Government Gazette: 2018 - Vol 2 by Government Gazette

Government Gazette Vol 2; 2018

£10.00, €11.00 ISSN 2042-4170

Allow your body to do the talking How to create a powerful executive presence

OPINION

EU action against Rare Diseases

Vytenis Andruikaitis ACCELERATING EUROPE’S DIGITAL TRANSFORMATION

Getting behind the connected promise of 5G, AI and autonomous cars

gdpr, fake news and more

Exclusive interview with Commissioner Julian King

inside

GDPR Cybersecurity Cancer control Air pollution Antimicrobial resistance Blockchain Smart cities

Government Gazette

Government Gazette Vol 2; 2018 Managing Editor Arvind Venkataramana editor@governmentgazette.co.uk +44 (0) 20 3137 8655 Commissioning Editor Janani Krishnaswamy janani.krishnaswamy@governmentgazette.co.uk +44 (0) 20 3137 8653 Editor, Performance Supplement Meliissa Gokhool melg@governmentgazette.co.uk Publisher Matt Gokhool matt.gokhool@governmentgazette.co.uk Advertising and sponsorship sales advertising@governmentgazette.co.uk © 2018 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.

08 EU Commissioner Julian King on GDPR, Fake News and more

also inside 10 GDPR & EU data landscape 32 Leading the way Geoffroy Didier MEP questions the data protection regulation

11 Europe’s copyright plan European Parliament votes in favour of copyright reform

12 Need for a 5G roadmap Michal Boni MEP analyses the way forward for the European 5G ecosystem

19 Dying to Work

Rory Palmer MEP fights for new protections for terminally ill workers

20 Event Coverage MEPs express concern over Europe’s chronic digestive disease burden

Antoni Monsterrat Moliner, Former Senior Expert on Cancer and Rare Diseases at the European Commission writes about the Commission’s ambitious efforts

33 Collaboration is key

Supporting the cause of Scleroderma & Raynaud’s UK, James Carver MEP writes about the importance of collaboration in the EU fight against rare diseases

34 Brexit and rare diseases Niall Dickson, Chief Executive of NHS Confederation, says public health must always come above politics

37 Parliament perspective Miriam Dalli MEP says social inclusion should be an integral part of Europe’s rare diseases policy

38 Access to drugs Dr Jasmin Barman-Aksozen, Scientific Advisor, Swiss Society for Porphyria and German Patient Organisation for Erythropoietic Protoporphyria, questions the role of EMA’s data collection in access to treatments

39 Cross-border healthcare Ruth Ladenstein from SIOPE, writes about the ERN for paediatric cancers

40 Future of rare diseases policy 24 Rare Diseases Report Report offers policy recommendations to create new impetus to face emerging challenges

28 Event Coverage ICPS roundtable presents next-gen public health response to Rare Diseases

30 EU action against rare diseases

European Commissioner for Health and Food Safety, Vytenis Andruikaitis offers renewed hope to patients

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36 Economist perspective Economists from the Office of Health Economics make an elaborate assessment of the access deadlock of orphan drugs

Yann Le Cam, CEO, EURORDIS says Europe should create a new impetus to face emerging challenges and ensure no one is left behind

42 EU fight against antibiotics MEPs Karin Kadenbach and Miriam Dalli call for an intensified fight against antibiotics

44 Lung Cancer Report Report offers policy roadmap to improve management of lung cancer

48 Event Coverage Experts urge policymakers to start planning for lung cancer screening

50 Lung cancer screening Dr David Baldwinn lists out the challenges and opportunities of low-dose CT screening for lung cancer

52 International viewpoint Dr Fabrice Barlesi from IASLC calls for low-dose thoracic CTscan screening

55 State of prevention Dr Mary O’Brien and Anna Minchom from Royal Marsden Hospital assess the state of lung cancer prevention and treatment in Europe

56 Quality of care Prof Jan Bussink and Dr Anne-Marie Baird write about how we can improve the quality of lung cancer care across Europe

57 Innovation in European healthcare Denis Horgan from the European Alliance for Personalised Medicine analyses why it is needed and where it is going

contents ON THE WEBSITE

Up close and personal with MR. GDPR

22 Interview with founder and CEO of EuropaColon

European Data Protection Supervisor Giovanni Buttarelli in an exclusive interview about everything relating to the new regulation on personal data

14-15 Commentary: EU Blueprint on Artificial Intelligence ‘GDPR is not about fines. It’s about putting the consumer first’

62 Allow your body to do the talking

Elizabeth Denham, UK’s Information Commissioner, reaffirms that the GDPR (General Data Protection Regulation) is an evolutionary process that seeks to put power back in the hands of individuals

58 Environment Bulgarian Minister for Environment and Water, Neno Dimov says iIt’s time to reconsider our approaches to solving issues related to air quality

61 Blockchain for elections Is blockchain really the ‘silver-bullet’ for election integrity that many claim it to be?

66 EU fight against prostate cancer What should the EU do differently to reduce the mortality of prostate cancer?

EU’s plan to ditch throwaway plastics

16-17 Connected cars

Maja Bakran Marcich, Deputy Director General, DG MOVE, at the EuropeanCommission writes about EU strategy on connected and driverless cars

70 Event Coverage

New EU laws to reduce throwaway single-use plastics, expected by the end of May, can slash pollution and drive exciting new production and consumption systems, writes Meadhbh Bolger from Friends of the Earth Europe

ICPS roundtable on prostate cancer sets agenda for change

72 UK perspective Angela Culhane wonders if the case for prostate cancer screening is changing in the UK

Europe’s action against air pollution

76 Prostate cancer management Prof Hein van Poppel elaborates on EAU’s vision for prostate cancer policy

82 Building tomorrow’s smart cities Carlos Zorrinho MEP writes about the European Parliament’s initiatives to promote the development of smart cities, smart services and products.

60 Cryptocurrencies Sirpa Pietikainen MEP says blockchain carries potential for the financial sector, but risks need to be monitored

President Juncker likes to talk about ‘a Europe that protects’, but when it comes to air pollution we seem to be suffering from ‘a Europe that’s small on the big things’. Margherita Tolotto, Policy Officer for Air and Noise at the European Environment Bureau, says now is the time to act

Government Gazette | 03

editorial view

Government Gazette, Vol 2, 2018

Janani KRISHNASWAMY

Commissioning Editor, Government Gazette

Accelerating Europe’s digital transformation

echnology permeates almost every aspect of our lives and is having a profound impact in our economy and society, transforming products, processes and business models in every industry from construction, healthcare and agriculture to tourism and media. This will transform how citizens interact with their governments, revolutionize industries and change the way we communicate with one another. Europe is on the cusp of an extraordinary technological transformation. Accelerating the transformation of European industry, policymakers at Brussels are currently enacting regulations to persuade investment in digital infrastructure and encouraging demand for digital services.

Before AI gets to the point of threatening humanity and becomes a superhuman tech, we should build clear rules to ensure that robots serve human interests at all times. The EU has the duty to stay united and defend our values by taking the lead. Rightly so, Europe’s secret weapon in the race against China and America is ethics. Ethics forms the nucleus of EU’s AI strategy unveiled in April 2018 by a team of European Commissioners under the supervision of Commission Vice President Andrus Ansip. In our current edition, Mady Delvaux MEP and EESC’s AI Rapporteur, Catelijne Muller write about the ethical debate around AI.

While a paradigm shift to digital is well underway, this summer we’ve taken a closer look at some of the most noteworthy digital transformation trends and interconnected regulations, including those relating to General Data Protection Regulation (GDPR) — the draconian data protection regulation, the controversial copyright reform, artificial intelligence (AI), connected vehicles, the state of 5G infrastructure that could potentially make connected mobility a reality, blockchain technologies and cybersecurity.

Over the past four years, the Juncker Commission actively supported the deployment of connected and automated cars, in an attempt to bring down the number of road fatalities, control harmful emissions and reduce congestion. Later this year, the Commission will propose a new legislation on what technological solutions can be used to underpin connected cars that are brought onto the market in Europe. Maja Bakran Marcich, Deputy Director-General, DG MOVE, offers a curtain raiser of the upcoming legislation. Let’s make sure connected mobility fully benefits from the 5G era.

GDPR calling In May, Europe’s new General Data Protection Regulation took effect. It required companies to notify users across Europe of pending changes to privacy policies and affirm consent to data collection practices. The arrival of GDPR meant huge penalties for data loss. Just three months after GDPR came into force, Europe witnessed a spike in the number of data violations. Tech companies, banks and ad tech firms are among the worst hit. Shortly after Facebook’s revelation and the shutting down of Cambridge Analytica, electoral integrity and disinformation gained paramount importance in the EU policy agenda. We caught up with Julian King, EU Commissioner for the Security Union, to learn about EU’s efforts against data breaches, fake news and manipulation. He campaigns for stricter regulations on how personal information can be collected and used for political purposes and reassures the role of GDPR in supporting data security. Leaving aside GDPR, we also looked at one other regulation that might prove to be a complete disaster for the internet — the controversial ‘internet-wrecking’ copyright law that ignited a major dispute between internet giants and content creators. Regulating AI in the era of big tech “Alexa, what’s the weather like?” Siri, call my mother.” “Cortana, turn off the light.” These are just a few commands that I said to my AI devices today. Virtual assistants are clearly becoming the norm. AI is turning mainstream. Beyond making our lives easier, AI is helping us resolve some of the world’s greatest challenges: from treating chronic diseases or reducing fatalities in traffic accidents to fighting climate change or anticipating cybersecurity threats. AI has grown so ubiquitous — owing to advances in chip design, processing power, and big-data hosting — that we barely notice it. www.governmentgazette.eu | 04

The connected promise of 5G, AI and autonomous cars

Blockchain finds its way Blockchain is poised to disrupt industries and departments from banking to HR. The tech is expected to improve traceability and security of online transactions. In our current edition, Sirpa Pietikäinen MEP writes about the promising tech and calls for a pre-emptive regulatory approach to monitor emerging risks. Are innovations accessible? AI is getting increasingly sophisticated at what humans can do, with the tech now used to detect cancers and rare diseases at early stages. On one hand, there’s a world where not a single day goes without a new innovation. On the other hand, there’s a wide spectrum of disease severity and control. In our current edition, we reflect on the progress made toward conquering rare diseases and recognise the continued unmet medical need for these devastating, complex conditions. In our exclusive coverage on rare diseases, Vytenis Andriukaitis, EU Commissioner for Health and Food Safety writes about the Commission’s ambitious efforts and explains how European Reference Networks offer renewed hope to patients with rare diseases. While getting the latest updates from the Brussels policy circle, don’t forget to catch up on our tips on how to create a captivating charisma. We’ve got world-renowned body language expert, India Ford to offer subtle adjustments to our bodies in order to instantly create a radiating ‘executive presence.’ Let her be your coach

MEPs earn millions in outside earnings

MEPs with biggest side jobs: (left to right): Renato Soru, Antanas Guoga, Guy Verhofstadt, Renaud Muselier, Rachida Dati, Nigel Farage, Daniel Buda, Jean-Luc Schaffhauser, Bogdan Brunon Wenta and Remo Sernagiotto BRUSSELS NEWS DESK early 60% of MEPs have paid side jobs, with up to 30 parliamentarians earning more from outside jobs than their existing EU salaries, according to a recent study published by the NGO, Transparency International EU.

In total, 751 MEPs have declared 1,366 activities, representing a 13% increase from the beginning of their mandates. Thirty-five MEPs have earned over €100,000 on top of their official salaries as MEPs. Paid outside activities have been particularly prevalent among French MEPs. Taken together, they have earned €4.8 million since 2014, more than double the figure for any other country. Belgium takes the top spot in regards to the share of its MEPs declaring income (62%) and a single Estonian MEP declared an income of €14 over the course of a four-year mandate. Outside incomes are particularly high among members of the Europe of Nations and Freedom (ENF), which has the highest share of its members (54%) declaring paid activities. Notably, United Kingdom Independence Party (UKIP) member Nigel Farage and Front National member Jean-Luc Schaffhauser have both increased their income by over €200,000 per year over the course of their mandate.

The ethics system within the European Parliament seems particularly weak in comparison with international best practice. “Moonlighting” — the practice of having a second job — is relatively common among politicians in democracies. Unlike in the United States, where Members of the US Congress are not allowed to have paid outside activities where a monetary relationship is established, having side jobs — if and when properly declared — is allowed within the European Parliament. The high incomes are particularly worrisome, as there is hardly any mechanism to trace where the outside revenues are coming from. “Ethics oversight remains weak,” the study says, citing MEPs who have failed to declare trips paid for by foreign governments. Shockingly, the Parliament has no access to tax records and does not even consult publicly available information from similar declarations to national authorities. Furthermore, as the report notes, “not a single MEP has been sanctioned for failing to declare income or for making erroneous declarations.” Commenting on the revelations of the report, the European Parliament’s rapporteur on transparency, accountability and integrity, Sven Giegold MEP,

said: “The fact that some MEPs earn so much in addition to their daily work is worrying for European democracy. In five years, there were 24 violations of the Code of Conduct for MEPs, but absolutely no sanctions for those violating the rules — this shows that the current selfregulation by the MEPs is not working.” Adding a word of caution, he noted that: “It’s high time for an independent ethics committee to enforce the rules. Parliament’s rules need to be tightened to ensure that MEPs work in the interests of their constituents rather than lobbying their colleagues for money. MEPs must disclose who is employing them, even if they are lawyers.” In order to strengthen the ethics system ahead of the 2019 European elections, Transparency International EU recommends to swiftly “enforce a ban on lobbying activities for sitting MEPs, improve the information that is provided in the declarations — including on clients and topic areas worked on — improve monitoring of declarations by cross-referencing EP’s declarations with other sources of information and establish an independent body to investigate and sanction violations.”

BRUSSELS ROUND-UP

Transparency Report

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Government Gazette Brussels News Round-up

UPCOMING EVENTS SEP Promoting an Inclusive Europe: 7 Supporting the Effective Integration of

non-EU Migrants

MEPs propose measures to combat mobbing and sexual harassment

The draft report underlines the urgent need for member states, local authorities and trade unions to understand the barriers that women face in reporting cases of sexual harassment in the workplace and to offer them full support to report these cases safely, without fear of possible consequences.

“

The #MeToo movement has shown the world how big and widespread the phenomenon of sexual harassment and mobbing is, including in public and work spaces,” says EP rapporteur Pina PiciernoMEP (S&D, IT). “With this report we ask the EU Commission to act at the European level, starting by proposing a clear legal definition of what sexual harassment

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OCT Symposium on the Future of Sustainable 9 Agriculture in the EU:

Assessing the Role of Pesticides and Biocides

OCT Reducing Drug Supply and Demand in the 18 EU: Developing a Holistic and Coordinated

Response Across Member States

OCT Protecting Migrant Children and 24 Unaccompanied Minors in the EU:

Developing a Coordinated Approach to the Emerging Crisis

NOV Reinforcing Cyber Security in the EU: 6 Building Coordinated Security, Confidence

and Capability in the Cyber Domain

NOV Boosting the Electric Vehicle Market: 29 Towards a Greener and More Sustainable

European Transport System

©Image: Freepik

BRUSSELS NEWS DESK n the context of the public debate prompted by the Weinstein scandal and the #MeToo campaign, members of the European Parliament’s Gender Equality Committee recently proposed measures to combat mobbing and sexual harassment within Europe.

SEP Assessing the EU Common Fisheries Policy: 12 Stepping Up Efforts Towards Sustainability

MEPs call on EU countries to tackle illegal trade in pets

is, stressing educational strategies and tackling the dramatic phenomenon of online harassment. Failing to do so would mean ‘tolerating’ mobbing and harassment and leaving women even more alone.” MEPs call on member states to encourage workplace policies based on prevention, confidential procedures to deal with complaints, and tough and dissuasive sanctions for perpetrators. All political parties should tackle sexual harassment by revising party rules to introduce a zerotolerance policy and sanctions for perpetrators. MEPs also urge national and local parliaments to fully support victims, investigate cases, maintain a confidential register of cases and ensure mandatory training for all staff and members on respect and dignity. Finally, awareness-raising campaigns and education at every level are fundamental tools in helping address gender-based violence in public spaces

©Image: Freepik

BRUSSELS ROUND-UP

Brussels, Belgium

BRUSSELS NEWS DESK he European Parliament’s Public Health Committee recently called for a series of measures to clamp down on illegal trade in pets.

Identifying and registering cats and dogs is a crucial and necessary step in combating their illegal breeding and trade, often in terrible conditions, says the committee. MEPs stress that much of this illegal trade crosses borders, therefore good cooperation between EU countries is urgently needed to break up criminal networks. The EU Commission should table measures to ensure that the national databases used to identify and register cats and dogs are mutually compatible and linked through an EU platform. The EU should develop breeding guidelines for pets, and member states should be encouraged to set up a register of authorised pet breeders and sellers, say MEPs

European Parliament creates first-ever joint fund to finance defense equipment BRUSSELS NEWS DESK

or the first time, members of the European parliament approved plans to support the joint development of military equipment and technologies.

capabilities. Also, for the first time, collaborative projects in defence technology, such as the development of marine surveillance drones, might be co-financed directly by the EU.

Rapporteur Françoise Grossetête MEP (EPP, FR) said: “This programme is a historic step forward for European defence industrial projects and responds to three challenges: budgetary efficiency, competitiveness and strategic autonomy. We have achieved in one year of negotiations a promising regulation to improve the innovation capacity of the EU.”

Under the new proposal, €500 million would be allocated from the EU budget for 2019/2020 to co-finance the joint development of new defence technologies and equipment.

Over the last two decades, the move toward cooperation has intensified and Pesco is the latest initiative to jointly develop European military

For the next long-term EU budget, 2021–2027, a European Defence Fund of €13 billion has been proposed to fund military development and research activities, while a €90-million research test programme for 2017–2019 has already been started. The development of defence products is required to be

carried out by a consortium of at least three companies established in at least three EU countries in order to be eligible for funding by the programme, while products prohibited by international law are excluded from funding. According to data presented by the European Parliament, the EU wastes as much as €26.4 billion ($30.75 billion) on defence every year due to “duplication, overcapacity and barriers to defence procurement.” More than half of Europe’s defence budget, which is equivalent to some 35% of the US defence budget, is spent on military staff, while investments in military research and development are 10% lower in relative terms than in the US ADVERTISEMENT

Commissioner Julian King presses tech groups to tackle disinformation

Campaigning for stricter regulations on how much information can be collected for political purposes and how it’s used, Sir Julian King, European Commissioner for the Security Union, says internet platforms have a vital role to play in tackling disinformation. In an exclusive interview with Government Gazette, he explains the European Commission’s efforts in the fight against disinformation and fake news

he internet has become fundamental to our daily lives. Almost every area of society —whether private or public — heavily relies on the internet, computers and online data. From transport infrastructure and hospitals to businesses of all sizes, we depend on the benefits which flow from this digital revolution. It’s not just about computers and phones that are connected — the news we read, the social lives we lead, the cars we drive are all shaped by the internet.

The recent Facebook/Cambridge Analytica revelations have demonstrated exactly how personal data can be exploited in electoral contexts, and are a timely reminder that more should be done to secure resilientdemocratic processes. While the General Data Protection Regulation (GDPR) that came into force on May 25th 2018strives to fight against data breaches, the European Commission is taking steps forward in the fight against disinformation and to ensure the protection of European values and security.

Whilst there are numerous benefits, there’s an adverse side to it too. Speaking exclusively to Government Dependence breeds vulnerability. Gazette, Julian King reiterated the The digital world carries considerable role of GDPR in supporting data potential to do good but also harm.

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security and called for action against internet companies that harvest personal data. Given that GDPR potentially offers data subjects the right to be forgotten, it will now allow criminals to easily erase their digital footprints. Will GDPR prove counterproductive for national security and intelligence gathering? No, that’s not the objective of the exercise, and that’s not what we are expecting. GDPR is important for all the reasons you know but it is part of a series of measures we are taking, including the related data protection directive for police and criminal justice authorities.

“The weaponisation of online fake news and disinformation poses a serious security threat to our societies. The subversion of trusted channels to peddle pernicious and divisive content requires a clear-eyed response based on increased transparency, traceability and accountability. Internet platforms have a vital role to play in countering the abuse of their infrastructure by hostile actors and in keeping their users, and society, safe.” Together, these different building blocks make it clear that, with all the provisions for protecting data rights, there is still a possibility to take action; to prevent, investigate or prosecute criminal offences. There is provision for preventing threats to public security. Restrictions to achieve those objectives are provided for. Of course, they have to be necessary — proportionate. Whilst normal people will get protection, law enforcement authorities will still be able to frustrate, detect and prosecute criminals. After the recent Facebook scandal and the shutting down of Cambridge Analytica, data protection, electoral integrity and disinformation have all become ever so important. There’s a need to build up our society’s resilience to cyber-enabled behavioural manipulation. How does the Commission plan to deal with the problem of fake news without undermining freedom of expression and publishers’ rights? The European Commission published a set of proposals to counter behavioural manipulation and fake news, demanding greater transparency from those who use them to micro-target messages at individuals. There has been a sense that it is just not possible to create more accountability, transparency and traceability online without falling into the trap of censorship. But recent events are forcing us to look again at what could and should be done. We can and should take steps to tackle the cyber threats to our digital democracies without undermining the values we stand for — free speech and critical debate. Indeed, we need to take action to protect those values or we might just wake up one morning to find that they have been critically undermined.

On one hand, we need to support and strengthen legitimate sources of information so that they are not drowned out by the noise made by fake news. On the other hand, we need to reduce the fertile soil disinformation often falls upon by encouraging greater critical thinking on a bigger scale. We are currently working with social media platforms and tech companies to promote greater transparency, traceability and accountability for news feeds so that people know more about what they are seeing on their social media feeds. Users should know who has created the content they are seeing, who might gain from it, and why it is being shown to them. We are working with these tech platforms to create a “code of practice on disinformation” that will potentially make it easier for users to know whether material they are seeing is sponsored, paidfor or promoted and whether it is coming from bots or real people. We also hope that this will allow users to ask questions about how their news feeds are built and assist in factchecking. The platforms also need to provide real transparency on sponsored content, such as the identity of the sponsor and the amount they have spent, clearly marking sponsored content as such to differentiate it from other content. This is particularly important with political content and during electoral campaigns. And it would help limit the possibilities for using mined personal information to push and amplify certain messages, especially political ones. Given that the EU has stepped up its campaign to counter disinformation and fake news from Russia by spending more than €1million a year on its specialist anti-propaganda unit, can you elaborate how the

taskforce is drawing up plans on how to spend the unprecedented cash injection? The European Parliament and the Council has urged us to boost funding, which we are very happy to do. Over the last couple of years, the Stratcom taskforce has catalogued over 4,000 examples of disinformation and patterns of stories, including 31 different disinformation narratives around the chemical attack in Salisbury and 57 different narratives about the MH17 disaster. This systematic attempt to misinform and confuse people needs to be taken very seriously and we therefore the support the efforts of this team to try and map this activity and bring it to public attention. With the extra funding, we also hope we can work with them and their network of contributors and fact-checkers to make sure that we are getting the highest standards of translations. Can you elaborate on the Commission’s efforts to ensure transparency about sponsored content, particularly political advertising? Transparency is a key part of our efforts. We want people who are using these platforms to be able to find out more the about materials they are being shown. The other thing we are going to do relating to that is to continue to support the development of a network of fact-checkers who look at news feeds and who can produce reports on the sources of material on social media feeds. We hope they will help us develop a fair, objective and reliable set of indicators for measuring the amount of transparency in news feeds

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data protection

More than two months into GDPR

Geoffroy DIDIER mep French member of the Group of the European People’s Party (Christian Democrats) at the European Parliament

‘GDPR still leaves room for companies to manipulate personal data’

ecently our inboxes were bombarded with privacy updates related to the General Data Protection Regulation (GDPR) that entered into force on 25th May 2018. The flood of emails aimed to inform us about the use of our personal data, a legal requirement under GDPR. The Cambridge Analytica scandal took the debates about data regulation toa different level. GDPR will alter the data landscape, going some way towards curbing the powers of the internet giants, but this will only be the beginning. How much of an impact will the current regulation have on how tech platforms store and use personal data? Can GDPR fully protect us from abusive data collection and misuse? Lack of responsibility At the beginning, GDPR was conceived with an honourable goal — to give control over personal data to users. In practice it had the reverse effect. Instead of giving more accountability to companies, GDPR put the full responsibility on users. This, in my opinion, is the first and the biggest problem of the regulation. GDPR doesn’t prohibit the use of data, but forces companies to inform users about the collection and use of their data. Companies that collect personal data have to provide a variety of notifications designed to inform the user about who is collecting their data, what it is being collected for, how it will be used, to which third parties it may be provided and how long it will be stored. As a result, GDPR arrived in the shape of email consent forms full of incomprehensible information and links to other sites with terms and conditions. It made it absolutely www.governmentgazette.eu | 10

impossible for users to get clear information about the use of their data or to choose when and in which applications they want to share their data and under which circumstances they don’t want to share any data. For instance, I spent countless hours trying to distinguish Google and Facebook applications that I use and give my consent to use my data from those that I don’t use, where I want to delete all information about myself. Each time I was redirected to a different link without any concrete result. Finally, I gave up. Unfortunately, this is an illustration of the fact that GDPR still leaves room for companies to manipulate personal data while avoiding responsibility for their actions. Data harvesting and data mining At present, personal data is the most precious asset, especially for tech firms. Here lies another problem: GDPR doesn’t protect personal data from interference by algorithms and use by advertisers. This problem mainly relates to tech firms. In order to have access to a newspaper, a customer needs to buy it. On the other hand, the internet and the digital world is available free of charge. Users do not pay to access Facebook, Google, Snapchat or YouTube. Tech firms generate revenues from advertisements. As a result, they create complicated algorithms and applications (so-called “persuasive technology”) that are aimed at pushing users to share their views, preferences and tastes in order to trace a detailed behavioural correlation scheme and create psychological portraits of users. It is about intentional cultivation and harvesting of data through persuasive technology in

order to eventually sell it to advertisers. Allthey need is an algorithm to help them understand behavioural correlations. Meanwhile, those complicated algorithms, the machine learning tools that power everything — from our news feeds on social media to the products suggested by search engines — remain opaque and unregulated. They don’t fall under the scope of GDPR. Moreover, they are protected and seen as intellectual property rights, making them trade secrets. A clear definition of personal data GDPR protects personal data such as travel records, religious affiliations, biometric data, web search results and credit card numbers. But what about the personal data generated by the persuasive technologies described above, aimed at targeting consumers for marketing or political campaigning purposes? Unfortunately, GDPR doesn’t provide a miracle solution to this problem. A big step forward, but not enough to catch up with fast-developing technologies There is enough vagueness in GDPR to ensure that companies will be tweaking well beyond the deadline. The simple fact is that the legislation has failed to keep up with the speed at which technology has advanced. GDPR doesn’t make direct reference to data harvesting and data mining. It doesn’t outlaw the use of personal data for marketing or political purposes. Finally, GDPR allows companies to claim a legitimate interest — usually commercial — not to disclose data. GDPR is a huge step forward towards data regulation, but certainly not a miracle solution. GDPR puts data protection debates on a new level and it’s for us to develop them further

Back at the EU drawing board

European Parliament votes in favour of copyright reform

BRUSSELS NEWS DESK

midst intense lobbying from tech players, the European Parliament voted to approve a controversial reform of the online copyright regulation, while carefully adding safeguards to protect small firms and freedom of expression. The Parliament voted with 438 in favor, 226 against and 39 abstentions for the amendments, supporting amendments put forward by Axel Voss MEP who has been actively driving the reform at the European Parliament. The European Parliament’s changes to the Commission’s original proposal aimed to make certain that artists — notably musicians, performers and script authors, as well as news publishers and journalists — are paid for their work when it is used by sharing platforms such as YouTube or Facebook, and news aggregators such as Google News. After the vote, rapporteur Axel Voss MEP said, “I am very glad that despite the very strong lobbying campaign by the internet giants, there is now a majority in the full house backing the need to protect the principle of fair pay for European creatives. There has been much heated debate around this directive and I believe that Parliament has listened carefully to the concerns raised. Thus, we have addressed concerns raised about innovation by excluding small and micro platforms or aggregators from the scope. I am convinced that once the dust has settled, the internet will be as free as it is today, creators and journalists will be earning a fairer share of the revenues generated by their works, and we will be wondering what

all the fuss was about.” Welcoming today’s vote at the European Parliament, Vice-President for the Digital Single Market Andrus Ansip and Commissioner for Digital Economy and Society Mariya Gabriel made a joint statement: “It is a strong and positive signal and an essential step to achieving our common objective of modernising the copyright rules in the European Union. Our aim for this reform is to bring tangible benefits for EU citizens, researchers, educators, writers, artists, press and cultural heritage institutions and to open up the potential for more creativity and content by clarifying the rules and making them fit for the digital world. ” Aiming to safeguard free speech, the Commission stands ready to start working with the European Parliament and the Council of the EU, so that the directive can be approved as soon as possible, ideally by the end of 2018.

copyright infringements. This would also apply to snippets, where only a small part of a news publisher’s text is displayed. In practice, this liability requires these parties to pay right holders for copyrighted material that they make available. The proposed law will allow journalists — and not just their publishing houses — to benefit from any remuneration stemming from this liability requirement. In an attempt to encourage start-ups and innovation, the reform exempts small and micro platforms from the directive. The reform also includes provisions to ensure that copyright law is observed online without unfairly hampering the freedom of expression that has come to define the internet. Thus, merely sharing hyperlinks to articles, together with “individual words” to describe them, will be free of copyright constraints.

“We are fully committed to working with the co-legislators in order to achieve a balanced and positive outcome enabling a true modernisation of the copyright legislation that Europe needs.”

The European Parliament also strengthens the negotiating rights of authors and performers, by enabling them to “claim” additional remuneration from the party exploiting their rights when the remuneration originally agreed is “disproportionately” low compared to the benefits derived.

Europe’s press publishers have applauded the historic adoption. A spokesman for the publishers said: “This reform is not just about the modernisation of copyright but about the fundamental function of our democracies.”

It would also empower authors and performers to revoke or terminate the exclusivity of an exploitation licence for their work if the party holding the exploitation rights is deemed not to be exercising this right

The Parliament’s position toughens the Commission’s proposed plans to make online platforms and aggregators liable for Government Gazette | 11

digital single market

Accelerating 5G infrastructure

Michal BONI mep

Polish Member of the Group of the European People’s Party (Christian Democrats) at the European Parliament

We need a proper roadmap for building the 5G ecosystem

installation of passive facilities, favourable rental charges for municipal sites and the removal of taxation on sites and antennae, as well as predictable and harmonised electromagnetic field emissions limits set in accordance with current knowledge rather than stereotypes. A lot of positive developments were achieved in the European Electronic Communication Code (EECC), but in my view they will turn out to be insufficient.

t can be a key enabler — not only for a better generation of internet networks, but for a new wave of the digital revolution. 5G is bound to change productivity and transform many industries. It will provide a strong background for the data-driven economy and thus change the economy horizontally. It will generate completely new services through various types of apps and systems, new possibilities for healthcare delivery, education, autonomous driving, tailored entertainment and commercial services tailored to customers’ expectations. However, we need to know more about 5G as a unique system and about all its technical challenges. It is time for all partners and the European Commission, in cooperation with industries and research institutions, to test and re-test solutions related to the network latency and responsiveness, increased network capacity and data rate requirements. It is crucial to speed up the work on standardisation and stimulate 5G trials in cooperation with the International Telecommunication Union (ITU). This will give the industry the green light to accelerate the design and implementation of equipment adhering to the standards. It is equally important for low-frequency bands, midrange and the high-frequency end of the spectrum. For proper implementation, the spectrum

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We need a proper roadmap to build the 5G ecosystem. needs of 5G should be segmented into three key frequency ranges: up to 1GHz, between 1 and 6 GHz and over 6 GHz. A harmonised spectrum allocation is a necessary condition for the successful implementation of 5G. It requires a common understanding of the 5G objectives across all member states. All countries should prepare national broadband plans, adjusted to the needs and requirements of 5G. We also need 5G strategies on a regional level among Baltic and Scandinavian countries. European institutions have a political duty to stimulate countries to implement 5G strategies; however, we cannot set up a 5G ecosystem without an adequate and friendly environment for investment. We need proper, complementary financial sources for 5G in the current and future EU budgets, in the CEF, in EFSI and in national envelopes for cohesion policy. 5G will require a step up in investment in mobile access points and fixed infrastructure. Achieving a dense deployment of 5G infrastructure will require the simplification of rules and future-oriented solutions that favour investment and innovation. It means long-term licences, infrastructurebased competition, flexible conditions for co-investments and certainty for business models. It also means the removal of barriers, including right way for the

It is important to have well-thought-out expectations based on the future benefits and advantages to consumers, a list of decisions and frameworks, a list of targeted actions, standardisation based on industry-led processes, and tests and large-scale pilots in all sectors involved and in all member states. In addition, we also should establish a public communication campaign on the advantages of 5G from a user’s perspective, as this could create a stronger demand for 5G solutions. A new, redefined roadmap will bring the necessary changes into this timetable: launching the pre-commercial 5G trials, launching the early 5G networks (in 2018?), launching fully commercial 5G services by the end of 2020 (is it still possible?), making the pioneer bands available ahead of the WRC-19 (will member states be ready?), and launching 5G in at least one major city in every member state by 2020. Unfortunately, I think we are slightly delayed. Therefore, the last year of the current term of the European Commission should focus on finalising crucial preparatory works, starting with the implementation of the proper EECC, pushing politically for as much harmonisation as possible for spectrum allocation decisions and reshaping the timetable in cooperation with all member states and partners. Doing this would make the 5G roadmap one of this Commission’s most important achievements.

cybersecurity

Facing the challenges of the IoT world

Angelika NIEBLER mep German Member of the Group of the European People’s Party in the European Parliament

Cybersecurity in a connected world

The new proposal for an EU ‘Cybersecurity Act’ hast two objectives: First, we have to improve consumers’ trust in digital technologies and secondly we should reinforce Europe’s cybersecurity efforts through European cybersecurity certification schemes. Why exactly is a strong European cybersecurity certification system necessary? Do you remember the global cyber-attack ‘WannaCry’ in 2017 which jeopardized the IT security of hospitals in the UK, computers of telecommunication systems in Spain and the train system in Germany? An increasing amount of attacks like the WannaCry ransomware attack of 2017, which not only affected one but several

©Image credit: iStock

echnology is a disruptive force. It shapes and improves our daily lives and enables new business models. However, ensuring security, privacy and compliance of this disruptive force is one of the major challenges our society is facing today. On one hand, we welcome and facilitate the global digital evolution, on the other hand the increasing number of cyber-attacks shows the vulnerability of our data and the need to protect them.

member states, is challenging the digital evolution and requires Europe to step up and be a leader in cybersecurity.

tasks does not touch the competences of member states regarding public security, defence, national security and criminal law.

Some member states already have high quality certification schemes in place but others still lack behind. To bring all member states up to speed and to ensure that Europe is equipped to face the challenges the IoT world is imposing on industries and consumers, we need a more coordinated European approach. Europe must be able to react in a rapid and coordinated way to tackle attacks like the WannaCry attack. Cyber attacks do not stay within borders, so our answers to these attacks cannot do that either.

Why is an increased consumer trust needed to master the digital evolution?

To put a strong european system in place, the European Parliament believes that a strong EU Agency for Network and Information Security (ENISA) is needed. We therefore strengthened the Agency by increasing its budget, staff and providing it with a permanent mandate. In line with a European approach, ENISA is also equipped with new tasks. Besides operational cooperation, support in capacity building and forwarding information, the Agency has new tasks such as the preparation of candidate European cybersecurity schemes. However, the exercise of its new

Do you remember toy doll Cayla, whose software vulnerability allowed hackers to listen and speak to the children playing with it? With more and more devices and related services connected to the internet, consumers are increasingly put at risk of cyber attacks. To support the acceptance of digital technologies in our daily lives, we believe that it is of utmost importance to create more trust in the security of the devices that we are all using and to inform the consumers respectively. Therefore, according to the European Parliament, consumers should be provided with product information for certified IoT devices, services and processes so that they can learn more about the security level and the risks against which the IoT device can provide resistance. The consumer also needs to be informed about available updates and recommended actions which allow the consumer himself to arrange for more cybersecurity. With its strong industrial base, Europe can become a leading player in cybersecurity Government Gazette | 13

artificial intelligence

Rise of the robots

Mady DELVAUX mep Luxembourg Member of the Group of the Progressive Alliance of Socialists and Democrats in the European Parliament

Robotics and AI: How to shape our future without leaving people behind?

ot too long ago, Stephen Hawking warned that the development of full artificial intelligence (AI) could spell the end of the human race. Hawking cautioned us against an extreme form of AI — wherein machines would operate by themselves and independently design and build ever more capable systems. Recently, several scientists and technologists made several doomsday predictions about the potential of AI. Tech billionaire Elon Musk called it an existential threat to the human race and expressed concern over a future shared with robots. Microsoft cofounder Bill Gates said robots doing more work in the future will be positive, but also expressed concern about the potential of artificial intelligence in the long run.

Science fiction author Isaac Asimov’s dystopian future, where humans are enslaved by malicious robots, is not far ahead. As scientists warn, once we build an artificial intelligence smarter than ourselves, a new frontier of artificial general intelligence is bound to evolve sooner or later. Beyond making our lives easier, today AI is helping us resolve some of the world’s greatest challenges, from treating chronic diseases or reducing fatalities in traffic accidents to fighting climate change or anticipating cybersecurity threats. Over the next few decades, the increased use of robots and AI will not leave any stratum of society untouched. As technological innovation continues to get ever faster, robots and AI will play an increasingly important part of our daily lives. This can bring huge benefits to society by assisting us with difficult and unpleasant tasks. The EU has a huge potential in this field: talented entrepreneurs, motivated research centres and a great market. It is an important opportunity that we have to seize now. And by “now,” I mean yesterday.

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We need clear rules to ensure robots serve human interests at all times and the rest of the world is not waiting to be led by Europe on this issue. If we don’t decide how we want to shape our future, it is highly likely that China and America will decide for us, leaving us as simply followers. The EU has the duty to stay united and defend our values by taking the lead. By delaying its action, it has incentivised different member states across Europe to adopt national legislation, which has endangered our cohesion and risks fracturing the market. The communication of the Commission’s AI Strategy is a good first step but the sole use of soft law does not meet my expectations. While I welcome the investment plan made

to support industry and our economy to overcome thelack of internet giants in the EU, I deplore the absence of a social vision. Although the strategy’s statements and the creation of groups of experts are nice initiatives, the time is ripe for the legislation to ensure the EU provides a protective framework for consumers and legal certainty for companies. More than a year after the adoption of my report on civil law rules on robotics, I still identify five pillars we should deal with. The first one is safety. The EU needs a standardisation of products to ensure a satisfactory level of safety for users within the single market and to strengthen the consumer’s trust. The second is about the adaptability of our liability regimes to ensure compensation for victims of accidents involving robots and AI. The third lies in ethical principles which we should define to frame the development of these new technologies. I hope that the EU alliance for AI set up by the Commission will fulfil this role. The fourth concerns the impact on employment. While we cannot assess whether jobs will be created or destroyed, my conviction is that the structure of the employment market will be profoundly modified. With this view, we have to prepare a framework for preventing inequalities and permitting good standards of living for everybody. Closely related to this is the fifth pillar: education. We should adapt our educational systems to ensure that our children will be well prepared for the future, while at the same time providing a dynamic and efficient lifelong learning system. I hope that the EU will tackle the problem head-on and I reiterate my call for a real public debate to decide which society we want and how to shape our future with the great opportunities of robotics and AI without leaving anyone behind

Catelijne MULLER

Member of the European Economic and Social Committee (EESC) and Rapporteur on Artificial Intelligence

‘Human in command’: the European blueprint for Artificial Intelligence

©Image credit: iStock

if a child playing ball breaks a window, we do not sue the child but the parents. For the current AI systems even the more “basic” product liability regimes apply. But, more importantly, our liability laws have a preventive and corrective function. They also prevent us from doing harm. They prevent a car maker, for instance, from putting a car without brakes on the road. Imagine what could happen if we took away the threat of liability for damage caused by an AI system. What would stop a developer, in this AI race, from launching the system prematurely?

ith its recent Artificial Intelligence (AI) initiative, the European Commission has charted a new course for the development of AI in Europe. The European Economic and Social Committee (EESC) fully subscribes to the Commission’s strategy. Its responsible, human-centric approach reflects the EESC’s own views on how to harness AI for the common good. Back in 2017, when I set out to draw up the EESC’s first report on AI, I was effectively launching myself into uncharted territory. There was very little European policy work on this topic apart from a report by the European Parliament’s legal affairs committee, which focused on the legal issues surrounding AI. The EESC chose to explore the broader societal impact of AI. We identified opportunities in healthcare, climate change, agriculture and the fight against poverty. But we also pointed to challenges: the impact on work, its ethical and safety implications, the explainability of the systems, the need for safety and quality standards and an education system that would prepare Europeans to deal with AI. First and foremost, we asked Europe to take the lead at a global level in setting the framework for the responsible development

and use of AI by developing a code of ethics and clarifying applicable laws and regulations. Europe is a huge market; its product standards and requirements cannot be ignored by players looking to export their products. The recent experience of the GDPR shows that Europe could leverage the power stemming from the sheer size of its market to steer the development of AI globally in the direction of its own principles and values. The Commission’s strategy acknowledges the opportunities and challenges of AI and takes on board the EESC’s suggestions. It announces ethical guidelines to be set, bringing together all the efforts being made around the world to define ethical standards for AI. It also provides for an AI-on-demand platform and outlines plans to screen European laws and regulations for compatibility with AI and boost research and investment in AI for the benefit of humanity. The Commission also started to explain how the liability legislation applies to AI. Some have argued in favour of granting smart systems legal personality, much like corporations. The EESC has come out against this, arguing that we have robust systems in place to deal with agents outside our control — liability laws that have been there for centuries. If a dog bites someone, we sue the owner, not the dog;

One of the main recommendations I made was to involve all stakeholders in discussions. The Commission has taken this on board both in the makeup of the High-Level Expert Group on AI (whose members, for example, include trade unionists, philosophers, businesses, ethicists, legal scholars and consumers) and the European AI Alliance, which is open for all stakeholders to join and contribute to the discussions. In order to ensure that those efforts at EU level are successfully transmitted to the national level, I decided, together with my two fellow Dutch members of the High-Level Expert Group, to set up the Dutch AI Alliance (ALLAI Netherlands). We aim to foster collaboration and cohesion both between member states and across the EU as a whole when it comes to the future of AI. To conclude, I have been advocating a “human-in-command” approach to AI. Humans can and should be in command of when, how and if AI is used in our daily lives — what tasks we transfer to AI and how transparent it is — if it is to be an ethical player. After all, it is up to us to decide if we want certain jobs to be performed, care to be given or medical decisions to be made by AI, and if we want to accept AI that may jeopardise our safety, privacy or autonomy. This technology does not have to overwhelm us Government Gazette | 15

mobility

The future of transportation

Maja Bakran MARCICH Deputy Director General, DG MOVE, European Commission

What’s driving the European strategy on connected and driverless cars?

e must pursue several goals at the same time — to make European mobility safer and more accessible, to make European industry more competitive, to make European jobs more secure, and to be cleaner and better adapted to the imperative of tackling climate change. We achieved great progress in the past decades and the EU has the world’s safest roads. Nevertheless, in 2016 alone, 25,500 people lost their lives on EU roads and a further 135,000 people were seriously injured, causing great human suffering and costs estimated at €100 billion annually.

The roads are also responsible for over 70 % of greenhouse gas emissions from transport and urban breaches of air pollution limits. The results are serious: premature deaths in the EU due to transport-related pollution are nearly three times higher than road fatalities. Finally, the dominance of the car has had huge implications on how

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we design our cities and transport networks. It not only allows people to live further from workand leisure, but also leads to congestion, causing inefficiencies estimated at 1% of EU Gross Domestic Product (€100 billion) and rising. In this context, the Commission proposes a comprehensive EU approach towards connected and automated mobility. We propose a clear, forward-looking and ambitious European agenda that provides a common vision and identifies clearsupporting actions for developing and deploying key technologies, services and infrastructure. The first milestone, however, was laid earlier, on 30th November 2016, when the Commission adopted its strategy on Cooperative Intelligent Transport Systems (C-ITS). Such systems connect all road users and traffic managers, enabling them to share and use information in real time and allowing coordination of their actions at an entirely new level. The strategy identified a clear

list of initial services and defined a hybrid approach for communication technologies to deliver them. • Combining complementary technologies with different advantages. • Making sure the system is unaware of which technology is used, thereby easing the integration of future technologies (e.g. 5G). • Acknowledging that, today, this hybrid approach combines 3G/4G and ITS-G5. Both are mature, tested and already-deployed technologies. Both are also complementary, as 3G/4G leverages the coverage of existing networks and ITS-G5 offers low latency for safety-related services. The strategy also announced the adoption, by the end of 2018, of a delegated regulation under the Intelligent Transport Systems Directive. The main idea behind this delegated regulation is to ensure interoperability (making sure everybody is connected to everybody), backward compatibility (making sure everybody remains

connected to everybody) and continuity of services (making sure everybody benefits from the same road safety and traffic efficiency services). This is essential to accelerate EUwide deployment, to give legal certainty to investors and early adopters and, most importantly, to ensure maximum road safety and traffic efficiency for all road users as soon as possible. It will contribute to the safe system approach to road safety and should start today, rather than waiting for the development and rollout of new technologies. Successful deployment also requires cooperation, not only between different companies, but also between vastly different industries. This we already see happening today; vehicle manufacturers and technology suppliers are working on interoperable communications and governments and road authorities are also doing the same on the C-ROADS platform. This is, however, only the first step

in a much longer process.

access to travel information.

Today, C-ITS is about creating awareness and sharing information in real time, but soon C-ITS will start integrating automation. First, this could be preparing the braking system for an emergency stop. Next, the vehicle could initiate emergency stops on its own. Later still, emergency stops could largely disappear as vehicles share their intentions and cooperate at an even more fundamental level. Ultimately, vehicles will coordinate all manoeuvres and we hope to achieve Vision Zero, meaning no road fatalities.

Meanwhile, vehicles are becoming increasingly clean, connected and automated, and, ultimately, could be driverless and zero-emission.

Deploying now will not only reap road safety benefits sooner, but will also secure a lead in preparing for a more automated future and a competitive advantage for the Union. This is important as citizensâ&#x20AC;&#x2122; mobility demands are growing and their attitude to mobility is changing. They want to shift seamlessly between different modes of transport and enjoy ease of

This opens the possibility for vehicles to become an integral part of multimodal mobility, providing first- and last-mile services and inclusive solutions for elderly, disabled and young people. As you can see, the future of mobility, and the place of the end user in it, is at the centre of our thinking and our actions. We must keep looking through the forest of challenges and interactions, new technologies and business models, and keep our eye on our goal. Mobility is the cornerstone of freedom of movement of people and goods, which is fundamental to the smooth functioning of the EU

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work-life balance

New start for working parents

Agnes JONGERIUS mep Dutch Member of the Group of the Progressive Alliance of S&Ds in the European Parliament

Maria ARENA mep

Belgian Member of the Group of the Progressive Alliance of S&Ds in the European Parliament

©Image: Freepik

MEPs back measures to improve parents’ work-life balance

he birth of a child is one of the most beautiful moments in a person’s life, and as a parent, you want to be there to enjoy those precious moments with your child, to see them grow up and to take care of them. You also want to be present in the life of your loved ones when they need you the most. In these moments, you wish for a system that does not oblige you to choose between your profession and your family. You wish for a system that enables you to balance your private responsibilities with your professional ones, and be fairly compensated. Is it too good to be true? Employment Committee MEPs recently approved paternity leave, non-transferable parental leave and measures to boost women’s chances in the labour market. The directive is a progressive and ambitious proposal that enables parents to balance their work and private lives without having to choose one or the other. The proposal hopes to be a driver for gender promotion at work. Under the new rules, each parent will have the right to take four months of individual parental leave that is fairly remunerated. Furthermore, working fathers will be entitled to take at least 10 working days of paid paternity leave around the birth of their child. Finally, carers can take a minimum of five paid working days per year to take care of relatives and friends. The proposal does not distinguish between biological, adoptive and LGBTI parents. Moreover, both parents and carers can request flexible working arrangements in order to better cope with their caring responsibilities. www.governmentgazette.eu | 18

It is clear that in Europe the unequal distribution of caring responsibilities accounts for considerable disparities between men and women in the labour market. The lack of effective possibilities for men and women to balance these responsibilities with their professional ones adds to the problem. This discrepancy is further exacerbated by stereotypes about gender roles that require women to take care of children and family members and men to pursue careers and remain the ‘breadwinners’. These perceptions are not only outdated, but also unfair and economically detrimental to societies and economies. Valuable workforce and expertise remain unused and the potential of millions of women remains untapped. Every year, €370 billion are lost in the EU due to the gender employment gap. Despite being equally qualified, European women face a pay gap and remain considerably underrepresented in the labour market. According to the European Commission, the overall employment rate of women is still 11.6% lower than that of men. Almost 32% of women, especially ones with children, work part time compared to 8% of men. The picture is even darker in full-time employment, where the gap between full-time working women and men goes beyond 25%. Lastly, 20% of economically inactive women remain inactive due to caring responsibilities, compared with 2% of men. The United Nations report on human development suggests that women perform three times more unpaid work than men.

The existing legal framework does not support the equal division of caring responsibilities. Leave provision in member states varies significantly and the EU legislation only governs maternity and parental leave. This new directive will set minimum standards at EU level which either preserve or extend existing rights, benefiting citizens, businesses and member states alike. Working parents’ and carers’ conditions will be improved, leading to a higher employment rate for women, greater participation of fathers in family life and a reduction of the gender pay gap. In the same vein, a larger talent pool will become available for businesses to choose from, while a reduction in unemployment rates and an increase in tax incomes will support public finances to allow the implementation of new collective services such as childcare. Overall, greater labour supply will boost competitiveness and address demographic challenges by making full use of our human capital. Therefore, this proposal is a question of social justice and fairness as much as it is an economic imperative. It is time for change and convergence at the EU level for the benefit of all EU citizens. Only if we invest in human capital can the EU remain competitive on the global scene. Only if we are bold and ambitious can we deliver on our domestic and international commitments to social justice. It is vital that we achieve a common European approach without further delay

dying to work

Protecting the terminally ill

Rory PALMER mep UK Member of the Group of the Progressive Alliance of Socialists and Democrats in the European Parliament

TUC’s Dying to Work campaign comes to the EU

hen it comes to social and employment rights, we have much to be grateful to the EU for. Be it rights for pregnant workers, paid annual leave or protection against discrimination, we should not forget how much progress we have made together. However, the battle to secure the rights that workers need is not over, and I want to use the UK’s final year in the EU to fight for new protections for terminally ill workers. It is hardly controversial to say that people who receive a terminal illness diagnosis should be supported as much as possible; after all, the way we treat vulnerable people is a fundamental litmus test of a civilised society. The terminally ill are undoubtedly one of the most vulnerable groups of all. However, the reality is that terminally ill workers across Europe do not have the necessary protections. Many people who receive a terminal diagnosis wish to continue working. They often feel that their work gives them a sense of identity, purpose and dignity, and there are financial drivers to consider, too, including a loss of death in service payments and reduction in household income that can create worries about their family’s financial security and stability. The terminally ill currently lack specific legal protections. There are several instances where a terminal diagnosis has led, one way or another because of a lack of fairness from an employer, to an employee unwillingly and unfortunately leaving their job. The financial implications of this are bad enough, but a situation where the terminally

ill feel their choice to continue working has been taken away is deplorable. The social progress we have seen in the EU is down to partnership, and a key partner in this has been trade unions. The Trades Union Congress and GMB trade union in my region launched the Dying to Work campaign to fight for terminally ill workers and introduce new protections. Many employers have already heeded the call for action and have signed the Dying to Work voluntary charter, which commits employers to treat terminally ill workers fairly and with compassion. I’m pleased that the campaign is receiving strong support from across the political spectrum, and as the campaign’s European spokesperson I want to make sure our fight for the terminally ill is echoed and amplified across the EU and beyond. I know from my conversations with other MEPs from different countries and parties that this is a problem across Europe. By working together at the European level, we can raise awareness of the situation and pursue permanent change that would benefit citizens in each of our countries, too. I will continue to fight for rights for terminally ill workers – and, indeed, our employment protections more broadly – to be fully enshrined in UK law after Brexit. As the first step, I recently launched the Dying to Work MEP Focus Group, bringing together politicians united by a shared determination to protect terminally ill employees. We’ll be working with trade unions, employers and civil society groups to seek positive change. I have also spoken in the European Parliament about the Dying to Work campaign European Parliament and

I will continue to make the case relentlessly in the coming year for stronger employment law protections for workers with a terminal illness. Of course, some people might wonder why a UK MEP is so determined to set the direction of travel within the European Parliament. The first reason behind this is that the UK has yet to leave the EU. I want to do everything I can up until that point to make the EU a better place. The second is a broader point about our future relationship. I’m a committed internationalist and socialist — none of that will change after Brexit. The UK and the EU will be governed by different laws, but many of the social challenges we face will remain the same. We know from experience that the fight for social justice transcends borders and language. Whether it’s fighting for better human rights, tackling tax evasion or working to reduce poverty, in a global community we are bound by the values that we share and our determination to make the world a better place. Regardless of the final deal on the table, we must continue to work towards defending the most vulnerable and voiceless people in our society. In the meantime, I want to use my final year as an MEP to make progress. With European elections around the corner, politicians from all parties are looking for new ideas to improve and develop our social fabric. And the importance of social justice to the European project could be reiterated and enhanced by taking action to stand up and support terminally ill workers

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healthcare

The burden of gastrointestinal diseases

Janani KRISHNASWAMY

Commissioning Editor, Government Gazette

MEPs express concern over Europe’s chronic digestive disease burden to increase across Europe. With chronic digestive diseases, our society fails and the burden is only going to become greater. We’re seeing notable increases in the incidence of most gastrointestinal disorders, from digestive cancers to liver disease.”

©Image: UEG

A number of digestive health conditions are on the increase in children and obesity presents a major risk factor in most of these. The current outlook for young people’s health, for example, is extremely disturbing, with childhood obesity rates likely to almost double by 2025. National and European strategies for prevention and early intervention are needed now more than ever, particularly for children.

ccording a recent report by United European Gastroenterology (UEG), about 28% of all cancerrelated deaths are reportedly caused by digestive cancers. The five most common digestive cancers, including colorectal, gastric, pancreatic, liver and oesophageal cancer, are responsible for over 365,000 deaths per year in the EU, representing almost one in three cancerrelated deaths. Of these, approximately 40% and 20% of deaths are represented caused by colorectal cancer and pancreatic cancer respectively. If current population trends continue, the estimated number of deaths across the EU per year from these digestive cancers will be over 515,000 people by 2035. Screening is in place throughout Europe for colorectal cancer and there is strong evidence that these programmes reduce incidence and mortality rates through early detection and prevention. However, there are vast differences in programme types and stark inequalities in participation rates, which range from less than 1% in Hungary to 65% in the Netherlands. Further

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research is required to find reliable, safe and cost-effective screening techniques and programmes to aid early detection of other digestive cancers. Europe has been struggling to deal with its chronic digestive burden In addition to the threat posed from digestive cancers, experts at UEG, which represents over 22,000 digestive health specialists, are warning of the socioeconomic burden inflicted by functional GI disorders, such as irritable bowel syndrome (IBS) and constipation — all of which cause great loss of productivity. Functional GI disorders are common conditions that can be extremely disabling for patients, yet sufferers often do not consult their physician about their symptoms. They are associated with educational and occupational absenteeism, imposing high costs on society, and are expensive to treat and manage. For instance, treating IBS in Germany alone is estimated to cost over €3.2 billion per year. Speaking to Government Gazette, Professor Markus Peck from UEG said: “The impact inflicted by digestive diseases continues

What’s more, current predictions, trends and attitudes demonstrate that the challenge presented by obesity, heavy alcohol consumption and poor nutritional choices is increasing and urgent action is required to reduce this burden and improve health outcomes in generations to come. “Rising obesity levels, functional GI disorders (FGIDs) and heavy alcohol consumption across Europe have major implications for future healthcare provision and it is essential that these largely preventable issues are tackled through health policy and action,” adds Professor Peck. Fortunately, half of all digestive cancers are reportedly avertable and their significant burden could be reduced by addressing lifestyle factors, such as increasing levels of obesity and heavy alcohol consumption. On the other hand, Professor Peck notes that the greater burden comes from FGIDs, “where the complexity often lies in diagnosing FGIDs, with a third of IBS sufferers reporting that they visit their medical professional more than five times to receive a diagnosis.” It is estimated that IBS patients record school or work absences of up to 13 days per year, compared with just five days for the general population. Even though functional GI disorders are

1 2 3

MEP Group vision

To ensure European citizens have equitable access to effective prevention programmes and high-quality treatment

To encourage the mitigation of alcohol-related harm across Europe To lobby for the implementation of quality-controlled digestive cancer screening programmes and for higher standards in cancer care and treatment across Europe

4 To raise awareness amongst policy makers of the social and economic costs of (chronic) digestive diseases and the cost-benefits of tackling digestive diseases

5 To encourage increased funding into digestive health; its causes, prevention strategies and improved treatments

To improve public education on the importance of nutrition and lifestyle factors in the prevention of obesity

To promote the importance of tackling digestive diseases in children to improve lifelong health and reduce the socio-economic cost burden

common, many patients are, unfortunately, negatively stigmatised and labelled. To improve the lives of people with FGIDs, “there needs to be greater acknowledgment of the disorders and advancement of scientific understanding to optimise patient outcomes.” To manage Europe’s chronic digestive burden, a group of dedicated parliamentarians in Brussels recently launched a new European Parliament Interest Group on Digestive Health in May this year. Speaking to Government Gazette, Pavel Poc MEP, Chair of the MEP Digestive Health Group, said: “The interest group brings together MEPs that are enthusiastic about promoting digestive health at the EU level and beyond and promotes related EU policy initiatives. The group’s overarching mission is to ensure that improving digestive health remains an integral part of the EU health agenda.” As obesity is quickly overtaking tobacco as a health risk, is the principal preventable cause of cancer and substantially threatens the sustainability of public healthcare systems, the group aims “to cultivate and promote awareness regarding digestive diseases and strengthen the competence of people to manage their digestive health.”

The group will serve as a platform for exchange between the scientific community and policymakers for this purpose. “Topics to be addressed include the implementation of quality-controlled screening programmes for digestive cancers, promotion of policy initiatives related to counter chronic digestive diseases, the mitigation of alcoholrelated harm, creation of healthier food environments, increasing EU funding into digestive health.” By facilitating conversation and discussion between leading digestive health experts and the 17 MEPs who have joined the interest group to date, MEP Poc says the group “will create greater awareness of the treatment, prevention and socioeconomic burden of digestive diseases throughout Europe and aim to implement change at both a national and the EU level.” Excessive European drinking is an extremely serious public health issue that imposes huge socioeconomic damage on the EU. A regulatory approach on alcohol labelling is needed to ensure consumers can make informed and clued-up purchasing decisions. “This, together with a tightening of regulations on the marketing of alcohol,” is one of the group’s central aims, says Nessa Childers MEP, Co-Chair of the European

MEP Digestive Health Group Chair: MEP Pavel Poc (S&D, CZ), Co-Chairs: MEP Nessa Childers (S&D, IE), MEP Michèle Rivasi (Greens, FR), MEP Jean Marinescu (EPP, RO) Members: MEP Miroslav Mikolasik (EPP, SK), MEP Annie SchreijerPierik (EPP, NL), MEP Sirpa Pietikäinen (EPP, FI), MEP Biljana Borzan (S&D, HR), MEP Ignacio Faria (EPP, PT), MEP Margrete Auken (Greens, FR), MEP Daciana Sarbu (S&D, RO), MEP Andrey Kovatchev (EPP, BG), MEP Jana Zitnanska (ECR, SK), MEP Soledad Cabezón Ruiz (S&D, ES), MEP Hilde Vautmans (ALDE, BE), MEP Kateřina Konečná (GUE/NGL, CZ), MEP Cristian Silviu Bușoi (EPP, RO)

Parliament Interest Group on Digestive Health. Talking about the group’s efforts to lessen the burden of digestive cancers and the need to increase awareness about the correlation between gastrointestinal disorders and digestive cancers, MEP Poc noted that “sharing and promoting best practice in the screening and surveillance of digestive cancers, promoting standardisation of colorectal cancer screening programmes and promoting screening uptake are all actions that can reduce the impact on high-risk groups.” He noted that an upcoming event of the MEP Digestive Health Group, planned for this autumn, will look into the burden and policy aspects of pancreatic cancer. “Currently, there is no screening test or early detection method for pancreatic cancer and, even more alarmingly, 64% of Europeans state that they know very little about the disease, making the chances of early diagnosis extremely slim.” Further activities of the group will centre around nutrition, particularly the danger of processed food to health and the indirect toxic effects of pesticides on health

Government Gazette | 21

healthcare

The burden of gastrointestinal diseases

‘Public perception about colonoscopy should change’

wenty years ago, when Jola rang the editor of a popular newspaper, whom she knew personally, to write about bowel cancer, he said: “Don’t be ridiculous. I am not going to write about bleeding bottoms.” Today, you open the newspaper and everybody talks openly about their symptoms. Speaking exclusively to Government Gazette, she said: “In the past, many people afflicted with this disease felt embarrassed to discuss their affliction. Today, there are a greater number of people speaking out to help break down the taboo around poo.” Acknowledging that colorectal cancer is preventable, treatable and beatable, she says: “The stigma on the whole has gone, or is much better than it used to be.” However, “the issue around the word ‘cancer’ still exists and the doubts about how treatable colorectal cancer is” continues to haunt those diagnosed with the disease. Several years back, Jola started off with the intention of setting up a colorectal cancer advocacy group in every country in Europe with the aim of pushing for screening, improving patient support, providing greater and equitable access to medicine, and improving survival rates. Today, EuropaColon works with patients, carers, clinicians, governments and

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the European Commission to create an effective and powerful colorectal and digestive cancers community. The organisation is committed to preventing deaths from digestive cancers and improving the quality of life of those affected by these diseases. Over the past two decades, early detection through screening has increased significantly across Europe, yet “there is a clear indication that not enough progress is being made towards implementing a system of colorectal cancer screening across the European Union.” According to Bowel Cancer UK, nearly 166,000 people in the UK are unaware that they have the condition. Though the UK has a wide-ranging screening programme, there were several recent calls on the government to improve the NHS’s current screening programme for the disease. Most recently, a grieving woman whose mother died from bowel cancer has delivered a petition to the UK Parliament demanding a reduction in the screening age limit. Despite the 2003 Commission recommendations on colorectal cancer screening, only six member states have formal, fully operational populationbased screening programmes. Most of Eastern Europe is still unprepared

If Europe should benefit from the existing screening programmes, “public perception about colonoscopy should change.” Government Gazette caught up with Founder and CEO of EuropaColon, Jola Gore-Booth, on the sidelines of a recent high-level roundtable on colorectal cancer, to discuss strategies to improve diagnosis, treatment and care of patients in Europe

Eastern European governments are not making screening programmes a priority, quality assurance mechanisms are not effective and often EU guidelines are not being followed. Participation rates are low — just 11 percent in Latvia, for example — and attendance at colonoscopy referral appointments following a positive test result is also poor. Some countries are planning and piloting organised programmes, but not all are effective. Moreover, there is a need to move towards a more personalised screening programme based on personal risk assessment, taking into account factors such as age, lifestyle and hereditary risk. To support and supplement a more personalised approach to screening, experts call for a shift in the role of GPs in personalised screening. While screening programmes differ widely across Europe, some of the biggest challenges in the screening of colon and rectal cancers relates to “negative attitudes to screening tests.” The promotion of CRC screening for older adults is becoming increasing difficult because reading CRC prevention information may evoke embarrassment, fear, and anxiety about the screening procedure and potential cancer diagnosis. If Europe is tobenefit from the

existing screening programmes, “public perception about colonoscopy should change.” As Jola notes, “the stigma relating to the disease has eased, but the fear of cancer and fear of colorectal cancer screening and colonoscopy specifically is still high.” Public awareness of colonoscopy and the benefits of the procedure remains low. Individuals are often deterred from attending their colonoscopy appointments and participating in screening programmes due to the often-negative perceptions of colonoscopy. Though every citizen has a right to opt out of screening, Jola says it is important to make informed and evidence-based decisions. “Just because Mrs James, who is 10doors down the street, had a bad colonoscopy, this should not stop you from having one yourself.” Another stumbling block on our road to screening relates to bowel cleansing. A successful colonoscopy is closely linked to adequate bowel preparation, with poor bowel preparation often resulting in missed precancerous lesions. “Without a new mindset on these issues, rates of attendance at colonoscopy appointments and participation in screening programmes will remain lower than they should be.”

down the misconceptions about undergoing the procedure and raise awareness about the importance of procedures. While it is important for European governments to improve their screening programmes, Jola points out that “people in Europe should start taking responsibility for their own health” and act on the information on hand regarding warning signs, symptoms and risk factors. Highlighting the link between obesity and colorectal cancer, she noted that more importance should be given to preventative diet and exercise

It remains crucial for us to break

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RARE DISEASES

Recommendations to reshape policy making

REPORT

Creating new impetus to face emerging challenges in rare diseases

Call for action

1 Unequal access to orphan medicinal products remains one of the central hurdles in the European fight against rare diseases. Policymakers should break the access deadlock and collaborate to ensure optimised delivery of new therapies.

Clinical trials are crucial: policymakers should support the efforts of the clinical community to evaluate different screening methodologies to support early detection of rare conditions.

Improve access to care: Policymakers should boost EU-level initiatives on early access, create links with experts and ensure patient management is erformed in multidisciplinary environments.

4 Addressing the data challenge: disjointed data systems pose blockages in

access to orphan drugs. Europe should develop legally and ethically robust agreements for collecting and exchanging health and genetic data about rare diseases.

Multistakeholder collaboration is key: we should have a collaborative approach that fosters research, ensures optimisation of the delivery of new therapies and transforms the care landscape of rare diseases.

RARE DISEAES REPORT

Introduction

Though individual rare diseases (RDs) affect less than five in every10,000 people, the aggregate number of individuals suffering from a rare disease is estimated to be nearly 400 million worldwide. The lack of efficient treatment, accurate and timely diagnosis and inequality of access to orphan drugs are clearly the main reasons behind the enormous burden. It is estimated that between 5,000 and 7,000 distinct rare diseases exist today, affecting patients in their physical capabilities, their mental abilities, and in their behaviour and sensorial capacities. Diagnosing rare diseases can be extremely challenging as symptoms are often out of sight and hide behind more common illnesses, and may initially appear to be of minor concern. Delays in diagnosis often lead to unsuitable management as well as disease progression. Misdiagnosis often leads to supplementary intervention, which is often considered inappropriate given the underlying disorder. The small number of patients, the logistics involved in reaching widely dispersed patients, the lack of validated biomarkers and surrogate endpoints, and the lack of clinical expertise and expert centres all present significant barriers. Due to the lack of data and medical records for individual rare diseases and the high cost of orphan drug development, only limited progress has been achieved. Lack of scientific knowledge often results in difficulties developing therapeutic tools, difficulties defining a therapeutic strategy and a shortage of therapeutic products. One of the main obstacles to clinical research and treatment advancements in RDs is the difficulty of conducting clinical trials. Finally, access to these treatments is often hampered because of the lack of incentives for research and development; it is also unequal because of differing pricing and reimbursement practices by companies and by national authorities, as well as assessment of added clinical value and awareness and expertise amongst health professionals. In addition, the European Medicines Agencyâ&#x20AC;&#x2122;s (EMA) unreasonable and disproportionate data collection reportedly hinders access to treatments

Contents altering the landscape of rare diseases

Key stakeholders discuss strategies to improve treatment and management of rare and life-threatening illnesses, reduce hurdles and barriers, identify new research opportunities and improve collaboration EU action against rare diseases

EU Commission’s joint action

European Commissioner for Health and Food Safety, Vytenis Andruikaitis offers renewed hope to patients wih rare diseases

Antoni Monsterrat Moliner, Former Senior Expert on Cancer and Rare Diseases, elaborates on the European Commission’s shared aims

Parliament perspective

Brexit & rare diseases

James Carver MEP says collaboration is key to improving the current landscape of rare diseases

With Brexit looming large, how can we ensure cross-border collaboration? Niall Dickson, Co-chair of Brexit Health Alliance answers

Industry perspective

Economist perspective

Ana Palma from Swedish Orphan Biovitrum explores how we can improve management of rare diseases in Europe

Bernarda Zamora from the Office of Health Economics writes about variations in access to orphan medicinal products

Economist perspective

Parliament perspective

Principal economist Martina Garau elaborates on the challenges of conducting clinical research on OMPs

Miriam Dalli MEP urges social inclusion to be an integral part of Europe’s Rare Diseases policy

Access to orphan drugs

European Reference Networks

Dr Jasmin Barman-Aksozen argues that EMA’s unreasonable and disproportionate data collection hinders timely access to treatments

Ruth Ladenstein from SIOPE elaborates how the ERN PaedCan facilitates effective crossborder healthcare

Voice of rare diseases patients

Industry perspective

Yann Le Cam, CEO of EURORDIS says we need to accelerate the momentum we have built over the last 20 years

Adrian Haigh from PTC Therapeutics writes about the challenges within conditional marketing authorisation and access to orphan medicines

ÂŠImages: ICPS

Towards a next-gen public health response to rare diseases

Despite significant medical advancements and breakthrough legislation for rare diseases, great challenges still remain in treatment access, while social care is still fragmented. Canvassing for change in the landscape of rare diseases in Europe, the International Centre for Parliamentary Studies recently brought together key stakeholders to discuss strategies to improve the treatment and management of rare and life-threatening illnesses, reduce hurdles and barriers to access, identify new research opportunities and improve collaboration.

are diseases are present across a broad range of medical conditions. All forms of paediatric cancer are considered rare, as are brain, pancreatic, ovarian, thyroid and stomach cancers. Other examples of rare diseases include lysosomal storage diseases, blood disorders, eye diseases and autoimmune disorders. Patients suffering from these and numerous other rare conditions may take several years to receive a precise diagnosis and effective treatment. Only a handful of rare diseases are wellunderstood, with most not receiving sufficient attention or funding for research. People with a rare disease face significant challenges and most rare diseases still take a long time to be diagnosed. Many patients go through years of testing and misdiagnosis before finally getting to see a specialist. Only 5% of rare diseases are reported to have therapies to date among which only a handful are curative and some transformative; most improve and prolong life.

and rare conditions, they bring together clinicians, researchers and patients to improve the knowledge base, as well as care, through cross-border collaboration. However, ERNs are still disconnected from national healthcare systems and patient pathways. While the European Commission has been making great progress by improving the pipeline for new medicines, a large proportion of orphan medicinal products (OMPs) are nearly inaccessible due to hurdles in reimbursement. We need to identify key policy priorities to address the fundamental challenges of managing rare diseases. In order to examine current policy guidelines and strategies to support member states in diagnosing, treating and caring for patients with rare diseases, the International Centre for Parliamentary Studies (ICPS) recently brought together EU policymakers, medical and clinical professionals, academic experts, healthcare payers and patient groups.

The European Commission has responded to these challenges by introducing legislation to create a favourable environment for investment in new medicines to treat rare diseases. This has increased the range of therapies available through suitable incentives.

Delegates at the roundtable analysed the current policy challenges, guidelines and national plans for rare diseases across EU member states, evaluated current screening and prevention practices, examined the role of ERNs and explored ways to encourage further research and ensure rapid translation of research results into clinical applications.

Thanks to European Reference Networks (ERNs), which aspire to provide highly specialised care for patients with complex

Delegates at the ICPS Rare Diseases Europe 2017 call on policymakers to overcome the bureaucratic obstacles to access to orphan

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drugs and create a favourable environment for investment in new medicines to treat rare diseases. They tabled a few significant recommendations to improve the management of rare diseases in Europe. 1. Collaboration is fundamental to improving the current landscape of rare diseases. We should collaborate globally to accelerate research on improving the lives of patients with rare diseases. To get the best results and benefits for people with rare diseases, their families and those who support them, it is important for patients, health and social care providers, research and industry to work together. Collaborative research is crucial because it will not only lead to improved treatments but also help raise awareness about individual rare conditions. Further, this can also reduce the wait for a diagnosis and reduce the instances of misdiagnosis. 2. People with a rare disease have lower than average life expectancy, with a majority of diseases currently having no approved treatment. To reduce instances of misdiagnosis, European policymakers should support integration and networking among research, patient and healthcare organisations. 3. There are many challenges associated with collecting data on rare diseases. Disjointed data systems pose blockages and sometimes health data is coded in an unidentifiable manner. Europe should develop legally and ethically robust agreements for collecting

RARE DISEASES REPORT

the patients. Policymakers should urgently address the access gap and improve frameworks within Europe to increase and accelerate access to rare disease medicines. Delegates at Rare Disease Europe 2017:

and exchanging the health and genetic data of patients with rare diseases in order to reduce the research and treatment gaps. 4. The available epidemiological data on most rare diseases is inadequate to give clear details on the number of patients with a specific rare disease. One of the main problems in planning healthcare and social care for patients with rare diseases is that the burden of most of these diseases are invisible to health systems due to misclassification and the lack of appropriate coding. Registries can form the cornerstone of more scientific research on rare diseases. 5. The average length of time from symptoms to an accurate diagnosis is reportedly 4.8 years for a rare disease. It is important to reduce this diagnosis gap in order to avoid further complications. Early intervention through genetic testing and surveillance among at-risk communities is essential. 6. Clinical trials are crucial for understanding the impact and efficacy of new and existing medicines for treating the rare conditions that affect people throughout Europe. Policymakers should support the efforts of the clinical community to evaluate different screening methodologies to support the early detection of rare conditions. Delegates agreed that regulations should be more flexible to conduct clinical trials for rare and life-threatening illnesses. Moreover, there’s a need to collaborate with family associations to empower patients to participate in trials. 7. Analysis of national plans and strategies on rare diseases in Europe shows that 16 countries have already set up national plans, with seven member states at anadvanced stage of preparation of their national plan. Existing plans show good consistency; however, approaches adopted by member states vary significantly and choices of specific measures are related to differences in the organisation of healthcare systems. More should be done to strengthen the implementation and monitoring of these national plans. 8. Primary care physicians play an

outstanding role as first points of contact within the healthcare system. Patient safety and health competence should be strengthened by objective, quality-assured and target group-specific information, thereby facilitating access to the best service. 9. There is little or no expertise in several member states for carrying out tests for a number of very rare diseases. Policymakers should boost EU-level initiatives on early access, create links with experts and ensure patient management is performed in multidisciplinary environments. 10. Patients with rare diseases and their families experience major difficulties in getting information and finding their way around the healthcare and social security system. Similarly, healthcare professionals facing rare diseases do not have easy access to information, and available information is scattered and scarce, with a lack of guidelines and validated evidence. National governments should consider strategies on how to give all patients with rare diseases clear and timely information about their condition and its development, treatment and therapy options, and practical support. More should be done to improve awareness among service providers and others of the effects that rare diseases can have on a person’s education, family, social relationships and ability to work. 11. Each EU member state negotiates pricing separately with the pharmaceutical companies. Despite incentives for developing and registering orphan drugs, access to orphan drugs varies widely across member states. Delays in the availability of orphan drugs have been reported in different member states, with countries with smaller populations usually suffering longer delays. Europe should urgently build sustainable solutions for our healthcare systems in order to improve patients’ access to medicines. Policymakers should encourage early temporary reimbursements of orphan drugs as soon as they receive market authorisation.

Chief Executive, ALS Liga Belgium; Research Director, Association of People with Physical Disabilities; President, Association of Patients and Friends of Inherited Metabolic Diseases; BioMarin; President, Cyprus Alliance for Rare Disorders; Head of MKSE, University Hospital Magdeburg, Central German competence network Rare diseases; Research Manager, Competence Network for Congenital Heart Defects Dsai eV Patient Organization for Congenital Immunodeficiencies; Head of Clinical Genetics, Dutch Centre for Rare Diseases, Radboud University Medical Center - Department of Human Genetics; Project Leader, EUROPLAN; Vice President, EuroHSP; Researcher, Necker Children’s Institute; Faculty of Medicine Paris Descartes; President, The Finnish Network for Rare Diseases; Project Manager, Flemish Patients’ Platform; President, Federation of European associations of patients affected by renal genetic diseases; Chairman, DSAKU - Germanspeaking self-help group For Alkaptonuria eV; Chairman, Hellenic Society for the Support of Children with Genetic Problems “THE FUTURE”; Chief of Paediatric Neurology, Hopital Robert Debré, Assistance Publique des Hopitaux de Paris (APHP); Board Member, International Huntington Association; Head of foreign relations, AIG - Italian Glycogenic Association; Head of biochemical genetics department, Institute of Neurology and Genetics; Scientific Coordinator, INSERM Orphanet, Rare Disease Platform; Consulting Physician, Kiel University/CAU - Department of Congenital Heart Disease and Pediatric Cardiology; Associate Professor, Medical University of Vienna, President, National Alliance for Rare Disease Support; Vicechairman, NET-groep Foundation; Senior consultant, Norwegian Society for Medical Genetics; Chair and Founder, NephcEurope Care and Cure for Nephrotic Syndrome; PTC Therapeutics; President, Portuguese Association of Leukemias and Lymphomas; Chairman, Pancyprian Association for Rare Genetic Diseases “Unique Smiles”; Medical Geneticist, Retina Italia Onlus - Italian Association for the Fight Against Retinal Dystrophy; Head of Laboratory, Rare Diseases Sweden RWTH Aachen, Patient Advocate, Sobrevivire vzw; Scientific Advisor, Swiss Society for Porphyria and German Patient Organisation for Erythropoietic Protoporphyria; Vice President, Syndrome International Network; Swedish Orphan Biovitrum, Sanofi-Genzyme; Emeritus Professor, University Institute of Clinical Research

12. Only half of all orphan medicinal products which receive marketing authorisation get funded and make it to Government Gazette | 29

RARE DISEAES REPORT

EU action against rare diseases European Commissioner for Health and Food Safety, Vytenis Andriukaitis, offers renewed hope to patients with rare diseases

n March 1st 2017, the European Reference Networks (ERNs) — virtual networks bringing together healthcare providers across Europe to tackle complex or rare medical conditions — kicked off. Twenty-four thematic ERNs are functioning currently, with over 900 highly specialised healthcare units from 25 EU countries and Norway working together on an array of issues ranging from bone disorders to haematological diseases and from paediatric cancer to immunodeficiency. More than a year after the launch of the initiative in the university hospital in Leuven, Belgium, Vytenis Andriukaitis, European Commissioner for Health and Food Safety, tells us how ERNs are helping patients and outlines his hopes for the years ahead. Elisa from Alessandria in Italy suffers from osteogenesis imperfecta (OI), also known as brittle bone disease. OI is a rare condition and it is estimated that the number of people born with the condition is approximately one in every 15,000. Elisa, aged 30, was diagnosed with the disease as a small child. “I couldn’t play like other children,” she recalled, “because if I fell, I would break something.” A year ago, when ERNs were just about to begin their work, we asked Elisa what she was expecting from them. “More research, for the people, for the children who are being diagnosed, to try and improve their quality of life,” she said. As a medical doctor, I have often witnessed tragic stories of patients with rare or complex diseases. Having been diagnosed young, Elisa is luckier than most. Most patients with rare diseases are often left in the

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dark for several years without an accurate diagnosis, let alone appropriate treatment. It is also quite frustrating for doctors hunting for “zebras”. Such is the nature of rare and complex diseases that specialist knowledge is scarce and fragmented and, therefore, often unavailable in the patient’s region or country. Yet to deal with this complexity of rare diseases, we connect our knowledge and expertise through ERNs to bring concrete benefits to thousands of patients. A year since their launch, these ERNs are treating more than 50 patients with rare diseases. For instance, Adam from Colchester* is a 12-year-old who suffers from neurological and muscular problems. His doctors are unable to pinpoint the symptoms to a specific disease. He has seen countless specialists who are treating him as best as they can, but they need to know what exactly is wrong in Adam’s body in order to find optimal treatment. Adam’s doctors are currently consulting with medical staff from as many as five EU countries through the ERNs and are already a step further towards diagnosing his illness. To review a patient’s diagnosis and treatment, medical specialists across different disciplines and from across the EU consult one another, exchange information and share knowledge, often by convening cross-border advisory boards —made possible by a special IT platform developed by the Commission — to discuss a patient’s file. This way, it is the medical knowledge that travels, and there is no need for patients to undertake exhausting trips

between regions and countries, as in the past. Adam is not the only patient benefiting from the cross-border expertise offered by ERNs. Patients from many other EU countries — including other young children — who suffer from very rare neurological disorders, cancers, blood and other disorders, are having their cases reviewed, and some have already received a proper diagnosis and treatment advice. With Adam and dozens of other rare disease patients who now have renewed hope, the ERNs are off to a good start. In the coming year, I expect the ERNs to help hundreds if not thousands of patients. In the longer term, I hope to see the ERN model extended to other diseases. As we reach a critical mass of patients who are diagnosed and treated, ERNs will boost research through large clinical studies and contribute to the sustainability of national healthcare systems. I am confident that ERNs will help improve the quality of life for many patients in the EU suffering from rare and complex diseases and conditions, children and adults alike. *Identifying details, including the name, age, and in some cases the country, have been changed to respect the patients’ privacy

RARE DISEASES REPORT

Â©Image credit:European Commission

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Antoni MONSTERRAT MOLINER

Former Senior Expert on Cancer and Rare Diseases, European Commission

European Commission’s shared aims are changing the face of rare diseases

are diseases (RDs) are defined by the EU as life-threatening or chronically debilitating conditions whose prevalence is so low that special combined efforts are needed to address them in order to prevent significant morbidity, early mortality or a considerable reduction in an individual’s quality of life or socioeconomic potential. This definition first appeared in EU legislation in Regulation (EC) 141/2000 of December 16th1999 on orphan medicinal products and was extended to the public health field by the EU Commission’s communication on RDs.

Nearly 6,000 diseases are described in the Orphanet database, affecting between 6% and 8% of European people. In other words, between 27 and 36 million people in the European Union are affected, or will be affected at some point in their lives, by a rare disease. There is perhaps no other area of healthcare where collaboration between 28 different national approaches can be so efficient and effective. Directive 2011/24/EU on the application of patients’ rights to cross-border healthcare clarifies patients’ rights to access safe and good quality treatment across the EU. The European Commission has adopted, through legal means, the criteria and conditions which the European Reference Networks (ERNs) and the healthcare providers must fulfil. These networks involve more than 900 highly specialised healthcare units from over 300 hospitals in 26 member states. The ERNs are an excellent example of pan-European collaboration, uniting many different stakeholder groups. The ERNs have access to a dedicated Clinical Patient Management System (CPMS) to provide virtual, cross-expert and cross-border consultations for real patients whose cases warrant the pooling of knowledge across the ERN community. The European Commission provides non-competitive funding opportunities and the 2018 Public Health Programme dedicates €13.8 million to ‘multiannual specific grant agreements www.governmentgazette.eu | 32

for European Reference Networks’ for the subsequent three years.

One of the main obstacles to clinical research and treatment advancements in RDs is the difficulty of conducting clinical trials. Clinical trials in RDs have to deal with the geographic spread of patients but also with the high heterogeneity within the same disease. The approval process of orphan drugs by regulatory agencies might have to deal with limitations inherent to the small populations. On these bases, the European Commission has proposed a common platform of RD registers that will allow improved and increasingly integrated uses. The Commission’s Joint Research Centre (JRC) develops and maintains this European Platform on Rare Diseases Registration. Currently, the migration of two surveillance networks, the European Surveillance of Congenital Anomalies (EUROCAT) and the Surveillance of Cerebral Palsy in Europe (SCPE), has been fully achieved. The Council recommendation of June 2009 recommended that member states adopt, by the end of 2013, a national plan or strategy for rare diseases. Twenty-four countries have now adopted such a plan or strategy compared with only four in 2008, and the focus has moved from adopting to implementing and evaluating the success of these implementations. The EU is also closely cooperating with the World Health Organisation (WHO) in revising the existing International Classification of Diseases (ICD) to ensure better classification of RDs, which should be adequately coded and traceable in all health information systems, contributing to their adequate recognition in national healthcare and reimbursement systems. In the meantime, the European Commission supports the Orphanet approach to improving the quality and traceability of RDs in health information systems by using Orphacodes on a voluntary basis at a national level. These Orphacodes refer to the Orphanet classification of diseases and it is a stable and evidence-based nomenclature

based on published expert classifications. The International Rare Diseases Research Consortium (IRDiRC), officially launched in 2011, was originally conceived with two main goals: to contribute to the development of 200 new therapies and to obtain the means to diagnose most rare diseases by the year 2020. Considerable progress towards these goals has been made: the goal to deliver 200 new therapies was achieved in early 2017 — three years earlier than expected — and the goal for diagnostics is within reach. Today there are 1,363 designated orphan medicines from which more than 122 orphan medicinal products have been authorised. The medicine is assessed by the Committee of Orphan Medicinal Products (COMP) in the EMA (European Medicines Agency). The EMA later publishes an orphan maintenance assessment report for every orphan-designated medicine as part of a medicine’s European Public Assessment Report (EPAR) after the European Commission has adopted its marketing authorisation decision. All these European achievements are envisaged to be instrumental in guiding policy and research in the field of rare diseases

RARE DISEASES REPORT

James CARVER mep Independent Member of the European Parliament for the West Midlands

Collaboration is essential to improve current landscape of rare diseases

hough individually the numbers for each rare disease are small, collectively they represent up to 36 million people in the EU. These are people whose quality of life is at risk through not accessing timely and effective healthcare. This lack of efficient treatment and accurate diagnosis represents an enormous unmet need and a major challenge for public health. This has to change.

My late wife suffered from a rare condition called scleroderma, an uncommon autoimmune rheumatic condition that results in hard, thickened areas of skin and sometimes problems with internal organs and blood vessels. I have seen the devastating impact this can have. About one in 17 people are reportedly affected by a rare disease at some point in their life — in the UK, that’s about 3.5 million people. About 20% of these conditions are non-genetic, among which are rare autoimmune rheumatic diseases, including scleroderma. These conditions can cause severe inflammation in various parts of the body, often simultaneously, leading to tissue or organ damage, which is often irreversible and can be fatal. They affect many parts of the body and often require cross-specialty medical expertise. Like many other rare conditions, treatment options are limited. Effects are often not outwardly apparent; many live with chronic pain and suffer from severe fatigue. Health varies from day to day, making it difficult to meet the demands of a job. Personal and social life can be devastated. Current landscape Following an EU Council recommendation, the UK Strategy for Rare Diseases was published in 2013, for the first time providing direction for the healthcare needs of people living with rare diseases. Unfortunately, the focus has been on genetic conditions, overlooking the 700,000 or so people living with non-genetic rare diseases.

The need to improve care for these people led to the formation of the Rare Autoimmune Rheumatic Disease Alliance (RAIRDA), bringing together clinical and patient organisations. Last summer, RAIRDA conducted a survey of 2,000 people living with lupus, scleroderma and vasculitis, to assess experiences of care highlighted by the UK strategy.

The resulting report, Reduce, Improve, Empower, published in February 2018, shows that half of respondents waited more than three years between experiencing their first symptom and correct diagnosis — and that they face ongoing struggles. The impact of these rare conditions can be devastating. One in five people have missed more than three months of work in the past year, with a similar number having to give up work altogether. These struggles in getting a diagnosis, accessing treatment and coping with the impacts should not exist. The report sets out solutions to those problems with three aims: to reduce delays in diagnosis, to improve the coordination of care and to empower people with greater knowledge. Working together to improve care Collaboration is essential in order to improve the current situation. RAIRDA brings together clinicians and patients, but we need the government, the NHS and other health bodies to work together to improve care. However, individual nations need to look beyond their own borders. The European Reference Networks (ERNs) are an excellent example for promoting collaboration and sharing expertise across the EU. UK institutions lead six of the 24 rare disease networks and provide around one-tenth of the membership. ERNs should speed up diagnoses for some rare diseases by allowing faster consultation with a wider pool of expertise. They should also help rapidly disseminate best practice, driving up quality of care.

Better data to inform decision making We need better and more reliable data on prevalence and incidence of rare diseases by the development of national audits or registries. But there is a wider issue, as none of the EU member states has enough data to conduct epidemiological, clinical or pharmacological studies to advance knowledge about these rare conditions. The information that is available is fragmented in hundreds of registries across Europe, and until now there have been no uniform standards on collection and organisation. The Commission has now defined the standard for rare diseases in Europe. This is a first step towards ensuring that data collected by European registries is comparable and the data registries are interoperable — which will improve treatment and outcomes for patients. Increase awareness Low levels of understanding of these conditions among healthcare professionals and the public result in delayed diagnosis and poor treatment and support. Working with the patient organisation Scleroderma & Raynaud’s UK as an ambassador, I have witnessed the impact of awareness campaigns in reducing the stigma and isolation faced by patients with rare diseases. The establishment of EU-wide initiatives to increase the visibility of rare conditions is vital to drive change and ensure that the thousands of people living with rare diseases gain greater access to treatment, care and support

Government Gazette | 33

Niall DICKSON

Chief Executive of the NHS Confederation Co-chair, Brexit Health Alliance

Patients must triumph over politics in Brexit negotiations

midst all the noise about the UK leaving the EU, it is inevitable that the big issues overshadow the little ones. But the importance of what may be regarded as â&#x20AC;&#x153;detailâ&#x20AC;? in the negotiations must be understood.

Even major issues such as healthcare, which is not an EU competence, could be at risk of being ignored, and within this sector there are a host of matters that should be resolved if patients throughout Europe areto be protected. The implications for patients suffering from rare diseases are a classic case in point. The sector is now facing considerable uncertainty because of the Brexit process. And although the diseases may be rare, taken together they are highly significant. These illnesses do not recognise borders, but because patients are spread far and wide they tend to be isolated with limited access to appropriate expertise. This in turn makes it hard to provide access to diagnosis or what can be lifesaving care and treatment. And to be clear, there are only a few effective treatments, which implies a tremendous burden of unmet healthcare needs. The move towards personalised genetic medicine will usher in more research into subtypes of diseases, which affect smaller numbers of patients. As a result, there will, in effect, be more rare diseases. And if there were one area of medicine which above others could claim to need collaboration, this would be it. No one country can tackle rare diseases alone â&#x20AC;&#x201D; collective action is essential for success. This is well illustrated by the success of the European Reference Networks (ERNs), which were set up to improve research, diagnosis and treatment of rare or low prevalence complex diseases. The 24 thematic networks are the most advanced and innovative form of cross-border cooperation between healthcare providers www.governmentgazette.eu | 34

across the European continent.

This has the potential to revolutionise crossborder healthcare for the benefit of clinicians and healthcare providers, but above all for patients. It would be a tragedy if the UK were to withdraw from this emerging collaboration. Six of the 24 networks are led by UK hospitals and 10% of ERN members are from UK hospitals. UK centres and clinicians contribute, with others, to a wide range of clinical areas. Professor Jill Clayton-Smith, a clinical geneticist from Manchester who coordinates the network on Rare Congenital Malformations and Rare Intellectual Disability, is adamant about the importance of European collaboration. She cites a patient with a complex, undiagnosed rare disorder which is almost certainly genetic but which has defied diagnosis. The patient has gone through a wide variety of tests, yet he is without an answer on the cause of his disorder. Today, there is hope.An EU-funded research project offers new opportunities to establish a diagnosis for this patient, and the network provides a possibility to seek a broader range of expert clinical opinions. But she is anxious that Brexit could mean losing these links, which are not only useful for clinicians and researchers, but vital for patients. For this reason, the clinical coordinators of all 24 ERNs, the European rare diseases patient community (EURORDIS), as well as the Brexit Health Alliance, have called on the European Commission and the UK government to make sure that a pragmatic solution is found, so that UK clinicians and researchers can continue to take part in the networks and every patient can benefit from the collaboration. Shared regulatory frameworks at the EU level have also been crucial in providing patients with faster access to treatments. In

the global market, separate national systems for regulating health technologies can slow down access. This applies particularly to smaller patient groups, which is why regulatory oversight across the EU brings particular added value for rare disease patients. Clinical trials for rare diseases need international collaboration, as no one country has enough patients. The EU regulation on orphan medicines has incentivised the development of products intended for the diagnosis, prevention or treatment of life-threatening or very serious rare conditions. The value of the current arrangements, whereby medicines for rare diseases and medical technologies get a single authorisation, could hardly be clearer. This also enables cost-effective licensing and distribution of medicines for small populations. This is why the Brexit Health Alliance wants a positive future cooperation model for research and innovation between the UK and the EU, which includes UK involvement in EUfunding programmes and which supports health research, innovation networks and clinical trials. Alongside this, we need maximum cooperation and harmonisation of frameworks governing the regulation of medical research, medicines and medical devices. In particular, a pragmatic solution should be found so that the UK can continue to engage with key regulatory bodies and shared infrastructures, including the new EU Clinical Trials Regulation. The key message is that pragmatic solutions are achievable, but patients and public health must come first, above politics, in the Brexit negotiations

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Ana PALMA Senior Director Global HTA, Community Engagement, Patient Access Lead BeNeLux, Swedish Orphan Biovitrum

How can we improve management of rare diseases in Europe?

s further multistakeholder collaboration a possible way forward to improve access across the EU? The pathway from ideas to patients is often complex and very lengthy. Such a pathway needs to be shortened in order to deliver access in a more equitable manner to patients with rare diseases (RDs).

For more than 20 years there has been a single European Medicines Agency (EMA), whose evaluation and opinion may end up attributing a single marketing authorisation that is valid across the EU. However, once the marketing authorisation holder (MAH) continues further along this pathway towards achieving access, it is often confronted with more than 30 very different national pricing and reimbursement (P&R) systems. Such systems are not only different in remit, but also very different in requirements, procedural aspects and timelines, and ultimately differ in the outcomes of their decisions. It is indeed crucial to remind ourselves that, today, the outcome of this complex environment is very patchy and unequal access to innovative therapies for patients across the EU, sometimes even within the same member state. To this already challenging P&R environment one still needs to add the growing economic and financial pressure which impacts the healthcare systems around the world. This in turn is further increasing the scrutiny by governments and P&R authorities on any new drugs, which ultimately may compromise access to innovative treatments. Clearly, we urgently need to build sustainable solutions for our healthcare systems if we are indeed to improve RD patients’ access. The challenges are shared — across borders and between stakeholders — therefore, sustainable solutions shall also be better explored collaboratively, rather than unilaterally, and by gathering all the stakeholders around the same table. To a certain extent, this is already

happening. A series of different tools has been developed and these are available today as a result of such multistakeholder collaboration: examples are the EMA–HTA Parallel Consultation, the Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) and the Multi-HTA dialogues, as well as various multi-country collaborations such as BeNeLuxA, a first collaborative step towards more balance in the pharmaceutical market. Each of these tools represents opportunities to refine development plans and ensure that the right evidence is being generated to meet the needs of different decision-makers over time in a continuous and iterative manner.

If all these tools are successful, it is believed that they will create the ecosystem that will be equipped to effectively deal with patients’ access to innovative therapies. However, more needs to be done. In the future, there is room for a refined 2.0 version of today’s adaptive pathways, which would be fully aligned and supported by the European HTA Agency, producing a single relative effectiveness assessment. This would be followed by an adaptive reimbursement and an adaptive price, which could finally lead to an adaptive access — all supported by a continuum of evidence generation, fulfilling everyone’s needs.

1700 orphan drug designations (ODDs) have been granted by the EMA, from which about 150 have received marketing authorisation approval (MAA), addressing approximately 90 different RDs. This reflects the huge and undeniable success of this regulation; however, the pathway between 90 and more than 6000 diseases is still very long. It is absolutely critical to maintain the spirit of this regulation, as well as the ecosystem of incentives, in order to ensure that innovation continues to be nurtured and incubated, so that the EU and all of us who are part of the healthcare system community do not fail the very many EU citizens suffering from rare diseases and awaiting treatment. By sustaining innovation via a robust system of incentives, the EU will continue to foster scientific excellence in this region of the world, which in turn will contribute to economic growth in addition to offering hope and more research into treatments for RDs. Predictability in the R&D environment is paramount, particularly for SMEs, to continue attracting the much-needed highly risky investment, which is why a robust and daring incentives framework is key

The objective would be a shared one, with healthcare systems committed to treating patients in a timely, equitable and sustainable way. A robust incentives framework is crucial to a sustainable R&D environment that continues to address the gap in the area of RDs. There are more than 6,000 rare diseases, affecting about 30 million EU citizens, 80 percent of these being of genetic origin, with more than 75 percent affecting children. Before the enactment of the OMP Regulation EC141/2000, there were eight treatments addressing rare, so-called “orphan-like,” diseases. Since then, around Government Gazette | 35

Bernarda ZAMORA

Economist, Office of Health Economics

Martina GARAU

Principal Economist, Office of Health Economics

Policymakers should do more to ensure timely access to orphan medicinal products

rphan medicinal products (OMPs) are treatments targeting rare diseases affecting fewer than one in 2,000 people. Yet considering over 6,000 rare diseases altogether, one in 17 people in the EU has a rare disease, totalling nearly 30 million people. Rare diseases can be chronic, progressive and life-threatening; many affect children and do not have an effective treatment. Marketing authorisation for OMPs is granted at the central level after receiving a positive opinion by the European Medicines Agency (EMA). This central authorisation process is only a necessary first step to commercialising OMPs in member states, but it does not guarantee that they will reach patients. In practice, patient access is determined by national healthcare systems through their processes of health technology assessment (HTA), pricing, reimbursement and clinical practice. In our recent study, we compared the access to 143 OMPs authorised in the EU (up to May 2016) across France, Germany, Italy, Spain and the UK (including its devolved nations). Our findings match other studies in the literature showing the strong variation of access to OMPs among European countries. OMPs are most widely accessible in Germany, where all 133 commercialised OMPs (93 percent of centrally authorised OMPs) were automatically reimbursed. France reimbursed 81% of centrally authorised OMPs, mostly via a scheme to cover chronic diseases and early access schemes. In the other countries, between 30% and 60% of OMPs are reimbursed. In particular, in England, less than 50% of OMPs are routinely funded by the NHS, and access is even lower in Scotland and Wales. Apart from the German automatic reimbursement, patient access is restricted by delays from central authorisation to national reimbursement which take on average between 19 and 29 months, with the shortest delays in France and Italy.

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In most countries, the challenges of conducting clinical research on OMPs lead to a high level of uncertainty in the evidence, which makes HTA processes complex and increases barriers to their reimbursement. In addition to the small size of patient populations and heterogeneous presentations of rare diseases, it is difficult to conduct health valuations in children. The extended remit of HTA in France facilitating pre-authorisation access circumvents these barriers. In England, the standard HTA methodology has been replaced with specific criteria to assess OMPs targeting the rarest diseases, the so-called ultra-orphan. However, the new assessment process does not recognise the need to adjust the standard methodology for handling uncertainty. HTA also overlooks social preferences in treating patients with very rare conditions, or the typical scale of the impacts beyond direct health benefits, involving a heavy burden on carers and families. Some policy mechanisms are important access routes for OMPs before marketing authorisation. These include early access schemes such as those implemented in France and Italy, where one third of OMPs were reimbursed through this route. There is scarce data on access to OMPs facilitated by other pre-licence mechanisms such as open extensions of pivotal clinical trials or compassionate programmes established and funded by the manufacturer, and individual patient funding requests (such as those observed in the UK). Another way to accelerate access to OMPs is to reinforce the role of pan-European assessments of benefits, which could inform HTA, price and reimbursement decisions at country level. This is in line with the recently introduced European Commission initiative on joint clinical assessment. The case for a common assessment is particularly strong for OMPs because of the limited evidence available at launch and the support needed by countries which do not have HTA capacity or expertise.

Given the characteristics of rare conditions, there is also a case for expanding the definition of value traditionally used in country assessments. With this spirit, the Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) process, a voluntary non-binding initiative involving country payers and manufacturers, has developed the Transparent Value Framework (TVF). In summary, equity in access to OMPs for European patients is far from being reached. We found that more than half of centrally authorised OMPs are available in the five selected countries, but that access to patients is further restricted by different national reimbursement policies, especially in the UK, Italy and Spain. The orphan drug designation and the central marketing authorisation are only necessary first steps to bring new OMPs to patients. More needs to be done to ensure that OMPs reach patients in a timely manner. National policies, such as early access schemes as seen in France, can avoid delays in access. The new EU HTA regulation and other initiatives facilitating joint assessments can help accelerate reimbursement decisions in individual countries

RARE DISEASES REPORT

Miriam DALLI mep

Maltese Member of the Group of the Progressive Alliance of Socialists and Democrats in the European Parliament

‘Social inclusion should be an integral part of European policy’

t is estimated that rare diseases affect over 30 million citizens in the European Union. It’s a major challenge for the public health sector, which struggles with a lack of efficient treatment options for rare diseases and difficulties in diagnosing them. The EU action on rare diseases focuses on reducing the number of people affected and promotes early diagnosis and establishing a higher quality of life for those affected by rare diseases. A disease’s rarity is determined by the fact that it affects no more than five in 10,000 people. Collectively, this number should not be overlooked. On a human level, this goes beyond numbers. Once symptoms of these diseases first appear, people may go for 10 years or longer without getting an accurate diagnosis, thus prolonging their suffering. Early and accurate diagnosis is crucial in determining corresponding therapies and medicines. In order to develop rapid diagnosis, the EU based its actions on establishing European Reference Networks (ERNs). Launched in March 2017, ERNs bring together more than 900 highly specialised healthcare units from over 300 hospitals in 26 EU countries. They work as a virtual

platform connecting medical experts, giving them the option to search the symptoms for related diagnoses and treatments. Considered to be part of cross-border healthcare, this is a progressive policy that standardises access to healthcare. But before ERNs were set up, the World Health Organisation (WHO) and the EU had urged member states to trace and code rare diseases in their respective national health information systems. It also pushed them to provide adequate recognition as well as reimbursement possibilities. This International Classification of Diseases enabled the verification of many rare diseases. Both these systems had one goal in common: to reduce the number of affected people. By improving symptom recognition, we can address rare diseases at earlier stages. Similarly, this was also the idea behind Orphanet, a multilingual platform providing information to medical care providers and specialists. For effective action, we need the right tools. Rare diseases were first put on the EU agenda for action in 2008, leading to 50 patients with rare diseases being treated. Since then, rare diseases have moved up the EU policy agenda and are now recognised

as a public health priority in Europe and an area of unique European added value for community action. More than €1 billion has been invested in more than 200 collaborative research and innovation projects related to rare diseases through the Seventh Framework Programme and Horizon 2020. Eleven new collaborative research and innovation projects were recently launched in Horizon 2020, specific topics focusing on new therapies for rare diseases and diagnostic characterisation of rare diseases, with total EU funding of more than €77 million. Social inclusion should be the next step of the European policy. A lot of research still lies ahead. Dealing with rare diseases requires not only a medical approach but also one in which a patient doesn’t feel discriminated against. Those who suffer from rare diseases may go for years feeling as if the medical profession is not helping them, as well as failing to receive the support of national healthcare systems. Educating and training healthcare professionals about particular cases may expedite the response to a patient’s particular case. In turn, this provides reassurance, awareness and security to the patient

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Dr Jasmin BARMAN-AKSOZEN

Scientific Advisor, Swiss Society for Porphyria and German Patient Organisation for Erythropoietic Protoporphyria

‘EMA’s disproportionate data collection hinders access to treatments’

he orphan drug afamelanotide is approved for patients with erythropoietic protoporphyria (EPP), a rare genetic blood disorder which causes an absolute intolerance to light. However, this orphan drug is nearly inaccessible.

Among patients with the ultra-rare metabolic disorder EPP, exposure to even a few minutes of sunlight and strong artificial light sources causes massively painful phototoxic reactions and severe burns in the vessels of the exposed skin, from early childhood. In 2014, the European Medicines Agency (EMA) approved afamelanotide (Scenesse), the first clinically tested treatment showing efficacy in EPP. Under treatment, EPP patients significantly increase their exposure to light and experience fewer phototoxic reactions and, when developing them, these are less severe in nature. The treatment enables them to take up jobs and sports and be wellintegrated into society. However, three years after EMA approval, most EPP patients in the EU still do not have access to this lifechanging treatment. Substantial access restrictions three years after approval After approval, the first hurdle for access to a new treatment is usually the health technology assessment (HTA), where national authorities evaluate the cost/ benefit ratio in order to adopt a decision regarding reimbursement. However, sustained and comprehensive access to the drug is not available, even in Germany and the Netherlands, where authorities approved reimbursement for the therapy. In Germany, only 60 of the approximately 400 patients eligible for treatment have access to the therapy. In the Netherlands, all 104 patients are being treated. However, they can only access the treatment for up to eight months per year despite the fact that artificial light sources trigger phototoxic www.governmentgazette.eu | 38

reactions in severely affected individuals throughout the year.

In Italy, Austria and Switzerland, special access schemes and case-by-case decisions enable treatment of some of the patients while leaving others untreated. In all other countries, afamelanotide is not yet available — more than three years after EMA approval. Up to four hours of data collection per appointment In Germany, one important reason for the observed access restriction is the postmarketing requirements imposed by the EMA. The extensive data collection causes three to four hours of additional workload for the treating physicians during each appointment — in contrast to the 20 minutes needed to actually administer the treatment to the patient. The therapy has to be renewed every two months and the hospitals offering the treatment have to allocate the required resources and/or limit the number of patients they accept. In the Netherlands, part of the data collection can be assigned to paramedics; however, in order to manage the workload, extra staff had to be recruited at the treatment centre. Patients and treating physicians do support reasonable safety monitoring. However, the majority of the data which has to be collected in the case of afamelanotide relates to efficacy, not safety. Over several weeks, patients under treatment have to record hundreds of data points related to their exposure to sunlight, whether they experience phototoxic reactions and the severity thereof. This is not only a substantial burden for the sufferers; the scientific value of the data is also highly questionable. For instance, a rainy summer will lead to a reduced total time spent in sunlight, and if the time in sunlight is measured as an outcome, the drug efficacy and benefit will appear to be lower than it is in reality. For a

meaningful data evaluation, a control group consisting of untreated patients would be necessary. To the best of our knowledge, no such untreated control group exists. In addition, the collection, storage and analysis of such data are usually elaborate and costly. European EPP patient organisations have repeatedly reached out to responsible EMA representatives and tried to make them aware of the consequences of the post-marketing requirements. So far, the answers have been scientifically inappropriate and disappointing. In order to reduce access hurdles and prevent unnecessary and disproportionate burdens on the healthcare system, we propose independent cost/benefit evaluations of the post-marketing requirements in question. Since the EU ombudsman does not evaluate the contents of drug approval decisions and related aspects, only compliance with the procedural regulations, the creation of an independent arbitration board is needed for cases like the one described above. This article is co-authored by Jasmin Barman-Aksözen, PhD, Switzerland and Germany; Cornelia Dechant, MD, Austria; Francesca Granata, PhD, Italy and Jeroen Verheul, Journalist, Netherlands, who are part of an informal working group of EPP patients with professional backgrounds in science or medicine

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Ruth LADENSTEIN ERN PaedCan Coordinator and SIOP Europe board member

ERN PaedCan facilitates effective cross-border healthcare

aediatric cancer is a very rare disease that comes in multiple subtypes and represents both a life-threatening disease and a major public health issue. Every year, 6,000 children and young people die of cancer in Europe, making paediatric cancer the leading cause of death from disease for children and adolescents. Average survival rates have improved over recent decades. Although progress has been dramatic for some conditions, outcomes remain very poor for others. Children and adolescents with cancer deserve the best possible healthcare, no matter where they live. However, the quality and availability of paediatric cancer treatment and care varies widely across Europe; between 10% and 20% of children die from curable forms of cancer where quality care is not accessible. Inequalities in survival are a major challenge for Europe, with worse outcomes experienced in Eastern Europe.

The European Reference Network on Paediatric Cancer (ERN PaedCan) was inaugurated in March 2017 at the third ERN Conference as one of 24 European Reference Networks. ERN PaedCan aims to help national health systems cooperate in the interest of patients. By aiming to reduce inequalities of childhood cancer outcomes across member states, ERN PaedCan enables access to up-to-date diagnostics and treatments by facilitating the exchange of expertise and knowledge by uniting the best specialists across Europe to tackle complex and rare paediatric cancer conditions that require highly specialised interventions and a concentration of knowledge and resources. ERN PaedCan intends to enable the provision of high-quality, accessible and cost-effective cross-border healthcare for children and adolescents with cancer, regardless of where they live. The network currently unites 57 institutions (EUapproved member hospitals) across 18 European countries.

ERN PaedCan implements eHealth technologies and facilitates cross-border consultations (e.g. through the Clinical Patient Management System (CPMS) provided by the European Commission), to share expertise in rare conditions and give cross-border advice through virtual discussions with experts across Europe.

To ensure that specialised knowledge and life-saving paediatric oncology treatments are broadly accessible, ERN PaedCan started to create a European Childhood Cancer Roadmap, planned as a guidance document for healthcare providers, to direct affected families to approved hubs of coordination with special childhood cancer expertise (e.g. reference diagnostics and highly specialised interventions) following CPMS advice.So far, eight networks have been identified in a bottom-up process. There is a special focus on very rare tumour entities where case numbers are too low to consider a clinical trial setting and where combined registries are of vital importance to share knowledge and to find evidence. This network expedites the lives of both healthcare providers and patients, whose conditions require specialist expertise and tools that are not widely available due to low case volumes or lack of resources. The network also helps young patients and their families make informed choices by providing clear information regarding access, quality, safety and reimbursement for treatments received in another EU country, ensuring more treatment options and less red tape for young patients and their families. There is still a long way to go to overcome inequalities and ensure safer and better treatment across EU borders. The need to improve access to standard care across Europe and to increase cure rates for all paediatric cancer types should be a priority.

and capacity to treat all rare and complex conditions.â&#x20AC;? Nevertheless, by cooperating and exchanging lifesaving knowledge at the European level, patients across the EU will be able to gain access to the best expertise available. This network offers a platform for the development of guidelines, training and knowledge sharing. There is no doubt that cross-border healthcare will unite specialists across Europe in tackling complex or rare cancer conditions that require highly specialised interventions and the concentration of knowledge and resources. The expected impact of ERN PaedCan is the increased likelihood of early and accurate diagnosis and effective treatment supported by the development of guidelines. ERNPaedCan will help to increase childhood cancer survival and quality of life in the long term by fostering cooperation, research, training and knowledge sharing to end professional isolation, with the ultimate goal of reducing current inequalities in childhood cancer survival and healthcare capabilities across Europe. It enables access to data diagnostics and treatments by facilitating the exchange of knowledge and expertise, allowing medical expertise and knowledge, rather than the patients, to travel through the implementation of a virtual consultation system. I believe that ERN PaedCan will provide concrete results for many patients so that they are no longer looking for answers in the dark but instead can benefit from the best knowledge available in Europe and lead healthier and longer lives

As EU Commissioner for Health and Food Safety, Vytenis Andriukaitis, has said: â&#x20AC;&#x153;No country alone has the knowledge Government Gazette | 39

Yann LE CAM CEO, EURORDIS

EU rare disease policy needs fresh drive for next 20 years

ver the last two decades, policy on rare diseases and orphan medicines has been driven by the rare disease patient community and EU institutions, with a strong leadership from the European Commission. The EU regulation on orphan medical products and the European Reference Networks (ERNs) are some of the most triumphant policies that improve the lives of the 30 million Europeans living with a rare disease. The current European regulatory framework has brought massive benefits to the rare disease community in terms of the number of orphan designations and indications, as well as paediatric medicines.

Research on rare diseases is strongly supported by the EU, with close to €900 million in more than 160 EU-funded projects. However, the current landscape of research on rare diseases is very fragmented. Next steps in EU rare disease policy — including the adoption of a European Joint Programme Co-Fund for Rare Diseases in 2019, which will structure rare disease research, and the possible adoption of the current legislative proposal for European cooperation on health technology assessment — will have a positive impact on the delivery of rare disease treatments. The existing regulatory and economic incentives have led to the development of hundreds of orphan medicinal products (OMPs) that did not exist two decades ago. To date, the EC has granted 1,952 orphan designations and 142 OMPs have obtained marketing authorisation. Patient organisations have reported that medicines developed using the incentives in the OMP regulation have significantly improved patients’ health and quality of life and decreased their reliance on supportive care. Despite these remarkable technological and scientific advancements, challenges in access to treatments prevail. www.governmentgazette.eu | 40

Up to 95% of the 6,000 identified rare diseases are yet to have an approved therapy.

According to a 2004 EURORDIS survey on the availability of 12orphan medicinal products that received a market authorisation in the EU, Denmark was the only country where all 12 products were available to patients. The number varies greatly in other countries, with the new EU member states and Luxembourg lagging behind. Patient access to orphan drugs often depends on the country where they live. With the recent dismantling of the EC expert group on rare diseases, and with no plans for a future joint action on rare diseases, it seems that the EU rare disease policy structure is under review. In future, ERNs should be firmly affixed to national healthcare systems and integrated into revamped national rare disease strategies to ensure individual patients can easily access the specific healthcare pathway they need. In order to address this evolving situation, and especially at a moment when certain EU policy actions are being discontinued, it is time to grow EU actions that will support and foster national actions and the EU citizens affected by rare diseases. More urgently, it is time we addressed the barriers to patient access at a national level across Europe. Speaking on the sidelines of the European Conference on Rare Diseases and Orphan Products 2018 in Vienna, Yann Le Cam, Chief Executive Officer of EURORDIS, says: “We need to accelerate the momentum we have built over the last 20 years and create a new impetus to face emerging challenges and ensure no one is left behind. We need to continue looking for solutions at a supranational level to help improve equity of access to health, and achieve universal health coverage and the healthrelated UN Sustainable Development Goals. EURORDIS calls for a strong drive from the EU institutions and in particular, a reaffirmed leadership from the European

Commission in the area of rare diseases.” The variation in how rare disease medicines are perceived, evaluated and funded across EU member states is one of the major problems we face at the moment. Whilst several OMPs receive market authorisation, they often fail to reach the patients due to several bureaucratic obstacles. One of the reasons for this delay in market access is the lack of large data sets and the limited knowledge about diseases. This makes it hard to demonstrate treatment value within existing frameworks, often leading to delays or failure to gain access for innovative therapies. Dr Christa Wirthumer-Hoche, Head of Austrian Medicines and Medical Devices Agency and Chair of the Management Board of the European Medicines Agency, said: “We have to continue our efforts — as researchers, regulators and the industry — to advance further in developing new medicines for rare diseases.” In order to break the access deadlock, solve the persisting problems in availability of treatments and transform the care landscape of rare diseases, we must bring everyone together and make it a shared responsibility. We should have a collaborative approach that ensures optimisation of the delivery of new therapies. As Yann Le Cam reiterates, “we need to close the gap between innovation and access. All stakeholders have an urgent collective responsibility to shape a new approach that will accelerate the translation of major scientific advancements into new therapies. We believe that a new ecosystem is possible, a framework based on a global approach to innovation for unmet medical needs and on sustainability for healthcare systems as well as financial attractiveness to industry and investors.”

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Adrian HAIGH Senior Vice President & General Manager EMEA & Asia Pacific Region, PTC Therapeutics Inc.

Conditional marketing authorisation: accelerated approval, but uncertain access

onditional marketing authorisation (CMA) is a process that allows early access to a very limited and selected number of promising medicines with clinical benefit for conditions with a high unmet patient need, but with data that is either not comprehensive or not conclusive enough to justify granting a standard marketing authorisation at the time of assessment. A CMA is valid for one year and can be renewed annually until comprehensive data, to be generated under a specific obligation, has confirmed the positive benefit/risk of the product. At this stage the CMA converts to a full marketing authorisation.

European-level policy and regulatory bodies understand the inherent difficulties of developing orphan medicines and are clear in their intent that “patients suffering from rare conditions should be entitled to the same level of treatments as other patients.”To this end, current regulation is intended to incentivise the research, development and marketing of new treatments for rare and chronically disabling or life-threatening diseases.

until it has been used for a considerable time, perhaps many years. However, this caution is negatively impacting patients’ ability to access treatments that have already been shown to offer clinical benefit and have been granted a marketing authorisation via the CMA process.

In PTC’s experience, many HTA bodies perceive that CMAs are granted on the basis of inadequate data rather than an imperative to allow expedited patient access to important, innovative new therapies with a positive benefit/risk ratio. The CMA route was implemented to address specifically the difficulties of data generation that are inherent in the very small patient populations that exist for rare diseases. Any notion that a CMA is a second-class approval is completely wrong and a distortion of the true intent of the regulation.

Unfortunately, many of the national health technology assessment (HTA) processes do not account for either the value offered by orphan medicines or the value attributed to them by patients and their families. This is particularly worrying as the majority of these treatments are for rare diseases where no other alternative is available. As stated in the recent EURORDIS reflection paper: “We must achieve a more acceptable balance between the conflicting demands of a scientific uncertainty that is here to stay, and of a financial sustainability that more than ever needs to be restored.”

The implementation of a more structured process for early parallel engagement with HTA bodies to discuss evidence generation plans is, therefore, a welcome step forward. However, this is still a voluntary process for the most part and there is no guarantee that the thinking from HTA representatives will remain the same at the point of submission, usually some time from the start of the regulatory approval process. For example, the recent changes to NICE’s Highly Specialised Technology process in England, which introduced strict incremental cost-effectiveness thresholds and a budget impact test, happened over a relatively short timeframe and has significantly altered the access landscape for an orphan medicinal product. Ultimately, there is no mechanism in place to provide a sufficient level of longterm certainty for pharmaceutical companies and, more importantly, patients.

The fundamental challenge appears to be that EU regulatory processes have allowed flexibility and levels of uncertainty when assessing the clinical benefit of orphan products, whereas national payers are much less willing to accept this uncertainty — particularly when the true value of an intervention will not be definitively proven

Crucially, there is a European-wide initiative, underway for a considerable number of years, that has the potential to improve access to high quality care for patients and provide a greater level of certainty for companies developing innovative new treatments —the European Project for Rare Diseases National Plans

Development (EUROPLAN).Since 2009, member states have been in varying states of developing and, in some cases, implementing their national strategies; however, eight years on, current discourse at a European level still centres on “developing plans”. Surely we have reached a point in time to begin evaluating national progress, with a view to refocusing efforts within the context of today’s challenges? The need for robust appraisal is not motivated by a desire to infringe member states’ rights to apportion health budgets as they deem appropriate, but to understand what progress has been made and enable renewed action in the fight to improve the outlook for patients with rare diseases. The imperative is to build an open and constructive dialogue between all stakeholders — manufacturers, regulators, HTA bodies, payers and politicians — who have a shared responsibility to accelerate the transfer of major scientific advancements into improved care and new therapies, in a predictable and sustainable way for all concerned

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healthcare

Intensifying the fight against superbugs

MEPs call for an intensified fight against antibiotics

very year 25,000 people die in the EU from infections caused by superbugs. About 700,000 people die worldwide every year due to resistance to antibiotics and it is feared that by 2050 this resistance may cause more deaths than cancer. The European Centre for Disease Prevention and Control (ECDC) estimates that around four million patients acquire healthcare-associated infections each year in the EU. But reliable estimates of the true burden are scarce. Countless lives have been saved over the years thanks to the use of antibiotics. However, misuse of antibiotics has eroded their efficacy and has led to the spread of highly resistant bacteria, to the extent that it has become a threat to humankind. Not only bacteria can be resistant to drugs used to fight infections, but also other microbes, such as parasites, viruses and fungi. Since 1999 the EU has invested more than €1.3 billion in research on this issue, but as antimicrobial resistance continues to increase, MEPs are calling for efforts to be intensified.

©Image: iStock

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What are MEPs proposing? Austrian S&D member Karin KadenbachMEP has written an owninitiative report on the new European One Health Action Plan against Antimicrobial Resistance. It was approved by parliament’s public health committee on 20thJune and will be voted on by all MEPs during a plenary session this autumn. The report stresses the need to take into account that the environment and people’s and animals’ health are interlinked and that diseases can be transmitted between different species. It highlights the importance of the correct and prudent use of antimicrobials. It calls for illegal sales to be tackled as well as for restrictions on the sale of antibiotics by health professionals. As the discovery and development of antibiotics has slowed over the past 20 years, investment in new substances should be stimulated. Rapid diagnostic tests that can determine if the cause of an infection is viral or bacterial should be made cheaper. In addition, good hygiene should be promoted and more awareness should be raised about the risk of overprescription and self-medication. According to a survey from 2016, 44% of Europeans are unaware that antibiotics are ineffective against a cold or the flu. Karin Kadenbach MEP worries that “if nothing is

done, antimicrobial resistance might cause more deaths than cancer by 2050. We have to start by looking at the whole circle, because the health of people and animals is interconnected. Diseases are transmitted from people to animals and vice versa.” Urging the European Commission to expand the role and funding of the ECDC to be better prepared against antimicrobial resistance, she calls on “the Commission to consider mandatory routine collection and the submission of monitoring data at EU level and to establish indictors to measure progress in the fight against antimicrobial resistance.” Miriam Dalli MEP, S&D spokesperson on environment and health, said:“We even risk the return of a ‘pre-antibiotics/ penicillin’ age, which would mean that previously incurable illnesses would once again become fatal. “The ‘One Health’ initiative would ensure better coordination in public health and veterinary services. Together, at the EU level, we must tackle the misuse and overuse of antibiotics, both in what is prescribed to humans as well as in animal treatment. Equally important is to look at the improper disposal of unused medicines, which many a time ends up in the groundwater posing a threat to our health.”

Fredrick Federley MEP hails the legislative reform reducing the over-use of preventative anti-microbial products in the agricultural sector: â&#x20AC;&#x153;This is a historic decision which will protect animals and humans alike. The reality is that healthy animals should not be given antibiotics. It is vital we stem the flow of unnecessary antibiotics flooding the livestock sector, which accounts for 70% of the problem with antimicrobial resistance bacteria. With this decision, a clinical assessment of the animal is required before antibiotics can be prescribed.â&#x20AC;?

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lung cancer

Recommendations to reshape policy making

REPORT

Policy roadmap to improve management of lung cancer

Call for action

1 Unequal access to diagnostics and advanced therapies remain one of the

crucial hurdles in the European fight against lung cancer. Policymakers should urgently address the isparities in access and high costs of innovations remain to be addressed.

Putting patients at the centre of all treatment decision: Shared decision making and patient centred care doesnâ&#x20AC;&#x2122;t mean anything unless the patient is truly at the centre, with care organised around them.

Lung cancer is responsible for more deaths than any other cancer, yet it was the subject of only 5.6% of all global cancer research in 2013. There is a significant unmetw need in lung cancer research globally and there is an urgent requirement for countries and governments to work togethet to address this challenge.

4 Managing the data challenge: There is a need to liberate data to strengthen our battle against lung cancer. It is imperative to develop standards for collecting and analysing patient data across Europe.

5 Multi-stakeholder collaboration is key: The approval and reimbursement pathway from the labs to the patients has to be improved through greater collaboration between all stakeholders

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Introduction

Lung cancer is responsible for more deaths than any other type of cancer and is associated with the highest economic burden in comparison with other cancers.

Lung cancer is the biggest cancer killer in Europe, accounting for 20.8% of all cancer deaths. It is the second most common cancer among men and the third most common cancer among women in Europe. Whilst the financial impact of lung cancer is rising, most of the economic burden of cancer is reportedly incurred in non-healthcare areas (almost â&#x201A;Ź43 billion in lost productivity attributable to early death) and only 27% of cancer-related healthcare costs are attributable to drug expenditure. A lot has changed in lung cancer with significant advancements in treatments. The introduction of immune therapies has changed the face of the disease. Several novel drugs have emerged during the last decade, employing biomolecular and targeted approaches. Despite the expanding research and knowledge about molecular drivers, not all countries across Europe receive equal access to the latest diagnostics and treatment modalities. Evidence suggests that there is a huge diversity of national regulatory and reimbursement processes between the east and the west. Sometimes, a lack of a formal reimbursement policy means access to diagnosis often varies between cities within a particular country. Furthermore, while rules for conducting clinical trials are often standardised, most of the clinical trials have been driven by Western European countries, leaving Eastern Europeans very few chances to get involved. Whatâ&#x20AC;&#x2122;s more crucial and requires urgent attention is the lack of high-quality radiotherapy facilities. Despite thoracic surgery departments in several European countries, radiation therapy facilities are underrepresented

Contents Action plan to promote lung cancer screening in Europe Specialised healthcare policy institutions present their fast-track strategy to promote EU-wide screening at ICPS Lung Cancer Europe 2017 Low-dose CT screening Dr David Baldwin, Consultant Respiratory Physician from Nottingham University Hospitals, writes about the challenges and opportunities of a low-dose CT screening for lung cancer Access to genetic testing

International viewpoint on screening Dr Fabrice Barlesi from the International Association for the Study of Lung Cancer calls for low-dose thoracic CT scan screening Role of Phase II clinical studies

Dion Warren from Takeda Pharmaceuticals highlights the inequalities persisting around access to genetic testing in Europe

Dr Jens-Peter Marschner from AbbVie Biopharmaceuticals analyses the challenges in clinical development of innovative new cancer drugs

State of care Dr Mary Oâ&#x20AC;&#x2122;Brien and Anna Minchom from Royal Marsden Hospital, make an assessment of the state of lung cancer prevention and treatment in Europe

Quality of care

Innovation in healthcare Denis Horgan from the European Alliance for Personalised Medicine, says Europe is too slow at bringing innovation into healthcare systems

Prof Jan Bussink from Radboud University Nijmegen Medical Centre and Dr Anne-Maria Baird from ECCOâ&#x20AC;&#x2122;s Patient Advisory Committee explore ways to improve quality of lung cancer care across Europe

ÂŠImages: ICPS

Experts urge policymakers to start planning for lung cancer screening

Despite significant advancements in diagnostics and treatments in recent years, major barriers exist in accessing these treatments across Europe. Being conscious that the EU must raise greater awareness of the disparities in lung cancer treatment, the International Centre for Parliamentary Studies recently brought together key stakeholders to review current lung cancer policy in Europe, address hurdles and barriers, identify new research opportunities and promote ambassadorship for lung cancer screening

ung cancer is the fourth most common cancer in Europe, accounting for approximately 20.8% of all cancer deaths. It remains the leading cause of cancer deaths worldwide, with 376,000 deaths in 2012 in Europe alone. The landscape of lung cancer treatment is rapidly evolving. Over the last decade, great progress was made in expanding the knowledge and understanding of molecular drivers of cancer in order to develop a new era of lung cancer treatments. The introduction of immune therapies to treat lung cancer has changed the face of the disease, extending both durable remissions and prolonging survival. Despite recent advances in surgery, chemotherapy and radiotherapy, seven out of eight patients die within five years of diagnosis. Significant barriers in accessing these treatments still exist, in the form of high regulatoryhurdles and access for new medicines and diagnosis at a late stage, with five-year survival rates remaining low in Europe. Furthermore, there is a lack of www.governmentgazette.eu | 48

specialised multidisciplinary structures to ensure adequate lung cancer patient care.

pressing challenges in managing and treating lung cancer in Europe.

Being conscious that the EU must raise greater awareness of the disparities in lung cancer treatment, the International Centre for Parliamentary Studies (ICPS) gathered EU policymakers, medical and clinical professionals, academic experts, healthcare players and patient groups to examine the ongoing challenges of managing lung cancer in Europe.

One of the major themes discussed during the day related to the need for an EU-wide population-based screening for lung cancer.

Chaired by John Bowis OBE, former MEP and Minister of Health (United Kingdom), the Lung Cancer Roundtable 2017 brought together representatives from across 12 European countries to examine a wide range of issues from prevention and screening, need for greater EU collaboration, reimbursement for treatment and datasharing to patient treatment. Followed by a series of policy updates from the European Parliament, European Commission and WHO Europe, delegates at the roundtable had a unique opportunity to appraise the efforts of the policymakers and provide solutions to some of the most

Currently, there are seven trials taking place in Europe, with the largest and most ambitious plan being the Dutch-Belgian Lung Cancer Screening trial NELSON. Europeâ&#x20AC;&#x2122;s largest sufficiently powered randomised lung cancer screening trial was designed to determine whether low-dose CT screening reduces lung cancer mortality by â&#x2030;Ľ25% compared with no screening after 10 years of follow-up. Whilst several delegates believed that the best way to reduce the high incidence of lung cancer is through primary prevention or targeting tobacco consumption, they unanimously agreed that lung cancer screening within clinical trials or in routine clinical practice is crucial for the future of the prevention of the disease. However, in order to have optimised population-based screening, delegates raised

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going into understanding and improving palliative and support care and quality of life issues. More research should be focused on diagnosis, screening and improving patient care. 9. Thereâ&#x20AC;&#x2122;s a clear need for increasing patient awareness about the science behind finding a cure for lung cancer, targeted medicine and advanced therapies. 10. Policymakers should inspire data scientists and medical communities across Europe to use artificial intelligence to improve lung cancer screening technology. 11. It is crucial to understand dataâ&#x20AC;&#x2122;s role in diagnostics and use it in our game. There is a need to explore the opportunities in data, regulate data sharing and streamline the use of unstructured medical data to improve early diagnosis and treatment of lung cancer.

a few key questions such as: how can we increase patient involvement? What should be the minimum requirement? How should we target the population? What should be the risk model? Would it ever be possible to share all patient data in Europe? Do we have the human resources to conduct such a study? Delegates recommended the implementation of a central European registry, including bio and image banks. They all agreed that there are a lot of challenges, but thecentral problems are the lack of advocacy, funding, human resources and the planning for implementation. Unequal access to diagnosis and treatments remains one of the crucial hurdles in the European fight against lung cancer. Delegates at ICPS Lung Cancer Europe 2017 call on policymakers to implement, as soon as possible, effective and longterm measures to prevent and manage lung cancer in Europe, and table a few significant recommendations to improve management of the killing disease. 1. Europe should implement higher taxes in all countries to avoid cross-border shopping and use the same packaging across the continent. The set of rules should be harmonised to be more effective. Profit from these taxes should then be used to raise awareness about improving treatment modalities. 2. While advanced treatment options such as targeted therapies and immunotherapy are bringing new opportunities to the lung cancer landscape, access to molecular testing and availability of treatment differs in individual member states. We should

create a platform to build harmonisation of treatment guidelines. 3. Relative to other cancers, lung cancer is associated with the highest economic costs, accounting for 15% of total cancer care costs. It is followed by breast cancer 12%, and colorectal cancer, 10%. Disparities in access and high costs of innovations should be urgently addressed. 4. There is a crucial need to raise awareness among policymakers about disparities in accessibility to diagnosis and treatment. Policy stakeholders should ensure that lung cancer patients gain timely diagnosis and access to the latest treatments. 5. One of the main reasons for disparities in diagnosis and treatment is due to separate regulatory frameworks to approve diagnosis and treatment. There is an urgent need to harmonise the regulatory pathway for diagnostics and treatment. 6. Radiotherapy remains an effective treatment to prolong the lives of lung cancer patients in Europe, yet there are vast disparities in the use of radiation therapy across the continent. European stakeholders should encourage a policy to increase access to high-quality radiotherapists. 7. Research into lung cancer has increased by just 1.2% since 2004 and the relative commitment to lung cancer research has actually fallen in most countries over the past ten years. There is a crucial need for a rapid increase in funding to address the lack of lung cancer research. 8. A majority of lung cancer research (53%) is focused on medicines, genetics and biomarkers, with just 1% of research

12. Finally, Europe should increase the presence of patient representatives, as new treatment modalities cannot be built without taking into account the requirements of lung cancer patients. Delegates at Lung Cancer Europe 2017: Clinical Head pathological anatomy, TOGA - Thoracale Oncologie Groep Antwerpen, Chest Physician/Expert in Diagnostics and treatment of lung cancer, University Medical Center Groningen, Professor, Department of Oncology and Pathology, Karolinska Institutet, Director of Research, RoyÂ Castle Lung Cancer Research Programme, The University of Liverpool, Professor and Chairman - Institute for Pathology, University Hospital Cologne, Physisian & Researcher, Charles University, MEP - EPP (Slovakia), European Parliament, Pulmonologist, CHU UCL Namur, Medical Doctor, Professor of Pneumology, Curie Sorbonne University of Paris VI, Senior Attending Surgeon, University Hospital Zurich, Pathologist, Clinical Centre of Serbia, President, European Society of Thoracic Surgeons, Policy Officer, Tobacco Control Team, European Commission, Expert Tobacco Control, Belgian Foundation against Cancer, Lung Cancer coordinator, H. Clinic; Barcelona University, Chief Thoracic Surgery, H. Clinic; Barcelona University, Chest - Radiologist, University Hospitals Leuven - Radiologye Senior Advisor, World Health Organization Chief Medical Officer, Tesaro, Oncology Medical Director Europe, R&D, AstraZeneca, Government Affairs Senior Manager, Western Europe & Canada, AbbVie, Head of Patient Advocacy and Communications, Takeda Oncology, Global Medical Affairs Lead - Tepotinib & Lung Cancer Portfolio, Merck KGaA

Government Gazette | 49

Dr David BALDWIN Consultant Respiratory Physician, Nottingham University Hospitals

Challenges and opportunities of low-dose CT screening for lung cancer

significantly larger number of people die from lung cancer in developed countries than from breast and bowel cancer combined. Both of these cancers have wellestablished screening programmes, yet the argument for lung cancer screening seems stronger. Nearly two-thirds of people with lung cancer present with advanced disease, when treatment has less effect on survival, than with both breast and bowel cancers. The impact of detection of lung cancer at an early stage, when it can be cured, is therefore greater. Considering the greater number of lung cancer deaths, this means that effective screening should have a larger www.governmentgazette.eu | 50

impact than existing programmes. Low-dose computed tomography (LDCT) is recommended in the United States and Canada. The US National Lung Screening Trial (NLST) showed both a reduction in lung cancer deaths and those from all causes (20% and 6.7% respectively) after three annual screens (1). Neither breast nor bowel cancer screening has an all-cause mortality benefit (2, 3). NLST is particularly convincing because the trial, in retrospect, was somewhat suboptimal in design and yet was stopped one year earlier than planned. There was dilution of the effect by the screening of many with a relatively low

risk and by stopping screening after three years. Referral and work-up criteria were suboptimal by current standards. NLST is the only adequately powered trial to publish mortality findings and the results of the Dutchâ&#x20AC;&#x201C;Belgian NELSON trial are awaited (4). The latter fact is the main reason why we still await implementation of screening programmes in Europe. However, many are now convinced that the available evidence for optimising a programme warrants implementation, especially as this will take time (5). The key elements that optimise programmes serve to ensure that benefits outweigh harms and cost effectiveness is maximised.

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1. Selection: people at high risk of lung cancer are more likely to benefit than those at low risk and the intervention is more cost-effective. The use of multivariable risk prediction models will probably increase the cost-effectiveness over the simple age and smoking criteria used in NLST. It is important that people who are also at low risk, some being the 10–15 % of people who develop lung cancer but have never smoked, understand why they should not be screened. There is also an intermediate risk group where cost is the main consideration. 2. Screen interval: evidence suggests that the optimum screening interval is annual except where a previous CT was negative (no significant pulmonary nodules), where it should be two years (6, 7). 3. False positive tests: this is often quoted as an issue but need not be. There are now clear criteria for “intermediate findings,” where the malignancy risk is relatively low and people can be safely managed by an interval LDCT. The false positive rate is 1–3 %. 4. Smoking cessation: smoking cessation support should be integral, as the overall quit rates are greater than in the general population (8). Intermediate findings are associated with benefit because in trials this more than doubles the smoking cessation rate, which will return an all-cause mortality benefit. 5. Psychological distress: psychological distress, although clinically significant where there are intermediate findings, returns to baseline after six months (9). 6. Overdiagnosis: analyses of NLST after six years of follow-up indicated the rate was 18% although this reduces to 9% with longer follow-up, one for every two deaths prevented (10). In breast screening there are threeoverdiagnosed cases for each death prevented. Overdiagnosis is minimised if modern pulmonary nodule management guidelines are followed (11, 12). 7. Physical harm: only a minority of individuals will need referral for further tests. Modern guideline-directed management reduces harm from biopsies and surgery by reducing intervention where the risk of malignancy is low. Applying this “intelligent” approach yields a benign resection rate of around 10% and in the most recent UK pilot it was zero (13, 14, 15).The radiation dose is low, and improving as technology improves. The cost-effectiveness of LDCT screening is dependent on all these factors. A recent analysis showed that the cost-effectiveness of LDCT screening is within many countries’ criteria for willingness-to-pay (16); these models still did not include much of the optimisation outlined here. Screening for lung cancer, a rapidly fatal disease that can be cured if caught early, makes logical sense and there is extensive evidence to guide

optimisation of programmes. The clinical community in the UK has started a number of pilots that have shown promising results, recruiting in the local community (15). The success of these has prompted NHS England to support programmes of “risk-based early detection,” essentially the same as screening but not as comprehensive as a programme. The widespread introduction of LDCT screening in Europe will require coordinated, quality-assured national approaches, as detailed in recent European recommendations (5). It is imperative that a decision to implement screening should be accompanied by clear guidance on how to approach people, how to handle screening results and how to communicate these results to individuals, and that this is supported by both national screening organisations and clinicians. A standard specification is being agreed in the UK that includes all of the optimisation reviewed above. References: 1. National Lung Screening Trial Research T, Aberle, D.R., A.M.Adams, C.D.Berg, W.C.Black, J.D.Clapp, R.M.Fagerstrom, I.F.Gareen, C.Gatsonis, P.M.Marcus and J.D.Sicks,‘Reduced Lung-Cancer Mortality With Low-Dose Computed Tomographic Screening’,New England Journal of Medicine, vol. 365, 2011, pp. 395–409. 2. Fitzpatrick-Lewis, D, M.U.Ali, R.Warren, M.Kenny, D.Sherifali and P. Raina,‘Screening for Colorectal Cancer: A Systematic Review and Meta-Analysis’,Clin Colorectal Cancer, vol. 15, 2016, pp. 298–313. 3. Gotzsche, P.C. and K.J. Jorgensen,‘Screening for Breast Cancer with Mammography’,Cochrane Database Syst Rev, 2013, CD001877. 4. Xu, D.M., H. Gietema, H. de Koning, R. Vernhout, K. Nackaerts, M. Prokop, C. Weenink, J.W. Lammers, H. Groen, M. Oudkerk and R. van Klaveren,‘Nodule Management Protocol of the NELSON Randomised Lung Cancer Screening Trial’,Lung Cancer, vol. 54, 2006, pp. 177–184. 5. Matthijs Oudkerk, A.D., RozemarijnVliegenthart, Thomas Henzler, Helmut Prosch, Claus P.Heussel, GorkaBastarrika, Nicola Sverzellati, S.D. Mario Mascalchi, David R. Baldwin, Matthew E. Callister, Nikolaus Becker, Marjolein A.Heuvelmans, WitoldRzyman, Maurizio V.Infante UP, Jesper H. Pedersen, Eugenio Paci, Stephen W. Duffy, Harry de Koning and John K. Field,‘European Position Statement on Lung Cancer Screening’,Lancet Oncology, vol. 18, 2017, e754–e766. 6. de Koning, H.J., R. Meza, S.K.Plevritis, K. Ten Haaf, V.N.Munshi, J. Jeon, S.A. Erdogan, C.Y.Kong, S.S.Han, J. van Rosmalen et al.,‘Benefits and Harms of Computed Tomography Lung Cancer Screening Strategies: A Comparative Modeling Study for the U.S. Preventive Services Task Force’,Ann Intern Med, 2013.

Screening Study’,Thorax, vol. 72, 2017, pp. 819–824. 8. Brain, K, B. Carter, K.J,Lifford, O. Burke, A. Devaraj, D.R.Baldwin, S. Duffy and J.K. Field,‘Impact of Low-Dose CT Screening on Smoking Cessation Among High-Risk Participants in the UK Lung Cancer Screening Trial’,Thorax, vol. 72, 2017, pp. 912–918. 9. Brain, K, K.J.Lifford, B.Carter, O.Burke, F.McRonald, A.Devaraj, D.M.Hansell, D.Baldwin, S.W.Duffy and J.K. Field,‘Long-Term Psychosocial Outcomes of Low-Dose CT Screening: Results of the UK Lung Cancer Screening Randomised Controlled Trial’,Thorax, vol. 71, 2016, pp. 996–1005. 10. Ten Haaf, K and H.J. de Koning,‘Overdiagnosis in Lung Cancer Screening: Why Modelling is Essential’,J Epidemiol Community Health, vol. 69, 2015, pp. 1035– 1039. 11. Callister, M.E., D.R.Baldwin, A.R.Akram, S.Barnard, P.Cane, J.Draffan, K.Franks, F.Gleeson, R.Graham, P.Malhotra et al.,‘British Thoracic Society Guidelines for the Investigation and Management of Pulmonary Nodules’,Thorax, vol. 70, 2015,Suppl 2, pp. ii1–ii54. 12. MacMahon, H, D.P.Naidich, J.M.Goo, K.S.Lee, A.N.C.Leung, J.R.Mayo, A.C.Mehta, Y.Ohno, C.A.Powell, M.Prokop et al.,‘Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017’,Radiology, vol. 284, 2017, pp. 228–243. 13. Field, J.K., S.W.Duffy, D.R.Baldwin, D.K.Whynes, A.Devaraj, K.E.Brain, T.Eisen, J.Gosney, B.A.Green, J.A.Holemans et al.,‘UK Lung Cancer RCT Pilot Screening Trial: Baseline Findings From the Screening Arm Provide Evidence for the Potential Implementation of Lung Cancer Screening’,Thorax, vol. 71, 2016, pp. 161–170. 14. Flores, R, T.Bauer, R.Aye, S.Andaz, L.Kohman, B.Sheppard, W.Mayfield, R.Thurer, M.Smith, R.Korst et al.,‘Balancing Curability and Unnecessary Surgery in the Context of Computed Tomography Screening for Lung Cancer’,J Thorac Cardiovasc Surg, vol. 147, 2014, pp. 1619–1626. 15. Crosbie, P.A., H.Balata, M.Evison, M.Atack, V.Bayliss-Brideaux, D.Colligan, R.Duerden, J.Eaglesfield, T.Edwards, P.Elton et al.,‘Implementing Lung Cancer Screening: Baseline Results From a Community-Based “Lung Health Check”Pilot in Deprived Areas of Manchester’,Thorax, 2018. 16. Ten Haaf, K., M.C.Tammemagi, S.J.Bondy, C.M.van der Aalst, S.Gu, S.E.McGregor, G.Nicholas, H.J.de Koning andL.F.Paszat,‘Performance and Cost-Effectiveness of Computed Tomography Lung Cancer Screening Scenarios in a Population-Based Setting: A Microsimulation Modeling Analysis in Ontario, Canada’,PLoS Med, vol. 14, 2017, p. e1002225

7. Yousaf-Khan, U, C.van der Aalst, P.A.de Jong, M. Heuvelmans, E. Scholten, J. Walter, K. Nackaerts, H. Groen, R. Vliegenthart, K. Ten Haaf K et al.,‘Risk Stratification Based on Screening History: The NELSON Lung Cancer Government Gazette | 51

Dr Fabrice BARLESI International Association for the Study of Lung Cancer (IASLC) Committee Member

IASLC calls for low-dose thoracic CTscan screening

hile the formal link between tobacco smoking and lung cancer has been established for almost 70 years, Europe has the highest prevalence of tobacco smoking among adults (28 %) and some of the highest prevalence of tobacco use by adolescents (up to 51% in Greenland) among the WHO regions. In this field, we know how important it is to adopt not only common rules and laws (regarding age restrictions to access tobacco, a ban on smoking in public places, etc.) but also uniform taxes and prices in the EU in order to limit intra-European traffic. Unfortunately, EU citizens still have to pay a large tribute to lung cancer, which accounts for 185,000 deaths per year. We can offer the best chance of acure by making the diagnosis as early as possible, when the disease is of small size and eligible for surgical resection. Unfortunately, twothirds of lung cancer patients are currently diagnosed at an advanced stage with limited potential to be cured.

We can probably change this with a lowdose thoracic CT-scan screening for subjects at risk (the definition of ‘at risk’ to be formally decided, but probably including >55 years old, large smoking exposure, low risk for surgical resection, etc). In this field, the European NELSON trial included more than 16,000 patients and its results are awaited in2019. The EU position statement on lung cancer screening (EUPS), published in December 2017, provided a set of nine recommendations on how to take lung cancer CT screening forward in Europe, dealing with many of the outstanding questions that were posed after the 2011 National Lung Screening Trial (NLST). Hopefully, the result from the NELSON trial, along with those already known from the NLST consortium (i.e. a 6 percent and 20 percent decrease in the risk of death from lung cancer and from any cause, respectively, by an annual low-dose CT-scan for three years), will definitively convince European countries to launch large screening programs. www.governmentgazette.eu | 52

Since 1995 and the demonstration of the superiority of chemotherapy over best supportive care for the management of advanced lung cancer patients, large progress has been made, with two major paradigm changes. The discovery of EGFR mutations in the 20th century was the first actionable molecular alteration. Now, advanced lung cancer patients must be screened for at least five alterations (EGFR, BRAF and HER2 mutations as well as ALK and ROS1 rearrangements), with a large number of complementary potentially actionable alterations assessable through Next Generation Sequencing (NGS) testing. It provides the clinicians with useful information in 50% of cases (and in up to 70% of the “never smoked” patients). Secondly, in early 2010 there was birth of immunotherapy and the demonstration of the efficacy of immune check point inhibitors (ICIs).

In the past five years, at least 10 randomised trials based on four different drugs confirmed the superiority of ICIs, alone or in combination with chemotherapy (+/targeted agents), over the previous standard of care for lung cancer patients. It led to the approval of these ICIs by the European Medicines Agency (EMA) and their use in clinical practice. Altogether, these changes provide a large proportion of advanced lung cancer patients with improved outcomes and sometimes prolonged overall survival. However, the price of precision medicine is rapidly growing, related to the drugs and the number of patients to be treated. Today, lung cancer accounts for the highest cost for cancer care in Europe. One of the main concerns is to ensure equal access to these technical, biological, therapeutic and medical resources for all European citizens. Besides getting clinical, pathological or biological results to decide which treatment will be the best for a given patient, access to the drug sometimes remains an issue. Indeed, either because of the time between EMA approval and reimbursement (which might take up to two years), or because of the lack of registered/reimbursed drug, some

European patients may be inadequately treated. There is, therefore, a need for more homogeneous access to approved drugs and also more opportunity to access new drugs, especially through clinical trials. In this field, European regulation is sometimes restraining companies or academics from opening/ conducting early phase trials across different European countries. Efforts should be made to facilitate this way of providing patients with innovative strategies. Lastly, education and research are also key components for equal access to precision medicine for lung cancer patients: education and communication to the public on the disease, which is sometimes viewed as a shameful pathology deserving less support than other cancers; education of the patients, who should be actors in decisions regarding themselves and also future strategies; education of healthcare providers (HCPs), who should be trained inthe new technologies and newly available drugs, with a focus on the management of safety issues. Concomitantly, continuous efforts in translational and clinical research are mandatory to understand primary and secondary resistances to available strategies and develop new treatment options. It supposes to fund lung cancer research at least equally to other cancers such as breast, prostate or colon cancer, which is far from the case today. In the UK, lung cancer research receives £329 per death in comparison to £3,540 per death for breast cancer, a situation which needs to be urgently changed. In summary, worldwide organisations based on experts, such as the International Association for the Study of Lung Cancer (IASLC), together with patients, are key actors to lead advances in lung cancer research and treatment, develop collaborations and lead both worldwide and regional educational events to turn all this progress into more saved lives

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Dion WARREN

Head, EUCAN Oncology Business Unit, Takeda Pharmaceutical Company Limited

Broadening access to genetic testing: the next step in improving lung cancer treatment

espite the growing understanding of the role of genetic mutations in influencing response to targeted treatment, inequalities persist around access to genetic testing in Europe. Overcoming these challenges is essential in improving lung cancer treatment outcomes, explains Dion Warren, Head, EUCAN Oncology Business Unit, Takeda Pharmaceutical Company Limited.

Lung cancer is one of the leading causes of cancer deaths in Europe (1 ), with nonsmall-cell lung cancer (NSCLC) representing approximately 85–90 percent of all lung cancers (2).Often diagnosed in its advanced stages, NSCLCcan be associated with short survival times. However, significant advances in the genetics and treatment of NSCLC have been made in recent years,and theyhave the potential to have a positive impact on lung cancer outcomes. In particular, growing understanding of the biology of NSCLC has led to a deepening recognition that the presence of genetic mutations can influence response to targeted therapy. Testing for genetic mutations and tailoring NSCLC therapy accordingly is now widely accepted as best practice. International guidelines recommend that genetic testing, primarily for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations, should be performed at diagnosis of advanced NSCLC (3) — regardless of age, sex, race, smoking history or other clinical risk factors — and the results of these testsshould guide decisions to ensure patients receive treatment according to their mutation subtype. However, while the use of genetic testing technology is increasing, inconsistent use by physicianspersistsat both national and European level. The potential to improve lung cancer outcomes by improving access to genetic testing is illustrated by the prevalence of mutations in the NSCLC population. For example, approximately 2–8 percent of patients with NSCLC have a chromosomal rearrangement in the ALK gene (4). Given the high numbers of people diagnosed

withlung cancer each year — 410,000 in Europe — this represents a large number of potential patients whose treatment outcomes may be improved via genetic profiling. To address inequalities in access to mutation testing, policy interventions are required to ensure that when a lung cancer diagnosis is made, mutation testing is undertaken promptly so that an appropriate therapy can be chosen which is tailored to the patient’s genetic make-up. It is the role of the industry to work towards educating and training physicians on the importance of mutation testing in guiding treatment decisions.

In addition, ongoing investment in research and development (R&D) is essential to increase our understanding of the many mutations present in lung cancer cells and how to unlock their potential to improve outcomes for patients, along with research to develop additional targeted therapies with high efficacy and broad mutational coverage. Efficient regulatory pathways and R&D funding mechanisms have a role here in fostering cutting-edge research. As part of our efforts to accelerate lung cancer R&D, we support many independent studies by academic, private and government organisations. In addition, ongoing efforts to integrate the patient perspective into R&D are essential. At Takeda we work with over 100 patient organisations in Europe and Canada, harnessing their insights to develop all our oncology initiatives, from clinical trial planning to developing patient resources. Ensuring widespread access to the latest therapies is also critical. Regulatory hurdles must be addressed by timely in-country approvals as well as innovative pricing solutions. The pharmaceutical industry can play a key role here in partnership with other stakeholders via new approaches to reimbursement and navigating commercial agreements with health technology appraisals (HTAs) at a local level. At Takeda we partner with key industry stakeholders to achieve a sustainable approach to pricing and have created patient assistance programs in many of the countries where we operate. There is also further work to be done around

education, awareness and prevention — not least in tackling the stigma associated with lung cancer in public perception, which can act as a barrier to patients seeking timely diagnosis and treatment.

Despite ongoing challenges, given the advances we have seen in recent years there has never been a more dynamic or more complex time to be working in lung cancer. For the ALK+ NSCLC population alone, we currently have 687 patients enrolled in a clinical development program from Phase I to III, as part of our continuous efforts to broaden access, expand knowledge and improve outcomes. Throughout 2018, we areeager to see what the future holds for lung cancer care and in particular how growing collaboration around areas of common interest between patient organisations, policymakers, governments, industry and other stakeholders can create a profound impact on patients’ lives. About Takeda Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. At Takeda Oncology, the oncology business unit brand of Takeda Pharmaceutical Company Limited, we endeavor to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology is available through its website, www.takedaoncology.com. References: 1. American Cancer Society. The Cancer Atlas. The burden: cancer in Europe. http://canceratlas.cancer.org/ the-burden/cancer-in-europe/ Accessed December 2017 2. European Society for Medical Oncology (ESMO). Non-small-cell lung cancer (NSCLC): ESMO patient guide series. 2017. 3. Lindeman N, Cagle P, Beasley M, et al. Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. J MolDiagn. 2013 Jul;15(4):415-53 4. Facchinetti F, Tiseo M, Di Maio M, et al. Tackling ALK in non-small cell lung cancer: the role of novel inhibitors. Translational Lung Cancer Research. 2016;5(3):301-321

Government Gazette | 53

Dr Jens-Peter MARSCHNER TA Head Oncology, Western Europe & Canada,

Global Medical Affairs, AbbVie Biopharmaceuticals

Role of Phase II, single-arm clinical studies in enabling timely access to novel therapies

ancer is the most prevalent cause of death and morbidity in Europe after cardiovascular diseases, with 1.2 million cancer deaths in 2014. Up to 2.5 million Europeans are diagnosed with cancer every year, and this creates a significant social and economic burden. Over the last decade, pharmaceutical companies have been increasing their research and development efforts to discover novel, innovative therapies to fight cancer. In the pursuit ofhigher efficacy and safety, more and more novel oncology therapies are developed for very specific patient populations, i.e. personalised medicines. Challenges in the clinical development of highly innovative compounds to treat cancer The vast majority of these new cancer drugs target specific markers of cancer cells and often require companion diagnostics identifying patients that benefit from these highly specific treatments. As a result of the smaller patient populations involved, it is difficult to generate clinical evidence via traditional large-scale controlled trials.

In addition, trials are often conducted in a salvage setting, without further treatment options, characterised by a high unmet medical need. Consequently, no appropriate comparator or control group exists, and comparing with best supportive care may raise serious ethical concerns and reduce patientsâ&#x20AC;&#x2122; willingness to participate. Based on the above-mentioned aspects, the only reasonable clinical trial design is often a single-arm design in the given smaller patient populations. Challenges in providing patient access to new compounds In the context of high unmet medical need for alife-threatening disease, the treatment has to be made available for patients as soon as possible. Unfortunately, reimbursement of novel regimens with Phase II single-arm clinical trials is a huge hurdle for patients ingetting access. Urgent actions are needed www.governmentgazette.eu | 54

to solve this issue.

high unmet medical needs.

How regulatory authorities adapt to enable timely patient access

Multistakeholder collaboration is key to adapt new solutions to enable timely patient access

Regulatory authorities such as the European Medicines Agency (EMA) have become more flexible with timings and the level of evidence they require to speed up the approval process for medicines. Expedited drug development programmes with early consultations during development may result in quick approvals of drugs that meet medical needs. Manufacturers are now working with regulators to develop a system that facilitates innovation in complex diseases, such as the so-called â&#x20AC;&#x153;adaptive pathwaysâ&#x20AC;? (AP) approach. This is based on stepwise learning of the clinical effects whilst acknowledging uncertainty to accelerate access. Currently, the EMA uses two different procedures to grant marketing authorisation (MA) on the basis of preliminary data. This implies that the EMA requires further clinical research whenever a product is conditionally approved, to close this data gap and to prove long-term clinical benefit. The system gap between regulatory and HTA/reimbursement approval process Patient access to innovative medicines often depends on the national reimbursement process. However, health technology assessment (HTA) agencies often still require large randomised controlled trials (RCT), ideally with an appropriate comparator, to grant reimbursement fordrugs. Novel regimens based on single-arm trials often experience delay or are put on hold for assessment until after Phase III comparative studies. There is a discrepancy between the risk/ benefit evaluation of new therapies by competent regulatory agencies based on medical and scientific aspects and the benefit/risk evaluations by HTA/payers based on cost considerations. These divergent requirements and approaches of regulators and HTA/payers create a gap in the system to the detriment of patients with

The approval and reimbursement pathway from the labs to the patients has to be improved through greater collaboration between all stakeholders. First, a better alignment of data requirements between HTA bodies and regulators is urgently needed to provide appropriate patient access. Second, early and continuous dialogue and collaboration between multistakeholders are critical. It is of utmost importance to achieve a full and common understanding of the value of the novel treatment across the full set of stakeholders, including regulators, HTAs, payers, governments, clinicians and, most importantly, patients. Finally, both the regulatory environment and the pricing and reimbursement mechanisms need to evolve together to allow for a more flexible pathway in order to benefit patients with high unmet medical needs. Conditional reimbursement could be facilitated with the requirement for continued data collection, as well as a more flexible price setting. This is likely to include the use of early access schemes and outcome-based risksharing agreements to facilitate early access. It will not only accelerate patient access to crucial lifesaving therapies, but also increase their probability of success, as the targeted therapies would be given to those patients most likely to respond

LUNG CANCER REPORT

Dr Mary O’BRIEN

Consultant Medical Oncologist, Lung Unit, Royal Marsden Hospital

Anna MINCHOM

Consultant Medical Oncologist, Drug Development Unit and Lung Unit, Royal Marsden Hospital

Assessing the state of lung cancer prevention and treatment in Europe

rognosis of lung cancer is extremely poor asonly 30 percent of men survive lung cancer for at least one year, and this is predicted to fall to 8 percentafter five years or more, as shown by age-standardised net survival for patients diagnosed with lung cancer during 2010–2011 in England and Wales. This is because 60 percent of patients get diagnosed with advanced stage disease, when curing by surgery or a combination of radical chemotherapy and radiotherapy is not possible. In the early stages, lung cancer is usually asymptomatic or only causesminor problems.

The UK government is aware of our need to investigate minor or new symptoms in a rapid way and introduced the TwoWeek Rule (TWR) referral pathway. This guarantees patients rapid access to diagnostic tests and treatment. However, this does not help patients with no symptoms. We must, therefore, identify patients who are at high risk of developing lung cancer and those who have early stage curable disease through effective screening programmes. High-risk patients are, of course, smokers who have a long history of smoking. The term “pack years” is a simple way a person can work out their own risk of lung cancer. The amount of cigarettes you smoke is measured in pack-years. If you have smoked one packet of cigarettes per day for one year, you have one pack-year. If you have smoked two packets per day for 20 years, you have 40 pack-years, and half a pack for 10 years is five pack-years. The risk of cancer increases with increasing exposure and dramatically increases after 30 pack-years, which is why this is one of the basic criteria ofscreening programs. The National Lung Screening Trial in America and the NELSON trial in Europe have both investigated low-dose CT scans for smokers. However, the challenge lies in adapting the results to individual country populations — setting the frequency of scans and identifying the ideal screening population.

In the past, treatment of advanced nonsmall-cell lung cancer has relied on chemotherapy, when drugs are given to slow cancer progression. Although effective, chemotherapy is toxic and often limited in the duration of response.

There have been developments in the treatment of advanced lung cancer in recent years. The first advancement has been the development of targeted drugs — the EGFR and ALK inhibitors. These oral drugs have truly revolutionised the treatment of patients whose cancers harbour the genetic changes that render them sensitive to the drugs. These mutations, however, are found in a minority of patients (both EGFR and ALK mutations are found in less than 10 percent of the European population of lung cancer patients). There is considerable scope to find other targets and treatments. Platforms such as the Stratified Medicine Programme in the UK,whichanalyses large numbers of patient biopsies and matches those with particular mutations to targeted drugs within the MATRIX trial, are working towards this.

cancer.

The number of people who smoke has been on the decline, but that number has plateaued. Continued smoking cessation campaigns, recognising the great addictive component to smoking, and greater governmental regulation of the tobacco industry is vital. In conclusion, lung cancer exemplifies a cancer for which drug development has produced huge benefits, and continued investment, building on this extraordinary foundation, will produce further gains. We can hope that if smoking rates decline we will see a decrease in lung cancer over the next decades, but at present we still have a population which has been fully exposed to prolific smoking for decades. Treatment is only one part of the picture. Investment in prevention and early diagnosis is necessary to ensure lung cancer loses its unenviable status as the number one cancer killer

Immunotherapy is a form of drug therapy using engineered intravenous antibodies, which harness the body’s own immune system to attack the cancer cells. The drugs are active but there are limitations. They are expensive — costs per month can run over £5,000 — and there can be toxicity. Immunotherapy does not work for all patients, but the Programmed Death-Ligand 1 (PD-L1) expression on tumour samples is useful when expressed to a high degree in predicting response to antibody treatment. Improving responses to immunotherapy by combining with chemotherapy seems to improve responses gained. Though many treatment options are available for those afflicted with lung cancer, prevention is always preferable, as it is estimated that 90 percent of lung cancer could be prevented through action and awareness. Smoking is highly correlated with the development of lung cancer, the leading cause of cancer death worldwide. Therefore, smoking cessation is key topreventing lung Government Gazette | 55

Prof Jan BUSSINK

Professor of Biological and Molecular Imaging at the Radboud University Nijmegen Medical Centre

Dr Anne-Marie BAIRD Member of the ECCO Patient Advisory Committee

How can we improve quality of lung cancer care across Europe?

espite considerable advances in diagnostics and therapeutics, overall survival rates for lung cancer have increased by only 4% over the last three decades. Whilst a common explanation for this observation is late-stage at presentation, it is important to ponder if there are other explanations for the modest improvements in lung cancer survival over time. At this juncture, it becomes essential to analyse what needs to be done to improve quality of care for lung cancer patients across Europe. The European CanCer Organisation (ECCO) is addressing these pressing concerns as it prepares to produce the Essential Requirements for Quality Cancer Care (ERQCC) for lung cancer. The ERQCC will set out consensus articulations of the fundamental components for achieving quality care, including, but not limited to, what is required in respect of: • A multidisciplinary team working among core and extended groups of professionals, in a dedicated comprehensive cancer centre or unit • Cancer care pathways • Timelines of care • Minimum case volumes • Audit of outcomes and care • Performance measurement of outcomes and care • Quality assurance of outcomes and care • Professional education needs www.governmentgazette.eu | 56

• Enrolment in clinical trials • Delivery of patient information The ERQCC offers descriptions of the organisational models of cancer care necessary to achieve the best outcomes and care experience for the patient. ECCO has already published such requirements in respect of colorectal cancer, sarcoma, melanoma, and oesophageal and gastric cancer, and is currently progressing similar charters for improvement for breast cancer and prostate cancer. Ahead of the ERQCC for lung cancer, we took some time to speak with a leading healthcare professional, as well as a patient advocate, about some particular concerns in respect oflung cancer care that could be addressed by the forthcoming ECCO Essential Requirements project. Writing for Government Gazette, Prof Jan Bussink, Professor of Biological and Molecular Imaging in Experimental Radiotherapy at the Radboud University Nijmegen Medical Centre in the Netherlands, reflected on what quality cancer care means in respect oflung cancer. Prof Bussink identifies provision of information to patients, patient empowerment and patient involvement as key areas for improvement. Prof Bussink laid emphasis on personalisation of a patient’s treatment, which involves healthcare professionals enabling patients throughout their care pathway with the information they require to make treatment choices.

For instance, he noted that “for patients with stage 1 lung cancer, for example, there is often a choice to be made between surgery and stereotactic ablative radiotherapy (SABR). One can add to this the choices to be made between differing types of surgery. Factors that might influence choice include the rate of growth of the tumour, but also personal choices related to the individual values of the patient, including the impact of different treatments on their daily lives and those of their families.” He noted that there is greater room for improvement in informing patients about these choices and involving them in a real and meaningful way. Canvassing her views on the role of patients in the decision-making process, Dr Anne-Marie Baird, who represents the Lung Cancer Europe (LuCE) patient advocacy organisation within the ECCO Patient Advisory Committee (PAC), says: “Quality cancer care means putting patients at the centre of all decisions relating to their treatment. This means the care team actively listening and acting upon individual patient choices and preferences. Shared decision-making and patient-centred care doesn’t mean anything unless the patient is truly at the centre, with care organised around them.” She insists that a quality cancer care pathway should cover patients from diagnosis through to survivorship and end-of-life care, with research, clinical trial access and psychooncology care playing an integral part of the pathway and not being minor afterthoughts

LUNG CANCER REPORT

Denis HORGAN Executive Director, European Alliance for Personalised Medicine (EAPM)

Europe too slow at bringing innovation into healthcare systems

ccording to the European Commission’s 2018 European Innovation Scoreboard, the EU’s average innovation performance has increased by 5.8%, and is expected to improve by an additional 6% points over the next two years.

Europe has a leading position in industrial sectors such as pharmaceuticals, mechanical engineering and fashion, accounts for 20% of global R&D investments, and yields onethird of high-quality scientific publications. It is strong in incremental innovation and moving ahead in key enabling technologies such as photonics and biotechnology. But Europe is lagging behind in many areas. EU companies spend less on innovation than their competitors. Venture capital remains underdeveloped in Europe. Public investment across the EU falls short of 3% GDP target. R&D intensity is still uneven among EU regions, with investment and research heavily concentrated in Western Europe. And 40% of the workforce in Europe lacks the necessary digital skills. Whilst the innovation performance has increased by 5.8% overall, there has been no convergence between EU countries performing at lower levels and those performing at higher levels. Denmark, Finland, Luxembourg, the Netherlands, Sweden and the United Kingdom are Innovation Leaders, with innovation performance well above the EU average. Austria, Belgium, France, Germany, Ireland and Slovenia are Strong Innovators, with performance above or close to the EU average. In this year’s edition, Luxembourg (previously a Strong Innovator) joins the group of Innovation Leaders, while Germany (in previous editions classified as an Innovation Leader) drops to the group of Strong Innovators. However, overall performance differences between

some Innovation Leaders and the top Strong Innovators are small. The report states that the EU performance gap with respect to Japan and South Korea is expected to increase, that the gap in respect of the US is expected to decrease, and that the performance lead over China is expected to decrease. It is encouraging that firm investments and venture capital expenditures have increased significantly. By contrast, public R&D expenditures as a share of GDP remain below their 2010 level.

So what about innovation in healthcare? Well, the future is hardly looking bright and shiny. There is plenty of great science in Europe, brilliant research and quality innovation, especially in healthcare. The question is how to fully integrate this into national healthcare systems. Personalised medicine is a growing trend. Despite its proven efficacy in certain areas and vast potential in others, it remains a struggle to embed innovative personalised medicine into the EU’s healthcare systems. This is not helped by the fact that healthcare is a member state competence under the treaties, so the European Commission can only do so much. The fact that a new medicine or innovative drug takes more than a decade to get from bench to bedside is totally unacceptable in the 21st century. There is clearly a need, for example, for up-todate incentives and a rewards structure to push forward research, and Europe needs to look at this seriously and quickly. The elephant in the room is that industry has a problem with producing new drugs, especially for smaller markets — rarecancer sufferers, for example — as the chances of them getting their money back under current systems are slender without charging high prices. This, in turn, leads to a lack of take-up of the drugs by healthcare systems across

the EU.

Pharmaceutical companies have to walk a tightrope between eventual market prices and the heavy costs of research and development. On top of this, healthcare system managers have to weighup the prosandcons of new, often expensive drugs, bearing in mind their efficacy and the numberof people who would benefit, while patients obviously want a cure and/ or better quality of life. Despite some incentives, there is a big gap between authorised and available drugs. The complex regulations that govern such products need to be simplified to ensure a faster take-up while obviously bearing in mind safety and efficacy in all cases. While existing systems were designed and developed to support innovation and access for patients to innovative medicines and treatment, these systems are falling short and need to be reassessed. Essentially, and demonstrably, Europe has been slow in taking account of new technologies. The European Commission hardly makes for optimism that this will change any time soon. One of the major concerns is the level of fragmentation between EU member states in the area of health technology assessment (HTA). The coexistence of a centralised procedure for marketing authorisation together with a great number of national (sometimes regional) pricing and reimbursement systems is seen by many as an obstacle to market innovation. Since the latter is a matter of national competence, greater coordination of health technology assessment at the European level would be a possible solution to this problem. Fortunately, attempts to tackle this are currently being made due to a recent proposal by the Commission to reduce repetition among HTA bodies, among other issues Government Gazette | 57

pollution

Campaigning for a cleaner Europe

Neno DIMOV

Bulgarian Minister for Environment and Water

‘It’s time to reconsider our approaches to solving issues related to air quality’

ir pollution is a problem that is recognised by all countries because it is directly related to the quality of life, health and wellbeing of citizens. The improvement of air quality is one of the key priorities of the Bulgarian Presidency of the Council of the EU. For the first time, the issue was raised at the highest political level during the informal meeting of EU environment ministers organised by the Bulgarian presidency on 10th and 11th April in Sofia. As it became clear, over two-thirds of EU member states, including Bulgaria and the western Balkan countries, have a problem with air pollution. There was a general understanding that the air quality issues have not only environmental but also significant socioeconomic dimensions. Transport and domestic heating by solid fuels were recognised as the main causes for the deteriorated air quality in residential areas.

The ministers pointed out, as effective measures to that end, the simplification of regulations in view of easier access to finance, innovative financial instruments, economic incentives, campaigns to raise public awareness, and change of attitudes and behaviour. It was explicitly stressed that the role of the EU funding instruments in the field of air quality should be strengthened. The next MFF should provide for more resources to combat climate change and air pollution. The discussion during the informal ministerial meeting showed that the air quality problem cannot havea single solution because the reasons for it are different. At the same time, its cross-border effect requires collective action, and its complex character requires measures at different levels — European, national, local and personal. The latter dimension is particularly important because it involves a change of attitudes and our daily behaviour patterns. This means that we, as citizens, need to realise that we ©Image: Freepik

www.governmentgazette.eu | 58

have to deprive ourselves of some of our habits and comforts because, ultimately, we are the ones who suffer from air pollution. Not the state or municipality — it is us who get sick. This effort will be the slowest but also the most sustainable one. Because once our consciousness is changed, it is changed forever. In order to stimulate this longterm change, we need to be more informed about the negative effects of polluted air and the existing environmentally friendly alternatives.

Bulgaria is among the countries experiencing serious air quality problems. Our main problem is the high levels of fine particulate matter due to the use of solid fuels for domestic heating. Legislative changes are underway, setting binding levels for sulphur and ash content. Our aim is to make these enter into force before the next heating season, so that no solid fuel below the standards enters the market. The second step, which should come into place by 2020, concerns the ecodesign of heating appliances. In order to be placed on the market, they will have to meet certain ecodesign requirements, including greater efficiency and significantly lower pollution. We are also dealing with the other major pollutant — cars. We have prepared a change of the environmental fee for cars, thanks to which the electric car fee will be abolished, the fee for hybrids and new cars will be significantly reduced and the fee for the old ones increased. But, most importantly, the biggest pollutants —heavy-duty vehicles — will be covered for the first time by this fee, which is undoubtedly a step towards cleaner air. In view of the fact that more than one million vehicles in Bulgaria are over 20years old, we are also imposing significantly higher environmental requirements,to be monitored during the technical inspection. We should not overlook the issue of diesel cars and the growing number of Western European cities where they are banned due to their high harmful emissions. Recently,

we have been hearing a lot about the growing danger of their influx in Eastern Europe. Because the moment you ban a commodity in a certain area, its price falls and it becomes attractive to other markets. This price drop, however, is artificial and not the result of market rules. The problem cannot be solved by a direct ban on their import into the member state concerned, as this would interfere with the free movement of goods within the EU and undermine the internal market. And the latter is one of the Union’s foundations. A pragmatic approach requires that the one who distorts the market should take the responsibility for this, because where there is a right, there is also a responsibility. The idea implies that the states that introduce such bans should not be able to “export” cars that are not “retrofitted” and do not meet certain standards. In order to work, however, this responsibility must be laid down at a supranational European level because it concerns not one but more member states, potentially even the whole EU. The idea is to be further developed and our driving force in the search for workable solutions will be to find a common approach in the name of our common European home. At the same time, our country is looking for innovative ways to solve the air qualityproblems. In February this year, the Bulgarian presidency organised the 21st Eco-Innovation Forum on Air Quality together with the European Commission. The event attracted a recordhigh number of delegates from national administrations, the business and the NGO sector, who presented new technologies, business and management models for improving air quality in the energy, transport and agriculture sectors. Because it is already crystal clear — air quality means quality of life! If we had to build a hierarchy of environmental values, air would be at the top, because it is what we breathe in each and every second

Daniel DALTON mep

UK Member of the European Conservatives and Reformists Group at the European Parliament

Dieselgate response sets the standard for EU cooperation on ENVI regulation

any people still feel very angry about Dieselgate. Consumers were let down badly by car manufacturers, air quality was undermined and the integrity of the European car approval system was brought into disrepute. Meanwhile, the only people to pay a financial price for Dieselgate are the victims who were mis sold non-compliant vehicles and then faced with the inconvenience and disruption of taking their vehicles into garages for recalls to repair the manufacturer’s faulty installations. To rub salt into the wound, European consumers are still awaiting meaningful compensation, unlike American drivers, whilst those responsible do not appear to have suffered significant penalties. When I was appointed draftsman for the European Parliament’s revision of the Commission’s proposed regulation on the type approval and market surveillance framework, which was the legislative response to the scandal, I was clear that the goal was to restore trust in the system of car testing and approvals in Europe. That meant creating a robust framework of checks and balances, with transparency at every stage. The new framework approved in April came after more than two years of work. It sets a framework which should ensure that a future scandal can’t happen again. It sets new, strong standards for regulatory and environmental cooperation across the 28, soon to be 27, EU member states. The European system is one of mutual recognition for car type approval certificates, which means any car approved in any EU country as meeting EU environmental and safety standards is legal to sell and drive in all EU member states. That has the benefit of avoiding the significant time and financial costs of a vehicle going through 28 different testing procedures. It provides a significant

competitive advantage for the EU car market. However, it also means that the safety and emissions standards are only as strong as its weakest components. So levelling the playing field and ensuring all testing and approval authorities meet a higher minimum standard of competence and rigour is key to preventing another Dieselgate. The reform of this framework does this through a number of complementary elements, some new to the EU, some improved from the old requirements.

Proper real-driving emissions testing, checking vehicle performance on the road, much harder to cheat than the old laboratory tests, was already agreed in 2017 and is now in place. Under this new regulation, test results will also be published online and available to expert third parties to check for the first time, adding many more pairs of eyes to look for inconsistencies and warning signs of another Dieselgate. The new framework has at its core a new principle for the post-Dieselgate world, that in a system of mutual recognition you need an umpire to check everyone is sticking to the rules. The European Commission will perform the role of umpire for car approvals. It will oversee a new forum for information sharing of all national type approval authorities and testing services, requiring information from the participants and gathering intelligence on their actions. The forum will also serve to encourage and facilitate the sharing of best practice among authorities, able to help highlight potential problems coming down the tracks and stop them before they become a serious noncompliance with the regulation.

The new role of umpire extends to market surveillance of motor vehicles after sale. Previously many governments undertook limited to no testing of on-road vehicles; now they will be mandated to undertake checks of hundreds of different vehicles of a variety of types and models to ensure they meet safety and emissions requirements. National market surveillance authorities are also required to send information on national testing programmes to the Commission, which will for the first time be empowered to undertake its own testing, based on the information it receives, to check for gaps and failings. It can then take action against a poorly performing national authority. So in future every stage of the process in which a vehicle is deemed legal to drive on Europe’s roads, and once it is on those roads, will be exposed to rigorous transparency requirements and checks and double-checks by the Commission. This new framework, still a national system but with an observant umpire and much greater sharing of best practice, is a good model for cooperation in a range of different regulatory areas in Europe and should help ensure there is no repeat of polluting vehicles illegally driving on European roads undetected for years

To further enhance its role as umpire and enforce the framework, inspection teams will be sent in by the Commission regularly and unannounced to audit the work of national approval and testing bodies. Government Gazette | 59

blockchain

Evaluating current regulatory frameworks

Sirpa PIETIKÄINEN mep

Finnish member of the Group of the European People’s Party (Christian Democrats) at the European Parliament

Blockchain carries potential for the financial sector, but risks should be monitored

he sudden expansion of the market has pushed cryptocurrencies onto the global regulatory agenda. Last year, the market capitalisation of cryptocurrencies surged by over 1,200 %, from US$17.7 billion at the beginning of the year to over US$230 billion in November, Forbes reported.

From a policy perspective, the introduction of virtual currencies, such as bitcoin, raises concerns about their speculative nature and excessive price volatility, risk of total losses, operational failures and a risk of fraud. A particular concern is the trend of startups issuing digital currencies through initial coin offerings (ICOs) and the current anonymity of cryptocurrency traders. Lack of transparency regarding the identities of cryptocurrency traders and their location is feared to encourage their use for moneylaundering, tax evasion and terrorism financing. As essentially a cross-border technology, cryptocurrencies raise a question regarding their impact on financial stability. A fundamental question related to cryptocurrencies is whether they should be treated as currencies or a category of securities. If they be treated as currencies, questions arise regarding their relationship with traditional currencies, central banks and foreign exchange, with implications for monetary stability. Cryptocurrencies, like Bitcoin, Ether and Ripple, lack key attributes of sovereign currencies: an intrinsic value and exchangeability guaranteed by a central bank. Therefore, I see it as more appropriate to talk about crypto-assets rather than currencies, as G20 and Financial Stability Board (FSB) have opted to do. Moreover, it is essential to distinguish cryptocurrencies, and the related problems regarding ICOs and tokens, from their underlying technology. Blockchain, and the distributed ledger technology underpinning it, is likely to have transformational applications in financial www.governmentgazette.eu | 60

services, healthcare, logistics and public e-services.

In financial services, the new technologies have the potential to lower costs of transactions and cross-border transfers, increase operational efficiency and security, and enable innovation around smart contracts with digital signatures. Despite the risks associated with cryptocurrencies, blockchain as technology is in fact expected to improve the traceability and security of online transactions. By facilitating access to services for those without a bank account and by lowering costs, blockchain can support socioeconomic and financial inclusion, provided that safeguards are developed in order to guarantee exchangeability and consumer certainty. By inducing greater competition among market actors, blockchain technology can contribute to a deeper Capital Markets Union. As in digital and innovation policy more broadly, a regulatory approach to cryptocurrencies will need to be pre-emptive yet technology-neutral so as to allow for a level playing field between FinTech companies and traditional ones. The same regulatory principles should be applied regardless of the technology or channel used for the service, following a risk-based approach rather than focusing on the entity or structure. Digitalisation is becoming an integral part of modern economy and cannot be distinguished from other forms of economy. Therefore, while a pre-emptive regulatory approach is needed to monitor emerging risks, a premature or excessive regulatory action needs to be avoided in order not to hamper nascent innovation. Still, regulators should be ahead of risks by monitoring them as they emerge. Here, the framework for monitoring risks related to crypto-assets, presented by the FSB on 16th July in response to a request by G20 finance ministers and Central Bank governors in March in Buenos Aires, is welcome in order

to keep emerging risks insight.

The framework looks at risks related to crypto-assets with a focus on key sources of risk related to cryptocurrencies, volatility, size, leverage, ICOs, the use of cryptocurrencies in payments, and financial institutions’ exposure to virtual currencies. Back in March, however, FSB Chair and Governor of the Bank of England, Mark Carney, reminded us that the size of the cryptocurrency market, less than 1 percent of global GDP, was still relatively small when it comes to posing a risk to financial stability. The EU has been poised to support innovation while combating criminal uses of cryptocurrencies. A recent parliament study found anonymity to be the key challenge permitting cryptocrime. In the latest update of the EU Anti-Money Laundering Directive, the EU introduced new requirements for cryptocurrency exchanges and custodian wallet providers to conduct due diligence procedures, such as customer verification, andreport suspicious transaction activity. Cryptocurrency platforms will need to apply for registration to operate. Going forward, there is a need to ensure market integrity, interoperability of cryptocurrencies with traditional payment solutions, investor protection and, ultimately, financial stability. Identification and know-your-customer techniques related to cryptocurrencies should be further developed. Finally, increased awareness of the risks related to cryptocurrencies is crucial, particularly among non-professional investors. As several member states are starting to develop their own regulatory approaches, for the integrity of the EU single market it will be crucial to have common principles to prevent regulatory arbitrage. A common approach would allow the EU to be competitive in the global competition visà-vis large jurisdictions such as China and the US

Mike SUMMERS Online Voting Program Director, Smartmatic

Blockchain for elections: Silver bullet or bust?

nless you have been living under a rock for the last two years, you will no doubt have heard about cryptocurrencies and in particular bitcoin, which was the first digital currency to achieve global notoriety and to realise subsequent value as an asset. Bitcoin and many other cryptocurrencies are underpinned by a fundamental technology called blockchain, the use of which has exploded to support uses above and beyond digital currency, into supply chain management, energy distribution, law enforcement, music streaming, copyrightcontrol and even wine-making!

For the purposes of explanation, blockchain is a decentralised digital ledger or database of transactions or information. The decentralised nature of blockchain means that there is no central server or authority to trust, which means that the database of transactions is held and updated independently by each participant (“node”) in a network. Any changes to the information in the database are reflected instantaneously to all other nodes so an exact copy of the database exists on all nodes in the network. Supporting this distributed approach is an underlying cryptographic protocol which organises the information stored in the ledger into sequential blocks of information which contain a cryptographic hash of the previous block, a digital timestamp and the transactional data. The blocks are linked or “chained” and the data in any given block cannot be altered retroactively without the alteration of all subsequent blocks, which requires consensus of the majority of nodes in the network. In this respect, blockchain offers an excellent tamper-proof mechanism for demonstrating the integrity of recorded information in a permanent and verifiable way. It is, therefore, no wonder that technology investors are clamouring to pump money into startups which are building products and services around blockchain. One of the potential uses for blockchain is within the election process and in particular for online voting. Online voting, which was pioneered in Estonia, is understandably gaining popularity with

election management bodies (EMB) who are seeking to address the ever-increasing decline in election participation, which, according to a 2017 World Bank report, has dropped 10% over the last 25 years. The promise of tamper-proof voting systems is clearly appealing to EMB and governments who are looking to make voting more accessible and convenient whilst being able to demonstrate the integrity of election processes in the face of a perceived increase in potential cyberthreats to the democratic process.

Blockchain is something that leading election technology companies are, therefore, keen to incorporate into their product portfolio. It has been an area of active research at Smartmatic since 2014. The first ever implementation of blockchain in a binding online voting project was conducted in 2016 for a presidential primary election for the Republican Party in Utah. In this project a private, permissioned blockchain was used as a mechanism to demonstrate the integrity of the digital votes in the electronic ballot box and to prove that no votes had been deleted or tampered with and no ineligible votes added. Since then, there has been a rush of other companies seeking to capitalise on the blockchain phenomenon and to specifically jump onto the blockchain voting bandwagon. But is blockchain really the “silverbullet” for election integrity that many claim it to be? The recent volatility in the price of Bitcoin has raised the question about the viability and promise of cryptocurrencies and sceptics have also raised concerns over the technical performance of some blockchain implementations. The reality is that, like all early stage innovations, blockchain has certain limitations and some blockchain platforms have experienced considerable “teething issues” which may not be immediately obvious among the almost daily claims of blockchain salvation. Firstly, many public blockchain platforms are slow when it comes to performance and scalability. Bitcoin is estimated as having a transaction processing capacity of between 3.3 and seven transactions per second, which would make it unwieldy at best and unusable at worst for large scale governmental

elections.

Secondly, the public nature of many blockchains raises issues around voter anonymity and privacy, which are fundamental properties of the democratic process. Additionally, the very public and decentralised nature of many blockchains is at odds with the standard governance model of elections, in which EMBs are singularly responsible and held accountable for validating election results and verifying the integrity of end-to-end electoral processes. It is also worth noting that blockchain in splendid isolation does little to contribute to the security of the online voting process. Fully secure, provable online voting requires a plethora of other processes and technologies, such as end-to-end vote encryption from the point of casting, digital signatures as a mechanism to validate vote eligibility and vote integrity, and verifiable cryptographic processes as well as other logical, physical and procedural security processes. So as with any supposedly “gamechanging” solution, it’s critical not to simply believe the hype around blockchain! That said, ongoing research into and development ofblockchain and other distributed ledger technologies will flush out and ultimately solve many of the earlystage performance and privacy issues. Our research team at Smartmaticisvery much at the forefront of these problem-solving efforts and is a key partner in a European Union Horizon 2020-funded research project called PRIVILEDGE, which seeks to solve the issues of voter privacy whilst still harnessing the immutable and integrityproving properties of blockchain. In conclusion, as it stands today blockchain on its own is not apanacea for online voting or the solution to help EMB run better elections. However, when applied to specific areas of the election process and when used in conjunction with other security, verification and auditable processes, it can help improve the integrity of an election in a public way. It is, however, only one of the many toolsets that need to be used by governments to help them run better, verifiable and auditable elections to help foster public trust in the election process Government Gazette | 61

India FORD Body language expert

Allow your body to do all the talking

Some people walk into a room with a powerful aura and immediately have the crowd following them. They just ooze confidence, credibility, competence and charisma — or in simple terms — radiate a powerful leadership presence. Even before they open their mouth, people in the room involuntarily grant this person the highly coveted alpha position — that of a leader. Creating such a powerful ‘executive presence’ is no easy task. From head-to-toe, body language expert India Ford offers simple and subtle adjustments, which instantly changes your ‘energy’ and creates a powerful executive presence

©Image: iStock

ost leaders have the skill and functional expertise, but often fail to manifest a striking executive presence — and the lack of such a powerful persona is likely to hold them back from reaching the pinnacle of their careers. People often refer executive presence to a set of behaviours – which create a first impression about you – and, amazingly, this presence is almost always felt instantaneously, long before the person utters a word. How can a person walk in and immediately create an impression that exudes executive presence? Are some people naturally blessed with an innate ability to attract, charm and influence the people around them? What is it that they do differently? How do they create this

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magical presence which is helping them boost their leadership brand?

a different way — in a more relaxed, open and all-embracing manner.

If this magical presence is created before one speaks, then we can obviously remove the verbal content from the equation, which now leaves the most powerful communication device to take precedence — our body language!

Executive presence is all about how people communicate through their bodies and control the powerful information imparted through their body language in order to make a good impression.

Most people assume that communication takes place only when we talk, but nothing could be further from the truth. By the time you speak to introduce yourself, your body language will have already spoken a thousand words by sending fleeting cues which others will unconsciously pick up and use to make a powerful assessment about your levels of confidence, credibility and competence. The people who create this magical presence move in

Words do not play a part in creating an executive presence, as our brains are hardwired to make an instant assessment based purely on certain cues emanating through our body language. These cues are transmitted through our posture, facial expression, the way we walk, the speed at which we walk, our gestures and several other factors. Each of these send powerful messages about our levels of confidence, credibility, competence

PERFORMANCE Make your mind your ally

trustworthiness and attitude. Even before we introduce ourselves, the other person unknowingly determines our levels of confidence, credibility, competence and our status —based only on what they see. How can one develop that charismatic presence? Let me give you four very quick tips you can immediately apply to create a powerful first impression: Posture: powerful body language begins with posture, i.e. the way you “hold” your body. It is vital because it creates the foundation. It is the first thing our brain is compelled to notice. Yes, your mother was absolutely right when she asked you to stand up straight! Before you start to walk, make sure to adjust your posture by pushing your shoulders back and down. Hold your head up in a vertical position and ensure your chin is parallel to the floor. Right from the moment you adjust your posture, you will boost the perception others have of you. Speed: what’s one thing that will instantly determine how others assess your status, confidence and competence? It is the “speed” at which you walk. Some of the world’s most powerful people often walk at a slow and measured pace. Do remember that rushing in with very quick, jerky movements could immediately send a subliminal message of low status and high stress — suggestive of the fact that things aren’t quite under control. So make sure not to rush in anywhere. Control the speed at which you walk and project a slow and relaxed demeanour in order to create a positive image of control. Facial expression: the next thing people notice is your facial expression. Your personality, attitude and state of mind will be visible by what people see on your face. When our face is at rest it can fall into what I call a default screensaver expression —

which canoften be stern. A stern expression can make people become defensive around you, or worse, avoid you altogether. Therefore, it is essential to keep your facial muscles calm and relaxed. The smile: the simple smile is our most powerful gesture to convey warmth, confidence and approachability. It is vital for creating good vibrations. We’re not looking for a ’70s game show host thousand-watt all-teeth smile — just a simple half-inch upturn at the corners of the mouth will create a facial icebreaker and instantly make you look nonchalant, confident and approachable. Think about the elements of a good impression that you want to be proficient at and work on them. The world’s most powerful and successful people understand the power of their body language and the part it plays in ensuring a successful outcome in every interaction. They understand how to harness the power of this influential language to ensure they exhibit a specific set of non-verbal behaviours which directly elevate their image, instantaneously creating that powerful executive presence while gaining a powerful competitive edge in every situation. Leaving body language to chance is one of the most fundamental mistakes many aspiring leaders make — blissfully unaware that 55% of their communication is unconscious. However, those who are aware of this will gain a huge advantage over others, because, as with anything important, knowing what not to do is just as important as knowing what to do. It is crucial for every leader to be mindful of how they “speak” through their bodies, simply because so much of the most powerful impression is created based on what people “see”.

congruently without having a basic knowledge of non-verbal communication. All our efforts to communicate effectively can be thrown out of kilter by the tiniest non-verbal gestures such as our posture, our walk, the way we make eye contact as we enter, our smile and the way we stand when getting ready to deliver a pitch. To gain a powerful competitive edge in any situation, you have to apply a new way of thinking and learn how to utilise 100% of your communication channels – and not just the 7% (the words) that most people focus on, because it is only through your non-verbal communication that you can create that powerful X-factor. For those who invest in understanding how to “speak” through their most powerful communication channel, the results will go beyond any professional qualification. Regardless of whether you desire to have an impact or influence and gain a powerful competitive edge in negotiations, meetings, speeches, pitches and presentations, it is your body language which will play a key role in the level of your success and how quickly you achieve it. India Ford is an internationally renowned body language expert based in central London. She is a highly respected trainer, executive coach, business consultant and keynote speaker who remains constantly in demand. India’s wide range of prestigious clients include global media corporations, major advertising companies, global PR agencies, leading production companies, top-ranking law firms, heads of state, politicians and leaders of multiple Fortune 500 companies

It is also almost impossible to communicate effectively and

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PERFORMANCE Make your mind your ally

Ivan ROBERTSON Co-founder, Robertson Cooper Ltd

The road to resilience

lthough being in work is generally better for mental health than being out of work, it is clear that the pressures and stresses of work life sometimes gets very difficult to handle. Stress and mental health problems are reportedly the major causes of short- and long-term absence from work. An individual does not need to fall sick to recognise the challenges and stress created by their work environment. Personal resilience is what enables people to cope with the pressure, whether it is workrelated or due to other factors. Resilience is about maintaining wellbeing under adversity, as well as supporting recovery. Its origins lie in the experience and the underlying psychological makeup. Resilience is not a fixed trait and can be developed.

©Image: iStock

Although there is a lot of enthusiasm for understanding personal resilience, there is no single agreed definition. Definitions vary from quite narrow ones that focus exclusively on recovery from trauma through to wider ones that see resilience as an ongoing protective capability that enables proactive learning and growth through conquering challenges as well as reactive recovery. In essence, resilience provides individuals with the capacity to cope with adversity. A useful practical perspective sees resilience as having both behavioural and psychological components: the psychological component of resilience enables people to maintain their mental health and wellbeing when faced with adversity — not necessarily only when recovering from trauma. The behavioural component of

resilience enables people to remain effective at home and at work and focus on the tasks at hand. Given the importance of personal resilience in maintaining psychological health and behavioural effectiveness, it is interesting to consider its origins. Are some people naturally more resilient than others? Can resilience be developed? Do stressful experiences make you more or less resilient? In fact, because of their underlying personality, some people are more likely to be naturally resilient. Recent research has indicated that people who are judged to be more resilient display specific personality characteristics linked to extraversion (they are assertive and cheerful), conscientiousness (they are focused and resistant to distractions from the task at hand) and openness to experience (they are not particularly receptive to their inner thoughts and imagination). One practical model that draws on research concerning the role of personality in resilience is embodied in the freely available “i-resilience” tool (http://www. robertsoncooper.com/iresilience/). This tool breaks personal resilience down into four key components: adaptability, confidence, social support and purposefulness. Although resilience may be related to the underlying personality, it is not by any means a fixed personal characteristic. The underlying personality may provide a platform for resilience but environmental and experiential influences play an important part. In fact, research strongly suggests that some stressful experiences may help build resilience, as long

as they are not too traumatic. Extremely damaging traumatic experiences may well predispose people to subsequent mental health disorders but there is also evidence indicating that exposure to significant adversity may help build resilience. For example, children exposed to moderately stressful events are often able to cope with subsequent stressors. The same inoculating impact of stressful events has also been observed in working adults when they have had to work in extremely challenging roles, e.g. recovering bodies after disasters. Research on resilience training has provided more direct evidence that resilience is amenable to change. A recent systematic review of all published research evaluating resilience training in the workplace revealed a positive effect of the training, especially on mental health and subjective wellbeing. It is important to emphasise, however, that resilience training in the workplace is not a panacea. If people are working within an environment that does not value them and which pays little regard to their wellbeing, broader cultural and management issues need to be tackled first, before resilience training can be of any value. Ivan is co-founder of Robertson Cooper Ltd which provides psychological wellbeing and engagement solutions to organizations. Ivan was at the University of Manchester (UMIST) for over 20 years, where he was Professor of Work & Organizational Psychology, Head of Manchester School of Management and Pro-Vice Chancellor. He is now Emeritus Professor at the university. He has worked on consulting assignments, published over 40 books on Work & Organizational Psychology and over 200 scholarly articles/conference papers

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Recommendations to reshape policy making

prostate cancer REPORT

Recipe to beat prostate cancer in Europe

Call for action

Putting patients at the centre of all treatment decision: Shared decision making and patient-centred care doesnâ&#x20AC;&#x2122;t mean anything unless the patient is truly at the centre, with care organised around them. It is necessary to remind that patients are and should always be at the centre of the treatment.

Improve population-based screening: The European Union should initiate population-based, organised PSA testing programmes.

Addressing the data challenge: There is a need to liberate data to strengthen our battle against prostate cancer. A concerted sharing of resources and information should be organised between member states. Data sharing at the EU level should be increased and regulation must be harmonised within member states.

Creating greater awareness: The European Commission should help create the same level of awareness as breast cancer. Civil society can lead these promotional campaigns and advocate prevention programmes as ambassadors.

PROSTATE CANCER REPORT

Introduction

Prostate cancer is the most common malignancy in men in Europe, affecting at least one in seven men in Europe and accounting for more than 4,17,000 new cases and 92,000 deaths annually.

The past decade has ushered in several promising treatments for advanced prostate cancer, with several new therapies approved between 2004 and 2013. However, despite the availability of new life-extending therapies, many patients across Europe are still not getting equal and timely access to treatment. Outcomes can be improved by effective screening programmes, early diagnosis and treatment in line with current guidelines. Evidence shows that early diagnosis gives men many more treatment options and improves their survival chances. Despite an endless debate on screening, we are yet to identify a way to catch prostate cancer early and simply donâ&#x20AC;&#x2122;t have an accurate and specific enough test for prostate cancer. Unacceptable inequalities persist in prostate cancer survival, which varies from 88% in Central European countries to 72% in Eastern European countries. Saving lives and ensuring quality of life requires urgent action at the political level

Contents policy recommendations to improve prostate cancer treatment

Specialised healthcare policy institutions present their fast-track strategy to promote EU-wide screening at ICPS Prostate Cancer Europe 2018 Prostate cancer screening Angela Culhane from Prostate Cancer UK analyses the screening landscape in UK

Prof John-Pierre Droz and Dr Helen Boyle write about the challenges in treating senior adults with prostate cancer

Prostate cancer in elderly

Focal therapy Dr Jeniffer L. Currin from AngioDynamics reviews focal therapy as an emerging treatment option for men with localised prostate cancer

Prof Hein van Poppel, Adjunct Secretary General for Education from European Association of Urology EAUâ&#x20AC;&#x2122;s vision for prostate cancer policy in EU

Quality of survival Gunnar Culhane from Bayer reminds us about the importance to preserve good quality of life during and after treatment

Prof Ola Bratt, Professor of Urology from Sahigrenska University Hospital calls for population-based, organised screening programmes

The EAU vision

Towards organised screening programmes

©Images: ICPS

EU fight against prostate cancer – an agenda for change

Over the years, the number of men that have been diagnosed with prostate cancer in Europe has steadily increased — thanks to greater awareness, early detection and an aging population that leaves us with a greater population of older men. Yet, prostate cancer continues to remain the main cause of death among men in Europe. Canvassing for a change in the world of prostate cancer policy, the International Centre for Parliamentary Studies recently brought together key stakeholders to review current policy and research challenges in prostate cancer, address hurdles and barriers, identify new research opportunities and promote ambassadorship for intelligent and organised PSA screening

rostate cancer is the most common malicious tumour in men, with every seventhman having the risk of developing prostate cancer. In the European Union, prostate cancer is ranked first among the most frequently diagnosed cancers among men, with around 345,000 new cases estimated in 2012. Over the years, the number of men that have been diagnosed with prostate cancer in Europe has steadily increased — thanks to greater awareness, early detection and an ageing population that leaves us with a greater population of older men. Despite significant medical advancements and promising treatments, several barriers in accessing these treatments still exist. Although survival rates after prostate cancer diagnosis have improved in the past two decades, survival analyses regarding the socioeconomic status suggest inequalities indicating worse prognosis. Prostate cancer is a considerable healthcare problem that would benefit from a uniform EU-wide risk-adapted early detection programme. Being conscious that the EU must raise greater awareness of the disparities in prostate cancer treatment, the International Centre for Parliamentary Studies (ICPS) www.governmentgazette.eu | 70

gathered EU policymakers, medical and clinical professionals, academic experts, healthcare players and patient groups to examine the ongoing challenges in managing prostate cancer. Chaired by Professor Hein Van Poppel, Adjunct Secretary General for Education, European Association of Urology, the Prostate Cancer Europe Roundtable 2018 brought together representatives from across 12 European countries and examined a wide assortment of issues ranging from prevention and screening, the need for greater EU collaboration, reimbursement for treatment, data-sharing and patient treatment. Followed by a series of policy updates from the European Commission, the European Association of Urology and the WHO Europe, delegates at the roundtable had a unique opportunity to appraise the efforts of the policymakers and provide solutions to some of the most pressing challenges in managing and treating prostate cancer in Europe. Tackling inequalities of treatment and care in Europe Cancer survival rates have been worse for Eastern European and UK/Ireland patients than those of other European regions. Access to drugs for men with advanced prostate

cancer is very different depending on which country they live in. Increased mortality is not only associated with delayed diagnosis. Greater risk of cancer death together with worse stage-specific survival suggest less effective care, probably in part because of fewer resources. There is a pressing need to tackle inequalities of treatment and care. Promoting latest advances in diagnosis and treatment While screening reduces spread and mortality, educating men from an early age to seek active surveillance is a necessity. In addition to advocating for more active surveillance in the EU, screening techniques need to be more harmonised and should provide patients with the best information available on the potential outcomes. The screening or diagnosis of prostate cancer has often been criticised as fostering overdetection and overtreatment and leading to potentially harmful and unnecessary procedures for asymptomatic patients. However, a lot has changed over the past 10years and this common assumption needs to be changed. In addition, modern multiparametric MRI of the prostate could address such challenges

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However, disparities betweencountries ofavailability and costs of such machines are very high, preventing its effective EU-wide implementation. In addition, we urgently need more training of medical staff to achievesuch images . Coming as a potentially positive prospect for the development offuture EU harmonised programmes, recent remarks from Vytenis Andriukaitis, European Commissioner for Health and Food Safety, recently highlighted that “the Commission will support under its Health programme a Joint Action starting in March 2018 to collect additional evidence for a possible inclusion of prostate cancer screening programmes in the National Cancer Plan.” While the current challenges in prostate cancer research and policy is multifold — pertaining to risk assessment, differential diagnosis, and improving development of and access to new treatments —delegates agreed that the EU should invest more in research. Delegates at the ICPS Prostate Cancer Europe 2018 call on policymakers to implement, as soon as possible, effective and long-term measures toprevent and manage prostate cancer in Europe and table a few significant recommendations to improve management of this killing disease. 1. Putting patients first: it is always necessary to remind ourselves that patients are, and should always be, at the centre of the treatment. Empowerment and involvement of patients and patients’ organisations would enrich reflection on how to tackle

prostate cancer. We should create patient advocacy groups in every EU member state to empower patients. 2. Patient registries and databases are essential to permit the pooling of data needed to achieve a sufficient sample size for clinical research. Regulations should be adapted to allow more sharing of patient data and biological materials. 3. Men should be carefully informed about the various methodsof treatment, which may also differ according to the individual patient’s needs and wishes. Only well-informed patients,along with their physicians,can choose the best treatment for themselves. 4. Not every cancer has to be treated with surgery immediately. Younger men have the chance and choice to undergo active surveillance. Men with a shorter projected lifespan of less than 10 years should undergo watchful waiting. 5. Improving outcomes: it is crucial to provide a prompt and accurate diagnosis of prostate cancer at all stages of the disease. Population-based prostate cancer screening should be implemented in the same way as breast, bowel and cervical cancers. The European Union needs be active in the ongoing change of the infrastructure of prostate cancer care and in theinitiation of population-based organised PSA testing programmes. 6. Inequalities of early detection and treatment between countries should be reduced.

7. The European Commission should allocate long-term funds for research into prostate cancer, with increased investment in research centres, and with advanced databases of biological and clinical data. More research intonew markers and specific treatment is needed. 8. It is essential to sustain awareness campaigns, both at European and national level, and it is particularly important to increase awareness among younger generations. 9. Access to innovative treatments and personalised medicines should be made fast and equitable for all prostate cancer patients who can benefit from them. 10. A concerted sharing of resources and information should be organised between member states. Data sharing at the EU level should be increased and regulation must be harmonised within member states. 11. Health economic analysis should be conducted regularly, enabling professionals to analyse the real costs of treatments,not just of survival but also oflong-term followups. We need to have an economic analysis of what we want to seeimplemented (price of machines, applicability and costs) if we want to be heard. The government could help, but they need a clear proposal. 12. Finally, policymakers should do more to ensure guidelines are followed and should play a bigger role in shaping them. Delegates at Prostate Cancer Europe 2018 AngioDynamics, Policy and Project Officer, Association of European Cancer Leagues (ECL), Medical Director, Amethyst Radiotherapy and Oncology Center, Bayer AG, Scientific and Policy Officer in charge of cancer research, European Commission - DG RTD, National Officer, Europa Uomo, Exact Imaging, Adjunct Secretary General for Education, President, European Association of Urology, Trustee, Estonian Society of Urologists, Trustee, The Graham Fulford Charitable Trust, Urologist, Italian Society of Urology, Janssen, Deputy Prime Minister and Minister for Health, Ministry of Health, Malta, Urologist, North Estonia Medical Centre Foundation, Senior Policy Manager, NHS European Office, Director, Queens University Belfast, Radiologist, Radboudumc, Urologist, Robert Schuman Hospital, President, Swiss Society of Urology, Associate Professor of Urology, Swedish Urological Association, Urologist, H.S.E - University Hospital Galway, Chairman and Head of Urology, University Medical Centre, Professor of Urology, University of Gothenburg, Technical Officer, WHO Regional Office for Europe Government Gazette | 71

Angela CULHANE Chief Executive, Prostate Cancer UK

Is the case for a prostate cancer screening programme changing?

active surveillance as an effective treatment option and improve how clinicians discuss this with men.

rostate cancer survival rates are, on average, better than those of some other cancers. However, on average doesn’t help much if you are one of the more than 8,000 men diagnosed each year with advanced (stage IV) prostate cancer in the UK. Ten-year survival rates drop from 98% for those diagnosed early to only 22% for those diagnosed late. It is easy to lose sight of this stark difference in survival when mortality is averaged across the large — and growing — number of men who get prostate cancer. It seems everyone knows someone who has had prostate cancer for years without it affecting their life expectancy. But the statistics highlighted by Prostate Cancer UK earlier this year, that prostate cancer is now the third biggest cancer killer in the UK, help to bring home that this is a major health problem. Early diagnosis gives men many more treatment options and improves their survival chances. So why, despite endless debate on the subject, do we not have a screening programme to catch prostate cancer early? The answer is that we simply don’t have an accurate and specific enough test for prostate cancer yet. The PSA (prostate-specific antigen) test on its own is just not up to the job. In 2015, Public Health England’s National Screening Committee determined that the harms of a screening programme based on PSA testing alone outweigh the benefits. www.governmentgazette.eu | 72

More recently, the US Preventive Task Force recommended against PSA-based screening. This is because the potential harm from false positives, unnecessary biopsies, overdiagnosis and unnecessary sideeffects from overtreatment all outweigh the reduced mortality gained from diagnosing men earlier. More recently, the CAP trial also found no statistically significant improvement in men’s survival at 10 years from inviting men to be screened using the PSA test. But the balance of benefits versus harm from screening is now starting to change. Multiparametric MRI before biopsy (mpMRI) allows for more accurate diagnosis, image-guided biopsies and fewer unnecessary biopsies. This reduces the potential harm of using the PSA test. Prostate Cancer UK has been working with NHS teams across the UK to ensure that men have access to mpMRI, addressing some of the barriers to its availability, including workforce capacity, scanner capacity and the technical calibration of scanners. Additionally, greater use of active surveillance can reduce the harm of sideeffects associated with more radical treatment. By identifying which cancers are likely to be low grade and monitoring them, rather than radically treating them, harm can be reduced. Prostate Cancer UK has been working with clinicians to develop a clinical consensus on a best practice approach to active surveillance. We are also exploring how to encourage men to see

Of course, the ideal solution would be a simple blood or urine test to improve on the accuracy of the PSA test. A number of research teams globally have been working on this. Prostate Cancer UK is looking at whether the Swedish Stockholm-3 test, made up of a panel of new tests for genetic and protein biomarkers, could be as effective in the UK’s more diverse population as it seems to have been in Stockholm in reducing the number of men referred for biopsy without reducing the number of aggressive cancers detected. It will be important to establish also whether it will work (and be costeffective) within the NHS. At the same time, Prostate Cancer UK is developing a risk assessment tool which can be built into GPs’ computer systems. It will use readily available information, such as age and other risk factors, alongside a PSA ratio to calculate a man’s risk of having aggressive prostate cancer. The gradual process of tipping the scales in the UK to a position where the benefits of a screening programme could outweigh the harm is well underway. Prostate Cancer UK is beginning a programme of work to engage with the various key stakeholders to ensure any concerns are being addressed, so that everyone involved can unite to improve outcomes for men. At this point the real work begins. There are many lessons that can be learnt from existing screening programmes, especially around workforce capacity and getting good uptake from people invited for screening. Just having a screening programme will not be enough and we need to be ready to overcome these challenges before any programme is introduced. It’s a difficult, complex process, but the prize is huge in terms of saving lives and taming prostate cancer. We won’t give up on this and we hope others will get on board to help us to achieve the change needed

PROSTATE CANCER REPORT

Dr Jennifer L. CURRIN

Director, Medical Affairs, AngioDynamics

Focal therapy - an emerging treatment option for localised prostate cancer

rostate cancer (PCa) is the fifth leading cause of death and the second most common form of malignancy among men diagnosed with cancer around the globe. (1) Prostate specific antigen (PSA) testing, which was considered to be a revolutionary screening technique for cancer diagnosis when it was developed in the 1990s, drastically increased the number of patients diagnosed with PCa. (2) The controversial use of PSA resulted in overdiagnosis and over treatments to cure early-stage cancers. (1) Guidelines recently issued by regulatory agencies such as the European Society for Medical Oncology and the European Association of Urology contain different recommendations regarding age groups and intervals for PSA testing for PCa. Despite the guideline changes, it is estimated that there are around 1,600,000 new cases of PCa and 366,000 PCa deaths annually. (2) Treatment options like active surveillance, radical prostatectomy (RC) and external beam radiation are the standard whole-gland therapies for PCa, because it was originally thought that PCa is a multifocal disease. (3) However, histological findings have demonstrated concentration of the disease in a single foci or just one half of the prostate. Along with an improved understanding of the pathology of the disease, improvements in imaging and biopsying techniques have made focal prostate treatment an attractive option for some men. (4) According to a recent study, using a template mapping prostate biopsy, 92% of men diagnosed with PCa were eligible for focal therapy (FT). (2) However, to date there is no consensus on who is a candidate for focal therapy, and men are encouraged to discuss treatment options with their urologists. The goal of FT is to halt the progression of the disease without the need for treating the entire gland, which reduces the risk of genitourinary adverse events related to the injury caused to the benign prostate tissue, the bladder neck, external urinary sphincter or the adjacent neurovascular structures, and minimizes treatment-related toxicity.

(3)(6) A recent systematic review by Walker et al demonstrated FT in general had less impact on erectile function than whole gland ablative therapies. (5)

There are many different modalities available for FT, each utilizing a different energy source. Examples include high-intensity frequency ultrasound (HIFU), cryoablation, interstitial laser ablation, photodynamic therapy (PDT), focal brachytherapy, radiofrequency ablation (RFA), and irreversible electroporation (IRE). (3) Irreversible Electroporation with the NanoKnife® system is a unique minimally invasive technique that has been used to treat focal prostate lesions. Unlike other ablation modalities that rely on tissue heating or cooling, the NanoKnife procedure delivers a series of high voltage direct current electrical pulses between electrodes placed transperineally under image guidance. The electrical pulses generate an electric field that disrupts cell membranes, causing nanoscale defects in the lipid bilayer. The cell death mimics apoptosis, or programmed natural cell death, and therefore is less inflammatory. (7,8) Since the NanoKnife technology does not rely on thermal tissue destruction, it can be used in close proximity to blood vessels and nerves. Preliminary studies have suggested this technique is safe and effective with limited gentio-urinary functional impact and encouraging short-term oncological outcomes. (4) Additional studies are ongoing, including a multicentered randomised control trial, an international prospective registry, and a study evaluating the use of IRE to treat radio-recurrent prostate cancer. In conclusion, the side effects of comprehensive treatment have paved the way for FT, which appears to be a promising and safe treatment option for PCa. Patients with Index lesion of 0.5 cm3 or more with Gleason pattern of 4 or more with any size are clinically significant and can be considered for focal ablation. (1) While

there are several FT modalities, such as cryotherapy and thermal laser, there is a concern of early toxicity and recto-urethral fistula, which has not been reported with IRE treatment. Additionally, IRE has shown potential benefits due to its non-thermal technique, and the procedural time is comparatively less than the other available FT. (9) Thus, increased focus on the use of FT--including evolving treatment options such as NanoKnife--is pivotal for patient care.

References: 1. Edison, E., Shah, T. T., & Ahmed, H. U. (2017). Focal Ablation of Early- Stage Prostate Cancer. Urologic Clinics of North America, 575-585. 2. Giannarini, G., Gandaglia, G., Montorsi, F., & Briganti, A. (2014). Will Focal Therapy Remain Only an Attractive Illusion for the Primary Treatment of Prostate Cancer? Journal of Clinical Oncology, 1299-1301. 3. Hoffman, R. M., Elmore, J. G., & O’Leary, M. P. (2018, January 15). Screening for Prostate Cancer. Retrieved from UpToDate: https://www.uptodate. com/contents/screening-for-prostate-cancer 4. W, V. D., MJ, S., AR, S., AMF, K., JE, T., F, T., . . . Shnier R, D. W. (2017). Focal Irreversible electroporation as primary treatment for localized prostate cancer. Urological Oncology. 5. Walker, N. A., Norris, J. M., Shah, T. T., Yap, T., Cathcart, P., Moore, C. M., . . . Minhas, S. (2018). A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review. Urologic Oncology, 67-76. 6. Zhang, K., Bangma, C. H., & Roobol, M. J. (2017). Prostate Cancer Screening in Europe and Asia. Asian Journal of Urology, 86-95. 7. Davalos RV, Mir LM, Rubinsky B (2005) Tissue ablation with irreversible electroporation. Ann Biomed Eng 33: 223–231. 13 8. Edd JF, Horowitz L, Davalos RV, Mir LM, Rubinsky B (2006) In vivo results of a new focal tissue ablation technique: irreversible electroporation. IEEE Trans Biomed Eng 53: 1409–1415. 14. 9. Valerio, M., Stricker, P. D., Ahmed, H. U., Dickinson, L., Ponsky, L., Ponsky, R., . . . Emberton, M. (2014). Initial Assessment of safety and clinical feasibility of irreversible electroporation in the focal treatment of prostate Cancer. Prostate Cancer Prostatic Dis, 343-347

Government Gazette | 73

Gunnar SCHROEFEL Patient Advocacy Relations, Bayer AG

‘Quality of survival matters as much as length of survival’ relationship.

In earlier disease stages of prostate cancer (for instance when patients do not have metastasis yet, or the tumor is still sensitive to hormonal treatment), patients have a longer life expectancy. In that setting, it is challenging to measure a statistically relevantoverall survival outcome within the timeframe of clinical trials that are used for the regulatory approval and health technology assessment. Thus, Metastasis Free Survival may be considered as a surrogate for Overall Survival.

rostate cancer is a persistent disease. After the primary tumor in the prostate is initially treated, the disease may stay stable for years, before its likely to progress. When prostate cancer spreads to different organs and also develops metastases into the bone, the disease becomes life threatening for patients. Studies find that 56% of patients are still alive 5 years after diagnosis when their prostate cancer has not spread to the bone, whereas only 3% are alive when it does involve bone sites. Furthermore, metastatic prostate cancer means increased pain for patients (especially when the bones are affected), and considerable deterioration of their quality of life. Due to this persistence and the burden caused by progression, intensive research is done on all the aspects of the disease. Novel treatment approaches are explored and developed, such as novel anti-hormonals, alpha-targeted treatment, or immuneoncology. A result of this research is that the treatment path of prostate cancer is getting more and more complex. The more we learn about the disease, the more research is done,the more clinical trials take place and eventually the more treatment options become available to patients and www.governmentgazette.eu | 74

physicians.This is good news for patients and doctors, but also creates challenges in finding the optimal treatment choice for men with prostate cancer to prolong their lives and maintain a high level of life quality. Prolonging the overall survival expectancy of a man affected by prostate cancer is seen as a natural aspired treatment outcome. But it is not a measure sufficient in itself: It must be associated with the quality of survival it brings. Quality of survival for a prostate cancer patient constitutes of him feeling well physically, emotionally and mentally. In this respect, the impact of prostate cancer and its treatments on the central nervous system and cognitive function needs to be taken into consideration, when it comes to assessing the value for patients. While the regulatory approval of new drugs in Europe is centralised, access to new treatment options for patients in the European countries differs from country to country and faces barriers of many kinds. One recurring barrier is the acceptance of surrogate endpoints in national reimbursement systems. In clinical trials, a surrogate endpoint (or marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpointbut does not necessarily have a guaranteed

There are still divergent understandings on the relevance and magnitude of quality of survival measures between regulators, HTA bodies, payers, clinicians, researchers and manufacturers. However, all these stakeholders pursue one common goal — enabling cancer patients to have access to best available treatment and care to improve their lives. Two guiding principles might help these stakeholders to find a common understanding to pursue this goal: First, delaying metastasis, so men have a better chance to prolong their life expectancy. Here, encouraging progress is visible. For example, the FDA has already approved the first drug based on its positive outcome of metastasis free survival and is currently reviewing another one for approval. Second, preserving a good quality of life during and after treatment, so men can continue to pursue their plans and aspirations in life. Here it is worth mentioning the initiative of the European Men’s Health Forum, advocating for men having a better chance of returning to workplace after being treated for their prostate cancer. Bayer strongly supports such initiatives. The article is co-authored by Tobias Helmstorf, Head, Health Policy, Bayer.

PROSTATE CANCER REPORT

Prof John-Pierre DROZ Past President, International Society of Geriatric Oncology (SIOG)

Dr Helen BOYLE

Department Medical Oncology— Centre Léon-Bérard, Lyon, France

Prostate cancer in senior adults: a challenge for the future

rostate cancer is the most frequent male cancer in developed countries. In Europe, according to the World Health Organisation (WHO) epidemiological section, in 2012 the total number of new prostate cancer cases was 419,915 and the total number of prostate cancer deaths was 101,419. Since incidence and mortality rise steeply with age, the prostate cancer burden will increase with the exponential ageing of the population. The median age at diagnosis is 66 years, and 69% of deaths occur in men ≥75 years. Particularities of prostate cancer in elderly patients

Heterogeneity is a strong marker of ageing. On one hand, the health status of men older than 75 years is highly variable: from fit elderly people to bedridden people. On the other hand, prostate cancer is a heterogeneous disease: from very indolent disease that may not require any specific treatment to very aggressive tumours, which may certainly benefit from prostatectomy and radiotherapy (if they are localised). It has been demonstrated that elderly patients generally suffer from more aggressive prostate cancers than younger patients. The questions are completely different in patients with localised disease and those with metastatic disease. The principal challenge with localised disease is to treat patients who are likely to benefit from treatment (that means to limit undertreatment) but also, and maybe more importantly, to avoid useless treatment (that means to limit overtreatment). In metastatic disease, the challenge is to know whether treatment, aimed atincreasing the quality and length of life, is adapted to elderly patients. Proposing optimal management of elderly prostate cancer patients SIOG has included this objective in its programs over the past 10years. The main reason is that prostate cancer has the greatest incidence in men and is principally a cancer of the elderly. Another reason is that patients who die of prostate cancer are often elderly

people; it is thus a major problem of endof-life management in this population. The SIOG planned a task force to evaluate the knowledge in this field (1) and propose guidelines to manage elderly prostate cancer patients using a comprehensive review of data and expert consensus. The guidelines were published in 2010 and updated in 2014 and 2017. The practical geriatric approaches were used to propose clinical tools in all urological cancers. The SIOG guidelines on elderly prostate cancer patient management were endorsed by the European Association of Urology. Practical findings derived from SIOG guidelines

The urological and oncological management of prostate cancer in elderly patients is basically the same as in younger patients: what is different is the decision-making process. Curative treatment, principally radiotherapy, is as active in elderly patients as in younger patients. Prostatectomy is less often proposed due to the increased risk of sexual and mainly urinary side effects. In metastatic disease, the medical treatments are as active as in younger patients; moreover, the profile of tolerance is quite similar. This means that androgen deprivation therapy is proposed, together with osteoporosis prevention. Chemotherapy, new hormone therapies (androgen receptor antagonists and androgen synthesis inhibitors) and radio pharmaceuticals are used with nonspecific palliative treatments. But the most important part of the clinical management is decision-making. Age is not the most important factor in decisions: health status evaluation is the principal tool. It is based on a three-step procedure: screening of frailty and cognitive impairment,using very simple tools, which can be performed by trained nurses in less than 10minutes. If some abnormality is observed, then a simplified assessment of dependence, nutritional status and comorbidities is made and only in complex situations is a comprehensive geriatric assessment mandatory. It is thus possible to classify patients in one of four

health status groups: fit patients, who can receive the same treatment as younger patients; frail patients who require geriatric interventions before receiving prostate cancer treatment; patients with severe comorbidities/dependant patients who should undergo geriatric intervention and then modified specific cancer treatment; and, finally,verysick patients likely to receive only non-specific palliative care. Benefits induced by this approach This urological and oncogeriatric approach allows medical professionals to define which patients may benefit from curative treatment and which optimal treatment could be proposed to metastatic patients. This will helpto minimise under- and overtreatments in localised disease patients and to increase the quality of life of metastatic patients. Geriatric interventions will act in the same way and, moreover, will facilitate the hard work of caregivers. The SIOG is planning future updates of the guidelines this year and in 2019 as well as teaching programs through e-learning platforms.

References: 1. Droz, J.P., L.Balducci, M.Bollaet al.,‘Background for the Proposal of SIOG Guidelines for the Management of Prostate Cancer in Senior Adults’,Crit Rev Oncol Hematol, vol. 73, no. 1, 2010, pp. 68–91. 2. Droz, J.P., L.Balducci, M.Bollaet al.,‘Management of Prostate Cancer in Older Men: Recommendations of a Working Group of the International Society of Geriatric Oncology’,BJU Int, vol. 106, no. 4, 2010, pp. 462–469. 3. Droz, J.P., M.Aapro, L.Balducciet al.,‘Management of Prostate Cancer in Older Patients: Updated Recommendations of a Working Group of the International Society of Geriatric Oncology’,Lancet Oncol, vol. 15, no. 9, 2014, pp. e404–e414. 4. Droz, J.P., G.Albrand, S.Gillessenet al.,‘Management of Prostate Cancer in Elderly Patients: Recommendations of a Task Force of the International Society of Geriatric Oncology’,EurUrol, vol. 72, no. 4, 2017, pp. 521–531. 5. Droz, J.P., H.Boyle, G.Albrand, N.Mottet and M. Puts,‘Role of Geriatric Oncologists in Optimizing Care of Urological Oncology Patients’,EurUrol Focus, vol. 3, nos. 4–5, 2017, pp. 385–394

Government Gazette | 75

Prof Hein van POPPEL

Adjunct Secretary General for Education, European Association of Urology

EAU’s vision for prostate cancer policy in EU

rostate cancer is the most common male cancer in Europe and nearly around 250 men die from prostate cancer every day. The yearly care of prostate cancer patientscosts Europe over €9 billion euros. The healthcare burden of prostate cancer is expected to dramatically increase in the coming years because of our ageing society and as a result of the costs related to the treatment of castrate-resistant prostate cancer. The EAU has produced guidelines on prevention, screening and early detection, diagnosis and management of prostate cancer. These guidelines are endorsed by the scientific national societies of the 28 EU member states and have been translated into more than 30 languages. The prostate cancer guidelines are updated every year by a panel consisting of urologists, radiationand medical oncologists, pathologists and patients. Besides these recommendations for healthcare professionals, the EAU has produced the most comprehensive patient information on prostate cancer based on the guidelines. These are also translated into multiple languages in collaboration with the national societies. Recommendations

Last year the EAU launched a white paper on prostate cancer in collaboration with the European Cancer Patient Coalition (ECPC), Europa Uomo, the European Cancer leagues, and with the approval of the European Alliance for Personalised Medicine and the joint action against cancer of the European Commission . The white paper was presented in Brussels at the prostate cancer roundtable organised by the International Centre of Parliamentary Studies. The white paper made six recommendations to improve prostate cancer care in Europe: (1)patient first, (2)equal access, (3)personalised care, (4) optimised resources, (5)increased awareness, and (6) support for survivors. These issues were subsequently discussed in the European parliament onthe occasion of European Prostate Awareness Day (EPAD), the leading idea being “saving lives by improving prostate cancer care in Europe,” on 27thSeptember 2017. The EPAD was organised by the EAU in collaboration www.governmentgazette.eu | 76

with Europa Uomo and the ECPC and was hosted by AlojzPeterle and Marian Harkin for MAC.Wewere honoured by an inspiring lecture by Vytenis Andriukaitis, who in the meantime has promised that “the Commission will support under its health programme a joint action, starting in March 2018, to collect additional evidence for a possible inclusion of prostate cancer screening programmes in National Cancer Plans 3”. The next joint action against cancer, led by Tit Albreht, will contain a work package on screening and the EAU has promised to be involved in this effort. The task of the EAU is to continue informing and educating the population in the different member states, through their healthcare professionals, with awareness campaigns about risk factors (age, race andfamily history) and the favourable effect of dietary measures and lifestyle adaptation on prostate cancer prevention (antioxidants, green tea, lycopene and vitamin D). Early detection

About screening, the EAU has recommended individual early detection programmes with PSA, but not without counselling the subject on the potential risks and benefits. The EAU advises an intelligent PSA testing strategy for early detection in well-informed men with a good performance status and a life expectancy of at least 10 to 15 years. The most recent update of the ERSPC database has shown that over the last 20 years the age-adjusted prostate cancer mortality has decreased by 54%, coincidentally with the use of PSA testing. No such improvement has been seen in countries without prevalent PSA testing. The mortality reduction was shown in properly performed large randomised trials and varies between 29 and 56% among men actually screened. The numbers needed to screen with intermediate follow-up is 293 per death avoided. Most importantly, the number who needed to treat at 14 years was12, and this figure is likely to decrease further with longer follow-up. It should be noticed that the number needed to treat for breast cancer screening to avoid one breast cancer death is 10 to 14; that for colonoscopy is 850. Differentiate aggressiveness In the past, non-aggressive prostate cancers

were often actively treated, because we did not know how to distinguish low- from high-risk prostate cancer. Today we are able to much better differentiate between the cancers that almost never kill a patient and which can be actively surveilled and those high-risk prostate cancers that need an aggressive — mostly multimodal — treatment strategy with surgery or radiotherapy or both, to avoid the patient dying from it.

The increased use of and better access to MRI in most member states has enabled us to reduce the number of prostate puncture biopsies and thereby reduce the number of insignificant cancers detected. Moreover, multiparametric MRI enables patients to be followedduring active surveillance strategies, for tumoursto be monitoredand the timely recognition of when the tumour’s behaviour changes, becoming more aggressive and needing active treatment. Increasing costs Obviously,access to MRI is not the same everywhere among the member states and decisions need to be made asto where the money for prostate cancer is best spent. The average patient who presents with a significant tumour and is treated locally and with drugs will, over the years,cost more than €300,000 till he finally dies, 20 years after his initial diagnosis, from metastatic castrate-resistant prostate cancer (MCRPC). Five thousand euros will be spentonsurgery, the same amount onadjuvant or salvage radiotherapy, €11,000 onmedical castration and then €240,000 on drugs and supportive care during the last four years of his life. The recent evolvement of immuno-oncologic drugs will further increase the cost per individual. FDA and EMA have in the last 10 years approved more than 50 drugs, of which somewhat more than half were shown to prolong overall survival. This means that somewhat less than 50% of these medications did not prolong life.We must continue our research to find out which patients will and which will not respond to a given treatment. This is obviously the main interest of the (slow) progress in research into personalised medicine and its application in optimised modern precision care

PROSTATE CANCER REPORT

Regional inequalities There are still important inequalities in Europe when it comes to general cancer survival rates,that are around 40% higher in Western than in Eastern Europe. The differences in prostate cancer survival range from 88% in Central Europe to 72% in Eastern Europe. As an example, a man in Italy has a 90% chance of being alive 5 years after diagnosis compared to 71% chance for a man in Croatia. While the European School of Oncology

(ESO) has setup a Prostate Cancer Unit project in Europe, and ECCO has built on Essential Requirements for Quality of Cancer Care (ERQCC) for a couple of cancers, including prostate cancer, the EAU has recently set up a consensus meeting in order to identify and accredit European Prostate Cancer Centres of Excellence, where the best medical care and the best onco-urological education and research is guaranteed through multidisciplinary patient-centred collaboration. The

implementation of multidisciplinarity and patient-centricity will be monitored by the newly born EAU patients and patient advocates working group, involving all European patients and patient advocate groups. Future intensification of the collaboration between the European Commission and Parliament and the EAU is a priority that we want to see come true in the months and years to come

Prof Ola BRATT

Professor of Urology, Sahlgrenska University Hospital, Gothenburg, Sweden

Towards specialised and organised screening

rostate cancer is directly or indirectly affecting a large proportion of the adult European population. Earlier diagnosis and improved treatments have led to decreasing prostate cancer mortality in most European countries, but simultaneously the haphazard use of the prostate-specific antigen (PSA) blood test has caused overdiagnosis and overtreatment of indolent cancers in millions of European men. Traditionally, most urologists and hospitals have independently diagnosed and treated men with prostate cancer, but as prostate cancer care has become more and more successful, it has also become increasingly complex. Multidisciplinary prostate cancer units are gradually replacing the dispersed facilities for prostate cancer care, but the process is slow and sometimes inhibited by forces not acting in the patientsâ&#x20AC;&#x2122; interest. The dilemma of diagnosing prostate cancer in asymptomatic men and the reformation of the infrastructure of prostate cancer care are currently twoof the most important cancer-related issues in the European Union. The following paragraphs give some background to this statement.

PSA testing is, with a few exceptions, still unorganised in European countries. As a consequence, many men are unaware that PSA testing may reduce their risk of dying from cancer, and many men are PSA tested without being informed about the potential adverse downstream effects of PSA testing. Moreover, many men are tested despite being too old to benefit from early diagnosis and treatment. Furthermore, many men with raised PSA values are not properly

investigated, particularly those with short education . The management of men with raised PSA values is currently consuming a large amount of healthcare resources, but they are commonly so ineffectively utilised that the current unorganised PSA testing may actually do more harm than good. Providing systematic information about the potential advantages and disadvantages of PSA testing, and offering organised PSA testing for those who wish to be tested, would enable a more cost-effective and equal utilisation of the limited healthcare resources. Organised PSA testing would also provide the necessary infrastructure for the development of new diagnostic tests and algorithms that can decrease overdiagnosis of indolent cancers.

To reduce the concomitant problems with overdiagnosis of indolent prostate cancer and the underdiagnosis of lethal prostate cancer, the diagnostic pathway is now changing from ultrasound guided systematic biopsies to targeted biopsies, guided by magnetic resonance imaging (MRI) and image-fusion computer software. MRI-based diagnostics has a long learning curve and involves costly technology. A high patient throughput is thus a prerequisite for providing a costeffective, high-quality prostate cancer diagnostics service. Men with recently diagnosed organconfined prostate cancer may be managed with either active surveillance or with radical local therapy. The local therapy may consist of either surgery or radiotherapy, or a combination of these. The treatment decision-making is a complex process that should involve an experienced

multidisciplinary team, including urological surgeons, radiation oncologists, cancer specialist nurses, pathologists and radiologists. As the equipment needed for prostate cancer surgery and radiotherapy is costly, and as treating large numbers of patients is necessary for achieving optimal oncological and functional outcomes, centralisation of these services is essential. Many prostate cancer survivors suffer from long-term side effects impairing their sexual function, urinary function or bowel function. Managing the side effects also requires a multidisciplinary approach to minimise their impact on the patientsâ&#x20AC;&#x2122; quality of life.

Over the past few years, several new effective treatments have become available for men. There is an overwhelming number of clinical trials of new treatments and of combinations of the currently available ones. It is absolutely essential that eligible patients are included in these and future trials, so that the costly new treatments can be used in ways that maximise their benefit to patients. To conclude, the ongoing developments of prostate cancer diagnostics and therapeutics have resulted in a complexity that strongly favours the creation of specialised multidisciplinary prostate cancer units that can provide integrated services for clinical management of patients, research, and training of healthcare professionals. The EU needs be active in the ongoing change of the infrastructure of prostate cancer care and in the initiation of population-based, organised PSA testing programmes. Why? Because European men and their families deserve it, as do European taxpayers Government Gazette | 77

Recommendations to reshape policy making

urban outlook

Best practices in the EU: What can we learn from existing projects?

Contents

knowledge sharing Annie Schreijer-Pierik MEP says where are now on heart failure is not acceptable and highlights what EU should do improve treatment and management of heart failure smarter planet Karin Kadenbach MEP highlights the urgent need for public policy interventions in managing cardiac health in Europe citizen involvement Susanne Logstrup, Director, European Heart Network says setting strategic policies for better heart health is crucial new wave Dr Robert C Kowal, Chief Medical Officer, Medtronic Cardiac Rythm and Heart Failure argues that we need more partnerships between regulators and providers

www.governmentgazette.eu | 80

ÂŠImage: ICPS

URBAN OUTLOOK

Building tomorrowâ&#x20AC;&#x2122;s smart cities

round three quarters of the European population lives in urban areas and even more Europeans are expected to move to cities in the years ahead. Cities are often the centre of economic, social and cultural life in Europe, contributing to quality of life. At the same time, city authorities face a long list of problems including long daily commutes, traffic congestion, social exclusion and air pollution, all of which have a negative impact on that same quality of life. Acting as hubs for food, water, housing, energy and transport, urban areas have a key role to play in addressing this situation. Cities can be designed to be more resourceefficient and energy-efficient, reducing the impacts to ecosystems, minimising pollution and acting to mitigate and adapt to climate change. Smart city solutions can be the answer to many of the challenges faced by European cities, including better safety, better healthcare, better traffic management, less air pollution or more efficient public administrations. But becoming a smart city requires scale. According to estimates, only a third of EU cities and towns are of adequate scale to carry out the necessary strategic planning

and to attract sufficient investment on their own. Others depend on working together to develop affordable solutions and to attract financing. As urbanisation is expected to increase in the following decades, there is an urgent need to work towards further developing models that promote more citizen-centred, economically viable and environmentally sustainable solutions in European cities. ICPS recently brought together EU policymakers, city councils, leaders oftransport authorities, energy regulatory authorites, local government authorities, chambers of commerce and industry, sustainable development stakeholders and other key stakeholders to discuss current policies and strategies to develop and implement successful smart cities projects in the EU. Delegates analysed the current state of smart cities projects in Europe, explored how businesses and commercial spaces can become more sustainable, and offered recommendations to policymakers to build tomorrowâ&#x20AC;&#x2122;s smart cities. Delegates agreed that it is time to strengthen cooperation between cities and think about joined-up planning, market research, tendering and procurement

URBAN OUTLOOK

Nathalie GURI Projects and knowledge sharing director, EUROCITIES

Knowledge sharing for a smarter Europe

meetings, focus groups and big events like hackathons where residents can come together to codesign solutions that work for them.

©Image: ICPS

This is by no means a one-way street. Truly smart cities are those that realise that they still have much to learn. Fellow cities help to hone the systems that lighthouse cities have in place, and provide the project with insights into how solutions must be adapted if they are to be successfully replicated across the continent.

hree quarters of Europe’s population isliving in an urban environment. With this trend on the rise, it is increasingly local government — the level of government closest to citizens — that must innovate to solve Europe-wide challenges. In a climate of high ambitions and scarce resources, it is the practice of knowledge sharing that will allow cities to succeed as the focal point of European innovation. Cities are striving to go beyond the basics, becoming safe and sustainable ecosystems where people can enjoy a high quality of life, good health and wellbeing; where mobility is not only efficient, but provides people with a “journey” in the fullest sense of the word; where people are not only represented, but enjoy real ownership of the city through active participation in the civic sphere. To achieve these ambitious goals, our cities must become “smart cities”. In part, smartness describes the way a city organises itself internally,creating cross-departmental synergies and cocreating solutions with the real city experts — citizens. The very first criterion for being smart, however, is realising that our challenges are shared and our solutions must be shared. Through city networks such as EUROCITIES, which brings together 140 major European cities, cities can function as living laboratories, testbeds for innovation. In coming together and getting a picture of their shared challenges and diverse solutions, cities can spread best practices to create the best of all futures, multiplying

the positive results with a fraction of the workload. This is a principle that we at EUROCITIES demonstrate through our smart city projects, such as Sharing Cities, or the Smart Cities Information System (SCIS). Through Sharing Cities, the lighthouse cities of Lisbon, London and Milan are paired with fellow cities Bordeaux, Burgas and Warsaw. European funding allows the lighthouse cities to pilot measures like smart lampposts, shared electric vehicles and building retrofit, to create healthier, less congested and more comfortable cities for residents. Importantly, the project also develops business models that will allow these solutions to sustain themselves and spread throughout Europe. This is where the fellow cities come in. Through structured communication, visits and staff exchanges, fellow cities gather knowledge of these solutions and replicate them in their own contexts. Burgas, inspired by Sharing Cities visits, webinars, and long-term communication with the other cities of the project, has extended its cycle lane network to 80 km, added electric bikes to its shared public transport system, and is expanding the number of charging stations. Through their mobile phones, residents can get live information about, and conveniently pay for, bikes and other public transport options. They can even check pollution levels thanks to smart sensors installed in lampposts. The city is also discovering new ways to harness the expertise of its residents through public

In the future, as these solutions catch on, increased demand for products such as electric car chargers will drive down prices, bringing enormous savings back to those cities that took the initial risk of piloting new technology and sharing their results. The Smart Cities Information System (SCIS) applies this principle even more widely. Through this platform we distil the findings and experiences of dozens of smart city projects, representing billions in EU funding, and ensure that this information continues to flow through urban knowledge networks, touching the lives of urban residents across the continent. Knowledge sharing at city level is the best route to achieving Europe’s social and environmental goals. But forming and spreading transferable, impactful practices is a long-term enterprise. It takes time, expertise and strong communication to understand a city’s journey, its difficulties and the factors which lead to success. City networks like EUROCITIES are a catalyst that allows local leaders and experts to work transversally, build capacity and benefit from each other’s experiences. It is only through sharing among cities that we can make the best use of all available resources to ensure the highest possible quality of life for all the people of Europe. EUROCITIES is the political platform for major European cities. We network the local governments of over 140 of Europe’s largest cities and more than 40 partner cities that between them govern some 130 million citizens across 39 countries

Government Gazette | 81

Carlos ZORRINHO mep Member of the Group of the Progressive Alliance of Socialists and Democrats in the European Parliament

Fighting for a smart future

digital skills and fight against exclusion, particularly the exclusion of people without competencies or the economic capacity to access the new European gigabits society. As a member of the European parliament, I was the main rapporteur in two files directly connected with the development of smart cities and smart services and products —the ISA2 programme to boost interoperability and the WIFI4EU initiative to improve connectivity in local areas.

©Image: ICPS

Interoperability and connectivity are crucial technological enablers. However, to fight for a smart future for our citizens we need more. We need vision, strategy, lifelong learning, access to information and a digital identity. In a global world, we need a global voice to achieve national and local improvements.

e are living in very interesting times. Our minds are being challenged daily with climate change, political unrest, constant stimuli, new meanings and new behaviour. We are living in a time of constant technological disruption.

of the renewables’ share in the national energy mix. They are also a helpful source of knowledge to further improve the smart cities dynamics that Portugal has — including the Smart Cities Portugal network and some specialised networks well known for their improvements in connectivity, mobility and service to citizens.

Inthis scenario, we need to make a choice. Should we follow the technology blindly or use it to fight for a better world? It is a road with two paths that lead to the same destination — that of profound change and innovation in our ways of life.

The EU is leading the fight against climate change. This is a civilisational priority and a survival challenge, but at the same time it is also a huge opportunity to lead the energy transition, create a new competitive and inclusive European gigabits society and develop the new economy of data, thereby creating wealth and jobs.

As history shows, by default, change is not always a good thing. We need to manage it in order to give ground to positive societal innovations. From 2005 until 2011, first as national coordinator of the Lisbon Strategy and afterwards as secretary of state for energy and innovation, I worked very hard on the ambitious project to create in Portugal a national living lab for energy efficiency and sustainable urban mobility. Some pilot projects in energy efficiency, like “Inovcity” in Évora or the national platform for sustainable mobility (MOBI-E), are examples of successful experiments in the framework of pushing for a strong growth www.governmentgazette.eu | 82

To improve the networks and the global voice of the European Union in accordance with the definition of a new sustainable society with an ever-growing data-based economy, we need to develop a European digital identity as a values platform to make adifference in creating a vibrant market for business while giving priority to citizens’ needs. We need a strategy with citizens at the forefront, capable of handling global competition while reinforcing the Union and reconnecting people with the European project. To achieve these goals, we need to bet and invest strongly in policies that improve

The Wifi4EU initiative, with an investment of €120 million, will be a means to face these challenges. It is a pilot project to recover “lost people,” not with technology but with delivery of information, by sharing and enabling access to information to effect real change in people’s lives. As a pilot project it can also become a reference to others and has the capacity to spread throughout the EU, promoting sustainability and dignity with a strong focus on people and on the planet. The WIFI4EU initiative is only a symbolic example of a strategy with citizens at the forefront. I hope that the seed we plant with this project will grow and create a large number of high-quality and free-access WiFi spots in the European territory, financed byEuropean vouchers (6,000–8,000 already predicted) or by other means, which would link to the WIFI4EU network. With a single authentication system and the sharing of concrete services and opportunities for all, WIFI4EU could give us a taste of what a platform with a European “digital identity” would look like and, if successful, has the potential to become a winning strategy to compete in a global and transforming world

URBAN OUTLOOK

Ruud SCHUTHOF

ICLEI Europe Deputy Regional Director

Involvement of citizens is crucial in making smart cities sustainable

s a global network of local governments, ICLEI has been working for more than 25 years on the topic of cities as sustainability champions. Digital strategies and “smart city” programmes are a way for us and our members to advance on the path towards the reduction of greenhouse gas emissions through energy efficiency, renewable energy and sustainable mobility. Also, they support new forms of governance and social innovation and enhance community engagement in urban development. ICLEI members are now involved in European-funded smart city projects, such as GrowSmarter and RUGGEDISED. In GrowSmarter, Stockholm, Cologne and Barcelona act as lighthouse cities by testing and implementing a series of smart solutions. In the RUGGEDISED project, the cities of Rotterdam, Glasgow and Umeå will further the path towards new smart districts. Also, ICLEI member cities represented in its Regional Executive Committee, Florence and Tampere, are part of smart city lighthouses projects in Europe.

Digital technologies have opened pathways to modernise European cities. “Smart cities” are about connections. Technological ones, with sensors and monitors sharing realtime data to optimise the use of resources, but also organisational ones, in the way we think, design and organise our cities. While the term “Smart City” seems widely used in the political, academic and business world, the “smart” concept is, surprisingly, not wellknown among the general public. ICLEI sees a necessity for the concept to progress from a mere technological to an inclusive approach in support of sustainable urban development. Smart also implies liveable, green and healthy cities. Citizen-centred districts However smart the technology, it is useless if it does not take into account the needs and concerns of the people directly impacted by it. Without considering people’s needs and ensuring they both understand and can

development of their areas, and not simply be passive recipients of change. For instance, neighbourhood management systems, which link energy and mobility, can be adjusted according to the needs of citizens. Thanks to open-data platforms, fed by real-time data from the sensors and monitors across the districts, the local population has direct access to valuable information and can contribute their vision of the city. Projects such as the EU Smarticipate project are developing and testing a web platform that enables interested citizens to better support the urban planning process.

afford these new technologies, digitalisation will face resistance. Change is rarely a unanimous path and only through a strong cooperation with local residents and end users can these solutions have the most impact. With a focus on the importance of citizen engagement, ICLEI initiated the Basque Declaration, which was adopted by the 850 participants of the 8th European Conference on Sustainable Cities and Towns, held in the Basque Country in April 2016. The Basque Declaration highlights the need for local leaders to find innovative ways to engage with civil society to drive transformation for meeting economic, environmental and social challenges. To promote these initiatives and inspire others, cities are invited to add their transformative actions on the Sustainable Cities website, giving them the chance to win the Transformative Action Award 2018. Recreating a local connection Smart cities are an opportunity to revive the connection between citizens and the neighbourhoods they live in, and address challenges faced in growing cities. It can foster new community-based activities and co creative processes to allow people to gain ownership of decisions related to the

“Smart city” projects can also help boost employment through the creation of new high-skilled jobs. In the GrowSmarter project, the creation of new jobs was high on the list of priorities from the very start, with the aim of seeing 1,500 new jobs by the end of the project. There is a further expectation that more will come as the new solutions continue to be developed. In the city of Rotterdam, this was also a precondition in the partnership agreement with the main business partner in the RUGGEDISED project. 300 jobs must be created locally as a result of the exploitation and regeneration of the Heart of South neighbourhood. In preparation for the future of liveable cities, it is key to talk to the next generation of decision-makers. In each project, the involvement of universities is an opportunity to create interest in these topics among the students — ICLEI member city Umeå, for instance, asked local design students to propose ideas for a “smart” bus stop. As these projects evolve, we will continue using innovative technologies and digitalisation to work with our members towards more integrated, liveable and sustainable cities, with their citizens always in mind

Government Gazette | 83

URBAN OUTLOOK

Nathan PIERCE

Programme Director for Sharing Cities at Greater London Authority

London must blaze a trail for a new wave of European smart cities

n June 11th this year, Mayor of London Sadiq Khan unveiled a roadmap to transform the capital into the smartest city in the world. As part of a raft of measures designed to radically increase the city’s uptake of smart technologies, the Smart London Plan sets out how the capital city can innovate in a bid to tackle some of society’s most pressing challenges such as population growth, crime, keeping healthy and wealth inequality.

Covering nine million Londoners living in 33 boroughs, the strategy makes concrete the city’s ambition tobecome a global testbed for smart innovation. Led by London’s Chief Digital Officer Theo Blackwell, the strategy brings together a host of organisations from Transport for London to the NHS. It builds on London’s position as a world leader in city data, which can be seen in our data store which has over 700 open data sets that link with a number of key public sector institutions. London has long been established as a global economic and cultural powerhouse. According to a report published in September last year, London is the world’s most influential financial centre (1). London is Europe’s biggest city economy, with a higher GDP than sovereign states including South Africa, the United Arab Emirates and Columbia(2). More than 300 languages are spoken in the capital’s schools, making London one of the most linguisticallyrich cities on Earth(3). Hardwired into London’s DNA, the city marches to the beat of diversity. London is buzzing with promise, yet the capital is still grappling with the profound quality of life challenges that have kept city leaders awake at night for decades. Last year it was revealed that every borough in London exceeds World Health Organisation limits for PM2.5 — tiny toxic airborne particles that cause respiratory and cardiovascular diseases as well as cancer(4). Despite an impressive decline in smoking, obesity is on the rise, with all the health implications this brings. And the ugly spectres of knife crime and moped thefts became

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increasingly problematic in 2017.

With London’s population set to near 10 million by the middle of the next decade, it’s clear that the capital must quickly find innovative ways of slashing pollution, cutting crime and protecting some of the most vulnerable people in society. Now more than ever London is counting on its leaders to fulfil the true promise of smart city technologies. Set to be worth more than US$2.5 trillion globally by 2025(5), the smart cities industry is delivering innovative solutions that city leaders in London and beyond must embrace. The next generation of electric transport, such as cars and e-bikes, will help to slash air pollution and confine traffic congestion to the history books. New ways of conducting big data analysis will allow police chiefs to predict crime patterns and target resources accordingly. In the future, smart technologies will be integral to creating dementia-friendly cities. EU smart cities programme Sharing Cities is helping to make the vision set out in the Smart London Plan a reality. The programme is helping to create world-class smart cities of the future across Europe. In London, the programme is bringing boroughs together to pilot and scale up smart lampposts with a host of functionalities including wireless connectivity, crime prevention, electric vehicle services and air pollution sensors. Through Sharing Cities, London shares its learning with two other major European cities, Milan and Lisbon, and leads the way on the global stage. By instigating conversations about innovative technology across multiple boroughs and internationally, the mayor and his chief digital officer hope to accelerate the uptake of smart technology in our streets that will help to solve some of our cities’ problems. Delivering truly world-class smart cities in London and beyond is no small task but it is a vital one. The pressing challenges presented by climate change, an ageing population and shrinking council budgets are only set to grow in magnitude in the decades ahead. With smart

city technologies set to provide increasingly efficient ways of tackling problems that have vexed municipal leaders for decades, it’s high time European cities embraced the innovation agenda as a top priority. We need to do more for our citizens using fewer resources, and we need to do this now. Nathan Pierce is current chair of the Board of Coordinators of the 12 Lighthouse Projects. He is programme director of Sharing Cities, one of 12 Horizon 2020 Smart Cities and Communities and Lighthouse Projects. References: 1. ‘The Global Financial Centres Index’,The Handbook Of World Stock, Derivative & Commodity Exchanges, MondoVisione,2008, pp.xxxv–xxxviii.Available from:http:// www.zyen.com/component/content/article. html?id=240 (accessed 24 August 2018). 2. Toly,Noah and Sam Tabory, 100 Top Economies: Urban Influence and the Position of Cities in an Evolving World Order, Global Cities, October 2016.Available from:https:// www.thechicagocouncil.org/sites/default/files/ report_100-top-economies_revised-20161026. pdf(accessed 24 August 2018). 3. Languages Across Europe, [website], BBC, October 2014,http://www.bbc.co.uk/languages/ european_languages/definitions.shtml, (accessed 24 August 2018). 4. Mayor of London Unveils Hard-Hitting Air Quality Campaign, [website], official press release, Mayor of London, October 2017,https://www.london.gov.uk/press-releases/ mayoral/mayor-unveils-hard-hitting-air-qualitycampaign, (accessed 24 August 2018). 5. Smart Cities Market Size Worth $2.57 Trillion by 2025 | CAGR: 18.4%: Grand View Research, Inc., [website], March 2018,http:// www.prnewswire.co.uk/news-releases/smartcities-market-size-worth-257-trillion-by-2025-cagr-184-grand-view-research-inc-675971813. html, (accessed 24 August 2018)

11th Annual Public Administration Reform Symposium Building Trust in the Public Sector: Inspiring Leadership for Transparency 3rd - 7th December 2018 London, United Kingdom

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Please visit www.publicsectorreform.org Tel: +44 (0) 20 3137 8648 Email: info@parlicentre.org

Government Gazette | 85

minority

Europe’s dark history

Cornelia ERNST mep German MEP for European United Left–Nordic Green Left (GUE/NGL) in the European Parliament

‘We need binding measures for Europe’s Roma population’

hilst much of the world’s media has been fixated upon Italy’s war on NGO rescue boats in the Mediterranean and the far-right government’s refusal to let African refugees and migrants come ashore, much less has been reported about the new Italian government’s statements about Roma people. These declarations continue a history of discrimination which has existed for centuries and remains to this day, with little being done to stop it. With up to 180,000 of them living in Italy, Roma people constitute one of the largest ethnic minorities in the country. In fact, they are the largest minority group in the EU with an estimated 20 million Roma people living also in Romania, Slovakia, Hungary and Bulgaria plus many more in the Balkans. Long seen as ‘outsiders’ and ostracised wherever they are, they remain one of the most persecuted minorities in our society – and antiziganism remains rife across Europe today. Italy, for example, has subjected the Roma to discrimination for centuries due to longheld prejudices. Some practises have been truly despicable — from forced labour, internment, forced sterilisation to mass extermination. Now, Italy’s hardline Interior Minister Matteo Salvini wants to ‘cleanse’ the Roma from Italy. The historical context of such fascist rhetoric is both frightening and sickening to the stomach. Roma people suffered greatly during the Holocaust - or the ‘Porajmos’, as they call it - by the Axis powers for the same reasons as Jews. Both were deemed ‘racially inferior’.

Estimates suggest up to 80% of Europe’s Roma population were exterminated during the Holocaust — accounting to some 1.5 million people. On August 2, 1944 alone, nearly 3,000 Roma men, women and children were gassed to death at AuschwitzBirkenau.

A Holocaust that was largely ignored until the 1980s, the legacy of prejudice has continued to this day. And as Salvini, who represented the Lega in the European Parliament until recently, pledged to carry out a census to find out how many Roma people there are in Italy, he boasted last month that, ”Unfortunately, those who have Italian citizenship, we have to keep - because we can’t expel them.” With rising discrimination and possible mass expulsion looming, Italy’s recent turn to the far-right has given a renewed sense of urgency to the plight of the Roma people. Yes, the Council of Europe, the Commission and Open Society have pledged a lot of funding to Roma-led and pro-Roma activism causes over the last 20 years — after all, they were one of the biggest losers from the post1990s transformation, especially in Eastern Europe. However, the EU Framework for National Roma Integration Strategies which was in place since 2011 is non-binding. Member states can decide their own policies on access to housing and essential services like healthcare for the Roma. Not only was this incoherent across the EU as the Commission’s own annual reviews clearly show. Old prejudices have persisted and discrimination has increased. And whenever there is discrimination, it can only mean one thing: exclusion from society. The current EU framework applies only

until 2020 and MEPs are currently in the process of drawing up new parameters for the period beyond. The only bright spot is that access to education has apparently improved for Roma children since 2011. However, the poor quality of education, the lack of documentation and physical access to the nearest schools remain a major handicap. So, what should be done? The post-2020 framework must be binding. EU politicians must commit to rooting out discrimination. The EU can keep throwing money at antiziganism, but this requires much more than money. Fighting racism and discrimination should be a priority pillar — not just in horizontal policy. Some have put forward the idea that a Roma framework should be replaced by a general EU strategy against poverty. That may work up to a point, but in essence, a Roma strategy is what that is needed to tackle racism, with specific measures to tackle Roma poverty. In addition, policies on housing, healthcare, education and the labour market need to be better coordinated and must work in conjunction with one another. They should also be integrated into the mainstream policies of these sectors. Likewise, plans for tackling poverty should both include the Roma in the overall approach, and complement other policies that support the Roma. To ensure that all the hard work is not lost, we need the participation of civil society. But what is more, we need to focus more on anti-Roma discrimination. Until we have a binding policy across the EU, no amount of money will undo the untold suffering endured by the Roma at the hands of the populist far-right

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