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Government Gazette Vol 1; 2018

ÂŁ10.00, â‚Ź11.00 ISSN 2042-4170


Bulgarian Presidency Clean Mobility Automated Transport Air Pollution Circular economy Green taxes Cardiac health Cancer


Is the EU on track for low-emissions mobility?


The EU vision for plastic-free oceans

Karmenu Vella


reasons why Brussels must be on your foodie list

Travel with... Emma McClarkin MEP

Government Gazette

Government Gazette Vol 1; 2018 Managing Editor Arvind Venkataramana (+44) 020 3137 8655 Commissioning Editor Janani Krishnaswamy (+44) 020 3137 8653 Editor, Performance Supplement Meliissa Gokhool Publisher Matt Gokhool (+44) 020 3137 8611 Advertising and sponsorship sales (+44) 020 3137 8653 © 2017 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.

also inside




EU Commissioner Karmenu Vella outlines the European Plastics Strategy


Susanne Løgstrup, Director, European Heart Network, presents strategic policy measures to improve heart health

Evgeni Krussev, Deputy Mayor of Sofia writes about the city of Sofia’s plan for sustainable urban mobility

12 POLICY ASSESSMENT Julie Girling MEP makes an assessment of the Plastics Strategy


Jonathan Gaventa, Director, Third Generation Environmentalism, explores whether carbon and plastic taxes can fund the European Union

16 BULGARIAN PRESIDENCY Eva Maydell MEP writes about the policy priorities of Bulgaria’s EU Presidency

18 CIRCULAR ECONOMY Sirpa Pietikäinen MEP says Europe cannot survive without improving resource efficiency

22 EVENT ROUND-UP High-level roundtable on cardiac health discusses strategies to promote healthy hearts in Europe

24 HEART FAILURE Annie Schreijer-Pierik MEP says we must continue to fight to keep heart failure on the political agenda

Jos Delbeke, Director General, DG CLIMA, defends the Commission’s clean mobility strategy

30 PREVENTION Prof. Lale Tokgozoglu, President, European Atheroscierosis Society says prevention must be priority in managing cardiac disease

31 AIR POLLUTION Simon Gillespie, Chief Executive, British Heart Foundation says we must clean the air to protect our hearts

34 SUSTAINABLE MOBILITY MEPs and senior policymakers present solutions to make European roads more sustainable

36 ELECTRIC MOBILITY Miriam Dalli MEP highlights the need to switch from fossil fuels to electric and writes about how Malta plans to tackle the city’s mobility challenges

38 PARLIAMENT PERSPECTIVE Keith Taylor MEP worries that Europe is running out of time to fix our transport habits



Karin Kadenbach MEP proposes public policy interventions to tackle cardiovascular disease in Europe

Daniël Termont, Mayor of Ghent writes about the city’s new plan to tackle the rising urban mobility problems | 02




The Danish city of Odense proves how cities can lead by example, making two wheels part of the mobility solution

Maja Bakran Marcich, Deputy Director General, DG MOVE, answers our pressing questions about EU’s clean mobility strategy


52 EVENT ROUND-UP High-level European roundtable discusses pressing challenges in managing bladder cancer in Europe

Is Europe ready for the driverless revolution? Maroš Šefčovič, Vice President, European Commission’s Energy Union, says Europe is moving fast towards that direction




Seb Dance MEP worries that the lack of policy coherence within the Commission remains a stumbling block

Alolz Peterle MEP writes about the importance of patient-perspective in healthcare

Senior policymakers and practitioners offer solutions to tackle Europe’s most neglected cancer

contents 42

performance Make your mind your ally

Our experts translate neuroscience and modern psychology research into practical strategies for better health, happiness and personal success

62 - 73

Unlocking creativity meliissa gokhool

Building healthy relationships with failure simon taylor

Pros and cons of perfectionism dr andrew p. hill

59 HEALTHCARE OUTCOMES Francesca Colombo from OECD writes why patient-reported outcomes can enable better healthcare outcomes

60 EPAD 2017 Policymakers commit to improve prostate cancer care in Europe at European Prostate Cancer Awareness Day

55 ACT NOW ON BLADDER CANCER Lydia Makaroff and Andrew Winterbottom explain what EU needs to do differently to beat bladder cancer

57 QUALITY METRICS Dr Badrinath Konety and DrVikram M Narayan define quality metrics for bladder cancer care

90 TRAVEL WITH.... Emma McClarkin MEP offers her tips, tricks and secrets to be a smart and creative business traveller

78 BREAST CANCER Susan Knox from Europa Donna and Peter Naredi from European CanCer Organisation write about the need to commit towards high-quality breast cancer servicesbetter healthcare outcomes

80 TREATING THE ELDERLY Breast cancer care in the elderly calls for a different approach, says Prof Hans Wildiers from the International Society of Geriatric Oncology

83 CASE STUDY Dr Suzana Manxhuka-Kerliu writes about Kosovo’s successful fight against breast cancer

86 FOOD & TRAVEL In our new interview series with Belgium’s best food bloggers, Maxine, a South African self proclaimed “foodie,”living in Brussels, talks about her favourite foodie experiences in the policy capital of Europe

Government Gazette | 03

Government Gazette, Vol 1, 2018

editorial view


Commissioning Editor, Government Gazette

Will EU’s war on pollution change the world?


russels is cracking down on pollution like never before, with new green policies so hard-hitting and extensive that they can be felt across the world, transforming everything from electric vehicle demand to plastic consumption. With the global shift towards a low-carbon, circular economy already underway, Europe is taking unprecedented action in response to the looming environmental challenges we face. Cities are under rising pressure from environmental campaigners and courts to conform to EU clean air standards by getting the dirtiest cars off city streets. Efforts to clean up Europe’s roads started in November last year, with the European strategy on low-emission mobility. The European Commission’s draft law opted for an emissions cut of 30 percent by 2030, compared to 2021 standards, with a midway target of a 15 percent reduction by 2025, which was a lot closer to the industry’s preferred target. Towards the end of 2017, several European cities announced their plans to ban petrol and diesel cars in a move to create a zero-emissions zone by 2035. The Commission upped the ante by opening a public consultation on a draft proposal further to improve the quality of car emissions tests to ensure more reliable results and rebuild consumer confidence. But is the Commission’s clean mobility package ambitious enough? How are European cities embracing the new challenge? Is Europe ready for the driverless revolution? In our extended coverage on recent sustainable mobility policies, we evaluate how EU’s war on air pollution fits neatly with another goal: domination of the global electric-vehicle industry and the switch to autonomous driving. The turnaround isn’t just limited to improving air quality. Following China’s decision to ban imports of foreign recyclable material, Brussels recently launched a plastics strategy to alter public attitude towards the consumption of plastics, and modernise plastics production and collection by investing €350m in research. If we don’t change the way we produce and use plastics, there will be more plastics than fish in our oceans by 2050. Keeping this in mind, and based on the results of a recent Eurobarometer survey, the European Commission developed a vision for the future of plastic production in its new strategy. Karmenu Vella pledged to make all packaging recyclable and reusable by 2030. While the European Commission has finally responded to the urgency of the plastics issue, will the plastics strategy be the vehicle to | 04

promote a whole new attitude to recycling throughout the food chain, from the farmer to the consumer? Inaction has consequences Every year, an astonishing number of citizens’ lives are cut short because of air pollution. We have known this for decades, and the air quality limit values have been in place for almost as long. And yet, in 2018, 400,000 people still continue to die prematurely every year because of a massive, widespread failure to address the problem. And many more suffer unnecessarily from air quality related diseases. Inaction has consequences. It has consequences for citizens and the polluted air they breathe. The link between air pollution and heart disease is getting clearer every day. Bold action is now needed from governments across Europe to clean up our air and protect those at risk. Renewing our commitment in the fight against cancer and cardiac disease, two of the main causes of increased mortality and disability in Europe, we make an in-depth assessment of the policy challenges in managing these deadly diseases within the continent. Our current edition brings together healthcare professionals, key policymakers and academic experts to discuss the impact of these deadly diseases across the European Union and offer policy solutions to improve care and treatment. Now, beyond policy matters Recently we have seen a dramatic upsurge in scientific studies on positive psychology and the science of happiness. On the internet and in bookstores, thousands of gurus tout different remedies to make our lives happier. Conventional wisdom holds that if we work hard we will be more successful, and if we are more successful, then we’ll be happy. How do we train our brains to become more engaged, creative, motivated, energetic, resilient and productive at work? Our Performance bulletin this quarter tries to find the happy secret to better work. It focuses on unlocking creativity and dealing with failures, and dwells on why not to be a perfectionist. Our experts translate neuroscience and modern psychology into practical strategies for better health, happiness and personal success. In our new column, Recipe for Success, we bring you striking thoughts from the world’s greatest achievers. Enter the mind of Bruce Lee through our first column and get behind his brawn. The power of his supple intellect offers pearls of wisdom that will help you play to your strengths in work and life.

Brussels wages war against plastic

If we do not change the way we produce and use plastics, there will be more plastics than fish in our oceans by 2050. We must stop plastics getting into our water, our food, and even our bodies.



very year, Europeans generate 25 million tonnes of plastic waste, but less than 30 percent is collected for recycling. Across the world, plastics make up 85 percent of beach litter. Plastics are reaching citizens’ lungs and dinner tables, with micro plastics in the air, water and food they consume, having an unknown impact on their health. In a measure to clean up the oceans and our tables, the European Commission in January this year, launched a war against plastics. Following China’s ban of plastic waste imports, Brussels has stepped forward to address plastic pollution with the release of its Strategy on Plastics in the Circular Economy.

seconds to produce and takes 500 years to break down again.” Noting that we cannot live without plastics, he pointed out that “we can be killed by them.” With 700 kilos of plastic disappearing in the ocean every second, he said: “If we do not change the way we produce and use plastics, there will be more plastics than fish in our oceans by 2050. We must stop plastics getting into our water, food, and even our bodies. The only long-term solution is to reduce plastic waste by recycling and reusing more. This is a challenge that citizens, industry and governments must tackle together”

With the EU’s plastics strategy, the European Commission is driving a new and more circular business model. The Speaking to European Commission has claimed that journalists, vice-president there is a strong business case for of the Commission, Frans transforming the way products Timmermans said Brussels’ are designed, produced, used, priority was to clamp down on and recycled in the EU. Taking “single-use plastics that take five the lead in this transition, the

Commission has promised to create new investment opportunities and jobs. Under the new plans, all plastic packaging on the EU market will be recyclable by 2030, the consumption of single-use plastics will be reduced and the intentional use of microplastics will be restricted. The strategy will transform the way products are designed, produced, used, and recycled in the EU. Too often, the manner in which plastic is produced, used and discarded, fail to capture the economic benefits of a more circular approach. It harms the environment. The Commission noted that the goal of the strategy is to protect the environment, whilst at the same time lay foundations to a new plastics economy, where the design and production fully respect reuse, repair and recycling needs and more sustainable materials are developed.


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Government Gazette | 05

Government Gazette Brussels News Round-up



#bladdercancer Post-Brexit scenario

MEPs vote to shrink European Parliament


According to the new proposal, the number of MEPs was reduced from 751 to 705. The plan is to reallocate the 46 seats in the reserve to new countries joining the EU and/ or pan-European electoral lists and re-distribute the 27 former British seats among the 14 EU countries that are currently slightly under-represented. The committee agreed that the number of MEPs elected from an EU-wide electoral constituency in the future should match the number of EU countries, as soon as the completion of the ongoing EU electoral law reform allows it. 16 seats would be put in “reserve” in case of a future enlargement. | 06

#PreP in #Europe Insightful @parlicentre roundtable discusses how key stakeholders – healthcare professionals, healthcare providers, and community advocates – can collaborate in speeding up implementation of #PrEP in #Europe

#telecom, #5G & #BigData @MichalBoni #Brussels @parlicentre To unlock potential of digital era, the EU is running sweeping reforms, deploying #5G #CloudComputing #BigData and create the new regulatory #telecom framework. At Digital Transformation, you need to identify and map your migration from the past to the future

#EUSpacePolicy “We should always remind ourselves that #space is an enabler to practically all other industries. I see it in particular in an area which is my daily bread: the #EnergyUnion” says VP @MarosSefcovic

BRUSSELS NEWS DESK n a move to strengthen EU citizenship and the European character of elections at the European Parliament, MEPs recently voted to shrink the size of the European Parliament, in a post-Brexit scenario.

@LieveWierinck from @MAC_MEPs, policy experts from @EuropeanCancer, @cancereu, @ europa_uomo, @cancernurseEU and patient groups offer recommendations to improve the state of care of #bladdercancer in #Europe at @parlicentre roundtable chaired by Prof. @ heinvanpoppel from @Uroweb

Sources confirm that Spain and France would both gain five more seats under the plan, while Italy and the Netherlands would gain three. Ireland would gain two MEPs while Denmark, Estonia, Croatia, Austria, Poland, Romania, Slovakia, Finland, and Sweden would pick up one extra seat each. MEPs hope the decision will make the institution leaner whilst ensuring political operability; however critics claim that it would make “Brussels look more out of touch and less democratic.”

MEPs to fight the spread of fake honey in the EU market


he EU boasts about 17 million beehives and 600,000 beekeepers, producing some 250,000 tons of Kazimierz Ujazdowski MEP, honey every year. This makes the constitutional affairs spokesman EU the second biggest honey producer after for the European Conservatives China. However, the EU also imports honey and Reformists group, said: “This to cover its domestic consumption, mainly is a flagship idea of European from China. In order to fight the spreading of federalists who naively assume fake honey, MEPs have vowed to protect the it will increase accountability apiculture sector by forcing producers who and participation in European elections when it will do the exact adulterate their honey to follow EU law or risk punishment. Look out for our next edition for opposite.” more on pesticides policy and EU’s ramped up bee protection efforts.

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NGO perspective

Environmental groups call for a rethink of EU’s plastic recycling plan

Proposal for plastic tax faces mixed response



hilst the European ommission has exhibited willingness to tackle the plastic pollution crisis, environmental groups and NGOs worry that the Commission’s roadmap for an EU strategy on plastics does not get to the root of the plastics problem.

stage and instigating prevention of plastic waste, the Commission has chosen to emphasise better recycling technologies and substitution with ‘renewable’ feedstock. These responses will not lead to a meaningful adoption of circular economy principles, nor will it necessarily reduce healthharming plastic pollution.”

According to the Break Free From Plastic movement in Europe, “to make a significant contribution to the circular economy, the roadmap needs to focus on reducing and optimising the use of plastics.”

The coalition regrets the Commission’s approach in addressing the lack of consumer awareness rather than addressing the producer’s responsibility in prevention of plastic waste.

Delphine Lévi Alvarès, European coordinator of the environmental group, said: “Instead of acting during the product design

In addition, she noted that “the Commission does not expand on the need to move away from the use of hazardous chemicals in plastics which can harm

public health.” “It is crucial that we reframe the debate around real solutions, take action to dramatically reduce throwaway plastics and acknowledge producer responsibility for a product’s end of life in the design process, rather than focusing on (unsustainable) replacement and recycling.” The Break Free From Plastic movement is a partnership of 90 non-governmental organisations from around the world, and the coalition’s 20 members from Europe, including Greenpeace, Friends of the Earth Europe and Zero Waste Europe, have criticised the EC’s vision of a circular transition for plastics.

EU states agree 35 percent renewable energy target by 2030 the total energy mix to 35 percent by 2030. Other targets endorsed by the Parliament include a 35 percent improvement in energy efficiency and a 12 percent share of energy from renewable sources in transport, by 2030.


embers of the European Parliament recently voted in favour of increasing efficiency and renewable energy targets. They voted to increase the contribution of renewable energy to

Jose Blanco Lopez (S&D, ES), rapporteur for renewables, said: “If Europe wants to fulfil its Paris commitments, to fight climate change and to lead the energy transition, we need to do more. Parliament was able to achieve a broad consensus for significantly higher 2030 targets.” In order to achieve these targets, he noted that

national targets should also be set, from which member states would be allowed to deviate by a maximum of 10 percent under certain conditions. Apart from this, MEPs also want a ban on the use of palm oil from 2021.They noted that the contribution of so-called ‘first generation’ biofuels made from food and feed crops, should be capped to 2017 levels, with a maximum of 7 percent in road and rail transport. In order to avoid encouraging the unsustainable use of biomass for energy production, the lawmakers also want to support schemes for renewable energy from biomass to be designed.


he flagship EU plastics strategy contained merely a fleeting reference to exploring the possibility of a plastics tax, proposed by Budget Commissioner Gunther Oettinger to reduce waste and plug the gap in the budget left by Brexit. The European Commission, in its official statement, said it will ‘explore’ the feasibility of the proposal, but fell short of supporting the idea amidst disagreement in the plastics industry. Similar green taxes have been recently proposed in the United Kingdom, where Prime Minister Theresa May vowed to introduce a tax on throwaway plastic packaging as a measure to protect the environment. No details of the proposed plastic tax were available, but the Treasury is poised to launch a consultation shortly. The initial focus of any such tax policy is likely to be on single-use plastics. Proposals for green taxes have received mixed response amongst environmental groups across Europe, though most of them have stressed that any eventual measures would need to be ambitious and coordinated. Industry groups worry that such a tax might be extremely complicated and ultimately end up on the consumer. Instead, they suggest the Commission should press to ban recyclable plastics from landfills. The Commission is now considering forcing countries to levy charges at point of sale for certain products like disposable coffee cups, copying a requirement already in place for plastic bags.

Government Gazette | 07

plastic strategy

Cleaning up EU’s oceans

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The EU vision for plastic-free oceans The European Commission has launched its plastics strategy, setting out an agenda to make all packaging recyclable by 2030, reduce ‘single-use plastics’ and ban microplastics. European Commissioner for Environment, Karmenu Vella outlines his plan to clean up Europe’s oceans


lastic is everywhere. Go to the beach, walk through a park, take a break in the countryside…and you will be forced to agree. The benefits that plastics bring to our society and economy are undeniable. But too much of it is used before being thrown away. Once littered, it remains in the environment for centuries. If we want to see clean beaches and clean oceans and if we don’t want plastic in our food and drinking water, this has to change. With the first-ever Europe-wide plastics strategy, we are doing just that. We are laying the foundations for a sustainable plastics economy. Under the new plans, all plastic packaging on the EU market will be recyclable or reusable by 2030. By transforming the way we design, produce, use and recycle plastics, Europe can take the lead creating new investment opportunities and jobs. European consumers generate 25 million tonnes of plastic waste, but only a third of it is recycled, the rest is incinerated or landfilled. This is quite a wasted opportunity. This discarded plastic could be worth €105 billion to the economy every year.

eaten plastic. And, our citizens are very worried about the impact of plastic on their health and the environment. They don’t want plastic waste in the oceans. They don’t want birds, turtles and sea life getting tangled in plastic bags, and old fishing nets. They don’t want microbeads in the fish they eat. And they’re increasingly fed up with our throw-away approach to plastic. The new strategy on plastics will tackle these issues head on. We take a holistic approach to the entire plastic life cycle, stimulating design for circularity, boosting recycled content and encouraging better waste collection. We have quite a way to go as currently only 6 percent of plastics come from recycled material. To change this, there will, among other things, be new rules on packaging to improve the recyclability of plastics. New standards for the quality of recycled plastics will give potential users assurance that materials are safe and reliable.

The damage to the environment is equally worrying.

We’re backing the strategy with a strong financial component and increasing support for plastics innovation. We are investing an additional €100 million to help plastics innovation. This comes on top of the 250 million already invested.

Across the world, plastics make up 85 percent of beach litter. If we don’t change the way we produce and use plastics, there will be more plastics than fish in our oceans by 2050 and 99 percent of seabirds will have

To stem the growing amount of waste and turn the tide of marine litter, we will come forward with new rules on single-use plastics and fishing gear later this year. Work on this has already started: we are

gathering evidence to determine the scope of the initiative. A public consultation is under way. There will also be new measures to restrict microplastics in products such as cosmetics and detergents. We will fix standards for biodegradable and compostable plastics so that consumers know what plastic is recyclable and make conscious choices. With plastic placing a huge burden on the environment we need to explore all avenues to lighten that burden. Among these is a possible plastic tax. There are many angles to be scrutinised, including who would pay – the consumer or the producer, or a combination of both. It is complex issue and will require careful analysis. As plastic value chains are global and as marine litter from one country ends up on the beaches of another, we must find a global response. If all actors at global, national and local levels join in, we can make the transition happen. Companies play a key role in making this happen, with their strategies and investment decisions. So do consumers, with their choices and behaviour. Making it a reality is our shared responsibility. Together we can make sure that plastic becomes truly fantastic.

War against plastics


Jonathan GAVENTA

Director, E3G, Third Generation Environmentalism

Can a tax on plastics and carbon fund the European Union?


n January 2018, EU Budget Commissioner Günter Oettinger floated a big idea: to fund the EU’s budget through taxes on plastic and carbon pollution, rather than only through member state contributions. The proposals speak to the biggest challenges of our age. Avoiding the most catastrophic climate change scenarios and keeping global warming to well below 2 degrees requires full decarbonisation of the economy by the middle of the century. The accumulation of plastic waste in the ocean is rightly recognised as a crisis with severe consequences for both wildlife and the food system. The need to move from a throw-away society to a ‘circular economy’ is the widely cited aim of both businesses and governments alike. There are strong reasons to support the proposals. Pollution from plastics and carbon are classic ‘environmental externalities’. They cause costs to the environment and society that are not fully reflected in market prices. Taxation of plastics consumption and of carbon pollution are making these hidden costs more visible. Shifting the burden of taxation from labour to pollution can support productivity gains and also address environmental problems. Fundamentally, it is sensible to take a European approach to these issues. Goods, services and energy are traded across the EU. A proliferation of | 10

national and local schemes makes trade more complex for both businesses and consumers. Coordinated European action can prevent a race to the bottom of environmental standards. Conventional wisdom suggests the politics of the initiative will be difficult to navigate. EU member states traditionally tend to prefer to keep direct control

of taxation issuesand are wary of handing over revenue streams. The European Commission has proposed various means for raising its own revenues in the past, including retaining revenues from carbon taxation, but has hardly been successful.

The EU has only recently completed a drawn-out reform of its Emissions Trading Scheme, so appetites for reopening the legislation will be limited. Meanwhile, the response of the plastics industry has been predictably dismissive.

It is also unclear how much support these ideas have within the European Commission itself. The flagship EU plastics strategy contained merely a fleeting reference to exploring the possibility of a plastics tax.

But we are not living in normal political times. The UK’s departure from the EU leaves a multi-billion euro hole in the EU budget that has to be filled. New demands on the EU budget, such as migration, security and disaster response, will also need to be funded. Faced with a choice of increasing national contributions to the EU budget or allowing an EU levy on plastics and carbon, national finance ministers may prefer the latter. As a result, this is the right time to put forward big ideas on EU budget reform, and the proposals stand a considerably greater chance of success than in previous budget cycles. If political backing can be secured, there are substantial policy design challenges that will need to be addressed. The price of carbon allowances in the EU’s Emissions Trading Scheme has fluctuated wildly since it was first introduced, from €30 to below €4 per tonne. This makes it very difficult to predict the potential revenues from the scheme over a sevenyear period. Current prices remain far too low to incentivise low carbon investment. A carbon ‘floor price’may be needed to stabilise revenues and ensure

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François de BIE

Chairman, European Bioplastics (EUBP)

European Bioplastics welcomes first plastics strategy in Europe targets are met. Revenues from a plastics tax may be equally unpredictable. If the tax is successful in discouraging plastics use, revenues fall. These effects need to be planned in from the outset. Decisions will still be required on whether plastics are taxed at the point of manufacture, the point of sale or the point of disposal. Adjustments may be needed to ensure the burden is not disproportionately met by poorer consumers or poorer countries. Finally, in order to be successful, carbon and plastics taxes need to be part of effective and consistent strategies, rather than stand-alone measures. We need to travel a considerable distance to ensure that the EU budget matches our climate goals. While the current EU budget aims for 20 percent of its expenditure to be climate-related, it also funds contradictory investments such as fossil fuel infrastructure. Wider reforms aimed at increasing investment in clean energy and industrial transformation will need to progress alongside the EU Emissions Trading Scheme. Success in limiting single-use will require not only taxing plastics but also investments in research and innovation and in retooling the industry towards a circular economy model. Ultimately, the new proposals add useful tools to the European toolbox for the shift to a sustainable economy and deserve full consideration as a result.


he European strategy for plastics, published on January 16, 2018 by the European Commission, sets clear goals to curb plastic waste, increase resource efficiency and create value and job growth in Europe. However, the strategy falls short on presenting a comprehensive approach by limiting the focus of the strategy on mechanical recycling. Concrete steps towards reducing the dependency on fossil feedstock by linking the circular economy with the bio economy and supporting innovative biobased plastics solutions have unfortunately been further postponed. Moreover, the contributions of biodegradable plastics to a circular economy are recognised but concrete measures are still missing. “Plastics made from renewable raw materials are a suitable alternative for many plastic products,” says de Bie, and adds: “For some applications, recycled plastics are not always suitable due to lower quality or for safety reasons. While the increase of recycled content in plastics is important to reduce virgin fossil feedstock, alternative sustainable feedstocks such as biobased feedstocks need to be encouraged as well in order to defossilise the plastics economy.”

Development Goals and the Paris Agreement.

benefits with respect to reducing the impact of some applications on the marine environment. In a At the same time, the next step, appropriate materials, mobilisation of EU-grown applications, standards, and biomass for the production of environmental claims and bio-based plastics would provide communication have to be impulses for jobs and growth specified together with the in the bioeconomy sector and Commission and other relevant the opportunity to EU farmers stakeholders in upcoming to valorise side streams and byinitiatives as outlined in the products and to tap additional strategy,” says de Bie. revenue streams. “We also appreciate the EUBP welcomes the importance commitment of the Commission the Commission has given to to make a clear distinction biodegradable and compostable between biodegradable plastics plastics and their role in separate and so-called ‘oxo-degradable’ collection systems for organic plastics that falsely claim to be waste in order to improve clean biodegradable. We therefore waste streams and recycling strongly welcome the decision of quality. The benefits and the Commission to restrict the circular use of biodegradable use of oxo-plastics in the EU,” plastics have to be foremost says de Bie. considered in this context of organic recycling. EUBP looks EUBP is looking forward to forward to collaborating with closely working together with the Commission on identifying the EU institutions and all applications and measures to relevant stakeholders in the stimulate innovation and drive upcoming discussions following market development in this the EU plastics strategy in field. order to ensure that the initial acknowledgements of alternative “In addition to organic bio-based feedstocks and of recycling, biodegradable plastics biodegradable plastics will be have the potential to further developed throughout offer the actions outlined in the annex of the strategy.

Replacing a significant proportion of the conventional fossil feedstock with plantbased alternatives would reduce greenhouse emissions and help to reach the UN Sustainable

Government Gazette | 11

Parliament Perspective on EU Plastics Strategy


Julie GIRLING mep

Member, European Parliament

An ambitious, yet sensible approach to reduce single-use plastics


urope generates nearly 26 million tonnes of plastic waste a year – and only 30 percent gets recycled. These are the figures to keep at the front of our minds as we discuss the future of a substance that changed our lives but now haunts our conscience. The January Strasbourg session in the European Parliament saw the launch of the longawaited plastics strategy from the European Commission, a commitment made in the December 2015 EU action plan for a circular economy. It has a simple aim – to reduce waste and keep the value of products, materials and resources in the economy for as long as possible. It addresses recyclability, biodegradability, the presence of hazardous substances in plastics and the reduction of marine litter. It also offers options to address the interface between chemicalproduct and waste legislation, as well as a proposed directive on port reception facilities for the delivery of waste from ships. The EU has always been a world leader when it comes to progressive and forward-thinking environmental policy and this new strategy is no exception. While 1.5 million EU citizens are employed in manufacturing all those tonnes of plastic, the Commission reckons we suffer an economic loss of €100 billion per year for plastic packaging alone. In order to tackle this growing problem, the EU has announced | 12

an ambitious yet sensible target to reduce single-use plastics and will produce a proposal on how to deal with them later this year. Other issues touched upon include the contribution of plastics production and disposal to climate change – approximately 400 million tonne of CO2 in the atmosphere every year – as well as another hot topic in recent years and an area of particular interest to me, the reduction in the use of microplastics. Between 150,000 and 500,000 tonnes of plastic waste enter EU oceans every year, and between 75,000 and 300,000 tonnes of microplastics are released into the environment every year in the EU. The dangers of plastics to marine life have been evident for decades but not all are as aware of the threat posed by microplastics that are so small that they can build up in every level of the food chain, with devastating effects on the ecosystem. These are seen most clearly in our oceans but the detrimental effects of microplastics on humans are still not clear. The proposal from the Commission goes some way towards protecting EU citizens from the negative effects of microplastics on human health. Environmental policies have until very recently been seen as expensive and non-essential. However, increasing news coverage of the devastating impact plastics is having on the environment, and the accelerated pace at which it is affecting our everyday surroundings, has brought the conversation back to

the forefront of public debate.

backfired badly.

We can no longer ignore the effects when we see the increasingly extreme weather conditions occurring all across Europe. When helping launch the plastics strategy, Commission First Vice President Frans Timmermans made the case: “many of you have children, like I do. If you explain that a plastic straw which took five seconds to make will be used for five minutes, and will last for 500 years, children won’t use it anymore”.

For now, we must wait a little longer to see how the Commission proposes to meet its ambitious targets. At this stage, the only new legislative proposal is for a directive on tackling discharges on waste from ships into the marine environment.

While taking the Commissioner’s point I feel that economic, not emotional, arguments are a better way of convincing the general public. This was the approach taken by Vice President Jyrki Katainen, who commented on how there should be interest in the estimated global loss of €100 billion in plastics packaging each year. Furthermore, the Commission believes that creating a new smart and sustainable plastic industry can bring growth and new jobs, while cutting dependence to imported fossil fuel and that new recycling schemes and infrastructure could lead to the creation of 200,000 jobs across Europe by 2030. I was pleased that the idea of a plastics tax, proposed by Commissioner Günther Oettinger, was not included in the plastics strategy. While the idea is not without its merits in theory, I believe this is something that should be decided at a member state level. Such a move from the Commission could have

Other legislation is foreseen, but it will be subject to separate impact assessments and consultation in line with better regulation principles. Expected proposals include restricting the use of oxo-plastics in the EU; ensuring plastic packaging can be reused or recycled in a cost-effective manner, with harmonised rules on defining and labelling compostable and biodegradable plastics; and quality standards for sorted plastics waste and recycled plastics. The Commission will also bring forward new measures under existing legislation including restricting the intentional addition of microplastics to products via the REACH Regulation, best available techniques to limit plastic loss from aquaculture and new ecodesign measures to support the recyclability of plastics. We can also expect new guidance documents, including those on improving the separate collection and sorting of plastics waste and eco-modulation of Extended Producer Responsibility (EPR) fees. I look forward to seeing what they come up with. It has taken time, but the EU is now ready to respond to the urgency of the plastics issue.

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Fostering the transition towards a circular economy in Europe By Enrica Belfiori, Public Policy Exchange 2008 and 2016 from 37 to 46 percent. When it comes to packaging waste recycling rates, the EU passed from 62 percent in 2008 to 66 percent in 2015, but the percentage remains at 40 percent when only plastic packaging is considered. The July 2017 announcement of the ban of 24 types of waste imports to China provides the final push national governments need to boost their recycling sector and avoid ending up drowned in a sea of waste they can no longer ship away. The Commission is already setting ambitious targets in the field of plastic, progressively eliminating single-use plastic.


circular economic model is juxtaposed with the classic linear system of produce-consumethrow away one that reuses, repairs, refurbishes and recycles materials, impacting on the whole product lifecycle. Prompted by the awareness that natural resources are limited and that the rate at which humans are consuming them is entirely unsustainable, the goal of the circular economy is to keep resources and their value in the economy for as long as possible to exploit their full potential, recuperating secondary-raw materials and thus limiting the need to extract new materials as well as waste production. The European Commission has posed itself as champion of the circular economy in the last few years. In December 2015, it launched the Circular Economy Package (CEP), followed by a number of directives and

initiatives in related fields, ranging from municipal and packaging waste to product design. With the launch of the latest plastics strategy in January 2018, the Commission issued the first findings of its monitoring indicators. Available data does not fully cover the period of action of the CEP, yet it is clear that a slow change is already taking place. Municipal waste generation per capita decreased by 8 percent between 2006 and 2016, while total waste generation per unit of GDP dropped by 11 percent. Furthermore, recycling rates for municipal waste increased between

The potential of circular economy is not exhausted by the environmental benefits; circulareconomy-related sectors have seen a private investment of ₏15 billion in 2014 alone, the creation of 3.9 million jobs and of ₏141 billion of value added, a notable 6.1 percent increase compared to 2012. Moving towards a circular economy is, in other words, a great investment. Change however cannot be achieved overnight: it requires a complete overhaul of our production and consumption model and must be backed up by re-education and awareness-raising actions for citizens, producers and decision-makers. The agreement reached by Council and Parliament on the European Commission’s legislative proposals is to be submitted for a vote in plenary in spring 2018.

Government Gazette | 13

security bulletin

Cyber security in the European Union and beyond

Europe’s new cyber security package With its new cybersecurity package, the EU is taking first step towards a higher level of resilience and preparedness. European Commissioner for Digital Economy and Society, Mariya Gabriel outlines EU’s new plan


uropean Commission President Jean-Claude Juncker earlier this year said “cyber-attacks know no borders and no one is immune.”Cyberattacks are a challenge for individuals, organisations and governments, and the EU as a whole. To deal with this threat we need to cooperate more – and better. Member states are building up their institutions, and at the EU level, we have proposed a stronger Cybersecurity Agency. The existing one, the European Network Information Security Agency (ENISA), which is based in Greece,will get a new mandate, around 50 percent more staff and an increased budget. It will continue to be a knowledge hub, conducting studies and advising policy makers. The agency already serves as the secretariat of the network of cybersecurity incident respond teams of the member states. In the future, it should do so with increased technical and analysis capabilities of its own, not least in order to provide independent input into more traditional situational awareness activities. The agency will continue its close cooperation with other EU-level bodies, such as the computer emergency response team of the EU institutions, bodies and agencies (CERT-EU), and the European Cybercrime Centre (EC3). We are upgrading ENISA, because this is what is needed right now – strong actors at all levels, which exchange information and respond in a coordinated way. The Commission has formally recommended member states to work with the EU institutions to establish a framework for responding to large-scale cybersecurity incidents and crises that affect several member states. A Blueprint annexed to the recommendation already shows how the cooperation could happen in

practice. Member states should work with the Cybersecurity Agency to test the Blueprint in the next panEuropean cybersecurity exercise to see what other improvements are needed. Of course, even stronger institutions will only be as good as the people they employ and the technologies they use. In the field of cybersecurity, we need more people of all kinds and backgrounds – students, researchers and IT professionals. We need to train them and they need to see a perspective for their development in Europe, and especially in the public sector. This is why we have also put forward the project to create a cooperation network of cybersecurity research and competence centres in Brussels and the member states. They should be involved in coordinating research and technological development and setting up infrastructure. Secure communications, encryption, data analysis and network defence all require substantial investments. Even when summing up private, member states and EU investments, we are outspent by other global actors and therefore it is imperative to avoid all inefficiencies, gaps and overlaps. The European Commission will table the necessary proposals for setting this up in 2018 and we will start with preparatory actions, worth €50 million, as soon as possible. We must also tackle the vulnerabilities in our systems and networks and devices. This is not only about fixing known software bugs or applying security by design principles to new products. It is also about creating the right incentives and frameworks to steer investments and behaviour into the direction of more and more systematic security. This is why the European Commission has put forward a European cybersecurity certification

framework. The Cybersecurity Agency will have a central role but experts from EU member states and industry will be deeply involved in the development of new certification schemes while the Commission ensures the validity of certificates in all member states. This is a process for deciding the rules for devices and services to get EU-wide certification. There is no decision on the types of devices and services for which the first such certificates will be developed. It is also not a decision on whether certificates, issued under such schemes, would become mandatory for certain product types or in certain contexts. The intention of the proposal is very clear – such decisions should be considered in the future, by legislators, by regulators and by public procurers. The economic rationale is clear, because vendors will only need one conformity assessment and one certificate for the whole EU, simplifying cross-border marketing, and providing significant savings. Even more importantly, anybody who needs to buy secure products in the Digital Single Market will be able to do so without the uncertainty and costs, caused by different rules. Cybersecurity is not the only barrier on the road towards a true Digital Single Market, and as we address each barrier, we must do so with measures that reinforce each other and create synergies. With its new cybersecurity package, the EU is taking first steps towards a higher level of resilience and preparedness. It does so in a way that is consistent with international trade and cooperation, and with the goal to help all stakeholders including citizens, companies and the EU member states.


Cybersecurity is not the only barrier on the road towards a true Digital Single Market and as we address each barrier, we must do so with measures that reinforce each other and create synergies.

security bulletin

Bulgaria EU Presidency

Eva Maydell says Bulgaria’s EU Presidency comes at the right moment to reconnect with citizens


ulgaria takes over the rotating EU Presidency at a time when we are to see the culmination of at least three interlinked strategic topics for the EU agenda. On one hand, we will witness the second phase of the Brexit negotiations, which will put European unity to a real test. | 16

On the other hand, just before the European elections, the debate on the Future of Europe, initiated with the European Commission’s white paper, will intensify and will provide tangible perspectives. In addition, after years of growing populism and Euro-sceptic movement across Europe, the Presidency comes at a moment which is crucial for

re-establishing the dialogue with the EU citizens. It seems like the wind is blowing in our sails –the levels of support for the EU as an institution are returning to those before the crisis. As much as 57 percent of Europeans today support their country’s membership in the EU and 64 percent believe EU membership has benefited their

country (2017, Eurobarometer Survey Commissioned by the European Parliament). In fact, many Europeans today are asking for a more engaged EU in spheres like migration management, security and even social policy. As the Presidency coincides with the last phase of the EU institutional mandate, it will need to show what tangible results the current policy cycle will deliver to citizens. Therefore, the Presidency will have to provide for political compromises in many of the areas on which political decisions have been lagging. Furthermore, Sofia needs to find a way to match the expectations with a somewhat constrained EU budget after Brexit. Last but not least, despite a

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German Chancellor dismisses plan of ‘total’ diesel ban targeted anti-EU disinformation, propaganda and fake news, the EU continues to be a power of attraction for the countries of its neighbourhood. Particularly, citizens in the Western Balkans not only are supportive of closer relations with the EUbut also welcome the tough reforms and rules that their countries need to meet to join the club. However, there is an atmosphere of insecurity as to whether the EU can deliver to them. That is why we believe that the Presidency is a good time to extend a hand towards the immediate EU neighbours. I am very pleased to see that the Presidency is not shying away from these issues. The Presidency will further develop some of the already functioning EU policies. One such policy which has been providing tangible results in all EU territories is the EU cohesion policy. This policy must become more targeted if it should support job creation, growth and social cohesion. I am also convinced that the Presidency will support the strategy for strengthening the Economic and Monetary Union in making the banking sector more stress-resilient on a way to a European Banking Union. In the area of youth and education policies, the Presidency will lay an emphasis on the New Skills Agenda for Europe and make a mid-term evaluation of Erasmus. In policy fields such as migration, the Presidency will be running against time and diverging national interests. A key priority will be to achieve progress on the asylum system and lead Europe to a more functional and responsible migration management. Striking the right compromises will be the only way to find a lasting solution to the migration crisis.

As already outlined, the Presidency foresees working on delivering a more concrete European perspective for the region of the Western Balkans. I am glad to see that Bulgaria has not only chosen the way of diplomatic dialogues and the EU conditionality towards the countries of the Western Balkans. Intensified functional regional cooperation with a connectivity focus in transport, digital, education or telecommunications will bring the Western Balkans even closer to the EU. Finally, I am confident that the Presidency is taking to heart the question of bridging the skill gap in Europe and working for the completion of a Digital Single Market (DSM). Both of these have been my personal priorities throughout my mandate as MEP and I am eager to see progress on the legislative files exactly during our presidency. The team of the Presidency definitely has on its radar the objective of making the DSM a core element for Europe’s competitiveness while preserving the necessary level of user protection. The success of the Presidency will depend on whether the Bulgarian government will manage to convince everyone to stay together on key issues, while maintaining ambitious goals and clear communication with the citizens before the elections. The stakes are high, but I am confident that we are prepared to excel: “United we stay strong!” Eva Maydell is a Member of the European Parliament’s European People’s Party.



erman Chancellor Angela Merkel has said that the country’s federal governments oppose any attempts to ban diesel car from the country’s streets and calls for ‘tailor-made’ efforts to control emissions. Merkel’s comments on dismissing diesel bans come after a landmark decision by Germany’s highest administrative court in Leipzig, which ruled in favour of upholding diesel bans in the cities of Stuttgart and Düsseldorf, two of the most polluted cities in Germany. Reassuring car owners in Germany, the government has insisted that nothing would change immediately. Germany’s environment minister, Barbara Hendricks said “Driving bans can be avoided, and my goal is and will remain that they do not come into force.” Merkel noted that the ban was only relevant to select cities and is not applicable to the entire country. Commenting on the sidelines of the court decision, the president of the Association of the German Automobile Industry, Matthias Wissmann, said that “ambitious air quality standards in German cities are

also achievable without driving bans”. He suggested that the air quality levels could be brought under control “if and when more vehicles with new exhaust standards entered the car pool”. Last November, Germany’s government launched a development fund of €1 billion to cut diesel pollution in urban areas and boost investment in green transport. Around one quarter of the fund will allegedly come from German carmakers. Merkel said the funds would be made available as soon as possible so that local governments could initiate ‘tailor-made’ solutions to improve air quality. The money is to be used for initiatives to make city traffic solutions more environmentally friendly, and to provide more electric charging stations and electric buses. In a pledge to avert such bans, German car makers have decided to provide software improvements of millions of diesel cars. VW-owned Porsche and Toyota have also indicated that they will stop production of diesel cars.

Government Gazette | 17

Circular economy - a win-win approach


Sirpa PIETIKÄINEN mep Member, European Parliament

Europe cannot survive without improving resource efficiency


t has been forecast that global demand for resources will triple by 2050. We already consume some 1.5 globes’ worth of resources every single year, and following the estimates, would need around four planets-full of resources to satisfy the demand by 2050 under a business as usual scenario. There is just one problem with this: we only have one planet. European economies cannot survive – let alone grow and prosper – unless we take some radical steps to improve our resource efficiency and move towards a true circular economy. We have to stop wasting precious resources and start using them more efficiently. What we need is a true paradigm shift, one that will benefit both our economy as well as our environment. Europe is extremely dependent on imported raw materials and energy. The EU has had a trade deficit in raw materials since 2005. Material costs often represent 50 percent of a company’s total costs. Both raw materials and energy have continued to see a rise in costs. With raw materials running short, Europe is either going to be hit the hardest by resource scarcity or | 18

benefit the most from resource efficiency. We have to stop wasting precious resources and start using them more efficiently.

percent before 2030 would create two million new jobs while boosting our GDP by 1 percent.

In this challenge, there also lies a huge opportunity. The one who can deliver solutions for the resource efficiency dilemma is also the winner of the new economic race: this means solving the problem of doing more with less – creating more added-value with fewer resources.

Many businesses have already recognised these facts and started acting accordingly. They have taken a leap to a different mindset, to one where the whole logic of successful business is turned upsidedown. These firms have created new business models to deliver greater resource efficiency and circular models including increased renting, sharing, leasing and remanufacturing.

Business-driven studies demonstrate significant material cost-saving opportunities for the EU industry and a significant potential to boost EU GDP. The Commission has, for example, calculated that increasing resource productivity by 30

In circular economy there is no waste; products are designed to be durable, repairable, reusable and recyclable, and when they come to the end of their life the resources contained in these products are channelled back into productive use. In order to support this change we need to change the rules of the game. Regulation is never neutral. Legislation is one of the essential drivers of the business revolution. A lot of our thinking and also a big part of the current legislation is created for the needs of a consumeand-throw-away society and therefore has to be changed to fit the new world order. To drive the business revolution, we need to create a stable

and predictable regulatory environment. We need harmonised indicators to measure the change. We need clear targets. We need to draft such legislation as will make sure that what is considered waste nowadays is not considered such anymore – but seen as a resource. This requires a change to how things are being produced: products need to become more durable, easy to upgrade, reuse, refit, repair, recycle and dismantle for new resources. A reformed and enlarged EU Ecodesign Directive is a crucial tool to ensure resources stay in the loop. The directive should guarantee the implementation of principles of durability and reparability across all products. At the same time, encouraging a market in repair and in buying and selling of second-hand goods can promote jobs and reduce the amount of waste. This would also satisfy the consumer: according to the 2014 Eurobarometer, 77 percent of Europeans would rather fix their old appliances than buy new ones. This offers a perfect win-win market opportunity benefiting the economy, the environment and people. Perhaps the most compelling reason to embrace resource efficiency and circular economy models is that we don’t really have a choice.

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security bulletin

Andrew FARRELLY Partner, CT Strategies

Why strong international partnerships create the most secure US borders


resident Trump has promised to make the nation safer by protecting our borders. This endeavour is more complex than attempting to seal off entry with a wall or blanketly banning entire countries from boarding planes to the US. In reality, high-risk individuals attempting to travel to and harm the US can depart from anywhere and be of any nationality. The solution to mitigate this risk is not to retreat from alliances, but rather to strengthen international relationships and information-sharing agreements with foreign partners that supply US intelligence and law enforcement agencies with greater access to US-bound traveller data. How vetting works The vetting of air passengers involves collecting and analysing multiple data points on individuals including biographic and biometric data, travel patterns and other pieces of information synthesised with open source and classified intelligence. Information is analysed prior to a passenger boarding a flight, and, if necessary, action is taken either before the passenger boards or upon arrival at their destination. Data exchanged with foreign authorities, along with coordination from the airline industry, are critical components of this process. However, creating and maintaining passenger data and other informationsharing agreements can be a complicated and fragile process, even with some of our closest traditional allies.

Different countries have varying perspectives on data privacy or varying federal structures that govern the legal authorities, roles and jurisdictions of their intelligence and enforcement agencies differently from US counterparts. Differing institutional structures and competing political perspectives can be further exacerbated when engaging regionally or with multilateral organisations, such as the European Union. As a key partner in the fight against terrorism, and hub for many global airlines, the European Union stands as a strategic US partner in exploiting travel as a means to identify international bad actors. Therefore, maintaining these agreements and the political will that supports their practical functioning requires tact and diplomacy. Rather than risk alienating key allies with whom the US has traditionally relied upon for US-bound traveller data and other critical intelligence, a more effective approach for the president to take would be strengthening these partnerships to further induce cooperative information-sharing. Managing partnerships While the president has, at moments during the first months of his term, taken a globally minded approach to foreign affairs, the aggressive tone set through rhetoric and policy proposals during his campaign and early months of his administration has pushed certain traditional allies away rather than embracing them. Specifically regarding the

president’s proposed travel ban of individuals from multiple Middle East countries, Michael Hayden, retired US four-star General, former Director of the US National Security Agency, and former Director of the US Central Intelligence Agency, stated that the proposed ban makes Americans “less safe” by alienating current and future intelligence sources in the Middle East. If such posturing continues it would jeopardize US efforts to gain intelligence from sources which have typically been cooperative with the US, but who may now react adversely. Tactful outreach and strategic partnership formulation is particularly critical in a time when certain governments are already not sharing sufficient information. Furthermore, while the current vetting process is already a robust one, the type and quantity of information the US receives from other governments can always be refined and improved through cooperation and collaboration rather than divisiveness. Smart technology investments While the US Congress weighs the cost-benefit of expanding the US/Mexico border wall, they should also consider the technology needs of US officials vetting international travellers at US air and land ports of entry. To process the growing volume of air passengers and their associated data, US Customs and Border Protection (CBP) Officers, coordinating with other US intelligence and law enforcement agencies, require state-of-the-art automated systems, utilising sophisticated risk assessment algorithms.

Adequate appropriations for this technology must be kept up to date. Moving forward Fortunately, there are highly capable officials at the US Department of Homeland Security (DHS), US CBP, the FBI, the US Intelligence Community and other agencies who will continue to leverage their institutional knowledge and experience in conducting risk management operations while collaborating with partners globally. However, words matter, the way we talk about things matters and US underlying partnerships matter. Strained relationships at a head of state level can have a trickledown effect through their respective government agencies and may disrupt the cooperative two-way flow of information vital to US and global security. The safety of Americans cannot be solely focused on border walls and overly simplified ’vetting’ of travellers. The process is more complex and requires forwardthinking political leadership, a commitment to international partnerships, collaboration with industry and the leveraging of smart technology tools.

Government Gazette | 19

cardiac health

Recommendations to reshape policy making


Putting cardiac health strategies under the spotlight Policy interventions and challenges

heart talks... action plan to promote healthy hearts Specialised healthcare policy institutions present their fast-track strategy to promote healthy hearts at ICPS Cardiac Health Europe 2017 heart failure 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 urgent action Karin Kadenbach MEP highlights the urgent need for public policy interventions in managing cardiac health in Europe strategic policies Susanne Logstrup, Director, European Heart Network says setting strategic policies for better heart health is crucial industry perspective Dr Robert C Kowal, Chief Medical Officer, Medtronic Cardiac Rythm and Heart Failure argues that we need more partnerships between regulators and providers preventive approach Prof Lale Tokgozoglu, President, European Atheroscierosis Society points out that prevention of cardiovascular disease should be the priority air pollution Simon Gillespie, CEO, British Heart Foundation writes about the connect between air pollution and cardiac health doing things differently Dr Susan Connolly, Clinical Lead for Preventive Cardiology at Western Health and Social Care Trust calls for a paradigm shift to patient-centred care


Promoting healthy hearts

cardiac health europe


High-level roundtable discusses efforts to promote healthy hearts A complex health issue that is interlinked with a number of other chronic conditions, cardiovascular disease (CVD) remains the number one killer in Europe. The International Centre for Parliamentary Studies (ICPS) recently convened the Cardiac Health Europe Roundtable to create a platform to address the key policy challenges in managing the deadly disease in Europe. Diane Rolland, International Programme Manager at ICPS, points out the recommendations tabled at the roundtable


ardiovascular disease (CVD) is the main cause of mortality and disability in Europe. Despite the fall in CVD mortality in Europe, more than 4 million people die from CVD across the continent every year, and more than 1.4 million die prematurely, before the age of 75, accounting for nearly half of all deaths in Europe. Many of these people have been exposed to unhealthy behaviours, including tobacco use, foods with high-salt content and inadequate physical activity. Consequently, one of the most imperative health issues for EU member countries now is to create comprehensive prevention plans and ensure that effective policy measures and interventions are in place in all European countries. Despite its prevalence and socioeconomic costs, CVD is yet to be seen as the largest threat in Europe and there is a lack of investment in cardiovascular medicine. New and innovative approaches are urgently required across the EU. The ICPS Cardiac Health Europe Roundtable 2017 gathered European policymakers, medical and clinical professionals, academic experts and patient group representatives, to examine the ongoing challenges in managing CVD and explore practical solutions in order to build a framework for action in cardiac | 22

health policy in the EU.

treatment remain unanswered.

Education and prevention

Is equal treatment for everyone achievable?

Europe’s growing girth is clearly a cause for concern. Cardiovascular health in Europe is a mirror of the current way of living and unhealthy behaviours including tobacco use, deskbound lifestyles, fast and junk food, lack of physical activity. There is a clear need for lifestyle change. This is where education needs to play the bigger role. There’s also a need to create preventive plans and ensure that effective policy measures and interventions are in place in all European countries. Charting the course for the future of care Technological breakthroughs are changing the course of heart-failure treatment; however, strong awareness programmes, primary care and early intervention are crucial in reducing mortality rates. In particular, active involvement of patients could improve delivery of care and increase knowledge about the disease. Such patient engagement could be sought through the use of novel technologies such as distance monitoring and e-heart technologies. Although such developments constitute the future of practice, questions of data protection, legal responsibility of the information and the subsequent

CVD inequalities are perpetuated by a range of factors including differences in rates of CVD (relating to socioeconomic status), poor health literacy, genetic predisposition to risk factors for CVD, unhealthy lifestyles, geographic differences and access to novel technologies. Policymakers should urgently address these factors and assess how new technologies can be made available at regular checkups. Other recommendations for policymakers: - More funding and clearer vision for research is needed; - Secondary prevention should be expended, a lot more could be done to identify patients at risk of CVD; - There is a need for distribution of money between education and prevention. Only by changing the current lifestyles of our societies can we achieve decrease of CVD; - We need to create a favourable environment for healthy life choices; - Health taxation should be high on the agenda; - Prevention and treatment should come together and not be dissociated; - A reimbursement scheme for telemedicine should be

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developed and made widely available across Europe to reduce disparities; - There is a need to find the right strategies to for primary and secondary prevention – more focused on specific fields; - It is important to ensure that the patient voice is heard at the highest level of policy; - We need to increase patient support at primary care where they have a more holistic view of the patient; - Better primary care, and especially community care,

can help to improve access to data on heart disease; - Countries should focus on providing access to evidencebased medicines, devices and diagnostics tests that are appropriate for every patient; - Practitioners call for a more flexible regulatory framework to foster innovation. Participants: Network Coordinator and Public Affairs Manager, European Heart Network, MEP Heart Group Supporter, European Parliament, Past President, European Society of Cardiology,

Head of Department, KaiserFranz-Josef-Spital Austria, Professor, University Medical Centre Maribor Slovenia, Senior Advisor, World Health Organization Office at the European Union, Director Government Affairs Europe, Amgen, VP Medical Affairs and Chief Medical Officer, Cardiac Rhythm and Heart Failure, Medtronic, Senior Director Medical Affairs EMEA, Abbott Vascular, President, Luxembourg Society of cardiology

Government Gazette | 23


Promoting healthy hearts

Annie SCHREIJER-PIERIK MEP Member of European Parliament’s ENVI Committee

Where we are now on heart failure is not acceptable


eart failure is a widely misunderstood but devastating chronic condition. Nearly 15 million people in Europe have heart failure, and this number is increasing. Up to one in five people are at the risk of developing a heart failure at some point in their life. Yet, awareness remains worryingly low. For example, just 3 percent of the general public can correctly identify all three key symptoms – extreme breathlessness, fatigue and swollen ankles. We cannot accept such low awareness of symptoms for such a common condition. Unfortunately, this poor understanding of heart failure often allows the condition to progress significantly before diagnosis and start of treatment. Even a delay of four to six hours after onset of symptoms can increase the risk of death significantly. This is just one of the reasons why I co-authored the Written Declaration 110/2016 on heart failure. We can do a lot to improve quality of life and life expectancy for people living with heart failure. We need to provide better support and care across all aspects of their lives.There is no cure for heart failure, so treatment aims to stabilise and manage symptoms to prevent | 24

progression.Information and support are essential in enabling enable people to adhere to treatment and make important lifestyle changes. We know what to do with heart failure, but quite often healthcare systems do not deliver it. The same could be said of many diseases, but there is a particularly compelling case for heart failure when we consider health systems’ readiness for the future. Heart failure is a chronic condition where the heart cannot pump enough blood to support the needs of other organs in the body. It is often (but not always) a result of many years of living with other cardiovascular diseases. The most common causes of heart failure include coronary heart disease, heart attacks, congenital heart defects and damaged heart valves. The numbers of people living with heart failure, as well as other conditions that can lead to it, are certain to rise. In general, there has been an increased focus on prevention of non-communicable diseases across Europe. However, we need to go further and see complex conditions and comorbidities as an essential aspect of health system sustainability. With an ageing European population, health strategies at all levels must recognise the value of prevention and promotion of wellbeing for those

with existing chronic conditions (eg, secondary prevention). These must be seen equally to health promotion and primary prevention in the general population. Therefore, heart failure is of huge relevance. Not only does it have a significant human and economic burden, but it can also act as a model for other chronic disease management. If we can get it right in heart failure, we will be well placed for many other chronic conditions. In heart failure, patients and clinicians must work together to succeed, but to do this, there must be significant support from politicians and decisionmakers. Investment in delivery and organisation of care,such as specialist nursing, self-management, education, palliative care and better care transitions, are essential and overdue. Where we are now on heart failure is not acceptable – and this is a leadership challenge. The European Parliament must continue to keep heart failure on its political agenda. It is our responsibility to ensure that people with heart failure receive the high-quality care and support that they need, and to build a common cause with other non-communicable diseases. Now more than ever, heart failure needs a seat at that table.

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Government Gazette | 25


Promoting healthy hearts


Co-Chair, MEP Heart Group, European Parliament

‘Public policy interventions are urgently needed to tackle cardiovascular disease’


onsiderations on the relationship between food and health are not new. Hippocrates, the ‘Father of Medicine’, believed that illness stemmed from inadequate nutrition and bad eating habits. Yet, over 2,000 years down the line and despite the abundance of scientific evidence on the damaging effects of unhealthy food, inadequate diets have continually remained the main risk factor for cardiovascular disease (CVD), the number one killer in the EU accounting for over three deaths per minute. In a world where obese and overweight people have outnumbered underweight individuals, and where diabetes, hypertension and hypercholesterolemia are on the rise, it appears logical that healthy eating should be a collective responsibility incorporating also a full spectrum of public policy interventions to address the very context within which individual | 26

choices are made. Ahead of a meeting in the European Parliament dedicated to discussing “Transforming European food and drink policies for cardiovascular health” Karin Kadenbach MEP, Co-Chair of the MEP Heart Group (1), explains why. Despite the fall in death rates observed over the past three decades, CVD (including heart disease and stroke) remains the leading cause of death in Europe, causing over 1.8 million deaths annually in the EU alone, with higher rates in Central and Eastern Europe than in the rest of Europe. The past 25 years also saw an increase in the absolute number of CVD cases, with 49 million people (9.6 percent of the total EU population) living with CVD today. This means that people are living longer but not better. (2) Disease patterns have also changed significantly in the EU. Although smoking remains a leading risk

factor for individuals, unhealthy diets are by now the biggest risk factor for CVD at a population level – responsible for 49 percent of the CVD burden, and generating an estimated annual cost of €102 billion – with growing trends of obesity (20 percent in my home country, Austria), and a steady increase in diabetes rates (in some countries by more than 50 percent) across Europe. (2) We may have reduced death from CVD, but we are still far from restraining its social and economic burden, or tackling its causes successfully. This gloomy picture calls for a collective effort addressing multiple levels from patient care, education and engagement (through healthcare professionals and patient organisations) to food systems ‘interaction’ (through dialogue with all actors along the food chain). Importantly, an overarching EU supported framework should

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complement these actions with targeted upstream initiatives aimed at creating supportive environments through public policy and regulatory measures. There is a positive track record in many fields (the most prominent being tobacco control), and there is no reason why upstream prevention should not be extended to all other risk factors, particularly nutrition. Indeed, there is an abundance of scientific evidence proving that dietary habits influence CVD risk. There is also broad consensus on what a cardiovascular health-promoting diet means, ie,a shift from an animal-based diet to a plant-based diet that includes vegetables, fruit and berries in abundance. Wholegrain products, nuts and seeds, fish, pulses and low-fat dairy products are important, as are non-tropical vegetable oils in modest amounts. Foods or drinks that are low in vitamins, minerals and dietary fibre and high in free sugars, saturated fat, trans fats or salt fibre should be avoided. Limited consumption of red and processed meat products would also contribute to better heart health in Europe. In an ideal world, individuals would request to have access to healthy food only. However, consumer demand interacts with other ‘forces’ on the market, which is why governmental interventions are needed to balance consumer, marketing, trade and other interests so that the healthy choices become the default choice: attractive, affordable and available. Concretely, EU policymakers can: - legislate on the composition of foods aimed at reducing energy density, intake of salt, saturated

fat, trans fatty acids (TFAs) and sugars in foods and beverages; - take measures to increase especially consumption of fresh fruit and vegetables; - take action towards restricting advertising and marketing of unhealthy foods and drinks to children on TV, internet, social media and food packages; - set mandatory and harmonised simplified front-of-pack nutrition labelling; - help reshape the Common Agriculture Policy (CAP) to align it with policies to promote public health, and take healthy nutrition into account in trade negotiations. Some of these measures which are supported both by healthcare professionals and patient organisations (3, 4) have already been attempted at the EU level and/or by individual member states with positive outcomes. For instance, six European countries (5) have adopted a legislation to restrict industrially produced TFAs in the food chain. At the EU level, the European Parliament resolution on transfatty acids (6) is now awaiting the outcome of the European Commission’s impact assessment. Encouragingly, recent EU presidencies have also been focusing on aspects closely related to healthy eating. In 2016, the Dutch EU Presidency paved the way for the adoption of Council Conclusions on Food Products Improvement (7), and in 2017, the Maltese EU Presidency proactively engaged towards halting the rise of childhood obesity in the EU by 2020. Preliminary plans of the upcoming 2018 Austrian Presidency of the EU are also aligned with these endeavours.

I trust that by joining hands with all stakeholders along the food chain – including patients and healthcare professionals – policymakers can make a difference. The first step is to ensure an open dialogue and identify joint actions which support winwin outcomes. This will be the aim of the MEP Heart Group meeting that I will be chairing this month in the European Parliament. Supporters of a heart healthy Europe – stay tuned. References: 1. 2. European Heart Network, European Cardiovascular Disease Statistics 2017, http://www. 3. European Society of Cardiology, 2016 European Guidelines on cardiovascular disease prevention in clinical practice https:// cle/37/29/2315/1748952/2016European-Guidelines-oncardiovascular-disease 4. European Heart Network, Transforming European food and drink policies for cardiovascular health 2017 http://www.ehnheart. org/publications-and-papers/ publications/1093:transformingeuropean-food-and-drinks-policiesfor-cardiovascular-health.html 5. Austria, Denmark, Hungary, Iceland, Latvia, Norway and Switzerland 6. European Parliament resolution on trans fats (TFAs), http://www. ?type=MOTION&reference=B82016-1115&language=EN 7. Council conclusions on food product improvement, http:// press/press-releases/2016/06/17epsco-conclusions-food-productimprovement/

Government Gazette | 27

Promoting healthy hearts



Director, European Heart Network (EHN)

Setting strategic policies for better heart health is crucial


ardiovascular disease (CVD) accounts for 45 percent of all deaths in Europe, causing over 3.9 million deaths each year in the member states of the World Health Organization (WHO) European Region, of which 1.8 million deaths occur in the EU (37 percent of all deaths).

Northern and Western European countries in both males and females; and since around 2000 to 2005, age-standardised death rates from coronary heart disease have also been falling in Central and Eastern regions. But between 1990 and 2015, most European countries reported an increase in the number of new CVD cases.

In 2015, there were more than 11 million new cases of CVD in Europe as a whole, of which 6.1 million new cases were in the EU. More than 85 million people across Europe are living with CVD; of these almost 49 million people are in the EU.

However, age-standardised prevalence rate has fallen in most European countries, though with greater decreases in Northern, Western and Southern European countries compared to Central and Eastern European countries.


Economic burden

Comparing the CVD mortality burden across individual European countries reveals substantial variation.

CVD is estimated to cost the EU economy €210 billion a year. Of this, just under €111 billion is the cost to the healthcare systems. This represents a total annual cost per capita of €218. Per capita costs vary over sevenfold

Within the EU, among men, the percentage of all deaths due to CVD ranges from 23 percent in France to 60 percent in Bulgaria, while in women, the burden ranges from 25 percent in Denmark to 70 percent in Bulgaria. Outside the EU, mortality varies significantly. CVD causes 24 percent in Israel and 59 percent in Ukraine of all deaths respectively, among men; and among women the burden varies from 25 percent in Israel to 75 percent in Ukraine. Trends Over the past 30 years, mortality rates from coronary heart disease have been declining in most | 28

between EU member states – from €48 per capita/year in Bulgaria to €365 in Finland. Production losses due to CVD mortality and morbidity cost the EU almost €54 billion, representing 26 percent of total cost of those diseases, with 58 percent of this cost due to premature death (€32 billion) and 42 percent due to illness (€23 billion) in those of working age. An additional important cost is that of informal care, which amounts to €45 billion. CVD – a star candidate for intervention CVD should be a top health priority. The data presented above shows that remarkable reduction in CVD mortality can be achieved. It also shows that CVD remains the number one cause of death and that there is still a significant mortality gap between countries in Europe. Stronger focus on addressing CVD can successfully reduce mortality further and close the gap between Northern, Western and Southern European countries on the one hand and Central and Eastern European countries on the other. Strategies to promote cardiovascular health need to address the whole population as well as those at high risk of and

those already living with CVD. This was acknowledged by the EU member states in the 2004 Council Conclusions on promoting heart health. It is echoed in the European Heart Health Charter and in the 2007 EP Resolution on action to tackle cardiovascular disease. Population-based interventions WHO estimates that 80 percent of premature deaths from CVD can be avoided by controlling three main behavioural risk factors: tobacco, unhealthy diet and physical inactivity. EU regulatory interventions related to food and tobacco, in particular, extend to all EU member states; such interventions have the potential to reduce health inequalities in the EU as inequalities in mortality from CVD account for almost half of the excess mortality in lower socioeconomic groups in most European countries. Unsurprisingly, EHN has a strong focus on policymakers, especially at the EU level, to effect changes in policies that can achieve a small reduction in risk factors across a population of more than 500 million, thus reducing the number of people at risk. It is our view that EU decision makers could do a much better job of conceiving policies that promote environments conducive to healthy lifestyles,

Follow us @GovtGazette which will help improve behavioural risk factors and stem the development of the medical risk factors that increase risk of CVD. One obvious area for the EU intervention is setting mandatory EU-wide upper limits for industrially produced trans fatty acids (TFAs). The evidence for cutting deaths from heart disease by limiting prevalence of TFAs is overwhelming. Such a regulatory intervention is wholly feasible, as shown by the move already made in five EU member states; it is a clear example of the EU using its competence to regulate the internal market to achieve simultaneously a large cardiovascular health benefit. Prevention and treatment The EHN and its members together have explored how to identify people who are at high risk of developing CVD and the benefits of doing so. We also work together on how best to support people living with CVD and invest in research. EHN members have funded – and continue to fund – research that has been instrumental in reducing deaths from CVD, controlling risk factors and improving patients’ quality of life. A role for the EU In 2007, the EHN together with the European Society of Cardiology, the European Commission and the WHO Regional Office for Europe developed the European Heart Health Charter, which was supported by 15 European organisations. Today, 10 years after its launch, we believe there is a need to review it and to look into how EU action could be deployed to alleviate the CVD burden; for instance taking a clue from EU action on cancer. EU action on CVD to support EU member states could include an in-depth comparison of cardiovascular strategies/ plans, looking at their resources, implementation and results. The EU could also play an important role in the provision of better quality data that is comparable across the EU. This could potentially be funded through the EU’s research programmes.

Dr Robert C KOWAL

VP Medical Affairs and Chief Medical Officer, Medtronic Cardiac Rhythm and Heart Failure

‘We need more partnerships between regulators and providers’


he issues impacting improvement of cardiovascular care in the European Union are best categorised in the realms of health policy and healthcare delivery. Both are of critical importance but bring to bear different resources and approaches at a time when ongoing financial pressures imperil healthcare funding. Strategies going forward must focus on access to health prevention and care as well as ongoing innovation in therapy delivery. In the realm of health policy, we must continue to focus ongoing efforts to target modifiable risk factors for the development of cardiovascular disease. These risk factors include obesity, sedentary lifestyle, tobacco and alcohol abuse. However, while the patient–physician interaction remains critical to patient health, the complex interaction between social pressures and medical disease, as well as the difficulties of their management, makes targeting these risk factors transcend the medical office to a more comprehensive strategy for population health. However, the critical role of healthcare providers in cardiovascular health and the primary prevention of cardiovascular disease should not be minimised. The importance of managing hypertension and hyperlipidemia as well as the recognition of early stages of acute and chronic cardiovascular conditions requires a welltrained and broadly distributed network of primary care providers and cardiovascular specialists. Optimal

cardiovascular care requires the combination of both education and policies that support patient access to treatment and care. While coronary artery disease is still a primary driver of cardiovascular illness, advances in prevention and treatment have continued to mitigate its impact over time. However, with the improvement of care for coronary disease, as well as the ageing of the population, we have witnessed an everincreasing burden of chronic heart disease, specifically heart failure, valvular disease and atrial fibrillation. Management of these chronic heart syndromes involves not only risk factor modification but also a combination of pharmacologic, invasive and device-based therapies. Further, the rapid innovation in the interventional capabilities to manage and treat these entities has increased the need for highly trained physicians and nurses to deliver the most appropriate treatment modality, often involving a redesign of clinical pathways and mechanisms for patient–provider interaction. In order to facilitate the necessary advances to manage the growing patient and financial burden associated with chronic cardiovascular disease, we believe that several principles should guide innovation in this space.

2. Reimbursement for therapy should be harmonised across the European Union; valuebased and risk-sharing models should be considered to promote patient outcomes and costeffectiveness. 3. Strategies that promote patient engagement and remote monitoring should be encouraged to broaden access to effective care strategies while minimising burden to current healthcare infrastructure. In summary, societal trends regarding obesity and modifiable habits along with the growing chronic cardiovascular health considerations that come with an ageing population mandate innovative approaches to both population health policy and disease-specific care strategies. Partnerships between providers, government regulatory agencies and industry are needed more than ever to innovate technology, pharmacology and care pathways. In parallel, regulatory and reimbursement approaches must emphasise patient outcomes. We look forward to ongoing collaboration with the International Centre for Parliamentary Studies and the European Union.

1. Technological innovation should be supported by a reasonable regulatory environment for approval that maximises patient safety but stimulates research in the European Union. Government Gazette | 29

Promoting healthy hearts


Prof Lale TOKGÖZOĞLU President, European Atherosclerosis Society

Prevention of cardiovascular disease should be the priority prevention of atherosclerotic vascular disease. Blood pressure control with lifestyle intervention as well as medications is also recommended depending on the level of blood pressure and the risk of the patient. Management of hyperglycaemia in diabetics reduces the risk of complications and to a large extent CVD. Decreasing cholesterol levels is also important for prevention. Randomised trials have consistently demonstrated that reducing LDL cholesterol reduces the risk of CV events, proportional to the absolute reduction in LDL cholesterol independent of other risk factors.


oday, we all know the causal factors leading to cardiovascular disease (CVD). The most important risk factors for CVD are smoking, high blood pressure, high cholesterol, diabetes and abdominal obesity. In addition, factors such as psychosocial deprivation, air pollution and unhealthy foods contribute to this epidemic. It is possible to prevent or retard the progression of the disease by controlling these risk factors. We also know that socioeconomic deprivation increases the dependence on alcohol and tobacco use as well as leading to consumption of unhealthy foods. Often, we notice that cardiovascular risk goes hand in hand with low income. Age-adjusted mortality has decreased significantly in Western Europe due to the reduction in cholesterol, blood pressure levels | 30

and smoking. There are success stories like the one in Kuopio, Finland, where by decreasing smoking, high blood pressure and cholesterol, the death rates from CVD decreased significantly. Unfortunately, the increase in other risk factors attributable to modern lifestyle like obesity, type 2 diabetes, sedentary lifestyle and psychosocial stress will have a negative effect on these gains. Lifestyle interventions are an integral part of therapy and have the advantage of targeting multiple risk factors all at once. One cannot emphasise enough the importance of diet, physical activity and abstinence from smoking in the prevention of atherosclerotic vascular disease. Stopping smoking is the most cost-effective strategy for

There is strong evidence showing that it is possible to decrease CVD by simply controlling the major risk factors. Although we know how to decrease CVD, in reality, it has not been possible to do so. Europe and especially low and middle income countries have undergone rapid industrialisation, urbanisation, economic development and market globalisation. Although these developments led to many positive changes in health outcomes and increased life expectancies, they all also caused inappropriate dietary patterns, physical inactivity and obesity. Fat and energy consumption is increasing mostly in Eastern Europe and smoking remains a key public health issue despite decline in some countries.Physical inactivity and sedentary lifestyle is also on the rise. There are strong geographical disparities between European countries. Eastern and Central European countries have higher rates of cardiovascular mortality

than Northern, Western and Southern Europe. The past 30 years have seen a decline in ageadjusted cardiovascular mortality in most Northern and Western European countries. This change has been less consistent in Central and Eastern Europe. The cost to the European Union economies is high at €210 billion per year. Looking at the percentage of total healthcare expenditure on CVD, more than half of the resources go to inpatient care and about a quarter to medications. Unfortunately, primary care gets a minor percentage despite the fact that prevention is much more important and cost-effective than treatment. CVD can be prevented or postponed by effective prevention policies. It is important for policymakers to make prevention the priority. Prevention of CVD needs to be the priority by creating healthier environments, strengthening the patient-centred primary healthcare and increasing universal health coverage. High quality research should be strengthened with partnership across countries and different sectors such as healthcare providers, cardiac societies, healthcare authorities and the European Union.

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Chief Executive, British Heart Foundation

We must clean up the air to protect our hearts


here’s something in the air and it’s affecting our heart health. It’s an invisible and potentially deadly problem that many of us aren’t even aware of, but it’s contributing to over 550,000 premature deaths across Europe each year. (1) The problem? Air pollution. While the impact of air pollution on our lungs is widely understood, its link with heart and circulatory disease is often overlooked. A 2015 poll commissioned by the British Heart Foundation (BHF) found that less than half of people surveyed were aware of the link between air pollution and heart conditions and just two out of 10 people knew that it can increase your risk of stroke. Globally, 80 percent of deaths related to outdoor air pollution are due to heart disease or stroke. (2) If more isn’t done to improve air quality in the UK and abroad, it has the potential to become one of the biggest public health crises of this generation. Research funded by BHF has helped demonstrate this link. We have invested £3.2 million into medical research in this area, since 2010. Our research shows that both short- and longterm exposure to air pollution can cause or exacerbate existing cardiovascular conditions. It has also demonstrated that there is a particularly strong link between heart and circulatory disease and the tiny particles in the air known as particulate matter or

PM that are often derived from vehicle exhausts. While the link between air pollution and heart disease is well established, there is still much more we need to understand about exactly how air pollution damages hearts. In April, new research published by the University of Edinburgh shed light on how this might occur. Researchers demonstrated for the first time that tiny nanoparticles in the air can travel into the blood and accumulate in diseased blood vessels where they could worsen coronary heart disease – the most common cause of a heart attack. The link between air pollution and heart disease is getting clearer every day. Bold action is needed from governments across Europe to clean up our air and protect those most at risk. Pledges to ban all new petrol and diesel vehicles by 2040, like those announced recently by the UK and France, are important ambitions and set out a positive vision for the future. But we also need steps that will start improving air quality now. The UK government’s recent air quality plan went some way to addressing this – announcing 29 clean air zones and providing investment in low emission vehicles– but this should go further. Measures such as charging the most polluting vehicles to enter clean air zones and delivering a targeted diesel scrappage scheme are still the most rapid and effective ways to improve the nation’s air quality.

We must also be more ambitious in the air pollution limits that we are seeking to meet and adapt the recommendations of the World Health Organization. The UK’s current legal limits are far less stringent than this. While individual governments have a crucial role to play in improving air quality, we must not forget the continued need for international cooperation. This is particularly relevant at a time when the UK is negotiating its new relationship with the EU. Air pollution does not observe national borders and each country’s air quality policies cannot operate entirely in isolation. This cooperation is important at a policy level, to establish common frameworks and systems, but also to conduct high quality research. Research collaboration allows us to share knowledge, pool resources and provide new perspectives on an area of research. A recent study at the University of Edinburgh mentioned earlier, for example, was carried out in collaboration with researchers in the Netherlands. This is not unusual. Between 2010 and 2014, almost half of all research papers acknowledging BHF funding had an international co-author. (3) There is evidence that internationally collaborative research has greater impact than research produced in isolation. (4) Post-Brexit, it is vital that this type of collaboration continues to ensure that we

produce high quality research that deepens our understanding of heart and circulatory disease and air pollution and provides the foundations needed to develop evidence-based policy. Now is the time for the United Kingdom to be bold and deliver on the UK government’s vision to become a global leader in air quality, but we cannot tackle this problem alone. If we are to make real improvements in the quality of the air we breathe, we must also preserve and strengthen our networks with colleagues across the world, from research right through to policy and practice. Getting this right is vital for the 85 million people across Europe living with heart and circulatory disease. (5) References: 1. Air quality in Europe – 2016 report, European Environment Agency 2016 2. World Health Organization, Burden of disease from Ambient Air Pollution for 2012, page 2 3. BHF research evaluation report, 2016 4. Technopolis, The impact of collaboration: the value of UK medical research to EU science and health, 2017 5. European Heart Network, CVD Statistics, 2017

Government Gazette | 31

Promoting healthy hearts



Clinical Lead for Preventive Cardiology, Western Health and Social care Trust

A paradigm shift to patientcentred care is needed


hile there has been a decline in mortality rates of cardiovascular disease (CVD) in developed countries, it remains the main cause of death in men in all but 12 countries of Europe and the main cause of death in women in all but two. Worryingly there are even some signals that this decline in CVD mortality is starting to reverse possibly due to the obesity epidemic (and diabesity) that started approximately 30 years ago. Furthermore, despite the wealth of effective preventive therapies at our disposal including newer more potent antithrombotics, blood pressure lowering drugs and high intensity statins (which are now mostly generic and thus very affordable), patients with established CVD remain at a significant risk for another cardiovascular event. Indeed recent research would suggest that less than 5 percent of the population have CVD but less than 40 percent of new cardiovascular events occur in this group (ie, constituting theses individuals’ second and third events and so forth). This so-called ‘residual risk’ is attributable in part to the serious gap between guidelines and recommendations for optimal secondary prevention and that achieved in clinical reality. EUROASPIRE surveys which span a 20-year period in Europe are a damning indictment of secondary prevention standards in Europe demonstrating scant improvement in smoking | 32

prevalence and blood pressure control, continuing suboptimal lipid control and rising obesity, central obesity and diabetes levels in those who have had a CVD event. Moreover the surveys have repeatedly shown that only the minority of patients are accessing cardiac rehabilitation programmes, despite the compelling evidence for such programmes in reducing cardiovascular mortality. Standards in primary prevention are no better with recent EUROASPIRE data from

surveys of high risk individuals (ie, those that have not yet developed CVD) showing a similarly grim picture. CVD prevention therefore is far from being done. But for those of us in clinical practice, many real barriers that thwart effective preventive care, including lack of time, training, and dedicated personnel/resources and chronic underfunding, still continue to persist. The World Health Organization (WHO) recognises three levels

of prevention– the population strategy, and the primary prevention and secondary prevention strategies –but the distinction between primary and secondary prevention is arbitrary and all patients require the same professional lifestyle intervention, risk factor and therapeutic management to reduce their risk of disease progression, hospitalisations and revascularisation, and to improve their life expectancy. Such an approach could be

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offered by a comprehensive integrated professional multidisciplinary CVD prevention programme that offers an ‘all-under-one-roof ’ approach with the patient at the centre of care. We have shown this model to be effective through the seminal EUROACTION study, which was conducted as a cluster randomised-controlled trial of a nurse-coordinated multidisciplinary, family-based CVD prevention programme in hospital and general practice across eight European countries. The programme used a behavioural approach to address lifestyle together with medical risk factor management and the use of cardio-protective medications. At the end of one year, the programme demonstrated healthier lifestyle changes and improvements in other risk factors for patients with coronary heart disease and those at high risk of CVD and their partners than those in usual care. We subsequently removed the distinction between primary and secondary prevention by integrating care of patients with established CVD (coronary heart disease, peripheral arterial disease, TIA/minor stroke) and those who were at high multifactorial risk of developing CVD into one community-based CVD prevention programme (ie, a pan vascular prevention programme) which we called MyAction. We piloted the feasibility of this approach and demonstrated that it achieved the same, or even better, outcomes as the EUROACTION trial, and the programme has since been successfully delivered in the borough of Westminster in London and also in Galway in partnership with Croí, the West of Ireland heart and stroke charity. Formal analysis of the programme’s cost-effectiveness has been undertaken in both the NHS and Irish healthcare setting and the programme has been found not just to be

cost-effective but cost saving. This is not surprising as there is mounting evidence that lifestyle modification reduces the incidence not only of CVD but also other chronic diseases such as cancer, chronic obstructive airways disease and cognitive dysfunction. Such individuals also live significantly longer and stay healthier longer, compressing morbidity closer to the end of their prolonged lives and costing less during their lifespan. But acute cardiovascular care or ‘fire fighting’, by its nature, continues to demand the lion’s share of the health budget while prevention is still perceived in comparison as a ‘soft intervention’. Currently less than 2 percent of national healthcare budgets are assigned to health and well being despite the fact that the burden of non-communicable diseases are making modern healthcare unaffordable and unsustainable. A paradigm shift from providercentred or disease-centred care to person-centred care is required but this will take courageous leadership – clinical and political – to drive forward an investment in evidence-based effective preventive services and models. References: 1. Wood DA, Kotseva K, Connolly S, et al. Nursecoordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. The Lancet 2008;371(9629):1999-2012. 2. Gibson I, Flaherty G, Cormican S, et al. Translating guidelines to practice: findings from a multidisciplinary preventive cardiology programme in the west of Ireland. Eur J PrevCardiol 2014;21(3):366-76 3. Connolly SB, Kotseva K, Jennings C et al. Outcomes of an integrated community-based nurse-led cardiovascular disease prevention programme. Heart, February 2017.

EU to strengthen HTA cooperation among member states



russels has put the wheels in motion for better quality of care and innovative healthcare for the benefit of patients, especially those with unmet medical needs.

Assessment cooperation at EU level boosts innovation and improves competitiveness of the medical industry. The healthcare sector is a crucial part of our economy; it accounts for approximately 10 percent of the EU’s GDP. We are proposing a The European Commission regulatory framework that will has put forward a proposal bring benefits to patients all to boost cooperation among over Europe, whilst encouraging member states for assessing innovation, helping the takehealth technology. Greater up of high-quality medtech transparency will empower innovations and improving the patients, by ensuring their access sustainability of health systems to information on the added across the EU.” clinical value of new technology that could potentially benefit Commissioner for Health them. and Food Safety, Vytenis Andriukaitis, said he expects More assessments could lead this initiative to result in “a to effective, innovative health more efficient use of resources tools reaching patients faster. by member states through For national authorities it means the pooling of resources and being able to formulate policies exchanges of expertise, thereby for their health systems based on avoiding duplications in the more robust evidence. assessment of the identical products.” Furthermore, manufacturers will no longer have to adapt to different national procedures. Vice-President Katainen said: “Reinforcing Health Technology Government Gazette | 33

Recommendations to reshape policy making

sustainable mobility


How do we make Europe’s roads more sustainable?

interview Maja Bakran Marcich, Deputy Director General, DG MOVE, European Commission answers Government Gazette’s pressing questions on the latest EU clean mobility policy electric mobility Miriam Dalli MEP writes about the need to switch to electric and elaborates Malta’s plan for sustainable transport urgent action Keith Taylor MEP says it’s high time we changed our transport habits and offers useful recommendations to make Europe’s roads more liveable cycling strategy Marianne Weinreich from Cycling Embassy of Denmark argues that Europe should make two wheels part of the solution to our mobility challenges city focus Daniel Termont, Mayor of Ghent discusses the city’s new improved liveability plan strategic policies Karen Vancluysen from Polis offers policy recommendations for sustainable urban mobility best practice Evgeni Krussev, Deputy Mayor of Sofia argues that cities are for people, not cars autonomous vehicles Are we ready for the driverless revolution? Maros Sefcovic, Vice President, European Commission’s Energy Union, writes all about how the Commission is steering and supporting the market for autonomous cars air pollution Seb Dance MEP fears that the European Commission lacks policy coherence amongst its departments might be a stumbling block in managing pollution defending eu’s clean mobility strategy Jos Delbeke, Director General, DG CLIMA, European Commission, defends the EU proposal for low-emissions mobility


Realising the electric vehicle revolution | 36

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Member of European Parliament’s ENVI Committe

It’s time to switch from fossil fuels to electric


n the EU, air pollution kills half a million people every year, whereas in Malta alone, air pollution is responsible for 220 deaths annually. This is one of the main reasons why the European Commission and the Maltese government are encouraging the transfer from vehicles powered by conventional fuels to electric vehicles, hybrids and the usage of low-carbon fuels, in a bid to tackle climate change and toxic air. In Malta, emission levels from road transport shot up by 16.4 percent between 2005 and 2014, which means that Malta is likely to fail to reach its 2020 emissions targets. However, the Maltese government has an ambitious plan to address this deficit. Through ambitious 2020 measures, the government presented the national transport strategy for 2050 and the master plan for 2025. After the first 100 days of his term, Prime Minister Joseph Muscat announced a plan to find a date whereby cars using petrol and diesel will no longer be sold. Transport Malta’s national plan and the master plan were based on the European Commission’s white and green paper, which outlined the guidelines and targets for introducing e-mobility. The targets concern every member state, enveloping issues such as reduction of the

EU’s dependence on imported oil and reduction of transport carbon emissions by 60 percent by 2050. Some 102 charging points for electric vehicles have been installed across the island so far and another 500 will be deployed soon. It is admittedly a challenge to encourage drivers to make the switch to clean energy vehicles, especially considering the high rate of second-hand cars that are sold in Malta. However, encouraging the switch to cleaner mobility comes in different ways. In a bid to further encourage the purchase of clean energy vehicles the Maltese government offers a number of grants. In future, Transport Malta endeavours to promote sustainable transport by including new maritime ferry service routes, upgrading respective infrastructure and exploring additional public transport services to increase capacity and reliability while also promoting softer modes of transport such as walking and cycling. Sustainable transportation will definitely result in a positive footprint on the ecosystem, but will it have a negative effect on the automotive industry? It is proven that shared mobility can slow global vehicle sales, but not reverse the trend. There are

€24 million loans which were announced by the European Investment Bank aimed at supporting the upcoming challenges in the automotive industry. Nevertheless, research suggests that shared mobility will only partially replace car ownership. At the same time, a balance has to be reached between decreasing traffic congestion and the opposition that may arise from the automotive industry. Although it looks likely that there will be fewer vehicles on the road due to the growth of the shared mobility market, innovative plans and strategies can prove an opportunity to automakers, suppliers and other mobility players to innovate and advance in a business that introduces new sustainable vehicles and modes of transport. This is no mean feat but we have to work for a more sustainable means of transport. The external costs of traffic congestion in Malta – mainly economic and environmental – have been estimated at €247 million. Decarbonisation can be achieved and is at the heart of a developing society. Initiatives from the European Commission and different national governments across Europe stress that this is an ongoing process. This is a unique opportunity to stimulate a clean and zerocarbon mentality and we should grab this opportunity sooner rather than later.

Government Gazette | 27


Towards sustainable transport in EU


Member of European Parliament’s ENVI Committe

We’re running out of time to fix our harmful transport habits


ver two years ago, international leaders put climate action at the core of the global agenda when 195 countries adopted the Paris Agreement, the first-ever universal, legally binding, global climate deal.

fuel dependence, we won’t meet our climate targets. Moreover, without fundamental changes to how people and goods move about, we will not onlyfailto halt climate change but also increase our dependency on imported oil and risk a future energy supply crisis.

Its central goal was to strengthen the collective response to the threat of climate change by limiting global average temperature rise this century to 2°C above pre-industrial levels, while aiming to limit the increase to 1.5°C.

The World Meteorological Organization’s findings, published last November, that 2016 concentrations of

Addressing transport is significant for this commitment. The sector’s emissions keep rising, accounting for 25.8 percent of greenhouse gas emissions in the EU and 24 percent in the UK in 2015. Furthermore, transport is responsible for 70 percent of EU oil consumption, largely due to the explosive growth in road, maritime and air transport. It is important to note that, disappointingly, emissions from international aviation and waterborne transport, referred to as the elephant in the room at the time of Paris negotiations, are not covered by the national reduction commitments. I made it clear from the beginning that while Paris is an important stepping stone, what happens after is just as, if not more, important. Without bold policies and stringent implementation of measures to reduce our fossil | 38

atmospheric CO2 surged to levels not seen in 800,000 years, serve as a stark reminder that the time to combat climate change is running out. Transport is also a major source of air pollution, which is linked to more than 400,000 premature deaths in the EU every year. Additionally, 70,000 premature deaths in Europe are caused by persistently high levels of nitrogen dioxide.

Millions suffer from respiratory and cardiovascular diseases associated with poor air quality, and there are also potential links between pollutants and conditions including Alzheimer’s disease. Unsurprisingly, poor air quality is most prevalent in urban areas with pollutants from motor and especially diesel vehicles one of the main causes of high particulate concentration in

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European cities. The fact that up to 80 percent of EU citizens will soon live in urban areas and urban mobility accounts for 70 percent of transport pollutants and 40 percent of road transport CO2 emissions shows the level of urgency to shift to more sustainable transport modes. Logistics and distribution for ‘last mile deliveries’need to make better use of existing infrastructure and networks, tackling congestion and bottlenecks as well as exploring non-motorised solutions, such as cargo bikes. There is huge potential for the creation of so-called intermodal sustainable mobility chains in cities, ie, facilitating the smooth flow of journeys that involve two or more modes of transport. One important factor in achieving this goal is to ensure compatibility between different European, urban and regional information systems, charging points and ticketing – often

referred to as ‘interoperability’ – in order to make public transport more attractive. Sixty percent of urban trips are less than 6km, which should be a clear inducement to prioritise and invest in non-motorised mobility such as walking and cycling, in combination with public or collective transport systems, and, where possible, the integration of sustainable waterborne transport including inland waterways, canals and rivers. Electric mobility is a part of the solution. However, the focus should be on e-bikes, public transport and shared cars. We should ensure that the energy consumed is sustainably produced and electric vehicles (EV) are assessed throughout

their lifecycle, including recycling and reusing batteries.

to take diesel vehicles off the road.

Unfortunately many member states, including the UK, want to tackle the issue of traffic-induced air pollution by encouraging more private car ownership and expanding road-building schemes – despite the well-known fact that if you sow roads you harvest traffic. And with air pollutants not just coming from fuels, but also from braking, it is important to acknowledge that EVs are cleaner, but not emission-free.

Finally, efforts are needed to coordinate EU projects, such as CIVITAS, Polis and Eltis, and include cities in the discussions about and implementation of new mobility policies. As an MEP, I have seen many positive examples where smart investment in public transport has reduced congestion and demand on the road network; for example, in the Öresund region, linking Copenhagen and Malmö, passenger rail has a 50 percent share and over 20 percent of daily trips in both cities are taken by bike. We have the knowledge and technology to make sustainable urban mobility a reality – let’s waste no more time!

Creating and expanding clean air zones across European cities is the most effective way to dissuade people from using their cars and reduce NO2 pollution and this should be combined with targeted scrappage schemes


Chairman, Cycling Embassy of Denmark

Make two wheels part of the solution CIVITAS FORUM


ver the last 60-70 years, cities all over Europe have been planned around one question – how many cars can we get into and through the city? The consequence is that cities all over Europe are full of cars. With cars come more congestion, air pollution, noise pollution, CO2 emissions, the lack of and poor quality of space, and lifestyle diseases related to passive transportation. Some people claim that in the future, autonomous electric cars will solve a great deal of these problems. This is of course not true. An autonomous car is still a metal box on four wheels that takes up a lot of space in the cities and transports people passively. While trying to solve

our mobility problems, we must not think about how we can adapt our cities to serve the needs of one particular mode or vehicle. Instead, we should explore ways to provide people with different sustainable, healthy and safe options to move around liveable cities. One of the solutions is to make it safe, easy and attractive to get around cities on two wheels instead of four when going on shorter trips within the city. The bicycle is the perfect choice for city transportation – it is democratic, sustainable and healthy and can get you to different places within a city, at a rather quick pace. More than anything else, spending money on cycling is an investment. A cost-benefit analysis shows that the society

gains €1 for every 1km travelled on a bicycle – mainly because of the resultant health benefits. In Copenhagen, the capital of Denmark, 62 percent of the Copenhageners go to work or school by bicycle, and recently, the number of bicycles exceeded the number of cars in the inner city. This is not due to some special Danish cycling gene, but the result of decades of political will to invest in and plan for cyclists. Several other cities across Europe are now acknowledging that the bicycle is a great means of transportation and are redesigning their streets to accommodate the needs of people on bikes.

Government Gazette | 39

Urban mobility at a tipping point


Daniel TERMONT Mayor of Ghent

Ghent, driving the way forward best practice

such as cycling, walking, improving public transport service and creating greener spaces in the urban environments are key ingredients of these new paradigms – all of which put citizens first, increase the quality of lives and address the urban mobility challenges.


ongestion, lack of space, air pollution and an urban planning approach that favours cars as preferred means of transportation, are taking a toll on the quality of urban lives. How we currently commute from A to B is not sustainable anymore. As cities, we need to instil a lasting change in the way we design and implement urban mobility policies within our territories. In 2017, the European Commission laid a strong emphasis on sustainable urban mobility. For the EU’s executive, sustainable urban mobility means establishing a widespread network of charging infrastructure for electric cars and replacing diesel cars with electric ones. As a result, increasing public concern over GHG emissions combined with latest | 40

In April 2017, Ghent city council adopted a new Circulation Plan for Ghent’s city centre, to improve the liveability for citizens and visitors of the city, guarantee accessibility for cyclists, busses, trams and cars with a

ring road. Citizens who want to travel by car from one sector to another will not go through the city centre anymore; instead they will use the city ring around the centre. Moreover, transit traffic on important roads will be prevented by closing some streets for motorized traffic. Through our Circulation Plan, Ghent’s city centre still allows cars that absolutely need to get in to reach their destination – in fact, they will even get there faster. Suppliers, healthcare providers, emergency services, taxis, refuse collection vehicles, cargo bikes and mopeds will be allowed to pass through streets which are closed to motorized vehicles and get to the central underground car park whenever required. The Circulation Plan provides pedestrians, cyclists,

The Circulation Plan provides pedestrians, cyclists, buses and trams more space in the center and enables them to travel faster from A to B. It has improved liveability of the city center as pedestrians and cyclists far less space than cars.

advancements in batteries and alternative fuels prompted a revolution of electric vehicles. But this doesn’t address the root causes of our urban mobility challenges. Even with electric vehicles instead of diesel cars, our cities would continue to be burdened by traffic congestion, lack of space and continue to force citizens to use cars in their daily commute. In order to make our urban mobility systems truly sustainable, we need to develop new mobility paradigms in our policymaking. Measures nurturing soft forms of mobility

destination in the centre and unburden the centre of drivethrough traffic. Thanks to our Circulation Plan - our citizens and visitors will now have more space to safely move around the city, reach their destinations faster and benefit from a healthy and comfortable living environment. In order to prevent cars from needlessly crossing the city centre, we have divided the city into 6 sectors and one large, extended pedestrian zone. The 6 sectors surround this car-free zone and are well-connected to one another through the inner

buses and trams more space in the centre and enables them to travel faster from A to B. Furthermore, the Plan improves the liveability of the city centre, as pedestrians, cyclists, buses and trams use less public space than cars would, which opens possibilities to transform this space. We have recently carried out a 6-month evaluation of the Circulation Plan, and the initial results are promising. Thanks to its implementation, there are now 20% more cyclists in Ghent and the use of public transport have increased by 15%.

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Karen VANCLUYSEN Secretary General, Polis

Moreover, the accident rate in 2017 has decreased by a staggering 28% compared to 2016. These intermediate results show that an urban mobility policy which implements an enabling framework for soft forms of mobility, public transport and public space can deliver multiple, tangible benefits to citizens. Cities are at the heart of urban mobility planning, and hold the key to drive the sustainable urban mobility revolution. It is critical that the EU and national legislation provide a flexible framework for cities, so that they are free to design and implement the mobility policies best suited to address the challenges of congestion, air pollution and scarce public space. Furthermore, cities should be involved in the mobility decisions made at the EU and national level right from the beginning. This way, effective and efficient sustainable urban mobility policies can be effectively co-designed. The over 9,000 European local authorities committed to the Covenant of Mayors, are ready to do their part in this crucial task.

Policy recommendations for sustainable transport


ntil today, the public sector has been the primary provider of public transport services and data in many European cities. But increasingly, third parties such as app developers, shared vehicle providers and connected minibus operators have entered this domain. The Mobility as a Service (MaaS) concept forwarded such a mobility ecosystem, where customers can plan, book and pay door-to-door journeys through a single app using all kinds of public and private transport modes and services. The routing and booking service is often provided by a private company. In the light of this paradigm shift, cities and regions started to reconsider their future role in mobility. Thus, a recent Polis discussion paper debates if and how transport authorities could enable and steer MaaS. In 2018, Polis will publish a similar paper on automated road vehicles. It recognises the potential advantages of automated driving regarding safety, space consumption and traffic flow but does not neglect challenges, such as pedestrian accessibility. Instead, it forwards an approach which enables cities to integrate automated vehicles ecologically and in a socially coherent way into transport systems. During the high-level plenary debate on the changing role of the local and regional authority in transport service provision at the Annual Polis Conference in December 2017, it was

recognised that whether the impact of disruption is positive, negative or neutral, it will depend on the policy framework you build around it. The debates at Polis and the paper exemplify how cities and regions in Europe and beyond see the need to steer these new developments by developing clear visions on the role of new transport systems and services. They want to make sure that emerging new mobility services will contribute to the policy goal of more sustainable urban and regional transport systems. Both MaaS and automation will contribute to a sustainable mobility transition if they ease multimodality and make passengers use a wider and more sustainable range of transport modes. New mobility bears high potentials, but regardless of the adopted approach, a need for public sector oversight remains, to ensure hitting the mark. The widespread introduction of automated vehicles, for example, could as well lead to increased congestion and suburbanisation. Both have negative social, economic, environmental and health impacts, especially if walking, cycling and public transport aren’t boosted. Newly elected Polis president Dr Jon Lamonte, chief executive at Transport for Greater Manchester, emphasises that “Neither MaaS nor automated vehicles are an end in itself. Instead, they need to contribute to the overarching policy goals, reduce air pollution and congestion, address climate change or increase road safety.”

In its papers, Polis recommends three key actions to give the vision of innovative, safe and sustainable transport systems a chance: 1. There is a need for a structured dialogue between the transport authorities, industry and service providers on various issues related to disruptive transport innovations, including the issue of data sharing and governance. 2. More research is needed on the impact of MaaS and driverless vehicles in the urban environment. 3. National governments and the European Commission should pay greater attention to sustainable mobility goals, in line with the EU transport white paper, as they develop policy on transport innovations. Cities, regions and their transport authorities should be systematically consulted. The Commission and the member states can also play a role in enabling the sustainable implementation of transport innovations, through research programmes, regulation and as facilitators of multi-stakeholder cooperation. These policy recommendations have been developed by Europe’s local and regional authorities that make cooperation a reality under the umbrella of the Polis network. Polis member cities and regions also understand the advantages of exchange on global level. The Polis Global platform fosters cooperation on global challenges and new mobility topics across the world.

Government Gazette | 41


Urban mobility at a tipping point

Evgeni KRUSSEV Deputy Mayor of Sofia

Cities are for people, not cars


best practice

ities are drivers of change. As a deputy mayor for transport, I know that getting it right in our cities means working with people to positively and tangibly improve their quality of life. Urban transport accounts for around 40 percent of all CO2 emissions from road use and passenger cars make up by far the most amount of traffic on our roads. This has obvious effects on people’s physical, social and mental wellbeing through noise, pollution, accidents, lack of space and exercise. At EUROCITIES, the network of major European cities, where I lead the work on mobility issues, we support cities in developing sustainable transport measures and contribute to EU research and policy recommendations through our involvement in different city-led projects. Cities face the double challenge of improving mobility while making urban transport more sustainable. A sustainable urban mobility plan can stimulate behavioural shifts away from the use of private carsbut must consider the needs and input of local people, businesses and other stakeholders. Building liveable cities Public transport should function as the backbone of transport systems, in providing high capacity transport services at an affordable price. In Sofia, public transport is our top priority: line 3 of the metro is currently under construction | 42

At the EU and national level, strategies for sustainable mobility should be developed together with city governments, given that cities are best placed to know which mobility measures are needed for their local circumstances.

with 12 new stations along the 12km line. We are currently upgrading our bus fleet with 20 electric buses and the forthcoming procurement of hybrid buses. We are renewing our tram fleet with 28 secondhand Swiss and 10 Czech trams. Thanks to the investment programme of Sofia Electric Transport for 2017-2020, we will also get 13 new low-floor trams. Six electric bus lines will

replace six conventional bus lines, with 30 electric buses. In addition, one new tram line and eight new trolley bus lines are foreseen to be constructed by 2025. Designing a mobility system around people offers the flexibility to switch between different modes of transport. It also means prioritising and creating the right environment for other active forms of

transport such as walking and cycling. Several cities, such as Amsterdam, Copenhagen and London, have invested in bicycle lane networks, and other cities, such as Brussels and Paris, are increasingly introducing pedestrianised areas. To increase the capacity of the existing transport network, cities can use ICT – so-called Intelligent Transport System (ITS) solutions – in combination

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best practice

with traffic management centres, as is the case in Birmingham. Similar systems can be used to inform and guide road users and operators with up to date information, as in Madrid. ITS can also help create opportunities for local SMEs. Open transport data portals can offer service providers the ability to set local sustainability objectives by creating a levelplaying field.

to know which mobility measures are needed for their local circumstances. The Urban Agenda for the EU, through the partnership on urban mobility, is a positive step in this direction, as it gives cities a seat at the table on important topics. We welcome EU strategies to boost the market of alternative fuels, such as the latest European Action Plan on Alternative Fuels. However, it is important to also remember that for cities, the most energy efficient solutions are walking, cycling, promoting public transport and car-sharing. Traffic, even with cleaner cars, remains a challenge in our cities in terms of congestion, liveability, road safety and parking space.

Transformation of city of Odense 5 year old cyclists are leading the way in this Danish city!

While deploying alternative fuels at local level will help improve air quality, this should be done in a technology-neutral way. Cities should be able to choose the options, including climateneutral fuels, which best fit their local circumstances.

Cities can lead by example, by greening their own vehicle fleet, by purchasing environmentallyfriendly vehicles or by incentivising electric car use, as in Oslo. We will follow the forthcoming EU negotiations on the review of the EU’s clean vehicle directive with high interest. Clearer definitions and simplifying procurement rules will help boost green procurement of vehicles in our cities. Creating a level playing field At the EU and national level, strategies for sustainable mobility should be developed together with city governments, given that cities are best placed

The ‘dieselgate scandal’ has revealed that real-life emissions in Europe are far higher than laboratory tests show. Air quality therefore remains a crucial challenge in our cities. We have pushed for more stringent emissions-testing legislation at the EU level. The new agreement to give the EU oversight of national car approval is a positive step forward to prevent another dieselgate in Europe. Our challenges are great, but so are our opportunities to move towards cleaner, more sustainable and healthier modes of mobility. As cities, we can steer Europe towards a sustainable urban future that works for all our citizens.



n the 1960s, cars were threatening to displace bicycles in the main Danish cities. Today, Denmark’s thirdlargest city has transformed into the most liveable city in Europe, which has changed because of its extraordinary commitment to getting the entire city cycling. Talking on the sidelines of a CIVITAS forum recently, Steen Moller, deputy-Mayor of Odense, proudly noted that the city of Odense was the first place in Denmark to have a designated cycling pathway as early as 1985. The city now has large network of designated bikepaths, more than half of municipal roads.

The city’s commitment starts at kindergarden, he noted. When kindergartners start school in Odense, they’re more likely to show up on a bike than on a public transport. The rate of kids going to school in a car has gone up 200 percent in the last 30 years. Nearly 80 percent of all Danish kids use bikes to school, and Moller says the day is not too far when all kids go to school by bike. Cities and municipalities play a very important role in creating sustainable mobility solutions, and five-year-olds are leading the way in the city of Odense.

Government Gazette | 43


Future of connected and automated driving


Vice President, European Commission’s Energy Union

Is Europe ready for the driverless revolution?


On the ground, Europe’s moving fast. The Swedish Transport Agency has already given the goahead to the first driverless buses in Sweden and Scandinavia. Most EU countries are expecting to see their first driverless buses by 2019. Vice-President Maroš Šefčovic, in charge of Energy Union, at the European Parliament writes about how the European Commission is steering, accelerating, and supporting the emerging European market of autonomous cars

he world is driving fast into a new reality, where ‘mobility’ has a whole new meaning. Driving may no longer be about holding the wheel and watching the road but about sitting back and reading a newspaper, holding a meeting or even playing games. Ownership will not be about buying a car, keeping it for a few years and selling it off but buying access to the sharing economy. It will therefore allow more affordable and accessible services. Today’s kids may never have a driver’s licence; even the concept of ‘car accidents’ might be something they will learn about in their history books. Air pollution, which kills hundreds of thousands of Europeans prematurely every year could sound to them like some medieval epidemic – simply because these problems will have been solved. Not to mention the role of transport in CO2 emissions and climate change, which can finally be pushed to minimum. For all these reasons, connected and automated driving has great potential for our economic prosperity, social cohesion and political stability. | 44

This future is not so far. Advanced driver assistance systems already exist (eg, lane keeping assistance or emergency braking). By 2019, we expect to see the first generation of cooperative vehicles. Automated vehicles should be available as mass market products by 2022. Europe is not waiting for other continents to drive this transition; we are making giant leaps in that direction ourselves!Most EU countries are expecting to see their first driverless buses by next year. In Sweden it might even happen earlier, as the Swedish Transport Agency has already given its green light. We are expecting automation to shape the future of all of Europe’s transport modes and could disrupt our entire mobility ecosystem. Of course, major challenges remain, notably with regard to upgrading our communication infrastructure, addressing cybersecurity threats, and answering ethical and legal questions. These challenges require a joint and holistic approach between the various industries, between the private and public sectors, and between European countries. The European Commission is a central actor

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in this endeavour. It is steering, accelerating and supporting the emerging European market of autonomous cars and innovative mobility solutions. We do so by financially supporting research in order to keep a European advantage in the global automobile industry; building cross-border platforms for exchanges of knowledge, technical expertise and best practices;providing investment support for cross-border infrastructure;and ensuring a stable and consistent regulatory framework across the entire EU market. One of the last major milestones towards our new mobility system was reached last May with the ‘Europe on the Move’ communication. Our work is not done. In order to reach a common EU approach to connected and automated mobility, we are preparing a set of legislative proposals and guidelines on legal issues. These will cover a wide range of issues like on road safety, liability, connectivity, cybersecurity and

data management, innovation and infrastructure. Many of these will be covered by the third mobility package, which we will present this year. The elephant in the room remains the investment gap. The public sector cannot and should not be spending the lion’s share of the necessary investment. I therefore call on the private sector to recognise the tremendous opportunity of investing in Europe’s physical and digital infrastructures, and to do so in a holistic manner. These investments will need to cover the creation, maintenance and storage of large amounts of data, as well as the means to share this data across platforms, brands and borders. But the investors will enjoy the first mover’s advantage of the future mobility market! Let us all change gears. Let us make 2018 the year we accelerate towards clean, connected and automated mobility.

Commission sets tougher targets on air quality



russels gets tough on EU countries that aren’t going the extra mile to combat air pollution. Nine member states, namely the Czech Republic, Germany, Spain, France, Italy, Hungary, Romania, Slovakia and the United Kingdom, face infringement procedures for exceeding agreed air pollution limits. More countries may be taken to the European Court of Justice, and eventually face fines, for breaching EU legal limits. EU national governments are also facing increasing pressure resulting from lawsuits filed by citizens and NGOs. Towards the end of 2017, several European cities announced bans on petrol and diesel cars in a move to create a zeroemissions zone by 2035. Paris has decided to ban all petrol and diesel-fuelled vehicles by 2030. Copenhagen announced plans to launch a ban from 2019. However, the UK plans to ban petrol and diesel cars from 2040. Despite these positive trends, air pollution remains the main cause of premature death in the European Union. Air pollution causes more than 400,000 premature deaths every

year and it brings respiratory and cardiovascular diseases to millions more. In light of urgency, European Commissioner for the Environment, Karmenu Vella,observed that “national governments are not doing enough, but the European Commission is not reacting fast enough either.” Though the recently set standards in the National Emissions Ceiling Directive will reportedly halve the negative health impacts by 2030, he highlighted the importance of a “concerted approach” among individual member states to speed the process. The European Commission has been trying its best to foster cooperation between different levels of government through its Clean Air Dialogue, where it brings officials together to discuss possible measures. While “failing to meet air quality standards is no more an option,” Vella emphasised the need for increased coordination between national policies, taxation and local decision to promote clean air.

Government Gazette | 45


Future of connected and automated driving

Seb DANCE mep

Member, European Parliament

Lack of policy coherence remains main stumbling block in managing pollution


ackling toxic air pollution has been one of the European Union’s main environmental concerns since the late 1970s. Although the thick smogs and acid rains of the 1970s and 80s are thankfully a thing of the past, today the threat comes primarily from nitrogen dioxide linked to diesel cars, which can lead to cardiovascular and respiratory disease, and tiny particles less than 2.5 micrometresin diameter, so small that they can penetrate deeply into the lungs. Air pollution has shot up the global political agenda in recent years and rightly so. It is one of the main environmental causes of premature death, having claimed 5.5 million lives globally and 430,000 in the EU in 2013. Furthermore, the European Commission estimates that the cost of air pollution linked to degradation of health in Europe to be between €330 billion to €940 billion per year – money that could be better spent on schools, policemen or indeed hospitals. Despite clear successes – for example, it is estimated that 80,000 premature deaths are avoided each year, thanks to EU air quality legislation and technological advancements – progress on tackling toxic pollution has been too slow and too piecemeal. National governments often prefer to protect the perceived shortterm economic interests of their polluting industries, instead of incentivising the technological | 46

change needed for a sustainable transition. One of the main stumbling blocks to tackling pollution is a lack of joined-up thinking and policy coherence. Air pollution knows no borders, and as a governance issue it is particularly complex. It is at the same time a supranational, national and local issue – with often conflicting priorities and interests (political and financial) undermining the ultimate aim of cleaning up the air we breathe. A few weeks ago, I spoke at the first ever Clean Air Forum in Paris. The aim of the Forum was to provide a basis for exchange of knowledge and best practices, and to enhance capacity of relevant stakeholders and policymakers. At the EU level, we have an extremely detailed and welldeveloped legislative framework for air pollution control as member states cannot handle the issue effectively alone. Whether it’s empowering cities to act or working with vehicle manufacturers and importers, it is important to get as close to a common European approach as we possibly can, and the EU institutions still represent the most advanced and best placed bodies to achieve this. Clearly more needs to be done though, and despite my relatively short time working in the European Parliament, I have some ideas of what can be improved at the EU level: Firstly there must be much more coherent policymaking. One

of the European Commission’s weaknesses is that it often works in silos and there can be a lack of joined-up thinking. There are at least four Commission departments with an interest and influence on air pollution policies: DG CLIMA (climate action), DG ENV (environment), DG MOVE (transport), and DG GROW (industry). Despite being competent for air pollution, DG ENV’s aims are often undermined by the policies of other departments. The dieselgate emissions scandal was a perfect example of this. Firstly the EU’s focus on climate action led to the promotion of diesel, which has worsened air pollution in the member states – particularly in cities. Secondly, DG ENV is competent for two out of the three levels of EU air pollution legislation – 1. national ceilings (as specified under the National Emissions Ceiling Directive) and 2. local concentration standards under the Ambient Air Quality Directive. However, the crucial third level – source control legislation, for example car emission standards – is often the responsibility of the Commission’s industry or transport departments. So while the overall reduction targets can be ambitious, weak or delayed, source level implementation can run counter to these aims. The dieselgate scandal also highlights what is probably the biggest problem facing governance of air pollution

legislation: national implementation, or lack thereof. What dieselgate showed was that EU member states were prepared to turn a blind eye to malpractice in the automobile sector, which exploited what they identified as grey areas in car emissions legislation. It should come as no surprise that there are currently 28 infringement cases underway for failure to comply with air pollution limits in 23 states. A solution was proposed by my political group in the European Parliament, the Socialists and Democrats – to create an EU Agency to oversee type approval and market surveillance of cars – but this was rejected narrowly due to opposition from right wing groups. Finally, there needs to be much more cooperation between the EU and local level. Cities are where the real ambitious and innovative action is being taken. For example, in my city of London, we were the first to introduce a congestion charge and have since introduced a Low Emission Zone, with an Ultra-Low Emission Zone to be introduced from 2020. The EU and national governments must do much more to support cities in their fight against air pollution, both financially and by involving them more in the policymaking process. All too often the burden of compliance falls on local authorities who do not have the resources or tools to meet the challenge they face.

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Director General, DG CLIMA, European Commission

Jos Delbeke defends balanced EU proposal on clean mobility


etting around is an essential part of life and how we do it, especially in urban areas, is fundamentally changing. To help tackle the urgent challenges of climate change, air pollution and congestion, new technologies and business models are developing – and in many cases already offering – innovative solutions. Road transport is seeing a big shake-up, with digitalisation and automation already transforming manufacturing processes and innovation in electric vehicles, autonomous driving and connected vehicles presenting significant opportunities as well as challenges. With road transport generating nearly a fifth of all EU GHG emissions, citizens are rightly demanding strong action on climate change and improving air quality. The industry is also a key part of the EU economy, accounting for 12 million jobs directly and indirectly and some 4 percent of EU GDP. Investment and innovation in sustainable road transport is well underway in many parts of the world, particularly on zero- and low-emission vehicles, with China to introduce mandatory sales quotas in 2019 and California and nine other US states stepping up their existing requirements. In this context, the EU cannot afford to play catch-up. This is why the European Commission has, over the past

months, put forward a range of significant, forward-looking proposals on clean, competitive and connected mobility. A first package – ‘Europe on the Move’ – came in May 2017, with initiatives to make traffic safer; encourage smart road charging; reduce CO2 emissions, air pollution and congestion; cut red-tape for businesses; fight illicit employment; and ensure proper conditions for workers. A second set of proposals – the ‘Clean Mobility’ package – followed in November 2017, notably including a proposal to significantly reduce CO2 emissions from new cars and vans by 2030, through new CO2 emissions standards and a range of accompanying measures. The proposal on cutting CO2 emissions from new cars and vans is both realistic – in view of the necessary changes ahead – and ambitious, given the required emission reductions. The sector must contribute to the EU’s commitment to cut its emissions by at least 40 percent by 2030 compared to 1990. The proposal, developed based on extensive stakeholder consultation and an in-depth impact assessment, is also feasible and cost-effective for the sector. Under the proposal, average CO2 emissions from new passenger cars registered in the EU will have to be 15 percent lower in 2025 and 30 percent lower in 2030 than in 2021. The same reduction targets are

proposed for new vans. The intermediary 2025 targets will ensure that emission reductions occur as early as possible and provide for a framework for manufacturers to invest and innovate sooner rather than later. However, they will also allow gradual steps towards the 2030 targets, to ensure no company, worker or region will be left behind. Alongside the targets, the proposal includes a flexible incentive mechanism for zeroand low-emission vehicles. This innovative mechanism will help address a key challenge: the ‘chicken-and-egg’ dilemma between manufacturers and providers of charging infrastructure. The mechanism provides a clear market signal to companies to invest in zero- and low-emission vehicles and continuously innovate, butpreserves technology neutrality and gives manufacturers flexibility in their strategic choices.The system consists of a mechanism for adjusting a manufacturer’s specific CO2 emissions target in case the share of zero- and low-emission vehicles in its fleet exceeds the benchmark of 15 percent in 2025 and 30 percent in 2030. Moreover, a strict monitoring and enforcement framework will allow the Commission to review progress and intervene if needed. In particular, the proposal addresses the ‘emissions gap’: the difference between

‘official’ fuel consumption and CO2 emissions, as measured during type-approval, and values actually experienced on the road. For this purpose, monitoring of real-world fuel consumption data and new inservice conformity checks are to be introduced. The wider Clean Mobility package also includes an action plan on alternative fuels infrastructure, a Clean Vehicles Directive to promote clean mobility solutions in public procurement, a revision of the Combined Transport Directive and a Directive on Passenger Coach Services. The Commissionalso recently launched an EU battery initiative, to support battery manufacturing in Europe, an issue of key strategicimportance. A key aim of the package is to ensure an integrated approach for the coming years, covering supply as well as demand. Under thealternative fuels action plan, almost €800 million has been made available for new funding opportunities, while the EU battery initiative will inject an additional €200 million into European battery innovation between 2018 and 2020. The proposals are now with the European Parliament and Council. The European Commission is ready to assist the EU decisionmakers, with a clear message: ambitious action is vital if Europe is to maintain global leadership in sustainable road transport.

Government Gazette | 47



Maja Bakran MARCICH

Deputy Director General, DG MOVE, European Commission

Is EU’s new clean mobility policy ambitious enough?


hile transport, environment and consumer groups have called the EU Clean Mobility Package “an ineffective regulation” that’s not going far enough, the European Commission has called it a “balanced package that allows everyone to contribute” and noted that it was developed based on “sound analysis and broad stakeholder involvement.” In an interview with Janani Krishnaswamy, Deputy Director General of European Commission’s DG MOVE Maja Bakran clarifies why the current proposal is a major leap forward in the right direction. Are the new targets ambitious enough? Can you elaborate how the European’s Commission’s new proposals will help accelerate the transition to lowand zero emission vehicles? The proposed 30 percent emission reduction target for passenger cars and vans is ambitious but realistic. It provides benefits for consumers, the environment and for employment. It will help member states meet their 2030 targets for non-ETS sectors – while it yields the cost-effective potential for emission reductions in road transport it also leaves space for further emission reductions from heavy-duty vehicles, which are forthcoming under the third Mobility Package in the first half of 2018. It also reflects positive impacts on consumer benefits and | 48

employment. Through setting requirements for the years of 2025 and 2030 we will ensure that the transition to lowemission mobility is being accelerated. China has just introduced mandatory zero- and lowemission vehicle quotas for manufacturers from 2019 on. In the US, California and nine other states have successfully established a regulatory instrument to enhance the uptake of zero- and lowemission vehicles. Why hasn’t the Commission fixed any quotas for carmakers to produce zero emission vehicles such as hybrids, electric cars and hydrogen vehicles? The EU legislation in this area has always been technologyneutral and will continue to be so in the future, also when it comes to supporting low- and zero-emission technologies. The Commission’s proposal for future CO2 emission performance standards does not include any technology-specific quotas or mandates, but it will act – in tandem with the Clean Vehicles Directive – as a major driver for the market uptake of electric vehicles, both BEVs and FCEVs. These proposals will help manufacturers to embrace innovation and supply lowemission vehicles to the market. Both proposals include targets both for 2025 and 2030. The 2025 intermediary target ensures that investments are already kick-started. The 2030 target

gives stability and long-term direction to keep up these investments. These targets help in pushing the lowemission mobility transition, in combination with other policy and financial support levers. Even with a rapid increase in zero- and low-emission vehicles

it is clear that conventionally fuelled vehicles will still make up an important part of the EU vehicle fleet in 2030. Why is there no system of penalties for exceeding the limits? How does the Commission intend to reduce the fleet of such conventionally fuelled vehicles?

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The European Commission’s proposal for future CO2 emission performance standards will help manufacturers to embrace innovation and supply low-emission vehicles to the market. Currently, the share of alternatively fuelled vehicles is around 5 percent. So indeed, there will still be conventionally fuelled vehicles in the EU vehicle fleet in 2030, given the time it takes to convert. Our main objective is to reduce the emissions of the total fleet, not to prescribe its components. Conventionally fuelled vehicles still hold potentials for emission reduction that need to be utilised while increasing the share of low- and zeroemission vehicles in a swift and decisive manner. The proposed governance approach of the new CO2 standards builds on the power of positive incentives to encourage further action. What kind of incentives is the European Commission offering car manufacturers to spur electric car production? In addition to measures that are in the discretion of member states, such as financial support for car purchases or tax exemptions, the Commission is offering a suite of additional incentives to spur electric car production, in addition to the CO2 emission performance standards and their incentive system.

establishing a backbone charging infrastructure with full coverage of the TEN-T network by 2025. We will also take action to ensure that this infrastructure and its services is interoperable, and hence easy to use across borders. The Commission will make available another €800 million to support roll-out of alternative fuels infrastructure in the EU. This money will back up additional public and private investment and hence trigger substantial follow-up investment. On the supply side, our objective is to bring the manufacturing of batteries back to Europe. We would like to ensure our competitive advantage in the race for next-generation batteries. Under the European Commission’s industry-led initiatives, we will tackle research, development and manufacturing of the nextgeneration battery packs.

On November 8, we adopted the EU Action Plan on Alternative Fuels Infrastructure. It supports Government Gazette | 49

bladder cancer

Recommendations to reshape policy making


New approaches to improve prevention, diagnosis and treatment

event round-up: bladder cancer europe 2017 Specialised healthcare policy institutions and policymakers present their recommendations to improve management of bladder cancer in Europe viewpoint Prof Hein van Poppel presents EAU’s recommendations to better manage bladder cancer in Europe doing things differently Lydia Makaroff from ECPC and Andrew Winterbottom from Fight Bladder Cancer discuss what Europe should do differently to beat bladder cancer better outcomes Grete Hogstad from Photocure discusses the role of early and improved diagnosis for better patient outcomes quality metrics Dr. Badrinath Konety and Dr. Vikram M.Narayan define quality metrics for bladder cancer care in Europe parliament perspective Alojz Peterle MEP says the patient perspective is a prerequisite for any modern programme in healthcare patient-reported measurements Francesca Colombo, Head of OECD’s Health Division says patient-reported measurements enable better outcomes

event round-up EPAD 2017: Policymakers commit to improve prostate cancer care in Europe


New approaches to beat bladder cancer

bladder cancer europe


Policymakers join hands to fight bladder cancer in Europe Despite the increasing prevelance of bladder cancer, it has been thus far overlooked by parliamentarians, healthcare practitioners and the pharmaceutical industry. The International Centre for Parliamentary studies brings together policy experts to address the policy gaps in effective diagnosis and treatment of bladder cancer. Diane Rolland, International Programme Manager from ICPS highlights the urgent policy recommendations discussed at the roundtable


ladder cancer is the sixth leading cause of cancer in Europe, with 124,000 people diagnosed and more than 40,000 people dying from the disease each year. While the EU has been very supportive to the member states in managing other cancers such as breast, cervical and colorectal, implementing national screening programmes and elaborating guidelines, bladder cancer has been highly overlooked by policymakers. Investment in research from public and private sources has been sparse in comparison. With that in mind, ICPS organised the Bladder Cancer Europe Roundtable on the June 20, 2017 in Brussels. The meeting brought together Members of European Parliament, senior representatives from European Commission, leading urologists, oncologists, patients groups, | 52

representatives from nongovernmental organisations and representatives from pharmaceutical and technology companies to improve preventative, screening, diagnostics and overall treatment of bladder cancer. Some of their major recommendations have been elaborated below. Multidisciplinary care Due to the complexity of the disease and higher prevalence among older population, effective care requires a concerted, multidisciplinary approach. Participants at the roundtable reached a consensus towards the need for multidisciplinary teams (MDT) to treat bladder cancer, integrating the expertise of urologists, oncologist, imaging experts and advanced nurse practitioners. Currently, multidisciplinary care in bladder cancer is poorly developed at an organisational level.

We need to build stronger, more comprehensive and more specialised MDTs in order to offer the most effective treatment for patients, specifically tailored to address their individual needs. A patient seen by a multidisciplinary team is more likely to receive a balanced perspective on the risks and benefits of all available treatment options. More so, MDTs provide ideal frameworks to conduct audits and facilitate peer evaluation. Research funding Research is crucial in understanding the complexity of bladder cancer and to address the high-mortality. The challenge lies in pooling common resources and expertise of European, national and regional authorities as well as scientific partners and patient organisations. There is also a greater need for funding trials

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- Centre for Excellence should focus on the development of multidisciplinary team, personalised medicine to reduce the economical burden of the disease in Europe. Participants:

which can only be achieved by raising awareness of importance and causes of bladder cancer. Recommendations for policymakers: - The role of specialised nurse is essential in the patient treatment and care. More training should be made available for them; - Patient-centred treatment, including access to the highest quality patient information and latest statistic evidence should be made available; - We need more awareness of the importance and causes of bladder cancer; - Multi-disciplinary teams for treatment and care should be more promoted; - There is a huge need for funding for trials and genomics research;

- There is a need for more centres of excellence and a panEuropean cooperation amongst them to answer the need of a patient; - There is a pressing need to raise awareness, educate on all the risk factors, including occupational, at primary care levels; - There should be a better dissemination and implementation of European Guidelines; - More should be done on a preventative level at ministerial levels. Exposure to certain industrial chemicals is the second biggest risk factor after smoking and more awareness needs to be created in this regard;

AstraZeneca, Medical Director, Immuno-Oncology, Europe, United Kingdom; Cochin Hospital Paris, Descartes University, Associate Professor of Urology, France; Cyprus Association of Medical Physics and Bio-Medical Engineering, Medical Physicist, President, European Association of Urology, Adjunct Secretary General, Education, Belgium; European Parliament, MEP, MAC Group Member; Erasmus MC, Assistant Professor of Urology, Netherlands; Erasmus MC, Pathologist, Netherlands; Faculty Of Medicine (Amc) - University Of Amsterdam, Urologist, Netherlands; Photocure, VP Strategic Marketing, Norway; UZ Ghent, Urology Nurse Specialist, Belgium; University Medical Center Utrecht, Oncological Urologist, Netherlands;

- The EU should do more on a political level to stop smoking and limit toxic exposure in certain professions;

Government Gazette | 53

New approaches to beat bladder cancer


Prof Hein van POPPEL

Adjunct Secretary General, European Association of Urology (EAU)

EAU presents recommendations to better manage bladder cancer in Europe We want to stop monodisciplinary management of bladder cancer and call for a patient-centred multidisciplinary approach. The EAU expects the policymakers in Europe to: - Create more awareness of the impact and the prevention of bladder cancer; - Promote anti-smoking campaigns across Europe and limit the toxic exposure in certain professions where bladder cancer is recognised as an occupational disease;


ladder cancer is the ninth most common cancer worldwide, with a 4:1 male to female ratio. In the European Union over 110,000 men and nearly 33,000 women in Europe are diagnosed with bladder cancer each year. And nearly 330,000 people in Europe are living with bladder cancer making it the fifth most common cancer in Europe. Within Europe, Belgium has the highest rate of bladder cancer. It was considered a forgotten cancer compared to prostate cancer and attracted much less general attention although it accounts for 3 percent of all cancer costs. In 2012 the costs of bladder cancer in Europe summed up to a total of €4.9 billion, with healthcare accounting for €2.9 billion. The fact that it is a forgotten cancer is translated in the research funding in the United States and the United Kingdom, | 54

where bladder cancer is among the poorest funded cancer types. On the other hand, bladder cancer continues to kill about as many people as 20 years ago. The five-year rate changes in mortality are impressively good for prostate, colon and lung cancer but are about zero for bladder cancer. Nevertheless, much can be done to reduce the incidence of bladder cancer since one of the most important causes is tobacco smoking; next to prolonged contact with chemicals are emissions from road traffic and pesticides. Together with the European Cancer Patient Coalition (ECPC), we also launched a white paper on bladder cancer in 2016 with recommendations based on the EAU guidelines on the management of bladder cancer. These clinical guidelines are updated yearly by a group

of urologists, pathologists, medical oncologists and radiation oncologists and have been endorsed by the National Societies of all 28 EU member states and also by the American Society of Clinical Oncology (ASCO), next to a number of countries outside Europe such as China, Australia, India, Indonesia, Argentina, Columbia, Hong Kong, Algeria, Malaysia and New Zealand, Taiwan and Thailand. The EAU have produced Patient Information leaflets which are also available online via http://, to provide access to the highest quality of unbiased patient information for every bladder cancer patient in Europe. These are now translated in about 20 languages. The EAU calls for wider dissemination and implementation of its bladder cancer guidelines in order to improve outcome and to lower costs.

- Address the issue of screening of people in risk groups; - Address the lack of funding for clinical trials, translational research and genomics that must improve the outcome of patients with bladder cancer and - Impose multidisciplinary collaboration and concentrate muscle invasive bladder cancer care in bladder cancer centres of excellence. We are convinced that we will be able to decrease the incidence by more awareness campaigns and better prevention and screening strategies. The mortality rates for muscle invasive bladder cancer are highly likely to decrease through a multidisciplinary approach, combining surgery or radiotherapy with chemotherapy, by centralising bladder cancer care, and by the use of the emerging effective and less toxic immuno-oncologic agents.

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Director, European Cancer Patient Coalition (ECPC)

What should Europe do differently to beat bladder cancer?


ladder cancer is the fifth most common cancer in the Western world, and claims more than 52,000 European lives each year. (1) Survival rates have improved over the past 30 years, increasing from 30 to 50 percent of people diagnosed with bladder cancer surviving their disease for more than 10 years. (2) However, a great deal of work remains unfinished. Although the EU has supported member states in the development of cancer screening programmes, supplemented with guidelines for breast, cervical and colorectal cancers, bladder cancer has been largely overlooked. Indeed, there is currently no international organisation representing people diagnosed with bladder cancer. In order to better represent the international community of people living with bladder cancer, the European Cancer Patient Coalition (ECPC) has established a Bladder Cancer Working Group. We continue to invite all bladder cancer patient organisations and organisations with an interest in bladder cancer to express their interest in joining the Bladder Cancer Working Group, and contribute to our bladder cancer activities. The ECPC Bladder Cancer Working Group is chaired by Andrew Winterbottom, Director of Fight Bladder Cancer UK. Early diagnosis is key to improving survival rates in bladder cancer. When diagnosed at its earliest stage, more than 80 percent of people with

bladder cancer will survive their disease for five years or more. (2) GPs are not always aware of the symptoms of bladder cancer, such as blood in the urine and recurrent urinary tract infections. As a result, opportunities to spot this cancer early are being missed, especially in women, who have a consistently lower survival rate than men.

in order to gain insight on the experiences of people diagnosed with bladder cancer. People with bladder cancer also need to be signposted as to where they can get peer support and evidencebased information.People diagnosed with bladder cancer need to be regularly monitored after treatment is considered complete, since bladder cancer has a high rate of recurrence.

The month of May is bladder cancer awareness month. In 2017, the bladder cancer awareness campaign was focused on educating, raising awareness and making sure that bladder cancer is no longer a forgotten disease. Throughout the month of May, members of the Bladder Cancer Working Group shared facts, statistics, risk factors and symptoms during national events and on social media. The ECPC created a social media toolkit to help organisations, supporters and allies coordinate activities. The toolkit contained useful guidance and tools including inspiration on what to post and explanations on relevant tools and suggested activities.

The ECPC’s white paper on bladder cancer (3) contains eight recommendations to prevent bladder cancer, improve diagnosis and improve outcomes:

Once a person with bladder cancer is correctly diagnosed and starts to discuss treatment, it is essential that their multidisciplinary treatment team ensures that they understand all the benefits and risks involved.People diagnosed with bladder cancer need good communication with their healthcare team, in order to understand their diagnoses, treatments and side effects. Health professionals need to work with advocacy groups,

1. Continue to reduce tobacco consumption in Europe –the main cause of bladder cancer. 2. Raise awareness of bladder cancer risk factors and early symptoms among clinicians and high-risk groups. 3. Consider initiatives to reduce and monitor the exposure to carcinogenic chemicals. 4. Ensure occupational health and safety legislation encourages continuous health surveillance for those at high risk of developing occupational cancers, as well as improved prevention measures and timely access to diagnosis, treatment and care. 5. Invest in research to identify the best approach to early detection in high risk groups. 6. Address the lack of resources available for bladder cancer, including research funding and reimbursement of medicines. 7. Ensure all health professionals are trained in bladder cancer risk

factors to enable them to make connections between exposure and disease. 8. Ensure people diagnosed with bladder cancer have access to multidisciplinary units involving urologists, medical oncologists, radiation oncologists, pathologists, radiologists, psycho-oncologists, physiotherapists, nutritionists and palliative care experts. The white paper on bladder cancer was presented to the European Parliament on April 20, 2016 in Brussels, and has since been presented to key stakeholders by the Members of the ECPC in Greece, Italy, Poland, Turkey and the United Kingdom. By bringing patient groups, health professionals and policymakers together, we can all work towards earlier diagnosis, increased awareness and better communication, in order to improve the care of Europeans diagnosed with bladder cancer. The article is co-authored by Andrew Winterbottom, director of Fight Bladder Cancer UK. References: 1. GLOBOCAN: estimated cancer incidence, mortality, and prevalence worldwide; 2012; World Health Organization: Geneva 2. Pezaro C, et al. Urothelial Cancers: using biology to improve outcomes. Expert Review of Anticancer Therapy; 2012; 12(v 1):87-98 3. European Cancer Patient Coalition. Bladder Cancer White Paper; 2016; European Cancer Patient Coalition: Brussels Government Gazette | 55

New approaches to beat bladder cancer



VP Strategic Marketing, Photocure

Early and improved diagnosis for better patient outcomes demonstrated detection of more patients with recurrences resulting in change of management in more than 1 out of 5 patients. (3) Future perspective –moving surgical procedures from the operating room to the outpatient/office setting


atient access to improved technologiesrequires policymakers to incentivise healthcare providersto do what they know is right, both from a patient and long-term societal cost perspective. Enhanced cystoscopic technologies – Blue Light Cystoscopy Blue Light Cystoscopy (BLC™) with Hexvix®was approvedfor better detection and management of nonmuscle invasive bladder cancer (NMIBC) as a breakthrough innovation in Europe a few years ago. Hexvix® is the drug that is selectively taken up in malignant cells, and when illuminated with a blue light enabled cystoscope, the tumours light up (fluoresce) in a bright pink/red colour. Making the tumours visible allows for early and better detection, more complete removal of tumours and a correct diagnosis leading to better patient management. Studies have demonstrated improved patient outcomes with reduced recurrence rates, a clear trend in increased time to progression in addition to demonstrating cost-effectiveness. | 56

(1,2) Recommended in guidelines The strong evidence from randomised clinical trials, supported by cost-effectiveness studies and real-world evidence, has led to inclusion in national and international bladder cancer guidelines. Confidence at first sight – both in the surgical and outpatient/ office facilities BLC™ is to date primarily utilised in the surgical (TURBT) procedure with rigid cystoscopes withthe patient under general anaesthesia, but the use with flexible scopes in the outpatient/ office setting for surveillance cystoscopies is emerging. Evidence from a recent randomised clinical trialusing BLC™ with flexible cystoscopes

The TURBT procedure is costly for the urologyand healthcare society, and a substantial burden for the patient. The estimated costs of bladder cancer across the European Union is €4.9 billion (4), and the highest costs of all cancers on a per patient basis due to the frequent procedures and long-term follow-up. Moving the removal of small recurrences from the operating room to the outpatient clinic would reduce the burden both for patients and for the healthcare society. BLC™ could be an important tool to ensure the detection of recurrences and securing the optimal management and follow-up of patients according to their individual needs. (5) Lack of patient access to ‘bestto-offer’ technologies Despite the strong evidence, and the method being standard

of care in a number of clinics, patient access to BLC® varies enormously across countries and between hospitals within a country, gatekeeping the potential societal effect of early diagnosis and improved treatment of bladder cancer patients. Incentives to drive change Patient access to care is highly dependent on the funding systems for the physicians and institutions providing the care. Complex systems, conflicting interests and incentives, long traditions and lengthy processes demand policymakers to have a holistic and long-term view. They need to establish appropriate measures to incentivise healthcare providers to do what is right both from a patient and cost perspective. The guidelines recommendations and compliance to these are good starting points as well as a review of the patient journey and existing funding systems. References: 1. Witjes JA et al., Clinical and Cost Effectiveness of HexaminolevulinateGuided Blue-Light Cystoscopy: Evidence Review and Updated Expert Recommendations; European Urology 2014; 66(5):863-871 2.Gakis G and Fahmy O, Systematic Review and Meta-Analysis on the Impact of Hexaminolevulinate- Versus WhiteLight Guided Transurethral Bladder Tumor Resection on Progression in Non-Muscle Invasive Bladder Cancer; Bladder Cancer 2 (2016) 293-300 3. Daneshmand S et al. JU 2017, Volume 197, Issue 4, Supplement, Page e608 (AUA Late Breaking abstract) 4. Leal et al., EurUrol 2016; 69: 438-447 5. Malmström, PU, Agrawal S, Bläckberg, M., Boström, P.J., et al., ‘Non-muscleinvasive bladder cancer: a vision for the future. Scand J Urol. 2017 Feb 7:1-8

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Dr Badrinath R KONETY

Professor, Department of Urology, University of Minnesota

Defining quality metrics for bladder cancer: challenges and opportunities


ladder cancer is the ninth most common cancer worldwide and the fifth most frequently diagnosed cancer in the European Union, with nearly over 120,000 cases annually. (1) The disease accounts for nearly €3 billion in expenditures and represents 5 percent of total healthcare cancer costs in the EU. (2) Costs associated with bladder cancer care are in part due to its protracted clinical course in early stage (non-muscle invasive) cases, with patients suffering from a high rate of tumour recurrence and requiring management with repeated endoscopy-based surveillance and intravesical therapy. (3) Care for patients with bladder cancer varies significantly depending on region, due to differences in duration of hospitalisation, inpatient versus outpatient practice patterns, cancer incidence and type of treatments offered. These variations underscore the need to clearly define quality metrics for bladder cancer care, in order to promote and verify the delivery of effective, efficient, patientcentred and evidence-based care. Quality metrics, if they are to be useful, should be based on clinical principles that have been shown to improve outcomes in patients with the disease in question. In bladder cancer care, these principles include (1) long-term surveillance after initial diagnosis to identify and treat recurrence; (2) high-quality transurethral resection for

staging and reduction of disease burden; use of intravesical therapies at appropriate schedules; and (3) radical cystectomy with neoadjuvant chemotherapy for patients who present with or progress to muscle-invasive disease. Yet adherence to these treatment principles is made challenging by the varying permutations that exist within each of them. For example, intensity of surveillance schedules can vary by provider and by region, as can the use of adjuvant diagnostic tools to help adjudicate recurrence, such as urine cytology and special urinary biomarkers. Transurethral resection can be augmented by enhanced endoscopic techniques such as Blue Light Cystoscopy (BLC™) and narrow-band imaging to varying reported benefit. (4,5) Techniques and energy sources used can differ between centres. Adherence to intravesical therapy schedules can be made more complicatedby drug availability, and dosing schedules are sometimes altered on a per-patient basis to help reduce treatment-related side effects. Timing of radical cystectomy and quality of the surgery itself can also vary between centres and surgeons, both with respect to the 30-day complication ratesas well as specific surgical factors such as lymph-node yield, positive margin rate, approach used (open versus robot-assisted) and type of urinary diversion created, which can affect post-operative quality of life. Further, the routine use of platinum-based neoadjuvant

chemotherapy is underutilised despite evidence to suggest improved survival. (6) Each of these permutations can make it harder to develop a consensus on selecting the right quality metrics to differentiate ‘good’ bladder cancer care from ‘bad’. Clinical practice guidelines (CPGs) and health technology assessments (HTAs) play an important role in standardising delivery of care and in better understanding the costs and consequences of complex treatment algorithms. Development of CPGs and HTAs is labour-intensive, however, and policymakers would be wellserved to improve the funding for development of these tools and to incentivise compliance with such recommendations. Though there will always remain the need to individualise the treatment plansfor patients suffering from this aggressive and lethal disease, tracking and even mandating adherence to well-developed and unbiased CPGs may ultimately serve as the most cost-effectivequality focused intervention. The article is co-authored by Dr Vikram M Narayan, MD from the University of Minnesota, Department of Urology, Minneapolis, United States. References: 1. Crocetti E: Epidemiology of bladder cancer in Europe. Gov. Gaz. 2016. Available at: http:// repository/handle/JRC101380.

2. Leal J, Luengo-Fernandez R, Sullivan R, et al: Economic Burden of Bladder Cancer Across the European Union. Eur. Urol. 2016; 69: 438–447. Available at: http://linkinghub. S0302283815010052. 3. Svatek RS, Hollenbeck BK, Holmäng S, et al: The Economics of Bladder Cancer: Costs and Considerations of Caring for This Disease. Eur. Urol. 2014; 66: 253–262. Available at: http://linkinghub. S0302283814000189. 4. Grossman HB, Gomella L, Fradet Y, et al: A phase III, multicenter comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of superficial papillary lesions in patients with bladder cancer. J. Urol. 2007; 178: 62–7. Available at: http://www.ncbi.nlm.nih. gov/pubmed/17499283. 5. Xiong Y, Li J, Ma S, et al: A meta-analysis of narrow band imaging for the diagnosis and therapeutic outcome of nonmuscle invasive bladder cancer. Edited by R Hurst. PLoS One 2017; 12: e0170819. Available at: journal.pone.0170819. 6. Fedeli U, Fedewa SA and Ward EM: Treatment of Muscle Invasive Bladder Cancer: Evidence From the National Cancer Database, 2003 to 2007. J. Urol. 2011; 185: 72–78. Available at: http://linkinghub. S0022534710045519. Government Gazette | 57

Patients’ perspective on quality of care


Alojz PETERLE mep

President, MEPs against Cancer, European Parliament

‘Patient perspective is a pre-requisite for any modern programme in healthcare’


he European Prostate Cancer Awareness Day (EPAD) offers an important opportunity to draw attention to the most frequently diagnosed cancer in men. Such an occasion allows us to shine a light on the impact of a prostate cancer diagnosis on individual patients and their families, and to advocate decision makers on the actions they can take to reduce the burden of this disease. The large majority of cases of prostate cancer occur in men aged 65 and over, and, thankfully, a diagnosis of prostate cancer is rare in men aged under 40. However, the disease is becoming more frequently detected in younger age groups. For example, in the United States, 10 percent of new diagnoses of prostate cancer occur in men aged 55 and under. Therefore, information on prostate cancer and its warning signs must be available to men from early middle age onwards. Over the past two decades, the incidence of prostate cancer has risen steadily, and continues to rise with the increase in longevity among developed economies. Each year there are over 417,000 new cases of prostate cancer in men in the member states of the European Union, and more than 92,000 deaths resulting from prostate cancer. There is a huge variability in incidence rates of prostate cancer even within the European Union. In Sweden, around 175 men per 100,000 (age-adjusted | 58

rate on the European standard population) are diagnosed with prostate cancer annually, whereas this figure falls to 34 per 100,000 in Greece. On a more positive note, the most recent data on five-year relative survival for cancers show that prostate cancer ranked fourth in Europe among the cancers with the best prognosis with a five-year relative survival of 83 percent. Yet, despite this favourable perspective, there is still clear variation in survival across Europe, ranging from 88 percent in Southern and Central European countries to 76 percent in Eastern ones. The rich array of data available is invaluable for policymakers to make informed decisions about the necessary policies and actions to be taken to adequately address this disease. But the statistics can only tell a certain part of the story. As an elected representative of the public, and cancer survivor myself, I believe that the utmost attention must be paid to the perspective of the patient and their families. The patient perspective is not simply complementary to epidemiological and clinical

data, but is a pre-requisite for any modern programme in healthcare. A diagnosis of any cancer could be a serious and life-changing event. For prostate cancer, in particular, a diagnosis can be a disorienting period given the serious possibility that the cancer may not progress or show further symptoms. Nonetheless, patients in this position are justifiably anxious about the future prognosis. Those patients for whom, sadly, the cancer does become more aggressive, the treatment of prostate cancer can have significant side effects that impact on the most personal aspects of a patient’s daily life. Taking into account the impact of a prostate cancer diagnosis on an individual patient, strategies in the European Union to diminish the burden of prostate cancer should be designed to empower the individual to make fully informed decisions about their treatment options in line with their personal values and preferences. Informed decisionmaking is especially important for men considering whether to undergo a PSA test to detect prostate

cancer given the degree of overdiagnosis associated with this test. The high level of overdiagnosis is what currently prevents systematic screening for prostate cancer from being recommended on a population basis. Therefore, strategies to reduce overdiagnosis should be taken as a public health policy priority before organised screening for prostate cancer can be advocated. From a societal perspective, the urgency for policymakers is to address the avoidable variation in long-term survival for prostate cancer by facilitating equitable access to the appropriate treatments and supportive therapies for patients in all member states. We must also not forget about the role of primary prevention and health promotion. Although the best understood risk factors for prostate cancer are age, ethnicity and family history, prostate cancer risk can be reduced by following the general recommendations of the European Code Against Cancer. This includes maintaining a healthy body weight and being physically active in your daily life. To conclude, as president of the MEPs Against Cancer interest group of the European Parliament, I will ensure that addressing prostate cancer remains high on the agenda of the group, and that we continue to work in a collaborative manner with all stakeholders to improve quality of life for prostate cancer patients.

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Francesca COLOMBO

Head of OECD’s Health Division

Patient-reported measurement can enable better outcomes


ancer is rapidly becoming one of the world’s most ubiquitous and devastating diseases. It is responsible for almost a third of all deaths in Europe and is catching up to cardiovascular disease as the leading cause of mortality. Nearly three out of ten Europeans are diagnosed with cancer before the age of 75. Ensuring high quality care must be a priority. But while we have good information on whether people survive following cancer, far less is known about how health systems care forpeople with cancer. We need to address this gap in how we measure healthcare performance. The last three decades haveseena 20 percent decline in deaths due to cancer. But when we ask patients, their families and carers about what matters to them it is clear that ‘success’ means much more than survival. Pain, function, independence and dignity are also important outcomes,especially as cancer treatment can have debilitating side effects. Patients also value being cared for with compassion and warmth during what isa highly distressing time.These important metrics are rarely reported, but they can reveal a lot about the quality and outcomes of care. Different treatment modalities exist to treat cancer:watchful monitoring, radiotherapyand surgery. Survival rates for thevarious treatments can often be similar. However, significant

differences in symptoms and outcomes such as pain, fatigue and function are often reported. People diagnosed with cancer thusface decisions and trade-offs spanning several dimensions in addition to survival alone. Such decisions will influence their and their families’ quality of life for years, andcan only be made with complete information about the effects of treatment as reported by other patients. Patient-reported measurement can also enable better outcomes in real time. A recent US study asked chemotherapy patients with advanced cancers to regularly report their symptoms through a web-based application. The patient-reported data was provided to the patients’ clinical teams, enabling them to respond to problems sooner. These patients survived longer than a control group who received only the treatment. They also experienced fewer hospitalisations and reported better quality of life throughout the care cycle. This simple yetcost-effective addition to the existingtreatment represents tremendous value to patients. But the importance of patientreported measurement extends beyond the clinic. However, these days, mortality statistics reveal only part of the picture. Meaningful crosscountry differences emerge when other metrics, such as quality of life, function and independence are examined. Healthcare organisations, administrators and policymakers need this information to

assess performance, enable continued improvement and informbetter decisionsat all levels of healthcare.For example, we know that resources spent on treating cancer can be extremelyhigh.

information is indispensable to good decision-making at every level of healthcare. With 200 million Europeans expected to be diagnosed with cancer during their lifetime, we need to get moving on this important issue.

More information on the quality of the additional yearsof life gained by those receiving care can help us better assess the effectiveness of pharmaceutical treatments and other resources.


Notable exceptions aside, most European – and wider OECD – health systems do not routinely collect this important information from patients diagnosed with and receiving care for cancer. This knowledge gap impedes the creation of people-centred health systems that create value for patients and for society. To address this gap OECD has commenced a new initiative called PaRIS, the PatientReported Indicator Surveys. PaRIS will support countries routinely and systematically collect patient-reported measures for various highimpact diseasessuch as cancer, and will also develop a new survey to capture outcomes and experiences of care by people withmultiple chronic conditions. Among the initial areas of focus is breast cancer care.

1. Basch et al 2016 https:// pubmed/26644527 2. Basch et al 2017 https:// journals/jama/articleabstract/2630810?redirect=true 3. OECD (2016), Health at a Glance Europe. OECD Publishing, Paris. 4. OECD (2017a), Health at a Glance. OECD Publishing, Paris 5. OECD (2017b), New Technologies in Health Care. OECD Publishing, Paris 6. European Observatory on Health (2017), Integrating care for people with multimorbidity: what does the evidence tell us? news/2017/04/integrating-carefor-people-with-multimorbiditywhat-does-the-evidence-tell-us

People-centredcare is a key lever to help overcome the challenges faced by our health systems. But to truly put people at the centre, we need to start asking patients, their families and carers about the things that matter to them. This Government Gazette | 59


EPAD 2017

Policymakers commit to improve prostate cancer care in Europe Researchers should therefore put more energy in identifying men at high risk as many genes are involved in PCa.” He also mentioned that the evidence for dietary changes is weak. However, the evidence of the role of exercise is increasing. “We should have a system in place to get men moving. In the European Union wecurrently lack a clearmechanism to actually make the changes,” Tombal concluded. Lydia Makaroff, director of the ECPC, noted that patients are co-creators of their own health. “Civil society can lead promotional campaigns. Patients can support wide dissemination and advocate prevention programmes as ambassadors, but patient organisations should be sitting at the table with politicians to discuss what patients really need. By speaking in one voice, we will raise the voice of people living with prostate cancer.”

European Association of Urology


rostate cancer (PCa) is on the rise and the most frequent cancer in men. In fact, it is the third most common cause of death in men in Europe, with important consequences for healthcare systems. Saving lives and ensuring a high quality of life requires immediate European actions. To raise awareness, understanding and knowledge of the management of prostate cancer, Europa Uomo, the European Association of Urology (EAU) and its partners brought together policymakers, scientific experts, European associations and patient groups in the European Parliament to discuss the next steps to lower risks and improve management of the deadly disease. Co-hosted by MEPs Alojz Peterle and Marian Harkin, the European Prostate Cancer Awareness Day addressed the misconception on the disease.

Prostate cancer is not always ‘an oldman’s disease’. Perhaps, the deadly disease can threaten the lives of younger men as well. Early detection is crucial and awareness campaigns at the EU and national levels should make men alert to take symptoms seriously. Sharing a common goal for Europeans “to remain as healthy as possible for as long as possible”, the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, noted that “better understanding and knowledge of health risks and how to manage them are crucial.” In his introductory speech, he underlined the importance of raising awareness to keep a healthy lifestyle and also to further investigate the opportunities of personalised healthcare as recommended by EAU’s white paper on prostate cancer.

Joining forces Addressing the need to collaborate with patient organisations, Francesco de Lorenzo of the European Cancer Patient Coalition(ECPC) and Ken Mastris of Europa Uomo noted that the European Commission should and could do more. Mastris noted that the Commission “should help create the same level of awareness as for breast cancer.” The awareness campaign, he said, should aim to target the local levels. Adjusting campaigns to language and different cultures increases the impact significantly. Prevention of PCa Prof Bertrand Tombal, president of the European Organisation for Research and Treatment of Cancer (EORTC),posed the question as to whether prevention of PCa is a utopia. He said: “There is no magic pill, because we have been naive in the development of PCa trials.

To screen or not to screen? “Prostate cancer kills, so it should be screened. However, no country has a structure in place to do so,” Prof Nicolas Mottet, chair of the Prostate Cancer Panel of the EAU Guidelines, stated. “The problem is that if we do systematic screening, a vast majority of the positive results might be insignificant. PCa, but still the general principle is that an early diagnosis is more readily treatable than late diagnosis.”An important recommendation in the EAU Guidelines for urologists is that the benefits and drawbacks of early diagnosis should be discussed with patients before an approach is decided upon. Former patient Paul Enders said that early diagnosis is a warning. If it’s positive, the decision has to be made together with the patient. A better differentiation between low and high risk prostate cancers is crucial in

for all. Imagine the new insight we would gain! However, the current structure is so inefficient that we cannot share data. What are we protecting each other from? Our most important innovations can save lives, but we have to be willing to share it.”

preventing overtreatment.The reliability of biopsy results should also be improved. Recent developments in using MRI help in better detection of the tumour. Prof Jochen Walz stated that, in the future, we might be able to achieve targeted treatment with less healthy tissue lost. There is a downside; MRI is costly, from €300 to 1,000 depending on where the patient lives. “We need to invest in a proper infrastructure with qualified and experienced urologiststhroughout Europe,”said Walz. Equal access to care Countries that are most affected by PCa-related deaths have fewer resources. “Higher income countries have a higher incidence, but their facilities increase survival rates,” said Dr Vitaly Smelov of the International Agency for Research on Cancer (IARC) andthe World Health Organization. “The incidence rate of low- to middle-income countries will increase further due to population growth. Education on preventive matters and early diagnosis are essential to prevent mortality rates rising at the same rateas incidence rates.” Treatment Luckily, treatment options are expanding, but so are the costs. What are the current costs of local treatment? Prof Dominik

Berthold presented a case where the total costs of prostate cancer treatment over a period of 18 years resulted in over €300,000. He strongly recommended intensifying research into widening the spectrum of therapeutic options, but Health Technology Assessments (HTAs) should be performed on all new technologies. “It’s not only about money,” said Tit Albreht, chair of the Joint Action Against Cancer (CanCon). More and more data is showing that the anxiety with PCa patients is a permanent reality. According to Ian Banks of the European Men’s Health Forum, most men just want to go back to work after treatment. “Treatment just involves a small part of the patient’s journey,” added Lawrence Drudge-Coates of the European Association of Urology Nurses (EAUN). According to all speakers there is a great role for the non-medical professional (trained nurse or psychologist), who is closer to the patient. “Nurses are identified as pivotal role in holistic care, not just medical but also physical and psychological. We should no longer talk about a multidisciplinary team, but about a multi-professional one.” Next steps: standardise, investigate and personalise care The variation between European countries makes it difficult to standardise care. “Prostate cancer

has guidelines for clinicians in 14 different countries, but for general practitioners this is far less,” said Albreht.“We must allow the patient to be informed and address inequalities in nurses and their level of education.” There are many opportunities for research funding, explains Jan-Willem van de Loo of DG Research and Innovation (EC). “We have had 83 research projects to advance healthcare with a total budget of €128 million. For prostate cancer there are several possibilities. The white paper is a clear document with recommendations for innovative technologies and personalised healthcare, but it is complex. We need more research, but we will bring together funding from different member states for this.” “How can we accelerate innovation in healthcare systems?” asked Denis Horgan of the European Alliance for Personalised Medicine (EAPM). Political involvement and commitment are key in technological advancement. Traditional approaches are limited in identifying a patient at an early stage of his disease. According to James N’Dow, chairman of the EAU Guidelines Office, big data can be a solution. “Imagine all experiences with the disease and all of our outcomes are centrally stored and accessible

MEP Peterle added: “When the terrorists attacked Brussels last year, we were shocked to realise that even police or intelligence structures don’t share data on criminals. Patients don’t have unified cancer registries amongst Europe; some don’t even have them on a national level.The EAU and Europa Uomo are not alone in addressing these issues. You can count on us.” “Money is not always the differentiator,” Peterle continued. “We are still lacking political will to do more together.” Prof Hein Van Poppel, co-organiser of the EPAD on behalf of the EAU, emphasised that all parties present need support from the European Parliament and the European Commission, but most importantly from patients. “They need to voice their concerns and knock on the doors of urologists.The white paper is the basis for this discussion, but this should also have some outcome.” Prof Poppel concluded: “It all starts with awareness to prevent prostate cancer, but we as urologists want to be heard in new Joint Actions when it comes to screening as well. All parties present are willing to work with the EU to improve care in a patient-centred, multiprofessional approach with equal access for all European men. Urologists and urology patientshope to be invited, so together we can save lives.”

performance Make your mind your ally

formula for success from... Bruce Lee In this new column, we bring you striking thoughts from the world’s greatest achievers

unlocking creativity With the right training, creativity as accessible to anyone and can be ignited and enhanced using mindfulness techniques Meliissa Gokhool, Editor, Performance

healthier relationship with failure Offering sensitive feedback following failure and sincere praise following success can foster a healthier environment with failure Simon Taylor, PhD candidate in Psychology of Sport, University of Stirling

pros and cons of perfectionism Do we want our students, employees, athletes, even children, to be perfectionists? Dr Andrew P. Hill, Director of the Motivation, Performance, and Wellbeing Research Group, York St John University

Formula for success from...


uce Lee I

n this new column, we bring you striking thoughts from the world’s greatest achievers. Bruce Lee is one of the most influential martial artists of our time. He formulated the martial art style JeetKune Do or the Way of the Intercepting Fist. In 1964 he came into the spotlight due to his performance in theLong Beach International Karate Championships, where he became better known for his ‘two-finger push-ups’ and ‘one inch punch’. Later, Bruce Lee secured his first major acting role in the television series The Green Hornet. Though the show only lasted for one season, Bruce Lee went on to achieve a great deal of box-office success.

This culminated in his final movie Enter The Dragon, which grossed more than $200 million. Bruce Lee in the movie popularised a new archetype of hero, which paved the way for broader depictions of Asian Americans within cinema. In 2004 the movie was preserved by the library of congress for being “culturally, historically, or aesthetically significant.” Alongside achieving near perfection in his craft of martial and making cinematic history Bruce Lee is also known for his philosophical writings. Here’s a compilation of Bruce Lee’s aphorisms that provide great insight into his formula for success.

All pearls of wisdom are from Bruce Lee’s book Striking thoughts

KEYS TO SUCCESS... Success is when preparation meets opportunity. Opportunities may come your way or they may not. Luck may come your way or it may not. But if it comes your way – and you call that luck – you’d better be ready for it! The price of success –He who wants to succeed should learn how to fight, to strive and to suffer. You can acquire a lot in life, if you are prepared to give up a lot to get it. The three keys to success–Persistence, persistence, and persistence. The Power can be created and maintained through daily practice. Enjoying your work is the important thing – At [one] time I wanted all the indirect things –money, fame, the big opening nights. Now I have it, or am beginning to get it, the whole thing doesn’t seem important any more. I have found that doing a thing is more important. I am having fun doing it. Money comes second.

FOCUS ON THE ACTION, NOT REWARD The reward is in the action, not from it – My only reward is in my actions not ‘from’ them. The quality of my reward is in the depth of my response, the centralness of the part of me I act from.

Watch out!

Watch this space for a recipe for success and happiness from the world’s greatest achievers.

THOUGHTS BECOME THINGS Thoughts are things– Thoughts are things, in the sense that thought can be translated into its physical equivalent. Don’t choose to waste energy – Never waste energy on worries or negative thought. All problems are bought into existence – drop them. Become what you think – What you HABITUALLY THINK largely determines what you will ultimately become. Cease negative mental chattering– If you think a thing is impossible, you’ll make it impossible. Pessimism blunts the tools you need to succeed. Mixing thought with definiteness of purpose – I begin to appreciate now the old saying “he can because he thinks he can.” I believe that anybody can think himself into his goal if he mixes thought with definiteness of purpose, persistence, and burning desire for its translation into reality.

ON ACHIEVING GOALS... Goals give life substance – To strive actively to achieve some goal gives your life meaning and substance. A goal is not always meant to be reached– A goal is not always meant to be reached. It often serves simply as something to aim at. Daily progress – Make at least one definite move daily towards your goal. One rarely reaches the goal in one step– The control of our being is not unlike the combination of a safe. One turn of the knob rarely unlocks the safe. Each advance and retreat is a step toward one’s goal. Always keep your goals in focus – Keep your mind on the things you want and off those you don’t. The first rule of achieving your goal – Know what you want. I know my idea is right, and, therefore the results would be satisfactory. I don’t really worry about the reward, but to set in motion the machinery to achieve it. My contribution will be the measure of my reward and success. When you drop a pebble into a pool of water, the pebble starts a series of ripples that expand until they encompass the whole pool. This is exactly what will happen when I give my ideas a definite plan of action.


Make your mind your ally

Meliissa GOKHOOL

Editor, Government Gazette’s Supplement on Performance

Unlocking creativity


hroughout time, the perceived benefits of creativity have moved from confinement within the arts to innovation within fields such as engineering and business. Recent scientific research has shown that uses of creativity are even more ubiquitous and are greatly useful for everyday problem solving. When approaching a problem | 68

a creative individual is likely to dip into a larger pool of resources in order to find the solution. This ability has been studied in terms of an individual’s ability to access and utilise information stored within their subconscious to solve problems effectively and innovatively. Research has shown that it is possible to increase this type

of creativity within problem solving through relatively simple methods. One of these practices involves entering the state between being asleep and awake known as hypnagogia. During hypnagogia your brain is hyper associative, so you are able to access information within your subconscious and form new connections that may not have been possible while

awake. While this is similar to what occurs during Rapid Eye Movement (REM) sleep, the added benefit of hypnagogia is that you are still conscious enough to observe and recall the ideas being formed (1) In this sense hypnagogia is an ideal creative tool, and better still it is possible to harness it by learning from the practices of one of the most creative artists of our time,

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Salvador Dali. Dali used dreams as an inspiration for his art by using a technique he coined as “slumber with a key” (2). This involved sitting in an armchair with his arms over the side, holding a heavy key between the thumb and forefinger, and placing a plate directly under. Upon falling asleep the key would drop, smashing the plate, and this noise would awaken him. It is possible to modify Dali’s method of entering hypnagogia, as it is essentially a brief nap. The additive role of sleep in harnessing the subconscious can be seen in the Tetris study conducted by Robert Stickgold. The study asked amnesiacs to play Tetris (a tile-matching video game) over three days and recorded their dreams as well as their performance in the game (4). The results were astonishing as it showed that some amnesiacs dreamt of Tetris pieces falling, turning when necessary and fitting together. This result was particularly remarkable as it was believed that in the first hour of sleep, which constitutes the hypnogogic stage, we see declarative memories, which play back recent events of the day (5). Due to their condition amnesiacs are unable to form these types of memories and would have had no memories of playing Tetris during the day; however, despite their condition,they still dreamt of the game. This was explained by Stickgold as access to implicit memories, which are those that are stored and utilised unconsciously (5). Therefore dreams are a valuable tool to accessing this resource, which is not possible to consciously do.

Despite the effectiveness of hypnogogic sleep in accessing your subconscious and facilitating creative problem solving, for those who are exhausted there is a risk that they may not wake, in which the method previously described may be disruptive to the working day. A possible alternative is mindfulness. Mindfulness is a type of meditative exercise, which involves focusing on present bodily sensations such as the breath. The key lies in doing so while practising non-judgmental observation of thoughts and any external stimuli which may come and go. Research has found a link between mindfulness and insight problem solving, which is the kind of problem linked to creativity and requires restructuring of the problem. The solution is often experienced as a sudden epiphany, an “ahaa” moment (3). A study was conducted to test how individuals’ baseline levels of mindfulness (trait mindfulness) affected problem solving ability. Participants were split into small groups of five and had their trait mindfulness assessed using the Mindful Attention Awareness Scale, after which they were given questionnaires with problems designed to test different types of problem solving. The results showed that there was a strong positive relationship between mindfulness and insight problem solving but not non-insight problem solving (3). Noninsight problems are those which require a specific set of rules or method to be solved, such as an algebraic equation.

While mindfulness is effective in solving insight problems, the experiment showed that this method of problem solving can act as a constraint when solving non-insight problems. In fact, mindfulness in its essence is designed to neutralise the very methodology that is required to solve non-insight problems as the effectiveness of mindfulness on insight problem solving can be explained by the latter practice breaking down the influence of past experience that keeps you confined within a set of rules when problemsolving and may be keeping you away from the light bulb moment. In another study, individuals were either assigned to a mindfulness group, where they received mindfulness training, or to a control group. The mindfulness training involved listening to a 10 minute audio tape which included instructions on bringing attention to the sensation of the body, the breath and the different areas of which the body is composed all in a non-judgmental way, for example accepting sensations such as pain. The results were positive and again mindfulness was showed to increase performance on insight problems (3).

And Wakefulness, Is Key To Creativity[Online] Available at: http://www. hypnogogia-dreams-creativity_ us_56c5d16ce4b0c3c55053de38 [12.01.18] 2. Carr, M. How To Dream like Salvador Dali. Psychology Today. [Online] Available at: https:// dream-factory/201502/howdream-salvador-dali. [12.01.18] 3. Ostafin, B.D. (2012) Stepping out of history: Mindfulness improves insight problem solving. Consciousness and cognition 21, pp. 10321034 
 4. Fernandez A. Sleep, Tetris, Memory and the Brain [Online] Available at: https://sharpbrains. com/blog/2008/03/24/sleeptetris-memory-and-the-brain/ [12.01.18] 5. Young E. Dream machine[Online]. Available at: article/dn70-dream-machine/ [12.01.18]

The good news therefore is that conventional belief that creativity is an inborn talent is now challenged. With the right training, creativity is accessible to anyone and can be ignited and enhanced usingmindfulness techniques, hence increasing the frequency of lightbulb moments within your life. References: 1. Gregoire C. Hypnagogia, the State between Sleep

Government Gazette | 69


Make your mind your ally


PhD candidate in Psychology of Sport, University of Stirling

Let’s build a healthier relationship with failure


n today’s day and age, we are obsessed with success: we are rewarded for success, but punished for failure. This focus, while important, comes at a price. While it is undoubtedly important to reward success, it is also important to consider how failure is conceptualised and treated. Otherwise, this obsession we have with avoiding failure can lead to us developing a fear of failure – something that has been found to be associated with a series of problems across a wide range of performance settings. It is easy to assume that fear of failure can work as a motivating force, encouraging individuals to work harder in the pursuit of success to avoid the very failure they fear. However, research suggests that long-term fear of failure can have debilitating effects, and in fact does more bad than good over time. Fear of failure can lead to antisocial behaviour (17) and lower levels of well-being. (10) Fear of failure has also been found to be associated with problems such as worry, anxiety, self-handicapping, stress, burnout and lower engagement (2,3,4,5,6,11) – all factors that can negatively affect a person’s performance in any aspect of his or her life. Failure in and of itself is meaningless. It is not the failure itself that we fear, but the consequences of that failure. (1) A dominant theory in the performance domain suggests that | 70

there are five main consequences we fear, either relating to ourselves or the people around us: fear of shame and embarrassment, fear of devaluing one’s self-estimate (ie, realising we’re not as good as we think we are), fear of uncertain future, fear of upsetting important others and fear of important others losing interest. (8). To understand how we can help people overcome fear of failure, we first must understand where it comes from. Research suggests fear of failure is developed in childhood, usually between the ages of 5 and 9, and that parents are largely responsible for instilling it (13,14). This is especially true among parents who react to their child’s failure with increased hostility, such as by blaming the child for the failure, or who show less affiliative behaviour, ie, decreased love and affection. (5) Those children end up believing that the affection they receive is dependent on their success, making them more sensitive to the threat of rejection. As a result, they avoid performance related situations whenever possible, causing them to lose out on opportunities to learn and grow from their failure. It’s a self-perpetuating cycle. (15) We must also begin to understand that failure, like success, is incredibly subjective. Take sport for example. If your favourite football team loses a tournament, you as a spectator – along with the team’s sponsors and the club’s owners – may see it as a failure.

However, the players may see it as a success if they lost while playing well against a particularly tough opponent. If we can understand what failure means to an individual, we can better understand the root of their fear of failure and, potentially, how it can be overcome. Very few studies have looked at how we can overcome fear of failure, yet there is some research is the sport psychology domain that can help us begin to understand the behaviours that influence it. For example, certain coach behaviours have been found to potentially influence levels of fear of failure (6). Coaches who blame players for their poor performance can in turn lead those players to blame themselves and become more critical of their behaviour, leading to an increased fear of failure. On the other hand, coaches who demonstrate affiliative behaviours, such as by using positive affirmations, can lead to increased autonomy among players, negatively affecting their fear of failure (6). These findings should be taken with a grain of salt, however, as they were found in a nonexperimental setting. How can we apply this outside the sports domain? We must recognise the impact that interpersonal relationships, and not just intrapersonal behaviours, can have on fear of failure. People in leadership roles, much like

coaches, may engage in behaviours that can change the levels of fear of failure felt by their subordinates. Understanding this influence is important, as the way we respond to the failure of others can potentially influence their fear of failure and, as a result, their performance. To positively influence someone’s performance in the face of failure, offer constructive feedback, not blame. Creating an environment that focuses only on rewarding success and punishing failure can be problematic. Instead, offering sensitive but constructive feedback following failure while equally offering sincere praise following success can foster an environment where people have a healthier relationship with failure and an increased interest in performing at the top of their game. References: 1. Birney, R., Burdick, H. & Teevan, R., 1969. Fear of Failure,New York: Van Nostrand. 2. Caraway, K. et al., 2003. ‘Self-efficacy, goal-orientation and fear of failure as predictors of school engagement in high school students’. Psychology in the Schools, 40(4), pp.417–427. 3. Chen, L.H. et al., 2009. ‘Fear of failure and self-handicapping

in college physical education’. Psychological Reports, 105(3), pp.707–713. 4. Conroy, D.E., 2001. ‘Progress in the development of a multidimensional measure of fear of failure: The performance failure appraisal inventory (pfai)’. Anxiety,Stress & Coping, 14(4), pp.431–452. 5. Conroy, D.E., 2003. ‘Representational models associated with fear of failure in adolescents and young adults’. Journal of Personality, 71(5), pp.757–783. 6. Conroy, D.E. & Coatsworth, J.D., 2007. ‘Coaching behaviours associated with changes in fear of failure: Changes in self-talk and need satisfaction as potential mechanisms’. 7. Journal of Personality, 75(2), pp.383–419. 8.Conroy, D.E., Willow, J.P. & Metzler, J.N., 2002. 9.‘Multidimensional fear of failure measurement: Theperformance failure appraisal inventory’. Journal of Applied Sport Psychology, 14(2), pp.76–90. 10.Elliot, A.J. & Sheldon, K.M., 1997. ‘Avoidance achievement motivation: A personal goals analysis’. Journal of Personality and Social Psychology, 73(1), pp.171–185.

& Stenling, A., 2016. ‘Fear of failure, psychological stress and burnout among adolescent athletes competing in high level sport’. Scandinavian 12. Journal of Medicine & Science in Sports, 26(10), pp.1256–1264. 13. McClelland, D.C. et al., 1953. The Achievement Motive, New York: Appleton-CenturyCrofts. 14. McClelland, D.C., 1958. The importance of early learning in the formation of motives. In J. W. Atkinson, Motives in Fantasy, Action, and Society, 1st ed. Princeton: Van Nostrand, pp. 437–452. 15. McGregor, H. & Elliot, A.J., 2005. ‘The shame of failure: Examining the link between fear of failure and shame’. 16. Personality and Social Psychology Bulletin, 31(2),pp.218–231. 17. Sagar, S.S., Boardley, I.D. & Kavussanu, M., 2011. ‘Fear of failure and student athletes’ interpersonal antisocial behaviour in education and sport’. The British journal of educational psychology, 81(3), pp.391–408.

11.Gustafsson, H., Sagar, S.S. Government Gazette | 71


Make your mind your ally


Dr Andrew P HILL

Director of the Motivation, Performance, and Wellbeing Research Group, York St John University

Pros and cons of being a perfectionist


t York St John University we have the largest group of researchers dedicated to examining the consequences of perfectionism in the UK. The most common question we are asked about our work is whether it is a good or bad thing to be a perfectionist. That is, do we want our students, employees, athletes, even children, to be perfectionists? Based on the findings of over 60 studies members of our group have conducted to date, and the many more conducted by other researchers around the world, the answer to this question is, well, complicated. Before we explain, first we | 72

should clarify what we mean by perfectionism. Perfectionism is a personality trait that includes two main features – the tendency to set exceptionally high standards (often referred to as perfectionistic strivings) and the tendency to be harsh and self-critical when these standards are not met (often referred to as perfectionistic concerns). It develops as the result of both genetic and social factors, so some people are born with a proclivity for perfectionism, but it can also be learned, particularly from parents. (1,2,3) Also, contrary to what people might think, there really is no such thing as a perfectionist. Like other personality traits,

perfectionism exists to some degree in everyone. Some people are highly perfectionistic (ie, report higher levels of the features of perfectionism) and other people are less perfectionistic (ie, report lower levels of the features of perfectionism). This is important because this means perfectionism is not an issue that concerns only the gifted and talented, as some people think. On the contrary, the effects of perfectionism are relevant for everyone. In regard to what the effects of perfectionism are, and herein lies the complexity, research indicates that for some people, some of the time, perfectionism

may have some benefits. However, for most people, most of the time, perfectionism is likely to come with significant costs. The benefits of perfectionism lie in the potential for the achievement behaviour associated with perfectionism to contribute to better performance. This is a relationship that has been found in multiple domains including school, sports and the workplace. This finding reflects the well documented benefits of setting high goals, hard work and single-minded dedication, all things we can expect to an extent from individuals who exhibit perfectionism. (4,5,6)

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The costs, however, lie in the relationship between perfectionism and both mental and physical illhealth. Evidence of the link between harsh selfcritical features of perfectionism and mental ill health is the strongest in research, by far outweighing the evidence of the relationship between its other features and performance. A number of large scale studies have recently been published that have collated all available research on these topics and have reported that harsh selfcritical features of perfectionism are positively related to anxiety disorders, burnout, depression and suicide ideation. Less research is available on perfectionism and physical health but what is available suggests that these features are also related to a range of illnesses such as insomnia and chronic fatigue syndrome, even earlier death. (7,8,9,10,11,12) Because individuals who report higher perfectionistic strivings also tend to report higher perfectionistic concerns, it is difficult not to consider one without the other. The consequences and desirability of perfectionism therefore reflect the potential for both some possible performance gains, at least in the shortterm, and likely health difficulties in the longterm. Another way of making sense of this complexity is to think of perfectionism as a vulnerability factor. That is, even seemingly well-adjusted, high-performing and healthy people are likely to develop mental and physical illhealth if they have higher levels of perfectionism and things become stressful. In this sense, rather than providing resilience to routine setbacks, perfectionism makes people

profoundly susceptible to inevitable bumps in the road. We have seen this in our own laboratory work where a single failure on a performance task is enough to induce more negative thoughts and avoidance strategies. (13) In considering existing research, our opinion is that the downsides of perfectionism by far outweigh the upsides. Do we want our students, athletes, employees and children to be more perfectionistic? No, perfectionism holds too few benefits and too greater risks for those who exhibit it. So, what are we to do? Our advice is that if perfectionistic tendencies are contributing to mental health issues, people should obviously seek support from trained professionals, starting with a GP. However, for people who are not suffering mental health issues, and like many of us simply live with more perfectionistic tendencies than we would like, we need to learn to better manage our perfectionistic tendencies and keep them in check. Some of the easiest things that we can all do are to recognise the potential costs of perfectionism to ourselves and others, remind ourselves that we can still achieve our goals without being perfectionistic (in fact, it is probably more likely and will definitely be more fun along the way) and, in our daily lives, be a little less critical and a little more flexible when things go awry. The article is co-authored by Michael Grugan, a graduate teaching assistant and doctoral student at York St John University. His research to date has focused on how perfectionism influences the

interpersonal behaviour of athletes. He is also interested in how the social environment encourages perfectionism. References: 1. Stoeber, J., & Otto, K. (2006). Positive conceptions of perfectionism: Approaches, evidence, challenges.Personality and Social Psychology Review, 10(4), 295–319. 2. Tozzi, F., Aggen, S. H., Neale, B. M., Anderson, C. B., Mazzeo, S. E., Neale, M. C., & Bulik, C.M. (2004). The structure of perfectionism: A twin study. Behavior Genetics, 34(5), 483–494. 3. Frost, R. O., Lahart, C. M., & Rosenblate, R. (1991). The development of perfectionism: A study of daughters and their parents. Cognitive Therapy and Research, 15(6), 469–489. 4. Verner-Filion, J., & Gaudreau, P. (2010). From perfectionism to academic adjustment: The mediating role of achievement goals. Personality and Individual Differences, 49(2), 181–186. 5. Stoeber, J., Uphill, M. A., & Hotham, S. (2009). Predicting race performance in triathlon: The role of perfectionism, achievement goals, and personal goal setting. Journal of Sport & Exercise Psychology, 31(2), 211–245. 6. Stoeber, J., & Kersting, M. (2007). Perfectionism and aptitude test performance: Testees who strive for perfection achieve better test results. Personality and Individual Differences, 42(6), 1093–1103. 7. Limburg, K., Watson, H. J., Hagger, M.S., & Egan, S. J. (2016). The relationship between perfectionism and psychopathology: A meta-

analysis. Journal of Clinical Psychology, 73(10), 1301–1326. 8. Hill, A. P. & Curran, T. (2015). Multidimensional perfectionism and burnout: A meta-analysis. Personality and Social Psychology Review, 20(3), 269–288. 9. Smith, M. M., Sherry, S. B., Rnic, K., Saklofske, D. H., Enns, M., & Gralnick, T. (2016). Are perfectionism dimensions vulnerability factors for depressive symptoms after controlling for neuroticism? A meta-analysis of 10 longitudinal studies. European Journal of Personality, 30(2), 201–212. 10. Vincent, N. K., & Walker, J. R. (2000). Perfectionism and chronic insomnia. Journal of Psychosomatic Research, 49(5), 349–354. 11. Luyten, P., Van Houdenhove, B., Cosyns, N., Van den Broeck, A. (2006). Are patients with chronic fatigue syndrome perfectionistic–or were they? A case-control study. Personality and Individual Differences, 40(7), 1473–1483. 12. Fry, P. S., & Debats, D. L. (2009). Perfectionism and the five-factor personality traits as predictors of morality in older adults. Journal of Health Psychology, 14(4), 513–524. 13. Hill, A. P., Hall, H. K., Duda, J. L., & Appleton, P. R. (2011). The cognitive, affective and behavioural responses of self-oriented perfectionists following successive failure on a muscular endurance task. International Journal of Sport and Exercise Psychology, 9(2), 189–207.

Government Gazette | 73

Breast cancer

Recommendations to reshape policy making


Identifying critical steps towards improved treatment of breast cancer

event round-up: breast cancer europe 2017 Specialised healthcare policy institutions present their fast-track strategy to provide high-quality care for breast cancer patients across Europe charity voice Susan Knox from Europa Donna says it’s time we committed toward high quality breast services ensuring quality Peter Naredi from ECCO argues about the need for better tools to ensure high quality care managing elderly with breast cancer Prof. Hans Wildiers, President-elect, International Society of Geriatric Oncology writes about a different approach for treating elderly patients metastatic disease Prof. Dr. Markus Kosch from Pfizer calls for more collaboration to meet the needs of metastatic patients evaluation Dr.Marjolaine Baldo from Agendia says genomic tests for breast cancer recurrence calls for an updated evaluation approach in Europe best practice Case study: Dr. Suzanna ManxhukaKerliu puts Kosovo in focus

personalised treatment Joanne Lager from Sanofi writes about the need for more personalised and effective treatments ensuring quality in care Asli Uluturk Tekin from ECIBC writes about the Commission’s upcoming plans to ensure high-quality care


Uniting against Breast cancer

breast cancer europe


Policymakers unite to develop a manifesto for consistent and superior breast cancer care Although breast cancer receives large amounts of media coverage, it remains a major burden for European healthcare. Canvassing for change, the International Centre for Parliamentary Studies recently brought together policymakers and healthcare stakeholders to debate unsolved clinical and policy challenges in managing and treating breast cancer in Europe. Diane Rolland, International Programme Manager from ICPS highlights the major recommendations tabled at the roundtable


reast cancer is the most common cancer in European women, with 1 in 8 developing breast cancer before the age of 85. It has the highest mortality of any cancer in women worldwide, claiming the lives of more European women than any other cancer. Causes include an increased sedentary lifestyle, weight gain, and reproductive and sociological changes. Continued investment in research and innovation is essential for improving diagnostic accuracy and developing novel therapeutic approaches. The EU must raise greater awareness of breast cancer through educating, highlighting the risk factors and symptoms and promoting healthier lifestyles as a preventive measure. With this in mind, the | 76

International Centre for Parliamentary Studies recently brought together EU policymakers, medical and clinical professionals, academic experts and patient groups to examine the ongoing challenges in managing breast cancer more effectively and explore practical solutions in order to reach an EU-wide consensus and implement a forward action plan. Chaired by John Bowis OBE, Former Member ofEuropean Parliament and Minister of Health (United Kingdom), the Breast Cancer Europe 2017 kicked off with a series of policy updates from representatives from the European Society of Breast Cancer Specialists (EUSOMA) and the European Commission Initiative on Breast Cancer (ECIBC). In addition to the presentation

of their latest guidelines and recommendations on the diagnosis and treatment of breast disease, EUSOMA reiterated their commitment to develop and implement Breast Centres in Europe, promoting increased contacts between scientists and healthcare professionals involved in breast cancer care. Lastly, a debate was pursued on screening programmes and the question of their limits and actual value was raised. To conclude, here are the recommendations which were presented by the clinicians, pathologists, researchers and patient group representatives present at the roundtable: - More investment should be made in biomarking and blood sampling and large-scale campaigning; - We should support the use

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of personalised biomarkers and liquid biopsies to monitor treatment response and disease recurrence;

as a routine part of their care. The approach must be personalised to meet the requirements of the patient;

- There is a need for the creation of EU guidelines for screening - Specialised oncology by age groups populations; nurses should be part of multidisciplinary teams; - Breast cancer centres for excellence should be more - The importance of developed and their access Continuing Medical should be permitted to all; Education (CME) and Continuing Professional - We need to develop crossDevelopment (CPD) border care and harmonisation should always be of treatment standards in the reiterated; EU. Actions on a European scale could improve national - We should always seek strategies against cancer in each improvement in the of the member states; quality of specialists’ care throughout the European - The Commission needs to Union; address and advocate more in favour of more research and - The ESMO (European Society funding for advanced metastatic for Medical Oncology) Clinical cancer which is currently Practice Guidelines on Breast overshadowed by non-metastatic Cancer should be continually and not enough represented; developed and maintained via the continuous inclusion of new - Chemotherapy is over-used clinics’ data. whereas its side effects and costs are too high; Participants: - Early and broad access to innovation in terms of treatments for patients should be one of the main priorities;

Agendia, Commercial VP EMEA, Albania American Hospital, Medical Oncologist, Antwerp University Hospital, Medical coordinator - It is essential that patient Gynecologic Oncology and choice remains at the centre of Senology, Antwerp University treatment; Hospital, Senior Oncologist, CHUV – Lausanne, Breast - Patients should always be offered appropriate psychosocial Surgeon, CCO - European Coalition of Cancer care, supportive care and symptom-related interventions Organisations, EU Policy

Affairs Manager, European Commission Initiative on Breast Cancer (ECIBC), Member, Public Health Policy Support Unit, European Parliament, Parliamentary Assistant to Dame Glenis Willmott MEP, European Society of Breast Cancer Specialists – EUSOMA, Past President, National Cancer Institute, Chief SIS Certified Breast Center of Excellence - President of Lithuanian Senological Society, North Estonia Medical Centre, Head of the Oncology Clinic, Pauls Stradins Clinical University Hospital, Head of the Breast Unit, Pfizer, VP Oncology Int Developed Markets, Sanofi Genzyme, European Head of Medical Affairs for Oncology, Haematology and Solid Organ Transplantation, University of Prishtina, Dean of the Faculty of Medicine.

Government Gazette | 77


Uniting against Breast cancer

Susan KNOX

CEO, EUROPA DONNA - The European Breast Cancer Coalition

It’s time we committed toward high quality breast services they are accessing high quality services for both diagnosis and treatment. Furthermore women with metastatic breast cancer have not been able to gain access to care in specialist breast units in most countries, even though this is required by the current EU guidelines. Europa Donna has worked for many years at the EU level to bring about improved services in all countries.


here are currently 361,608 new cases of breast cancer in the EU each year and 91,585 deaths occurring each year from this disease in the EU. High quality early detection, followed by treatment in a Specialist Breast Unit, is still the best way to ensure living a full life after breast cancer. Not providing these services results in higher costs for expensive and extensive treatment and loss of life for many women at a time in their lives when they could be caring for families and be employed. As Europe’s breast cancer advocacy organisation, Europa Donna (ED) seeks to ensure that all the women of Europe have information about, and access to, early detection through mammography screening programmes set up in accordance with the EU guidelines for quality assurance in breast cancer screening and | 78

diagnosis and access to care and treatment in Specialist Breast Units as defined in those EU guidelines. Our efforts over the last 20 years have been dedicated to making women aware of the services they should have the right to receive through consistent education, information and policy programmes. While much has been achieved over the years, many inequalities still exist between countries and even in different regions of countries in the EU. Our advocacy training programmes and the translation of ED’s Short Guide to the EU Guidelines have enabled many more women to be aware of what quality services should be provided and have given them the tools to advocate for these services in their countries. Of great concern today is that there is still no certification, no EU-wide quality assurance programme that enables women to be sure

Europa Donna’s advocacy work began in the late 1990s and led to the first European Parliament Resolution on Breast Cancer (2003), which was also the first disease-specific Resolution to be passed by the European Parliament. In synthesis, this EU Resolutioncalled for the EU member states to introduce nationwide mammography screening programmes run according to the EU guidelines; all women with breast cancer to be treated by a multidisciplinary team, in a certified Specialist Breast Centre (SBU); for national cancer plans; and for improved data collection and national cancer registries. It was followed up by a further EU Resolution, in 2006, which added a deadline of 2016 for the provision of multidisciplinary SBUs and for a certification protocol for those units; EU guidelines on the profession of breast nurse; research into breast cancer prevention and biomarker tests; and the protection of workplace and employment.

EU Written Declarations, passed in 2010 and 2015, reiterated the items called for in the EU Resolutions and emphasised the importance of treating those with metastatic breast cancer in an SBU, and their psychological care. In terms of the certification protocol called for in the 2006 EU Resolution, for which Europa Donna advocated for many years, the European Commission has now started the European Commission Initiative on Breast Cancer(ECIBC). The ECIBC, which is coordinated by the EC’s Joint Research Centre (JRC), and for which two expert workgroups have been convened, will produce a new version of the EU guidelines, which will now be continuously updated, along with a quality assurance scheme for breast cancer services, underpinned by accreditation. This is positive, but it is essential that the health systems of all EU countries agree to implement the new EU guidelines and provide these essential services to all women in their countries. The ECIBC will be completing its work over the next few years. Now is the time for all countries to make the commitment to high quality breast services. The article is co-authored by Karen Benn, ED’s Deputy CEO. Susan Knox, ED’s CEO, serves on the expert workgroup developing the new EU guidelines, and Karen Benn serves on the expert workgroup developing the QA scheme. EUROPA DONNA is an independent, non-profit organisation whose members are affiliated groups from countries throughout Europe.

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Past-President, European CanCer Organisation

We need tools to ensure high quality care across Europe


ow can a breast cancer patient in Slovenia, Spain or Switzerland know if they are receiving high quality care? How can a health system manager in Iceland, Ireland or Italy recognise whether or not the improvements they plan to breast cancer care will take them to the destination of high quality care? How can a politician in Latvia, Lithuania or Luxembourg, seeking to scrutinise health system performance, know how their region or country is performing in respect to quality of breast cancer care, or what alternative modernisations to propose? In all of these cases, what is required are some simple tools. Like building a piece of flatpack furniture purchased from a large chain store associated with my country, achieving quality cancer care requires both a picture of what quality cancer care should look like and a list of the components that should be present. It is exactly to meet these needs, and be that helpful friend to health system designers, that the European CanCer Organisation (ECCO) has embarked on an ambitious and long-term project with its 25 member organisations. ECCO is creating a suite of expert-written documents for each major tumour type, which describe checklists and explanations of organisation and actions that are necessary to achieve high quality cancer care.

Entitled ‘Essential Requirements for Quality Cancer Care’ (ERQCC), the first two projects are complete for colorectal cancer and sarcoma, and nearing completion at the time of writing for melanoma and oesophageal & gastric cancer. In 2018 we will provide major organisational focus on expanding and articulating the meaning of quality care for patients with breast cancer. It is gratifying, too, that as our Essential Requirements documents gain traction and awareness, the desire for others to come onboardand be part of what we are doing grows. ECCO, as much as anyone, seeks to avoid reinventing wheels or conducting knowing duplication. Synergy and partnership with others interested in achieving the same goals is always preferable in all walks of life. It increases the chance of success. Indeed, it was with this philosophy much inmind that ECCO came into existence. Bringing professions and disciplines together in common cause, the cause being improving outcomes for cancer patients. So it was without hesitation that ECCO embraced a suggestion of special partnership with the European Society of Breast Cancer Specialists (EUSOMA) for the creation of Essential Requirements for Quality Cancer Care for Breast Cancer. As those following the quality

debate in breast cancer will be familiar, EUSOMA have for many years undertaken excellent work in providingboth panEuropean definition to what constitutes a true specialist breast cancer centre, as well as conducting accreditation activity based on that. I was therefore delighted when a proposal emerged for our organisations to work in special collaboration in 2018 to update together EUSOMA’s quality framework, as well as lead together in the creation of a broader Essential Requirements for Quality Cancer Care for Breast Cancer. The Essential Requirements for Quality Cancer Care for Breast Cancer will set out a consensus on such crucial matters as: - the components of the care pathway, including maximum waiting times; - the definition and scope of a specialist breast cancer centre;

use for, such a pan-European consensus document, and I look forward to its publication at the ECCO 2018 European Cancer Summit on September 7–9, 2018 in Vienna. Peter Naredi is the president of the European CanCer Organisation (ECCO), and a former president of the European Society of Surgical Oncology (ESSO). Peter is also a professor of surgery and has been head of the Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg since 2012. ECCO is a collaboration of 25 member societies, representing over 170,000 healthcare professionals involved in providing care to cancer patients. More information about the Essential Requirements for Quality Cancer Care (ERQCC) is available here: Quality-Cancer-Care

- membership of both the core multidisciplinary team and the expanded multidisciplinary team, including roledefinitions; - patient involvement in their care decisions, and the information they should always be provided with; and - critical elements of follow-up and survivorship need. I believe that all of us interested in ensuring that every breast cancer patient receives the highest quality care, will welcome, and find important Government Gazette | 79


Uniting against Breast cancer


President-elect, International Society of Geriatric Oncology (SIOG)

Breast cancer in the elderly should it be treated differently?


reast cancer is a disease of older people.Older people represent the majority of the breast cancer population; they are not a minority or niche population. Unfortunately, research and drug development focuses on younger, ‘besides the cancer healthy’ patients. Frail older persons are rarely included in clinical trials and it is very questionable if study results obtained in younger populations can be extrapolated to older frail populations. Treatment efficacy probably doesn’t differ so much between young and old, but treatment side effects may be more problematic in older individuals who generally have less physical reserves to cope with treatment side effects (eg, dehydration due to diarrhoea). Many new anticancer therapies provide rather small absolute benefits (in terms of few months’ longer disease control) at the cost of increased toxicity. If toxicity becomes a more important issue in older people, it can become questionable if the few months’ benefit is worthwhile. This highlights the need to study treatments and new drugs specifically in older populations. Older people don’t need identical therapies compared to younger people: for instance, the absolute benefit of preventive chemotherapy and radiotherapy decreases with age, and frail older persons do not tolerate standard (rather toxic) preventive chemotherapy | 80

and last but not least, it allows for intervention with the discovered health problems (for instance, unknown nutritional problems can be dealt with, leading to better general health status, treatment tolerance and survival).

regimens. Older persons also have ‘competing risks of death’; at high age, there is a reasonable chance that a person dies from another cause than their breast cancer. You don’t want to give preventive (sometimes toxic and costly) treatments if that person would die a few years later from another age-related disease (eg, stroke). If older people were treated the same way as younger people, there would be a huge ‘overtreatment’, ie, useless therapy that does not improve outcome but generates toxicity, quality of life decline and costs. On the other hand, omitting therapies systematically in older women with breast cancer clearly leads to higher breast cancer relapse, and breast cancer mortality. We also need to avoid ‘undertreatment’ because this also associates with psychological burden, quality of life decline and costs.

The best way to avoid both overand undertreatment is to have an in-depth evaluation of general health status in all older cancer patients before starting therapy. This can be done by a ‘geriatric assessment’, a tool developed by geriatricians evaluating the most important health care domains in older persons: functionality, cognition, depression, nutrition, social status, comorbidities, polypharmacy. Performing a geriatric assessment in the older cancer population has been shown to have major benefits: it detects age related health problems that were previously unknown to the treating physician in more than 50 percent of patients; it predicts treatment tolerance and chemotherapy side effects (allowing upfront treatment adaptation); it gives information on life expectancy (which is important to take into account when the benefit of a specific therapy needs to be estimated);

Unfortunately, performance of geriatric assessment takes time, and is not reimbursed by most European healthcare systems, the reason why it is often not performed in busy oncology practices. The European Union and its countries should invest ‘a little’ in reimbursement of geriatric assessment; it can be performed by a nurse or trained healthcare worker in 20-30 minutes, and its cost price is many times lower than the monthly cost price of most newly registered cancer drugs. Geriatric assessment can avoid overtreatment and undertreatment, and as such save money, rather than adding costs to society. SIOG, the International Society of Geriatric Oncology, has been created to improve the care of older cancer patients and to streamline and promote international collaboration. Its main activities focus on the political level (mainly European, but also US), and educational level (for instance, development of guidelines for specific cancer topics by a team of international experts; yearly congress with over 400 participants). I have the honour of being the next president for SIOG from 2018 till 2020.

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Prof Dr Markus KOSCH Vice President Oncology Portfolio, Europe, Japan, Korea, Australia & New Zealand, Pfizer

Collaborating to meet the needs of metastatic breast cancer patients


n the last decade, there has been progress in detection, treatment and outcomes for patients with early breast cancer, and great efforts continue to increase public awareness about breast cancer and its risk factors. But patients with advanced or metastatic breast cancer (mBC) have often been left in the shadows.This article explores the need for appropriate data, better policy responses and collaborative development of resources for patients, to address unmet needs and improve quality of life. mBC currently has no cure. It is a major global health issue responsible for over half a million deaths worldwide each year, and over 90,000 in Europe. What’s more, public understanding about mBC is low, resulting in patients experiencing unnecessary isolation. Across four European countries (France, Germany, Poland and the UK), around half of people think that mBC is curable. And surprisingly, a substantial minority (between a fifth and a third) believe that mBC patients should not talk about their condition with anyone other than their physician. These results come from the Global Status of Advanced/ Metastatic Breast Cancer 2005-2015 Decade Report. The European School of Oncology (ESO) worked with Pfizer, Inc., to develop this comprehensive analysis of the mBC landscape, shed light on the challenges

faced by mBC patients and the gaps in their care, and highlight the urgent need for change within the global breast cancer community.For more information, please visit http:// These challenges are reflected in the lack of attention given to mBC in National Cancer ControlPlans (NCCPs). An analysis conducted for the Global Decade Report found that across 29 NCCPs reviewed in detail, only the UK referred to mBC specifically. At the EU level, July 2015 saw the first specific political reference to mBC, in the European Parliament’s written declaration on fighting breast cancer in the EU (driven by patient organisation Europa Donna). The written declaration also highlighted the important role for specialist breast units in meeting patient needs, as previously discussed in the Government Gazette by Dr Fatima Cardoso and colleagues. Amid all the challenges faced by mBC patients, there is also one basic question that remains unanswered, and which is crucial to developing better policy: how many patients are living with mBC? Globally, 20-30% of early breast cancer patients will go on to develop mBC, but we have no reliable prevalence statistics for mBC, globally or even at a national level. Without access to accurate numbers, policymakers cannot make informed policy decisions and prioritise resources where they are needed most.

This could be addressed if policymakers chose to include mBC in NCCPS and in related cancer patient registries. At Pfizer, we seek to play our part through collaboration to help meet the needs of patients as highlighted in the Global Decade Report, in policy and in everyday life. Working closely with stakeholder organisations, Pfizer has sought to help raise mBC on the EU political agenda through a series of policy breakfasts (see #betterpolicybreakfast) and a workshop organised in collaboration with Irish MEP Deirdre Clune in November 2016 (see #betterpolicyworkshop). Participants highlighted a better understanding of the role of mBC patients in the workplace, and better information for carers of mBC patients, as particular areas for action. Indeed, carers play a crucial role in supporting mBC patients, and any action that can help support carers of mBC patients will also help to support the quality of life of mBC patients themselves.

their loved ones. Through initiatives like these, alongside the dedicated work of researchers, healthcare professionals and patients themselves, momentum is building. To harness this, and drive forward a collective approach, in November 2016, ESO established the ABC Global Alliance – a multistakeholder platform for all of those interested in collaborating on common projects relating to advanced breast cancer. The Alliance will develop the ABC Global Charter. Pfizer looks forward to the charter being made available at the Advanced Breast Cancer Fourth ESOESMO International Consensus Conference (ABC 4) in November. While I am humbled by the experiences of the mBC patients that I meet, I am proud to be part of Pfizer Oncology. We won’t rest until mBC care is transformed for the hundreds of thousands of women around the world who face its challenges every day.

Pfizer also partnered with advocacy organisations to cocreate practical resources that can address patient needs. These include a toolkit to help improve doctor–patient communications, the Me&MBC handbook with wide-ranging information for patients, and the EmotionSpace app that can help patients track their emotions, discuss these with their healthcare professionals and connect with Government Gazette | 81


Uniting against Breast cancer

Dr Marjolaine BALDO

EMEA, Commercial Vice President, Agendia

Genomic tests for breast cancer recurrence needs an updated evaluation approach across Europe


he past 15 years have seen a revolution in our understanding of the human genome, enabling the development of gene-expression tests that assess the biology of the tumour at a molecular level. Traditional factors such as age, tumour size, hormone-receptor status and lymph node involvement are important indicators but can have limitations in predicting the risk of distant metastasis (cancer recurrence). Adding information based on the ‘molecularbiology’ of a tumour enables physicians to tailor treatments and better identify patients with good prognosis who may safely forgo chemotherapy or reduce endocrine therapy. Breast cancer is the most common cancer in women, affecting one in eight during their lifetime. Distant metastases account for the majority of breast cancer deaths and are a significant threat to patient survival. Chemotherapy can be used to reduce the risk of the cancer recurring; however, some patients are already at a low risk of recurrence and are therefore unlikely to see a significant benefit from chemotherapy. Hormone therapy is also another way to reduce distant metastasis; however, 50 percent of women stop treatment within five years due to the side effects. At Agendia, we have developed the MammaPrint geneexpression test to identify women who either have a high | 82

or a low genomic risk of their cancer recurring, by assessing the activity of the 70-genes most associated with breast cancer recurrence. Is a ‘traditional’ evaluation process appropriate for geneexpression tests? Across Europe there are multiple evaluation processes in place. Stakeholders such as policymakers or physicians also have their own, additional criteria for assessment. What is often missing but, in my view, even more important is deciding the quality of the evidence required to confirm clinical effectiveness, and the long-term value, as opposed

to up-front price, to define cost-effectiveness. Evaluation processes are rarely tailored to complex gene-expression tests like MammaPrint and are often the same as those used for drugs or more traditional diagnostics. As a result, valuable information such as key evidence from clinical trials, or the long-term benefit of reducing expensive, unnecessary treatment through more accurate prognosis, can be missed. Evaluating clinical evidence: Consensus is needed The existence of different European reimbursement agencies and the lack of agreement on the framework

of evidence required to assess gene expression tests means that different committees could potentially review the same clinical data set, but draw different conclusions due to the lack of consensus on the parameters for evaluation. This can result in unpredictable reimbursement processes, decisions and inequalities in how breast cancer patients in Europe access diagnostic tests, depending on their geographical location. For MammaPrint, clinical utility was proved with the highest level of evidence based on the MINDACT trial. MINDACT was designed by leading breast cancer experts across Europe and led by the European Organisation for the Research and Treatment of Cancer (EORTC). The outcome of MINDACT led to MammaPrint’s recommendation in multiple international clinical practice guidelines for breast cancer including the St. Gallen Breast Cancer Consensus and American Society for Clinical Oncology (ASCO). Despite this, it is still challenging for women to access the test. Reimbursement assessment agencies require independent experts to evaluate clinical utility and cost-effectiveness data to avoid conflicts of interest that could influence their assessment. However, these experts are often selected from a different field of expertise than that being assessed. This can cause the assessment to be disconnected

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case study

from clinical practice and the need to establish equal access to a test. Evaluating cost-effectiveness: Transitioning from up-front cost to long-term value Unlike pharmaceuticals, diagnostics are generally assessed on the cost to the healthcare system rather than the additional value they create. This can be problematic for gene-expression tests as their relative complexity means that they are more expensive than traditional diagnostics. In reality, however, the longerterm savings in omitting unnecessary treatment are often far greater than the original cost to the healthcare system. Aless expensive diagnostic with a lower level of evidence may therefore be recommended over another with a higher level of clinical evidence, purely due to the price. Next-generation diagnostics benefit payers, physicians and patients Gene-expression tests benefit not only patients with breast cancer but payers too. Determining whether an expensive treatment is likely to be effective for a patient allows for selective de-escalation with significant implications when applied across an entire population. The MINDACTtrial found that MammaPrint reclassified 46 percent of women with a high-clinical-risk as genomiclow-risk of distant metastasis and therefore unlikely to benefit from chemotherapy. Seen on a national or European scale, there is a clear cost and quality-of-life saving if chemotherapy usage can be reduced by almost 50 percent. Providing physicians with proven tools to make better informed treatment decisions and protecting patients from the rigors of therapies that may not benefit them can only be a good thing. However, the current assessment methods must be revised to enable the clinical and cost-effectiveness benefit to be evaluated in an appropriate and consistent way.


Dean, faculty of Medicine, University of Pristina

Kosovo’s successful fight against breast cancer


iven that the new cancer resolution was recently passed at the 70th World Health Assembly (WHA) in Geneva, we are determined to effectively translate this significant achievement into concrete national actions. In this regard, Kosovo has already made inroads by contributing to the World Cancer Declaration Report in 2016. We have explored numerous innovative approaches to tackle the psychological and emotional burden that cancer survivors face and ultimately improve healthcare outcomes. One particular approach that has proven successful for our community is the incorporation of creative arts to transform the cancer care into a holistic one. This project was initially piloted with a group of Kosovar artists with the idea of leveraging the power of the arts to enhance the psychological and emotional state of cancer survivors and impact the physiological state. This programme showed that creative arts not only brought breast cancer (BC) patients together but also promoted intra patient creativity and self-confidence, consequently changing behaviour and thinking patterns positively. In addition, our country has made progress towards achieving World Cancer Declaration (WCD) Targets, by taking a number of steps including: 1. Establishment of cancer registry training sessions to build skills at national level with coverage of topics on improving surveillance systems, cancer

reporting and data entry. 2. Promotion of equal access to cancer control measures through a cervical screening programme in the municipality of Pristina. 3. Promotion of educational activities to improve professional and public understanding of cancer. Another important milestone for our nation’s effort against cancer has been the drafting of the National Programme for Cancer Control for the period of 2014-2020 by the Kosovo National Board for Cancer Control, which has prioritised the improvement of cancer registry, cancer screening programmes, early detection and continuing medical education. Furthermore, since 2014 we have established a mobile mammography project, which aims to encourage women’s mammographic examination and raise BC awareness. Given the limited mammographic services for a prolonged time in Kosovo (pre-war, post-war period), this project has proven invaluable in intensifying screening efforts and closing the gap in care. This project was also implemented in municipalities inhabited by Serb and Bosniak communities and in 2016 was expanded to also include women from RAE (Roma, Ashkali and Egyptian ) communities Through this project a total of 44 new BC cases (1.1 percent) were identified. In 2016 alone, there were 296 new cases of BC out of 1,196 new cancer cases in general. Unfortunately, despite an increasing rate of early stage

diagnosis, in Kosovo, there is still an ongoing trend of new BC cases being diagnosed at late stage of disease. Consequently, we are aiming to accelerate the activities aimed at early detection and prevention. During the past year, Kosovo was represented at the World Cancer Leaders’ Summit 2016 and the World Cancer Congress 2016 held in Paris as well as at the Breast Cancer Europe Roundtable 2016 and 2017, organised by the International Centre for Parliamentary Studies in Brussels. The latter meeting involved an interdisciplinary discussion where there was an opportunity to share different points of view from experts representing the EU countries as well as developing countries with regard to optimal BC management. One clear consensus arising from this meeting was the need for establishment of European guidelines for quality assurance in BC screening and diagnosis. These national strides attest to Kosovo’s dedication to developing programmes that not only support current international efforts against cancer but also transform the country into a leader. BC surpasses all borders and therefore requires united international efforts, which can be achieved only if developing countries equally partake and lead in the process. We challenge others to see that no action and no country is too small to make a difference in the fight against cancer.

Government Gazette | 83


Uniting against Breast cancer

Joanne LAGER

Head of Oncology Development, Sanofi

Towards more personalised and effective treatment of breast cancer


atients with metastatic breast cancer (mBC) in Europe have seen limited gains in overall survival in recent years. Most patients receive treatment with standard hormonal therapies and chemotherapies, and have seen limited benefit from the few novel therapies that have emerged. At the recent Breast Cancer Europe Roundtable, hosted by the International Centre for Parliamentary Studies, we welcomed the recognition of patient selection biomarkers as important for personalisation of care for patients with mBC through better treatment selection. The discovery of new biomarkers offers real opportunities for improving the treatment outcomes for patients, and should be supported by broad collaborations and research partnerships. Biomarkers – biologic markers that can help oncologists match a patient to the right targeted therapy – present a new opportunity to deliver effective, personalised treatment to cancer patients. By identifying these markers, researchers can identify key drivers of cancer, improving health outcomes and forging a new path to improved overall survival. Advancements in the study of the estrogen receptor (ER), for example, are now at the forefront of understanding the treatment of mBC. The ER pathway is an important driver in many cases of breast cancer; three-quarters of all breast cancer tumours are driven by | 84

and avoid or minimise the toxicity seen with standard chemotherapies. Following the approval of the first ADCs, several new molecules are in development for mBC and a new generation of ADCs is on the horizon. With recent advances there is hope that the science is now rapidly advancing towards better outcomes for women with mBC.

high estrogen expression. While treatments exist to reduce levels of estrogen, at least half of these patients do not respond to current endocrine (hormone) therapies, leaving these patients with drug-resistant tumours and few therapeutic options. Recent research has shown that two immune system molecules (IL1 and TNF) and the development of mutations in the estrogen receptor may be important mechanisms of drug resistance in estrogen-driven breast cancers.

Sanofi of a selective estrogen receptor down-regulator (SERD) that may target and maintain long term inhibition of ER, and that we hope could lead to better outcomes for patients. By advancing diagnostics for patients together, including the identification of promising biomarkers to predict which patients will benefit from new treatments, and developing new targeted treatments, we may achieve progress in treatment for metastatic breast cancer.

By understanding how these changes maintain the estrogen signalling pathways, there is potential for future treatments to more effectively reduce estrogen signalling and the metastases of cancer. The discovery of these biomarkers has been supported by new techniques in quantifying ER expression. Work is now ongoing to develop new compounds based on these insights, including the development by

Another finding of the roundtable was that, despite advances in treatment, chemotherapy still remains an important first-line approach for breast cancer. Antibody–drug conjugates (ADCs) make use of antibodies to specific proteins which are on the surface of cancer cells to deliver very potent chemotherapy leading to destruction of the cancer cells. This selective approach may increase the effectiveness

Underpinning these advances in the science of anti-cancer treatment are research partnerships and collaborations that have developed across Europe and globally. The Innovative Medicines Initiative (IMI), Europe’s largest public– private initiative, provides one very important example of the power of collaboration to speed the development of healthcare innovation for patients. For Sanofi, as we continue to advance our own research in oncology, we strongly support external partnerships that bring together diverse assets, skills and expertise with a common goal of finding better treatments for patients. So in summary, let me be clear: the standard of care for mBC is going to improve – it’s just a question of how rapidly. At Sanofi, we believe that progress in effectively treating breast cancer is going to accelerate through the efforts of public and private partners, and we are grateful for the invaluable support of European policymakers who are helping to make this happen.

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Member, Public Health Policy Support Unit, European Commission Initiative on Breast Cancer

ECIBC strives to ensure high-quality care


reast cancer is a heavy burden over Europe. Each country deals with this burden with different approaches. This may be among the causes of the significant diversity in incidence, prevalence, mortality and survival across countries. Europe has many valid quality assurance schemes for breast cancer care to ensure high quality of care. But it lacks a harmonised person-centred approach. The European Commission Initiative on Breast Cancer (ECIBC) is currently halfway in developing the European Quality Assurance scheme for Breast Cancer Services (BCS) (European QA scheme), which will harmonise the quality of the entire care pathway among European countries from the point of view of women and patients. The scheme will be supported by the evidence-based recommendations from the European guidelines for breast cancer screening and diagnosis within the Initiative and by the trustworthy guidelines collected in the Guidelines Platform for other processes of care than screening and diagnosis.

ECIBC strives to develop high quality recommendations and requirements for breast cancer screening and care, involving nearly 70 experts from physicians to patients, quality managers and methodologists. It will empower European women by assuring quality in line with the latest available evidence. But this ambitious goal can only be achieved through its Europewide implementation. To ensure that the scheme is implemented, ECIBC takes a transparent and inclusive approach. It consults countries to obtain information on how breast cancer care is organised then produces implementable outputs adaptable to the varying local contexts and, finally, ensures inclusion of stakeholders’ feedback on those outputs. It strives for the scheme to be actually implemented, by involving and constantly collaborating with countries, the public and professionals, to improve awareness and facilitate the uptake of the initiative. ECIBC implementation will produce an impact whose measurement is being planned (key indicators are being selected along meaningfulness and availability at country level). The agenda of the ECIBC Plenary 2016 was very focused on implementation. Countries were asked to discuss the potential benefits and barriers for the implementation in

respect to their own healthcare settings of the European QA scheme and the first four screening recommendations of the European Breast Guidelines published in the very same meeting. Most countries considered the recommendations as a guiding tool and they did not see barriers to implementing the ECIBC recommendations; the barriers detected were generally about the recommendation for the 45-49 age range and the recommendation itself was perceived as a useful basis for dialogue with policymakers during the discussions to overcome the barriers against it. In 2019, before its final launch, the European QA scheme will be piloted by a maximum of 15 BCS reflecting the variety among services and countries. This piloting phase will allow the testing of the scheme for its robustness across diverse situations, contexts and settings. The variety of national and local contexts has fostered flexible means of interaction such as opening invitations to express interest for QA scheme piloting and for receiving proposals for dialogue and engagement. This invitation is open as from autumn 2017 and aims at facilitating the upcoming call for piloting and the implementation phase of the European QA scheme and European Breast Guidelines. ECIBC will meet stakeholders and BCSs which express their interest to raise the

countries’ preparedness, address their concerns and reinforce (or establish) relations with facilitators. It will help including ECIBC in the health agendas and also prompt the interest of BCSs to provide data to assess the European QA scheme via the piloting. To grant access to the most updated information ECIBC provides a personalised communication interface: the ECIBC web hub. This web hub hosts the documents prepared within the initiative, the description of all meetings, the recommendations of the European Breast Guidelines and the requirements of the European QA scheme. Via the different modules for different user profiles, the individuals, professionals and policymakers can reach the outputs of the initiative in a language targeted to them. The recommendations and the requirements of the European QA scheme are categorised and prioritised according to the needs and interests of each user profile. This targeted presentation of the information allows informed choices. The web hub will transparently and in a timely manner map the BCSs certified along the European QA scheme requirements, with respective performance levels, thus helping women and patients to see where they can be guaranteed the latest evidence-base screening and care. Government Gazette | 85


reasons why Brussels must be on your foodie list In our new interview series with the best food bloggers from Brussels and Luxembourg, Maxine, the South African self-proclaimed foodie living in Brussels, reveals her culinary adventures and tells us what not to miss in the European policy capital


lthough there are many foodie experiences to savour in Brussels, what spots do you absolutely recommend?

Belgian meatballs at Ballekes in St Gilles, Italian pasta and wine at La Piola at Place du Châtelain in Ixelles, Portuguese pastries known as pastéis de nata at Forcado in St Gilles and finally, fish and chips at Bia Mara near the Bourse. Brussels is known for its Belgian treats, but what would most visitors be surprised to know about its culinary scene? That the area of Belgium & Luxembourg has 144 Michelin starred restaurants! And that some of the Friterie (or Frituur) shops in Brussels use beef fat to get their fries so tasty and crispy! Classic bistro or urban eatery? Classic bistro with its relaxed and comfortable surroundings. Check out La Bugatti in Ixelles serving up traditional Belgian cuisine.

Choose a Belgian food event: Tram Experience or Dinner in the Sky? I have had the pleasure to experience both, so it is very difficult to choose. But if I truly had to pick one, it would have to be Dinner in the Sky. It may seem quite pricey, but in all honesty, it is worth every cent for enjoying a five-course meal with wines while suspended 150 feet at Parc Cinquantenaire – magnificent views across the city. Choose a Belgian market: Place du Grand Sablon or Gare du Midi? Place du Grand Sablon... but only because COCO Donuts is there! Wine taste-off: French wine or Italian wine? Italian wine! I met my husband at an Italian restaurant so I have to confess that I am somewhat biased about this. Belgian chocolate or waffles? Definitely chocolates – with so many chocolatiers to choose from, you are guaranteed to find a favourite. (My current go-to is a little boutique called La Maison du Cacao in Uccle.)

About Why I am Not Skinny blog: Maxine is a South African (self proclaimed “foodie”) living in Brussels. A full time working mom who documents her love of eating and drinking through reviews, recipes and interesting food experiences on her personal food blog. She shares her culinary adventures with her Portuguese husband and their 2 year old daughter.

Emma McClarkin MEP is the Co-treasuser of European Parliament’s Conservatives and Reformists Group

Travel with... Emma McClarkin


hether I am travelling to my East Midlands constituency, or on business trips related to my role as the coordinator for the International Trade Committee, I can more often than not be found in transit. In


travelling. When it comes to packing, I am very British and always make sure that I have tea bags on hand. A new foodie addition to my suitcase is a bottle of Tabasco sauce to help spice up my breakfast! I always keep emergency toothpaste in my case – got to protect the smile! Another essential is a pair of earplugs, as they make it much easier to rest on planes, trains and in different hotel rooms.

experience of travelling so frequently, I’ve picked up some useful tips and tricks to make sure that my business trips go as smoothly as possible. Before travelling, it is so important to charge up all your devices and take back-up battery chargers (as well as making sure that your back-ups are charged too!). After all, there is nothing more frustrating than running out of power when you are | 90

Apps are very useful for ensuring that travel goes smoothly. Some of my most frequently used apps are Google Maps, Uber, Trivago and of course TripAdvisor. However, my favourite is Vivino, which I use to record the beautiful wines that I find on my travels. If I have more time before a trip, I tend to research foodie blogs to find hidden gems that I can explore on my travels. When I arrive at my destination I always make sure to keep a

spare dress and a pair of heels in the office, as you never know when a last-minute invitation will arrive. It is so easy to stay put in your hotel when travelling on business, but I do always try to see or taste something from the places I visit so that along with business, I will have a memory of the country I’m in. This also helps build relationships with the counterparts I am visiting and gives a taste of cultures that I may otherwise not experience. It is inevitable that sometimes

even the best organised plans can go wrong, but if you’re prepared, even situations that seem disastrous can be handled. Always remember that you are never too far from home, and can always get back if need be. Family comes first, and people will understand if you need to drop everything for your family. Most work dramas can be dealt with easily, since the world is 24/7 and so interconnected. With Wi-Fi even on aeroplanes, you can be in communication at any given time. Make sure to use time-zone differences to your advantage

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Watch this space for more travel tips and tricks from your fellow parliamentarians in Brussels! If you want to be featured in this space, write to us at janani.krishnaswamy@

when resolving a work-related crisis on the move. You can also buy any items you might have forgotten anywhere now, so there is no point in stressing about a lost suitcase. We live in difficult times, and it is also important to think about security when travelling. Always take advice if you are travelling to unstable regions, including information on possible dangerous scenarios and how to deal with them. Should you find yourself in danger, don’t tweet or use social media as it can endanger you more by locating your position. Overall, it is crucial to be prepared. Use your travel time to brief yourself well ahead of business meetings, and leave some flexibility in your agenda for events that overrun, or for unforeseen invitations. After all, overpacked agendas lead to stressful trips. If you are relaxed and on top of your brief, you will maximise your success when travelling.


The integrity of electronic voting technology

Antonio MUGICA CEO & Founder, Smartmatic

Is confusion about Russian interference in US elections clouding our judgment on election modernisation?


he allegations that Russia interfered with the 2016 US elections has led countries to assume that hacking emails and weaponising social media are the same thing as hacking an electronic voting platform. That is false – the US voting system was never hacked – and we are in real danger of dismissing the benefits of election technology because of confusion around the threat of cybersecurity. The accusation that someone hacked the email accounts of senior Democrats to release them and sway the US election has prompted some countries to assess the threat of cyber-attacks on democracy. Last year, the United Kingdom’s Government Communications Headquarters (GCHQ) summoned political parties to a summit to discuss the risks of hacking during a general election. Shortly after, the Netherlands announced that it would count all its votes by hand, and France scrapped electronic voting in the June elections for citizens living abroad. But truth be told, when election technology is properly designed, cyber-attacks such as the ones allegedly perpetrated by Russians against US targets are not a significant risk. Modern automated voting platforms have a series of highly secure countermeasures in place to prevent being hacked that email services and other web-based applications do not have. I say this not only because I believe it,

the votes worked properly, and recounts only served to prove it. To this day, absolutely no one has provided any credible evidence proving the results were altered. When you compare this to the risks involved in pen and paper voting, where the possibilities for mistakes and fraud are endless – from postal votes getting lost to human error during counting – it is worrying that this manual system is being touted as a safer alternative to election technology. Cast your mind back to 2004, where 570,328 votes across the London Assembly and Mayoral elections were invalidated (a 6.75 percent of the total) because of errors on the ballot papers – the voter’s intent was not clearly stated.

but because at Smartmatic –the company that I lead – we have counted over 3.7 billion votes without a single security breach. In order to create a fully secure and transparent system, we combined several security mechanisms and protocols: encryption, security codes, digital signatures and asymmetrical keys, shared encryption keys, protected consolidation of results, source code revisions and extensive auditing. These measures not only protect the votes and identity of voters; they make the election more auditable. That

means that the integrity of the votes can be verified at any point in the voting process. When these measures are implemented, there is a near impossible chance of electronic votes being compromised and any attempt at tampering can be immediately blocked and identified. In spite of all the noise, the 2106 US elections also served to demonstrate how reliable election technology is. Although some of the technology deployed was 10 years old or older, no significant incidents occurred in the 2016 elections. The machines used to vote and count

Panic is never a wise counsellor. With election participation declining across the globe and public disaffection with governments increasing, we must do everything within our reach to improve how elections are run and how people engage with their leaders. The challenge of conducting credible elections in the information age should be solved via more and better technology, not less. Of course, let’s fight fake news, email hacking and other cybersecurity threats. But let us not throw the baby out with the bathwater: electronic voting technology protects the integrity of votes and our democracy; it doesn’t threaten it.

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Government Gazette 2018: Vol 1  
Government Gazette 2018: Vol 1