly exposed to carcinogens, patients have timely and equitable access to personalised treatments, and that information about ongoing and completed clinical trials data is accessible to patients. References: 1. De Matteis, S., et al. 2012. Impact of occupational carcinogens on lung cancer risk in a general population. Int. J. Epidemiol. 41 (3): 711-721 2. Ferlay, J., et al. 2013. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. European Journal of Cancer, 49(6): 1374 – 1403 3. Jenks, S. 2016. Is Lung Cancer Incidence Increasing Among Never-Smokers? JNCI J Natl Cancer Inst. 108 (1): djv418 4. Molina, Julian R., et al. 2008. Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. In: Mayo Clinic Proceedings. Elsevier. 584-594 5. Sen, S. et al. 2016. Silicosis in Current Scenario: A Review of Literature. Current Respiratory Medicine Reviews, Volume 12, Number 1, March 2016, pp. 56-64(9) Bentham Science Publishers, USA 6. Vargas, AJ & Harris, CC. 2016. Biomarker development in the precision medicine era: lung cancer as a case study. Nature Reviews Cancer 16, 525–537

Why is lung cancer so under-reported? By Stefania Vallone, President, Lung Cancer Europe

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ung cancer is one of the most common cancers worldwide and while cancer rates are decreasing, lung cancer still remains the leading cause of cancer-related deaths across the world. Apart from late stage diagnosis, poor survival outcomes and denied or late access to innovative treatment that make lung cancer a particularly devastating and emotional disease for people to deal with, there are still many negative perceptions and stigmas due to the disease’s link to smoking, which strongly impact on funding, resources, on media interest, on public empathy and support and over all add an emotional burden to an already frustrating situation that can affect quality of life. Many studies reveal that the diagnosis of lung cancer and its treatment have more than a physical impact; it has social, emotional, psychological, spiritual and practical consequences. The emotional stress of daily coping with this disease and its treatment can create new or worsen psychological distress for patients, their families or other caregivers, but there must be additional factors that explain quality of life variance among lung cancer patients. The potential role of stigma should not be underestimated. People have a negative attitude about smoking and this attitude transfers to the perception of those who are diagnosed with lung cancer. Although this connection cannot be denied, the stigma still persists, in part, because lung cancer is considered a self-inflicted disease and patients feel stigmatized for it, whether they smoked or not. A lot of people assume that these patients smoked, despite the fact that about 15% of lung cancer patients never have. In 2010, research carried out by Ipsos MORI on behalf of the GLCC (Global Lung Cancer

Coalition), which surveyed over 16,000 people in 16 countries, found some evidence that sympathy levels were influenced by rates of smoking in each country. Between 10% and 29% of people admitted to feeling less sympathetic towards lung cancer sufferers because of its association with smoking. But lung cancer is not just a smoker’s disease. There are other risk factors to consider and public education plays a key role in leading people to change their negative attitude. The dissemination of adequate and up-to-date information about the disease, the commitment of celebrities in campaigning and advocacy on this issue and the promotion of effective anti-smoking campaigns are crucial and may help to dispel the stigma. Smoking can no longer be considered a bad habit, it is a serious addiction and we need to be motivating and encouraging smokers to quit rather than blaming them. Unfortunately the stigma surrounding lung cancer affects media interest in the topic. Though there has been an overall increase in news on lung cancer, the media coverage is still low when compared to other cancers, Lung cancer is certainly not being reported in a manner that it deserves. Media are more interested in highlighting the strong connection between lung cancer and smoking and the volume of stories discussing new treatments, pilot screening programs or positive lung cancer survivor stories is really poor, contributing to increasing the stigma that patients feel. People living with lung cancer need and deserve care and support, not an evaluation of the possible causes of their disease and for this reason raising the awareness is one of the main goals of any Lung Cancer Advocate worldwide.

People have a negative attitude about smoking and this attitude transfers to the perception of those who are diagnosed with lung cancer. Lung cancer is not just a smoker’s disease. There are other risk factors to consider and public education plays a key role in leading people to change their negative attitude.

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BATTLINGLUNG CANCER IN EUROPE

How do we solve the hardest challenges in cancer? Cancer Research UK has made lung cancer a priority and has increased funding towards the deadly disease as against other cancer types. Dr. Karen Noble, Head of Research Training and Fellowships, Cancer Research UK, makes an assessment of the challenges in fighting cancer and offers solutions for change

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hile survival across all cancers has doubled in the last 40 years, that progress hasn’t been equal for all types of the disease. Lung cancer has lagged behind and there has been little improvement in recent decades. That’s why we’ve made lung cancer a priority at Cancer Research UK. It is one of the most common cancers in Europe and it is responsible for the most deaths from the disease. Through our extensive research and policy work, we’ve started to tackle some of the most important challenges that are preventing advances in lung cancer - but we need to do more. We urgently need to change the status quo and deliver on new ways to prevent, diagnose and treat the disease. Building a sustainable research community It’s vital that we strengthen our world-class science base, building on and developing new global collaborations and exploring opportunities to create an environment that more effectively supports lung cancer research. We’ve made a commitment to increase funding in lung cancer but we need to support and develop more junior researchers

throughout their careers to create strong senior leadership in the field for the future – ensuring that there will be more high-quality research to fund. We’ve already taken significant steps. For example, we’ve opened the Lung Cancer Centre of Excellence, helping to create a hub which provides training for researchers and helps to strengthen connections and foster collaboration within the community. Getting better treatments to the people who need them We’ve made significant investments into studies that focus on lung cancer and provide crucial infrastructure that is accessible to the wider research community. One of the most ambitious is our National Lung Matrix trial – working in close collaboration with funding partners and a network of hospitals and genetics labs to test new treatments in patients, based on the genetic changes driving each individual patient’s tumour. And pioneering projects such as our TRACERx study which tracks how lung cancers evolve over time and take us one step closer towards an era of precision medicine. This type of research provides the foundations for future discovery, and ultimately new treatments for cancer patients. It’s crucial that these new

treatments then reach patients. This is why we continue to focus on improving how drugs and other technologies are licensed and appraised so that each cancer patient has access to the best, evidence based treatment for their condition. Improving tobacco control Better research isn’t the only way to tackle lung cancer – this is a disease that can largely be prevented. Smoking is responsible for over 8 out of 10 cases of lung cancer in Europe. Smoking rates are at an historical low in the UK after decades of successive action to tackle tobacco use; we’ve been involved in encouraging the Government to put advertising restrictions in place, implement tax rises and provide cessation services to help people stop smoking. We have an ambition to see a tobacco-free UK by 2035, (which we would define as smoking prevalence at less than 5%). This can only be achieved by radically accelerating efforts to stop children from starting and helping adults quit. With partners across the Europe, including the Smoke Free Partnership, we have advocated for strong regulatory measures to tackle tobacco use. This includes the Tobacco Products Directive which introduces large cigarette pack graphic health warnings across Europe. In the UK

While we’re making big strides towards speeding up progress for people with lung cancer, there is a long way to go - we won’t take our foot off the accelerator until our work translates into a better outlook for patients.

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HEALTH REPORT we have gone further by introducing plain, standardised packaging - a measure which signals the end of glitzy cigarette packaging shown to appeal to children. Detecting the early signs of cancer Lung cancer experts are unanimous on one point - survival is low because many people are diagnosed too late to be treated successfully with life-saving surgery. We are working to ensure that the public is aware of the symptoms of lung cancer to increase the chances of diagnosis at a stage where people are more likely to survive. We support symptom awareness campaigns like

Be Clear on Cancer. Previous evaluation has shown that this campaign led to hundreds more people in England receiving surgery after an earlier diagnosis. One potential solution to this problem is screening - to test healthy people with no symptoms - for signs of lung cancer. There is currently no reliable screening test that has been proven to reduce overall lung cancer mortality at a population level and so we do not presently support the introduction of a lung cancer screening programme for the general population or for smokers. We are however monitoring ongoing clinical trials of screening strategies and look forward to

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seeing their results. Time for change… While we’re making big strides towards speeding up progress for people with lung cancer, there is a long way to go - we won’t take our foot off the accelerator until our work translates into a better outlook for patients. We’ll continue to work alongside other cancer research organisations, and instigate change from the UK Government to improve survival for those affected by this disease.


BRIDGING THE CLINICAL GAP

At the forefront of a new era of clinical research The International Association for the Study of Lung Cancer is at the beginning of a creative period of bottom-up research activity. Dr. Giorgio Scagliotti, President Elect, IASLC, makes an assessment of the challenges within respiratory oncological research and notes that the right amount of coordination and encouragement from all healthcare players is required to facilitate better clinical developments

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ung cancer is the most frequent cause of cancer death in the world. Annually, 1.8 million people are diagnosed with this disease and 1.6 million die of it, making this disease a relevant social problem. The 5-year survival rates vary from 4–17%, depending on stage and regional differences. Tobacco smoking remains the main risk factor for lung cancer, though a rising incidence of the disease in smokers has been observed only in the last two decades, and the vast majority of the clinically diagnosed lung cancers are in an advanced stage, both locally or internationally. In the last 15 years, a series of studies indicated a potential role of low-dose CT scan as a potential effective tool for early diagnosis. Cancer screening is a process chain and each link in the chain needs to be performed correctly in order to maintain its significant but fragile benefit. While the primary goal in cancer screening is to achieve an objective reduction in cancer-related mortality, the utility of a screening approach is also defined by the extent of resultant harms, such as latrogenic injury and psychological stress, from the delivery of that process. At a time of profound financial stress on healthcare systems, if screening is to be delivered then it is essential to ensure that it is of high quality and includes optimal intensity cessation services so that harms and costs are minimised. Nowadays physicians are often making diagnoses using symptoms-based disease archetypes as opposed to underlying molecular patho-physiology. The growing concept of “precision medicine” addresses this challenge by recognising the vast yet fractured state of biomedical data, and calls for a patient-centred view of data in which molecular, clinical, and environmental measurements are stored in large shareable databases. Such efforts have already enabled large-scale knowledge advancement, but they also risk enabling large-scale misuse.

Patient-centric advocates will be more critical, from one side, in promoting the right social pressure for the systematic implementation of the results of preclinical and clinical research

With the completion of the human genome we understood that life is based on dynamic molecular networks rather than on a direct connection between genotype and phenotype. The genomic revolution is still “work in progress” and represents an unprecedented opportunity with regard to emerging cancer diagnosis and therapies. Advances in genomic technologies have made it possible to sequence candidate oncogenes in cancers, quickly and affordably, and gene expression profiling, and/or full genome sequencing

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will hopefully characterize a reasonably wide collection of tumours. These data provide critical information about the spectrum and frequencies of mutations in cancers and will facilitate the development of drugs against targets that are most frequently mutated. Despite the early successes of targeted therapies, it is also becoming evident that primary and acquired resistance will be major limitations. Most solid and liquid tumours will not be overcome by singleagent targeted therapies. Even in those cases in which a single agent dissolves the tumour,


HEALTH REPORT the victory is short lived and the tumours re-emerge. More often, single-agent trials involving targeted therapies administered to solid tumours result in modest effects, or no responses, even when confined to patients who have mutations in the target oncogene. Clearly, there is much yet to understand about in vivo tumour biology and exploring resistance mechanisms is essential to decide what combination of drugs will treat resistant tumours, or even to prevent the emergence of resistance. However, the genomic revolution impasses only a portion of the emerging hallmarks of cancer, which include enabling characteristics and a better understanding of the tumor microenvironment. In this context an understanding of the immune landscape of the tumours, including immune-evasion strategies, have led to breakthrough therapeutic advances for patients with nonsmall cell lung cancer and made a platform for future therapeutic developments. We are at the beginning of a creative period of bottom-up research activity, organised through pilot projects of increasing scope and scale, from which best practices would progressively emerge. Particularly given the size and diversity of the healthcare enterprise, a single approach to data gathering that will populate the space is probably not appropriate for all contributors. As in any initiative of this complexity, what will be needed is the right level of coordination and encouragement of the many players who will need to cooperate to create a higher level of biomedical knowledge. Patient-centric advocates are and will be more critical, from one side, in promoting the right social pressure for the systematic implementation of the results of preclinical and clinical research and, from the other, in developing a work in progress and continuous discussion with the regulatory bodies and national health care systems in the attempt to guarantee to every patient drug accessibility but also in helping national authorities in maintaining the long term financial sustainability of the health care systems.

Treating elderly with lung cancer With the European continent aging faster than any other region, evaluation of new drugs in the elderly is becoming a major issue. Dr. Ilona Rousalova, Pulmonologist & Thoracic Surgeon, Czech Lung Cancer Cooperative Group, studies the problems in treating geriatric cancer patients and says criteria for clinical trials should be carefully reconsidered to help better pharmacological developments

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he elderly population is the fastest-growing portion of the population in western countries.

Lung cancer is the third most common cancer type and the leading cause of cancer-related deaths in Europe. This is an increasingly common problem in older individuals since more than 50% of cases of advanced non-small cell lung cancer (NSCLC) are diagnosed in patients over the age of 65 years. (1) Biological changes associated with aging Risk of cancer development in the aging population can be mainly linked to two processes; first, DNA damage caused by cumulative exposure to carcinogens, radiation, and viruses and second, decline in different host defenses against tumor growth. Aging has a significant effect on the responses to pharmacological interventions. Age-related physiological and pathological changes play a major role in altering pharmacological actions of drugs. Most important coexisting pathologies are changes

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involving metabolism, cardiovascular, respiratory, renal, and hepatic systems as they adversely affect the patient’s functional status and treatment outcome. It has been reported that individuals aged 65-77 years have at least six chronic diseases on average. Comorbidities and functional status are key factors in the overall survival of patients as well as the benefits and toxicity of therapy. Performance status (PS) is the major prognostic factor in lung cancer, but it cannot accurately predict outcome in elderly patients. However, there are other tests which demonstrate treatment tolerance and survival in elderly, such as Activities of Daily Living (ADL) or Instrumental Activities of Daily Living (IADL). But, at the present time, Comprehensive Geriatric Assessment (CGA), though criticised for being timeconsuming and non-standardised, remains the most useful tool for evaluating the elderly who are fit and most likely to benefit from standard therapy. Treatment Treatment of the elderly is particularly challenging because of the coexistence of


GERIATRIC ONCOLOGY

Elderly patients are the majority of the users of many medicines despite being poorly represented in clinical trials. In fact, there are multiple physician-related, patient-related and trial-related barriers in recruiting elderly patients to clinical trials. In an ageing population such as Europe, medical oncology is becoming geriatric oncology, therefore the criteria for recruitment of the elderly to clinical trials should be carefully reconsidered.

variable comorbidities, which predispose them to less toleration of toxicity of medical treatments compared to their younger counterparts. This patient population is at risk of both empirical under treatment, resulting in poor survival, or excessive toxicity from standard therapy. Therefore, treatments designed to address the special needs of this population are critical. Chemotherapy Elderly patients with metastatic NSCLC and epidermal growth factor receptors (EGFR) and non-mutated tumors should be considered for treatment with chemotherapy. The choice between monotherapy and a platinum-based (preferably carboplatin) doublet should be based on considerations such as PS and geriatric assessment. Elderly fit patients or PS 0–1 (asymptomatic or symptomatic but completely ambulatory) and some cases of PS 2 (symptomatic, 50% in bed during the day) should be treated with a platinum-based doublet, whereas those who are more vulnerable and the majority of PS 2 patients should be considered for a reduced-dose carboplatinbased doublet or monotherapy. (2, 3) Newer regimens – anti-angiogenic treatment, targeted therapy Combination of first line platinum-based chemotherapy with bevacizumab, the antiVEGF monoclonal antibody, could offer the same benefit in patients aged >65 years as are seen in younger patients, to be used cautiously due to higher toxicity, although there is no compelling evidence to support

its use in patients older than 65-70 years of age. (4) Among targeted therapies, tyrosine kinase inhibitors (TKI) associated with the EGFR (erlotinib and gefitinib) are involved in many cellular processes such as proliferation, growth, migration, invasion and survival. Erlotinib was the first target agent approved for the treatment of NSCLC in second and third line, in patients unselected for EGFR mutations. Gefitinib was the first EGFR TKI approved for the treatment of NSCLC in all lines of setting in patients harbouring EGFR mutations. In elderly patients, with a poor prognosis, and different co-morbidities, erlotinib and gefitinib is recommended as valid therapeutic options (5, 6). While there is little data about elderly patients with adenocarcinoma harbouring EML4-ALK translocation, there is no reason to believe that this group would derive less benefit from ALK TKI therapy (crizotinib, cerinib). Clinical trials design Elderly patients are the majority of the users of many medicines despite being poorly represented in clinical trials. Although persons aged ≥65 years represent only about 13% of the population, they consume nearly one-third of all medications. (7) Moreover, the overall proportion of older oncologic patients (> 65 years of age) in trials conducted by the Southwest Oncology Group was 25%. Hence, the evaluation of new drugs in the elderly is a major issue. The lack of data on octogenarians suggests

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that clinicians should exercise caution when applying the existing data on chemotherapy and targeted therapies for patients aged 7079 years to those aged >80 years. Moreover, the evaluation of promising therapies (immunotherapy such as PD-1/ PD-1L checkpoint inhibitors – nivolumab, pembrolizumab) should continue, with comprehensive analyses of patient selection, efficacy, toxicity, and quality of life. In fact, there are multiple physician-related, patient-related and trial-related barriers in recruiting elderly patients to clinical trials. Furthermore, with an ageing population in Europe, medical oncology is becoming geriatric oncology, hence the criteria for recruitment of the elderly to clinical trials should be carefully reconsidered. References: 1. Maione M et al. Ther Adv Med Oncol 2010; 2 (4): 251-260. 2. Blanco R et al., Annals of Oncology, 2015; 26 (3): 451-463. 3. Dawe DE and Ellis PM, Frontier in Oncology 2014; 4: 174. 4. Zhu J et al. JAMA 2012; 307: 1593– 1601. 5. Lin CC and Yang CH. Targ Oncol 2009; 4: 37–44. 6. Unger JM et al. J Clin Oncol. 2006; 24(1):141–144. 7. Shenoy P and Harugy A. Perspect Clin Res 2015; 6 (4): 184-189.


HEALTH REPORT

Urgent policy action needed to tackle the burden of lung cancer In Lung cancer, urgent action is needed at the policy level. Roche supports opportunities for broad collaboration in the area, involving policy makers, professional societies, healthcare professionals and patient organisations.

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ung cancer is the most common form of cancer worldwide with three people dying from this disease every minute. (1) It accounts for 15% of overall cancer costs in Europe (€18.8 billion), causing the largest loss in productivity of all cancers. (2) Despite recent advances in treatment and care, five year survival rates remain low in Europe (13%). (3,4) Seventy-seven percent of patients are diagnosed with lung cancer at an advanced stage, when their survival chances are lower.(5) In addition to this, diagnosis and treatment pathways vary significantly from country to country, leading to differences in outcomes and survival rates. (6) Focusing specifically on the patient journey, the challenges are numerous. Many patients leave the treatment pathway before getting the right help. Public perception of lung cancer is that it is a self-inflicted disease, due to its association with smoking. This creates stigma which can isolate patients and prevent them from seeking timely help. Given the significant burden, the opportunities presented by a greater understanding of genetics, and the ability to produce more targeted therapies, so much more can and should be done to support people living with lung cancer. Lung cancer treatment is becoming increasingly sophisticated and accurate, new agents have transformed the disease to give significant life prolongation and improve quality of life. Identification and targeting of ALK and EGFR mutations being particular cases in point and with immune therapy, may even transform it into a chronic disease. Over the next few years there will be a field change in diagnosis to much better accuracy, targeting the actionable mutations, via next generation sequencing - allowing

the right patients to be treated with the right medicine and avoiding the side effects of chemotherapy wherever possible, thus bringing benefits to patients and healthcare systems. Advances like these, that improve patient outcomes and reduce hospitalisations could offset some of the economic burden associated with the disease. Research and development of innovative treatments and supporting educational efforts to reduce barriers to patient access, are all essential measures to help patients at every stage of their journey. The destructive force of lung cancer for individuals and societies and the systemic nature of the challenge is such that not one group or organisation can bring about positive change on their own. For change to happen, urgent action is needed at the policy level. Roche supports opportunities for broad collaboration in the area, involving government bodies and other policy stakeholders, professional societies, healthcare professionals, and patient organisations.

4. Support research to better understand the socio-economic aspects of lung cancer treatment and identify how current reatment pathways can be improved to make full use of new diagnostic and treatment technologies; 5. Ensure flexibility in regulatory pathways and sustainable funding mechanisms to encourage R&D innovation and 6. Improve the coordination of services from patient presentation to treatment to reduce the amount of patients that give up hope and drop out of the treatment pathway. About Roche: Roche, the world’s largest biotech company, is a world leader in the development of medicines for oncology, in vitro diagnostics and tissue-based cancer diagnostics. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them numerous life-saving cancer medicines. References:

Working together to take policy action, governments and other stakeholders should:

1. GLOBOCAN. Cancer Factsheets: estimated incidence, mortality and prevalence worldwide in 2012. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx Last accessed November 2016.

1. Raise awareness of the advances in knowledge about lung cancer: Lung cancer can take many forms. Novel treatments can provide new opportunities, following timely diagnosis;

2. European Union: a population-based cost analysis. Lancet Oncol. 2013;14:1165-74.

2. Update policy frameworks such as national cancer strategies and/or action plans to reflect the patients’ need for timely diagnosis; 3. Make the most of new technologies that support improved diagnosis and new treatment opportunities, including combination therapies;

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3. National Cancer Institute. SEER Stat Fact Sheets: Lung and Bronchus Cancer. Available at: http://seer.cancer.gov/ statfacts/html/lungb.html 4. Aggarwal A, Lewiston G, Idir S, et al. The State of Lung Cancer Research: A Global Analysis. Journal of Thoracic Oncology. 2016;11(7):1040–1050 5. Cancer Research UK. Lung cancer incidence by stage at diagnosis. 2013. Available at: http://www.cancerresearchuk. org/health-professional/cancer-statistics/statistics-by-cancertype/lung-cancer/incidence#heading-Five 6. Allemani C, Weir HK, Carreira H, et al. Global surveillance of cancer survival 1995-2009: analysis of individual data for 25,676,887 patients from 279 populationbased registries in 67 countries (CONCORD-2). Lancet. 2015;395:977-1010.


BREAKING THE BARRIERS OF PERSONALISED MEDICINE

Relevance of policy in shaping personalised medicine and tackling lung cancer

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Recent advances in personalised lung cancer medicine can dramatically change an entire treatment paradigm.


HEALTH REPORT Policymakers have a significant role to play in bringing about a Europe in which personalised medicine, in all its forms, can be integrated into healthcare systems. Denis Horgan, Executive Director, European Alliance for Personalised Medicine, argues that a lot remains to be done to help Europe realise the promise of personalised medicine

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ersonalised medicine is changing the way we look at and respond to cancer. The concept of personalised medicine is not new. It has already emerged in the here-and-now, and its influence is growing everyday. This exciting change relies on new technologies (genomics etc), Big Data and better-targeted clinical trials, among other aspects, in order to deliver the right treatment to the right patient at the right time. Lung cancer is the leading cause of cancer related deaths throughout the world, and treating the patient with therapies that are predicted to be effective based on the molecular characteristics of the tumor, can certainly add years of life for those patients whose tumor harbour specific abnormalities. Recent advances in personalised lung cancer medicine can dramatically change an entire treatment paradigm. However, there are several practical barriers in realising the full potential of personalised medicine, and policymakers have a cruicial role to play in overcoming these barriers in order to kick-start a new wave of cancer treatment. There is a need for more research, education programmes, incentives for innovators and, not least, better regulation and commonly accepted (and widely implemented) best practices. While it is true that healthcare remains a member state competence, the EU as a whole is becoming more involved in various aspects (legislation, clinical trials, crossborder healthcare, data protection and more) which, theoretically at least, span all 28 EU countries. Product approval, for example, through MAPPS (Medical Adaptive Pathways to Patients) is aimed at getting innovative treatments/medicines onto the market much more quickly than has been the case, in order to potentially save lives. But the EU cannot act alone, member states have to adapt, take a look at their Health Technology Assessment/approval procedures and collaborate much more with their fellow EU countries across borders in many spheres, including the sharing of knowledge

and research (to avoid duplication, and the pooling of Big Data). It is evident that the EU, in tandem with member states, needs to ensure the proper transposition of its legislation and policies regulation at a national level. More work needs to be done on agreeing treatment guidelines, and encouraging their implementation, quickly and effectively. All member states look at healthcare from a different angle, sometimes due to wealth (or lack thereof ), a high (or, indeed low) incidence of a particular disease or diseases in its population, the cost of pharmaceuticals, cross-border payments to patients, the strength of patient advocacy and more. There are often many more differences within the regions of the larger nations. Clearly, optimal treatment is not being offered in every country and the above are only some of the reasons. Ineffective or non-existent cross-border collaboration, meanwhile, only adds to the barriers to access for patients. So what should policymakers address to fulfil the vast potential of personalised medicine? Innovation is key to progress. As things stand, there is a surfeit of incentives to promote investment in developing diagnostics. Experts note that coordinated timing when it comes to reimbursement and approval of a companion diagnostic is essential. On top of this, the transferring of technology and public health assessments differ from state-to-state. The translation of research is another key issue. This affects both treatment once a disease has been discovered and, importantly, prevention - with all the cost savings that go along with the latter, not to mention continuation of the best quality of life. Translating cutting-edge research effectively in the arena of personalised medicine will save lives and lower costs.Education is another vital cornerstone. Policymakers should fully understand the needs of modern-day patients and how personalised medicine has the potential to change healthcare for the better. They must be aware that it is vital to develop training for healthcare professionals (HCPs) whose disciplines are essential to the successful

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development of personalised medicine. Therefore, what is required is a long-term approach to education, to facilitate all healthcare professionals in close contact with patients and their families to remain up-todate with all current aspects of personalised medicine and its latest breakthroughs. From a policymaking and regulatory perspective, European healthcare has reached a point where clear, harmonised rules and guidelines have to be in place. But, none of the above can be successfully achieved without the involvement of all relevant stakeholders. These include patient groups, academics, researchers, IT professionals, industry representatives, health care professionals, HTA bodies from the EU 28, the EMA and, of course, policymakers and payers. Policymakers at both EU and national level (European Commission, Parliament, Council and Member State health care payers) have a significant role to play in bringing about a Europe in which personalised medicine, in all its forms, can be integrated into national healthcare systems, via the sharing of data, cross-border collaboration in research projects, exchanging of best practices, and a seismic shift from a silo mentality, not only in the main cross-disciplinary fields but within single disciplines. The EU cannot, as it stands, assume responsibility for all healthcare systems across Europe, but it can certainly recommend (as did the breakthrough Luxembourg Council Conclusions on Personalised Medicine) in the areas over which it does not have legal competence. In order to make this possible, policymakers must thoroughly understand all the issues affecting access to personalised medicine. This would go a long way in opening the door for a new form of treatment that will bring better and longer lives to many patients across Europe’s borders.


BRIDGING THE CLINICAL GAP

Illumina Launches TruSight Tumor 170

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Illumina’s newest addition in clinical cancer research portfolio aims to establish a standardised method for tumor profiling

llumina, Inc. has launched TruSight® Tumor 170, a 170 gene next-generation sequencing solution to support the transformation of the tumor-profiling paradigm from a series of single-gene tests to a multi-analyte approach, providing a more thorough picture of a tumor’s genomic landscape. TruSight Tumor 170 offers an integrated DNA and RNA enrichment-based workflow, targeting cancer-related genetic aberrations, including small variants, gene amplifications, gene fusions, and splice variants. With optimised bioinformatics tools and automation options, laboratories can implement the assay on an in-house, research use only NextSeq® instrument. Designed to support limited nucleic acid input from formalin-fixed, paraffin-embedded (FFPE) samples, TruSight Tumor 170 facilitates efficient evaluation of biomarkers.

This new assay is poised to help realise the potential of precision oncology. By integrating DNA and RNA into one protocol, clinical researchers are able to accelerate comprehensive analysis of cancer-related variants and maximise the data obtainable from precious specimens. Looking forward, Illumina aims to deploy the underlying assay method at the heart of TruSight Tumor 170 as a universal standard for optimised tissue assessment across a variety of applications with both fixed and customisable panels. TruSight Tumor 170 offers broader investigational power: • Enrichment-based assay that evaluates DNA and RNA in one integrated protocol • 170 unique genes informed by partnering pharmaceutical companies, academic community leaders, and industry guidance

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• Integrated workflow requires only 40ng of DNA and RNA from FFPE samples, allowing more comprehensive testing while preserving precious samples • Underlying assay method to serve as a standard for optimised tissue assessment across a variety of applications


HEALTH REPORT

‘Low-dose CT screening best for high-risk patients’ By Prof Mathias Goyen, Chief Medical Officer Oncology, GE Healthcare

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n the European Union, lung cancer is the 4th cancer in incidence with 313,000 new cases per year, but remains the number one killer, accounting to 268,000 deaths per year. Lung cancer represents 21% of all cancer deaths in the EU thereby killing more people each year than breast, prostate, colorectal and pancreatic cancer combined. (1) The overall five-year survival rate for lung cancer is among the lowest (17%) of all types of cancer but is significantly higher when the cancer is diagnosed at an early stage (54%). However, currently only 15% of lung cancer cases are diagnosed at such an early stage.(2) Researchers have continued to seek an effective lung cancer screening tool that might decrease mortality in the way that other commonly accepted screening practices have done for their respective diseases. Early detection with low dose CT can improve prognosis and treatment and reduce mortality rates for patients with a high risk of lung cancer. The landmark National Lung Screening Trial (NLST) was conducted at 33 medical institutions with over 53,000 older, otherwise healthy patients at high-risk due to smoking history. Half of the participants were screened using low dose CT (LDCT), the other half were screened using chest X-ray. The trial demonstrated that the use of low dose CT screening decisively reduced the mortality rate from lung cancer by 20 percent compared to use of chest X-ray. The NLST also revealed a significant 6.7% reduction in the rate of death from any cause using low dose CT screening. (3) The Dutch-Belgian Randomised Lung Cancer Screening Trial (Dutch acronym: NELSON study) was designed to investigate whether screening for lung cancer by lowdose multi-detector computed tomography (CT) in high-risk subjects will lead to a decrease in 10-year lung cancer mortality of at least 25% compared with a control group without screening. Since the start of the NELSON study in 2003, 7155 screened participants were followed up for a median of 8.16 years, during which time 187 (3%) patients were diagnosed with 196 screendetected cancers. In addition, 34 (<1%)

patients were diagnosed with a further 35 interval lung cancers, including 19 patients in the year after screening and 15 patients in the second year after CT. When the results of the first three screening rounds were pooled with a 2-year-follow-up, CT screening was 84.6% sensitive and 98.6% specific for lung cancer detection, with positive and negative predictive values of 40.4% and 99.8%, respectively. (4) Considerations in screening

The challenge with any screening tool is finding a balance between falsenegative and false-positive results. Falsenegative results cause false security in the patient and delay diagnosis of disease that is actually present. False-positive results cause increased anxiety for the patient, as well as increased healthcare costs and exposure to potential risks with further diagnostic procedures. An inverse relationship often exists between false negatives and false positives; a tool sensitive enough to reduce false negatives will increase false positive results.

Many questions surround the concept of LDCT screening for lung cancer. Who should be screened, how frequently, how much will it cost, and how will repeated exposure to LDCT radiation affect patients? GE Healthcare first to receive FDA clearance for Low Dose CT Lung Cancer screening GE Healthcare is the first company with a low dose computed tomography (CT) lung cancer screening option that is cleared by the U.S. FDA for lung cancer screening. Both the U.S. Preventative Services Task Force (USPSTF) and the Centers for Medicare and Medicaid Services (CMS) recommend the use of low dose CT lung cancer screening for high-risk individuals. Additionally, Medicare has approved insurance reimbursement for its beneficiaries who are eligible for the use of low dose CT lung cancer screening in high-risk patients. Early detection from an annual lung cancer screening with low dose CT in high-risk persons can prevent a substantial number of lung cancer–related deaths. Physicians using low dose CT for lung cancer screening will now have access to the benefits from a screening

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Physicians using low dose CT for lung cancer screening will now have access to the benefits from a screening indication, including GE Healthcare’s new low-dose screening reference protocols.

indication, including GE Healthcare’s new low-dose screening reference protocols. These new protocols are tailored to the CT system, patient size, and the most current recommendations from a wide range of professional medical and governmental organizations. Now, qualified GE Healthcare CT scanners can be confidently used by physicians within their FDA cleared indications for use, delivering low dose, short scan times, and clear and sharp images for the detection of small lung nodules. These nodules are critical in identifying lung cancer at its earliest stages when it is the most treatable and curable. References: 1. The World Health Organisation 2. American Cancer Society. Cancer Facts and Figures 2015. 3. Reduced lung-cancer mortality with lowdose computed tomographic screening. N Engl J Med. 2011;365(5):395-409. 4. Detection of lung cancer through low-dose CT screening (NELSON): a prespecified analysis of screening test performance and interval cancers. Lancet Oncol. 2014 Nov;15(12):1342-50


BATTLINGLUNG CANCER IN EUROPE

Healthcare stakeholders join hands to fight lung cancer

By Arvind Venkataramana, Research Director, International Centre for Parliamentary Studies

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he 2016 Lung Cancer Europe Roundtable organised by the International Centre for Parliamentary Studies took place in Brussels on Tuesday, 27th September. Members of the European Parliament, senior representatives from the World Health Organisation and European Commission, medical and clinical experts, NGOs, patient groups and other key stakeholders attended the roundtable to examine the ongoing challenges in managing lung cancer more effectively and explore practical solutions in order to reach an EUwide consensus and implement a forward action plan. Here are some key themes, outcomes and recommendations put forward by the group to the European Parliament, the European Commission as well as the member states. The European Parliament viewpoint The European Parliament’s viewpoint was delivered by Dr. Therese Comodini Cachia MEP, who is a part of the European Parliament’s interest group, MEPs Against Cancer (MAC). Dr.Cachia highlighted three points which she felt were crucial in the fight against lung cancer. First, patients should be the focal point in the diagnosis and treatment of lung cancer. Often, decisions about their treatment are made by their doctors with limited consultation with

patients and their families. This can have a negative effect on the patient’s wellbeing. Therefore, more needs to be done to ensure patients are part of the decision making process. Secondly, the onus of driving new research should not just lie with the European Commission or the European Parliament – member states should take greater responsibility and initiative in improving funding. Thirdly, the treatment of lung cancer should be holistic – we need more hospices to improve the quality of life of patients. The World Health Organisation viewpoint Dr. Marilys Corbex, Technical Officer – Regional Office for Europe at the World Health Organisation made a short presentation on the current state of affairs and offered recommendations to policy makers. She laid emphasis on the role of tobacco in lung cancer, the importance of screening and the need to improve personalised medicine. The ECCO viewpoint The third viewpoint of the roundtable came from Françoise Van Hemelryck, Patient Affairs Manager at the European CanCer Organisation (ECCO). ECCO’s vision is to improve the outcomes for cancer patients in Europe through multidisciplinarity. She stressed the need to bring a more rounded and multidimensional approach to screening,

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diagnosis and treatment of lung cancer. European Commission viewpoint Dr. Jan-Willem van de Loo, Scientific and Policy Officer in charge of cancer at the Directorate E – Health Research, DG Research and Innovation shared the European Commission’s viewpoint. He shared the latest developments in research funding and provided an update on Horizon 2020 as well as the European Commission’s areas of focus in lung cancer. He mentioned that nearly 500 million Euros has been spent between 2014 and 2016 on cancer research with about 62 million Euros spent towards 46 lung cancer research projects. The Commission’s focus for the near future is on reducing risk factors, education, molecular pathogenesis, biomarkers, investigator-driven clinical trials, furthering research on ‘quality of life’ among other areas.


HEALTH REPORT

Where should EU act? The ICPS Lung Cancer Europe Roundtable 2016 aims to put forward recommendations and proposals to key policy makers in the EU from different stakeholder perspectives. Here are some of them:

1.

2. 3. 4.

Member states should encourage the sharing and consolidation of existing resources in research, clinical trials, treatment methodology, education and risk management; The ban on smoking is just a starting point in a series of preventative measures that member states and the EU should take to reduce the number of lung cancer cases; The care received in different member states should be consistent; Professional care has been neglected and more needs to be done to support it;

5.

Approval of drugs needs to be made more dynamic. Resources should be allocated towards the assessment of information that is flowing at a very fast pace through the European Commission;

6.

The danger of delays could result in cutting edge technologies and drugs not being available to the patients that need it the most; Collaborative initiatives need to be driven by member states and encouraged by the European Commission; There has to be constant dialogue between clinicians, policy makers, patient groups and pharmaceutical companies; One of the areas that is lacking adequate funding is the training of young physicians in order for them to record early symptoms of lung cancer; High quality screening for patients should be consistent across all member states, which currently is not the case;

7. 8. 9. 10. 11. 12. 13. 14. 15. 16.

Lung cancer needs more research funding from the cancer research pool; Preventative measures need to be the primary focus – smoking bans should come into effect in countries where it has not been adequately limited/banned; Harmonisation of testing remains key and should be done through certification; The number of existing studies on lung cancer have to be consolidated as there are far too many closely related research projects in the EU; More data and information is required on molecular testing – there is still uncertainty over its cost/benefits Improving the quality of life for patients and their families should be the end goal.

Delegates at Lung Cancer Europe Roundtable 2016

For more information about the topics that were discussed this year, please email information@parlicentre.org. For details about the next edition of the Lung Cancer Europe Roundtable, please visit www.lungcancer.parlicentre.org

Medical Director Immuno-Oncology, Europe, AstraZeneca, Pulmonary Physician & Thoracic Oncologist, AZ Delta Hospital, Director, Global Regulatory Sciences & EU Strategy and Liaison, Bristol-Myers Squibb, European Lead Policy, Advocacy and Government Affairs – Specialty Care, Bristol-Myers Squibb, Secretary General, Cancer Patients’ Association of Slovenia (ONKO), Head of Research Training and Fellowships, Cancer Research UK, Chair of Lung Cancer Division, Cancer Trials Ireland - Midwestern Cancer Centre at University Hospital Limerick, Global Disease Area Leader, Celgene, Department of Pneumology and Thoracic Surgery Third Faculty of Medicine, Czech Lung Cancer Cooperative Group, Patient Affairs Manager, European CanCer Organisation (ECCO), Director, European Cancer Patient Coalition, Policy Officer on Cancer and Rare Diseases, European Commission, Scientific Officer in charge of the Cancer area of the Unit for Non-Communicable Diseases, European Commission, Public Affairs Manager, European Coordination Committee Of The Radiological, Electromedical And Healthcare It Industry (COCIR), President, European Oncology Nursing Society (EONS), MEP Malta, European Parliament, MEP Romania, European Parliament, Oncology Physiotherapist & Edema Therapist, FysioHolland, Cancer Care Centre Amsterdam, Physical Therapist, Edema Therapist and Oncology Physiotherapist, Cancer Care Centre Amsterdam, Physical Therapist, CT & AW Clinical Leader, Europe, GE Healthcare, Clinical Manager CT, Europe, GE Healthcare, Associate Professor in Pathology, Hôpital Erasme - Université Libre de Bruxelles, Regional Market Manager, Diagnostics, Illumina, Lab Manager and Immunologist, KU Leuven, President, Lung Cancer Europe, VicePresident, Senior Global Clinical Program Head, Novartis Oncology, European Clinical Development Head, Novartis Oncology, Head of Clinical Cancer Research Unit, Oslo University Hospital, Commercial Portfolio Lead, International Developed Markets, Pfizer Oncology, Brand Director, International Developed Markets, Pfizer Oncology, Vice President, Head Franchise Oncology, MDx, Qiagen, Group International Medical Director, Lung Cancer, Roche, International Health Policy Leader, Roche, President, The Danish Cancer Society, Thoracic Oncologist, University of Antwerp, Technical Officer, World Health Organisation

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DEMOCRACY UPDATE

The Future of Elections report, a perspective on elections from world experts By Samira Saba, Integrated Communications Director, Smartmatic technologies to reverse declining participation and arrest the weakening of democracy. “For democracy to thrive, high levels of voter participation are required. Election officials ought to consider new tools like internet-based voting to fully engage younger voters in democracy,” he states. Africa joins the election technology trend

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ast October, the International Elections Advisory Council (IEAC) published The Future of Elections report, a collection of essays offering a unique behind-the-scenes perspective on what it takes to run an effective election. The Future of Elections comes amidst growing evidence of ubiquitous political discontent over democratic institutions, even in some of the most solid democracies. A recent Pew Research Center survey found that across 31 emerging and developing nations, an average of 52% are dissatisfied with their political system. According to Gallup, dissatisfaction with how the U.S. Government works increased from 23% in 2002 to 65% in 2014. Joining efforts to take on 21st century challenges As democracy loses some of its appeal, it follows that people have become disenchanted with elections. This worrisome landscape makes The Future of Elections report all the more relevant. As Lord Mark Malloch-Brown, a former UN Deputy Secretary General and now Chairman of Smartmatic, wrote in the foreword to the report: “Solutions to global challenges such as gender equality, ending poverty, disempowerment or exclusion start at the ballot box. By pooling knowledge, using the cutting edge tools at our disposal and working together, we can play our part in ensuring that voters all over the world are able to hold their governments to account.” Richard Soudriette, Chairman of the IEAC, also sounds a clarion call to modernise election administration and leverage current

Two IEAC members, Dr. Brigalia Bam and Professor Attahiru Jega, provide an interesting look at election administration in Africa in the report. Across the continent, there is rising interest in the use of biometric technology in hopes of curbing one of the most ancient forms of voter fraud and voter impersonation. Nigeria is at the forefront of the trend, along with Zambia and Uganda. Detailing his experience as the head of Nigerian elections from 2010 to 2015, Professor Jega highlighted the benefits biometrics can bring in terms of transparency and credibility of election results. Along those lines, Dr. Bam explains “Over the years these “zip-zip” scanning machines have significantly improved voter verification. In the 1994 elections, the creation of an operation centre where results were electronically received from polling stations was welcomed by political parties, media and civil society organisations.” Enfranchising citizens through technology Enfranchisement is one of the most soughtafter benefits of technology. Although Dr. S.Y. Quraishi, Paul DeGregorio and Charles Lasham have led elections in very contrasting environments, they all reached a similar conclusion: technology will be key to enfranchise citizens in this 21st century. DeGregorio brought a global approach in his essay. Around the world, expatriates and disabled voters are among the most consistently disfranchised groups in democratic nations. He concludes that societies “should recognise that new technology now exists to empower disenfranchised voters, and mandate the use of such technology when public officials drag their feet in serving such voters. The time for using 21st century voting technology and methods is now—and long

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overdue.” With 22 official and 1652 unofficial languages, a territory stretching over 1,269,346 square miles, more than 840 million voters, and a high illiteracy rate, India found in technology a magnificent tool to empower citizens through more efficient elections. Based on India’s successful experience pioneering in election automation, Quraishi concludes: “Technology will rule both in the run up to the vote and at the ballot box itself.” Lasham came up with a different story. Despite the United Kingdom being a beacon for democracy for many emerging nations, turnout and overall citizen engagement have been decreasing at alarming rates in the country. Lasham also hinted at technology as a possible solution to this problem. “Declining turnouts, increasingly mobile populations, diverse electorates and ever more frequent elections demand that the UK’s trusted electoral system adapts and evolves to meet the needs and lives of 21st century voters. If the UK wishes to remain a global leader in the 21st century, then we must think beyond the 19th century that gave us elections using the pencil, the paper ballot and the ballot box.” Technology in Latin America, a single solution for a diverse region Although Latin America made an impressive transition to democracy in the latter decades of the 20th century, the region still faces major challenges, chief of which is efficient election administration. Leonardo ValdésZurita, former President Councilor of the Federal Electoral Institute of Mexico, believes fledgling democracies in the region have much to gain from the use of technological solutions to this and other problems. In conclusion, The Future Of Elections is a must read for government officials, electoral management bodies, and many others who work on the frontline of elections. Around the world, countries are finding different ways to overcome the challenges that new social, political, technological and economic dynamics are imposing on democracy. I invite you to visit thefutureofelections. com and learn from the shared knowledge and experiences of the IEAC members.


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Government Gazette November 2016