Government Gazette - Vol 1, 2019

Government Gazette Vol 1; 2019

driving the day

Brexit and the uncertainty around European elections REALITY CHECK

Europe’s role in the new AI world order WOMEN SHAPING BRUSSELS

Joanna Maycock puts back gender balance on EU agenda

inside

• Digital Europe • Gender Balance • Cancer Control • Alzheimer’s Disease • Cardiac Health

£10.00, €11.00 ISSN 2042-4170

MORE SATELLITES

MORE SOLUTIONS Smarter policy making with the world’s best imagery

w w w. e u s p a c e i m a g i n g . c o m

Government Gazette Vol 1; 2019

Government Gazette

Commissioning Editor Janani Krishnaswamy janani.krishnaswamy@governmentgazette.co.uk +44 (0) 20 3137 8653 Editor, Performance Supplement Meliissa Gokhool melg@governmentgazette.co.uk Publisher Matt Gokhool matt.gokhool@governmentgazette.co.uk +44 (0) 20 3137 8653 Advertising and sponsorship sales advertising@governmentgazette.co.uk +44 (0) 20 3137 8653 © 2018 CPS Printed by Mail Boxes Etc., 334 Kennington Ln, Vauxhall, London SE11 5HY. 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.

50 europe’s role in the new ai world order

Vera Jourava, European Commissioner for Justice, Consumers and Gender Equality, exclusively writes about a European brand for AI

08 the brexit morass

also inside 14 women shaping brussels

Joanna Maycock, Secretary General of the European Women’s Lobby puts back gender equality onto the EU list of priorities

Sir Michael Leigh, a former chief negotiator for EU enlargement at the European Commission writes about Brexit and the uncertain future of the Europe

62 cardiac report Government Gazette asesses how policymakers deal with EU’s chronic cardiovascular disease burden

28 vehicle safety

Antonio Avenoso is the Executive Director of the European Transport Safety Council writes about EU action on infrastructure and vehicle safety

36 work after cancer

12 gender equality

Angelika Mlinar MEP, Member of EP’s Committee on Women’s Rights and Gender Equality assesses European Parliament’s action plan

Fighting for cancer patients across Europe, Dr. Fatima Cardoso, Chair, ABC Global Alliance, writes about the burden of returning to work

22 breast matters 67 heart failure

Ed Harding, Managing Director of Health Policy Partnership writes about why he thinks Europe should make heart failure a strategic policy

Special report aims to inform a coherent policy approach to Breast Cancer prevention, control and treatment at European, regional and national levels

82 genetic side of alzheimer’s disease Teresa Griffin MEP reviews European Parliament’s action against the neurodegenerative disease

30 fighting childhood cancer

The SIOP Europe and CCI Europe present their policy manifesto for the upcoming European elections

76 europe’s fight against alzheimer’s disease

41 breast clinics in europe

Special report drives policy action to support Europe’s fight and includes expert recommendations from key industry stakeholders

Dr Martine Piccart-Gebhar, Chair of Breast International Group, writes about a plan to implement breast clinics across Europe

104 obituary

16 prostate cancer Chris Booth, Clinical Director, CHAPS Men’s Health Charity, highlights the policy challenges in managing the commonest male cancer killer

26 colorectal cancer

Remembering one of the pioneers of the Euro and many times European Commissioner, Frans Andriessen

68 Cardiovascular realities

Failures in colonoscopy affect detection of colorectal cancer across Europe, writes Prof Evelien Dekker, a leading CRC screening expert

Professor Panos Vardas, Chief Strategy Officer for the European Society of Cardiology explains why economic factors play a major role in delivering healthcare

48 digital transformation

21 pancreatic cancer

How do we get EU industry get ahead with emerging technologies?

54 event coverage iCPS Roundtable: How can Europe fasttrack its commitment for 5G?

www.governmentgazette.eu | 04

Whilst lung, breast and colorectal cancer have seen significant reductions in death rates since 1990, deaths from pancreatic cancer continue to rise. Prof Thomas Seufferlein assesses the current state of Europe’s deadliest cancer

editorial view Government Gazette, Vol 1, 2019

Janani KRISHNASWAMY Commissioning Editor

It’s time to get real

W

ith the European Parliament election set to take place from 23-26 May, we are heading into a phase in which the polls should, in theory, become more reliable and trustworthy. Yet, ahead of this election, there are still so many moving pieces in European politics that its outcome remains much undecided.

If there’s a single word that captures the changes to Europe’s politics in 2019, it’s disintegration. The spring edition of Government Gazette takes a look at how Brexit will shape and impact the outcome of the upcoming elections.

Over the last several decades, a broad alliance of big parties has called the shots in the EU. Politicians from the mainstream center-right and center-left parties have held a comfortable majority in the EU’s principal institutions, including the European Parliament, European Council, and European Commission. However, this era could come to an end with the upcoming elections.

Perhaps most surprisingly of all, with the two initial dates for the United Kingdom’s departure from the European Union now behind us, it seems almost certain that the country will participate in the European Parliament election. Indeed, the UK’s political parties have called for candidates to stand in the vote. The British Prime Minister’s politicking since losing the first vote on her deal in January has not come to an end.

She remains determined to prevent the UK from participating if possible. But now that the UK’s deadline for leaving has been extended until October 2019, the only way not to avoid participating would be for its parliament to agree on an exit deal before 23 May. Only yesterday, David Lidington, Theresa May’s de facto deputy, had finally admitted that there was no hope of the UK avoiding the European elections. Regardless of whether the UK participates in the May 2019 European Parliament election, anti-European parties look likely to become the second-largest group in the parliament, with up to 35 percent of seats. UK’s participation in the vote could lead to a “one foot in, one foot out” situation, which might without doubt paralyse the already fragile functioning of the union’s institutions.

In our latest edition, we cover everything about Brexit and the unprecedented uncertainty around European elections.

With a new batch of MEPs, a new president of the European Council and European Central Bank, as well as new commissioners due to take up their posts, the new president faces an uphill struggle to reshape the bloc over their next fiveyear term.

Equality is suddenly all the rage in this year’s elections. But can it really make a difference?

Over the last three decades, the EU has passed nine directives on gender equality. EU anti-discrimination directives have been agreed, framed as guarantees to ensure the working of the

internal market. But policymakers have had trouble when these laws strayed into cultural territory.

Nearly 70 years after the European Union’s birth, men are hugely overrepresented in positions of power. It is now more than ever before that policymakers and opinion leaders have increasingly shown greater interest in improving gender parity in all walks of life. We need a Europe that realises women’s equality in political decision-making and adopts a zero tolerance policy towards discrimination. In our new section Women Shaping Brussels, Joanna Maycock puts back gender equality on the top of EU agenda. Angelika Mlinar MEP, Rapporteur for the report on Gender Mainstreaming at the European Parliament writes about how we can boost the power of women in politics.

While a paradigm shift to digital in underway, this spring we’ve taken a closer look at ways to build a stronger digital Europe. Why is Europe lagging behind in the tech race? What do we need to build a stronger digital Europe and how can we get there? Our latest policy resources analyse key opportunities and challenges within Europe’s 5G ecosystem. We believe 5G can be a key enabler — not only for a better generation of internet networks, but for a new wave of digital revolution.

The current edition features must-read analysis and insights from some of the top technology experts in Europe. Don’t miss out the exclusive op-ed from European Commissioner Věra Jourová who writes about Europe’s changing role in the new AI world order.

What will the Spring MEPs focus on in the European Parliament?

Our flagship demand - the European program to fight cancer.

This edition features the latest policy updates on the European fight against prostate, pancreatic, colorectal, breast and childhood cancers.

Whilst lung, breast and colorectal cancer have been seeing significant reductions in death rates since 1990, pancreatic cancer has the lowest survival rates of all cancers in Europe.

Despite the rise in deaths, pancreatic cancer receives less than 2% of all cancer research funding in Europe. On the other hand, failures in colonoscopy and lack of populationbased screening are affecting early detection of colorectal and prostate cancers, respectively. A lot remains to be done in order to “save thousands of Europeans” from a disease that killed 1.9 million people last year.

Our healthcare bulletin this quarter also features special reports on two of Europe’s pressing concerns — cardiovascular disease and dementia. Government Gazette’s roundtable unit covers two high-level roundtables bringing together key healthcare policy stakeholders in Europe.

This quarter, we introduce a new Obituary section. We say goodbye one last time, to former Dutch finance minister and many times European Commissioner - Frans Andriessen.

Government Gazette | 05

direct access to key decision makers across europe Organises high-level policy discussions on pressing European policy issues Trusted platform of engagement between policy makers and stakeholders Offers exclusive networking opportunities with Europe’s key policymakers and thought leaders For more information visit www.publicpolicyexchange.co.uk Follow us @PublicPolicyEx

BREXIT BRIEFING

It’s time to rewire British politics

I

ts perhaps time to admit that a good deal is nearly impossible, and get on with getting out. Back in 2015, the Conservative Party won an absolute majority when former Prime Minister David Cameron promised a referendum on EU membership. However, now 49% of Conservative voters think that was a bad idea, according to a new poll by the Observer. Among Labour voters, 72% think the referendum should never have been held, while only 18% think it was the right thing to have done.

Brexit has exposed a deep rift in British politics. And it’s not just May’s government that’s under threat — it’s a whole system of British governance. This lack of vision and preparation, which was evident all along, have dogged May’s government, and culminated in her monumental parliamentary defeats. Britain’s broken political system was evident in the latest local elections.

As the Brexit muddle worsens, both Labour and the Tories are stuck on a political merrygo-round. The EU strategy to keep pressure on the British government with short deadlines barely worked out.

To avoid a no deal which would be the worst option for both EU and UK, the EU Heads of State and the UK government have now opted for a longer extension to give more time for a solution.

EU leaders for the second time granted an extension of Article

50 — and this time, a six-month one, until October 31, but Theresa May still don’t seem happy. Noting that she “never wanted” to agree a potential delay to Brexit until October, she appealed to MPs to pass a deal before May 22 to ensure the UK does not have to take part in the European election.

The choice of the EU Heads of State and governments not to pull the plug on British membership was driven by political realism. Obviously, the extension of the Art.50 for only a few months creates risks to the good functioning of the EU. But it also creates opportunities for all those in the UK to increase the political pressure towards a second referendum.

However, the fact that the UK is now very likely to participate in the European elections will provide an opportunity for proEU forces in the UK to stand up and mobilize.

What happens between now and October 31, as European Council President Donald Tusk says is totally in UK’s hands.

If the withdrawal agreement is ratified by both parties before this date, the withdrawal will take place on the first day of the following month.

However, if the position of the United Kingdom were to evolve, the European Council will still prepared to reconsider the political declaration on the future relationship.

No UK politician is passionate about Europe: Juncker

‘May risks public faith over EU election’

C

hairman of the UK Electoral Commission Sir John Holmes has warned that participating in European election might raise “serious concerns.”

T

he European Commission president Jean-Claude Juncker often mourns that the former UK Prime Minister, David Cameron, had blocked him from campaigning during the 2016 referendum.

In another meeting with the British media, Juncker went on to claim “the EU could have swung the Brexit referendum in favour of Remain if David Cameron had not prevented it from intervening in the 2016 campaign over membership.”

No wonder he thinks British politicians aren’t “passionate about Europe.”

Speaking with Hungarian outlet HVG, he reportedly noted that his “impression has always been that they don’t feel at home in the EU.” Particularly, he mentioned that he had “not met anyone in their political elite who was passionate about Europe.”

In his opinion, British politicians “for decades” told voters that the EU was primarily about economic cooperation, not about common values.

Asked whether he thought countries “that are not passionately European” should leave the EU, Juncker said: “No, I’m not saying that.

Article 50 does give everyone the possibility to leave, though. The Brits have shown us that you cannot imprison those who don’t want to stay.”

If the elections go ahead as planned, he noted that no one can tell whether those elected will take their seats or, if so, for how long. Numerous questions abound on the impact on voters, now and in future. If the UK leaves the EU before the new European Parliament sits in July, any MEPs elected in the May 23 vote would not take their seats.

British Prime Minister Theresa May — he noted — will certainly “risk undermining voters’ faith in politics” by allowing them to elect representatives in an election whose results are clouded by the uncertainty around Brexit.

‘EU will get ‘disruptive and resentful’ British MEPs’ - Liam Fox MP

B

ritain’s trade secretary, Liam Fox, has warned that EU will end up with 50 “disruptive and resentful” British members of the European Parliament if the UK takes part in the upcoming EU elections. The prominent Brexiteer voiced concerns about the effect of the new European Parliament on the formation of the next European Commission. “The last thing our European partners want are 50 disruptive and resentful UK MEPs,” he added.

Government Gazette | 07

brexit

Driving the day - What’s next for the EU?

A way out of the Brexit morass?

The Tories face a major setback after the prime minister’s repeated failure to win approval for the withdrawal agreement and the postponement of Brexit. They will struggle to raise funds, agree a manifesto and field candidates.

REALITY CHECK

B

rexit-bound Britain will participate in this month’s European Parliament (EP) election, unless UK prime minister, Theresa May, and opposition leader, Jeremy Corbyn, manage to push the thrice-rejected EU withdrawal agreement through the House of Commons in the coming days.

They have every incentive to avoid the EP election, which, following the local elections, promises to be a rout for the Tories, a set-back for Labour, a victory for Nigel Farage’s Brexit Party, and a moderate success for the Liberal Democrats, Scottish Nationalists, Greens and new pro-EU Change UK Party.

A “deal” would consist of Corbyn’s accepting the withdrawal agreement in exchange for the prime minister’s undertaking to ask the EU for a commitment to a customs union (CU), as the basis for Britain’s future relations with the EU. The two parties are wrangling with each other and internally over the principle of a CU, whether it should be temporary or permanent and whether the “deal” www.governmentgazette.eu | 08

the EP election. Neither major party has even begun to campaign while the smaller Leave and Remain parties are rearing to go.

should be endorsed by a referendum. A CU would reduce the need for systematic border controls between the UK and the EU-27, supposedly making the controversial Irish “backstop” unnecessary.

If the UK House of Commons quickly approves the withdrawal agreement on this basis, Britain would not participate in the EP elections, sparing both major parties an embarrassing defeat. The UK would leave the EU as soon as the necessary legislation is adopted.

Corbyn could claim that the government had adopted his preferred scheme, a CU, even if under another name.

Theresa May could give way to a Tory successor, as she has promised, her mission accomplished.

But even if Theresa May and Jeremy Corbyn stitch up such a deal, they will find it hard to corral enough of their MPs into the division lobby to approve it. Customs union is anathema to many Tories because they think it means “Brexit in name only” and would exclude their dream of beneficial British free trade agreements for goods with countries around the world. Many Labour MPs, seeking a softer Brexit, would question whether Theresa May’s successor, probably an uncompromising Eurosceptic, would stick to any agreement she might have reached with Mr Corbyn. Some Labour parliamentarians would insist on a “confirmatory referendum,” abhorred by Corbyn, a closet Leaver, because of the risk of a popular vote to remain in the EU. Corbyn will wish to avoid the taint of backing a Tory Brexit and may be setting the prime

Sir Michael LEIGH is senior fellow at the German Marshall Fund in Brussels and senior adjunct professor at the Johns Hopkins University School for Advanced International Studies in Bologna minister up for another failure in prolonging the talks.

In any event, customs union, alone, would not be enough to ensure “frictionless” trade between the UK and the EU-27, including Ireland. The UK as a whole would still have to implement EU single market rules to remove the need for veterinary, plant health and other checks on goods transported between the UK and the EU. It is far from certain that the two sides would agree to this.

For the EU, cherry picking single market rules, while excluding free movement of workers, has always been a non-starter. For the UK, alignment with single market regulations would make the country a permanent decisiontaker – the opposite of “taking back control.”

Nonetheless both sides might be ready to bury their differences and use creative drafting to permit Brexit to go ahead.

But British politicians are not counting on a deal and the smaller parties are preparing to contest the EP elections.

In the EP elected five years ago, Labour had 20 of the 73 British seats that were due to be eliminated or re-allocated to other member states before Britain won its latest Brexit extension.

Labour forms part of the Socialist group (S&D) in the EP that stands to lose seats in the election.

Labour’s ambiguous election manifesto, sidestepping a possible second referendum, would not inspire many of its supporters to come out and vote.

The Conservatives also have 20 Members of the European Parliament (MEPs), 18 in the largely Eurosceptic European Conservatives and Reformists Group, with 2 belonging to the centreright European Peoples’ Party (EPP – Christian Democrat). The Tories are struggling to raise funds, agree a manifesto and field candidates for

The EPP will lose seats, mainly to illiberal nationalists, but is most likely to remain the largest group in the new EP. With its lacklustre, right-leaning Bavarian lead candidate, Manfred Weber, the EPP will fall short of the previous controlling majority it enjoyed together with the Socialists (S&D).

The EPP, S&D, and their allies, will probably have to share power in the new EP with the Liberals who look like forming a new political group together with French President Emmanuel Macron’s La République en Marche.

The Greens may also be needed to form a majority.

This broadening of the main working alignment inside the EP would be healthy in itself. But it will be hard to negotiate and could delay the choice of leaders for the EU’s main institutions. Several heads of government, eying jobs for themselves or their protégés and unimpressed with Weber, will challenge the “lead candidate” arrangement, adopted informally in 2014, whereby the head of the political group receiving the most votes becomes Commission president. Resulting squabbles might mean that caretaker teams are still in office in Brussels at the end of October, when Britain might again face the cliff edge of a no-deal Brexit, if the withdrawal agreement is not approved earlier.

Across the EU, illiberal nationalist parties will garner additional votes.

Nigel Farage’s legions

EP ELECTIONS would give Eurosceptic populists in the EP a further temporary boost if the UK participates in the election. Matteo Salvini, Italy’s deputy prime minister and leader of the far-right Lega, has tentatively brought together for the EP election Eurosceptic hardliners from Austria, Denmark, Estonia, Finland, France, Germany and Italy. But they are riven with disputes, especially on minorities and relations with Russia. If they manage to stay together, after the election, they could form the second largest bloc in the EP, with up to a third of the seats. This could give them a voice in post-electoral power-broking.

“

European Parliament’s big Brexit debacle The European Parliament’s game of musical chairs is bound to be messier than expected. The biggest uncertainty surrounds around how many people will actually vote in the European Parliament elections. With nearly six million people having signed a petition to revoke Article 50, doubts persist if they will be motivated to come out and convert their protest into votes. However, campaigners for a second Brexit referendum will use the European elections to tell Europe, Westminster and the world, that “the British people – are not happy with the undeliverable promises made to us in 2016,” and that “now we know the costs, we want to put Brexit to the people with a confirmatory People’s Vote.”

Lib Dems hope to carry through success in council elections to the EU and general elections

The EP must approve the new Commission team to be nominated at a summit after the election. At this meeting, EU heads of government will bargain over the appointment of new bosses for the top EU

No more Mr. Nice Guy According to YouGov, the new Brexit Party, launched by Nigel Farage is 15 points ahead of the Tories, and is on course to win the European Elections.

Some view the EP election in the UK as a substitute referendum, but splits on Europe in the two main parties may prevent a clear-cut choice.

bodies (Commission, Central Bank, Council, Parliament, and diplomatic service - “EEAS”).

They do not wish continuing British participation to contaminate these already difficult decisions. In Britain, both Conservative and Labour leaders want to spare their parties the embarrassment of participating – unsuccessfully - in the EP election, at a time when Britain is heading for the door.

This is a spur for them to reach a compromise on the withdrawal agreement but may not be strong enough to persuade Parliament to approve a compromise that crosses so many red-lines. So, a fresh crop of British MEPs will probably be heading to Strasbourg in July. However, their tenure will be rather brief with a new cliff edge looming by 31 October. If the EP elections, and how to avoid them, do not lead Britain out of the Brexit morass a second referendum may become inescapable.

Many of the Liberal Democrats campaigners who scored stunning results in the recent local elections are now hoping to carry through the success to the upcoming EU elections.

Writing for The Observer, Lib Dem leader Vince Cable, noted that as Conservatives and Labour parties have failed to get together, “the only hope left is that voters will make a hard-headed assessment about who can make an impact.

While Nigel Farage’s Brexit party will undoubtedly do well if it becomes the main political vehicle for strongly committed Brexit supporters he expects voters to turn out in force, welcoming a clear, honest message from the Liberal Democrats.

55%

of British public now think it would have been better never to have held the EU referendum given the difficulties of reaching an agreement on Brexit

Promising “a revolution in British politics,” the party pledges that there will be “no more Mr. Nice Guy.” The Brexit Party, he said, will be “deeply intolerant of all intolerance.”

Farage has claimed his new party has raised more than £750,000 in donations since its launch and said more than 1,000 people have applied to be candidates for the European election.

“In 25 years of campaigning, I have never seen such a reaction,” he wrote.

Government Gazette | 09

regional

Driving the day - What’s next for the EU?

kingmakers of the mainstream Will an anti-EU right block emerge as the new political force? constituting 80% of all seats in EP, there is a distinct possibility that anti-European parties could form the secondlargest political group in the parliament, with or without the participation of the UK.

opinion

A The next European Parliament will be highly fragmented, with no clear majority and multiple forces

ccording to a new pollingbacked report – Kingmakers of the mainstream: predictions for the European Parliament elections – published by the European Council on Foreign Relations (ECFR), as part of its Unlock Europe’s Majority project, anti-Eiropean parties could dominate the next European Parliament (EP).

According to data collected across 14 member states

The report, shows that in either scenario the European Parliament will be a fine balance between the three largest groups, named above, meaning that the Centre coalition will have a potential ‘kingmaker’ role in forming deals between the groups.

The report asserts that “everything will depend on the coalitions that mainstream parties form between one another, and on how they work to disrupt the formation of anti-European coalitions in the next parliament.”

This means that proEuropean parties can no longer prevaricate, and must now expedite their attempts to think beyond

traditional political families in the way they battle for seats in the EP. It argues that the role of the UK will be critical to the battle of ideas in this election campaign because its participation would risk convincing antiEuropean parties that the EU is irreformable: the argument could be that “the UK wanted to leave the club and was not allowed to do so”.

This argument is potentially powerful in light of strong forecasts for the newly-formed Brexit Party, as well pan-European ECFR/ YouGov polling which finds that three-quarters of Europeans believe that their national system or the European system – or both – is broken. The ECFR/YouGov polling also shows that twothirds of voters believe that their children’s lives will be worse than their own.

In its conclusion, the report notes that mainstream parties must now recast themselves as symbols of change, in an environment in which anti-European parties will portray them as defenders of the status quo in Europe.

In addition, the ECFR report also explores the likely positions of MEPs within party groups.

On average, following the May 2019 European Parliament election, it finds that MEPs will be marginally more rightwing and marginally less positive about the EU. The EP will have a slightly more Eurosceptic slant after Brexit, with no group becoming more pro-European than it was in the previous parliament.

The report concludes that pro-European parties should focus their message on the issues they want Europe to deal with after the elections, and not on EU institutions. These issues vary from country to country, but many European voters prioritise affordable housing, inclusive economic growth, social integration and cohesion, the fight against corruption, and action to mitigate climate change.

Pro-European parties must disseminate their messages in the next month and, immediately after the European Parliament election, begin to deliver on their promises. ECFR/YouGov research shows climate issues could form part of this platform: “in the 14 countries in which the poll asked whether climate change should

www.governmentgazette.eu | 10

EP ELECTIONS

What does UK’s participation mean to EU elections?

be tackled as a priority even at the risk of curbing economic growth, only a minority of people responded in the negative. In our surveys, respondents cited cooperation on climate change as one of the biggest losses that would result from the EU’s collapse”.

Commenting on the report’s findings, Simon Hix, ProDirector for Research and Harold Laski Professor of Science at the Mainstream parties must now recast themselves as symbols of change, in an environment in which anti-European parties will portray them as defenders of the status quo in Europe.

London School of Economics and Political Science, and Visiting Fellow at ECFR, said: “Will an anti-EU right block emerge as the new political force, or will younger proEuropeans mobilise around an optimistic and progressive vision for Europe? A lot is still to play for, but one thing looks certain: the next European Parliament will be highly fragmented, with no clear majority and multiple forces, with radically different visions for Europe, battling for influence.”

Susi Dennison, Senior Policy Fellow and Director of the European Power programme at ECFR, said: “A European Parliament that is finely balanced between antiEuropeans and divided proEuropean forces presents a real risk of paralysis at the centre of the EU. This places a real premium on co-operation beyond the traditional political groups and looking for issues- like climate, like building the EU up as a global actor- where they can find common ground and where voters are desperate to see results at a European level.

W

hile antiEuropean parties are predicted to perform strongly in the European Parliament election, there os a distinct possibility that they could form the second-largest political group in the parliament. With UK participation, they could be second only to the left bloc.

If the UK somehow avoids participating in the vote, they are still likely to be the second-largest group, albeit with the EPP the largest. In either scenario, the European Parliament will be finely balanced between the three largest groups, meaning that the centre coalition will have a potential kingmaker role in forming deals between the groups.

A new report published by the European Council for Foreign Relations (ECFR) warns that the UK’s participation in the upcoming European Parliament elections would “risk convincing anti-European parties that the EU is irreformable: they will make the argument that the UK wanted to leave the club and was not allowed to do so.”

The report makes the argument given that three-quarters of Europeans believe that either their national system or the European system – or both – is broken. And two-thirds of them believe that their children’s lives will be worse than their own.

It is, therefore, crucial that mainstream parties think about how to position themselves as symbols of change, in an environment in which antiEuropean parties will portray them as defenders of the status quo in Europe.

The ECFR report argues that Pro-European parties should focus their message on the issues they want Europe to deal with after the election, not on EU institutions. These issues will vary from country to country, but many European voters prioritise affordable housing, inclusive economic growth, social integration and cohesion, the fight against corruption, and action to mitigate climate change. Pro-European parties must disseminate their messages in the next month and, immediately after the European Parliament election, begin to deliver on their promises.

Government Gazette | 11

interview

Women’s rights and gender equality at the European Parliament

GOVERNMENT GAZETTE ASKS

How can we boost the power of women in politics? to policy initiatives, which benefit women and increases trust in governments.

Angelika MLINAR MEP is Member of EP’s Committee on Women’s Rights and Gender Equality

E

quality between women and men is one of the objectives of the European Union.

This year we must highlight the importance of women presence in politics particularly in the framework of the coming European elections.

Clearly, women’s representation is not the only factor, but it is a critical factor for the development of inclusive, responsive, and transparent democracies.

Female politicians in government lead www.governmentgazette.eu |12

As the Standing Rapporteur for the report on Gender Mainstreaming in the European Parliament, I call on The European Parliament to enhance the gender sensitivity of, and gender equality among, MEPs and parliamentary staff.

While the representation of women in the EP has increased (36,1%), it still does not match women’s broader representation in society. Increasing access to parliament through gender-sensitive changes will help increase the number of women parliamentarians.

So how can we boost the power of women in politics?

To start, we need to boost the self-esteem of women in order for them to have the courage to run for office.

Mentorship, confidence building and media training and political campaign education

are all effective tools to increase women’s political aspirations.As more women run for and win elective office, they can help challenge stereotypes of who can lead.

Political parties must ensure equal representation and ranking of women and men in their electoral list. This can be done by zipper lists or quotas.

But I believe it can only “hurt until it gets better”, meaning this could be the necessary push women need to get to the top.

Political parties should also include gender equality as a priority in their programmes for the elections.

Member states should propose candidates as Commissioners in a way that equal representation of women and men among members of the European Commission is ensured.

Furthermore, the EU needs a robust political strategy on gender equality. This strategy should cover the mandate 2019-2024, and it

should reflect the EU’s obligation to ensure equality between women and men.

The strategy must contain commitments to address discrimination, promote gender mainstreaming and ensure that a gender equality perspective is adopted in the post-2020 generation of EU funding programmes.

The EU must give women incentives to pursue a political career, and enhance the gender sensitivity of, and gender equality among, parliamentarians and parliamentary staff. Increasing access to parliament through gender-sensitive changes will help increase the number of women parliamentarians.

Women working in parliaments should be well-informed about measures to improve work-life balance, such as maternity/paternity leave, parental leave, carer’s leave and flexible working arrangements.

Parliaments should also encourage better sharing

of caring responsibilities between women and men, improve the quality of women’s employment and their well-being.

The political sphere must be made a safer space for women. Violence occurs in all countries, irrespective of social, economic, religious or cultural groups. Violence against women knows no boundaries. And we female politicians are no exception. We are also targets of cyber violence and cyber harassment.

All work places must strongly condemn acts of violence against women candidates and parliamentarians and adopt legal and practical measures to prevent and punish such acts!

I want to emphasize that democracy is not democratic without equality. Women must be free to vote, campaign, hold political office and speak out on behalf of their parties, free from discrimination, disbelief or toxic rhetorics.

Government Gazette | 13

interview

Women’s rights and gender equality at the European Parliament

WOMEN SHAPING BRUSSELS

Bringing gender equality back onto the EU’s list of priorities

I

t does sound like a cliché, but some cold facts about the current situation of women in the political sphere definitely bear repeating. Nearly 70 years after the European Union’s birth, men are hugely overrepresented in positions of power in the EU — two thirds of seats in the European Parliament are held by men, only nine commissioners out of twenty eight are women, and only three women are head of States sitting in the European Council. The list could go on, demonstrating the persistent lack of parity in the European Union’s decisionmaking institutions, which undermines the legitimacy of the whole system.

There is no real democracy without parity

Government Gazette caught up with Joanna MAYCOCK who has been the Secretary General of the European Women’s Lobby (EWL) since May 2014. Joanna has been working to develop a new strategic vision for the EWL, to strengthen its joint vision and work towards a feminist Europe. www.governmentgazette.eu | 14

Women, in all their differences and diversity, represent half the European population.

Yet, we still have institutions where men, most often old and white, are over-represented at all levels, from the Heads of State to European Commissioners to Mayors. It means that, even though we are in 2019, we still cannot truthfully declare that the European Union is a democracy where half the population is missing from all instances of decision-making.

The European Women’s Lobby, working with our members throughout the EU has been demanding for years, for all our institutions and parliaments to have 50/50 representation of women and men. This is, primarily, a basic

Vote for women, vote for feminists We are often asked: why should I vote for a woman? It is funny enough to remark that no one ever inverts the question: why do I always vote for a man? We never ask If there is a risk of a man being elected even though he’s incompetent, we only worry about women and their capacities: the former is often the case without it being the subject of countless discussions and debates.

Joanna MAYCOCK is Secretary General of the European Women’s Lobby question of equity. To have a European Union that truly represents every citizen and listens to all their concerns, we need to make sure women haveequal representation at the table.

Women still face many obstacles to their participation in politics, including sexism and sexual harassment that are met with both online and offline (across continents, women are 27 times more likely to be harassed online).

By imposing legislative quotas, member states, who still have not taken such measures, would create what could be described as a virtuous cycle — demanding an overhaul to systems that maintain the over representation of men in power.

When quotas are in place, political parties

and institutions are required to examine and lift the barriers to women’s full participation and representation and women finally get the opportunity to enter the political arena.

This creates role models, which the next young women leaders can look up to and feel that politics is not only for the stale, male and pale segment of the population. Most people understand the need for quotas based on nationality inside the European Union’s institutions: it allows a fair representation of all EU member states in the EC, the EP and in the EESC. So, why do we encounter such resistance when asking for the same type of measures for equal representation of women and men?

You should vote for a woman because we need their voices. We need it to have a truly fair system, but we also want women to be elected because it will lead to better decisions, taking into accounts all the citizens’ views, and even allow the introduction of new or neglected issues on the political agenda. A research in Sweden actually showed that, depending on the politician’s sex, their pursuance of women’s interests changed: with the increase of women’s participation in politics, more of them were addressing issues of care and social policies as well as gender equality , which benefit everyone.

Women are leading the resistance - creating the Europe we want We know the far right is getting stronger, and is more and more targeting women’s rights, both threatening them – notably their sexual and reproductive rights – but also closing down space for civil society, and for women’s voices.

Against these sexist, racist, homophobic political parties and

movements, women have been rising for years and are now fearlessly leading the resistance from Hungary to Spain andto the climate marches led by young women like Greta Thunberg. They chose not to fall into despair but to stand up and propose their hopeful vision of the Europe they want: a European Union that is inclusive protects people and the planet: a feminist Europe.

Joanna Maycock has been Secretary General of the European Women’s

Nearly 70 years after the European Union’s birth, men are hugely overrepresented in positions of power in the EU : two thirds of seats in the European Parliament are held by men, only nine commissioners out of twenty eight are women, only three women are head of States sitting in the European Council.

Lobby (EWL) since May 2014. Since joining the EWL in 2014, Joanna has been working to develop a new strategic vision for the EWL, to strengthen its joint vision and work towards a feminist Europe.

A lifelong feminist, Joanna has 20 years’ professional experience in senior leadership and governance positions in European and International Civil Society. For the past 12 years, she worked in Brussels for

ActionAid, a global Federation working for an end to poverty and injustice. Developing and implementing EU campaigns on aid effectiveness, women’s rights, and policy coherence for development. Her most recent role at ActionAid was as Director for Country Coordination, and Head of Europe. Joanna is also a former President of CONCORD, the European Confederation of Development NGOs.

She has also been involved in strengthening organisational development and civil society governance. She is particularly interested in the concept and practice of feminist leadership, and has established a network of women CSO leaders in Brussels and is working with others to establish a global network of women leaders in CSOs.

Government Gazette | 15

healthcare

The state of cancer policy in Europe

britain’s growing problem

UK cannot overlook prostate cancer anymore

The United Kingdom lags well behind its European neighbours for early diagnosis and cure of Prostate Cancer

www.governmentgazette.eu | 16

P

rostate cancer is the third biggest cancer killer in the United Kingdom, with a majority of the deaths occurring because of a delay in diagnosis.

Canvassing for a screening programme for prostate cancer, three of

UK’s leading charities focusing on men’s health — CHAPS Men’s Health Charity, ORCHID and Tackle Prostate Cancer — recently brought together key policymakers, members of the prostate cancer community and patients in a Parliamentary Reception to discuss the urgent need for prostate cancer screening. In this article, Chris Booth, Clinical Director, CHAPS Men’s Health Charity, highlights the policy challenges in managing the commonest male cancer killer The United Kingdom lags well behind its European neighbours for early diagnosis and cure of prostate cancer (PCa).

Every year 47,000 UK men are diagnosed with PCa and nearly 12,000

die from it (1). It is our commonest male cancer and second commonest male cancer killer with deaths now exceeding those for breast cancer (2).

As there is no way of preventing PCa, our efforts should be to detect it early when it is confined within the prostate and thus curable.

The only practical way to do this is with the blood test PSA (Prostate Specific Antigen); there is no other simple, cheap marker on the horizon.

Since its widespread introduction as a PCa screening tool in the early 1990s, the death rate from PCa has fallen consistently in all countries making significant use of the test.

Unfortunately this came

at the cost of substantial over-diagnosis and over-treatment of nonaggressive, insignificant PCa that has possibly outweighed the benefits of early diagnosis and cure for many other men.

This problem was highlighted by the United States Preventive Services Task Force who decreed in 2012 that these harms outweighed the benefits (3).

As a consequence there has been a downturn in screening both in the USA and the UK, where the death rate has stopped falling and the presentation of cases of metastatic PCa has risen (4,5), raising the spectre of the pre-PSA era when most men presented with advanced, incurable disease. This is

unacceptable.

The longest, clinically valid trial evidence on the benefits and harms of PCa screening comes from Europe. Speakers at the European Prostate Cancer Awareness Day 2019 presented clear, objective evidence showing that the benefits now easily The UK does not require further screening trials but should implement proven screening strategies based on multidisciplinary international guidelines outweigh the harms.

What follows is therefore not mere opinion, but hard, objective, scientific evidence from screening studies running for up to 20 years.

The Facts Since 2012, death rates from PCa in the USA and UK are rising (4,5).

PSA-based screening trials have reduced PCa mortality by up to 64% (6,7,8).

After 20 years’ follow-up the number of patients needed to screen and to diagnose PCa have fallen to 101 and 10 respectively to prevent 1 PCa death – figures substantially lower than for diagnosing colorectal cancer and breast cancer (6).

Quality of life studies show that early treatment of PCa lowers the risk of complications such as incontinence and impotence whereas treatment of metastatic disease has a disproportionately negative effect on quality of life for both the sufferer and his partner (9).

Early measurement of PSA in a man’s 40s can largely define his lifetime risk of dying from PCa. Low risk men with consistently low PSAs (<1ng/ml) can stop screening in their 60s as subsequent risk of death from PCa is only 0.2% (10).

Early PSA measurement should be linked to family history, ethnicity and freely available risk calculators to further define lifetime risk.

Second line biomarkers provide further information that assists identification of aggressive PCa (11-14). mpMRI scans should now be used before biopsy to better target significant disease and avoid the need for biopsy where significant disease is unlikely to exist (15).

Active surveillance is a proven, safe, management option for “insignificant”, lowgrade, low-volume PCa (16).

In the UK treatment options are determined jointly by multidisciplinary teams and informed patients to avoid over-treatment, the rate of which has fallen to 8% (17).

The cost of early curative treatment is approximately €15,00018 compared with approximately €300,000

for long-term treatment of advanced PCa (19).

Scand J Urol, 2018.

52(1): 27-37.

Conclusion

7. Bokhorst, L.P., et al: Eur Urol. 2014. 65: 329-336.

The UK cannot continue to overlook PCa, our commonest male cancer, now that the twin threats of over-diagnosis and over-treatment are clearly outweighed by PSA-based screening programmes and recent advances in clinical practice.

The UK does not require further screening trials but should implement proven screening strategies (20) based on multi-disciplinary international guidelines (21).

More support and funding should be directed to PCa screening programmes and research.

The evidence is clear.

The only thing lacking is the political will.

References: 1. Cancer Research UK. Cancer incidence.

Accessed 25/1/19.

2. Prostate Cancer UK: Feb 2018.

3. Moyer, V.A., et al.

Ann Intern Med, 2012.

157(2): 120-34.

4. American Cancer Association, Cancer statistics, 2019.

5. https://www.bb.com/ news/health-43669439.

2018.

6. Hugosson, J., et al:

8. Alpert, P.F. Urology 2018. 118: 119-126.

9. Roobol, M, et al: Presentation. European Parliament 22/1/19.

10. Vickers, A.J., et al: BMJ, 2010; 341: C4521 11. Vickers, A.J., et al: Eur Urol, 2018. 74(4): 535-536.

12. Zapala, S.M., et al: Rev Urol, 2017. 19(3): 149-155.

13. Loeb, S, et al: BJU Int, 2017. 120(1): 61-68.

14. 13 Van Neste, L., et al: Eur Urol, 2016.

70(5): 740-48.

15. Ahmed, H.U., et al: Lancet, 2017.

389(10071): 815-822.

16. Hamdy, F.C., et al: NEJM, 2016. 375: 14151424.

17. National Prostate Cancer Audit, 2017.

18. Forsmark A., et al: Eur Urol. 2018. 74(6): 816-824.

19. Wu, B., et al: J Clin Oncol, 2018. 36(suppl.): 88 20. Arsov C., et al: Eur Urol. 2013. 63(4): 87375.

21. Melbourne Consensus: BJU Int 2014;113: 186-88.

Government Gazette | 17

healthcare

The state of cancer policy in Europe

Bringing back prostate cancer screening on EU agenda Parliament to debate the latest evidence and case studies demonstrating the efficacy of prostate cancer screening. The Policy Paper on populationbased PSA screening for prostate cancer was officially launched during the meeting and formed the starting point of the discussion.

EPAD 2019

A

fter years of decline, prostate cancer mortality has increased in several countries. The late detection of advanced prostate cancer —often due to a lack of awareness — is likely a reflection of this reversing trend.

Although it is wellknown that Prostate Specific Antigen (PSA) tests in population-based screening programmes reduce the prostate cancer mortality rate, the discussion on overdiagnosis and overtreatment continues.

On 22 January 2019 policy makers, scientific experts, European associations working in the urological field and representatives of European patient groups with an interest in prostate disease gathered at the European Parliament to debate the latest evidence and case studies demonstrating the efficacy of prostate cancer screening www.governmentgazette.eu | 18

The event was hosted by the Members of European Parliament Dubravka Šuica MEP, member of the MEPs against Cancer group (MAC) and Lieve Wierinck MEP. It focussed on how early diagnosis will improve outcomes in European PCa patients. Scientists, patient representatives, urologists and politicians covered key topics such as the latest evidence, consequences of not performing PSA screening, overdiagnosis and overtreatment in a well-attended session.

PSA history MEP Šuica welcomed all attendees and laid out the context of the discussion, followed by Prof Monique Roobol who introduced the 35-year history of PSA by comparing it to a scenic drive from The Netherlands to Italy.

“The easy ride that started in flat Holland in the late 80s was quickly followed by gradually climbs at high speed in Germany”, Roobol begins. “Then the high (but very difficult to drive) summits and beautiful valleys of Switzerland arrived, representing PSA testing practices in the new millennium and the decline in metastatic disease and related mortality. Entering Italy’s Po valley, she noted, is comparable to PSA testing rates in the US after the recommendations of the

That was a good reason for the European Association of Urology (EAU) to publish a policy paper on this topic and invite European influencers to rediscuss the need for populationbased prostate cancer screening programmes at a European level during the European Prostate Cancer Awareness Day (EPAD) 2019.

On 22 January 2019 policy makers, scientific experts, European associations working in the urological field and representatives of European patient groups with an interest in prostate disease gathered at the European

Dubravka ŠUICA MEP is member of EP’s Members against Cancer Group

USPSTF, where mortality rates start to increase again. The question is what will we do next?

Will we take a left turn and slowly disappear into the sea like Venice or return to the valleys in Switzerland?”

Risk-adapted screening Prof Peter Albers explained why we should adopt structured population-based PSA screening for prostate cancer by comparing screening programmes for other types of cancer.

“Registry data have shown that death from prostate cancer has overruled death from colorectal cancer and is now the second most cause of cancer-related death in men behind lung cancer. Despite the significant public health burden, relatively little is performed on prostate cancer screening at the EU level, particularly in comparison to breast,

cervical and colorectal cancers”, says Albers.

“The aim of future PSA screening programmes should be focussed on reducing overdiagnosis.

Risk-adapted screening will prevent unnecessary screening in 90% of men, is cost-effective and will still identify 1-2% of men with early PCa.” Lessons learned in Sweden

“

In Sweden, prostate cancer is a major public health problem, according to Prof Per-Anders Abrahamsson. “Mortality results from a 14-year follow-up in the Goteborg study showed that prostate cancer deaths were reduced with 44% in a randomised populationbased screening trial and the absolute mortality still continues”, states It is about finding a balance in “maximising benefits and minimising harms.”

Prof Per-Anders Abrahamsson Abrahamsson.

According to the former EAU Secretary General it is about finding a balance in “maximising benefits and minimising harms.”

His five golden rules for transforming PSA screening are the first step to success.

Quality of life “Early detection of PCa is not only about decreasing mortality rate, but also about Quality of Life”, noted André Deschamps, chairman of Europa Uomo. Their study shows that a minority of European men (48%) is aware of the risks of PCa. Looking at health care professionals, about half of the GPs promote PSA testing. Deschamps states: “Early treatment for prostate cancer lowers the risk of incontinence and impotence significantly, while treatment at

metastatic phase has a negative effect on the quality of life. Hence, there is a big opportunity to improve the quality of life if early detection is achieved in combination with avoidance of overtreatment.”

Deschamps pleas for a new strategy based on increasing awareness at EU level, promote PSA led screening with treatment in specialised cancer centres.

Costs vs savings The main advocate of the policy paper and event in the European Parliament, Prof Hein Van Poppel, discussed the consequences of less screening. “In the United Kingdom, 4 out of 10 prostate cancer diagnoses are currently diagnosed at a locally advanced or metastatic stage. In the United States, after a documented long decline of death rates of prostate cancer, prostate cancer mortality is increasing for the 1st time since early 1990. Moreover, an increase in the number of patients with metastatic and advanced disease has been observed at the

same time. This all has happened in parallel with PSA screening decline”, says Van Poppel. “The total costs of prostate cancer care sums up to €240,000 in the lifetime of a metastatic patient”, Van Poppel continues. “These costs are applicable in case of late detection. Early detection equals €5,000 per patient on average.

If we wouldn’t have had the overdiagnosis issues, we would have saved

With the upcoming EU elections, the new college of Commissioners should be empowered by the European Parliament and Member States to support Member States with European guidelines on prostate cancer screening

the lives of thousands of men.”

Lack of guidelines at EU level Since PSA screening ultimately reduces the rate of men with metastatic PCa at diagnosis and, in turn, mortality, different organisations have reconsidered their views on screening. The European Association of Urology (EAU) released its recommendations on early detection in the year 2013. According to Prof. Nicolas Mottet, the chairman of the EAU Guidelines panel for prostate cancer, the only way to find aggressive prostate cancer at an early stage is an early diagnosis. With the upcoming EU elections, the new college of Commissioners should be empowered by the European Parliament and Member States to support Member States with European guidelines on prostate cancer screening.

Hitting the target It is clear that early diagnosis is the remedy, Government Gazette | 19

healthcare

The state of cancer policy in Europe

but how to select those men that benefit from early testing to prevent overdiagnosis?

Prof Monique Roobol explained the benefits of risk stratification in combination with new developments as MRi and targeted biopsy. “Hitting the target has never been this easy”, she noted.

“With coordinated we will be able to improve mortality reduction, avoid unnecessary testing and overdiagnosis, but also uncertainty, anxiety and costs!”

Call to action After all the presented evidence, the European Union can no longer continue to overlook the most common cause of cancer in men in Europe which developed to be the number two cancer killer in men.

The Policy Paper on population-based PSA screening for prostate cancer was officially launched during the meeting and formed the starting point of the discussion www.governmentgazette.eu | 20

Urgent action is now required to ensure the new Commission is mandated to support EU Member States in prostate cancer screening in their national cancer plans. EAU Policy Coordinator,

Recommendations 1. The 2003 Council Recommendations on population-based screening need to be urgently reviewed, with prostate cancer added to the list of cancers to be addressed.

2. Member states should support a policy update on prostate cancer screening through their work on the EU Joint Action, the Innovative Partnership for Action Against Cancer (IPAAC) 3. MEPs should ensure that European action on Prostate Cancer screening is included in the group manifestos as they prepare for Europe elections.

4. The new college of Commissioners mandated in 2019 should be empowered by the European Parliament and member states to support member states with European guidelines on prostate cancer screening.

5. Member states should bring good practice on prostate cancer screening to the Steering Group

on Health Promotion, Disease Prevention and Management of noncommunicable diseases.

6. The European Commission should encourage to channel more support and funding to Prostate Cancer screening and research.

PCa Screening in Joint Action Dr Tit Albreht, coordinator of Innovative Partnership for Action Against Cancer (iPAAC) Joint Action, reflected on early detection and screening from a political point of view.

He raised the need to continue to work on reducing stigma about cancer to help improve, among other issues, early detection, but identified some challenges such as the complexity of targeted screening and identification of gaps.

Nevertheless, he is committed to adding prostate cancer screening on the Roadmap on Implementation and Sustainability of Cancer Control Actions. This

important step is the opening to implementing recommendations on prostate cancer screening at a European level.

Finally, Wierinck MEP endorsed this commitment by Albreht: “Evidence in PSA screening for early detection of prostate cancer is clear. We now need to take action. I will encourage my fellow MEPs to put this topic on their agenda for the upcoming EU elections”, Wierinck concluded.

The Policy Paper on PSA Screening for Prostate Cancer can be downloaded at epad. uroweb.org

Pancreatic cancer deaths increase across Europe REALITY CHECK

P

ancreatic cancer death rates in the European Union (EU) have increased by 5% between 1990 and 2016, reveals Pancreatic Cancer Across Europe, a report published

by United European Gastroenterology (UEG).

This is the highest increase in any of the EU’s top five cancer killers which, as well as pancreatic cancer, includes lung, colorectal, breast and prostate cancer.

Whilst lung, breast and colorectal cancer have seen significant reductions in death rates since 1990, deaths from pancreatic cancer continue to rise.

Experts also believe that pancreatic cancer has now overtaken breast cancer as the third leading cause of death from cancer in the EU.

Whilst lung, breast and colorectal cancer have seen significant reductions in death rates since 1990, deaths from pancreatic cancer continue to rise.

Experts also believe that pancreatic cancer has now overtaken breast cancer as the third leading cause of death from cancer in the EU.

Pancreatic cancer has the lowest survival of all cancers in Europe.

Responsible for over 95,000 EU deaths every year, the median survival time at the point of diagnosis is just 4.6 months, with patients losing 98% of their healthy life expectancy.

Often referred to as ‘the silent killer’, symptoms can be hard to identify, thus making it difficult to diagnose the disease early which is essential for life-saving surgery.

Despite the rise in death rates and dreadfully low survival rates, pancreatic cancer receives less than 2% of all cancer research funding in Europe.

Markus Peck, UEG expert, explains, “If we are to take a stand against the continent’s deadliest

of the microbiome on pancreatic cancer is a particularly exciting new area, as the pancreas was previously thought of as a sterile organ. Such research will also improve our understanding of the microenvironment in a metastatic setting and how the tumour responds to its environment. This will inform the metastatic behaviour and ultimately alter disease progression.”

“With continued investment in pancreatic cancer research, we should have new, important findings within the next five years and, hopefully, find that targeting the microbiome Prof Thomas SEUFFERLEIN is a pancreatic cancer expert at United European Gastroenterology (UEG) as well as tumour cells will significantly improve treatment outcomes and cancer, we must address growth and enable the reduce death rates”, adds the insufficient research body to develop its own Professor Seufferlein. funding; that is where the ‘defence mechanism’.

References: European Union can lead The microbial population the way.

1. Pancreatic Cancer Across of a cancerous pancreas Europe: Taking a united Whilst medical and has been found to be stand (2018). Published scientific innovations approximately 1,000

by United European have positively changed times larger than that Gastroenterology. the prospects for of a non-cancerous 2. Ferlay J., Partensky C., many cancer patients, pancreas and research Bray F. More deaths from those diagnosed with has shown that removing pancreatic cancer than breast pancreatic cancer bacteria from the gut cancer in the EU by 2017. have not been blessed and pancreas slowed ACTA Oncologica, August with much clinically cancer growth and 2016. meaningful progress. To ‘reprogrammed’ immune 3. Our World In Data, deliver earlier diagnoses cells to react against Cancer death rates by type and improved treatments cancer cells. (per 100,000), world. we need to engage now Available at: https:// This development in more basic as well ourworldindata.org/cancer could lead to significant as applied research to changes in clinical 4. European Cancer see real progress for our practice as removing Information System patients in the years to (ECIS), Estimates of cancer bacterial species could come.” incidence and mortality in improve the efficacy 2018, for all cancer sites.

Microbiome – the key of chemotherapy or to turning the tide? immunotherapy, offering 5. Pancreatic Cancer Europe, 10 things you need to know hope that clinicians will After forty years of about pancreatic cancer. finally be able to slow limited progress in Available at: https://www. tumour growth, alter pancreatic cancer pancreaticcancereurope.eu/ metastatic behaviour and research, experts claim work-streams/awarenessultimately change the that new treatment and-diagnosis/3$CEstRela disease’s progression. options could finally tiveCanc$X1_8-3$X1_9be on the horizon as Professor Thomas AE28 researchers investigate Seufferlein, pancreatic how changing the cancer expert, pancreas’ microbiome comments, “Research may help to slow tumour looking at the impact Government Gazette | 21

healthcare

The state of cancer policy in Europe

Fighting for equal access to medicines for childhood cancer

S

urvival for many adults with cancer has significantly improved in recent years thanks to innovative targeted drugs. Innovative and experimental therapies are curing the more difficult to treat cancers like never before in today’s ‘golden age’ of cancer research.

ghost trials where there are too few patients recruited to the trial for any useful data to be collected.

This occurred with a drug for the treatment of melanoma, which was approved in Europe for adults in 2012. A trial for adolescents with melanoma was opened in 2011 in ten countries and four continents.

Four years later, still only six patients had been recruited (Gaspar et al, 2018).

However, such treatments for children/adolescents regrettably still lag far behind. Today, the vast majority of children are still treated with conventional chemotherapy, which may lead to long term health problems due to the late effects of treatments.

Children and adolescents often do not benefit from potentially lifesaving treatments mainly because clinical trials often exclude those aged 18 years and below.

The reason for this is not related to safety and science but simply because ‘this is the way things have been done’.

If adult trials were more flexible with their age of entry, this could generate more opportunities for better access to medicines for children and adolescents with cancer.

Children and adolescents often do not benefit from potentially life-saving treatments mainly because clinical trials often exclude those aged 18 years and below. The state of care and access to medicines can drastically change if adult trials were more flexible with their age of entry. www.governmentgazette.eu | 22

Breaking out of the status quo So why do we typically do the things that we do?

Because it is what we’ve always done, we feel it is the most suitable way of doing something, or it might just be easier.

It doesn’t require us to challenge and change anything. Of course, there is nothing wrong with the status quo as long as it is working, thriving and flourishing.

Prof Pamela KEARNS is the President of SIOP Europe (SIOPE) But the status quo for children/adolescents with cancer is not acceptable.

The reality is that each year across Europe, more than 35,000 children and adolescents are diagnosed with cancer and 6000 die from their disease.

It is said that ‘children are our future’, and so it is surprising to learn how far research into young people’s cancer are far behind those for adults.

What can be done to challenge this status quo? There is an urgent need for the cancer research community to make clinical trials more inclusive for both better science and because this could save more lives.

Separating children and adults in clinical trials It is quite remarkable that oncologists are making breakthroughs

in cancer care, but we’re not able to get these treatments to children fast enough.

In a study in 2016, Whelan and Fern demonstrated that out of 49 trials of cancers common in teenagers and young adults, only six had age eligibility criteria that corresponded to the biological age range of the diseases.

Current clinical trials that are ‘adult-only’ are in fact holding back young people from getting access to new treatments.

For example, a new drug for Hodgkin’s Lymphoma was approved for adults in 2012. However, a paediatric trial for the same drug and the same disease was still ongoing in 2016. Current practices also lead to

We need to overcome this artificial idea of separating children and adults in clinical trials.

We should instead rethink the idea of someone turning 18 and suddenly becoming an adult. This artificiality is failing children and young people with cancer but is also hurting medicine.

FAIR(Fostering Age Inclusive Research) Trials to change the status quo Th eFAIR Trials working group was set up to facilitate age inclusive research. The key proposal is for the age of entry to clinical trials be reduced to 12 years in all early phase studies (where medically justified), with no need of a prior paediatric trial. This may look like an ambitious target, but there is no great obstacle in terms of law, regulation or safety.

The issue is rather one of awareness and generating willingness within the research community.

The FAIR Trials working group therefore intends to work towards a culture change through: 1. Identifying trials that are truly age inclusive

and give visibility to these success stories; 2. Engaging with ethics committees, national and international research networks and with industry; 3. Giving media visibility to the topic of FAIR Trials.

There is a growing body of evidence supporting the need for age inclusive research and this factbased information should reach all stakeholders to enable a culture change.

Many assume that children with cancer would be at the front of the queue for newly developed drugs, but sadly the reverse is true.

FAIR Trials is trying to change this reality.

Together, we should remove the age limits for clinical trials.

There is a need for better and stronger partnership between scientists, clinicians and pharma companies, particularly since significant improvements have to be made when trying to identify which drugs should be developed.

Going forward, it is crucial to have a multistakeholder collaboration especially with industry.

The science is evolving and, as more knowledge emerges about the fundamental drivers of paediatric oncology, there has to be a willingness and an openness by industry to work together with all those seeking to remove this artificial age barrier and deliver better health care.

Professor Pamela Kearns, President SIOPE said: “EU regulations don’t say that a young person

Many assume that children with cancer would be at the front of the queue for newly developed drugs, but sadly the reverse is true. FAIR Trials is trying to change this reality.

should not be included in trials, but this is just the way boundaries have been set historically. It is my hope that age limits will not be a barrier in the future.

We don’t look at the fact that a child is below or above 18 years of age. It is about the way the drug works, the biology of the

disease and the needs of the patient. That’s where the future of clinical trials needs to be.”

In such a context, it is very important for the European paediatric community to work closely with parent groups and pharma companies to get targeted anti-cancer drugs to

children and adolescents as soon as possible.

For the children and adolescents suffering now, change can’t come fast enough.

Government Gazette | 23

healthcare

The state of cancer policy in Europe

beating childhood cancer

Towards zero deaths and zero late effects

opinion

The SIOP Europe and CCI Europe Manifesto for the European Elections of 2019 was launched at the International Childhood Cancer Awareness Day event hosted

by MEP Elena Gentile (IT, S&D) at the European Parliament on 6 March 2019. MEPs Alojz Peterle (SL, EPP), President of the MEPs Against Cancer (MAC) Group, and Lieve Wierinck (BE, ALDE) also contributed on this occasion.

T

he paediatric oncology and haematology community in Europe together with parents, patient and survivors invites the next European Parliament to sustain and reinforce its support for the paediatric cancer cause.

Despite some progress, paediatric cancer remains a major public health and social issue in Europe as cancer remains the main cause of death by disease in Europe in children aged one year and over. Each year, more than 35,000 children and young people are diagnosed with cancer and more than 6,000

Lieve WIERINCK MEP is member of EP’s Members against Cancer Group www.governmentgazette.eu | 24

young patients die of cancer. Moreover, there will be nearly half a million childhood cancer survivors by 2020-2025.

Over two-thirds of these childhood cancer survivors experience long-term health and psychosocial problems due to their disease and treatment, which may be severe and affect their daily life and participation as EU citizens.

Our 2019 European Elections Manifesto, launched and adopted on 6 March, gives key recommendations to the MEPs: 1. To advance an enabling legislative environment for faster and more efficient development of affordable innovative medicines for children with cancer and other life-threatening diseases 2. To foster allocation of resources to childhood cancer research with an increased focus on big data and deep learning tools

3. To ensure sustainability of the European Reference Networks (ERNs), of which ERN PaedCan is dedicated to paediatric cancer, especially to combat inequalities in access to the best available treatment and expertise for children across Europe 4. To support collaborative efforts on the development and implementation of appropriate surveillance guidelines and longterm models of care for survivors of childhood cancer 5. To support initiatives on interoperability, harmonisation and security of eHealth platforms to foster cross-border research and knowledge transfer for the benefit of childhood cancer patients and survivors 6. To support initiatives that foster and promote patient advocacy and empowerment in research, healthcare, and

Alojz PETERLE MEP is President of EP’s

Members against Cancer Group

socio-economic areas Individual types of cancer in children and adolescents are rare, but taken together, they represent a leading public health and socio-economic issue in Europe.

The rarity of individual paediatric cancer types and their high collective health burden across Europe make coordinated EU level approaches crucial. Patients and affected families stand to gain considerably from pan-European cooperation in both research and healthcare.

Ensuring equal rights and adequate social protection for parents, patients and survivors is an important underlying priority.

EU legislative processes should be proactively monitored so they integrate the health, research and socioeconomic needs of the paediatric haematology oncology community into new initiatives.

Elina GENTILE MEP is President of EP’s

ENVI Committee

The European Elections 2019 will be an important opportunity to raise further political awareness and consolidate the support for the childhood cancer cause in Europe.

During its 2014-2019 mandate, the European Parliament provided resolute support to the paediatric oncology and haematology community. Key milestones included:Launch of the SIOP Europe Strategic Plan – A European Cancer Plan for Children and Adolescents in cooperation with the MEPs Against Cancer Group (MAC); European Parliament vote on the resolution regarding the Paediatric Regulation; Celebration of 20 years of action towards a brighter future for children and adolescents with cancer at a special event in cooperation with the MEPs Against Cancer Group (MAC); Expression of continuous commitment and support from our champion MEPs at the Annual International Childhood Cancer Awareness Day event at the European Parliament. We are very grateful for the drive, commitment and support the outgoing legislators have shown

to the paediatric cancer cause.

MEP Elena Gentile (IT, S&D) said: “During the current European Parliament term, we have gathered many times to state the urgent public health and societal issues that childhood cancer continues to pose in Europe.

We have also formulated solutions and most importantly took resolute actions to advance the necessary changes. The European Elections 2019 will be an important opportunity to raise further political awareness and consolidate the support for the childhood cancer cause in Europe.”

Professor Pamela Kearns (SIOP Europe President) said: “The keywords that have been crucialare:working together, collaboration and partnership. Such firm and committed alliances have enabled

us to make progress in paediatric oncology over the past 20 years.

Working together and collaboration are at the heart of improving outcomes for childhood cancers.”

Anita Kienesberger(CCI Europe) said: “It is crucial that our lawmakers at the European level support the vision of

The rarity of individual paediatric cancer types and their high collective health burden across Europe make coordinated EU level approaches crucial.

collaboration with all stakeholders on research and healthcare initiatives by encouraging patient, parent and survivor empowerment, with consideration for the socio-economic dimension.”

Both SIOP Europe and CCI Europe are committed to working with the incoming European legislators to meet the challenges that greatly impact children/adolescents cancer patients and survivors’ lives. With elections to the European Parliament due soon, the entire paediatric cancer community looks forward to paediatric cancer staying high on the agenda for the upcoming legislature.

Government Gazette | 25

healthcare

The state of cancer policy in Europe

Failures in colonoscopy affect detection of colorectal cancer across Europe

L

eading European gastroenterologists are calling for widespread improvements in the quality of colonoscopy throughout the continent to help reduce colorectal cancer (CRC) mortality rates.

Traditionally considered a disease that affects people over the age of 50, CRC is the second most common cancer across Europe, with approximately 500,000 new cases every year and incidence rates higher in men than women. Studies have found that young-onset CRC is often more aggressive and more likely to be diagnosed at an advanced stage than CRC in older populations.

Strong evidence supports that screening for CRC reduces incidence and mortality rates,

www.governmentgazette.eu | 26

although many CRC screening programmes in Europe commence at the ages of 50 and 55. Inequalities in the type of screening offered, as well as participation and detection rates, are currently present throughout the continent.

Dr Vuik adds, “The highest increase in incidence was found in adults between 20-29 years of age. Therefore, identifying those young adults at high risk of CRC is essential to ensuring early diagnosis and optimal patient outcomes.”

Colonoscopy is a widely performed procedure for patients with lower gastrointestinal symptoms, conducted to aid CRC detection and explore causes of unexplained changes in bowel habits. An integral element of CRC screening programmes, it is fundamental

Leading CRC expert, Professor Evelien Dekker, from United European Gastroenterology (UEG), explains, “Progression from non-cancerous polyps to colorectal cancer will usually take between 10-15 years, leaving a long window of opportunity to detect and even prevent this disease. Besides prevention, early detection of colorectal cancer can lead to a 90% chance of survival and, to ensure these survival rates are achieved, high levels of quality in colonoscopy procedures are essential.”

practice example for the rest of Europe after becoming the second European country to report on quality indicators of colonoscopy.[1] Their CRC screening programme demonstrates the highest participation levels across the continent [73%] and recent pilot and implementation studies have taken place to investigate the most effective way of organising screening programmes, including the choice of the screening method and how to encourage participation from members of the public.[2] “Our studies concluded that the Faecal Immunochemical Test (FIT) is the optimal screening method”, commented Professor Dekker.

“Those with a positive result are referred for a colonoscopy.”

Experts believe that the Netherlands can act as a best

A key indicator of colonoscopy quality are rates of post-

that colonoscopy procedures are of the highest possible quality to maximise early cancer detection and ensure patient comfort and wellbeing.

Prof Evelien DEKKER is a member of the UEG Public Affairs Committee and a CRC screening expert at the Amsterdam University Medical Centers

colonoscopy colorectal cancer (PCCRC)[3], which occurs when individuals receive a negative colonoscopy result but are subsequently diagnosed with cancer. Whilst this can be the result of a rapidly growing new tumour that was not present during the colonoscopy, it is more commonly an indicator of suboptimal endoscopy quality.

PCCRCs are more likely to be diagnosed at a later stage than screen-detected cancer[4], decreasing the chance of survival.

To ensure colonoscopy is performed at a quality level that minimises the incidence of PCCRCs, the Dutch CRC screening programme outlines certain criteria and requirements for endoscopists conducting the procedure. In line with this, the European Society of Gastrointestinal Endoscopy (ESGE), in collaboration with UEG, has recommended seven

key performance measures that should be adopted across Europe.

“We believe that our Dutch experience can serve as an example for colonoscopy quality assurance programmes across Europe”, comments Professor Dekker. “As well as ensuring that the programme maximises detection rates, the criteria assesses patient comfort scores so we can analyse and account for the wellbeing of our patients.

Performing procedures that are as comfortable as possible for patients will help to reduce the negative stigma associated with colonoscopy.”

References: 1. Gastrointestinal Endoscopy.

2019. Quality assurance of colonoscopy within the Dutch national colorectal cancer screening program.

2. Dutch Ministry of Public Health. 2019. Available

at: https://www.rivm.nl/ bevolkingsonderzoekdarmkanker-voor-professionals/ achtergrond-en-ontwikkelingen/ feiten-en-cijfers. (Accessed 14 March 2019).

3. BMJ. Post-colonoscopy colorectal cancer (PCCRC) rates vary considerably depending on the method used to calculate them: a retrospective observational populationbased study of PCCRC in the English National Health Service. Available at: https://gut. bmj.com/content/64/8/1248.

(Accessed 14 March 2019).

4. United European Gastroenterology. One in four cases of CRC diagnosed within two years of a negative screening result. Available at: https:// www.ueg.eu/press/releases/ ueg-press-release/article/onein-four-cases-of-crc-diagnosedwithin-two-years-of-a-negativescreening-result/. (Accessed 14 March 2019).

5. ECIS. Estimates of cancer incidence and mortality in 2018, for all cancer sites.

Available at: https://ecis. jrc.ec.europa.eu/explorer. php?$0-0$1-AE28$4-1,2$3All$6-0,14$5-2008,2008$78$2-All$CEstByCancer$X0_83$CEstRelativeCanc$X1_83$X1_9-AE28. (Accessed 14 March 2019).

6. ECIS. Estimates of cancer incidence and mortality in 2018, for all cancer sites.

Available at: https://ecis. jrc.ec.europa.eu/explorer. php?$0-0$1-AE28$4-1,2$3All$6-0,14$5-2008,2008$78$2-All$CEstByCancer$X0_83$CEstRelativeCanc$X1_83$X1_9-AE28/. (Accessed 14 March 2019).

7. Gastrointestinal Endoscopy.

2019. Quality assurance of colonoscopy within the Dutch national colorectal cancer screening program.

8. NCBI. 2017.Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. Available at: https:// www.ncbi.nlm.nih.gov/ pubmed/28507745. (Accessed 14 March 2019).

Government Gazette | 27

transport

Life-saving technologies in vehicles

EU action on infrastructure and vehicle safety could dramatically reduce road deaths

A

tleast 25,300 people lost their lives on EU roads in 2017, a figure that has hardly changed in four years. The number of annual road deaths reduced by 20% between 2010 and 2017 but we are still way behind where we need to be to reach the EU target of cutting deaths by half over the decade to 2020.

Members of the European Parliament’s Committee on Internal Market and Consumer Protection (IMCO) voted in February to approve a range of new vehicle safety standards.

But two initiatives announced by the European Commission in May last year could help get us back on the right road.

The first is an update to minimum road infrastructure safety standards in the EU. Under a provisional deal agreed by the European Parliament, Council and Commission in February 2019, these rules will be now be extended to cover national roads.

The legislation represents a major step forward for road safety in Europe, and could save 25,000 lives within fifteen years of coming into force. But it will only apply to new vehicles.

So it’s incredibly important that a final deal is reached as soon as possible, so cars with these new safety features fitted as standard start driving off production lines sooner rather than later. www.governmentgazette.eu | 28

Existing EU rules already require governments to carry out regular road safety audits, identify high-risk sites and prioritise safety when building new roads but the legislation currently applies only to major European roads known collectively as the TransEuropean Transport Network (TEN-T).

The revised version of the rules would extend these measures to all motorways, all “primary roads” and all non-urban roads that receive EU funding. ETSC, and other organisations, have been calling for all main urban and rural roads to be covered. But EU policymakers did not agree to extend the mandatory rules that far, though countries will still be able to go further if they wish.

Antonio AVENOSO is the Executive Director of the European Transport Safety Council (ETSC) According to research for the European Commission, the proposed measures could save 3,200 lives and prevent more than 20,000 serious injuries over the period 20202030.

The legislation contains the introduction of new procedures that will lead to better road design, better safety management, and more high risk sites being treated. Ultimately we would like to see this approach applied to every road in the EU – but this deal is nevertheless an important step forward.

Road authorities will be able to choose some lowrisk roads, or roads with little traffic to opt-out of the legislation. However, those decisions will be subject to oversight from the European Commission, who will also publish a map of roads covered by the rules.

The EU has also

agreed that common specifications for road signs and road markings across Europe should be developed. A high standard of road signs and road markings across Europe could be an important issue for higher levels of automation, when cars increasingly take away control from the driver under certain circumstances.

For the first time, the legislation will also require road management authorities to take into account the safety of vulnerable road users, such as pedestrians and cyclists when planning and managing road infrastructure.

The informal political deal will now have to be approved officially by both the European Parliament and Member States before becoming law.

The second initiative concerns new vehicle safety technology.

The measures include new crash testing requirements, mandatory installation of driver assistance systems including Automated Emergency Braking (AEB) with pedestrian and cyclist detection, overridable Intelligent Speed Assistance (ISA) and Emergency Lane Keeping, as well as a new direct vision standard for lorries and buses to enable drivers to have a better view of other road users around their vehicle.

The requirements also include installation of Event Data Recorders, which record critical information on the status of a vehicle in the moments before a collision and, as in the aviation sector, could help crash investigators understand the causes of collisions in order to help prevent them in the future.

The legislation represents a major step forward for road safety in Europe, and could save 25,000 lives within fifteen years of coming into force.

But it will only apply to new vehicles. So it’s incredibly important that a final deal is reached as soon as possible, so cars with these new safety features fitted as standard start driving off production lines sooner rather than later.

Minimum vehicle safety standards in the EU were last updated in 2009, so there is no time to lose.

ETSC is urging policymakers to do their utmost to achieve a final agreement before the upcoming elections at the European Parliament.

New measures to make safety features compulsory in new cars

E

U roads are the safest in the world with an average of 49 road fatalities per million inhabitants, against 174 deaths per million globally. Road fatalities in the EU have more than halved in the last two decades, but the latest figures show that the decline in the fatality rate is stagnating and that further efforts are needed to improve road safety and save lives.

Polish EPP rapporteur Róża Thun MEP, said: “Intelligent Speed Assistance will provide a driver with feedback, based on maps and road sign observation, whenever the speed limit is exceeded. We do not introduce a speed limiter, but an intelligent system that will make drivers fully aware when they’re speeding. This will not only make all of us safer, but also help drivers to avoid speeding tickets.”

The new rules, adopted on 16 April, will make advanced safety equipment mandatory in all new road vehicles sold on the EU market. They are likely to apply as from May 2022 for new models and from May 2024 for existing models.

What would change?

The rules aim to adapt existing legislation to take into account technological developments and social trends such as an aging population, new causes of distraction for drivers (especially the use of electronic devices while driving) and the increasing number of cyclists and pedestrians on EU roads.

• Driver drowsiness and attention warning

• All new vehicles will have to include about 30 life-saving technologies.

Among them: • Intelligent speed assistance to make a driver aware when exceeding the speed limit

• Advanced driver distraction warning to help keep attention on the traffic situation • Emergency stop signal in the form of a light, signalling road users behind the vehicle that the driver is braking suddenly

• Reversing detection system to avoid collisions with people and objects behind the vehicle, with the help of a camera or a monitor • Tyre pressure monitoring system warning the driver when a loss of pressure occurs • Alcohol interlock installation facilitation allowing aftermarket alcohol interlock devices to be fitted • Event data recorder to register relevant data shortly before, during, and immediately after a road accident • For passenger cars and light commercial vehicles, it will also be mandatory to have an emergencybraking system - already compulsory for lorries and buses - as well as an emergency lane-keeping system.

• Trucks and buses will be required to include direct vision features, allowing the driver to see vulnerable road users, and alert systems detecting the presence of cyclists and pedestrians in the immediate vicinity of the vehicle.

• Compulsory safety features could drastically reduce the number of road fatalities, given that human error is involved in about 95% of all road

traffic accidents.

The rules will also have to be approved by the Council before they can enter into force.

Government Gazette | 29

Government Gazette A report by the Government Gazette Roundtable Unit

Breast cancer report A multistakeholder collaboration

Policy Roadmap to

IMPROVE MANAGEMENT

of the Cancer Burden in Europe The Breast Cancer Report aims to inform a coherent policy approach to Breast Cancer prevention, control and treatment at European, regional and national levels. It provides policymakers with key information and recommendations.

CONTENTS Our thanks are due to the following experts who have offered their expert insights to improve breast cancer treatment and management in Europe

Executve Summary

Expert Recommendations

PART I : Background The state we are in and why breast cancer matters now PART II : Call fot Action Policy recommendations tabled at the iCPS Breast Cancer Europe 2018 PART III : Expert Recommendations Independent policy recommendations from policymakers, breast cancer experts and academics

Working through cancer Dr Fatima CARDOSO

Director Breast Unit, Champalimaud Clinical Center, ESMO Board of Directors & Director of Membership, Chair ABC Global Alliance

Implementation of breast clinics Dr Martine PICCART-GEBHART

Chair, Breast International Group and Former President, European Society for Medical Oncology (ESMO)

Promoting high standards of breast cancer surgery Dr Tibor KOVACS

Executive Director, European Society of Surgical Oncology (ESSO)

The importance of multidisciplinary approach Dr Lorenza MAROTTI Executive Director, EUSOMA

European Commission Initiative Luciana NEAMTIU

Project Officer, Healthcare Quality Team & Cancer Information Team, Directorate General Joint Research Centre, European Commission Initiative on Breast Cancer

Avoiding recurrence and metastasis in women Dr Hiltrud BRAUCH

Deputy Head, Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

Exercise as medicine for cancer survivors Yvonne WENGSTROM

Professor and Director of Nursing Development Neurobiology Care Science and Society, Nursing, Karolinska Institutet

Transforming breast cancer care in Europe Susan KNOX

Professor and Director of Nursing Development Neurobiology Care Science and Society, Nursing, Karolinska Institutet

The state we are in 1.

Breast cancer is the most commonly occurring cancer in women and the second most common cancer overall, with over 2 million new cases in 2018.

2.

According to GLOBOCAN 2018, breast cancer was by far the most common cancer among women in 2018 (24%), with 2.1 million people diagnosed and no fewer than 627,000 deaths worldwide, of which 98,755 in Europe.

3.

4.

It is the cancer that causes the most deaths in absolute terms. Breast cancer incidence rates are highest in the so-called developed regions (Australia, New Zealand, Europe and North America), but the world record is held by Belgium with 188 cases per 100,000 women.

The European Cancer Information System (ECIS) estimates that 404,920 women in Europe were diagnosed with breast cancer in 2018.

D

espite significant advancements in treatment pathways, there are clear inequalities in access to rapid diagnosis and treatments across Europe. While there are several good breast cancer services across the continent, wide variations in healthcare systems have resulted in inequalities in multidisciplinary care. Metastasis is the leading cause of breast cancer deaths, killing half a million people per year across the world, yet quality of life and survival of patients living with metastatic breast cancer.

While many groups have worked to identify the remaining gaps in the provision of care, the goal of this report is to examine Europeâ&#x20AC;&#x2122;s preparedness, assess current policy guidelines and schemes, explore new ways to improve prevention, diagnosis and treatment and discover practical solutions in order to build comprehensive prevention plans and ensure that effective measures, policies, and interventions would be in place.

The recommendations in this report are the result of desk research, includes expert editorials from industry leading stakeholders and have emerged from the conversations among the experts participating in the iCPS Breast Cancer Europe Roundtable 2018, with a view to making practical and actionable recommendations across the breast cancer care pathway, in order to facilitate and accelerate breast cancer research and improve treatments and quality of life for all women and men with breast cancer.

The call for action is addressed to policymakers at EU and national levels, healthcare professionals, academia, advocates, patients and members of the cardiac health community and required collective and collaborative approach across all member states.

healthcare

Policy Roadmap to improve management of breast cancer in Europe

Call for action The European Commission and the European Parliament should call on member states to make Specialised Breast Units (SBUs) mandatory by law.

Europe should advocate an approach towards personalised medicine and filter patients to improve treatment outcomes.

It is crucial to have a more systematic and organised approach towards screening of breast cancer.

It is crucial that governments ensure the implementation of uniform guidelines across member states and facilitate uniform and superior multidisciplinary care throughout Europe.

The European Commissionâ&#x20AC;&#x2122;s Joint Research Centre should stimulate strategies to gather and process continuous, complete, consistent and relevant data around the epidemiology, incidence and burden of breast cancer in Europe.

Our Breast Cancer Policy Recommendations come from the latest iCPS Breast Cancer Roundtable and from the conclusions of an independent panel of experts â&#x20AC;&#x201C; including policymakers, breast cancer professionals, academics and industry leaders

Breast cancer is the second most common cancer killer in Europe with metastasis accounting for most of cancer deaths. However metastatic breast cancer is yet to receive the required attention from policymakers. With an aim to close the gap on metastatic breast cancer and to brainstorm ways to improve prevention, diagnosis and treatment of breast cancer in Europe, the International Centre for Parliamentary Studies (ICPS) recently brought together policymakers, breast cancer professionals, academics and industry leaders at a high-level policy roundtable in Brussels.

www.governmentgazette.eu | 32

How can Europe manage breast cancer effectively?

W

ith more than 360,000 new cases per year, breast cancer is the most frequent cancer in the European Union, even when considering men and women together.

It is the 2nd biggest killer after lung cancer with 91,000 deaths per year. Metastasis is the leading cause of breast cancer deaths, killing half a million people per year across the world, yet quality of life and survival of patients living with metastatic breast cancer remains vague. The exact number of people living with metastatic breast cancer (MBC) is currently unknown. Moreover, there is a gap between

he public understanding and patient experience of MBC. Despite significant advancements in treatment pathways, there are clear inequalities in access to rapid diagnosis and treatments across Europe. While there are several good breast cancer services across the continent, wide variations in healthcare systems have resulted in inequalities in multidisciplinary care.

For instance, the average 5-years survival rate in Northern Europe is high at 85% compared to Eastern Europe where it is 75%.

For change to happen, we need regulatory measures that reduce the discrepancies in screening

and diagnosis; improve treatment modalities and perk up the quality of life. In order to examine the ongoing policy challenges in managing breast cancer in Europe and explore strategies to improve treatment and care pathways, the International Centre for Parliamentary Studies recently convened a high-level policy roundtable on June 27, 2018 in Brussels. The goal of the roundtable was to examine the Europeâ&#x20AC;&#x2122;s preparedness, assess current policy guidelines and schemes, explore new ways to improve prevention, diagnosis and treatment and discover practical solutions in order to build comprehensive prevention plans and

iCPS Breast Cancer Europe 2018

Breast matters

B

reast cancer is the most commonly occurring cancer in women and the second most common cancer overall, with over 2 million new cases in 2018.

Breast cancer incidence rates are surprisingly high in the so-called developed regions such as Australia, New Zealand, Europe and North America, but the world record is held by Belgium with 188 cases per 100,000 women.

According to recent figures (GLOBOCAN 2018), breast cancer was by far the most common cancer among women in 2018 (24%), with 2.1 million people diagnosed and no fewer than 627,000 deaths (72 deaths per hour) worldwide, of which 98,755 in Europe.

The European Cancer Information System estimates that 404,920 women in Europe were diagnosed with breast cancer in 2018.

Fortunately, mortality rates are falling thanks to the research conducted to date, which has led to more personalised treatments.

Though the overall risk of dying from breast cancer has been decreasing over the years; there is a wide variation in these mortality rates across several member states, particularly owing to significant disparities in treatment and care and late diagnosis associated with advanced stage cases of breast cancer.

According to the CONCORD study, five-year relative survival for breast cancer in Europe ranged from 57.9% and 62.9% in Slovakia and Poland, respectively, to 75.5%, 79.8%, and 82% in Germany, France, and Sweden with regional variations evident.

Rates of incidence are higher in western European countries, partly owing to availability to early detection through screening and care.

ensure that effective measures, policies, and interventions would be in place. Chaired by Prof Robert Mansel CBE, former president of the European Society of Breast Cancer Specialists (EUSOMA) and a world-renowned expert in breast cancer research, the Breast Cancer Europe Roundtable 2018 brought together 40 breast cancer experts from more than 15 European countries to analyse the ongoing

policy and clinical challenges in managing breast cancer patients, weigh up strategies to improve outcomes of metastatic patients and develop a roadmap for consistent, premium and multidisciplinary cancer care in Europe. Delegates included members of the European Parliament, senior representatives from the European Commission, breast cancer professionals, patient groups, academics, industry

leaders and other key stakeholders.

Following a briefing about the descriptive epidemiology of breast cancer in Europe, the day’s discussion commenced with policy updates from representatives of the European Commission and European Parliament, who presented an overview of the ongoing policy efforts in the European fight against breast cancer.

According to Europa Donna, the situation in Romania is the worse, and “exemplifies these disparities well”. A study conducted by The Coalition for Women’s Health indicates that Romania’s average survival rate for patients with breast cancer is almost 10% lower than the EU’s average, despite the lower incidence of the disease. According to the study, there would be three possible reasons for this worrying discrepancy: the lack of a national screening program, inadequate education and insufficient financial resources for breast cancer care.

Another statistic uncovered by the Coalition for Women’s Health report is that for women over 65, the mortality due to breast cancer has increased by 28% in Romania in the period 1990-2013. Over the same time, the mortality rate in the EU has decreased by 14% in the same age range.

The lack of a viable national screening program has disadvantaged patients’ health in Romania.

Indeed, Romania ranks second to last in Europe for the percentage of women who have had a mammogram test in their lives.

Government Gazette | 33

healthcare

Policy Roadmap to improve management of breast cancer in Europe

Reducing inefficiencies, improving outcomes The group unanimously accepted that, while there have been tremendous effort to advance the management of early breast cancer, there is considerable room for improving treatment, care and support to patients with metastatic breast cancer. They presented the following key recommendations to support policy making.

Delegates 2018: Oncologist, Antwerp University Hospital (UZA), Consultant Breast and Oncoplastic Surgeon, Bedford Hospital NHS Trust, Breast Surgeon, Breast Center Zurich, Plastic Surgeon, Breast Centre American Medical Center, Consultant Radiologist, Clinical Lead and Director of Breast Screening, Bristol Breast Cancer Centre North Bristol NHS Trust, Head of BreastScreen Norway, Cancer Registry of Norway, Breast Surgeon, Centre Hospitalier Universitaire de Liège (CHU), Plastic & Reconstructive Surgeon, CHC - Liege, Gynecologist specialized in senology and in colposcopy, CHU - Liege, Epidemiologist & ECIBC Working Group Member, Center for Cancer Prevention, Deputy Director, Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Corporate Affairs, Oncology, Eli Lilly & Company, Medical Oncologist Erasmus MC Cancer Institute, Past-President / Emeritus Professor of Surgery & Breast Cancer Europe Chair, EUSOMA / Cardiff University School of Medicine, National Co-ordinator / Breast Surgeon, Europa Donna, President-Elect, European Society of Surgical Oncology (ESSO), Project Officer, European Commission Initiative on Breast Cancer (ECIBC), Member of the European Parliament’s MAC Group, Treasurer, FECMA - Spanish Breast Cancer, Chairman, Breast Cancer Group, Gustave Roussy, President, Hellenic Senologic Society, Head, Institut Bordet J.-C. Heuson Breast Cancer Translational Research Laboratory (BCTL), Head of the Department of Surgery, LKH Graz Süd-West, Medical Doctor, Marmara University Training Hospital, Breast Unit Coordinator, Parc de Salut Mar, Barcelona, Consultant Oncoplastic Breast Surgeon, Pennine Acute Hospital NHS Trust, Breast Clinic Director, Portuguese Oncology Institute (IPO), Head of Clinical Research Department, SOLTI Breast Cancer Group Hospital 12 de Octubre, Professor of medical genetics and cancer epidemiology, St. Mary’s Hospital - University of Manchester, Reg. Nurse, Swedish Cancer Nurses Society, Director, Think Pink, President, Ukrainian Anti-Cancer Institute in Vienna, Technical Officer, WHO Regional Office for Europe

www.governmentgazette.eu | 34

Policy recommendations 1. More public awareness among patients and policymakers should be generated about the European Commission initiative on Breast Cancer (ECIBC) which aims to harmonise the quality of the entire breast cancer care pathway across Europe; 2. While primary prevention of breast cancer is often quite complicated and predominantly biology-driven, national governments should increase social investment on prevention strategies and health-literacy efforts to increase awareness about risk factors; 3. Whilst several European countries boast of good breast centres, access to diagnosis and treatments have been quite varied across the continent. It is therefore crucial to have a more systematic and organised approach towards screening of breast cancer; 4. In the EU, 53% of breast cancer occurs among women who are out of the age range for

screening (that is 50-70 in most countries).

Therefore rapid diagnosis of symptomatic cancers which present at GP level should not be overlooked.

5. Despite the mushrooming of specialist breast centres across Europe, not all of them are fully accredited to provide superior multidisciplinary care to patients; 6. The European Commission and the European Parliament should call on member states to make Specialised Breast Units (SBUs) mandatory by law to increase patient outcomes and access to quality care; 7. It is important to ensure the issue of metastatic breast cancer is kept firmly on the European Parliament’s agenda. Policymakers must recognise the unique needs of patients with metastatic disease in national cancer plans.

8. The European Commission’s Joint Research Centre should develop clear guidelines on how to treat elderly

women with metastatic breast cancer. Each multidisplinary team (MDT) should have trained specialists to treat geriatric patients and patients with the advanced disease; 9. EU and national policymakers should encourage and support collaboration between the research and clinical communities in the development of statistical and methodological tools that address the need for proper data analysis, while overcoming existing data challenges; 10. Limited data on MBC’s distinctiveness from early breast cancer remains an issue which affects access to quality treatment and support services, thereby affecting patient outcomes. The European Commission’s Joint Research Centre should stimulate strategies to gather and process continuous, complete, consistent and relevant data around the epidemiology, incidence and burden of breast cancer in Europe. Data collection and data monitoring has to be

benefits;

made in an optimal setting in order to better inform the decisionmaking process; 11. Policymakers should develop strategies to increase access to quality breast care across Europe.

Every patient should have the option to be treated in accredited breast centres;

It is important to ensure the issue of metastatic breast cancer is kept firmly on the European Parliament’s agenda.

Policymakers must recognise the unique needs of patients with metastatic disease .

12. Treatment efficacy 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 the side effects.

Europe should encourage and provide greater access to geriatric assessment in the older cancer population as it has been shown to have major

13. There is a clear need to improve the presence of patient representatives as new treatment modalities cannot be built without understanding and addressing the requirements of breast cancer patients. Apart from this, there is also a need for universal policy to implement and bring the innovations to the patients; 14. As there is a need for a pan-European collaboration and widespread use of data to improve patient outcomes, policymakers should toughen the national capacity to collect, analyse and use representative data on the burden and trends of

early and advanced breast cancers and its key risk factors; 15. Supportive and palliative care that alleviates symptoms, physical pain as well as psychological suffering is a human right for all breast cancer patients. In addition, every patient with an advanced disease should have an option to have a cancer nurse navigator; 16. Wide variations in healthcare systems have lead to inequality in access to care. It is crucial that governments ensure the implementation of uniform guidelines across member states and facilitate uniform and superior multidisciplinary care throughout Europe.

More importantly, there

should be no difference in quality assurance between private and public breast cancer centres; 17. Europe should advocate an approach towards personalised medicine and filter patients to improve treatment outcomes; 18. In order to improve quality of multidisciplinary care, policymakers should invest more on training programmes for surgical oncologists and specialist breast surgeons; 19. Finally, there is a crucial need to close the gaps between policy and clinical practices by sharing best practices between member states.

Where should Europe act?

I

n Italy, if a mother or wife wants to get a mammography regularly, at least every six months, she will have to pay up to €1,000 per year,” says, Italian EFDD member Daniela Aiuto MEP, who is preparing a Parliament report on Breast Cancer.

She noted that not all Italian families can afford these expenses nowadays. “This means that many women at risk

of developing cancer give up prevention. It is here that we must act.”

Daniela also highlighted the differences in prevention and treatment in different EU countries, saying women in northern Europe have more possibilities to have breast cancer diagnosed earlier and that this should be the same in all countries.

Although breast cancer

can also develop in men, women are about 100 times more likely to be struck by it. In 2013 about 93,500 people died of breast cancer in the EU, 99% of which were women.

Over the years MEPs have raised awarreness of the issue in various ways, for example by adopting resolutions on breast cancer in 2003 and 2006.

In 2010 MEPs adopted a

declaration to underline their support for the EU’s commitment to fight breast cancer, by ensuring implementation of screening programmes and creation of specialist breast units and reliable data collection.

In 2015 MEPs adopted a written declaration on breast cancer in the EU, calling for the implementation of measures to fight this disease.

Government Gazette | 35

healthcare

Policy Roadmap to improve management of breast cancer in Europe

I have cancer but I want to work

C

osts of cancer have an important impact on the global economy and encompass direct and indirect costs. The latter are often related to loss of productivity due to the inability to continue or return to work from many cancer patients and survivors. Cancer has an enormous impact in the personal, social and working relationships of people. To address the cancer burden in Europe, it is crucial to address disparities and harmonise standards for all Europeans. Many people want to continue working for financial security and to have a helpful distraction from their illness, and they should expect flexible support from their employers, as the effects of cancer treatment such as pain and fatigue can differ at various times. European and national politicians and policymakers need to implement consistent and flexible policies to enable cancer patients and cancer survivors to return to work.

Scale of the issue

The article is coauthored by Lieve Wierinck1, Karen Benn2, Barbara Wilson3, Richard Sullivan4, Donatella Decise5, Sonia Ujupan6, Vincent Clay7, Roberta Ventura8 and Marc Beishon9, on behalf of the ABC Global Alliance www.governmentgazette.eu | 36

One out of 8 to 10 women will have breast cancer in their lifetime, and the number of annual deaths will rise to more than 800,000 globally by 2030, about 43% more than the 560,000 deaths recorded in 2015. In Europe, there is a breast cancer diagnosis every 2.5 minutes and a death every 6.5 minutes.

The latest Globocan 2018 data show that, in Europe, more than half a million women (and some men) are diagnosed with breast cancer annually and about 140,000 die from this disease each year.

About a third of those

financial stability, a sense of normality and of purpose. But treatment and medication can cause fatigue, cognitive dysfunction, pain and other symptoms, and the path to getting better is not smooth; there are good days and weeks, but also bad times, and getting back to “normal” is often not possible. Cancer is life changing – physically and emotionally – it would be wrong to think otherwise.

Fatima CARDOSO is the Director of Champalimaud Clinical Center and ABC Global Alliance diagnosed with early stage breast cancer will later have a relapse/ recurrence, even if diagnosed early and with access the best available therapies. It is unfortunately unknown how many advanced cancer patients currently exist in Europe since the majority of cancer registries do not record the occurrence of recurrence, but only incidence and mortality.

This makes it harder to allocate resources and to implement the needed changes to address the needs of these patients.

Recently, the European Network of Cancer Registries (ENCR), which focuses on finding ways to integrate data from Europe’s cancer registries, started to be run at the European Commission’s Joint Research Centre (JRC).

It is crucial that the JRC includes mandatory collection of data on metastatic recurrences in breast and other cancers.

The ABC Global Alliance has made a thorough

needs assessment of ABC patients and defined 10 priority goals to be addressed and achieved during the current decade: the ABC Global Charter.

These goals include doubling of median survival, increasing access to multidisciplinary care, include ABC in cancer registries, improving communications and information, and reducing stigma. Last but by no means least among the goals is “help patients with ABC continue to work by implementing legislation that protects their rights to work and ensure flexible and accommodating workplace environments”, which given the rising incidence of breast cancer will mean more women (and some men) having to negotiate workplace arrangements.

Working with employers and employees Work is an important part of one’s identity, it fulfils the need for social structure and provides

Three important aspects to keep in mind are: 1) It is possible for most people with cancer, including those with advanced cancer, to continue to work; 2) Information must be given to employers and employees on what to expect during and after cancer treatment and how to manage at work. This means regular communication about the side-effects of treatment and having the flexibility to make adjustments for a gradual and successful return to work; 3) There must be a consistent EU-wide framework that supports all people with cancer who face discrimination in the workplace.

As an example, the UK Equality Act 2010, while not fully taken onboard by every employer, does a lot to protect cancer survivors against discrimination at work and to support their return to work, through for example, the requirement for employers to make reasonable workplace adjustments.

Employment/return to work issues facing people with ABC The EU’s Employment Equality Framework Directive 2000 is the legislative framework that

should protect people with both early and advanced cancer from discrimination. But it is an EU Directive and not an EU Regulation, and while it must go onto the statute books of the EU member states, each country has the flexibility to define what constitutes disability, and therefore whether or not cancer fits their definition.

Some countries, such as the Nordic countries, Netherlands, Ireland, France, Belgium and the UK do give cancer patients the ability to “register” as disabled and therefore to benefit from this legislation for their working rights, among other things. However, in many European countries, formal protection is either nonexistent or the situation is legally ambiguous, and there are no data on how many cancer patients return to work or how easy they find it to do so. There are also big disparities in how countries help people to return to work after longterm illness – here the Scandinavian countries are good, offering cancer survivors a return to

work plan.

Europa Donna, the European Breast Cancer Coalition, did a short survey of people with metastatic breast cancer about their experiences and support in their countries for employment and return to work. It found that, according to the survey respondents, a majority of the 35 countries represented do indeed have disability discrimination legislation that protects cancer patients, and some countries also have other legislation which protect people living with cancer from discrimination.

A majority also said there is information available on social security and welfare, and on leave of absence and return to work, and on working part time, although the latter is mostly dependent on the employer. Surveyed advocates and patient advocate also reported that pressure from employers and colleagues can discourage return to work, and there is stigma and lack of awareness of living and working with cancer.

There is some movement at EU level. A report from the European Parliament, “On pathways for the reintegration of workers recovering from injury and illness”, (2017/2277 (INI)), now includes amendments on cancer.

In May 2018, a group of MEPs led by Rory Palmer (UK) launched the EuropeanDying to Work campaign, which aims to protect terminally ill workers from dismissal;as it stands, there are no specific protections for terminally ill employees. Also, in 2018, MEP Deirdre Clune (Ireland) proposed a pilot project to the European Commission on collecting data on the number of people with metastatic cancer in the workplace, using breast cancer as a model; however, this project has not yet been funded.

The aim of the project is to assist in designing better policies and service provision.

Costs and value in cancer care There are big threats to achieving equitable care for breast cancer and

other diseases – social inequalities, which are rising in Europe, and the impact of technology such as new drugs and imaging, which must be subject to guidelines and also must have anexperienced healthcare workforce that can deliver appropriate care. Breast cancer and colorectal cancer, due to their incidence, are the two cancers that particularly determine economic burden and whether policy response can control costs.

Economic impact is framed by direct healthcare costs and informal costs, balanced against productivity losses – and the figures are substantial. In Europe, total costs for breast cancer are over e14 billion, made up of 43% healthcare, 22% informal care, and 35% productivity lost to mortality and morbidity.

Productivity loss of people unable to work is one of the biggest concerns for employers, although these figures also show the sheer cost that advanced cancer has on societies as people are lost to the disease. Several

studies have shown that the percentage of indirect costs related to cancer is superior to the direct costs of treating the disease. Tackling the problem of loss of productivity would benefit substantially Europe and the World’s economy.

Reports and projects Previous published reports have highlighted the problem of loss of productivity angle. The Cancer in the Workplace report, published by the Economist Intelligence Unit in collaboration with Bristol-Myers Squibb in 2016, assessed the challenges that cancer poses for employers and reported that loss in productivity of cancer survivors who were unable to return to paid work in the UK was £5.3 billion in 2010. In a survey, productivity loss was ranked highest among the concerns of employers, followed by rising insurance premiums and the cost of days off sick.

Notably, high among the concerns was the ability of managers to support employees with Government Gazette | 37

healthcare

Policy Roadmap to improve management of breast cancer in Europe

cancer.The report also surveyed employees and, encouragingly, when asked whether they feel confident that their employer would support them during the period of illness and up to 1 year thereafter, around 75% of respondents said that they would be fairly confident or very confident. This figure is higher among respondents in large companies. However, in a more recent survey in the Netherlands, it was small, family owned businesses that offered the most support, ahead of larger companies and the public sector.

The Policy Roadmap on Addressing Metastatic Breast Cancerreport, published by a multistakeholder steering committee and Eli Lilly & Company, raised awareness on clinical, economic and societal burden of metastatic breast cancer and issued some recommendations, that include: 1) provide wider support systems and decision-making tools for metastatic breast cancer patients for coping with their diagnosis, handling their disease, managing their treatment’s sideeffects, and organising their lives to allow for minimal disruption; 2) the European Commission should use the European Pillar of Social Rights as a policy framework to initiate adequate measures to ensure member states provide patients and informal carers with employment regulations that sufficiently protect their work-life balance; 3) increase recognition of the role of informal carers and formalise their rights and access to available support systems.

The two Novartis-led projectsHere & Nowand My Time, Our Time have focused on the needs of ABC patients. www.governmentgazette.eu | 38

In 2013, 40% of women in Europe with advanced breast cancer who were surveyed were working and of those, 25% worked full-time; about 50% of patients had to change their work situation due to advanced breast cancer and 37% had to give up work temporarily or altogether.

As a consequence, 56% of patients experienced a decline in household income as a result of being ill.

The road to a better normal: Breast cancer patients and survivors in the EU workforce is a recent report published by the Economist Intelligence Unit in collaboration with Pfizer and showed that societal and medical trends in Europe are intersecting to increase the number of breast cancer patients and survivors who are likely to want to work.

In the past 15 years the proportion of European women aged 50-64 in employment has risen steadily, so that now a majority (59.6%) of that group are active in the labour force. The rate at which breast cancer patients and survivors return to work is highly uneven, suggesting

substantial room for improvement. National return-to-work rates for breast cancer patients and survivors who were in a job at the time of diagnosis ranged from 43% in the Netherlands to 82% in France. Breast cancer and treatment side-effects make returning to work harder, but they are far from the only issues. Important non-medical barriers also impede a return to work, including lack of employer or colleague support, the extent to which work is physically demanding, and the level of education of the women involved. Such factors overlap to make specific populations vulnerable, particularly working-class women.

In addition to the summarized reports, it is important to consider that there are substantial numbers of self-employed women who do not have a formal workplace to return to, and face financial difficulties in particular. Younger women with breast cancer are likely to be most affected.

Conclusion Returning or maintaining a productive professional

life is a crucial factor for cancer patients and cancer survivors.

Reducing the costs associated with loss of productivity due to cancer would substantially decrease the economic burden of this disease in all countries.

The majority of cancer patients and survivors want and/or need to return to work but they face several limitations as a consequence of disease and treatments and need flexibility and understanding in their work environment.

Some employers are willing to provide such flexibility but would need incentives and support.

The public sector should lead by example, but government employers are often the worst at supporting return to work. Organisations may respond better to incentives to adopt flexible policies rather than penalties and financial support is crucial to enabling flexibility for employers that find it hard to support unpredictable patterns of absence for cancer patients.

Replacement income from welfare that

switches in on days when an employee cannot work would help solve this.

Legislation protecting the right to return to work part time or with flexible hours, coupled with financial support and/or tax exemption for employers who apply that legislation, could be a solution to protect both employees and employers. Doing so, would substantial decrease the burden of cancer on each country’s healthcare budget.

The 5-year prevalence (i.e. people who had a diagnosis of breast cancer in the last 5 years and are still alive) of breast cancer in Europe is over 2 million people.

When considering all cancers, there are over 12 million people who had a diagnosis of cancer in the last 5 years and are still alive, the majority of whom are in their most productive years (40’s, 50’s and 60’s). Europe cannot afford to lose this wealth of workforce.

Author affiliations: European Parliament MEP Belgium, 2Europa Donna, The European Breast Cancer Coalition, Milan, Italy, 3Working Wwith Cancer, UK, 4King’s College, London, UK, 5Novartis, 6Eli Lilly & Company, 7Pfizer, 8ABC Global Alliance, 9Cancerworld.

1

BRESSO sets high standards of breast surgery in Europe

T

factor (3.688) and significant publications on breast topics

he European Society of Surgical Oncology (ESSO) is pleased to announce that a breast surgery specific working group has been recently established within the Society as a joint venture with EUROPADONNA (European Breast Cancer Coalition), EUSOMA (European Society of Breast cancer Specialists), the European School of Oncology (ESO), UEMS -European Board of Breast Surgery Qualification and the Oncoplastic Breast Surgery Consortium (OBSC).

BRESSO is the Breast Surgical Oncology Project Team working to promote accredited specialist breast surgical care for breast cancer patients and high risk women for breast cancer as a joint venture between key stakeholders.

It’s vision is that all women affected by breast cancer should be treated by specialists trained and accredited in breast surgical oncology.

BRESSO is promoting the highest quality and most innovative, evidence based breast cancer care.

It intends to develop the highest standards of breast surgical oncology in a multidisciplinary setting, for the benefits of our patients who should receive the best available care across Europe, no matter which country they live in.

BRESSO is supporting breast cancer patients to receive their treatment form accredited breast cancer surgeons within a multidisciplinary environment, benefiting from the expertise of highly skilled and trained surgical oncologists.

BRESSO aims to achieve this goal through a range

-Breast surgical network via ESSO membership -Global and European Curriculum and Textbooks of Surgical Oncology and Breast Surgery -Breast surgery and oncoplastic course portfolio with a expert faculty from across Europe - University degrees in breast surgery and certification

of activities including: - offering the leading platform for education and training in breast surgical oncology (courses, workshops, masterclasses, University linked Diplomas and Fellowships, Observerships) together with ESO, EUSOMA and other breast surgery organisations - Europe-wide accreditation of specialist breast cancer surgeons (examination via UEMS delivered jointly by the UEMS, ESSO and EUSOMA, Fellowships adhering to the UEMS/ ESSO Breast Surgery Curriculum) - Promote and initiate multi-national audits of standards in breast cancer surgical care, prospective data collection in collaboration with EUSOMA - Facilitate availability and compliance with multidisciplinary

guidelines and practice of quality cancer care, including the availability of oncoplastic breast surgery and reconstruction for all cancer patients across Europe - Lead on and collaborate with policymakers on homogenisation of quality breast cancer management within Europe to achieve best long term outcomes and patient satisfaction - Coordinate and bring together specialists involved in breast cancer surgical oncology and reconstructive surgery within a multidisciplinary environment - Promote collaboration with core members of the multidisciplinary breast cancer care specialties - Work closely with patient advocacy and support groups to provide them guidance in achieving the common

goal of “highest quality cancer care for all European breast patients” - Publishing position papers, guidelines, reviews BRESSO intends to take on a leading role on the above topics at European level, with the clear intention to closely collaborate with key stakeholders in Europe, involved in breast surgery specialisation and accreditation (UEMS, EUSOMA, EUROPADONNA, ESO and other key organisations). Our goal is to raise and harmonise the quality and standards of breast surgical oncology across Europe.

Current important assets of BRESSO: -Leading role in the UEMS/ FEBS European examination, jointly with EUSOMA -EJSO, the Journal of Surgical Oncology with an increasing impact

The BRESSO Project Board is keen to collaborate and communicate with patient organisations and policymakers; establish strategic directions for the group and lobby for European recognition of breast cancer surgery as a surgical oncology subspecialty.

BRESSO will have a widely inclusive approach in creating a platform for representatives from leading educational, training, research and accreditation organisations and will thrive to achieve it’s goals in a collaborative manner, keeping always in mind the best interests of our patients across Europe.

The group recently joined forces to promote accredited specialist breast surgical care for breast cancer patients and high risk women and our motto is that all women should be treated by specialists trained and certified in breast surgical oncology.

The article is authored

by Dr Tibor Kovacs, Executive Director, European Society of Surgical Oncology (ESSO).

Government Gazette | 39

healthcare

Policy Roadmap to improve management of breast cancer in Europe

Exercise and medicine for cancer survivors

A

Yvonne WENGSTROM is Professor and Director of Nursing Development at Karolinska Institutet

dvances in anti-cancer treatments mean that more people with cancer are living longer, but many people aren’t actually living as well as they could be. Cancer survivors may experience considerable morbidity, increased risk of losing independence as they age, and significantly reduced quality of life.

These effects also place unnecessary economic burden on the health care system. Addressing the detrimental effects of cancer and its treatment has been consistently identified as a central component of survivorship care.

Numerous systematic reviews and meta-analyses have concluded that regular exercise is a safe and effective intervention to counteract many of the adverse physical and psychological effects of cancer and its treatment.

The current evidence of the various health benefits of exercise support a paradigm shift in oncological care. www.governmentgazette.eu | 40

Consistent evidence from epidemiological studies suggests that being more physically activite after a cancer diagnosis reduces the risk of cancer specific death and recurrence for certain cancer types.

An increasing body of evidence has led

international exercise organizations such as the American College of Sports Medicine (ACSM) and Exercise and Sports Science Australia (ESSA) to develop guidelines onexercise for cancer survivors. The ACSM guideline was published almost a decade ago with an update due in 2019. While the message for cancer survivors to be physically active and reduce sedentary behaviors such as prolonged sitting, is important, evidence supporting the exercise guidelines arises from interventions that are appropriately prescribed and monitored, and research continues to add insight to the precautions, adaptations, and optimal prescriptions for exercise in people with cancer. Appropriate exercise is an effective intervention for the long-term management of cancer and should be put forward as a critical element of survivorship care.

Need for an exercise medicine model of care The current evidence of the various health benefits of exercise support a paradigm shift in oncological care.

Survivorship guidelines released by the American Society of Clinical Oncology specifies exercise as a core component of high quality survivorship care. Survivors have clearly indicated a desire to participate in appropriately designed and supervised exercise programs; however, no such services are routinely available for cancer survivors in most countries. The challenge is to develop a sustainable model of care that isaffordable and effective. Including exercise as an established and standard component of cancer survivorship may help to reduce

some of the barriers to exercise, such as unequal access to evidencebased information, lack of access to exercise equipment, facilities, and exercise specialists.

Additionally, creating a standardised model of care for exercise in cancer survivorship will minimize the risk of missing the patients groups who are less likely to ask about exercise or to ask questions about their health in general.

Recent studies suggest that larger effects have been observed for interventions delivered at exercise facilities by appropriately qualified allied health professionals. Exercise should be prescribed and delivered under the direction of a qualified exercise physiologists, specialists or physiotherapistsin order to maximize safety and therapeutic effect.

These health professionals have expertise in understanding and identifying potential exercise contraindications and considerations and are able to use their clinical judgement in complex clinical scenarios. While not all people with cancer will require ongoing supervision, these practitioners will allow for exercise to be prescribed in line with evidence-based guidelines to help individuals with cancer meet exercise recommendations, which is important for the health, function, quality of life and, potentially, survival of people with cancer.

We now have enough evidence for the positive effects of exercise during and after treatment for breast cancer and it is time to take responsibility to make exercise as medicine available and part of

treatment for women.

References: Blaney, J. M., A. LoweStrong, J. Rankin-Watt, A. Campbell, and J. H. Gracey. “Cancer Survivors’ Exercise Barriers, Facilitators and Preferences in the Context of Fatigue, Quality of Life and Physical Activity Participation: A Questionnaire-Survey.”

[In eng]. Psychooncology 22, no. 1 (Jan 2013): 186-94.

Giovannucci, E. L. “Physical Activity as a Standard Cancer Treatment.” [In eng]. J Natl Cancer Inst 104, no.

11 (Jun 6 2012): 797-9.

McCabe, M. S., S. Bhatia, K. C. Oeffinger, G. H. Reaman, C. Tyne, D. S. Wollins, and M. M. Hudson. “American Society of Clinical Oncology Statement: Achieving High-Quality Cancer Survivorship Care.” [In eng]. J Clin Oncol 31, no. 5 (Feb 10 2013): 631-40.

Schmitz, Kathryn H., Kerry S. Courneya, Charles Matthews, Wendy DemarkWahnefried, Daniel A. Galvão, Bernardine M. Pinto, Melinda L. Irwin, et al. “American College of Sports Medicine Roundtable on Exercise Guidelines for Cancer Survivors.” Medicine and science in sports and exercise 42, no. 7 (2010): 1409-26.

Support, Macmillan Cancer. “Cured but at What Cost? Long Term Consequences of Cancer and Its Treatment.” edited by UK Macmillan Cancer Support, 2012.

Zopf, Eva M, Prue Cormie, Kathryn H Schmitz, and Xiaochen Zhang. “The Impact of Exercise on Cancer Mortality, Recurrence, and Treatment-Related Adverse Effects.”

Epidemiologic Reviews 39, no. 1 (2017): 71-92.

A plan to implement breast clinics across Europe to favour drug administration before surgery, a strategy called “neoadjuvant therapy”,which evaluates how sensitive the primary breast tumor is to the drugs, with the hope that this sensitivity mimics the one of distant cancer foci.

Martine PICCART-GEBHART, MD, Phd is Chair of Breast International Group

I

t is estimated that 404,920 women will be diagnosed with breast cancer in 2018 in the European Union, while 98,755 women will die from the disease. Unfortunately the disease is here to stay.

Indeed, its high incidence is in part related to modern life style, with delayed first pregnancies and fewer pregnancies depriving the mammary gland from full maturity and from enhanced “protection” against carcinogens.

After 15 years of conducting “neoadjuvant” clinical trials, one has learned that, for the most aggressive breast cancer subtypes (called “HER2-positive” if they overexpress the HER2 receptor or “triple negative” if they are devoid of both HER2 receptors and hormone receptors), not achieving a complete eradication of the primary tumour at surgery is associated with a significantly higher risk of cancer relapse (this risk being a smallpercentage only for women in “complete response”).

Since, until recently no “salvage” drugs had been identified for poor responders to preoperative therapy, this “neoadjuvant”strategy has been mostly restricted– in routine clinical practice – to women for whom shrinkage of the breast tumour might allow for another wise impossible breast conservation “upfront”.

While there is no doubt that progress has been achieved through earlier diagnosis and improved multidisciplinary treatment, one in four women will develop a recurrence and die from the disease, since breast cancer still remains incurable once it has spread to distant organs.

In other words, today, most women with early breast cancer are offered drugs after surgery, implying a relatively smooth and easy coordination among breast cancer specialists along a treatment path where surgery comes first, followed by drug therapy (also called “adjuvant treatment”) and radiotherapy.

Hoping to eradicate undetectable micro-metastatic cancer cells (i.e., foci) in bones, lungs or in the liver, medical oncologists usually prescribe anticancer drugs to breast cancer patients deemed at risk of relapse. This is most often done after surgery and without any mean to assess whether the drugs wil lreally work for the individual patient.

Drastic changes in this sequence of interventions will take place tomorrow for women with HER2-positive and triple negative breast cancers considered at intermediate or high risk of relapse : indeed two landmark clinical trials – “Katherine” and “Create X” – have identified “salvage drugs” for women with residual invasive cancer in the breast following standard neoadjuvant therapy1,2.

In order to accelerate the development of more effective drugs against “micrometastases” clinical investigators have started

The most robust of these trials, Katherine, which included 1400

women, showed an impressive gain of 11% in freedom of recurrence at 3 years followup for women receiving 14 postoperative courses of T-DM1 (an antibody-drug conjugate targeting the HER2 receptor) instead of additional treatment with trastuzumab (an antiHER2 antibody) to complete 1 year of anti--HER2 therapy.

Create-X, on the other hand, has already impacted many national and European treatment guidelines for women with triple negative breast cancer not eradicated by preoperative drugs, since it showed a striking survival benefit for the oral cytotoxic drug capecitabine, when given in 8 postoperative cycles .

The implications of these two trials for optimal delivery of breast cancer care are very important : one in threewomen with an aggressive form of early breast cancer (HER2-positive or triple negative) will no longer be suitable for adjuvant drug therapy. Postponing surgery after initial drug therapy will become the new “must”, as this will be the only way to identify those women for whom “salvage” drugs might be needed in order to optimise the chances of cure.

Many European women continue to be treated in “satellite” breast clinics which do not reach a minimum of 150 breast cancer patients treated per year

The only caveat is that this different sequencing of treatment modalities requires a more complex coordination between breast cancer specialists, as well as a greater involvement of pathologists and imaging specialists. Some of the most critical steps here include 1) full molecular characterisation of the disease on a tru-cut biopsy (i.e. a small piece of tumour tissue); 2) “clipping” the breast cancer tumour, which might disappear under drug therapy; 3) characterising the status of axillary nodes with fine needle aspiration in case of suspicious clinical or sonographic features and 4) deciding on the most adequate type of surgical and radiotherapy treatment as a function of response to drug therapy.

Such a sophisticated multidisciplinary management is unlikely to be delivered with quality standards outside the framework of breast clinics.

Looking at the implementation status of breast clinics in the EU one gets very scared : only two countries have mandated them by law (Italy and the Czech Republic) and no country, so far, has linked reimbursement of care to the place where care is actually delivered.

As a result, many European women continue to be treated outside breast clinics or in loosely defined “satellite” breast clinics which do not reach a minimum of 150 breast cancer patients treated per year. This is also the situation in Belgium, my home country, with the additional worrisome observation of a paucity of breast clinics in the South compared to the North.

If politicians are serious about their desire to fight cancer – and in this case breast cancer – there is now a real urgency: breast clinics must be implemented taking into account geographical considerations and must form the basis for reimbursement of treatment interventions.

Government Gazette | 41

healthcare

Policy Roadmap to improve management of breast cancer in Europe they can advocate for them effectively in their own countries.

The ECIBC provides concrete evidencebased recommendations that can and should be implemented by all countries.When it is completed the ECIBC will delineate the entire breast cancer pathway including diagnosis, treatment, follow up and rehabilitation etc thus providing an outline of what breast services should be provided to women across Europe.

Europa Donna supports transforming breast cancer care in Europe

T

here are currently 404,920 new cases of breast cancer in the EUeach year and 98,735 deaths (1). 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.

As Europe’s breast cancer advocacy organisation, Europa Donna (ED) seeks to ensure that all European women have information about, and access to, early detection through mammography screening programmes set up in accordance with the EU Guidelines and access to care and treatment in Specialist Breast Units as defined in EU guidelines.

As Europe’s breast cancer advocacy organisation, Europa Donna (ED) seeks to ensure that all European women have information about, and access to, early detection through mammography screening programmes set up in accordance with the EU Guidelines and access to care and treatment in Specialist Breast Units as defined in 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 many inequalities still exist between countries.

See our websitewww. europadonna.org for policy and other initiatives undertaken.

Central to overcoming inequalities is training advocates from our member countries on current best practice so that they can take this information back to their

www.governmentgazette.eu | 42

Susan KNOX is CEO of EUROPA DONNA - The European Breast Cancer Coalition countries and advocate for implementation locally.

following this initiative closely since its inception in 2013.

Europa Donna has been conducting training programs for advocates since 2001. Each year advocates from all our member countries are invited to participate in advocacy training courses, advocacy leader conferences and most recently advocacy conferences for women with MBC(metastatic breast cancer).

Susan Knox, ED’s CEO, serves on the Guideline Development Group for the new EU Guidelines and Karen Benn, ED Deputy CEO, serves on QASDG Quality assurance scheme development group working on the QA scheme. Both serve as individual experts and not as ED representatives, in accordance with EC rules.

In this way we ensure that advocates have the most up to date information on all aspects of early detection, breast cancer diagnosis, breast cancer surgery, imaging, and current treatments available for the disease. They are informed about evidencebased guidelines for mammography screening and how specialist breast units should be set up and conducted. Now this training includes a module on the ECIBC - European Commission Initiative on Breast Cancer. Europa Donna had been advocating for a Europe wide program such as this and has been

The GDG Guidelines Development Group, has recently published its first recommendations on screening which are available at http:// ecibc.jrc.ec.europa.eu.

Europa Donna is now actively promoting the implementation of these important EU guidelines and has begun by publishing “The Europa Donna Advocates Guide to the ECIBC”. This is currently being used in all our training courses to ensure that advocates know the content of these new guidelines and understand how they were developed so that

The ECIBC will only be valuable if it gets implemented,so our main priority today is working toward that goal. We see that it is included in all of our training programs, conferences, information materials, as well as in key European scientific conferences such as EBCC of which we are a co-organiser with EORTC and EUSOMA. It is now imperative that all policy makers active both at the European level and the National level join together to ensure the implementation of the ECIBC in all countries.

Another key priority for advocates and for policy makers is ensuring that high quality research is carried out in Europe.

Europa Donna’s role and involvement in research is broad and a number of our organisational goals are dedicated to breast cancer research.

Our involvement in the EU and international research agenda spans policy, education and direct involvement in research; this includes promoting relevant research trials that address important questions from the patient’s point of view; being the informed link between professionals and prospective trial participants, representing

patients’ needs and the consumer perspective, thereby adding balance; advocating for the dissemination of study results and availability of effective drugs across all countries.

must be included from the outset of the research.

Advocates are not there to “rubber stamp” trial protocols; they need time to study materials in advance, ask questions and participate actively in order to ensure credibility, independence, and provide real consumer perspective.

In terms of policy, ED has always advocated for increased funding for all types of BC research, including ensuring that the EU Resolutions on Breast Cancer of 2003 and 2006, and Written Declarations on Breast Cancer of 2010 and 2015, include a commitment to highquality, multi-institution, independent breast cancer research.

ED’s extensive education and information programmes, including attending EU breast cancer conferences and meetings, ensures that ED’s members, and patient advocates in its member countries, remain abreast of the latest scientific research and are trained to understand and participate actively and effectively on research committees.

Effective advocacy involvement means that Europa Donna advocates

To this end Europa Donna has conducted education programs for advocates and has published 3 booklets on research engagement that can be found on our website at https:// www.europadonna.org/ research/.

Susan Knox, ED’s CEO, serves on the Guideline Development Group for the new EU Guidelines and Karen Benn, ED Deputy CEO, serves on QASDG Quality assurance scheme development group working on the QA scheme. Both serve as individual experts and not as ED representatives, in accordance with EC rules.

ED has been also been directly involved in the European research agenda for many years. We are the patient advocacy partner of BIG, the Breast International Group, which is a consortium of more than 50 institutions and academic breast cancer research groups headquartered in Brussels.

Through the BIG consortium we are currently serving on the steering committees of the MINDACT trial, the Olympia trial, and

the AURORA research programme; in addition, ED representatives serve on the BIG Survivorship taskforce.

ED has also collaborated for many years with other EU consortia who receive EU funding, frequently through DG Research’s programmes, including the Horizon 2020. We are currently engaged as consortium partners, or as external advisors, in 4 Horizon 2020 funded projects, PREFERABLE, BOUNCE, Mesi-stratand MyPEBS. ED also has a representative on the Steering committee of EBCTCG - Early Breast Cancer Trialists’ Collaborative Group, and on the ethics committee of IBCSG – International Breast Cancer Study Group; in addition, ED representatives are involved at an advisory level in the IBCSG’s POSITIVE trial.

Europa Donna’s involvement in clinical trials and studies can influence numerous areas including: ensuring that the research answers an important question of interest and use to patients and

the public, leading to better and more userfriendly trial design, and ensuring that patientoriented information, including consent forms, is presented in clear, comprehensible language, leading to a better understanding by potential trial participants.

Finally Europa Donna has a key role to play in explaining clinical trials and research in general to the public, to policy makers and to other stakeholders.

References: 1.Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2018). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer.

Available from: https:// gco.iarc.fr/today, accessed [25March 2019].

The article is co-authored

by Karen Benn, Deputy CEO of EUROPA DONNA.

Government Gazette | 43

healthcare

Policy Roadmap to improve management of breast cancer in Europe

How to avoid recurrence and metastasis in women with hormone sensitive early breast cancer?

B

reast cancer is the most common cancer in women in Europe and worldwide (1). Once diagnosed, the prime goal of breast cancer treatment is to avoid the formation of metastasis which is the primary cause of death.

Based on the observed beneficial effects of prolonged anti-hormonal treatment (10,11) current guidelines and opinionbased recommendations propagate prolonged therapy for up to 10 years particularly for women at high risk for relapse (large tumors, positive lymphnodes) (12,13,14).

Breast cancer is not a singular disease but represents a diverse spectrum of biological features, prognoses, therapeutic options, and outcomes. Sub classification and drug treatment decisions depend on the presence or absence of receptors as these can bind hormones to enhance tumor growth or promote aggressiveness. Three prominent receptors may or may not be present: estrogen receptor (ER), progesterone receptor (PR), and HER (2).

Long-term every day drug intake however presents a challenge for the patients particularly when the drugs have unpleasant and severe side effects. Side effects of anti-hormonal drugs include menopausal symptoms such as hot flashes as well as muscle and bone aches which considerably lower women’s quality of life, yetother reasons may also prevent womenfrom adhering to treatment (15,16).

Most breast cancers (two out of three) depend on estrogen for growth as they express ER. They can betreated with drugs that target the ER in order to block estrogen signaling, a concept that is referred to as antihormone (endocrine) therapy.

Breast cancer is not a singular disease but represents a diverse spectrum of biological features, prognoses, therapeutic options, and outcomes. Sub classification and drug treatment decisions depend on the presence or absence of receptors as these can bind hormones to enhance tumor growth or promote aggressiveness. www.governmentgazette.eu | 44

Two valid treatment options exist: Tamoxifen (TAM), a selective estrogen receptor modulator (SERM) that competes with estrogen for the binding to the ER to stop growth signaling, and Aromatase Inhibitors (AI) that block the enzyme aromatase to inhibit estrogen formation from androgens thereby decreasing womens’ estrogen levels.Whereas TAM is the sole option for young women prior to menopause, women

Dr Hiltrud BRAUCH is Deputy Head of Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology beyond menopause have a choice between TAM and AI. The benefits from antihormone therapy are impressive with longterm estrogendeprivation beinga mainstay in clinical breast oncology.

However, there is a lack of drug efficacy in about one third of the treated patients that manifestsin recurrence, metastasis and premature death (2,3,4).

trials (3) demonstrated that therapeutic estrogen deprivation must occurfor 5 years in order to control the disease.

5-year treatment is needed as the mechanism of action is not immediatecytotoxicity but the reprogramming of micro metastatic cell(s) that remained in the woman’s body after breast surgery so that these will no longer be susceptible to growth stimuli (5,6,8).

Given the high 5-year prevalence of breast cancer (1) with most women being on antihormone treatment, the predicted failure rate concerns several hundred thousands of women in Europe and probablymore than a million women worldwide. As of yet, it is not clear why some patients respond to a treatment and others don’t.

This is well in line with the clinically observed carry-over effect which prevents recurrence and reduces mortality during the decade after the actual treatment period (2,3,4). Thus, the completion of the 5-year treatment is strongly encouraged.

Evidence from basic research (5,6) and clinical

Yet, a considerable fraction of women is at constant risk for recurrence and premature death for as long as 20 years after stopping endocrine therapy (9).

Although the benefits of anti-hormone treatment scientifically and medically are indisputable, it is of no surprise that women frequently discontinue treatment prematurely.

Having gone through the distress of diagnosis, breast surgery, radiationand potentially chemotherapy, women usually get started on endocrine treatment but eventually stop using it,as they may feel well againand perceive their improved condition as being cured.

Unfortunately, women in Europe and worldwide are not sufficiently aware of that endocrine treatment is essential to prevent disease events/death in the future (9). In line with current guidelines and recommendations (13,14,15), it is of utmost importance

to raise the patients’ awareness that long-term anti-hormone treatment is necessary to keep micro metastases at bay and stay alive.

While researchers are in charge to make antihormone treatment more efficient and safer it is to a large extent the patient’s own authority to prolong her life by completing the planned treatment.

To raise this awareness must be the critical starting point for authorities and governments on their road map to reduce metastatic breast cancer in Europe.

To this end, patients must be empowered through knowledge provided across all countries and social classes in order to support their compliance to adhere to the planned duration of drug treatment. Removing critical barriers for getting patients to stick to therapy willhave enormous public health benefits.

Trialists’ Collaborative Group (EBCTCG).

Davies C et al Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level metaanalysis of randomised trials. Lancet, vol. 378, 2011, pp 771-84 4. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG).

Aromatase inhibitors versus tamoxifen in early breast cancer: patientlevel meta-analysis of the randomised trials.

Lancet, vol. 386, 2015; pp 1341-52 5. VC Jordan. The new biology of estrogen induced apoptosis applied to treat and prevent breast cancer.

Endocrine Related Cancer, vol. 22, no 1, 2015, pp R1-R31 6. Maximov PY, Abderrahman B, Curpan RF, Hawsawi YM, Fan P and Jordan VC.A

Suffice to say that current costly developments towards improved drug treatment outcomeswill only serve their purpose provided the patient is willing to use the drug in the first place.

References: 1. Stewart BW, Wild CP (eds). World Cancer Report 2014. Lyon, France: International Agency for Research on Cancer 2014, pp26-41.

2. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG).

Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials.

Lancet, vol. 386, 2005, pp 1687-1717 3. Early Breast Cancer

Unfortunately, women in Europe and worldwide are not sufficiently aware of that endocrine treatment is essential to prevent disease events/death in the future. It is of utmost importance to raise the patients’ awareness that long-term antihormone treatment is necessary to keep micro metastases at bay and stay alive.

unifying biology of sex steroid-induced apoptosis in prostate and breast cancers. Endocrine Related Cancer, vol.

25, no. 2, 2018, pp R83-R113 7. VC Jordan, Linking EstrogenInduced Apoptosis With Decreases in MortalityFollowing Long-term Adjuvant Tamoxifen TherapyJornal of the National Cancer Institute,vol. 106, no. 11, 2014, pii: dju296. doi: 10.1093/jnci/dju296.

8. Abderrahman B and VC Jordan. Rethinking Extended Adjuvant Antiestrogen Therapy to Increase Survivorship in Breast Cancer JAMA Oncology, vol. 4, no.1 4, 2018, pp 15-16 9. Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, Peto R, Pritchard KI, Bergh J, Dowsett M, Hayes DF; EBCTCG.20Year Risks of BreastCancer Recurrence after Stopping Endocrine Therapy at 5 Years.

New England Journal of Medicine, vol. 377, no.

19, 2017, pp1836-46.

10. Davies C, Pan H, Godwin J, Gray R, Arriagada R, et al.

Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptorpositive breast cancer: ATLAS, a randomised trial.Lancet vol381, no 9869, 2013, p805-16.

11. Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor

Adjuvant Therapy to 10 years. New England Journal of Medicine vol 375, no 3, 2016, pp 209-19 12. Burstein HJ, Temin S, Anderson H, Buchholz TA, Davidson NE, et al Adjuvant endocrine therapy for women with hormone receptorpositive breast cancer: american society of clinical oncology clinical practice guideline focused update NCBINCBI Logo. J ClinOncol. Vol. 32, no. 21, 2014, pp 2255-69.

13. Gnant M, Harbeck N,Thomssen C. St. Gallen/Vienna 2017: A Brief Summary of the Consensus Discussion about Escalation and De-Escalation of Primary Breast Cancer Treatment.

Breast Care vol. 12, 2017, pp102-107 14. van Hellemond IEG, Geurts SME, TjanHeijnen VCG. Current Stautus of Extended Adjuvant Endocrine Therapy in Early Stage Breast Cancer.Currrent Treatment Options in Oncology vol. 19, no. 52018, pp26 doi: 10.1007/s11864-018054115. Hershman DL.Sticking to It: Improving Outcomes by Increasing Adherence.

Journal of Clinical Oncology, vol.34, no. 21, 2016, pp 2440-42.

16. Chirgwin JH, Giobbie-Hurder A, Coates AS, Price KN, Ejlertsen B, et al.

Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence.

Journal of Clinical Oncology, vol 34, no. 21, 2016, pp 2452-9

Government Gazette | 45

healthcare

Policy Roadmap to improve management of breast cancer in Europe

The importance of multidisciplinary approach and quality control in a Breast Centre

B

reast Centre is the place where breast cancer is diagnosed and treated; it has to provide all services necessary from genetics to prevention, to the treatment of the primary tumour, to care of advanced disease, to palliation and survivorship and psychosocial support.

EM et al Br. Med J 2012;344:e2178), evaluating the effects of multidisciplinary approach on nearly 14.000 women, showed that this approach was associated with a 18% lower mortality at 5 years.

Quality control is an essential tool to monitor the activity of the Breast Centre, the compliance with the adopted recommendations and protocols, the performance with regard to Quality Indicators.

Since 2000, EUSOMA has published a milestone document on the requirements of a specialist Breast Centre, which has been pivotal for the setup of breast centres not only in Europe but also overseas and has been taken into consideration by national Authorities to define the organization of breast cancer management in their countries.

Despite this, as highlighted in the EBCC-10 Manifesto (EJC 72 (2017) 244250), still too many European Countries have not deliberated on the management of Breast Cancer, missing the 2016 deadline for all patients in European Countries to access specialist multidisciplinary breast cancer units or centre.

Requirements are important referring tools and, as such, need to be regularly up-dated.

In this view, EUSOMA, with the endorsement of the European CanCer Care Organisation (ECCO) as part of the ECCO project “The Essential Requirements for Quality Cancer Care” - ERQCC, has finalised the updating of the paper “The requirements of a specialist Breast Centre” (EJC2013;49,35793587), with the contribution of European experts and representative of ECCO www.governmentgazette.eu | 46

It is necessary that each Breast Centre collects its data in a database and has within the team a data manager, i.e. a person qualified and trained to be responsible of the breast Centre data.

Dr Lorenza MAROTTI is Executive Director of EUSOMA member discipline societies involved in the management of Breast Cancer Care.

This document will contain the updating of the existing Eusoma requirements taking into consideration changes in organization and care in the past 5 years and will also include sections on epidemiology, challenges in breast cancer and quality and audit processes.

Multidisciplinary approach, based on dedicated health professionals and quality control are two essential aspects of a specialist breast Centre,which has to offer harmonised quality care, regardless in which European country a person lives.

Multidisciplinary approach is based on the concept that not a single specialist but a group of specialised and dedicated experts will take shared decision on the diagnosis and care to be delivered to each patient.

Therefore, each Breast Centre must hold weekly multidisciplinary case management meeting to discuss diagnostic preoperative and postoperative cases and any other issue related to breast cancer patients, which need multidisciplinary discussion.

As highlighted in literature, this approach results into a great impact on patient survival.

A 2012 UK observational cohort study (Kesson

The data manager works under the supervision of the breast Centre clinical lead, organises audit meeting, monitors the trend of the Quality Indicators, keeps the team informed on that and takes part in the, at least yearly audit meeting, where all the team together discusses on the breast centres performance, on the need for any changes, improvements.

Again, with a multidisciplinary approach, the team identifies the necessary corrective actions, which might be not only clinical but also organizational or structural and therefore needs the involvement of the hospital management.

Quality control is very important not only for the single Breast Centre but also for the entire scientific community, because the benchmarking of the results of the different centres represent a helpful resource in the

up-dating of national and international guidelines, in identifying new quality indicators or amendments of the existing ones.

Collecting data is essential for the scientific research at the breast centre, to allow to develop specific project and to publish local experience or to join national and international project.

There is evidence on the benefit of external audit, i.e. certification or accreditation, to better performance and outcomes, and this is true also for a breast centre.

Therefore, it is advised that a Breast Centre undergo a voluntary certification/accreditation process based on the offer at national or international level such as for example German Cancer Society and German Senology Society, National Accreditation program for Breast Centre (NAPBC) run by the American College of Surgeons, Breast Centre Certification, accredited scheme based on the Eusoma requirements and Quality Indicators.

The contribution of policymakers and politicians to make sure that all women in Europe are treated in specialist breast centres is fundamental.

Only joint forces from health professionals, patients’ advocates, policymakers and politicians can ensure that breast cancer patients have access to specialist breast centres in any European countries.

ECIBC commits to ensure effective and safe breast services across Europe reflecting the latest scientific developments with the aim to improve and harmonise the quality of breast cancer services and to overcome inequalities in accessing careacross Europe.

The ECIBC is operated by the EC-JRC under the umbrella of collaboration with the EC Directorate General for Health and Food Safety (DG SANTE).

Luciana NEAMTIU is Project Officer at European Commission (JRC)

B

reast cancer is the most common cancer among women in the European Union.

Data from the European Cancer Information System (ECIS),managed by the European Commission’s Joint Research Centre (JRC), indicate that more than 400,000 new cases were diagnosed in 2018.

Indicators of quality of care and patient experience and of accessibility to breast cancer centres were showing discrepancies among member states and within member states; this discrepancies push the Commission to launch the ECIBC with the view to tackle these inequalities through updating the previous European Guidelines for quality assurance in breast cancer screening and diagnosis,

It involves today 35 participating countries across Europe. In addition to representations of all EU Member States, also Island, Macedonia, Montenegro, Norway, Serbia, Switzerland and Turkey are collaborating on the European Commission’s initiative.

The ECIBC objectives are achieved through the development of: (1) new European breast guidelines on screening and diagnosis, and (2) of an associated quality assurance scheme with particular attention on the patients’ needs, using the latest scientific evidence available.

The ECIBC covers the entire breast cancer care pathway, from screening of asymptomatic women to diagnosis, treatment, rehabilitation, management of recurrence and palliative care.

These recommendations focus on many crucial aspects of breast screening and diagnosis, for example: when and how often women should attend mammography screening, which technology should be used, how women should be invited to ensure high population coverage, how results should be communicated, how more vulnerable parts of populations should be addressed and which diagnostic methods should be used. ECIBC’s recommendations aim to guide healthcare professionals and policymakers to plan, organise, and deliver effective and equitable breast cancer services. At the same time, the recommendations can also help women to be better informed on their care options.

The European Breast Guidelines are developed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology.

The ECIBC recommendations are being published online as they are progressively developed.

Guidelines developers and screening programmes organisers of several countrieshave already expressed their interest to either adopt and/or adapt ECIBC recommendations for their own National or regional programmes , such asfrom countries of the European Union (Bulgaria, Czech Republic, Greece, Estonia, Italy, Malta, Romania, Slovakia, Spain, United Kingdom) as well as from Armenia, Bahrain, Brazil, China and Macedonia.

The GRADE Evidence-toDecision framework grants full transparency about the process followed for each ECIBC recommendation.

The ECIBC Quality Assurance (QA) Scheme will, once finalised in 2020, cover the entire breast cancer care pathway, from screening to palliative care. The

QA scheme sets quality criteria needed to guarantee that breast cancer care is effective and safe when implemented in breast services.

The ECIBC working groups include health care professionals as well as patients and patient advocates, such as Europa Donna – The European Breast Cancer Coalition, who participate in every phase of the discussion and development of both the guidelines and the quality assurance scheme.

Moreover, several calls for feedback were posted on the ECIBC website in the recent years which outcome was considered during the activities of the various working groups to ensure that the various stakeholder needs are properly considered during the development of ECIBC. The implementation of the ECIBC scheme into national contexts is voluntary. Therefore, the European Commission initiative has been developed in a flexible and adaptable way to allow local guideline developers to make best use of ECIBC by incorporating individual recommendations into local programmes or adopting ECIBC in total in breast services.

2019 will be an important year for ECIBC: the work on recommendations development will be finalised and the ECIBC will experience the first practical applications of the QA scheme to be ready for the final roll-out of the ECIBC scheme in 2020.

Government Gazette | 47

Government Gazette A report by the Government Gazette Roundtable Unit

technology

report

Getting inside Europeâ&#x20AC;&#x2122;s struggle to build a truly global tech giant Now is the best time in decades for the continent to battle its way back to relevance and take control

Building a stronger Digital Europe

CONTENTS Executve Summary PART I : Background How to build a stronger Digital Europe PART II : Taking Action Policy recommendations tabled at the ICPS 5G Infrastructure Roundtable 2019 Part III : European Commission Europe’s changing role in the new AI world order PART IV : Event Coverage Reporting from ICPS 5G Infrastructure Roundtable, Brussels PART III : Expert Recommendations Independent policy recommendations from policy makers, technology experts and academics

Executive Summary The internet and digital technologies are transforming our world, yet barriers online can deny people the full benefits that digital developments can offer. Now is the time to embrace the changes of digitalisation with a lucid vision and responsible leadership.

Making the EU’s single market fit for the digital age requires tearing down unnecessary regulatory barriers and moving from individual national markets to one single EU-wide rulebook.

The “fifth generation” of telecommunication systems, or 5G, has the potential to be one of the most critical building blocks of our digital economy and society in the next decade. Europe has taken significant steps to lead global developments towards this strategic technology.

Europe’s mobile industry faces a next-generation conundrum with major ramifications for mobile network operators (MNOs), policymakers, consumers, and businesses.

Beyond making our lives easier, today, artificial intelligence (AI) is helping us resolve some of the world’s greatest challenges: from treating chronic diseases or reducing fatalities in traffic accidents to fighting climate change or anticipating cybersecurity threats.

Over the next few decades, the increased use of robots and AI will not leave any stratum of society untouched. As technological innovation continues to get ever faster — robots and AI will play an increasingly important part of our daily lives. This can bring huge benefits to our societies by assisting us with difficult and unpleasant tasks.

The EU has a huge potential in this field: talented entrepreneurs, motivated research centres, and a great market. It is an important opportunity that we have to seize now.

And by “now,” I mean yesterday.

For too many years, Europe’s tech sector has lagged behind third countries such as the US and China. We need a coherent Union-wide approach and an ambitious investment to secure a solution to the chronic mismatch between the growing demand for the latest technology and the available supply in Europe.

In particular, the EU has not been the leader of telecommunications changes so far; however, by fostering cooperation among vertical, telecom and policy stakeholders, Europe has the potential to become the leaders of the next revolution in telecommunications: 5G. 5G will also be the “eyes and ears” of AI systems as it will provide realtime data collection and analysis.

At this year’s Davos economic forum, US executives warned that China may be winning the so-called AI race with Europe. In another recent article, Bloomberg pointed out that countries are rushing to not be left behind. In our exclusive, Commissioner Věra Jourová raises similar concerns. However, speaking of a race is both wrong and dangerous to start with.

What do we need to build a stronger digital Europe and how can we get there?

This Technology Report provides solutions to pressing digital policy issues and presents policy recommendations tabled at a recent high-level policy roundtable on 5G infrastructure.

EXCLUSIVE

Europe’s role in the new AI world order ‘united we stand, divided we fall’ We in the European Commission understand that the AI is the future and therefore we want to support the development of AI. That’s why last December, together with EU governments, we prepared a plan on AI to focus on joint actions in four areas: increase investment, make more data available,attract and develop talentand ensure trust.

First of all, we want to help Europe to become more competitive.

Europe needs to invest more if we want to count in the global race.

For example, France is investing 1.5 bn Euro, while one single city in China, Tianjin, 13.5 bn Euro.

Věra JOUVARA is European Commissioner for Justice, Consumers and Gender Equality

W

hen we think about AI, we would rather picture some dystopian robotic future like in the Blade Runner or the Black Mirror TV show, but the reality is much more mundane.It is clear that AI is already here in ever day use.It’s also clear that AI will revolutionise the way we live and work.

The question is how to benefit from this innovation, while addressing the risks.

www.governmentgazette.eu | 50

If we find the political will to invest in AI on the necessary scale – we estimate that we could invest in Europe, through public and private efforts, EUR 20 billion between 2018 and 2020, and by

2025 EUR 20 billion annually – then we have good chances to succeed.

The level of digitisation depends on the ability of businesses to access strategic resources such as skills, finance and knowledge networks.

For this, the aim is to establish Digital Innovation Hubs by 2020 at working distance of every company in Europe to help ensure these are available.

In order to ensure the take up of AI, I have no doubts we have to ensure that users – citizens, consumers, but also firms using AI – have trust in the technologies.And it is important to address the fears of many that because of AI they might lose their jobs.

That’swhy we hear more and more calls for regulation. I believe we need an extremely careful approach to any potential

regulation. .Given that AI could be applied in almost any field we should think carefully before creating specific set of rules for AI alone.

We need to have a systematic approach to decide where and for which aspects we need regulation, and if we do, whether it’s better to focus on self-regulation and how to agree on a system of compliance with our values.

The way I look at it reminds me the situation of architects. An architect needs to respect and comply with the building code and a number of safety legislations. For the digital world we should think of a similar system, a mix of ethical, legal and societal norms that would ensure continuing trust in the greatest revolution of our lifetimes.

We need to change our mind-set in this sense

and apply the rules that we have for the offline world in the online environment.

a particular decision and have the right to understand why and how such a decision is taken.

Europe has found a unique path when it comes to our regulatory approach. It is a liberal path, focused on giving people more control and more freedom, even in the online environment.

It is a path where even the governments, or, especially the governments, have to respect limitations and safeguards when it comes to data processing of their citizens. But this is also a path where we want to support the innovation, as long as it based on the law or as long as people gave their consent.

The idea is similar as when you go to a hospital to have a surgery. Not all of us studied medicine, but the doctors explain to us the procedure, the risks and the consequences in the language that we can understand. We cannot accept that AI will become a ‘black hole’ in which crucial decisions, such as credit ranking or jobs, will be taken automatically without us even knowing it.

In the EU we have our fundaments, including strong rules on data protection. They are not specific about AI, but they tell all of us what are our rights and what are some obligations of the companies that will use AI. These rules specify for instance that people should first know that it is the machine that takes

Moreover, we have started addressing the new ethical and legal questions raised by some AI applications. The Commission has initiated the process of drawing up draft AI ethics guidelines by the group of independent experts.

I want to stress we do it with businesses in mind.

We are building on interesting self-governing initiatives that businesses have developed

themselves with their ethical code of conducts or similar initiatives.

Ethics have to be complemented by law and the analysis of the impact of AI on fundamental rights, which is the form in which democratic decisions are transformed into binding norms in society. That’s why we are looking at civil liability rules to ensure that the technology can deliver these benefits for the EU. It has to be clear to everyone what happens if, for instance, a self-driving car has an

accident.

So, we don’t have an urge to regulate, but rather to create an environment where Europe can be competitive on the global scale. Otherwise, we will be marginalised by the US and China, to say the least.

Therefore we do need to think and agree on our European brand of AI. On our European model. I am convinced that our ‘made in Europe’ brand must be a seal of quality, privacy and ethical high standards. It must be technology that

is compatible with our values.

Our model is not protectionist. We stress privacy, but we invite everyone as long as they respect our rules which are based on the ultimate right to protect your intimate sphere against intrusion of private companies and governments.

We don’t stop data flows or force data localisation in Europe. We allow them as long as the laws are respected.

We live in exciting times and AI is already discussed all over Europe and beyond. It’s time that the European Union, the EU governments, companies and other stakeholders, step up their game to help Europe become one of the global AI leaders on the one hand, and to ensure that no one in our society is left behind, on the other.

Government Gazette | 51

Will this robot take your job?

A

rtificial Intelligence permeates almost every aspect of our lives and is having a profound impact in our economy and society, transforming products, processes, business models and work. Robotics, AI and machine learning have put Europe on the cusp of automation.

At present, AI systems are feared to have the capacity to replace humans in undertaking narrowly defined tasks — including both physical and intellectual routine tasks — at a much lower cost per unit.

In the next 20 years or even before that, more than half of today’s workplace activities could potentially be automated.

Gartner recently predicted that AI will create 500,000 additional jobs for medium and high skilled workers over the next three years.

While we all know AI will change the future of jobs, we don’t know just how.

In less than a decade, machines could take over 52 percent of the current workload, compared to 29 percent today, according to a report from the World Economic Forum.

The growth of AI will mean a huge rise in tech jobs and will create numerous job opportunities within related sectors and may give to the rise of new industries. AI rise might also signal the potential boost in demand for “human-centric jobs.”

However it is feared to cause an academic brain drain as major tech companies have been aggressively recruiting some of the top AI researchers from universities. Most notoriously, in 2015, Uber reportedly poached 40 of Carnegie Mellon’s top AI engineers to build self-driving cars.

The European Commission has invested €27 billion over the period 2014-2020 supporting skills development, out of which the European Social Fund invests €2.3 billion specifically in digital skills. It has increased its annual investments in AI by 70% under Horizon 2020, reaching EUR 1.5 billion by 2020. Efforts have been taken to persuade business-education partnerships and encourage member states to modernise their education and training systems. Recently, leading computer scientists in Europe recently established a large pan-European AI research institute, aimed at nurturing the creation of a unified community of AI European researchers.

Regardless of heavy investment in reskilling the workforce, more remains to be done to stop the academic brain drain.

With an already intensified global competition for talented engineers and data scientists and an aggressive recruitment drive across Europe, several universities are left without the next generation of educators. Several academics are of the opinion that the EU should regulate the salaries that tech companies offer researchers and carefully craft attractive environments that would retain European talent.

technology

Europe’s struggle to build a truly global tech giant

5G: Europe’s chance to lead for a decade 5G is going to be the new internet, Europe missed the internet, we have telecoms – the big end is internet. Europe cannot miss the opportunity of missing 5G. 5G will enable much more; it will be a big business model transformation – we are reasonably well on track.

E

xpectations of 5G is quite high, with the innumerous assumptions that it will deliver a transformative experience, opening up to a world of new applications and new business models on the back of gigabit speeds, improved network performance and reliability. 5G networks are forecast to deliver very significant economic

www.governmentgazette.eu | 54

gains. The European Commission considers 5G to be the most critical building block of our digital society in the next decade and has earmarked a public funding of €700 million through the Horizon 2020 Programme to support this activity.

At iCPS, we believe 5G can be a key enabler — not only for a better generation of internet networks, but for a new wave of the digital revolution. It is bound to change productivity and transform many industries. It will provide a strong background for the data-driven economy and thus change the economy horizontally.

It will reduce prices and democratise smart cities, enabling the improvement of European citizen’s lives.

Public services will be provided by a new

efficient generation; personalised and contextualised. This can affect a plethora of aspects of life: from social media to the health sector. It will generate completely new services through various types of apps and systems, new possibilities for healthcare delivery, education, autonomous driving, tailored entertainment and commercial services tailored to customers’ expectations. As enabler of many other technologies, much more can be done to embrace all challenges and opportunities that 5G presents, in particular, to vertical stakeholders.

Upon competition, 5G network infrastructures will be a breakthrough in the sector, comparable to the smartphone revolution, or as some might argue — the

internet. As enabler of many other technologies, much more can be done to embrace all challenges and opportunities that 5G presents, in particular, to vertical stakeholders.

Its myriad opportunities can solely be enhanced if vertical stakeholders embrace the possibilities that 5G brings.

Stakeholders believe that cooperation between telecom organisations and verticals should be in place since research phases — albeit this has not been the case up to now.

It is time for all partners and the European Commission, in cooperation with industries and research institutions, to test and re-test solutions related to the network latency and responsiveness, increased network

capacity and data rate requirements. With this in mind, iCPS brought together policy makers, industry leaders and academics in Brussels in September this year to craft a future-oriented implementation to speed up the work on standardisation and stimulate 5G trials.

By fostering the cooperation of vertical, telecom and policy stakeholders, we believe Europe has the potential to become the leaders of the next revolution in telecommunications. The objective of the roundtable was to shape the 5G environment through contributing, intervening and recommending policy direction and laying the adequate foundations for commercial maximisation.

At the roundtable, delegates analysed the current EU policy and strategy developments, evaluated the state of

The European Union has not been the leader of telecommunications changes so far. However, by fostering cooperation among vertical, telecom and policy stakeholders, Europe has the potential to become the leaders of the next revolution in telecommunications: 5G. The ICPS European 5G Infrastructure Roundtable, chaired by Dr. Colin Willcock from the 5G-PPP Association, was a good start for bringing together key stakeholders: verticals, operators, academics and policy-makers. Delegates addressed several key aspects of 5G networks such as spectrum, network infrastructure, vertical business models, regulatory policy, and trials and in other words — analysed the key opportunities and challenges within the entire 5G ecosystem.

5G infrastructures, promoted the collaboration between vertical industries and 5G developers, and finally left with a complete vision of the 5G network. It was unanimously agreed that telecom organisations and verticals should cooperate at the start of early research phases – although this has not been the case up to now.

The iCPS European 5G Infrastructure roundtable was recognised as a starting point to a long and fruitful relationship among telecom and policy stakeholders.

Nonetheless, more work needs to be done. For example, a verticals engagement taskforce could be set in place for ensuring cooperation. Operators, regulators, verticals and vendors need to fully communicate during the development of 5G. Given that 5G is an enabler, without the participation of other industries, we risk not using 5G’s full potential.

The need for an EU-wide approach The EU developed 4G but fell behind in deploying the standard compared to the US and Asia. Nevertheless, there is a latent possibility for 5G to turn into the most critical building block of Europe’s digital society in the next decade.

European telecoms have had their share of struggles over the last year, but they’re pinning all their hopes on 5G. So far, China has been beating the rest of the world in terms of deployment.

However, Europe is still very much in the game. In order to complete with the world and improve its economy, Europe needs to up its game and win the innovation race.

Europe has taken significant steps to lead global developments towards this strategic technology. Yet, there is a huge opportunity in 5G within vertical ecosystems we need to tap into.

The European Commission has provided public funding and an ecosystem that fosters greater innovation and incentives to create newer business models. The 5G PPP gave the technology leadership and used the experience from deployment of previous generations of mobile technologies. But, we’re seeing the same problems that we saw in Europe’s efforts to adopt the previous generations of mobile networks.

The European Union, alongside with all member states, has the capacity to develop 5G at a pan-European level since its start, supporting infrastructure, agreeing on regulation or in how to address spectrum licenses.

Insofar Europe has done remarkable well in particular in spectrum-bands, therefore the EU is in a good position to support harmonisation and learn from previous rollouts.

It is of utmost importance that member states have regulation in place for the development of 5G. However, the European Union should ensure that regulation is mindful and flexible to allow Europe to lead the 5G revolution. For example,

localised licenses rather than nation-wide licenses could be explored. A holistic vision is needed for creating spectrumpolicy and the Commission should lead the way, The priority for both policy and regulation should be investment, especially in the next-generation infrastructure that can enable further technological advances.

It’s time to start engaging at a bottom-up level in order to have effective policy making.

In particular, one of the biggest challenges of 5G is going to be funding and risk sharing while ensuring that proper regulation is in place protecting the public interest.

Future policy direction The 5G Action Plan looks at early deployment which was recognised and supported by member states alongside the ambition to work closely and to coordinate on spectrum policy.

The European Communications Code developed cooperation on licenses and small cells for commercial deployment by 2020 in one city per member state and then the comprehensive roll-out by 2025 within smart cities and major transport routes.

Strategic opportunities can be achieved within automated driving, train connectivity etc through strength in infrastructure as opposed to services and instead provide industry with the basis for digital transformation.The 5G PPP phase 2 research projects have been important to try out ideas for verticals to invest. Phase 3 builds on 5G infrastructure for others build on the platform and improve 5G services. Once the platforms have been agreed then they can be built upon.

In relation to research and standardisation, the first standards have been made available. With basic research and early collaborations with other industries, we have developed and contributed to a standard that meets the needs of different industries and the society. We are only at the start and the technology will take some time to reach its potential.

Government Gazette | 55

technology

Europe’s struggle to build a truly global tech giant

Need to enhance verticals engagement in 5G-PPP There’s a need to bring verticals and IoT closer in conjunction with defining spectrum to explore what is possible with 5G today and tomorrow. As vertical sectors such as transport, media, and manufacturing will likely be the leading adopters, it is important to coordinate and monitor activities related to working with vertical sectors. The future of 5G is verticals.

This can be achieved through overcoming standardisation, spectrum and business model issues.

underlying concerns of verticals are addressed.

Verticals need to ensure that their operational capacities are being used as efficiently as possible.

Investing in 5G trials, for example in collaboration with universities or cities would provide the necessary results that verticals need to see to fully embrace 5G networks. Trials would show concretely what 5G is about. We should promote pan-European multi-stakeholder trials as catalysts to turn technological innovation into full business solutions.

While engaging with verticals is seen as necessary, this engagement will not be possible until the

At the same time, the initial costs might be seen excessive by verticals and, at the moment, there is no clarity in

Recommendations for policymakers:

1

More public investment into the development in 5G is needed. In particular, on trials that could attract more private investment and enhance cooperation between stakeholders.

2

5G deployment will need a certain level of bottom up approach; involving the needs of industries such as agriculture or healthcare.

3

There should be a special impetus in ensuring that 5G is secure. A breach in security could allow foreign powers to intercede in the normal functioning of many industries using 5G. The evolution from 2G to 4G has been positive; but security should be ensured in 5G.

4 5

Cooperation is needed to ensure that Europe does not miss the train of 5G. More work should be done by all stakeholders to craft a shared vision on 5G. Europe needs to find its strength in building 5G infrastructures. Policymakers and regulators need a change in thinking and approach on the part of publicsector stakeholders. Past policy has focused on incentivizing competition and keeping prices low, however now the priority for both policy and regulation should be investment, especially in the next-generation infrastructure that can enable further technological advances.

www.governmentgazette.eu | 56

which stakeholder will have to endure the costs.

However, operators are heavily investing in services that, ultimately, are services for the community: such as automated safety on the road.

Up to now, 5G is seen as “4G with new shoes.”

A joint view will enable Europe to move forward.

This can be done by agreeing on the basic objectives and draw a plan how to implement 5G in reality, the more specificity, backed on successful business cases, the easier that will be to have all stakeholders on board. With 5G still in works, 6G is already shaping up.

Europe should continue with research partnerships

I

t is expected that the European 5G Infrastructure will be operational by 2025. It will provide European citizens, businesses, industries and public services with access to advanced telecommunication services, including enhanced mobile broadband,ultrareliable low latency communications, cloud computing, programmable network management, flexibility, agility …. etc, operating at high levels of energy efficiency. The vision is for it to become a stakeholder driven, holistic ecosystem for technical and business innovation integrating all the key elements into oneprogrammable and unified infrastructure.

The European 5G Infrastructure is currently being researched, developed, trialled and piloted inprojects under theEU Horizon 20205G contractual Public Private Partnership (5G cPPP).These projectsare monitored and reviewed by the 5G Infrastructure Association(private side), and the European Commission (EC)(public side). The 5G cPPP isa three-phase work programme covering2015 to2020. The total EC funding provided is0.7 B€, and itis leveraged 5 times by private funding, totalling4.2 B€, making it the biggest 5G research program worldwide.

Projects to date comprise consortia includingEU telecommunications research centres, universities, systems manufacturers (both EU and non-EU), network operators, and SMEs. A full demonstration

Gerard KENNEDY

is H2020 Leadership in Enabling and Industrial Technologies ICT National Expert and Contact Point, Enterprise Ireland infrastructure is expected by 2020.It will provide programmablenetwork infrastructure using software defined networks, virtualisednetwork functions, network slicing, and network orchestration.Other key developments include wireless technologies enabling full radio access for high density urbanareas, satellite linked access for remote areasand photonics/ fibre optic innovations.

Ongoing trials and pilots to date in Phase 1 projectsverify the operational aspects of these innovations. The research and innovation during all three phases will place Europe at the leading edge of the 5G infrastructure industry.The progress of each project funded to dateis obtainable in the 2016, 2017, and 2018 editions of The European 5G Annual Journal, athttps://5g-ppp.eu/ annual-journal/.

The 2016 Journal provides data for all 17 projects fundedin the

Phase 1 (research) call for proposals.These address a rich cross section of the research challenges leading to a European 5G Infrastructure demonstration by 2020. The aim is for a seamless infrastructure satisfying everyone’s communication needs in an invisible totally dependable way. The topics addressed includes detailed system research and development for all access means, core networks, software defined networks, network function virtualisation, network slicing, automatedmonitoring, managingnetworks, security and resilience, agile exchange, control ofheterogenous radio access networks, developing the overall 5G radio access network design, single air interface below 6 GHz, unified channel model 6-100 GHz, flexible and efficient hardware/ software platforms,agile service development and orchestration in 5G virtualisednetworks,

virtual and rogrammable industrial network, etc.

The 2017 Journal provides interim progress reportsforall the 17 projects that started under the Phase 1 (research) call for proposals.

The 2018 Journal provides a final update on the Phase 1 projects ending in 2017. These provide the first technology building blocks to be leveraged in Phase 2 projects. The 2018 Journal also provides data for 21 projects that started, having been funded in the Phase 2 (optimisation) call for proposals. Phase 2 aims to master the 5G technologies,developed under Phase 1,and to investigate their application with vertical industries(“business sectors”).The topics addressed includes developing an overall 5G architecture for“vehicleto-everything” services, multi-tenant small cell networking, edge computing, orchestration and optimisation, scalable 5G infrastructure, 5G architecture for large scale immersive media delivery, optical space division multiplexing, millimeter wave and visible light communications, smart optical metro infrastructure, Smart Energy-as-a-Service, advanced radio resource allocation, virtualised slicing-friendly infrastructure, service platform for media applications, photonic technologies for high-density software defined networks, hierarchical orchestration mechanisms, Platformas-a-Service, virtualised radio access network, dense networks, etc.

interim progress reports for Phase 2 projects and data for all projects that will have started, having been funded in the Phase 3 (large scale trials) call for proposals.

To achieve 5G expectation, innovation is necessary, not only in technology but in business models within verticals integrated.

The requirements for 5G differs from vertical to vertical, yet higher throughput, lower energy and lower latency are traffic profiles which can help the digitalisation and beyond of any vertical.

Therefore, it is my recommendation that after the 5G cPPP has ended in 2020 that the European Commission continues with their research partnership with the private telecommunications industries to ensure that the EU stays at the forefront of this important area, which is a key enabling technology for all sectors of EU society and economy and which provides the basis for all internet services and critical infrastructures.

It is expected that the 2019 Journal will provide Government Gazette | 57

technology

Europeâ&#x20AC;&#x2122;s struggle to build a truly global tech giant

How can Europe realise the potential of 5G and take leadership in future smart networks?

Dr Colin Wilccock

is Chairman of the 5G Infrastructure Association

The existing 5G-PPP programme has been a clear success for Europe with thousands of researchers and developers across Europe successfully working on innovative solutions for the definition of 5G.

T

he 5G Infrastructure Association (5G-IA) is committed to the advancement of 5G in Europe and to building global consensus on 5G. To this aim, the Association brings together a global community of telecoms & digital actors, such as operators, manufacturers, research institutes, universities, verticals and SMEs. The 5G-IA carries out a wide range of activities in strategic areas including standardization, frequency spectrum, R&D projects, technology skills, collaboration with key vertical industry sectors, notably for the development of trials, and international cooperation. It also represents the private side in the 5G-PPP. The existing 5G-PPP programme has been a clear success for Europe with thousands of researchers and developers across Europe successfully working on innovative solutions for the definition of 5G.

www.governmentgazette.eu | 58

These efforts have had a significant effect on the initial 5G standards we have today, especially in the areas of system design, evaluation aspects, air interface innovations, network management, security innovation, virtualization and service deployment innovations.

In addition to the hundreds of standardization submissions, the 5G-PPP projects were the key place for building global pre-standardization consensus. As well as key input to the current 5G version, 5G-PPP is closely involved in the development of further releases of the 5G standard, which will address vertical industries. Through far sighted and early funding from the European Commission, the 5G-PPP programme has enabled Europe to lead 5G research and provide the related European technology to the world.

This effort is recognised by international counterparts in Brazil, China, India, Japan, Korea and the US.

However, 2020 is not the end of the story.

Communication infrastructure will continue to evolve driven by cutting-edge research and it is vital to ensure a continuation of research partnerships between the EU Commission and the private side to ensure that Europe stays in the forefront of this important area, which is a key enabling technology for all sectors of society and economy, and which provides the basis for all Internet services and critical infrastructures.

In the view of the 5G IA, communication networks will be the life blood of the digital society with connectivity evolving from a luxury towards a basic human right. We believe that research, development and deployment of communication networks will be a key future economic differentiator.

Smart Networks of the future will bethe nervous system of the Next Generation Internet (NGI) and other commercial networks. The will provide the platform for driving the digital transformation of vertical industries (providing smart connectivity to economy and society).

Smart Networks will be characterised byIntegrated Connectivity, Computing and Control (the 3Cs).

They will form converged heterogeneous networks, integrating the 3Cs, so as to enable the broadest range of ubiquitous and affordable mobile and fixed uses. They will provide ubiquitous coverage with support for hundreds of trillions

(1014) of connected, active, devices and terminals with a massive number of tailored costeffective services.

The European Commission has understood the importance of smart networks and included this area in the latest version of the Horizon Europe proposal. This foresight is welcomed by the 5G IA, but it is still vital to ensure that this area receives sufficient funding to enable Europe to retain its technological leadership. Overall the horizon Europe proposal has many interesting areas highlighted in the Global Challenge Digital and Industry, both at a high-level like human centric internet and artificial intelligence and at a low level such as silicon technology, and the association would like to emphasise the need for a significant infrastructure part to tie all these concepts together and actually make them work.

In summary, in order for Europe to realize the potential of 5G and take leadership in future smart networksit is vital that Smart Networks (communication infrastructure, digital security and connectivity) plays a significant rolein the Horizon Europe proposal. Due to the nature of network technology there is a need for creating a longterm Smart Networks research instrument in Horizon Europe to create European smart communication technology for the world and enable a unique innovation space for Europe.

ETSI – the home for all players in 5G

E

TSI is one of the primary ICT standards bodies recognised at the global level. In our European home, we provide standards and specifications that support EU regulation as well as policy objectives. We have a collaborative relationship with the European Commission and other EU bodies, as they strive to provide appropriate industrial policy making. A major achievement of the European standards process – in support of EU policy - is demonstrated by how ETSI standards help prevent operators and technology users from being caught in restrictive supplier lock-ins, by providing a fair environment for all.

From the start ETSI has been a key driver for the development of 5G. The focus has been on the creation of standards for 5G so that its potential can be delivered. ETSI has already produced the first 5G standards (around 1 200 documents by now) this year and work continues to prepare for the next phase by the end of 2019 which will provide the full 5G system specification ready to be applied world-wide. The 5G New Radio (NR) is one of the first steps and the basis of 5G, which together with new 5G core network capabilities, promises a broad expansion of services which are sure to attract new industries into this technology stream.

With that in place companies can confidently promote their plans for 5G networks.

Priorities are still evolving, but the focus will now turn to massive machine type communications and the delivery of ultra-reliable and low latency communications, which - combined with the enhanced broadband speeds provided by the 5G radio - will deliver full-blown 5G. Not only will 5G be fast but it will also take us into an era of ubiquitous computing, enabled by intelligent, transformed networks, designed to support billions of devices and “things.”

5G networks will provide the foundation for innovation

efficiency and this will be pivotal. Users will be able to do more with the same smartphone battery life. The low power consumption capabilities will be highly advantageous elsewhere too. Remotely located IoT sensor nodes employed in industrial, agricultural or environmental monitoring will draw less electrical current when interfacing with the network - and consequently run for considerably longer periods without the need for battery replacement.

Luis JORGE ROMERO is DirectorGeneral, ETSI within industries for vertical sectors including broadcast/ media, finance, transportation, automation, manufacturing, healthcare, retail, agriculture, aerospace, satellite technology as well as smart cities and smart homes/buildings – it’s really a key enabler for the 4th Industrial Revolution.

With a rapidly growing number of devices – and things – being connected to mobile networks and many activities becoming more data intensive, 5G is not a luxury but a necessity.

5G also offers greater energy

Thanks to the low latency operation that 5G will deliver, it is certain to be of value to many applications. 5G’s scope will go further, playing a key role in allowing ‘connected cars’ to communicate with one another and the surrounding infrastructure, so that accidents can be prevented, and the safety of road users can be assured.

On the factory floor, it will lead to the implementation of highly sophisticated automation processes, making production lines more efficient and safer too. There will also be the possibility for tele-surgery, with medical specialists located long distances away now able to carry out critical operations on patients using remotecontrolled equipment, and many more fields of application that

will create the smart cities of tomorrow.

All these applications also need to cater for very high security requirements, which 5G is ready to comply with, way beyond the capabilities of current systems.

The goal must also be to achieve interoperability.

Standards need to be developed by all relevant stakeholders.

ETSI has attractedover 850 members worldwide from 66 countries who participate in this development. Stakeholders include leading companies from the manufacturing and service sectors along with regulatory authorities and government ministries, SMEs and innovative start-ups, working alongside universities, R&D organisations and social interest groups.

Standards are produced by our members through active participation, cooperation and consensus where all contribute as equals. ETSI works in partnership with other Standards Development Organisations as well as communities, fora and consortia.

We are at the forefront of emerging technologies and have close relationships with research communities and other innovative bodies addressing technical issues driving the economy of the future and improving the life of the next generation. ETSI as a founding partner and European representative plays a key role in the 3rd Generation Partnership Project (3GPP) and has successfully included input from the 5G PublicPrivate Partnership (5G PPP) and research projects fed into the development of the 5G standards which will be used world-wide.

Today, ETSI has been a significant meeting place for all of the players in the industry during the standardization discussions around 5G. This is set to continue as full 5G comes fruition, providing a gear-shift in technology development that will change society in so many ways.

Government Gazette | 59

technology

Europe’s struggle to build a truly global tech giant

Where is Europe now, what are its success prerequisites and changing vectors?

To become 5G leader appropriate policies and strategies are necessary but where is Europe now, what are its success prerequisites and changing vectors?

U

ltrafast broadband networks are vital to Intel as the leading semiconductor manufacturer delivering state of the art processors, memories, modems etc. to the entire ICT industry inclusive telecom operators and their suppliers.

When publishing their objective Europe to become the 5G global leader by 2025, European Commission recognized, inter alia, that affordable and accessible broadband infrastructure is a fundamental platform that fosters innovation and drives the development of economies and of the information society.

To become 5G leader appropriate policies and strategies are necessary but where is Europe now, what are its success prerequisites and changing vectors?

A lot of production capabilities have been outsourced to the Far www.governmentgazette.eu | 60

East. Popular examples are consumer electronics inclusive photo cameras, computers and telephones, industries like aluminium or steel, clothing or toys, etc., etc.

Most probably they will never come back.

The ICT market makers like Google, Facebook, Amazon, Microsoft, or Apple are originated in and operate from USA. Europe has de facto given up these consumer oriented, fast moving markets. Europe’s strength is to develop and to deliver long lasting, infrastructure and business-to-business oriented concepts and solutions. European car makers are on top of a global suppliers’ ecosystem. Automation, energy, or transportation industries with Siemens or Airbus, business software with SAP, or mostly unknown but specialized hidden champions, the small and medium enterprises, are executing most complex projects and delivering products highly desired by customers world-wide.

European success bases on the excellent education, stable and predictable regulatory and legal frameworks, transparent market structures and business reporting, long term oriented entrepreneurship, financing and risk taking culture, and resulting, still first class, infrastructures for transportation and education.

There is only one infrastructure where Europe is lagging behind the rest of the world – the communication networks in the last mile.

Europe competes with the rest of the world to become a champion on the intellectually most sophisticated and economically challenging fields like 5G communication, on artificial intelligence or autonomous driving in the future.

But Europeans are not connected properly.

Europe’s biggest challenge is to transport a content between consumers’ devices like PCs, laptops or smartphones and the server farms of providers delivering services like TV-streaming, shopping, banking, education, medicine, or just a simple information transfer from A to B between the small and medium enterprises generating most of the European gross domestic product.

The bottlenecks are the copper cables in the last mile of the fixed networks and the radio links between the base stations of mobile networks.

Both must be replaced by the optical fibre.

The statistics says that only 9% of households were connected to FTTH and 5% to FTTB in Europe Union’s 28 countries in February 2017; in Germany, the leading European economy, only 1% of households were connected to FTTH and 1.3% to FTTB. The European Electronic Communications Code approved by European Parliament and Council in June 2018 has been announced as a step towards meeting Europe’s growing connectivity needs, as a groundwork

Christoph LEGUTKO is Corporate Government Affairs Broadband Connectivity Policy Europe, Intel for the deployment of 5G across the continent, as designed to boost investments in high capacity networks across the EU, including remote and rural areas.

The industry has postulated consequent fostering the facilitiesbased competition, straightforward and unambiguous rules on co-investment, favouring ex-post oversight over ex-ante control, the remedies balancing between the impact on incentives to make risky, expensive broadband investments and on static competitive benefits, and also continuing the support of the end-users interests and rights as well as of further development of robust content and application ecosystems.

The EECC though, following the consensus oriented European fashion, is trying to satisfy the interests of all market players, telco and cable operators, incumbents and newcomers, supporters and opponents of ex-ante and ex-post regulation, etc. and leaves the

market players with uncertainty about the regulatory treatment thus undermines the ability to build investment cases.

When comparing the regional approaches to foster the deployment of ultrafast broadband, the administrations in Asia have defined clear industry policies and implement them expeditiously, USA consequently left this task to the markets and Europe apparently decided to follow a middle, thus slow and inefficient, way between them both, knowing that without the optical fibre in the last mile 5G will not happen.

Europe begun the telecommunication reforms in 1998 and was successful in bringing competition to the markets based on the existing copper networks.

The EECC is a step in the right direction but Europe should continue the reforms to promote investments in ultrafast broadband and to meet the needs of the gigabit society of 21st century.

Whatâ&#x20AC;&#x2122;s the key role of SMEs in creating market-leading 5G innovative solutions?

European SMEs can take advantage of the potential disruption brought by the deployment of 5G in various vertical sectors to become global market leaders

T

he 5G Infrastructure Public Private Partnership (5G PPP) is a joint initiative between the European Commission and European ICT industry (ICT manufacturers, telecommunications operators, service providers, SMEs and researcher Institutions). Started in 2014,the 5G PPP delivers solutions, architectures, technologies and standards for the ubiquitous next generation communication infrastructures of the coming decade. Its main challenge is to secure Europeâ&#x20AC;&#x2122;s leadership in the particular areas where Europe is strong or where there is potential for creating new markets such as smart cities, e-health, intelligent transport, education or entertainment & media. The 5G PPP will reinforce the European industry to successfully compete on global markets and open new innovation opportunities.

deploying 5G technologies, both to help with disruptive technologies and to address the needs of various vertical sectors. European SMEs have a great added value in providing innovative concepts and solutions that are having an important impact on the 5G value chain. They have the agility and flexibility required in a fast evolving technical and market landscape. This has been well understood within the 5G PPP, where a specific objective was set from the start, for SMEs to reach a 20% share in the programme.

The 5G Infrastructure Association (5G IA), which represents the private side of the 5G PPP, also recognised the importance of SME involvement:since 2017, the Board of the 5G Infrastructure Association includes two SME representatives out of 11 members, instead of one previously.

The 5G PPP has already been playing an essential role in the development of 5G technologies (Phase 1) and ensuring the feasibility of deploying those technologies in various vertical sectors (Phase 2). With the advent of Phase 3, starting in 2018 i.e. now, the European Commission and the European industry, along with academic organizations, are looking on the one hand at deploying 5G test infrastructures, and on the other hand at experimenting 5G-based solutions in various vertical sectors, with the objective to speed up the commercialization of 5G technologies and 5G-based solutions, thus ensuring European global leadership.

The involvement of SMEs in the 5G PPP has been progressing along the Phases, almost reaching 20% in Phase 2. Now, with Phase 3 and the actual 5G experimentations starting, SME involvement should again increase, as there are many SMEs already present in vertical markets such as media, transportation, energy, smart cities, public safety, just to mention a few.

Small and Medium-sized Enterprises (SMEs) have an important role to play in developing, piloting and

SMEs employ 93 million people in Europe, account for 67% of the total employment in the EU-28 non-financial business sector, and generate 57% of value added, again in the EU-28 non-financial business sector. From 2013 to 2016, EU-28 SME employment grew by 5.2%, almost 50% faster than overall employment in the EU-28 economy over the same period. Even in the EU-28 manufacturing sector,

Jacques Magen

is Chairman, InterInnov Member of the 5G Infrastructure Association

in which large enterprises are generally dominant, SMEs still account for 58% of total employment and 42% of total value added. In the business services sector, where most of the ICT work is performed nowadays, SMEs account for 82% of total employment and 76% of value added .

The deployment of 5G and its introduction in many vertical sectors could prove very disruptive not only for the stakeholders currently involved in the telecoms sector, but also for the players of the vertical sectors. Their business models might need to be reshaped to consider a completely new paradigm. This might prove to be an opportunity for European SMEs, who are by nature more flexible and may be less reluctant to change than larger incumbent players. This maybe hopefully leading to large growth and global leadership for those SMEs who will be the first ones to take this path i.e. using 5G technology to develop new and innovative solutions and applications in the vertical markets they already know well, or to take advantage of their expertise in 5G to develop disruptive solutions to reach new markets.

This evolution needs to be planned now, to be best prepared when it is time for 5G-based solutions to be commercialized and deployed.

Demonstrating the feasibility for SMEs to develop and deploy 5G innovative solutions in vertical markets should allow other SMEs to follow a similar path, eventually gaining European market share on the global scale.This will strengthen the chances that European SMEs achieve eventually sustainable growth and become key players in the new business environment created by the 5G paradigm.

Facilitating the future involvement of many European SMEs in the development of 5G related solutions and applications in various vertical sectors should be one of the key objectives of the 5G PPP and more generally of the public and private sectors.

If this is prepared properly, then there is a chance that European SMEs may prove to be major beneficiaries in the potential economic disruption brought by 5G, and the consequent deployment of innovative 5G-based solutions and applications in many vertical sectors, thus ensuring a European leadership in many vertical sectors.

Jacques Magen, Chairman of InterInnov, Member of the Board of the 5G Infrastructure Association. He chairs the NetWorld2020 SME Working Group, which works in close relation with the 5G IA and the 5G PPP.

Government Gazette | 61

Government Gazette A report by the Government Gazette Roundtable Unit

cardiac health report

A multistakeholder collaboration

Driving policy action for

IMPROVING CARDIOVASCULAR HEALTH in Europe

The recommendations in this report are the result of desk research and have emerged from the conversations among the experts participating in the ICPS Cardiac Health Europe Roundtable 2018, with a view to making practical and actionable recommendations across the cardiovascular care pathway.

CONTENTS Our thanks are due to the following experts who have offered their expert insights to improve cardiovascular treatment and management in Europe

Executve Summary PART I : Background The state we are in and why cardiac health matters now

Expert Recommendations Making heart failure a strategic policy priority Ed HARDING

PART II : Call for Action

Managing Director, Health Policy Partnership

Policy recommendations tabled at the iCPS Cardiac Health Europe 2018

Discussing cardiovascular realities in Europe Prof Panos VARDAS Chief Strategy Officer, European Society of Cardiology

Prevention and management of Atrial Fibrillation Dr Rüdiger SMOLNIK

Senior Medical Director, Global Medical Affairs, Daiichi Sankyo

Building cardiovascular healthcare for tomorrow Dr Jan De RAET

Chairman Cardiac Surgery, Brussels Heart Center

PART III : Expert Recommendations Independent policy recommendations from policy makers, cardiovascular experts and academics

Beyond hospital walls Francesca COLOMBO Head, OECD’s Health Division

How researchers can improve cardiac health

Federica CENSI

Lead Researcher, Department of Cardiovascular, Dysmetabolic and Ageing-Associated Diseases, Istituto Superiore di Sanità

The state we are in 1.

2.

3.

With an ageing population, the global cost of CVD is set to rise to over $1 trillion by 2030.

Each year cardiovascular disease causes 3.9 million deaths in Europe and over 1.8 million deaths in the European Union. CVD accounts for 45% of all deaths in Europe and 37% of all deaths in the EU. CVD cost the EU economy €210 billion a year: 53% (€111 billion) is due to health care costs, 26% (€54 billion) to productivity losses and 21% (€45 billion) to the informal care of people with CVD. © European Heart Network

C

ardiovascular disease (CVD) is a major cause of disability and premature death throughout the world, and contributes substantially to the escalating costs of health care. CVDs cause more death and disability than cancer – 4 million compared to 2.1 million deaths in 2016 – yet funding for CVD research lags behind. Oncology has the largest share of health and biomedical papers at 23%, compared to just 10% for CVD, suggesting less research activity. It is estimated to cost the EU economy almost €210 billion per year, which is more than the total EU budget. With more than 1.8 million people dying every year, Europe’s challenge is to reduce the inequalities in treatment and reorganise healthcare delivery by implementing proven initiatives in prevention, treatment and management of cardiovascular health.

Despite recent significant progress made in improving care, clinical decision-making, and policy implications, CVD remains the leading cause of illness and disability for men and women across Europe. Despite good progress in the management of patients with atrial fibrillation (AF), arrhythmia remains one of the major causes of stroke, heart failure, sudden death, and cardiovascular morbidity in the world. Persisting inequalities in treatment remains one the main issue which affects the management of cardiovascular health.

While many groups have worked to identify the remaining gaps in the provision of care, this policy report is intended as a practical document that showcases specific policy actions that can be taken to close these gaps across Europe.

Representing the voice of cardiovascular health experts and healthcare policymakers in Europe, we have identified three core areas where legislators in the new European Parliament and policymakers at memberstate level can achieve these ambitious goals.

The call for action is addressed to policymakers at EU and national levels, healthcare professionals, academia, advocates, patients and members of the cardiac health community and required collective and collaborative approach across all member states.

HEALTHCARE Driving policy action for improving cardiovascular health

All to tackle the world’s number one killer ICPS calls on all 2019 political candidates and parties to pledge their commitment to improving cardiovascular health.

Create adequate awareness • Establish widespread awareness about risk factors • Health education campaigns should be targeted at the young and other subgroups of society • Develop knowledge on the efficacy and safety of therapies to reduce risk factors • Tobacco smoking remains the most important preventable cause of premature mortality, so policymakers should promote anti- smoking as the most cost-effective strategy to prevent CVD

Promote prevention • Invest more in the earliest possible prevention of CVD from childhood onwards, and in prevention of the development of an increased CVD risk • Support restrictions on advertising, promotion and marketing of unhealthy foods and drinks to children on television, internet, social media and food packages • Promote structural measures such as product information, and nutrition labelling

Heart-healthy lifestyles

• Promote development of dietary targets to prevent cardiovascular disease • Promote policies to transform neighbourhoods into heart-healthy environments so that we can achieve a 25% reduction in premature death from cardiovascular disease (CVD) by 2025 • Legislate to encourage individuals to make heart-healthy choices, such as choosing healthy food options, increasing physical activity and saying no to tobacco

How to we deal with EU’s chronic cardiovascular disease burden?

A

lthough there has been a decrease in the mortality of cardiovascular disease (CVD) across Europe, it remains the leading cause of death and a major cause of illness and disability for men and women in Europe. More than 49 million people in the EU live with CVD. www.governmentgazette.eu | 64

Each year, more than 1.8 million people in the EU die from CVD. Huge inequalities persist with CVD accounting for more than 50% of all deaths in many middle income countries compared with less than 30% in the high income countries of Western Europe.

CVD is estimated to cost the EU economy almost €210 billion per year, which is more than the total EU budget. Of this €111 billion is due to direct health care costs, €54 billion is due to productivity loss and €45 billion is due to informal care of people living with CVD.

The price we pay is huge.

In order to better manage

Cardiac Health Europe Roundtable 2018

of prevention in reducing Europe’s cardiovascular burden.

Education and Prevention Dietary risks account for over half of deaths in men and over 40% of deaths in women in both the European region and the EU. The total economic cost of the burden of diet-related CVD is estimated to be 49% of the total yearly costs of CVD in the EU, equivalent to €102 billion. Reducing dietary risks, therefore, offers great potential to reduce the €102 billion in annual costs to the EU of diet-related CVD

the growing burden of CVD in Europe, policymakers must reorganise healthcare delivery by implementing proven initiatives in prevention, treatment and management of cardiovascular health.

The International Centre for Parliamentary Studies recently convened a high-level policy roundtable to examine CVD from a multistakeholder perspective on June 19, 2018 in Brussels. Chaired by Prof Chris Gale, consultant cardiologist and professor of cardiovascular medicine from the University of Leeds, the Cardiac Health

Europe Roundtable 2018 brought together healthcare experts, key policymakers, academics across Europe, who examined a wide array of issues within the CVD regulatory environment concerning prevention, surveillance, diagnosis and treatment.

The roundtable commenced on a passionate note with a policy update from MEP Karin Kadenbach, CoChair of the MEP Heart Group, who recapitulated the European Parliament’s current work in managing Europe’s cardiovascular disease burden. Highlighting the inequalities in disease

burden and emphasizing on a strategy focusing on prevention, she noted that preventing health problems is cheaper, easier and better than fixing them. Reinforcing the importance of spelling out the cost of ‘non action’, she elaborated how fiscal policies and marketing controls to influence the demand for tobacco, alcohol and foods high in saturated fats, trans fats, salt and sugar – can efficiently support the reduction of CVD in Europe.

A central theme that emerged from the roundtable discussion related to the importance

Promoting a cardiovascular health-promoting diet that is rich in fruit, vegetables and fibre, and with limited intake of salt, sugar, transfatty acids and alcoholic beverages, will help reduce the burden of CVD. Consequently, access to food products that make up a healthy diet is crucial.

Policies promoting healthy diets Delegates agreed that policies which contribute to making food products healthier can have a positive impact. In addition to these, taxation policies or price policies which lead to reformulation are also important: less salt, less saturated fats, less free sugars in food, or less energy dense products will all contribute to cardiovascular health promotion and disease prevention. Policies which influence the price we pay for certain products can be extremely stimulating.

Delegates at the ICPS Cardiac Health Europe 2018 call on policymakers to implement, as soon as possible, effective and long-term measures to prevent cardiovascular disease in Europe and table a few significant recommendations to improve management of the killing disease.

1. As the primary cause of death and disability in Europe, cardiovascular diseases deserve greater Government Gazette | 65

HEALTHCARE Driving policy action for improving cardiovascular health

attention at the policy level.

We must communicate to the public at large and to policymakers the urgent need and unprecedented opportunity to prevent cardiovascular disease in order to establish widespread awareness and concern about the conditions, as well as confidence in the ability to prevent and control them; 2. National health policies, supported by implementation strategies, have a critical role to play in reducing CVD. Europe must develop policies for preventing heart disease at European, national and local levels to assure effective public health action and develop new knowledge on the efficacy and safety of therapies to reduce risk factors; 3. Creating adequate awareness of cardiovascular diseases and their risk factors may help reduce the populationâ&#x20AC;&#x2122;s exposure to these and contribute to prevention and control strategies. More importantly, it is crucial to educate the younger generation about the risks of CVD; 4. The burden of cardiovascular disease can be mitigated by careful risk reduction. Reducing cigarette smoking, body weight, blood pressure, blood cholesterol, and blood glucose all have a beneficial impact on major biological cardiovascular risk factors. Behaviours such as stopping smoking, taking regular physical activity and eating a healthy diet promote health and have no known harmful effects;

www.governmentgazette.eu | 66

5. Strategies to promote primate prevention, effective secondary prevention among those with risk factors as well as those that survived a clinical event and population-wide interventions are all essential in effectively managing CVD. In the era of precision medicine, primary prevention strategies should increasingly focus on fine-tuning the intensity of interventions to match individual patient risk. It is crucial to gain more funding for interventions and it is essential that these interventions are actively monitored by member states; 6. European policymakers should conceive policies that promote environments conducive to healthy lifestyles, which will help improve behavioural risk factors and stem the development of the medical risk factors; 7. Policies which contribute to making food products healthier do have an impact. A radical change in food production is essential to create an environment where the healthy food choice is the default choice.

Working in unison with the European Food Safety Authority, Europe should 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; 8. Other effective measures that demand political action include reducing marketing of unhealthy food products to children, or setting nutrient profiles in the context of the EU regulation of

health and nutrition claims or to develop front of pack labelling; 9. Policymakers should take policy action towards restricting advertising and marketing of unhealthy foods and drinks to children on TV, internet, social media and food packages and set mandatory, harmonised and simplified front-of-pack nutrition labelling; 10. Fiscal interventions such as taxation and regulations on tobacco production and sales; regulations on tobacco and food marketing and labelling; alterations in subsidies for foods and other food and agricultural policies; and strategies to make rapid urbanization more conducive to health.

11. MEPs can promote heart healthy lifestyles in their own countries by calling for and supporting WHO and EU policies that discourage smoking and encourage a healthy diet, exercise and physical activity; 12. Europe should act on the growing health inequalities perpetuated by a range of factors including differences in rates of CVD (relating to socioeconomic status), poor health literacy, genetic redisposition to risk factors, geographic differences and access to novel technologies.

Individual member states should develop specific screening strategies to suit the needs and preferences of their population as one approach might not work for all; 13. More work should be done to improve diagnostics in lower

and middle-income countries.

There is a need to increase the access to high-quality experts to make research more equitable; 14. Patients should be actively involved in all stages of intervention and treatment and trained to participate in healthcare delivery.

Strategies that promote patient engagement and remote monitoring should be encouraged to broaden access to effective care strategies while minimizing burden to current healthcare infrastructure; 15. It is crucial to understand dataâ&#x20AC;&#x2122;s role in diagnostics and use it to our game. There is a need to explore the opportunities in data, regulate data banks and streamline the use of unstructured medical data to improve early diagnosis and treatment of CVD; 16. Partnerships between providers, government regulatory agencies and industry are needed more than ever to innovate technology, pharmacology and care pathways. Open communication between industry and healthcare professionals is integral to identify pathways for research.

Active involvement of industry is crucial in maximizing the potential of technological innovations. There is greater room to improve diagnostics and treatment by implementing new technologies; 17. Finally, there is an urgent need for more research into how guidelines are implemented across Europe.

advocacy groups, policymakers and other stakeholders from across Europe, was established in 2015 to raise awareness of the unmet needs surrounding HF and its care.

Europe should make heart failure a strategic policy priority There are at least 26 MILLION ADULTS in Europe living with HEART FAILURE. It is the most common cause of hospital admissions in people over 65 and the leading contributor to unplanned hospital readmissions.

Yet only a handful of governments recognise its strategic significance, and health outcomes for people living with heart failure.

The article is coauthored by Sara C MARQUES, Policy Researcher at HPP

T

he need for partnerships to overcome the challenges around chronic diseases is now more pressing than ever. Heart failure (HF) is a good example of a shared sustainability challenge in both human and economic terms, where the case for pan-European work is strong. Member states have much in common with regard to HF; the financial burden of disease is significant, and current models of care, based largely on crisismanagement,are unsustainable and ineffective in keeping patients out of hospital.

HF is the most common cause of hospital admissions in people over 65 and the leading contributor to unplanned hospital readmissions. Inpatient hospital care is a major cost driver, reported to account for up to 70% of HF healthcare costs in western countries.

Outcomes for HF remain poor; one in four HF patients is readmitted to hospital within one month of discharge, and two in three are readmitted within one year.

To develop healthcare systems and invest in more efficient models of care, member states must take advantage of the opportunity to learn from each other and to pool resources

Ed HARDING is Managing Director of Health Policy Partnership as they investigate and implement solutions.

International research, scientific consensus, and the development and testing of best practice models across countries is the only real option for this.

HF specialist nurses are central to many best-practice models.

They can provide routine monitoring, management and patient therapeutic education, and can run longer and more individualised consultations than other healthcare professionals.

This allows the development of care away from acute centres andensures better patient outcomes. In many ways, the full potential of such roles working at scale has only just begun to be explored, but the benefits are clear. Yet definitions of the role of HF specialist nursescan vary widely, and the extent to which their status is recognisedis hugely inconsistent across Europe.

Critics of the European

project have often cited transparency and accountability as a rationale for the withdrawal of competencies and resources to the national or regional level.

However, certainly in HF and doubtless for many other chronic diseases, accountability to citizens by national governments fundamentally depends on some element of international pooling of resources and policy coordination. This includes alignment on standard measures of quality and comparison of outcomes across geographies and populations.

Developing and using quality measures is not only more efficient and feasible when coordinated in a pan-European way, but arguably flawed if not based on such coordination.

In 2017, it set out to develop The handbook of multidisciplinary and integrated heart failure care, an overview of the challenges that HF poses on individuals, health systems and societies in general, and a collection of innovative solutions to help solve problems and drive change. The handbook identifies five â&#x20AC;&#x2DC;pressure pointsâ&#x20AC;&#x2122;: key areas along the HF care journey that frequently present the greatest challenges and missed opportunities.

It includes examples of best practice in the integrated management and multidisciplinary care for HF, and can serve as a starting point to facilitate national policy discussions, panEuropean partnerships and the development of sustainable healthcare systems.

On 5th September 2018, the handbook was launched at the European Parliament in Brussels, Belgium, in the presence of HF Policy Network members, people living with HF, healthcare professionals and parliamentarians.

The event highlighted the needs of people living with HF and persistent inequalities they face in accessing care. It also issued a call for action to policymakers to develop sustainable health systems capable of dealing with the HF challenge.

The Heart Failure Policy Network, an independent and multidisciplinary group of healthcare professionals, patient Government Gazette | 67

HEALTHCARE Driving policy action for improving cardiovascular health

Discussing cardiovascular realities in Europe across Europe and the Mediterranean area (1.8 million deaths in the European Union alone), with 30% premature deaths.

Economic factors play a major role in the delivery of healthcare.

But it’s not just about the money.

It’s about hard facts and targeted policy measures. Professor Panos Vardas, Chief Strategy Officer for the European Society of Cardiology (ESC), explains why.

Prof Panos VARDAS is Chief Strategy Officer for the European Society of Cardiology

D

espite declines in overall mortality over the past decades cardiovascular disease (CVD) continues to be the number one killer in Europe, causing 3.8 million deaths per year

This immense societal impact is exacerbated by a massive economic burden, with cardiovascular disease costing €210 billion a year in the EU alone in direct costs, as well as indirect costs related for instance to absenteeism and lost productivity.

This hard truth presents countries with a clear social and economic imperative to develop adapted policies to protect their populations from cardiovascular disease. These include, first and foremost, public health measures to address the main risk

factors for heart disease, which are unhealthy diets, alcohol abuse, smoking and physical inactivity. Indeed, reducing population cardiovascular risk by 1% would prevent 25,000 cardiovascular disease cases and generate savings of €40 million per year in a single European country.

Measures aiming at ensuring equitable healthcare delivery should complement such actions, as disease management is and will remain a priority for an ageing population.

The ESC believes that evidence-based decision making is essential to ensure real progress in health promotion and disease prevention, while guaranteeing

the sustainability of healthcare systems through a cost-effective allocation of resources and efficient foreword planning.

To this end, the ESC created the ESC Atlas of Cardiology (ESC Atlas), a unique and unprecedented online compendium that documents cardiovascular statistics with data collected from national cardiac societies from ESC member countries, as well as well known organisations.

It maps, analyses and compares data on cardiovascular disease prevalence and mortality, including major risk factors, and features novel data on health infrastructure and cardiovascular services

Cardiovascular Realities in Europe Premature Deaths

ESC Atlas of Cardiology

Cardiovascular disease is the world’s biggest killer. Cardiovascular diseases are also responsible for a large proportion of premature mortality. More precisely, they account for 30.4% and 25.3% deaths before the age of 65 in Europe, in men and women, respectively.

30% 25%

www.governmentgazette.eu Source: Timmis A, Townsend |N,68 Gale C, Grobbee R, Maniadakis N, Flather M, Wilkins E, Wright L, Vos R, Bax J, Blum M, Pinto F, Vardas P. European Society of CardiologyCardiovascular Disease Statistics 2017. Eur Heart J 2017; 39(7):508-579. www.escardio.org/atlas

to highlight inequalities in service provision and cardiovascular outcomes across systems.

Smoking Prevalence The average percentage of smokers across European countries is 31% for men and 16% for women. However, in some countries smoking prevalence is much higher, peaking at 55% for men in Russia and 33% for women in Bulgaria. Smoking is a major risk factor for cardiovascular disease.

ESC Atlas of Cardiology

Key findings from the 2017 edition of ESC Atlas indicate lower hypertension and smoking prevalence in high- versus middleincome countries.

Additionally, such inequalities in risk factors could well be attributed to more cardiovascular disease-related deaths in middle-income countries.

Cardiovascular Realities in Europe Risk Factors

Findings also reveal considerable inequalities in treatment facilities and that countries providing the most advanced contemporary care generally showed the most pronounced declines in coronary mortality.

This clearly suggests that economic resources are not the only driver for delivery of equitable cardiovascular healthcare.

In this respect allocation of resources could be a key factor for reducing inequalities, and that is an important lesson for policymakers.

By providing a greater understanding of current European cardiovascular realities and the enhanced ability to predict future trends, ESC Atlas aims to become an indispensable tool for the identification

1 in 5

20%

Obesity

Raised Blood Pressure

The average prevalence of obesity across European countries is above 20% (more than 1 in 5) for both men and women. Obesity is a major risk factor for cardiovascular disease.

High blood pressure is a major risk factor for cardiovascular disease. The average proportion of men and women with raised blood pressure across European countries is 28% and 20%, respectively.

Source: Timmis A, Townsend N, Gale C, Grobbee R, Maniadakis N, Flather M, Wilkins E, Wright L, Vos R, Bax J, Blum M, Pinto F, Vardas P. European Society of CardiologyCardiovascular Disease Statistics 2017. Eur Heart J 2017; 39(7):508-579.

www.escardio.org/atlas

Cardiovascular Realities in Europe Heart Transplants

ESC Atlas of Cardiology

Interestingly however, the data showed that unequal health outcomes were not always an inevitable consequence of limited economic resource. For example, some middleincome countries, e.g.

Bulgaria and Turkey, reported rates of cardiac catheterisation and coronary stenting, which compared favourably with the best highincome countries.

28%

> 0-1.9 Transpants per million people

> 2-2.9 Transpants per million people

> 3-5.9 Transpants per million people

> 6-13 Transpants per million people

There are wide disparities across Europe in access to hearts for transplants. Norway leads at 13 transplants per million people, followed by Austria at 7.4 transplants per million people.

Source: Timmis A, Townsend N, Gale C, Grobbee R, Maniadakis N, Flather M, Wilkins E, Wright L, Vos R, Bax J, Blum M, Pinto F, Vardas P. European Society of CardiologyCardiovascular Disease Statistics 2017. Eur Heart J 2017; 39(7):508-579.

of effective targets for reducing the burden of cardiovascular disease and delivering equitable healthcare across Europe.

Moreover, if ESC Atlas provides valuable insights into the inequalities surrounding

ESC Atlas aims to become an indispensable tool for the identification of effective targets for reducing the burden of cardiovascular disease and delivering equitable healthcare across Europe.

cardiovascular disease and its treatment across European ESC member countries, it is anticipated that the findings will be relevant to many other countries around the world allowing international benchmarking of

www.escardio.org/atlas

cardiovascular risk factors, disease prevalence, healthcare delivery and outcomes.

Government Gazette | 69

HEALTHCARE Driving policy action for improving cardiovascular health

Beyond hospital walls: towards improving the full care pathway hospital performance indicators since 2000, with AMI being one of the first indicators selected.

Francesca COLOMBO is the Head of OECD’s Health Division Analysis of hospital characteristics reveals that many factors are playing an important role, such ashospital size, teaching status, ownership type, and location.

Delegates at iCPS Cardiac Health Europe 2018: Cardiologist, Assistance Publique - Hôpitaux de Paris, General Manager, Belgian Heart League, Chairman Cardiac Surgery, Building Healthcare for Tomorrow, Chief Wealth Officer, Building Healthcare for Tomorrow, Professor in Exercise and Cardiovascular Physiology, Brunel University, London, Senior Medical Director, Global Medical Affairs, Specialty & Value Products, Daiichi Sankyo Europe, Scientific Project Officer, European Commission RTD, Co-Chair MEP Heart Group, European Parliament, Advocacy Director, European Society of Cardiology, Department of Cardiovascular, Dysmetabolic and Agingassociated Diseases, Italian National Institute of Health, Director Cardiovascular Program ICCC, Institut Recerca-HSCSP, Cardiologist, Maribor University Medical Centre, Head of department for management of prevention and promotion programmes, National Institute of Public Health, Senior Research Scientist and Head of Group of Cellular and Molecular Cardiology, Norwegian University of Science and Technology, National Lead for Cardiovascular Disease Prevention, Public Health England, Specialist nurse heart Failure, Universitair Ziekenhuis Gent, Full Professor of Cardiovascular Diseases, University of Palermo, Professor of Cardiac Surgery, University Rostock, Professor of Cardiovascular medicine and consultant cardiologist, University of Leeds.

www.governmentgazette.eu | 70

C

ardiovascular diseases (CVD) are the main cause of mortality in nearly all European Union member states.

Despite the substantial decline in mortality since the 1970s, CVDs still account for almost 40% of all deaths. Dietary factors make the largest contribution to the risk of CVD mortality while high blood pressure makes the largest contribution of all the medical risk factors.

Acute Myocardial Infarctionrates are decreasing but…

Sharp falls in smoking rates and improvements in the treatment of CVDs have played a large role in the decline, along with changes in diet and exercise. Clinical practice guidelines such as those developed by the European Society of Cardiology have also helped optimise treatment.

A good indicator of acute care quality is the 30-day AMI case-fatality rate (CFR) (those who die within 30 days following admission to a hospital).

The OECD has been collecting and reporting international data on

This measure reflects the quality of care including the timely transport of patients and effective medical interventions, and is also influenced by non-quality factors such as hospital transfers, coding practiceses and AMI severity.

Another important contributing factor is the relationship between higher spending and better quality. On average, greater health care inputs are associated with improved quality of care.

For example, a 1% increase in health expenditure is associated with an approximate 0.37% and 0.52% decrease in the female and male AMI 30-day CFRs. Acute care performance requires optimisation along the chain of care Analysis of hospital characteristics reveals that many factors are playing an important role, such ashospital size, teaching status, ownership type, and location.

Large variations in AMI 30-day case-fatality rates are observed across EU countries, ranging from 4.5% in Sweden to 15.4% in Latvia.

Country variation is very large as well. For instance, heart attack survival ranges from 2% to 12% depending on the place of residence in the United Kingdom.

This range may reflect variations in prehospital emergency care, treatment or transfer patterns, or case severity, among others.

Rate variability within countries may also be the result of policy differences. In Sweden, for example, a national programme of quality improvement that includes public reporting, rapid diffusion of technology, use of evidence-based practice and a system of evaluating and reporting quality and outcomes of care is likely to have contributed to a reduced variation in hospital care

of patients after an AMI. Strategies to improve hospital performance and reduce variation should be a top priority.

Looking beyond the hospital to care before and after hospitalisation, however, reveals a more complete picture of performance and points to the need to involve every single aspect of the health system, from policies and prevention to primary care, emergency care, acute care and rehabilitation, as critical to improve quality outcomes for both the hospitals and the patients.

In Eastern Denmark, the implementation of a national reperfusion strategy has changed the outcome for AMI patients considerably by focusing efforts on pre-

hospital services. This involves the collaboration of local hospitals, university clinics, EMS and military helicopters in using the same telemedicine system and field triage for STEMI patients. Reports show an all-time low 30-day mortality rate of 5.7%.

This transition toward care pathways mirrors a general move away from episodic care to continuous care of the individual.

This requires an evolution in the position of hospitals from being at the top of the care chain, acting as the reference point and implicit care leader, to being an integral player in the overall lifecycle of care provided by the health system.

Primary care is central to optimising the prevention, diagnosis and management of CVD to reduce adverse health coutcomes, higher health care needs and costs.

This highlights the importance of integrating and co-ordinatng primary care with other parts of the health care system and a continuity of care focused on the patient’s needs.

Where next?

Hospital performance variation persists across and within countries, signalling the importance of transitioning towards hospital-level innovations that will produce favourable outcomes.

It is imperative we break down hospital walls to integrate care for the patient throughout their entire journey not only for chronic but acute disease to continue to improve patient outcomes. Hospitals implementing these shifts are already experiencing favourable outcomes in

the form of improved efficiency and reduced mortality rates.

The opinions expressed and arguments employed herein are those of the author and do not necessarily reflect the official views of the OECD or of the governments of its member countries.

References: 1. Anderson, R. 2018.

“Recent declines in life expectancy at birth in the United States.” Presentation preared for the OECD, “Health Committee Meeting”Paris.

2. Arah, O.A., Wester, G.P., Hurst, J., and Klazinga, N.S. 2006. “A Conceptual Framework for the OECD Health Care Quality Indicators Project”, International

Looking beyond the hospital to care before and after hospitalisation, however, reveals a more complete picture of performance and points to the need to involve every single aspect of the health system, from policies and prevention to primary care, emergency care, acute care and rehabilitation, as critical to improve quality outcomes for both the hospitals and the patients.

Journal of Health Care Quality, (18) 1: 5-13.

3. Chung, S.-C., J. Sundström, C. P. Gale, S. James, J. Deanfield, L. Wallentin, A. Timmis, T. Jernberg, and H. Hemingway. 2015.

“Comparison of Hospital Variation in Acute Myocardial Infarction Care and Outcome between Sweden and United Kingdom: Population Based Cohort Study Using Nationwide Clinical Registries”.

4. Clemmensen, P. Schoos, M.M. Lindholm, M.G. Rasmussen, L.S. Steinmetz, J. Hesselfeldt R. Pedersen, F. Jørgensen, E. Holmvang, L. Sejersten, M. 2013.

“Pre-hospital diagnosis and transfer of patients with acute myocardial infarction—a decade long experience from one of Europe’s largest STEMI networks.” Journal of Electrocardiology, 46(6): 546-552.

5. OECD (2016), “Mortality following acute myocardial infarction (AMI)”, in Health at a Glance: Europe 2016: State of Health in the EU Cycle, OECD Publishing, Paris, https://doi.org/10.1787/ health_glance_eur-201641-en.

6. OECD (2017), Health at a Glance 2017: OECD Indicators, OECD Publishing, Paris, https:// doi.org/10.1787/health_ glance-2017-en.

The article is co-authored

by Tamara Ehler, Intern at OECD’s Health Division.

Government Gazette | 71

HEALTHCARE Driving policy action for improving cardiovascular health

Working together to support prevention and management of Atrial Fibrillation

W

ith an ageing population preventing and managing cardiovascular diseases is one of the most important tasks for healthcare systems to tackle.

element that contributes to an effective disease management.

Therapy Adherence as a key to Better Outcomes

The most common heart rhythm disorder is Atrial Fibrillation (AF), affecting approximately 1.5-2% of the population in the developed world.

It is one of the major causes of stroke with a five times higher risk, a three times higher risk of heart failure, sudden death and cardiovascular morbidity.

AF is also associated with poorer quality of life and symptoms including lethargy, palpitations, breathlessness, chest tightness, sleeping difficulties, and psychosocial distress.

Despite good progress in the management of patients with atrial fibrillation (AF), arrhythmia remains one of the major causes of stroke, heart failure, sudden death, and cardiovascular morbidity in the world. AF is projected to develop in 25% of currently 40-year-old adults, provokes many, often severe strokes, is associated with increased mortality and often leads to heart failure or sudden death even in well-anticoagulated patients.Dr Rüdiger

SMOLNIK writes about how industry can play a key role in empowering patients.

www.governmentgazette.eu | 72

Strokes that result from AF are more severe and are associated with a high risk of mortality (32.8%) and with a 50% probability of remaining disabled or handicapped within 3 months of having a stroke.

The prevalence of AF is expected to double in Europa from 8.8 to 17.9 million adults aged over 55 years in the 50 years between 2010 and 2060. AF is therefore likely to become a major public health issue over the coming decades in Europe.

The big question is therefore how all players in healthcare can effectively support the management and prevention of AF to tackle this issue.

This also includes the pharmaceutical industry which can contribute

Dr Rüdiger SMOLNIK is Senior Medical Director, Global Medical Affairs, Daiichi Sankyo significantly in various ways. Doing research is one important contribution andranges from developing a better understanding of diseases, their epidemiology tocurrent clinical diagnostics and management.

The generation of new evidence is finally focused on new treatment alternatives and their implementation in clinical practice.

New evidence will eventually be reflected in treatment guidelines of large professional societies like the European Society of Cardiology (ESC). In its 2016 “Guidelines for the Management of Atrial Fibrillation”, the ESC recommends a variety of measures that health care practitioners and patients should implement to manage AF. Empowering patients Besides prevention and

general management of AF which includes the adequate treatment of underlying cardiovascular conditions such as hypertension or valvular heart diseases, the involvement of patients is key.

This is where the industry can play an important role besides developing and providing medicines such as anticoagulation therapies.

Raising awareness for AF, providing information and education empowers (potential) patients to play an active role in the detection and management of their condition.

An example is a very simple, well explained pulse check which can help detect AF. Providing resources and inspiration to support lifestyle changes, e.g. concerning a heart healthy diet to lower blood pressure or exercise also suitable for the elderly, is another

Another aspect to improve AF therapy is the patients’ adherence to their therapy.

Recent research has found that more than 25% of patients with NVAF (non-valvular atrial fibrillation) have suboptimal adherence to their NOAC (NonVitamin K antagonist Oral Anticoagulant) medication, which increases their risk of mortality and stroke compared to patients with optimal adherence.

There are many different factors which can lead to non-adherence, one of which simply lies in the circumstance that people often miss taking prescribed medication e.g. due to forgetfulness or changing medication schedules.

The industry can support by providing medicine packages that help patients to better adhere to their therapy.

Aspects such as integrated reminders to renew prescriptions or a top opening for easy access for patients with reduced finger dexterity can already help improve the regular intake of medicines.

All members of the healthcare community should work hand in hand to improve outcomes for patients.

Education, raising awareness for diseases and their detection, and empowerment of patients can play an important role in this regard.

Building cardiovascular healthcare for tomorrow Economic resource questions are at the center of prevention, treatment and management of cardiovascular health.

It is important to rethink the reallocation of healthcare budgets and be more open to new forms of funding.

Dr Jan De RAET is Chairman - Cardiac Surgery, Brussels Heart Center

C

ardiovascular disease (CVD) is a worldwide epidemic, both in terms of public health and healthcare costs. CVD does not exist in a vacuum, but it may involve all body systems and, in turn, these body systems may provide clues about our cardiovascular health. In order to better manage the growing burden of CVD in Europe, policymakers must reorganise healthcare delivery by implementing proven initiatives in prevention, treatment and management of cardiovascular health.

Economic resource questions are at the center of prevention, treatment and management of cardiovascular health.

Money is needed for a healthy population but in our modern systems resources are diminishing due to more expensive investments, aging/growth of population and chronical diseases. Therefore it is important to rethink the reallocation of healthcare budgets and be more open to new forms of funding.

1. People education & prevention: Currently the most important part of healthcare expenditures are going to cure patients. Savings on the long term is first of all based on citizen education starting from a very early age.

School programs on healthy lifestyles are not emphasized enough today and education does not only concerns children.

Although evidence has not fully elucidated the

onset of CVD risk in early childhood, welldocumented trends on youth tobacco use and childhood obesity present an immediate obstacle to achieving future reductions in CVD burden.

Furthermore, chronic disease prevention in child health should be taken into consideration in order to achieve not only short-term child outcomes, as well as to promote lifelong health.

The impact of health promotion and health education in children on adult CVD outcomes as well as the effectiveness of active CVD prevention programs in early childhood, youth, and adolescence in low and middle income countries are areas to be emphasized for further intervention research.

Therefore preventive care is one of the three important worldwide healthcare shifts and may be sustained by friendly, simple and educative mobile apps and wearables.

2. New levers & incentives: It is long known that, for instance, nutrition is an important component of heart health, from limiting salt, cholesterol, saturated fat, and calorie intake to eating heart-healthy fats and antioxidants. New levers as taxation of unhealthy substances (e.g. sugars, salt, fatty foods,â&#x20AC;Ś ) may be used to create a source of dedicated revenues to tackle these expenditures. In return, VAT reduction on healthy food and sports may incent consumers to make healthier choices.

Not only public health

authorities may use incentives to improve the financial balance. Private insurance companies will probably in the near future encourage their affiliates by using such levers on a private basis.

3. Continuum of care & environment adapted guidelines: The sector should have made better links between the different interveners around cardiovascular pathologies. Organizing healthcare per pathology asks for fundamental changes in mindset.

Researchers, caregivers, industries, public health regulators have to rethink their intervention in terms of fitting environment adapted guidelines per pathology, by associating multidisciplinary teams for a better (pre)diagnosis initiated - patient driven - care.

Implementing such care ways and making them accessible and understandable for patients and interveners, by using new technological tools and wearables, will help to abandon silos and improve efficiency. Guidelines are the impulse, to the extent that they fit their own environment and that the importance of such approach, in terms of savings, is underestimated.

approaches is needed.

Those approaches have to be incentivised to invest a part of their profits and dormant account funds into research programs for innovation and novelties. Investing in R&D is not a guarantee for return on investment but it is a vital process for humanity.

More charity funds should be sanctioned in order to meet tax deadlines, while reducing taxation on return on investment in research to encourage private investment funds and new capital ventures.

5. Anonymous medical data sharing as a civic duty: A hard-hitting example is the obligation of filing a yearly tax return and hence sharing our private financial asset and revenue situation to the government.

This mentality should be broadened to our health data in order to feed a government-controlled institutional database.

This database will help research and teaching institutions to improve current guidelines as well as process efficiency.

Adherence to guidelines is still a major issue today, since money and global environment are the first enablers of current practices.

4. Research & charity: An improved financing model including industries and charity Government Gazette | 73

HEALTHCARE Driving policy action for improving cardiovascular health

How can researchers and policymakers improve cardiovascular health

HDL cholesterol, smoking habit and diabetes.

ITALIAN PERSPECTIVE

T

he CUORE Project of the National Public Health Institute represents one example of assessing cardiovascular health (1). In Italy, it started in 1998, supported by the Ministry of Health with the aim of implementing a monitoring system of coronary and cerebrovascular events through population based registries; mapping risk factors and high risk conditions by the Health Examination Survey conducted every 10 years in a sample random of general adult population; assessing 10-year prediction of fatal and non-fatal first coronary and stroke events with simple tools applicable in public health based on level of 6-8 risk factors (2,3).

It is important to take into account that a key strategic challenge for public health is to achieve a progressive steady increase in the proportion of the population at low risk. This can be achieved by education and awareness campaigns and preventive actions, led by national health institutes, general practitioners and policy makers. www.governmentgazette.eu | 74

Later the project was expanded with two other public health objectives: training the GPs in the use and application of the risk assessment, and more recently updating of the Italian tools risk score and charts.

The project is still ongoing, at present the overall mean global risk in the age range 35-64 years is 3% in women and 8% in men4 % of the population is at high risk, 47% at moderate risk and 49% at low risk.

Thus as a policy, it is important to take into account that a

Federica CENSI is Lead Researcher, Department of Cardiovascular, Dysmetabolic and Ageing-Associated Diseases, Istituto Superiore di SanitĂ

A specific software, CUORE.exe, was elaborated and put on the website of the Progetto CUORE as freely downloadable from General Practitioners more than 3 thousands and 8 hundreds General Practitioners have been trained throughout the country.

At present, 108,000 cardiovascular risk assessments have been measured through the CUORE.exe software as part of the Cardiovascular Risk Observatory.

Cardiovascular risk reassessed after one year in high risk persons shows risk improvement in spite of increased age of about one year (4).

This platform and approach can strengthen surveillance, monitoring and evaluation, and research, and can improve detection rates and prevent the recurrence of heart attacks and strokes.

key strategic challenge for public health is to achieve a progressive steady increase in the proportion of the population at low risk.

This can be achieved by education and awareness campaigns and preventive actions, led by national health institutes, general practitioners and policy makers.

In particular the socioeconomic impact on CVD, high risk and lifestyles is evident: the educational level impacts on the modifications of lifestyles in terms of physical activity and smoking habits. After

informative campaigns, positive changes can be seen at higher educational level in both genders.

Involving general practitioners in assessing cardiovascular risk A training program for GPs has been implemented, on use and application of tools for risk assessment as preventive action the cardiovascular risk chart and the individual risk score. Risk factors included in the score are: age, sex, systolic blood pressure, antihypertensive medications, total and

Education to healthy diet and physical activity At a community level, in Italy there is an important initiative, called Guadagnare salute (Gaining Health, make healthy choices easy choices) which promotes formative and informative campaigns in favour of healthy diet (in particular with the reduction of salt consumption in bread),physical activity, and against smoking habit and alcohol consumption. This

initiative involves also schools, food producers, restaurants, work environments.

The Italian Institute of Health which has the National Centre on Addiction and Doping, acts as an observatory on smoke, alcohol and narcotics and which established tollfree numbers which help people in managing their addictions.

Implementing adequate institutional framework for telemedicine Telemedicine has many potential benefits and possible uses. An actual and positive telemedicine delivery modelsis represented by the remote control of cardiac implantable devices (pacemakers and defibrillators). Potential advantages of remote control patient management include: early detection of device technical troubles; early reaction to changes in patient clinical status, such as atrial and

ventricular arrhythmia development or heart failure progression; reduction of unnecessary out-patient visits and optimization of health-care resource allocation.

At a community level, in Italy there is an important initiative, called Guadagnare salute (Gaining Health, make healthy choices easy choices) which promotes formative and informative campaigns in favour of healthy diet (in particular with the reduction of salt consumption in bread),physical activity, and against smoking habit and alcohol consumption. This initiative involves also schools, food producers, restaurants, work environments.

A critical point in introducing device remote control in standard clinical practice is represented by the health-care resource consumption.

Moreover, remote control generates a great amount of data per patient and allows a complete information on the evolution of patient clinical status and device functionality.

The analysis of data collected daily for 3.5 years, in terms of hours of physical activity and episodes of atrial fibrillation, pointed towards an inverse correlation between these two variables: the more the physical activity, the lower the

number of episodes of atrial fibrillation. A seasonal trend has also been reported, with more AF episode in winter than in summer.

This result shows the potential impact of new monitoring technologies on management of CVD and future policy.

References: 1. Giampaoli S. CUORE: a sustainable cardiovascular disease prevention strategy.

European Journal Cardiovascular Prevention Rehabilitation 2007, 14: 161-2 2. Giampaoli S, Palmieri L, Donfrancesco C, Panico S, Vanuzzo D, Pillotto L, Ferrario M, Cesana G, Mattiello A. Cardiovascular risk assessment in Italy: the CUORE Project risk score and risk chart.

Italian Journal Public

Health 2007, 5 (4): 102-9 3. Donfrancesco C, Palmieri L, Cooney M-T, Vanuzzo D, Panico S, Cesana G, Ferrario M, Pilotto L, Graham I M, Giampaoli S. Italian cardiovascular mortality charts of the CUORE Project: are they comparable with the SCORE charts? European Journal Cardiovascular Prevention Rehabilitation 2010,17(4):403-9 4. Palmieri L, Rielli R, Demattè L, Donfrancesco C, Ciccarelli P, De Sanctis Caiola P, Dima F, Lo Noce C, Brignoli O, Cuffari A, Giampaoli S. CUORE project: implementation of the 10-year risk score.

European Journal Cardiovascular Prevention Rehabilitation 2011, 18(4):642-9 5. Censi F, Calcagnini G, Mattei E, Calò L, Curnis A, D’Onofrio A, Vaccari D, Zanotto G, Morichelli L, Rovai N, Gargaro A, Ricci RP.Seasonal trends in atrial fibrillation episodes and physical activity collected daily with a remote monitoring system for cardiac implantable electronic devices.Int J Cardiol. 2017 May 1;234:48-52.

Government Gazette | 75

Government Gazette A report by the Government Gazette Roundtable Unit

Alzheimer’s Disease

report

A multistakeholder collaboration

Driving policy action to support

EUROPE’S FIGHT AGAINST ALZHEIMER’S DISEASE The recommendations in this report are the result of desk research and have emerged from the conversations among the experts participating in the iCPS European Alzheimer’s Roundtable 2018, with a view to making practical and actionable recommendations across the Alzheimer’s Disease care pathway.

CONTENTS Our thanks are due to the following experts who have offered their expert insights to improve cardiovascular treatment and management in Europe

Executve Summary PART I : Background The state we are in and why Alzheimer’s Disease matters now

Expert Recommendations

PART II : Call for Action Policy recommendations tabled at the iCPS Alzheimer’s Disease Europe 2018

Investigating the contribution of arts-based intervention Prof Dr Justine SCHNEIDER

Professor of Mental Health and Social Care, School of Sociology & Social Policy, University of Nottingham

The genetic side of Alzheimer’s Disease Teresa GRIFFIN MEP

Member of the European Parliament

PART III : Expert Recommendations Independent policy recommendations from policy makers, cardiovascular experts and academics

How is Alzheimer’s Disease and architecture related?

Dr Ing. Birgit DIETZ

Architect, Uni. Cert. Gerontology

Europe should invest more in care-oriented training Dr. Patrizia BRUNO

Geriatrician, Association Amnesia

Living with Alzheimer’s Disease Alison LAWRENCE

Director Public Affairs, Otsuka Pharma Europe

ADI’s recommendations

Paola BARBARINO

Chief Executive Officer, Alzheimer’s Disease International

Developing a care pathway Dr Karen Harrison DENING

Head of Research & Publications, Dementia UK & Admiral Nursing

Why early detection needs to be a priority

Dr Alison EVANS

Head of Policy and Impact, Alzheimer’s Research UK

Nurses leading the change Paul De RAEVE Secretary General, EFN

Tackling AD from all sides Dr Aoife KIELY

Research Communications Officer, Alzheimer’s Society

The future of AD therapy Tobias HARTMANN

Director, Deutsches Institut für Demenzprävention (DIDP) Experimental Neurology, Saarland University

The state we are in The global ratio of publications on neurodegenerative disorders versus cancer is an astonishing 1:12. At the same time, not enough people are getting into research on dementia. There are three million papers on cancer as opposed to 250,000 papers on dementia and neurodegeneration.

The total estimated worldwide cost of dementia in 2018 is US$1 trillion. This figure will rise to US$ 2 trillion by 2030.

50 million people worldwide are living with dementia in 2018. This number will more than triple to 152 million by 2050.

T

here are over 9.9 million new cases of dementia each year worldwide, implying one new case every 3.2 seconds. The number of demented will increase considerably from about 10 million today to about 14 million demented persons in 2030. The total estimated worldwide cost of dementia is US$1 trillion in 2018. By 2030, the global cost of dementia is estimated to rise above a US$ 2 trillion.

The total cost of illness of dementia disorders in EU27 in 2008 was estimated to 160 billion euros, of which 56% were costs of informal care. In September 2018, the International Centre for Parliamentary Studies, representing the voice of Alzheimer’s Disease experts and healthcare policymakers in Europe, identified pressing issues to be addressed by the legislators in the new European Parliament and policymakers at member-state level.

This report provides an overview of the policy recommendations tabled during the roundtable and includes independent from policy experts and healthcare stakeholders.

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease

Reformulating the European approach to managing Alzheimer’s disease Alzheimer’s Disease (AD) imposes a tremendous burden on individuals, families, communities and societies. It currently affects nearly 6.4 million people within Europe and more than 47 people worldwide, with the numbers potentially expected to rise in the years to come. If this situation is to change, urgent action is required at the policy level and broader collaboration is essential among policy makers, healthcare professionals, patient organisations and industry stakeholders. Calling for a more proactive approach against the neurodegenerative disease, the International Centre for Parliamentary Studies recently brought together key stakeholders to formulate a strategy to better manage AD in Europe

A

pproximately six million people are affected by Alzheimer’s disease (AD) or related diseases in Europe, and the number of new cases diagnosed each year continues to increase. Billions of dollars has been spent on research, yet there is currently no curative treatment for AD. Nevertheless, some drug treatments can help to slow the process and early detection can assist in better supporting patients and their carers.

The European Commission and the Council have recognised AD and related diseases as a public health priority in Europe and have united in their aim to tackle the neurodegenerative disease burden, but while increases in research investment have been welcome, funding is still low in proportion to the scale of the challenge.

If we are to head off a global dementia crisis, we must find better treatments and ways to prevent the condition.

The International Centre for Parliamentary Studies recently brought together EU policy makers, medical and clinical professionals, academic experts and key industry stakeholders to examine the ongoing challenges presented by AD and to explore practical solutions in order to build a framework for policy action across the EU. Chaired by Prof. Gordon

www.governmentgazette.eu | 78

life-changing treatments for dementia and the continuous investment of pharmaceutical companies, which bring resources and expertise in drug discovery and clinical trials. Efforts to restructure the multifarious regulatory process could play an imperative part in delivering new drugs faster, and sustained investment in research is fundamental for ensuring leads for new treatments are taken forward.

European Alzheimer’s Roundtable housed over 30 experts from across Europe, including representatives from the European Parliament, the European Commission, members of national Alzheimer’s associations and key healthcare stakeholders.

Willcock, Emeritus Professor of Geratology, University of Oxford, the second edition of the European Alzheimer’s Roundtable housed over 30 experts from across Europe, including representatives from the European Parliament, the European Commission, members of national Alzheimer’s associations, leading clinicians in the fields of psychology and neurology, and key industry stakeholders to formulate a strategy to better manage the disease in Europe. Key policymakers analysed the current policy framework of Alzheimer’s disease in the EU and discussed a wide range of issues including prevention, need for early

intervention, sustained research, innovation and the current state of treatment and care.

A central theme to emerge from the roundtable is that research holds the answer, but our scientists must have the patronage and support of governments worldwide if we are to transform the lives of millions of people across the world.

Support for areas like cancer, respiratory diseases and circulatory diseases has resulted in lower mortality rates, while support for AD lags behind. We need a recommitment from pharmaceutical companies to continue efforts to fund research into AD. We still require

Reinforcing what was discussed during the first edition of this meeting, participants stressed that we cannot pursue preventative treatments while neglecting our responsibility to improve the quality of life for those living with dementia through investing in caresystems and supporting caregivers.

While the social and economic implications of AD are substantial, treating and caring for people with the neurodegenerative disease costs the EU more than €160 billion per year. These costs are predicted to rise, with an estimated quadrupling of Alzheimer’s cases globally by 2050. We have no time to lose. The cost of inaction could be even greater. The importance of early detection and diagnosis in addressing the economic burden of Alzheimer’s was highlighted by participants among several other areas.

The iCPS European

Alzheimer’s Roundtable 2018 set out a few clear actions to bring about a new management plan to end AD. 1. Different kinds of dementias pose multifaceted challenges which require niche solutions. Facing up to this challenge requires doing things differently.

Europe needs a dementia strategy focussing on future generation. A clear priority is to raise quality standards, beginning with diagnosis. Early diagnosis and stratification of the population is needed to prove that the onset of AD can be delayed by pre-symptomatic treatment.

2. National governments must increase funding for dementia research to widen the search for effective treatments and plan for their swift delivery. We must improve early detection and accurate diagnosis, and provide greater support following diagnosis to better the lives of families living with the condition today.

And government-led health campaigns should

take a crucial role in preparing the society by creating greater awareness and understanding of all stages of AD and the reiterate the importance of timely intervention.

The European Commission and the Council have recognised AD and related diseases as a public health priority in Europe and have united in their aim to tackle the neurodegenerative disease burden, but while increases in research investment have been welcome, funding is still low in proportion to the scale of the challenge. If we are to head off a global dementia crisis, we must find better treatments and ways to prevent the condition.

3. We must end the inequity people with dementia face by reforming the social care system. We must focus on ways to measure and improve quality of life, access to postdiagnostic support and homecare to create life-altering implications for people with AD. There’s a need to create a new accelerated care pathway which involves improving training and development of health and social care workers, analysing cost-effective care initiatives to manage end of life symptoms, and developing advanced care plans.

4. European countries should unite to develop and describe an optimum pathway of care for dementia, from diagnosis to death and beyond in supporting families and carers in their bereavement. We should examine, contrast and

compare best practice models across the EU of case management in dementia care and develop a consensus of what elements constitute the optimum pathway of care in dementia.

5. Delegates discussed about the importance of the palliative care approach that provides appropriate control of symptoms, emphasises overall quality of life, takes a holistic approach, involves the patient and the family in decisions, fosters good supportive communication between all concerned and presents an opportunity to honestly acknowledge the terminal nature of the advanced disease.

6. It is important to motivate and educate our GPs to improve diagnosis, care and treatment. For instance, the waiting time for a neurologist in Slovenia, for example, is a year and a half. We either employ more, or make the diagnosis and treatment process more time effective.

7. Although disease-

modifying treatments aren’t available yet, dementia research is in the most promising position for years.

We must promote research to increase the understanding of AD and support the development of improved diagnostics and promising therapies.

There is greater need for proactive research on early intervention, more long-term interdisciplinary studies, wider collaborative projects and increased stringency in evaluating trials. Governments should consider increasing umbrella funding for brain research, which will undoubtedly positively affect Alzheimer’s funding.

9. One response to the looming pandemic of AD and related illnesses is the development of biomarkers that can aid in diagnosis, prognosis, selection for clinical trials, and objective assessment of therapeutic response.

Advances in biomarkers and neuroimaging have shown that disease pathology begins well Government Gazette | 79

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease before onset of the symptoms associated with AD. These biomarkers cannot replace clinical diagnosis, but it is important to recognise their clear utility in enhancing treatment.

10. European governments should update national strategies for dementia and neurodegerative diseases to take advantage of new health technologies that will enable earlier and more accurate diagnosis of AD and the appropriate use of new treatments.

11. AD and related disorders often suffer from a wrong or negative image. In order to change the way people think, we encourage any measure promoting the Delegates at iCPS European Alzheimer’s Roundtable 2018: AbbVie; Geriatrician, Dementia Centre, Association Amnesia; Chairman of the Board, Alzheimer Finland; Research and Communication Officer, Alzheimer’s Society; Head of Policy, Alzheimer’s Research UK; Dementia Workstream Lead, British Psychological Society; EU-Project Manager, Catholic University of Applied Sciences; Consultant, Cognitive Medicine; Head of Research & Publications, Dementia UK; Head of Sector: Neuroscience, DG R&I, European Commission; MEP, European Parliament; Alzheimer’s Alliance; Advisor on Civil Liberties, Justice and Home Affairs, European Parliament; Secretary General, European Federation of Nurses; Founder and Medical Director, Fundació ACE ICNA; Deputy Director, Fundació ACE ICNA; Researcher, London School of Economics; Principal Clinical Scientist, Medtronic; Psychiatrist/ Neurologist, Masstricht Unviersity Medical Centre; Secretary General, Norwegian Health Association; Early Stage Researcher, Maastricht University; National Observatory for Dementia - Athens; Neurologist-Psychiatrist, Alzheimer Association; Otsuka Pharmaceutical Europe; Medical Doctor, Sorbonne University; Director, Saarland University; Emeritus Professor of Geratology, University of Oxford; Director of the Department of Psychiatry, University Hospital of Cologne; Professor of Mental Health and Social Care. University of Nottingham Lecturer and Honorary Consultant, University of Cambridge; Speaker and Senior Research Group Leader at the DZNE/Witten, German Center for Neurodegenerative Diseases; PhD researcher at the Faculty of Social Sciences, University of Leuven; Head, Translational Medicine Neuroscience, UCB Biopharma Sprl

80

social inclusion of the individuals affected by these diseases. We should launch governmentled communication campaigns at a national scale in order to deconstruct the common stereotypes.

12. Half of people who find out they have a cognitive deficit do not seek further advice, especially as people find it difficult to talk about cognitive decline at early stages. The education component is vital. It’s high time the society wakes up to this and realise how environmental noise influences early stage of cognitive impairment.

We must focus on pathways after diagnosis and create better linkages with social care systems.

13. European governments must continue to amplify its efforts in favour of clinical research and social sciences. We should call for easier access to therapeutic innovation, especially by promoting the patients’ participation in scientific research.

14. Efforts must continue

to give signals to pharmaceutical industry that we want them to continue efforts in finding a cure or even symptom-modifying treatment for a complex disease that is believed to develop decades before symptoms emerge.

15. The identification and validation of biomarkers in diagnosing AD and other forms of dementia are increasingly important. Advances in biomarkers and neuroimaging have shown that the disease pathology begins before the onset of the symptoms commonly associated with AD. There’s a need for developing new biomarkers that can detect abnormal levels of amyloid and support in early diagnosis of AD. 16. Among the actions designed by delegates to diminish the dementia burden is the creation of a new accelerated access pathway for selected breakthrough treatments and medical technologies that fill an unmet need, transform patients’ lives or dramatically improve efficiency.

We should work with relevant stakeholders to prepare for a new era of treatment and to support health systems to achieve the full benefit of scientific advances in AD. 17. Delegates stated that using assistive technology has a lot of potential benefits, but also has its difficulties. Some pieces of assistive technology have been designed specifically for people with the condition but a lot of potentially helpful technology has not.

Providing an overview of a range of assistive technologies helping people with dementia and associated families, delegates agreed that technology can never substitute human contact. It can only assist people in improving their safety and wellbeing, not provide perfect solutions.

We shouldn’t use tech for tech’s sake. We should we use tech to make things easier and advocate changes while making sure citizens notice impact. Insisting on more rigorous trials, delegates agreed that patients should be involved in developing and designing such assistive technology.

18. National governments should ensure policies are in place that will support the needs and rights of people living with dementia. Employers must be prepared to support the people aged under 65 with dementia, many of whom continue to work following diagnosis.

19. Last but not least, delegates emphasised on a crucial need for good data repository systems.

We need to liberate data to strengthen our battle against AD. We need more data projects having patients in mind.

bp.113.141119 Machacova, K., et al., Dance as Prevention of Late Life Functional Decline Among Nursing Home Residents. Journal of Applied Gerontology, 2017. 36(12): p. 14531470.

Investigating the contribution of arts-based interventions

D

ementia affects not only the individual and family circle, but the wider community and society at large. We need to know more about the psychosocial methods that bring most benefit to individuals with a diagnosis of dementia and to their carers, while taking account of their societal impact as well as costs. A priority here is social inclusion, to avoid the harmful isolation and neglect that can arise when communities fail to address the needs of people with dementia and their close supporters.

Most people with dementia live in their own homes with family carers, and therefore research is needed into the best approaches to improve their quality of life. This should be multi-disciplinary because of the need to adapt interventions to individual needs and circumstances in a wide range of social contexts.

While neurology, psychiatry and clinical psychology have much to offer efforts to improve post-diagnosis care, a contribution can also be made through the insights of social psychology, social work, sociology and social policy. For example, the reliance on family carers to support people

with dementia is largely unquestioned by policymakers. Do carers have a choice? Is everyone willing and able to take up this role? What are the consequences for carers’ health and employment of assuming caring responsibilities?

Most people with dementia at some point experience distressing symptoms, such as depression, agitation and repetitive vocalisations that appear to have little communicative function.

Whether carers are family members or paid professionals, knowing how to deal with such symptoms is vital.

In care homes, agitation can be addressed through communication skills training, person-centred care, music therapy and other approaches (Livingston et al., 2014).

Research is now needed into how these skills can be taught most effectively and implemented more widely by people with sufficient training and preparation.

In relation to the quality of life of individuals with a diagnosis of dementia, the evidence base for cognitive stimulation therapy (Woods et al., 2012) and reminiscence therapy (Woods et al., 2018) is reliable and positive. Knowledge about the benefits of music is growing (Sihvonen et al., 2017)

Särkämö, T., et al., Pattern of Emotional Benefits Induced by Regular Singing and Music Listening in Dementia. Journal of the American Geriatrics Society, 2016. 64(2): p.

439-440.

Prof Dr Justine SCHNEIDER is Professor of Mental Health and Social Care, School of Sociology & Social Policy, University of Nottingham and there are promising results from a range of arts-based activities although studies are not o the highest quality overall, or not focussed on dementia. Specifically, research using more robust methodsis needed into the potential benefits to people with dementia of arts-based interventions such as singing (Särkämöet al., 2016) , dance movement therapy (Machakova et al., 2017), visual art appreciation and object handling(Beard, 2012; Young et al., 2015).

Most people with dementia live in their own homes with family carers, and therefore research is needed into the best approaches to improve their quality of life.

This should be multi-disciplinary because of the need to adapt interventions to individual needs and circumstances.

These interventions are relatively low-cost to develop and may be easy to deliver because they are already embedded in many cultures.

Moreover, harnessing the power of the arts in the care of people with dementia and their supporters taps into a new source of skills, talent and labour that is likely to be a boon to the effort to improve the lives of people with dementia, while benefitting society through their cultural inclusion.

References: Beard, REL, Art therapies and dementia care: A systematic review.

Dementia - International Journal of Social Research and Practice, 2012. 11(5): p. 633-656.

Livingston, G., Kelly, L., Lewis-Holmes, E., Baio, G., Morris, S., Patel, N., Cooper, C. (2014).

Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials. British Journal of Psychiatry, 205(6), 436442. doi:10.1192/bjp.

Sihvonen AJ, et al., Music-based interventions in neurological rehabilitation. The Lancet Neurology, 2017.

16(8): p. 648-660.

Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia.

Cochrane Database of Systematic Reviews 2012, Issue 2. Art. No.: CD005562. DOI: 10.1002/14651858.

CD005562.pub2 Woods B, O’Philbin L, Farrell EM, Spector AE, Orrell M. Reminiscence therapy for dementia.

Cochrane Database of Systematic Reviews 2018, Issue 3. Art. No.: CD001120. DOI: 10.1002/14651858.

CD001120.pub3 Young, R., et al., The Impact of Viewing and Making Art on Verbal Fluency and Memory in People with Dementia in an Art Gallery Setting.

Psychology of Aesthetics, Creativity, and the Arts, 2015.

Government Gazette | 81

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease

The genetic side of Alzheimer’s Disease Teresa Griffin MEP reviews European Parliament’s action against AD

A

lzheimer’s is a growing concern and a recurrent topic amongst policy and research circles.

There are currently 6.4 million people living with some form of dementia in the European Union and more than 50 million worldwide. Estimates suggest that this number will almost double every 20 years, reaching 75 million in 2030 and 131.5 million in 2050. However, despite

available for those family members who would like to know their chances of developing the disease. Neurologists do not recommend DNA tests to identify whether genetic markers are present because 1) even if biomarkers are present, it does not mean that the disease will manifest itself and 2) without a known cure, there is no real benefit of knowing. This is the position held by some www.governmentgazette.eu | 82

the amount of money, research and time spent studying the disease, we are still far from a proper understanding of what causes it.

This notwithstanding, researchers have identified several different factors that can increase the risk of developing Alzheimer’s.

neurologists at least. The contrary argument is that the earlier the diagnosis, the earlier people can make lifestyle changes, such as changing their diet and environment or reducing stress levels, that may help slow down disease progression, as well as being better able to make better informed decisions for the future.

Indeed, there are genetic factors and environmental factors, and it is not an ‘eitheror’ situation, but rather a mix of factors that can make a person more or less at risk of developing Alzheimer’s. We cannot change the most important risk factors, such as age, family history and heredity, but

We need, therefore, a holistic approach to Alzheimer’s. Here at the European Parliament, we have the privilege of being a part of the decision-making process.

That means we are able to listen to the latest researchers and healthcare professionals dealing with these issues, but those views have

more and more, we hear studies indicating other influences, confirming the need for a multidisciplined approach to tackling the disease.

For instance, a family history of Alzheimer’s is not necessarily an indication that an individual will in fact develop the disease.

However, the research shows that those who have a parent or sibling with Alzheimer’s are more likely to develop the disease than those who do not. Those who have more than one first-degree relative with the disease are at an even higher risk. Either genetics, environmental factors – or both – may play a role when diseases tend to run in families.

In the case of genetics, unless it is early-onset Alzheimer’s, there is a smaller chance that it is hereditary but the risk is still higher. In this case, the immediate family members still do not know for sure whether they will develop the disease, thereby leaving them in a state of limbo. Meanwhile, caring for relatives with the disease can significantly affect their own mental health, thus further increasing their chance of developing the disease themselves.

This is because mental health problems and depression, in particular, are seen as contributors to Alzheimer’s, as some evidence suggests that people who are depressed produce high levels of the hormone cortisol, which in turn has an adverse effect on the hippocampus — a part of the brain responsible for new learning and shortterm memory.

Furthermore, there are not many options

been both disparate and sometimes pessimistic.

More optimistic voices claim that we will have a cure in 10-15 years, while others regret that there will never be a cure and that we need to start looking at prevention rather than cure. Yet there appears to be no real means of prevention given the disparity of the causes. As things stand, being diagnosed with Alzheimerâ&#x20AC;&#x2122;s means people with it are merely surviving, coping with whatever means are available to them. This is incredibly dispiriting for those who are afflicted with the disease or have seen their loved ones suffer through it.

Europe has been - and must continue to be - a trailblazer in scientific breakthroughs.

Concerning Brexit, being a member of the EU has enabled huge amounts of collaboration in dementia research. Once the UK leaves the EU, it is vital that infrastructure is put in place to continue the important work happening in cross-border research programmes across Europe and the government must secure maximum co-operation and alignment with EU regulations.

Therefore, we need to be more ambitious in finding a cure (or cures) for Alzheimerâ&#x20AC;&#x2122;s disease, as well as incorporating the needs of patients, their immediate family members and caregivers.

We cannot leave people in limbo; they need to believe that there will be a cure, that they will have access to the best care possible and that they will keep their dignity in the face of such an overwhelming and devastating disease.

Government Gazette | 83

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease

Living with Alzheimer’s Disease

I

n Europe, there are over 11 million people estimated to be living with dementia, of which 60-80% have Alzheimer’s Disease (AD) as the underlying cause. Expectations are that this number will rise to over 18 million by 2050 .Alzheimer’s Disease is a chronic, debilitating, complex and challenging illness that places a significant strain on the quality of life for those affected, patients and caregivers alike. In addition the growing number of people living with the AD places a burden on already stretched healthcare resources with the societal and economic cost of AD in Europe estimated to increase by 43% from 2008 to 2030 to in excess of €250bn.

People living with AD and their caregivers are central to developing and implementing services, treatment options and care.

The ultimate goal is to ensure that people with AD and their families have a good quality of life and are able to live well at every stage of the illness.

For all involved in the research and development of treatment and care; the way in which services are structured and funded, we must take account of the whole of the life course of the illness. www.governmentgazette.eu | 84

It is clear that providing good quality, patient centred, co-ordinated care for individual patients and caregivers is a priority for governments and health systems. According to the Alzheimer’s Europe Dementia Monitor 2017, 21 European countries had published strategies and put in place guidelines. In addition there areinitiatives investing in research, raising awareness of AD and working to build dementia friendly communities within the European community.

Whilst the details of country strategies vary there are common themes that aim to improve the quality of life for those living with AD. The strategies and policies acknowledge the essential need to provide good quality, accessible care and treatment care throughout the life course of the disease.

addressing neuropsychiatric and behavioural changes – just 8 of which are in phase III specifically for neuropsychiatric and behavioural changes.

Memory difficulties, problems with other aspects of thinking, perception and communication are well recognised and document symptoms of Alzheimer’s Disease . Asking a family member if their loved one knows who they are over simplifies the complexity of symptoms.

Alison LAWRENCE is Director Public Affairs at Otsuka Pharma Europe Perceived opinion being that if we are able to support people to live well it will ease the economic pressures for governments and health systems.

Not surprisingly there is considerable interest, publically and among experts, in finding a pharmaceutical intervention that will stop or slow the progression of AD (a disease modifying treatment or DMT).

The setbacks in recent years have been well documented and whilst much is learned at each stage a breakthrough has yet to be realised.

DMTs and the associated requirement for advancement in early detection and diagnosis remain an essential goal.

Yet focussing on this end point runs the risk of losing sight of the not insignificant unmet care and treatment needs for people living with AD and for those not eligible

potentially for a DMT in the future.

Until such time people with AD and their families require high quality care, support and information to manage the complex challenges they face living with AD. It is essential that we continue to research new treatments and therapeutic strategies for all symptoms, cognitive and behavioural alike, and at all stages of the disease.

Cummings et al noted that “there is a paucity of clinical trials for new treatments targeting the moderate to severe symptoms of AD”. In addition his report shows that whilst there is an increase in total number of agents in research (2017 vs 2018) of the 112 agents in the pipeline as shown on clinicaltrials.gov 34% are symptomatic cognitive enhancers andsymptomatic agents

Whilst these memory challenges for patients and carers are not without their impact on peoples’ quality of life, the behavioural and psychological symptoms of dementia (BPSD), often present the greatest challenge for the person with AD and their carers .BPSD can occur at any stage of AD and are not necessarily a reflection of how a family member may recall a person’s character before the onset of AD. When pausing to contemplate the range of symptoms, such as agitation, anxiety, apathy, depression, wandering, hallucinations, insomnia, incontinence,disinhibition, it is possible to comprehend how distressing it must be for the person with AD and their caregiver.

Studies show that 90% of people living with AD will experience at least one BPSD during their illness and caregivers report these symptoms cause them more stress and distress than cognitive decline.

Furthermore, evidence suggests that, if untreated, BPSD can accelerate the decline in quality of life and be the leading factor for people living with AD moving into residential care.

Moving into residential care is not only costly it can be stressful as often the move is triggered by a crisis of some kind. Caregivers often have little choice as to where they would like their loved one to live, be cared for and spend the remaining time of their life.

People living with AD and their caregivers are central to developing and implementing services, treatment options and care. The ultimate goal is to ensure that people with AD and their families have a good quality of life and are able to live well at every stage of the illness. For all involved in the research and development of treatment and care; the way in which services are structured and funded, we must take account of the whole of the life course of the illness.

Guidelines and policies must be aligned to a clear patient pathway that enables accessible, patient centred, integrated services at all stages of the disease.

Patients and caregivers will

live with AD for many years and until there is a means to prevent or stop the progression patients and caregivers have the right to as good a quality of life as possible.

References: 1 Alzheimer Europe, Cost of illness and burden of dementia in Europe – Prognosis to 2030, www.alzheimereurope.org/Research/ European-Collaborationon-Dementia/Cost-ofdementia/Prognosisto-2030 2. EurActiv, Rising dementia numbers in EU causes alarm, www. euractiv.com/section/ health-consumers/news/ rising-dementia-in-theeu-causes-alarm/ 3. EuroCoDe, European Collaboration on Dementia project, www. alzheimer-europe.org/ Research/EuropeanCollaborationon-Dementia/ Cost-of-dementia/ Prognosis-to-2030

2017 Alzheimer Europe Report: European Dementia Monitor 2017 Comparing and benchmarking national dementia policies and strategies chapter 4, page 23 4. Cummings J et al, 2018, Alzheimer’s disease drug development pipeline: 2018.

Alzheimer’s and Dementia: Translational Research and Clinical Interventions, www. ncbi.nlm.nih.gov/pmc/articles/ PMC6021548/

Psychiatry 157:5, May 2000: 708-714

18, No.2, pp. 742, ISSN 1522-4821 201

8. Psychological and Behavioral Disorders in Dementia Sales A, Mayordomo et al International Journal of Emergency Mental Health and Human Resilience, 2016 Vol.

9. Behavioural and Psychological Symptoms in Dementia (BPSD) and Its Impact on Caregiver Burden, A Yahya et alJMSCR Vol06 Issue06Page 560-568June 2018

5. Alzheimer’s Society, Symptoms of Alzheimer’s fact sheet https://www.alzheimers. org.uk/about-dementia/typesdementia/alzheimers-diseasesymptoms#content-start accessed Jan 2109 6. Alzheimer’s Association.

“Treating non-cognitive symptoms of people with dementia.” ScienceDaily.

ScienceDaily, 24 July 2018. www.sciencedaily.com/ releases/2018/07/180724110043. htm 7. Mental and Behavioral Disturbances in Dementia:Findings from the Cache County Study onMemory in AgingC Lyketsos et al Am J

Anne de JONG-LAIRD, MD MSc is Medical Director CNS at Otsuka Pharma Europe

Government Gazette | 85

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease

ADI’s recommendations to reduce the global burden of Alzheimer’s Disease

F

ifty million people are currently living with dementia, with someone developing dementia every 3 seconds. Figures are forecast to increase to 152 million by 2050, with the majority of increase in low- and middle-income countries.

(1) It is ADI’s role to advocate for and to raise the profile of dementia globally. After 10 years of advocacy, we saw concrete policy action when the WHO implemented its Global action plan on the public health response to dementia 20172025, with targets for the advancement of dementia awareness, risk reduction, diagnosis, care and treatment, support for care partners and research. (2)

National dementia plans are an essential tool for responding strategically to the global dementia epidemic and for measuring health and care preparedness.

However, only less than 15% of WHO Member States currently have a national plan. www.governmentgazette.eu | 86

National dementia plans are an essential tool for responding strategically to the global dementia epidemic and for measuring health and care preparedness.

However, less than 15% of WHO Member States currently have a national plan. Much more progress is needed to meet the WHO’s target of 75% by 2025. It is my belief that a series of simple policy measures could drastically improve the lives of people living with dementia. There are many that we support but the few listed below should resonate easily in Europe.

1. Countries should share experiences and best practices There are currently only 30 national plans globally; over half of

those are in Europe.

However, the existence of a plan doesn’t mean it is funded and fully implemented –take Italy as an example.

Our report on progress -one year into plan implementation revealed that certain areas, such as data sharing, risk reduction and research, are being overlooked in national plans (3). We also really need more plans in lowand middle- income countries as we know that the majority of people with dementia are living in those.

More sharing of best practice from high income and better resourced countries is needed. I recently visited South Korea, where they are on their third version of the national dementia plan. They are innovating on many levels and they are funding and resourcing their effort adequately. There are 256 large dementia care centres across the country catering for all stages of dementia. I saw classes for at-risk and early stages, where cognitive training helps reduce the risk of getting dementia or slows down progression. They are pioneering a mobile application called the “Dementia-Free Index” which gives individuals a score based on limiting their lifestyle behaviours that increase their risk of dementia. There is also a widespread dementia awareness education programme.

Their database of people with dementia in the country ‘K-DREAMS’ has a dashboard that shows progression for each person at-

Paola BARBARINO is Chief Executive Officer at Alzheimer’s Disease International a-glance, encourage people to access services they have not yet used,pinpointshotspot areas andmay eventually become an instrument for fine tuning their research priorities. I encouraged the Korean government to become an advocate, and an example for other countries developing dementia policies. This can only be done by sharing.

It seems like a simple policy prescription, but it is essential if we are to achieve progress towards global goals.

2. Involve people living with dementia and caregivers in the discussion The voices of people living with dementia and their carers need to be included in the development and assessment of strategic plans. This is so important as we know the diagnostic experience of people with dementia can be extremely difficult, leading to depression

in many cases. We need strong post-diagnostic care, rehabilitation and support, which many people do not get.

Involving people with dementia in the drafting of national plans, for instance, can uncover where institutional stigma needs to be addressed and enable person-centred care.

We encourage the inclusion of a rightsbased approach to the development of national plans, ensuring that they are embedded with human rights and Conventions on the Rights of Persons with Disabilities (CRPD) Articles. The ultimate goal of any policy on dementia (until we have a cure) should be to support people to live positively with dementia, and this can only be achieved by listening to people’s lived experiences.

3. Develop a dementia friendly society Dementia awareness and friendliness are a

prerequisite for any meaningful dementia policy – especially at the global level. The Dementia Friends programme was pioneered in Japan and successfully exported to many countries (4).

Effective dementia friendly initiatives such as this help to alleviate pressure on health systems. We do need to ask ourselves, however, what a dementia friendly society looks like because only by having a society, not just a community, that homogeneously includes people with dementia will we make any real progress. And I would like to emphasise that dementia friendly initiatives should be locally acceptable and cannot simply be transplanted from one cultural setting to another.

One of the cornerstones of dementia friendliness is access to appropriate healthcare,and we need to ensure that healthcare systems themselves are dementia friendly. A recent report revealed a lack of awareness and specific training in dementia among primary health workers in OECD countries, where primary care doctors correctly identify only around 50-75% of dementia cases (5). By adequately training primary doctors and not relying too heavily on specialist services, governments can also enhance efficiency and help achieve the goals of universal health coverage (UHC).

4. Make care accessible It is a fact that ageing societies will demand advances in care. It is also a fact that people living with dementia have a right to access adequate healthcare and social protection.

(6) Governments need to improve mainstream health and specialist

services for dementia.

Post diagnosis support needs to be addressed, using examples such as Scotland (where people are given at least 1 year of post-diagnostic support) as the basis for inspiration. We must give consumers confidence aspeople need a guarantee and coordinated services.

We also need to build on integrated care given that financial costs associated with dementia are so burdensome on individuals, often intensified by lengthy duration of illness and co-morbidities. The example of Slovenia’s government-run care homes - recent recipients of a European award - is one of the best in Europe.

In line with SDG target 3.8, governments must pursue sustainable solutions for financing and implementation of dementia services, spanning the continuum of care; risk reduction, early diagnosis, treatment, rehabilitation and palliative care.

In response to the scale of the global challenge, and the increasing pressure on health and care systems, innovative approaches to care in the community and community responses are also needed.

5. Develop flexiblee mployment laws The economic costs associated with dementia are huge: US$1 trillion per year and set to double by 2030. 40% of this cost is attributable to informal or unpaid care, which amounts to the equivalent of 40 million full time jobs; a number that is forecast to reach 65 million by 2030. I urge governments to be innovative in drafting employment laws around flexible working for carers, to reduce the burdens of loss of income and career interruption.

Such policy should

acknowledge that women are disproportionally affected by dementia; as well as more women developing dementia, 71% of informal carersare female (7). Singapore is a country that is making steady progress on this front.

6. Education Education at primary level can have a lasting impact on children, for example by increasing dementia awareness and influencing healthy lifestylebehaviours from an early age. Many resources are already available for children – we have seen examples from Argentina to Israel.

There are, however, fewer examples of dementia education among older cohorts. One example is a pilot project at the Universidad Latina de Costa Rica to provide standardised dementia education. South Korea are really leading the way with a dementia awareness education programme which extends to students, parents, and teachers by including courses in elementary and middle school curriculums.

Conclusions Dementia is a global epidemic requiring global policy responses.

The ones outlined above are easily adaptable to multiple country contexts – especially, I would argue, in Europe.

Sharing of best practices among countries at different levels of Global plan implementation is essential. High-income countries must take a leading role in this.

Developing a dementia friendly society which is appropriate to the country’s cultural context is the first step towards effective dementia policy.

Governments should also make care accessible; make labour laws flexible to support informal carers and people with

dementia as far as possible; and develop strong educational programmes. All of thiswillhelp relieve the pressure on health and social systems later in life. Importantly, any policy must directly involve people living with dementia and caregivers; whilst remembering that one size does not fit all, people centred care is what we all should aspire to.

References: 1. World Health Organization, Dementia [online]: https://www. who.int/mental_health/ neurology/dementia/en/ [Last accessed 26/02/19].

2. World Health Organization. Global action plan on the public health response to dementia 2017–2025.

Geneva: World Health Organization; 2017.

Licence: CC BY-NC-SA 3.0 [online]: https:// www.who.int/mental_ health/neurology/ dementia/action_ plan_2017_2025/en/ [Last accessed 26/02/19].

3. Alzheimer’s Disease International. From plan to impact: Progress towards targets of the Global action plan on dementia, London: Alzheimer’s Disease International, 2018.

4. Dementia Friends [online]:https://www. dementiafriends.org.uk/ [Last accessed 26/02/19].

5. OECD. Care Needed: Improving the Lives of People with Dementia, OECD Health Policy Studies, OECD Publishing, Paris, 2018.

6. Dementia Alliance International. The Human Rights of People Living with Dementia: from Rhetoric to Reality, 2016.

7. Alzheimer’s Disease International. Global Estimates of Informal Care, London: 2018.

Government Gazette | 87

ALZHEIMERâ&#x20AC;&#x2122;S DISEASE INTERNATIONAL: WORLD ALZHEIMER REPORT 2015

The global impact of dementia Around the world, there will be 9.9 million new cases of dementia in 2015,

one every 3 seconds

131.5 74.7 46.8 million people worldwide are

46.8

million

million

million

living with dementia in 2015.

This number will almost double every 20 years.

2015 2030

68% 2050

2050

Much of the increase will take place in low and middle income countries (LMICs): in 2015, 58% of all people with dementia live in LMICs, rising to 63% in 2030 and 68% in 2050.

This the e num peop with in ea regio

The total estimated worldwide cost of dementia in 2015 is US$ 818 billion.

By 2018, dementia will become a trillion dollar disease, rising to

US$ 2 trillion by 2030

2015

2018 Dementia $818 billion

If global dementia care were a country, it would be the

18th largest economy

Apple $742 billion

in the world exceeding the market values of companies such as Apple and Google

Google $368 billion

EUROPE

10.5 MILLION

THE AMERICAS

9.4

MILLION

s map shows estimated mber of ple living h dementia ach world on in 2015.

ASIA

AFRICA

4.0

22.9 MILLION

MILLION

We must now involve more countries and regions in the global action on dementia.

The World Alzheimer Report 2015 was independently researched

by Kingâ&#x20AC;&#x2122;s College London and supported by Bupa.

(source: Forbes 2015 ranking).

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease

Nurses leading change in Europe’s fight against AD

T

are needed to ensure the safety of prescriptions.

Nurses as health coaches and as care coordinators have proven to be effective in leading change in the health and social care ecosystems.

he EFN led the European stakeholders consortium in the European Public Health Forum calling for the coordination and collaboration between policy actors, greater recognition and involvement of all relevant players and changes in the management and governance of the health and social care ecosystem in order to accommodate quality care for people with AD.

Alzheimer’s Disease (AD) imposes a tremendous burden on individuals, families, communities and societies. It currently affects nearly 6.4 million people within Europe and more than 47 people worldwide, with the numbers potentially expected to rise in the years to come.

The six million nurses in Europe are in a unique and privileged position of having direct access to the daily care needs of people with AD and having a key role to play both in managing and preventing this condition. www.governmentgazette.eu | 88

The European Commission and member states are ready for upscaling existing best practices that have shown their excellence, impact and sustainability: community nurses delivering home nursing and involving patients and their caregivers in all procedures in order to get over the barriers of their disabilities and enhance their independence; nurse-led clinics to educate and engage people in their care; and community nursing for older adults involving counselling and guidance to promote independence and greater quality of life, while at the same time reducing healthcare costs.

Sweden was one of the first European countries to create nurse-led clinics for patients with longterm conditions such as AD, but these clinics are now becoming integrated in many countries: they are present in Denmark, England, Estonia, Finland, France, Sweden and two regions of Spain (Andalucía and Catalonia). In Iceland, nurse-led clinics have been developing

Paul De RAEVE is Secretary General at European Federation of Nurses (EFN) where there is a special emphasis on assisting patients and their families towards greater self-care management, particularly in relation to the treatment of chronic illnesses.

The six million nurses in Europe are in a unique and privileged position of having direct access to the daily care needs of people with AD and having a key role to play both in managing and preventing this condition.

Nurses’ unique insight into the patient conditions and familiarity with people’s social and family contexts enables them to form a comprehensive assessment and to develop a more holistic picture of needs that form the input for ‘personalised care’.

Policy-makers, researchers and politicians should

recognise this.

Nurses have unparalleled access in the co-design of people’s care plan and treatment profiles and, through regular reviews, they can ensure their medications are fit for purpose (medication reconciliation) and respond to the complexities of comorbidities. Nurseprescribing has a key function in supporting people with AD to cope with their (at times) overloaded medication regimes bysafeguarding the appropriateness and accuracy of prescriptions; providing education on medication safety and its proper administration to people with AD, their families and carers; and by reviewing medications regularly so that the needs of the individual are met and that referral is timely when relevant investigations

To make personalised ‘medicine’ more inclusive, deployable and accessible, continuity of care becomes a key enabler supported by ‘fit for practice’ ICT solutions which operate within the big data approach, which are with the support of technology supporting the motivated and highly qualified nursing workforce with the appropriate skills mix to deliver high quality and safe care.

The EFN ENS4Care project, with a consortium of a mix of professional associations in nursing and social care, nursing regulators and unions, informal carers, patients, researchers and research communities, civil society representatives and industry, delivered five EU evidence-based guidelines for nurses and social workers on the use of eHealth services, building on existing 175 best practices across the European regions, in prevention, clinical practice, integrated care, advanced roles and e-Prescribing.

E-health services constitute an effective vehicle for managing the current challenges and realising the benefits from a shift towards personalised care as people who suffer from AD experience the full spectrum of healthcare services due to the nature of their condition.

Blockchain is therefore

an excellent tool to foster patient empowerment and boost integrated care along the care continuum to ensure optimal health and social outcomes being achieved for all people living in the EU, and especially those burdened with chronic disease and complex care needs who require attention from a range of professionals from primary and secondary health and social care sectors. Integrated care through blockchain can improve the continuity

Nurses have unparalleled access in the codesign of peopleâ&#x20AC;&#x2122;s care plan and treatment profiles and, through regular reviews, they can ensure their medications are fit for purpose (medication reconciliation) and respond to the complexities of comorbidities.

of care for individuals by breaking down any barriers between primary and secondary care settings, in this way ensuring a smooth patient trajectory through the simulation of nursing care pathways and its expected outcomes. Integrated working of acute, community, primary and social care services is critical to reduce the fragmentation within the health and social care systems and deliver improved patient/health

outcomes. A renewed focus on delivering health and social care in the community therefore implies an appropriately designed frontline community nursing workforce composition at the interface of health and social care services and the use of blockchain to empower people/ patients. I

collection pending on nurses, allowing them to spend more time at the bedside, in the community.

ntegrated care should increase direct patient care with blockchain potentially to decrease the burden of data Government Gazette | 89

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease

How is Alzheimer’s Disease and architecture related?

T

he body changes with age and populations around the world are getting older. Increased age is accompanied by physical, sensory and mental changes as well aspotential cognitive impairments due to dementia. If the senses can no longer “read” the environment and the memory can no longer retain previously known patterns, the result is uncertainty and fear.

For example, when a person suffering from Alzheimer’sis unable to find the toilet or thinks it is occupied because the mirror has beenmounteddirectly opposite the entry door, this is case of architecture meeting Alzheimer’s.

If the toilet space were designed in a different way, it could result in three major benefits: 1. The Alzheimer’s patient would not feel uncertain orconfused, avoiding a humiliating experience 2. The Alzheimer’s patient would not need assistance, maintaining a degree of independence 3. The caregiverwould not be required to help the patient, giving them more time for other tasks This brief example illustrates the link between Alzheimer’s and architecture. The more the physical, sensual and mental capabilities decrease with age and/or dementia, the more architecture and design are called upon to compensate those deficits.

The perception of the environment in a healthy adult is acquired up to 85% through www.governmentgazette.eu | 90

sight, this being the foremost human sense in determining spatial orientation. Age-related alterations result in a decrease in sharpness of vision, decreased color vision, poor contrast sensitivity, glare sensitivity and a reduction of the visual field.

In addition, a steady decrease in the size of the pupil necessitates an increased amount of light, while the depth of focus becomes more difficult to adjust.

Protein deposits may also restrict the flow of short-wave blue color spectrums to the eye.

Warm colors, such as red, orange, yellow or brown, remain distinguishable longer (think of the red traffic light!) and are also preferred. The degenerative process brought on by aging often affects the retina.

The macula, the area responsible for sharpness of vision, becomes cloudy under the effects of macula degeneration (AMD) in the elderly.

The surroundings then appear more clearly, rendering them easier to recognize than the objects or faces that are being focused upon. Consequently, everything must be easy to understand: if the floor is a little darker than the wall it provides more orientation and security,clearly defining the edges of the room.

Blue floors are repeatedly associated with water and are thus best avoided. Doors that can be usedare emphasized by color, the others, painted in a similar color to the wall, remain “hidden” as though part of the wallpaper and present no further

support the independent use of the bathroom.

Dr Ing. Birgit DIETZ is an Architect, Uni. Cert.

Gerontology interest. Light switches should be outlined in a strong color, rendering them easier to see than a white light switch on a white wall. There are a wide variety of such modifications that can be made.

Distinct contours with a high luminance contrast can be very helpful.

Darker color fields used on floors or dark shadows may appear lower than the rest of the floor and can be seen as barriers, potentially leading to falls.

Building for the elderly means thinking about acoustics, colors, orientation aid, lighting and additional details.

As we age, we all have to adjust to the increasing functional limitations of our bodies, of our senses and those of our mind. Individuals can compensate for as long as they are still able to understand what is happening around them.

However, when the normal ageing process is accompanied by dementia, we must strive to offset all limitations of our surroundings with the help of our design solutions. A decline in abilities should trigger our efforts to make our surroundings safe and understandable. Our goal is to maintain as much balance for as long as possible. If this does not occur, a loss of competence becomes evident. Such a loss of competence leads to a feeling of fear, which in turn may result in actions like running away or hiding and eventually social isolation.

We can minimise the feelings of incompetence and uncertainty by adopting a sensory architecture for the elderly and/or cognitively impaired.

Let us go back to the toilet example. We now highlight the importantareas to

While this action is simple, itcould save 58700 of valuable working hours in an800-bed hospital. This isbased onan assumed 560 patients, 20% of whom require nursing support, each using the toilet six times a day.For each toilet visit, around 16 minutes of care timeis required.

Should the case for the improvements in safety, orientation, well-being and independence for elderly and cognitively impaired patients not be convincing enough, there are also strong financial arguments for a supportive architecture for the elderly and/or cognitively impaired.

Consequently, there is currently an immediate need for interdisciplinary and international research and exchange in this field.

Postgraduate courses in this area combining the relevant research fields in both architecture and medicine would make a significant contribution to meeting this need, resulting inwell-trained professionalswith an indepth understanding of the key issues at hand.

Europe should invest more in care-oriented training AD elapses completely unnoticed in its earliest and intermediate stages and it’s called to the attention of medical professionals only when it is already in its advanced stage and all the therapeutic possibilities are further reduced.

A

lzheimer’s Disease should be a priority in diseases field since it is affecting the population worldwide, both due to the increase in cases and to its long duration which can sometimes be several decades.

The lack of scientific knowledge on the onset and development of the disease and the heterogeneous clinical manifestations, are limiting the study of new drugs, resulting in reduced interest from pharmaceutical companies.

Moreover, the impossibility of having diagnostic tools that help the formulation of a firm diagnosis, creates confusion and underestimation of the problem also by the health professionals themselves involved in this work, and then also by other professional figures involved in various ways in the process.

AD elapses completely unnoticed in its earliest and intermediate stages and it’s called to the attention of medical professionals only when it is already in

its advanced stage and all the therapeutic possibilities are further reduced.

All these reasons create a delayed diagnosis, which occurs when the disease is at its most severe phase, when the clinical symptoms leave no diagnostic doubt, when the behavioral changes appear and other symptoms that make management difficult for the family and at home.

At that point everything is more difficult for the doctor, for the family members/caregivers and for the PWD too.

The negative spiral in which all are projected is no way out, very often requires the misuse of drugs for both the PWD and the family in burn out, and occurs the use of dedicated facilities. This causes an uprooting of the person from his living environment and entrusts their care to professionals who often don’t have the proper competences.

In the initial stages of the disease, when it is possible to identify it, people are reticent, with enormous difficulty talking about it and they are not available to perform psycho-social interventions.

Only after a long educational process a small percentage of these people decide to carry out non-pharmacological interventions.

Our experience in setting up a Meeting Center was proposing to a group of people with mild dementia, a comfortable and welcoming environment where they could meet, even with their spouses and families, and discuss the process of awareness of AD with experienced professionals, share and analyze needs emerged and work to give voice to their own needs.

Then we could decide together which activities perform in order to exercise the main physical functions and giving them an active part in their life and not only passively receive our external interventions.

At the same time the spouses were informed and supported by professionals.

Working with PWDs and their closest relatives multiplies the scientifically proven benefits, improves the knowledge of the disease that is necessary for the development of

compensatory strategies to reduce the criticality in their disease process and provide the tools to overcome the functional limitations due to the aggravation of the clinical condition.

In this general framework, there are several desirable interventions: 1. Activating improvement processes of the diagnosis through the promotion of specific studies both with the improvement of instrumental technologies, and through observational studies of the population that involve significant population samples; 2. Implementing the financing of national policies to increase awareness of AD, launching prevention campaigns, promoting a healthy lifestyle through specific actions, including group actions also to overcome loneliness and isolation within the communities; 3. Starting and constantly monitoring the training of all the professionals, in order to improve the healthcare itself.

The article is authored by Dr. Patrizia Bruno, Geriatrician at Association Amnesia.

Government Gazette | 91

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease

Developing a care pathway: the place for case management in dementia European success bases on the excellent education, stable and predictable regulatory and legal frameworks, and transparent market structures.

D

ementia is a growing global challenge.

As the population ages, dementia is one of the most important health and care issues facing the world. The number of people living with dementia worldwide is estimated at approximately 44.3 million people and predicted to reach over 75.6 million by 2030 and 135.46 million in 2050 (ADI 2013). The needs of people with dementia affect global functioning and are often long term, cumulative, and also have a significant impact upon the health and well-being of family carers, and as such require support from a complex matrix of health and social care networks and services (Koch et al. 2012).

However, whilst there has been a strong thrust to identify the needs of people with dementia against a background of person centred care they actually live within relational contexts, whether that be with family members or with www.governmentgazette.eu | 92

professional carers but often, both. There are an estimated 670,000 family and friends acting as their primary carers in the UK alone (Newbronneret al.2013)and any intervention is required to support their family carers also. Such family centred interventionsare best delivered through a relationship centred approach and one that delivers this is case management (Harrison Dening et al. 2017).

Case management has a long and successful history in supporting people with long term conditions and people with a diagnosis of severe mental illness.

Case management For many families,concern arises very early on when it is detected that ‘something is not right’, often before a diagnosis is established.

Once a diagnosis has been made, interventions structured around a family-centred approach can help to untangle and clarify issues, and provide a structure to help unite families, whilst still recognising individual values. Case management in dementia care can provide longitudinal structure in supporting families affected by dementia.

Case management was developed to provide specialist services or to support narrowly defined

population groups with severe and/or intractable illnesses to improve outcomes through coordination of care, reducing fragmentation of service delivery and supporting the receipt of the right level of care at the right time for an individual. Case management has since been applied in the UK for the coordination of other long term conditions and for those experiencing multiple conditions and more recently in dementia (Ross et al. 2011).

In a Cochrane Review Reilly et al. (2015) assessed 13 studies and found that how case management was organised and implemented varied widely across European Union (EU) countries in respect of access, national policy drivers and funding arrangements.

They found clear benefits to adopting a case management approach in dementia; such as, reducing admission to hospital, delaying admission to residential or nursing homes; reducing length of stay in hospital and reduction in behaviour disturbance. They also found evidence to suggest that whilst a case management approach may increase the use of community services initially, cost savings were demonstrated within the first year and indeed research since has shown significant health economic value to case management (Vroomen et al. 2012).

Case management for families affected by dementia in many EUcountries is a relatively new concept with early research being inconclusive (Koch et al., 2012), however, it is proving to be a successful model in Holland (Vroomen et

Dr Karen Harrison DENING is Head of Research & Publications, Dementia UK & Admiral Nursing al. 2012; Van Mierlo et al. 2014). The Dutch approach offers support to the family unit from the point of diagnosis throughout the period of time the person with dementia resides in their own home; indeed its emphasis is on supporting the person to live in their own home for as long as possible.

Discharge from the case manager’s caseload only comes about upon the death of the person with dementia or upon their admission to a care home (Vroomen et al. 2012).

However, care home provision in Holland is very different to that in other EUcountries; the Dutch provide specialist units of care with the support of a dedicated multidisciplinary team led by a ‘care home physician’.

Thus the Dutch case manager would hand over care to this skilled and professional workforce.

In the UK the prevailing models are care homes, staffed by unqualified care workers, and nursing homes where the care staff are led by a qualified nurse. Pathways of care for families affected by

dementia in the UK, and in many other EU countries is patchy with few consistent approaches.

Recommendations for research 1. EU countries unite to develop and describe an optimum pathway of care for dementia, from diagnosis to death and beyond in supporting families carers in their bereavement.

2. Examine, contrast and compare best practice models across the EU of case management in dementia care.

3. Develop a consensus of what elements constitute the optimum pathway of care in dementia.

References 1. ADI (2013) The Global Impact of Dementia 2013 – 2050. https://www.alz. co.uk/research/Global impactDementia2013. pdf [Accessed 15 April 2016].

2. Harrison Dening, K., Aldridge, Z., Pepper, A. &Hodgkison, C. (2017) Admiral Nursing: Case management for families

affected by dementia.

Nursing Standard.

31(24): 42-50.

3. Koch, T., Iliffe, S., Manthorpe, J., Stephens, B., Fox, C., Robinson, L., Livingston, G., Coulton, S., Knapp, M., Chew-Graham, C. &Katona, C. (2012) The potential of case management for people with dementia: a commentary.

International Journal of Geriatric Psychiatry, 27(12): 1305-1314.

4. Newbronner, L., Chamberlain, R., Borthwick, R., Baxter, M. &Glendinning, C. (2013) A Road Less Rocky – Supporting Carers of People with Dementia. Carers Trust, London.

5. Reilly, S., MirandaCastillo, C., Malouf, R., Hoe, J., Toot, S., Challis, D. &Orrell, M. (2015) Case management approaches to home support for people with dementia.

Cochrane Library. https://www.cochrane. org/CD008345/ DEMENTIA_casemanagement-approacheshome-support-peopledementia [Accessed 30 September 2018].

6. Ross, S., Curry, N. & Goodwin, N. (2012) Case management: What is new and how it can best be implemented.

London, Kings Fund.

7. Van Mierlo, L.D., Meiland, F.J.M., Van

Hout, H.P.J. &Droes, R.M. (2014) Towards personalized integrated dementia care: a qualitative study into the implementation of different models of case management. BMC Geriatrics. 14:84. http:// www.biomedcentral. com/1471-2318/14/84 [Accessed 30 September 2018].

8. Vroomen, J.M., Van Mierlo, L.D., van de Ven, P.M., Bosmans, J.E., van den Dungen,

P.mMelland, F.J.M., Droes, J.M., van Charante, E.P.M., van der Horst, H.E., de Rooij, S.E. & van Hout, H.P. (2012) Comparing Dutch Case Management care models for people with dementia and their caregivers: The design of the COMPAS study.

BMC Health Services Research. 12:132. http:// www.biomedcentral. com/1472-6963/12/132 [Accessed 30 September 2018].

Why early detection of AD needs to be a priority

T

oday, there are over 8.7 million people living with dementiaacross Europe. With an ageing population and no effective treatments, this number is set to rise to 152 million globally by 2050, highlighting the huge unmet need of this condition. In the UK, the health and social care costs of dementia aremore than cancer and coronary heart disease combined. The sheer number of people living with dementia and the cost of providing make dementia is one of the greatest medical challenges of our time.

We need to see increased investment in research into understanding the early changes in the brain associated with Alzheimer’s disease and identifying effective ways of detecting these changes at an early stage.

Dementia is the only leading cause of death with no treatments to prevent, delay progression or cure the diseases that cause it.

Investment in research has helped to change the outlook in other diseases like cancer and HIV, with people now surviving cancer or living with HIV to a normal life expectancy. We know that investing in research will make similar breakthroughs possible in treating Alzheimer’s disease.

Most people living with Alzheimer’s disease,the most common cause of

Dr Alison EVANS is Head of Policy and Impact, Alzheimer’s Research UK dementia,are diagnosed when either they or a loved one started to notice changes in their memory, orientation or behaviour, allcommon symptoms associated with dementia. Because dementia is a progressive condition, these diseases slowly, and unforgivingly, attack people’s ability to think, move and communicate over time.

But current scientific evidence suggests that changes in the brain can occur 10-15 years before these symptoms develop. While this sounds scary, this may be the hidden saving grace in this devastating condition. At Alzheimer’s Research UK we believe that if we could identify the diseases that cause

dementia at this early stage, we could treat and delay progression, even before the symptoms arise.

Until recently, researchers focused on treating the symptoms of Alzheimer’s disease.But for newer treatments aimed at slowing the progression of the underlying disease, scientific evidence suggests that the onset of symptoms may be too late for such treatments to be effective. It is now widely believed that detecting the diseases that cause dementia before symptoms occur willnot only provide the best chance of developing treatments to slow progression of these diseases but will

be vital in ensuring these treatments can be effectively administered.

Furthermore, earlier detection of Alzheimer’s disease would enable people to start making lifestyle changes, such as a healthy diet and exercise, that could help to maintain their brain health as well as giving them the opportunity to participate in clinical trials, an opportunity which is too often already closed to those diagnosed at a later stage of the disease.

This turning point in our understanding demonstrates why early detection of Alzheimer’s disease must be a European priority.

We need to see increased investment in research into understanding the early changes in the brain associated with Alzheimer’s disease and identifying effective ways of detecting these changes at an early stage.

This effort is likely to be enhanced by advances in big data and technology such as artificial intelligencethat were not previously available, which are opening the door to new ways to shed lightin these areas.

Through this research we can work toensure Government Gazette | 93

HEALTHCARE Driving policy action to support Europe’s fight against Alzheimer’s Disease

that people will be able to benefit from the right treatments at the right time.

Alongside investment in research, we need to facilitate data sharing from research cohorts and clinical trials among the research community so that we can glean additional insight and make further progress through this data. The complexity of the disease and sensitivity needed to detect it at an early stage

means that datafrom clinical trials and longitudinal cohortsmay help unlock new insights into early detection.

While protection of this data and appropriate consent must be upheld, the benefits of using this wealth of information to make progress in dementia research cannot be understated. People living with dementia who have taken part in these research studies have been generous

with their time to help advance research, and we owe it to them to ensure that we learn as much as we can from this data to improve the lives of people affected by this condition.

The new European framework, Horizon Europe, offers the opportunity to consider mission-oriented areas for research investment.

With the large and growing unmet need associated with dementia

and with one in three people born today likely to develop the condition, it is critical that we increase research investment now to change this trajectory.

The current investment in dementia research pales in comparison to the cost of dementia to the economy. In the UK, we currently only spend 0.3% of the £26bn cost of dementia on research in the UK. Across Europe, this is

just 0.18%. Increasing investmentin research to the equivalent of just 1% of the cost of dementiawould enable progress to detect the disease early when treatments are likely to have the biggest impact,improve our understanding of the underlying diseases, andhelp to develop better treatments for people living with Alzheimer’s disease.

Alzheimer’s Society UK is tackling dementia from all sides their independence and reducing hospital admissions.

In 2014 Alzheimer’s Society launched the ‘Dementia Friendly Technologies Charter’ – to help every person with dementia to have the opportunity to benefit from technology appropriate to their needs. The charter also provides detailed information to inform commissioners of services for people with dementia on implementation and best practice for technology in dementia care.

Dr Aoife KIELY is Research & Communications Officer, at Alzheimer’s Society

T

here are an estimated 46.8 million people living with dementia and the numbers affected will double every 20 years, rising to 115.4 million in 2050. There is no cure for Alzheimer’s disease or any other type of dementia. Delaying the onset of dementia by five years would halve the number of deaths from the condition, saving 30,000 lives a year.

Dementia research is desperately underfunded.

For every person living with dementia, the annual cost to the UK economy is over £30,000 and yet only £90 is spent on dementia research

www.governmentgazette.eu | 94

each year.

There are not enough researchers and clinicians joining the fight against dementia. Five times fewer researchers choose to work on dementia than on cancer.

Alzheimer’s Society is committed to ensuring the rights of people affected by dementia are recognised and until the day we find a cure, we will continue to support anyone affected by dementia.

The UK health minister Matt Hancock recently stated that the British

healthcare system can become the most advanced in the world by embracing the best innovations in new technology and artificial intelligence. With over 850,000 people in the UK currently living with dementia and that number being set to rise to one million in the next three years Alzheimer’s Society is working to ensure that dementia is at the forefront of the care technology revolution.

Alzheimer’s Society is investing in, and accelerating dementia research. We’re committed to spending

at least £150m in the next decade on dementia research. As part of this we have pledged £50m to fund the UK Dementia Research Institute (UK DRI), a highly collaborative, multicentre research initiative of over 700 world class researchers. Research at the UK DRI is split into two work streams – biomedical and care and technology.

The latter will launch in the New Year and is set to investigate care technologies that can benefit the quality of life of people living with dementia by increasing

We also funded and are still funding research into the application of technologies for the care of people affected by dementia. For example, one of our researchers looked into the acceptability and use of GPS tracking devices and concluded that they can be of use to people affected by dementia if introduced at the right stage and with full consent. GPS trackers are an example of technology that can help people with dementia remain independent for longer.

Alzheimer’s Society is also using technology to drive advancements in diagnostic tools and

assistive care. This year Game Changer was launched – a smart phone app research project led by University of Oxford and supported by Alzheimer’s Society.

Since the launch thousands of healthy volunteers have signed up to play simple games on their smart phones for five minutes a day.

These games assess how the brain works and this data will be used to build a baseline against which researchers hope to be able to spot the very earliest changes in the brains of people with dementia in the future, and use this information to develop new treatments.

Improving diagnosis, understanding the underlying causes and developing new treatments for dementia is a priority for Alzheimer’s Society, as is improving the quality of life of those living with the condition today.

Improving standards and access to dementia care is a key part of this. To help to tackle this issue Alzheimer’s Society has launched a campaign urging the British government to ‘Fix Dementia Care’.

We know that the social care crisis is a dementia crisis – three fifths of people using homecare and 70% of people in care homes have dementia. Decades of squeezed Government funding have left people with dementia and their families enduring inadequate care and crippling costs. From the man forced to choose between a hot meal and being washed during a homecare visit, to the husband spending over £370,000 on his wife’s care – decades of starved funding is causing neglect, suffering and forcing people with

dementia and their loved ones to foot the bill.

We are calling on the Government to put in extra funding to fix the social care system once and for all.To increase the evidence base, we have also funded a care Centre of Excellence at University College London with the focus of developing new solutions to help people with dementia maintain independence at home We are working to make community as a whole more understanding and supportive of people affected by dementia.

Alzheimer’s Society’s Dementia Friends programmes is the biggest ever initiative to change people’s perceptions of dementia.

It aims to transform the way communities, businesses and nations act and speak about the condition.

Mayor of London Sadiq Khan has committed to making London the world’s first dementiafriendly capitol city by 2022. Talking to people affect by dementia in every borough of London, we have identified five key areas for improvement: transport, housing, health, care and emergency services, business and retail and social inclusion.

Through our research, campaigns and innovative care and technology strategies Alzheimer’s Society is making an impact to further research and to improve the lives of people in the UK affected by the condition. We hope that you will unite with us in our vision for a world without dementia.

The future of Alzheimer’s disease therapy is early intervention

latter point arguably being somewhere at the interface between prodromal AD/MCIAD and mild dementia.

This describes the very time span when Alzheimer pathology has already kicked in, but neurodegeneration is still sufficiently subtle so that affected persons feel no or only small cognitive impairment.

Tobias HARTMANN is Director, Deutsches Institut für Demenzprävention (DIDP) Experimental Neurology, Saarland University

W

ell established routine diagnostic procedures easily identify the presence of the Alzheimer’s Disease years before the patients function in every-day life notably declines.

This opens a window of opportunity for prevention.

Past research provides us with a wealth of information on lifestyle, medical, environmental and genetic risk factors. Extensive and more-often-thannot controversial epidemiological data highlight many potential interventions for primary and secondary prevention.

However, we currently don’t understand how to implement this knowledge. Hardly any of those risk factors have even been tested yet in high-quality clinical trial settings designed to answer the question whether modifiable risk factor management would be of benefit in dementia treatment? In the rare instances when

this had been done in a highly reliable setting the answer had always been that it can’t. E. g., epidemiological data point to a correlation of physical activity with a lower Alzheimer’s risk, yet a well conducted randomized controlled clinical trial failed to observe any clinical benefit for dementia patients undergoing a physical exercise intervention program. Even worse,if anything, exercise patients experienced acceleratedcognitive decline At the moderate and severe dementia stage therapy development failed, without exception, to provide evidence that treatment can change the disease process beyond marginal and short-term symptomatic-only relief.

Instead the evidence points in the direction that risk reduction or slowing, stopping or reversing the disease processhappens between mid-life and the hypothetical pointof-no-return. The

Most recently, randomized controlled clinical trials in that population provided us with the first evidence that patients with genuine AD pathology can responded to treatment by beneficial alterations in pathophysiology, evidenced by biomarkers, and cognition and function, e.g. clinical dementia rating, the cornerstone of any AD disease modifying treatment.

Now is time to harvest those first achievements and to move future research in the direction to improve the clinical benefit over what pioneering studies already accomplished.

The need is to move forward and to evaluate the treatment approaches in this most relevant population, early stage Alzheimer’s disease. Many of those approaches will be risk-factor modifying non-pharmacological therapies. Because such approaches don’t promise a commercial return on investment the political challenge to fund that research is even higher.

If action is taken now, first such therapies may be ready for implementation rather swiftly as development time for non-pharmacological intervention is short.

Government Gazette | 95

ICPS International Training and Government Exchange â&#x20AC;&#x201C; The full Service training organisation for governance and policy making around the world ICPS International Training provides a comprehensive suite of certificated open training courses, delivered in London. At the forefront of current international research and thinking in good governance and policy making, we equip our delegates with the knowledge and skills to manage the constantly evolving challenges faced by Governments and the public sector. Our research team is constantly developing new courses, such as The Professional Certificate in Management of Electoral Processes and The Professional Certificate in Management and Leadership, alongside updating our existing courses to ensure our training remains relevant.

As well as hearing from leading international experts, delegates on our open courses also benefit from excellent networking opportunities, learning from peers around the world as we facilitate an exchange of professional experiences and best practice. All our professional training courses are accredited by the Chartered Management Institute (CMI) and lead to a Level 5 or 7 Certificate in Management and Leadership.

Our experience and expertise enables us to both tailor and create fully custom-built context-sensitive courses to meet your organisationâ&#x20AC;&#x2122;s specific learning requirements, delivered on your own premises as in-house events. ICPS International Training works with a wide range of key international organisations including The World Bank, Organization for Security and Co-operation in Europe (OSCE), Council of Europe, African Development Bank, The Global Fund, The Association of European Election Officials (ACEEEO), USAID, DfID, and many UN bodies including the UNDP and UN Women.

Specifically for the UK, our subsidiary Government Exchange provides CPD certified open and in-house courses, either standard or customised,offering specific insight into the workings of the UK Parliament,Government and policy making. Government Exchange courses are particularly relevant for Civil Servants, Agency and Non-Departmental Public Body staff, but are equally useful for those from the private, voluntary and wider public sectors who are involved or interested in any aspect of Government affairs. All Government Exchange courses are hostedat quality venues,in the vicinity of the Houses of Parliament.

Tracy Capaldi-Drewett Executive Director International Centre for Parliamentary Studies Email - tracy.drewett@parlicentre.org Tel - +44(0)20 3137 8645

MANAGING NEW CHALLENGES IN ELECTORAL MANAGEMENT

BUILDING BETTER ELECTIONS Looking for well-run and informative courses on electoral management?

As a crucial part of our comprehensive training platform, we would like to highlight our electoral courses for all committed conference attendees. Effective management and timely reform of electoral processes are key to all successful elections globally. Our courses provide those involved in electoral affairs with a clear understanding of successful electoral management, the mechanisms behind comprehensive electoral reform and how challenges in either area can be overcome.

“ “

I enjoyed the didactic flow of ideas and intellectual interchanges.

I will gladly recommend to my colleagues.”

(Director, Electoral Institute, Independent National Electoral Commission, Nigeria)

This course has provided everything I need in preparation for the general election.”

(Regional Elections Coordinator, Independent Electoral and Boundaries Commission, Kenya)

Professional Certificate in the Management of Electoral Processes

Professional Certificate in Strategic Reform of Electoral Processes

13th – 17th May 2019

14th – 18th October 2019

http://training.electoralforum.org/

http://www.icpsert.org/

TOPICS INCLUDE: • The electoral cycle • Types of planning for electoral management bodies • Election field operations - Project managing the logistics of elections • Working effectively with electoral observation missions • Transparency of polling place results

TOPICS INCLUDE: • Electoral systems and how they are chosen • Initiating reform of electoral processes, legal structures and adjoining administrative frameworks • Electoral systems, voters and campaigners stakeholder engagement and education • Voting technologies in an electoral reform context • Transparency of polling place results

Level 5 CMI Certification

Level 7 CMI Certification (Taught at Master’s Level)

BOOK BOTH COURSES TO GET 30% OFF Or as a returning delegate, claim 10% for your loyalty

CONTACT US Email - enquiries@parlicentre.org Tel - +44 (0) 20 3137 8642

Training professionals to work with victims of human trafficking The training brought together representatives from various entities such as the Police, Identity Malta and the health and social authorities, encompassed a wide array of aspects relating to human trafficking including the legal and economic aspects, forced labour, and sexual exploitation.

I

t is estimated that there are more than 40 million victims of modern slavery and human trafficking in the world. Malta is not isolated from this reality and the Government is committed towards eliminating these circles of organised crime.

In practice, this commitment is translated into various initiatives such as the one concluded this week which provided professionals that work with victims of human trafficking with an intensive training programme. The latter was organised by the Commission for Domestic Violence and Gender-Based Violence and was led by Dr Ruth Van Dyke from the Institute of Modern Slavery at St. Maryâ&#x20AC;&#x2122;s University of London.

relating to human trafficking including the legal and economic aspects, forced labour, and sexual exploitation.

information campaigns being held in the UK and equipped with the best investigative and evaluation tools.

strengthened the laws on gender-based violence which also protects victims of human trafficking.

The training, which brought together representatives from various entities such as the Police, Identity Malta and the health and social authorities, encompassed a wide array of aspects

The participants were trained to recognise different forms of human trafficking, how to identify such victims and how to best protect the victims. The participants were also briefed on

The Minister for European Affairs and Equality Helena Dalli recalled Maltaâ&#x20AC;&#x2122;s ratification of the Istanbul Convention through which the Maltese Government

To find out more about our custom developed instructor led training courses please contact training@parlicentre.org

iCPS trains policy professionals to work with the more than 40 million victims of modern slavery and human trafficking in the world.

Recognising electoral achievements

T

he 17th edition of the International Electoral Affairs Symposium and Awards took place in Accra, Ghana, at the end of January. About 100 representatives from 21 countries and industry stakeholders from 11 countries came together at the 3 day event in Labadi Beach Resort, to honour and recognise the talent within the electoral world.

Ghana hosts 120 delegates from 31 countries for the 17th International Electoral Affairs Symposium

Following the rich tradition of the meeting, some of the most pressing opportunities and challenges in electoral management, trends and technology were discussed and also on display during the event. With the introduction of information and communications technologies (ICT) into the electoral process gaining both interest and concern among voters and EMBs across the globe, this year’s meeting did not forget to reflect on the digital transformation of elections.

The Awards dinner on the last evening of the event recognised outstanding organisations and people within the field of elections, in a range of categories including accessibility, gender equality, citizen engagement, and minority participation and election management.

ICPS collaborates with Election Commission of India

Left to right: Sunil Arora, Chief Election Commissioner of India, Ashok Lavasa, Election Commissioner of India, Tracy Capaldi-Drewett, Executive Director ICPS, Umesh Sinha, Senior Deputy Election Commissioner

I

n January 2019, the Election Commission of India (ECI) hosted an International Conference on ‘Making Elections Inclusive and Accessible’, in congruence with the 9th National Voters’ Day which was held on January 25, 2019.

Along with heads from six Election Management Bodies (EMBs) namely, Bangladesh, Bhutan, Kazakhstan, Maldives,

Russia and Sri Lanka and three International Organisations including Malaysian Commonwealth Studies Centre, UK and International Institute for Democracy and Electoral Assistance (IDEA), the International Centre for Parliamentary Studies (ICPS) took part in this well-timed conference.

The conference provided an opportunity

to meet the most inspiring minds of the electoral world to share the experience of different EMB’s, international institutions and experts with regard to analysis of barriers, policy interventions, strategies, programmes, good practices and technological innovation for inclusive and accessible election.

During the one-day Conference, there were sessions with Heads and senior delegates from EMBs and International Organisations, giving their presentations and sharing of their experiences, best practices and initiatives aimed at electoral engagement, enrolment and active participation aiming towards inclusive and accessible ballot exercise in their respective countries.

On the sidelines of the international conference, the Election Commission of India also renewed a Memorandum of Understanding (MOU) for cooperation in the field of election management with the Election Commission of Bhutan, seeking the promotion of exchanges of knowledge and experience in the field of organisational and technical development, with a view to strengthen the administration of electoral processes.

performance

Make your mind your ally

Happiness, stress and the role of gratitude, compassion, and the art of forgiveness There are developmental challenges such as aging, children emerging and then growing up and away, unemployment and retirement. There are the ongoing challenges of difficult people and our temperamental physical bodies that require attention.

THE LAST WORD

Happier folks are easier to get along with, they are more successful at work, they create better marriages, and they have lower rates of disease, disability, and premature death. More than anything else happier folks know that happiness is a choice.

Dr. Loren TOUSSAINT is a professor of psychology at Luther College in Decorah, Iowa

www.governmentgazette.eu | 100

A

lbert Schweitzer defined happiness as wanting what you have.

Our corollary thesis is stress is wanting anything else. Happier folks know that happiness is a cultivation of choices that lead to sustained good feelings and greater satisfaction and meaning in life.

Happier folks are easier to get along with, they are more successful at work, they create better marriages, and they have lower rates of disease, disability, and premature death (1, 2).

More than anything else happier folks know that happiness is a choice. (3) It is a choice of where we put our attention and how we respond to the ongoing and emerging situations in our lives. (4) The rest of us tend to practice stress. Stress being the necessary ability to want more or different than what we have. Stress is what happens when we complain about our jobs or our relationships.

Stress is what happens when we argue with someone over and over and stress is what happens when we have enough money to live a good life but continue to want more. Stress is what happens each time we lament our pasts or beat ourselves up for things that went wrong.

Stress is what happens when we fail to recognize what we have as we relentlessly search for something more.

Cross cultural data suggests that happier folks make their happiness important

Dr. Frederic LUSKIN is the Director of the Stanford Forgiveness Projects and the author of the best -selling books Forgive for Love and Forgive for Good every day (5). They make their happiness a goal in the same way most of us make money, relationship, health, power and status our goals. They learn to pay attention to the simple pleasures of life such as food, family, and health and learn to let the difficult stuff go. While this sounds simple it is not easy as it requires the cultivation of three related and synergistic practices: gratitude, compassion, and forgiveness.

Gratitude is the easiest to practice as it is available as a stress management practice 24/7. It means saying thank you for the simple and obvious goodness of life (6). You wake up in a bed with running water and food in the refrigerator. You have transportation to a job and your kids are safe, and the most appropriate response is

a resounding thank you.

You have legs that carry you around and a mind that thinks and lungs that bring air into and out of your body and life is good.

You have people who care for you and you want to teach yourself to really notice. You might want to ask at the end of each day â&#x20AC;&#x153;who was kind to me todayâ&#x20AC;? and reflect on your good fortune. You might want to remember before every meal how many folks in this world do not share your good fortune.

Compassion is an appropriate response to the other 24/7 aspect of life. Life is often difficult, and challenges emerge daily unannounced and unwanted. There is traffic and illness and financial stress and political discord and competition.

Through each of these experiences we can cultivate compassion, the generation of sympathetic concern for the suffering of ourselves and others (7, 8). We can recognize the inevitability of difficulty in life and develop strategies based on compassion to deal with them. We can use compassion to be gentle with ourselves when we struggle or have obstacles to deal with and kind hearted when we make mistakes. In its most critical manifestation compassion helps us see that our sufferings and difficulties are like those of everyone else and we can create community.

Forgiveness emerges from our understanding that there is much in life that is good and that our suffering is matched by the suffering of others (9). Forgiveness allows us a clean slate after things have hurt us or after we have made mistakes.

Forgiveness is the most challenging of these three practices as it is a direct response to injury or harm. The human brain operates with a negativity bias (10). Negative events are remembered more, are more strongly attended to, have easier recall and are more defended against with constant vigilance than positive events (11).

Forgiveness allows us to make peace with these

experiences and with its success teaches our minds to be less afraid.

Forgiveness allows us to create alternative pathways around the negativity bias and reduces our anger, depression, and anxiety (12).

When we remember to make happiness our goal, we are more likely to practice gratitude, compassion and forgiveness (9). We do so because it preserves our well-being and allows us to create less stress.

That frees up energy to be used for enhancing relationships, or greater productivity at work or better use of leisure time.

One study on gratitude showed that a simple practice once a week led to more time at the gym (13).

The daily choice of happiness as practiced through gratitude, compassion, and forgiveness is ultimately what allows us to feel safe

enough that we can often want the life we have.

And that will manifest in oneâ&#x20AC;&#x2122;s work and home life.

Saying thanks is good for your head and your heart. You can choose to hold a grudge or let go and enjoy a better life.

Compassion connects us to others and brings meaning and happiness. Forgiveness and gratitude lift our thoughts and feelings which brings us authentic happiness.

A world with more gratitude, compassion, and forgiveness is a happier and more peaceful place.

Gratitude, compassion, and forgiveness focus us on others and in so doing benefit ourselves. Learning to be a happier person is learning to wisely choose gratitude, compassion, and forgiveness when faced with difficulties in life.

References: 1. Andrew S. Happiness and Health. Annual Review of Public Health.

2019;40(1).

2. Lyubomirsky S, King L, Diener E. The benefits of frequent positive affect: Does happiness lead to success?

Psychological Bulletin.

2005;131(6):803-855.

3. Kaufman BN, Clark S. Happiness is a Choice: Fawcett Columbine New York; 1991.

4. Gilbert D. Stumbling on happiness: Vintage Canada; 2009.

5. Joshanloo M, Weijers D. Aversion to happiness across cultures: A review of where and why people are averse to happiness.

Journal of happiness studies. 2014;15(3):717735.

6. Emmons RA. Thanks: How the new science of gratitude can make you happier: Houghton Mifflin Harcourt; 2007.

7. Barnard LK, Curry JF. Self-compassion: Conceptualizations, correlates, & interventions. Review of general psychology.

2011;15(4):289-303.

8. Goetz JL, Keltner D, Simon-Thomas E. Compassion: an evolutionary analysis and empirical review.

Psychological Bulletin.

2010;136(3):351-374.

9. Luskin F. Forgive for Good: A Proven Prescription for Health and Happiness. New York, NY: HarperCollins; 2002.

10. Ito TA, Larsen JT, Smith NK, Cacioppo JT. Negative information weighs more heavily on the brain: the negativity bias in evaluative categorizations. Journal of Personality and

Social Psychology. Oct 1998;75(4):887-900.

11. Bisby JA, Burgess N. Differential effects of negative emotion on memory for items and associations, and their relationship to intrusive imagery. Current Opinion in Behavioral Sciences. 2017;17:124132.

12. Toussaint LL, Worthington ELJ, Williams DR. Forgiveness and health: Scientific Evidence and Theories Relating Forgiveness to Better Health: Springer; 2015.

13. Emmons RA, McCullough ME. Counting blessings versus burdens: an experimental investigation of gratitude and subjective well-being in daily life. Journal of Personality and Social Psychology. Feb 2003;84(2):377-389.

Government Gazette | 101

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

Travel with...

Emma McClarkin

W

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

my

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 www.governmentgazette.eu | 102

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

Follow us @GovtGazette

Watch out!

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@ governmentgazette.co.uk

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, donâ&#x20AC;&#x2122;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.

obituary

Remembering one of the pioneers of the Euro

Objectively ruthless OBITUARY

E

uropean integration has always been a very fascinating and stimulating adventure for the Dutch, like for the Belgians and Luxembourgers. The Germans to a certain extent, the French, Italians, but the Benelux (nations), Belgium, the Netherlands and Luxembourg, have always taken a very special interest. Perhaps it has to do with an international orientation of these countries, perhaps due to the fact that they are small countries. They are outward-looking countries. The Dutch, the Belgians, particularly the Flemish, have always had that idea. That was precisely what drew the Dutch politician and Former EU Commissioner Frans Andriessen into the process of European political integration.

In his 13 years in Brussels — eight as VicePresident of the Commission and the rest as commissioner for competition, agriculture and external affairs — Andriessen was highly regarded as a tough negotiator. It was back in the days when the EU was called the European Community, and was well-known for its butter mountains, wine lakes and milk lakes, that Dutch politician Frans Andriessen was negotiating his first farm budget at the European Commission. One of his most prominent policies was the introduction of milk quotas, which sought to temper production around the mid-eighties.

In his 13 years in Brussels — eight as Vice-President of the Commission and the rest as commissioner for competition, agriculture and external affairs — Andriessen was highly regarded as a tough negotiator.

Though he was not known for his charisma, he was branded as the smartest boy in the class.

Former minister and former European Commissioner Frans ANDRIESSEN (89) died after a short illness, his family announced.

European community and the integration process is something which goes beyond the national boundaries and national interests.

As vice-president for French man Jacques Delors, In an interview with Berkeley, he once mentioned the he played an important role in the creation of the difference between working in national politics and European Union and the establishment of the working within the European Commission.

Economic and Monetary Union, which later led to the introduction of the euro.

In a national context, “you try to defend as much as you possibly can the Dutch, in my case, or your People devoting themselves to the European case, to national interests. That’s what you are for. The national a certain extent, are more idealistic than other people common interest is your goal. In Europe, the European you meet in politics. Andriessen was one of them. interest is your goal. That is not separate from the One the pioneers of the Euro, Andriessen played an national interest, but it is just a bit more than the important role in making Europe’s economy fit for national interest. That is the basic difference.” the turn of the century by helping the European steel He resigned under very dramatic circumstances from industry to innovate and the agricultural sector to national politics — and always refused to comment on modernise.

Dutch policies from the moment he was in Brussels, At the start of 1989, Andriessen took the external with one exception, and that was their European policy. relations portfolio. The Uruguay Round of GATT Andriessen has been an international-oriented man talks was at the top of his agenda; as a free-trader and, in particular, toward the European Community. he saw a faint hope of breaking the deadlock with From the moment that he was in the Dutch Parliament America. in ‘67, he realized that “Europe is our future.” Being He will remain an inspiration and motivation for floor leader of his political group, he always was very Europe to defend our multilateral rules-based order interested in what Dutch men were doing in Strasbourg today. and the European Parliament.

Andriessen succeeded his father in 1967 and joined the House of Representatives for the Catholic People’s Party (KVP). Andriessen held the position of party chairman for six years, after which he was a finance minister in the Van Agt I cabinet between 1977 and 1980.

However, he gave up his ambitions to go back to national politics, as soon as he stepped into the European Commission. He strongly believed that the www.governmentgazette.eu | 104

So when he resigned as Minister of Finance, he asked the government to be appointed as the Commissioner for the Netherlands in the European Commission, which was the beginning of his journey in European politics.

SAVE THE DATE 12-14 September 2019 Brussels, Belgium

EUROPEAN CANCER CARE: ACROSS BORDERS The ECCO 2019 European Cancer Summit will bring together worldwide leaders from cancer care, research, patient advocacy and public-private sectors in a unique multi-stakeholder forum.

Reaching the 70:35 Vision for cancer â&#x20AC;&#x201C; 70% long term survival for all cancer patients across Europe by 2035 â&#x20AC;&#x201C; requires breaking down the borders of cancer care: between countries, professions, sectors and stakeholders.

Join us to chart how to make that happen sooner, and be part of the border-breaking community in cancer care!

eccosummit.eu ecco@eccosummit.eu #eccosummit