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Government Gazette £10.00, €11.00 ISSN 2042-4168

September 2016

After Brexit, what now? Bringing together the voices of Parliamentarians in Europe and their counterparts in the United Kingdom

also inside

What makes a smart city?

Review of the steps taken by city Mayors and senior policy makers across Europe to achieve smart growth and transform their cities into resilient and sustainable spaces

Decarbonising Europe’s roads

Members of European Parliament’s ENVI Committee find out how to make it a reality

European Health Report

Analysing policies promoting the prevention, treatment and care of bladder cancer and diabetes


Government Gazette

Government Gazette September 2016

Editor

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

Commissioning Editor

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

Publisher

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

Analysing the impact of the historic plebiscite

Subscriptions

As the British Referendum to leave the European Union, leaves Britain on the front line of some of the biggest political issues of our time, the current edition of Government Gazette includes a special section on Brexit, covering all aspects of Britain’s vote to leave the European Union

subscriptions@governmentgazette.co.uk (+44) 020 3137 8612 © 2016 CPS Printed by The Magazine Printing Company plc, Mollison Avenue, Brimsdown, Enfield, Middlesex, EN3 7NT. The acceptance of advertising does not necessarily indicate endorsement. Photographs and other material sent for publication are submitted at the owner’s risk. The Government Gazette does not accept responsibility for any material lost or damaged.

what’s inside? voices of the brussels policy circle

Battling against uncertainty! Most economists agree that a Brexit would have a substantial negative impact on the UK economy. The National Institute of Economic and Social Research warns that the economy has a 50% chance of slipping into recession in the next 18 months. Inflation would increase to more than 3% for the first time in five years by late 2017 and economic growth might slow down. Some economists suggest that a Brexit Lite that would allow the single market access to Britain might potentially save Britain from a major recession.

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Hurrah, before the predicted Brexit recession!

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Britain’s economy has posted 14th consecutive quarter of growth, with GDP rate increasing by 0.6%

voices of whitehall

Economic repercussions of a political convulsion Philippe Legrain, a former economic adviser to the president

also inside

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of the European Commission, scrutinises the UK’s economic and political options and details the major economic lessons lost in the Brexit brouhaha.

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contents

04 mep dimitrios papadimoulis

brexit and the new balance of power mep papadimoulis argues that Brexit might potentially risk disrupting the base of power the bloc has come to rest on and calls for the European Union to recreate itself altogether.

06 mep tanja fajon

brexit and the rise of the far right The post-Brexit commotion has stirred widespread Eurosceptic sentiments and led to the rise of insecurity amidst European voters. mep fajon reiterates that the European Union must fight against the growing anti-immigrant narrative and inform it’s electorate about the benefits of a united Europe.

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mep françoise grossetête what does the future hold for britain?

Beyond Brexit

mep grossetête questions if Britain will ever gain its true sovereignty, after it steps out of the European Union. Noting that none of the legal options can truly reconcile the United Kingdom’s aspirations of independence, she argues that the country might be caught in a difficult state of affairs and should choose between applying foreign legislation and cutting access of its companies to the largest consumer’s market in the world.

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europe’s sustainable revolution

Interview with Mayors and senior policy makers in cities across Europe, including Basque, Aalborg, Helsinki, Stockholm, Cologne, Warsaw, Rome, San Sebastián, Rotterdam and Ghent inside:

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decarbonising europe MEPs Miriam Dalli and Merja Kyllonen evaluate the current transport scenario and finds out how we can make decarbonisation of road transport a reality

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bladder cancer health report

diabetes health report


editorial view

BEHIND THE WHEEL : What does Brexit really mean

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t’s now a little more than two months since the eventful British Referendum to leave the European Union.

As the real consequences of the historic plebiscite open up, the impact is being felt across every sector, ranging from housing, healthcare and education to trade, global markets and the economy at large. Britain remains in the EU for the moment; so little has changed for business, other than the mood and the levels of confidence. Yet, the question of what a Brexit will look like is still unanswered. Week after week, both parties of the divorce are travelling through unfamiliar paths. Given the ongoing questions over how Britain’s relationship with the European Union will evolve, the potential for major political ramifications and the possible economic penalties, several economists have admitted that trying to predict the possibility of a recession remains a challenge. In fact, the British economy grew at a faster-than-expected pace between April and June, despite the ambiguity surrounding the upshot of the Leave vote. As the UK’s relationship with the European Union hangs in balance, a growing number of citizens lack convincing answers about where we go from here and what promises of the referendum will be kept. In the present climate of uncertainty, Government Gazette tries to find out what a real Brexit might look like. Reflecting on the political, social and economic consequences of Britain’s vote to Leave the European Union, the current edition brings together the voices of parliamentarians in Europe and their counterparts in the United Kingdom, and offers a wide range of perspectives from hard-core Brexiteers to ardent supporters of the Remain camp. With the Brexit government departments in the UK not being fully operational, there is no concrete news on what Brexit plan Whitehall intends to pursue. The Liberal Democrats continue to call for an election to have a democratic debate to decide Britain’s future with the European Union. As ambiguity continues to rule the roost, what we do know at the moment is that Britain’s divorce from the EU will not be a quickie. At the present moment, 2019 appears to be the likely end date of UK’s membership of the European Union. Whilst Britain’s Prime Minister, Theresa May has made it absolutely clear that Brexit means Brexit and that there’s no going back, her newly formed Cabinet is in the process of working out what kind of Brexit it wants. Senior policy makers in Europe are considering a Brexit Lite option that might potentially allow Britain an exemption from EU rules on freedom of movement for up to seven years while retaining access to the single market. However, if such a scenario plays out, there will be a revolt amongst hardcore Brexiteers. Resonating the thoughts of several other Eurosceptic MPs of the UK’s Leave camp, the former Cabinet minister, John Redwood MP took to the pages of the Government Gazette, to reiterate that the aim of Britain’s electorate was not to trigger renegotiation with the EU, but to end up with some version of membership which the UK can live with. Several Eurosceptic MEPs including Jeppe Kofod MEP warn that no one gains from extending Britain’s exit from the European Union. As all eyes are on the unchartered political landscape that lies ahead for Britain, the policy leaders in Europe believe that Brexit shook the foundations of the European Union and its position in the world. Britain’s withdrawal from the continental bloc, they fear, might shake the balance of power in Europe. In particular, the rise of racial attacks immediately after the exit vote and resultant spread of Eurosceptic sentiments has worried several pro-European MEPs. Echoing the concerns of fellow MEPs belonging to the Remain camp, Tanja Fajon MEP, Vice-Chair of European Parliament’s S&D Group, says Europe and the United Kingdom should unquestionably focus all its attention in preventing the wave of hate crime and racial abuse.

MEPs across Europe worry that Brexit would undermine Europe’s balance of power, however they believe now is the chance to reform Europe. Proposing plans for a re-launch of the European Union, Dimitrios Papadimoulis MEP, Vice President of the European Parliament and head of Syriza party delegation, writes that the EU should build a new model that advances the role of the European Parliament, while cooperating with the European Commission and the European Council. Europe remains divided over how to bounce back after Brexit and how to defeat the mounting Euroscepticism, however as Sirpa Pietikäinen MEP puts it, ‘the core idea of the EU is not outdated despite it sometimes getting buried under the critique.’ As insecurity clouds the future of European nationals living in Britain, immigration policy expert Will Sommerville from the Migration Policy Institute writes that the Government of the United Kingdom will face several challenges in drafting and implementing a withdrawal agreement, in terms of setting criteria for residency of European nationals, setting cut-off points and implementing whatever is decided. Immigration experts and MPs have warned that there could be a spike in UK migration ahead of Brexit. Keith Vaz MP writes that now is the time for the United Kingdom to stand up against all discrimination and expose its welcoming nature. Now, this means that Theresa May’s new government faces an enormous task in delivering on some big promises made by the Leave camp. With official Brexit announcements on hold, what will indeed happen is yet to be seen. The Article 50 of the Lisbon Treaty has not been triggered yet. There is severe opposition from lawmakers as the UK Parliament might require further consent even before that. Moreover, Scotland and Northern Ireland could further complicate Britain’s exit plan. Stephen Gethins MP, Member of the Scottish Nationalist Party, confirms that another Scottish referendum is highly possible if the Government of the United Kingdom fails to protect Scottish interests while exiting the EU. There are no answers yet on what will happen to the border between the Republic of Ireland and Northern Ireland when Britain leaves the EU. In Theresa May’s own words, ‘no one wants to return to borders of the past.’ Nessa Childers MEP, Vice-President of European Parliament’s MAC Group, argues that it would be a dramatic step backwards. Meanwhile, politicians in Northern Ireland have threatened to launch a legal challenge should the UK trigger Article 50. Whatever is going on in the UK and the EU, economic signals have been pretty mixed so far. While the poor, the jobless and the pensioners would apparently face the severity of the Brexit storm, its ripple effects will be felt in every aspect of Britain’s trading relationship with the EU, writes Philippe Legrain, former advisor of the president of European Commission. He makes a thorough scrutiny of Britain’s political, economic and trade options, and pinpoints some of the major lessons we’ve missed thus far. Moving beyond the confines of Brexit, the current edition includes a special feature on sustainable and smart cities. As cities across Europe face increasing pressures to grow, innovate and transform to face the challenges of growing urban populations, Government Gazette interviews mayors and senior policy makers in several European cities and brings together the latest trends and developments in building resilient and sustainable environments. The current edition also includes an exclusive health report that analyses policies promoting the prevention, treatment and care of bladder cancer and diabetes. Including perspectives from health professionals, pharmaceutical companies and academics, the report analyses the various key challenges in addressing these health priorities and provides recommendations for future policy

Amid an increase in hate crimes, security experts warn that Brexit will pose general and specific threats to internal and external securities of both the UK and the EU.

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voices of the european parliament

Papadimoulis provides an alternative vision for the future of Europe

Dimitrios Papadimoulis MEP, Vice President of the European Parliament worries that removing Britain from the continental bloc will shift the balance of power within Europe and force a rethink of its role in the world. Pushing for an an inspiring alternative vision for the future of Europe, he proposes that the European Union should build a new model that advances the role of the European Parliament, while cooperating with the European Commission and the European Council

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he result of the British referendum was a huge development in the history of the European establishment. The conditions under which Britain will leave the EU will be the subject of negotiations in the next few months. However, at this stage a growing number of citizens still lack convincing answers about the future of the EU. Conservative, far-right and xenophobic forces in the EU are cooperating closely, forming an asphyxiating setting for the European citizens that see a Union that distances itself from its founding principles. Lack of transparency in decision-making, the increasing intermingled fusion between politics

and financial interests, the failed austerity politics and the continuous incapacity to deal with the structural, almost existential problems of the EU are among the major problems that progressive and democratic forces are called to address efficiently. This is a long, complex and demanding process that takes a specific plan and strategy to put forth, necessitating a binding involvement of the EU citizens who can no longer be spectators of the future developments. British and European citizens are puzzled British and European citizens can hardly understand where the EU is heading. The refugee crisis, the economic and monetary policies, youth unemployment, de-escalation of investments in many regions of the EU and

the imbalanced policies of regional funds are all elements of this big turmoil. Furthermore, irresponsible and catastrophic decisions of both British and European politicians are hardening the ongoing fragile balances and nourishing fractious politics. An eloquent example is that, since the day the British referendum was announced until when it is was done, there were neither debates nor exchange of arguments and different views on the pros and cons of Brexit, both by the British political parties and the EU altogether. Fear and narrow-minded approaches prevailed, with citizens missing the chance of getting properly informed. Therefore, a big number of British and EU citizens never understood the real implications of the final outcome. Growth and Stability Pact has to be revised One of the major, institutional pillars of the EU and the eurozone is the Growth and Stability Pact. Its provisions proved to be counter-productive and obsolete as a growing number of member states can neither keep their public deficit below 3% nor maintain their public debt in sustainable levels. These provisions cause a number of problems in public policy, leading to the imposition of extra austerity, further weakening macroeconomic indicators, and thereby leading to the complete renunciation of the current policy framework. The Pact has to be revised and adjusted as it impedes social and economic development and reproduces a culture of sanctions that neither feeds good relations between member states nor solidifies a bona fide approach. No progressive politician will want a European


the future of european parliament, post brexit

Union, which operates under the threat of sanctions or a Union with divergence and a multi-speed model, where financial interests influence decision-making and citizens are not in the core of policy-making. The European Parliament to assume a more active role Progressive and democratic forces of the European Parliament ought to be cooperative in the coming period in order to define the elements of the agenda and stand against the neoliberalism that reigns in Europe, threatening the survival of the entire European establishment. Brexit prevailed for many reasons with the most striking one being the negative perspective of a big part of the British electorate over Berlin and the taking over of decision-making by Brussels. Younger voters from urban centers clearly stood for Bremain, acknowledging the gains of being part of the single market and taking advantage of the open borders policy in education. Nonetheless, concerns of both “Bremainers” and “Brexiteers” from the different social and professional groups, should not be underestimated and should find their place at the heart of the debate over the future of the EU. The EU is a monumental achievement, but we need to take into account how many mistakes we’ve made and how some of our major economic and social policies of the last decade were often misleading. All these have led to the rise of euroscepticism and the empowerment of political forces that want the dissolution of the EU. As leftist and progressive forces, we are called to give convincing answers to the challenges of our era and the deep concerns of the citizens. Our efforts should start from the need for a “better Europe” with growth, social cohesion and justice. Moreover, we should start building on a new model that advances the role of the European Parliament as the only elected body of the EU, without downgrading but cooperating with the European Commission and the Council on a new, common vision


voices of the european parliament

‘It’s high time we combated the rise of the far-right’ Ever since Britain’s Leave vote, widespread Eurosceptic and anti-immigrant sentiments, have without doubt dominated in the United Kingdom and across Europe, triggering the rise of political parties supporting the anti-Europe rhetoric. European far-right groups are now finding their way into mainstream politics, with greater acceleration. Tracing the rise of the far-right, Tanja Fajon MEP, Vice-Chair of Parliament’s S&D Group, writes that Europe should unquestionably focus all its attention in fencing the wave of hate crime and racial abuse

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t has been more than a month since the UK voted to Leave the European Union and Thursday 23rd June 2016 will most certainly be remembered in history. The UK’s membership within the European Union is now on the line. The aftermath has severely shaken the economy and the world’s oldest currency the pound sterling. Most political parties in Britain are in turmoil but what is even more worrying is the impact Brexit has had on the far right movement in the UK and the rest of Europe. Will the EU change and how? Who really lost and who really won the referendum in the UK?

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These are the questions all of us seek answers for. While the extent of influence of Brexit on the EU and the potential future relationship between the UK and the EU remains uncertain, Brexit will without doubt change the way Britain operates. The consequences of Brexit have largely been underestimated by the political establishments in Westminster – from both sides - and to some extent, in other European capitals. The referendum campaign was very dirty and dishonest. It even resulted in the death of Jo Cox - an event that broke my heart and continues to upset me. The arguments of the Leave campaign were often misconstrued, populist, xenophobic and racist. The Remain camp did not effectively challenge

Government Gazette

and counter the Leave camp, offering little concrete solutions to convince the undecided. Unfortunately, both camps eventually failed many of their supporters. What remains particularly worrying is that the campaign led by major mainstream politicians and parties legitimized the anti-immigration rhetoric and xenophobia. There was a surge in racist attacks on immigrants or people of immigrant descent, immediately after the vote. More than a hundred incidents of racial abuse have been reported ever since Britain’s Leave vote. This is the main reason for concern and all of us have to forcefully condemn it. The UK has to admit that it has a problem that has been largely ignored thus far. We have to combat this growing anti-immigration rhetoric, and guarantee that high social standards remain


the future of european parliament, post brexit untouched, including for foreign workers. The reactions across Europe were coherent in calling for the ‘immediate’ triggering of the exit procedures, threby ending the period of uncertainty and a wave of hate crime. European far right hails the Brexit vote and parties across Europe have seized the moment, calling for similar referenda in their respective countries. What happened in the UK must be a lesson for all of us. On one hand, we should improve the way in which we communicate our policies to our electorate who are starting to feel more detached from Brussels. We urgently need to find ways to convince our citizens about the benefits of a united Europe and the opportunities it holds. Our response has to be more concrete and should instantaneously relate to our voters. People should become more involved in decision making through an enhanced democratic processes. People in the rest of Europe seem to understand the benefits of a united Europe. Several recent surveys on the EU’s popularity have revealed a big surge in support of the EU. In fact, according to a IFOP survey, Denmark, Sweden and Finland have all backed continued EU membership, with surges in support to 69%, 52% and 68%, respectively immediately after Britain’s Leave vote. Another lesson we ought to learn from this is that we cannot take anything for granted. We must not let things get out of hand, the way they did in the UK. Peace and prosperity were the principles of our founding fathers when they established the European project. They have to be fiercely defended against nationalism and populism. Now, this means that the new Conservative government faces an enormous task in delivering on some big promises it made to its electorate. One of its greatest challenges remains in countering the rise of far-right movement. The latter will undoubtedly be a challenge for all other European governments. But what will indeed happen is yet to be seen. The Article 50 has not been triggered yet. There is severe opposition by the lawmakers as the UK parliament might require further consent before releasing the trigger. Moreover, Scotland and Northern Ireland could further complicate Britain’s exit plan.

‘Far more unites us than separates us’ Fondly recalling the principles of the Schuman Declaration of the 1950’s,

Sirpa Pietikäinen MEP, Member of the Christian Democrats, writes that despite Britain’s withdrawal from the European Union, the same needs will unite us more than separate us

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n his declaration for an establishment of the European Coal and Steel Community, 9th May 1950, the Luxembourg-born French statesman, Jean-Baptiste Nicolas Robert Schuman stated: “Europe will not be made all at once, or according to a single plan. It will be built through concrete achievements, which first create a de facto solidarity.” This statement is now as timely as it was at the time of its first reading. Despite the fact that the European Community was established on a seemingly industrial and technical way, the underlying reason behind it was to preserve peace and create solidarity amidst diversity. The second important notion is that Europe will not be “finished”, rather it is an ongoing project, which will be

formed by each generation at a time. The European Community later turned into the European Union (EU), and we’ve witnessed several developments that have deepened integration between countries ever since. Time and again, the discussion on the European Union has circulated around petty regulations that make the life of citizens harder, particularly on how jobs get lost because of the single market or lower priced labour coming from other countries. It is true that we still have problems to solve, and there is need to be creative in making fair but enabling rules at the same time. The core idea of the EU, however, is not outdated despite it sometimes getting buried under the critique. We need fundamental rights

“The more things change, the more they stay the same” - (Fr. ‘plus ça change, plus c’est la même chose’) are the famous words of JeanBaptiste Alphonse Karr in an epigram in the issue of his journal Les Guêpes in January 1849, in which he often explained with bitter wit and satirical tones, some of the greatest artistic and political celebrities of the age. The oft quoted, timeless epigram is seldom used to describe current political events that do not affect reality on a deeper level other than to cement the status quo. Only time will tell if this holds good for Britain’s future relationship with the European Union

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the future of european parliament, post brexit for people, equal treatment, social security as well as protection against violence as much as ever. The EU has delivered on all of them, which is demonstrated for example by the Charter of Fundamental Rights, directive on equal treatment in employment and occupation, securing social security rights to all its people, even when moving from one country to another. However, more needs to be done, in order to secure the rights and well-being of all citizens residing in Europe. Within the past forty years of membership, the United Kingdom has become closely integrated with the other member states in all these sectors. Therefore, it is hard to see how the UK could maintain purely economic relations after

it has left the Union. The situation compared to the EU’s free trade partners is dramatically different, since we have generations of people whose lives have been built on both sides of the canal. Many UK citizens will remain living in the EU, and vice versa, so there is a clear need to ensure equal rights to all of them also in the future. If the UK wants to adopt a model similar to that of Norway, that would be practically easy, but I don’t see what are the economic or political benefits compared to an EU membership, where the country can at least influence the decisions from the inside. While the future of Britain is unclear at the moment, and it will be for as long as the

negotiations on separation haven’t started, we can only know one thing. The EU will continue its way forward, creating more harmonization and policies that unite its countries and people. As the UK has been one of the best examples of a democratic country ruled by liberal values in Europe, the EU would appreciate maintaining close ties with it. We share the same history and cultural heritage. The most natural way to proceed now would be to activate Article 50 in the European Council, start the official negotiations on the UK’s separation, and to work for a best possible deal for everybody; people, companies and future generations

British democracy is facing crisis; it’s time to take back control What was the vision of democracy of the Leave campaigners? Questioning their idea of “taking control” and the manner in which Theresa May was elected to power, Keith Taylor MEP, Green Party Member of the European Parliament for South East England, calls for a proportional voting system and an overhaul of the House of Lords

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small majority of the British public voted to Leave the European Union and I am still muddled, as are many people across the country - Remain and Leave voters alike. It is, now, a little more than two months from that fateful day. David Cameron has resigned; the seemingly perpetual question of Labour leadership has reignited; the pied piper of UKIP has abandoned his ship, and the British people find themselves governed by the unelected leader of the most right-wing government, the country has witnessed in post-war times. Was this the vision of democracy, the Leave campaigners had in mind? Is this their idea of “taking back control”? The expediency with which the Tories crowned Theresa May, with minimal party friction, seems, certainly to media commentators, like a political manoeuvre to be admired and commended for its bloodless efficiency. However, where some observers see political efficacy, I see symptoms of a serious democratic malady at the heart of not just Conservative party politics, but the British political system itself. The major parties in the UK have a lot less reverence for democracy than many people would care to admit. May ascended to Number 10 on the backing of just 199 Conservative Party MPs. Andrea Leadsom, Theresa’s rival in the Tory leadership battle, was, apparently, persuaded to stand down by the party machine. Tory members, therefore, were denied a chance to express

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their democratic will, owing to the fear they would elect an inexperienced gaffe-prone Prime Minister. In the Labour party, Jeremy Corbyn became, less than a year ago, the first leader elected under the democratic electoral system introduced by Ed Miliband. For the first time, ordinary Labour members had an equal say on who should lead their party. The victory, however, was strongly opposed by the Labour party establishment and many MPs. Following a sustained campaign to undermine their leader, the parliamentary Labour party staged a failed coup resulting in the current leadership election. A leadership election that is being marred by goalpost-shifting rule changes, absurd legal challenges by wealthy donors, and the open hostility of MPs to the democratic will of their members. The Labour party is attempting to close its members out of its internal democracy, while the Conservative party continues to deny its members access in the first place. Party political democracy is in a dire state. While the major political parties’ lack of respect for members and democracy itself is, clearly, a problem, it is merely an indication of a scandal that is endemic to the entire British political system. Britain’s head of state is unelected. The House of Lords is unelected. The House of Commons

is the only chamber of Parliament elected by the British people. Just 15 million people voted for the 649 MPs representing the entirety of the country. Of the 30 million votes cast in the 2015 General Election, and subsequent by-elections, only half actually counted. Shockingly, precisely 15,411,611 Brits wasted their time at the ballot box. In 2015, 46 million were eligible to vote, but the total number of votes cast for the Conservatives was just 11 million. In other words, 76% of Britons didn’t vote for the current government. In 2016, is it acceptable for half of all votes cast to be worthless? Is it acceptable for a party to govern with a majority after being elected by less than 25% of the electorate? During the EU referendum campaign, it was no wonder that “take back control” was the message that resonated with people. Voters feel powerless. Not least the almost four million people who voted for UKIP or the more than one million people who voted for the Green Party in 2015, who all have just one MP representing them. Our electoral system isn’t up to the task of representing the genuine political differences that exist in Britain. The last UK General Election proved that two party politics is dead, 45% of the electorate didn’t cast a vote for Labour or the Tories; the EU referendum campaign raised awareness of

voices of the european parliament

the need for a representative democratic system; the referendum ballot itself revealed that, across all age groups, political engagement is likely to increase, when every single vote counts. Now is the perfect time to change the system once and for all. So here’s my challenge to Leave campaigners: if you’re serious about democracy and giving people back control, join the campaign for a proportional voting system and an overhaul of the bloated House of Lords. We are already seeing the beginnings of the truly cross-party campaign we need to deliver the British people a political system that represents their views. We need to have a constitutional convention and take this conversation to the people. The referendum gave us a taste of real democracy, but we’re still hungry

The Finnish perspective The United Kingdom may not leave the European Union very soon or at least, not until 2019. Reflecting on the unfamiliar path taken by both parties of the divorce, Heidi

Hautala

MEP, Chair of the Delegation to the Euronest Parliamentary Assembly, suspects that Brexit might not be just Brexit, at the end of the day

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rom the perspective of a small EU member state, it is indeed very difficult to understand why one would want to disconnect the ties as thoroughly as a fully fledged Brexit. Finland found its solid place in the Western world, mainly through its integration with the European Union. Every Finn pays 25 euros a year for the UK rebate, but even so very few welcome Brexit. Would Britain be more secure, outside the union and its common foreign and security

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the future of european parliament, post brexit policy? I hardly think so. On the other hand, the departure of Britain would certainly be a major loss for the European Union, not least because of the able British diplomatic corps. Perhaps, the most rational reason why Brexit happened is the failure of the prevailing economic models. Neither the EU member states nor the EU as such has done enough to cope with the inequalities in societies, which are exacerbated by the rough forces of globalization. Those who feel there is no future for them in the European society have voted for the option, which may eventually render them, more vulnerable.

Lib Dems continue to call for General Elections On a pledge to stop Brexit, the Liberal Democrats want to offer voters the chance to call for General Elections, writes Catherine Bearder MEP, Liberal Democrat Member of European Parliament for South East England. Echoing the thoughts of the leader of the Lib Dems, Tim Farron, she argues that Britain must carry on working with its nearest neighbours to tackle common challenges

Brexit could indeed happen in other countries. It is easy to see, why many in Scotland look towards the Nordic countries in which active politics towards welfare for all still prevails. Brexit is a serious warning, which should lead to rethinking economic and social policies. Week after week, both parties of the divorce are increasingly treading on a completely unknown territory. The ties formed during 42 years of British membership with the EU are so complex that Brexit has rightly been compared to amputating a leg without anesthesia. The British government has now realised that even planning such a surgery will be much more demanding and will take much longer than thought. The European Parliament´s Legal Affairs Committee will soon start exploring the legal ties and what it would mean for both sides. According to Article 50 of the Lisbon Treaty, the future relationship of the exiting country with the EU can be considered only in the exit negotiations. The so-called Norway model has appeared to be a possible option. However, whatever is written into the statute books of the European Economic Area membership effectively excludes all influence on decisionmaking on future EU legislation. It is hard to see how such a status would satisfy the loud demands to take back control from Brussels. As for trade agreements, one could note that the new generation free trade agreements such as TTIP are increasingly based on harmonization of legislation and not so much on reducing customs and tariffs. A lot will happen until the end of 2019, which currently appears to be the likely end date of UK’s membership in the EU. The exit treaty will be subject to thorough examination by all EU member states and the European Parliament. This will also dominate the next European elections, which will be held in May 2019. It is truly saddening to think that the first attempt to create a transnational democracy would fail and fall apart in this manner. I suspect that Brexit will not be just Brexit. At the end of the day, it may look a lot like the present relationship between the UK and EU but with some exemptions, in a European Union which has reformed some of its failed policies

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t’s been a difficult time for all of us who believe in the European ideals of cooperation and trade between nations, building peace and security, protecting the environment and promoting cultural exchange for both young and old. The vote to Leave the EU by the British people must be respected, or we risk diminishing public faith in democracy. But it is clear that this vote stemmed from a variety of factors, many of which have nothing to do with the EU membership. It also followed a campaign packed with lies and distortions, which followed on from decades of misinformation by much of the UK media. As if the result of the referendum wasn’t bad enough, the rapid resignations and disappearance of many of those responsible for this debacle was undignified and irresponsible, leaving the UK the laughing stock of the world. On my return to the European Parliament the week following the vote, I was overwhelmed by support from colleagues from across the EU. But the result will have a profound effect on the rest of the EU: the balance of power, continuation of current projects and overall direction. Some in the UK may feel that perhaps the longer we wait, the better the

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outcome may be. However, in reality, the remaining members of the EU are anxious to get on with planning for their own future. I am concerned that the longer we leave them in limbo, the worse the deal we will get eventually. The stark truth is we don’t have a lot of cards in our hand at the moment. To make matters worse, a number of leading Tory Brexiteers have been elevated by Theresa May to the highest offices of the state. We have seen Brexit minister David Davis pledging to create a free trade area ten times larger than the EU, which would be one and half times the size of the entire global economy. Unless he’s counting on a boost in interplanetary trade, even the most optimistic Brexiteer will struggle to explain how that could be achieved. And now we have Andrea Leadsom, who once had to ask if climate change was real, in charge of protecting our environment and facing the unenviable task of explaining to UK farmers how they will be able to thrive in a post-Brexit Britain. But, of all the changes in government that Mrs May have made, the most damaging of all was to give the


voices of the european parliament Foreign and Commonwealth office to Boris Johnson. Whether as a journalist or leading Brexit campaigner, he has made a career out of inventing myths about Brussels. Now, he is expected to play a leading role seeking cooperation in the upcoming negotiations from his counterparts in capitals across Europe. Why should European leaders trust a man who has such scant respect for the truth? This appointment risks doing further damage to Britain’s standing in Europe and the world. In this difficult context, there was never a more urgent time for a moderate, internationalist and centrist party. That is why I am immensely proud of the response of the Liberal Democrats and of our leader Tim Farron. We have been clear that Britain must carry on working with its nearest neighbours to tackle common challenges such as protecting the environment, tackling cross-border crime and managing globalisation. That is why we will be fighting for the closest possible relationship with the rest of the EU to continue, most vitally full access to the single market. Secondly, it cannot be right that a handful of Conservative MPs decide what our future relationship with the EU will look like. This is a momentous decision that must be put to the public for a renewed mandate, particularly as Leave campaigners failed to agree on an alternative to EU membership throughout the referendum campaign. It isn’t just the Liberal Democrats who think that a change of circumstances as great as these should require a General Election. Both Theresa May and David Cameron called on Gordon Brown to go to the country and get a mandate for his new government back in 2008. The Liberal Democrats will continue to call for an election to have a democratic debate and mandate for the profound changes to our country that lie ahead. The people of Britain deserve no less

Crossing the line The Republic of Ireland, which is part of the EU and Northern Ireland, which is part of the UK, have been united for more than 100 years, entwined through trade and culture. Worried that Brexit might change this situation dramatically by reinstating border controls, Nessa Childers MEP, Vice-President of European Parliament’s MAC Group, argues that it would be a dramatic step backwards, in a practical and politically symbolic sense

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f the many aftershocks felt in Brussels after the Brexit vote, its implications for the future of the peace process in Northern Ireland and UK-Ireland relations are perhaps among the least noticed across the Channel. Yet, they must be carefully pondered and navigated as all the parties involved carve a new position for the United Kingdom in Europe. As it happens, whatever you make of the promises made by the leading Leave voices, their clash against the realities of mutually incompatible trade-offs casts a dark cloud over the fragile peace that emerged from the Good Friday Agreement. The breakdown of the votes immediately confirmed that the shared history and geography of these islands does not lend itself to straightforward solutions to respond to the narratives on offer. From partition and the establishment of the Irish Free State in 1922, citizens of both countries were allowed to travel back and forth without a passport, a state of affairs which was eventually enshrined in a Common Travel Area agreement in 1952. It grants virtually equal treatment to citizens of either jurisdiction in the other country, including reciprocal access to the labour market, welfare benefits and the right to vote in national elections, which in some cases goes beyond EU citizenship rights, but this was by and large camouflaged against the latter EU rights for younger generations.

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Indeed, prior to the question marks raised by Brexit, knowledge of the Common Travel Area had become a matter of academic interest. When the UK decided to remain outside the Schengen area, the Republic of Ireland ensured the continuity of this arrangement by staying out of Schengen, and a protocol was added to the EU Treaties, to recognise the CTA’s arrangements concerning the movement of persons. As David Cameron negotiated restrictions on welfare provision for EU migrants, the CTA was an obscure legal curiosity no more. Experts cast doubt on his pre-referendum assurances to the Irish Government that Protocol 20 would cover their special welfare rights against challenges of discrimination on the grounds of nationality in the EU, which would dramatically affect the lives or prospects of about 600.000 Irish-born immigrants in the UK. While Brexit rendered Cameron’s gambit null and void, the fate of the protocol is in question, adding to the uncertainty that reigns at the moment, especially in the absence of reassuring voices from the Conservative camp and the changed atmosphere in the wake of the strong focus on immigration we saw during the campaign. Even more dramatically, at a first glance, in a scenario of outright UK withdrawal, the border between the Republic and Northern Ireland would become part of the European Union’s external borders. All EU external borders are logically accompanied by border controls, but Brexit must lead to a rethink of this state of affairs in the case of the border with Northern Ireland, which is crossed daily, by roughly 15.000 and 25.000 commuters. Today, that map line is virtually imperceptible when crossed on the ground, bar the proverbial change from metric to imperial system on the road signs. But for the three decades of sectarian violence which claimed over 3.500 lives from the 1970s, the British military sealed the border and manned checkpoints, roadblocks and watchtowers at the crossings, where those coming through were routinely searched.

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the dilemma of the post-brexit united kingdom The reinstatement of border controls would be a dramatic step backwards, in a practical and politically symbolic sense, from the dividends of the tentative peace brought about by the Good Friday Agreement, which led to the complete dismantlement of the last military checkpoints by 2005. An idea floated by David Cameron, which would allow for Brexit, without the reinstatement of passport controls along this border would in turn necessitate checks on those travelling from Northern Ireland into Great Britain.

A joint paper from the Universities of Newcastle and Durham, where the different post-Brexit scenarios are teased out, indicates that, apart from a Free Trade area solution, for which there is no EU precedent without freedom of movement, customs controls would be required, at a minimum, along this land border. The sheer number of questions these uncharted paths are raising for individuals, families and communities whose lives and welfare are so inextricably entwined across these islands, has led to a first run for Irish passports for eligible

UK citizens.No sooner did consular services run out of forms, than the Leave campaign ran out of leaders. We must now wait for Theresa May’s answers to start taking shape. What we know for sure is that the economic and trade implications for Ireland and the UK, the loss of special, structural and cohesion funding in the Northern Ireland – not to mention the programmes jointly managed in the border regions - and the changes to bilateral relationship between both countries, must be handled with extreme care

Caught between a rock and a hard place The people of Britain voted to Leave the European Union, in a decision which will transform the political, economic and cultural relationships between Britain and the EU. Françoise Grossetête MEP analyses the potential consequences of the Leave vote and explores what a new relationship between Britain and the European Union might look like

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s the real consequences of the Leave vote slowly unfold, Britain’s decision to put an end to its EU membership appears for what it really is: an economic catastrophe. While Prime Minister Theresa May and her government are building an action plan to make Brexit a reality, the United Kingdom is indeed confronted with a Shakespearian dilemma: choosing between its economic interests and the sovereignty of its people. Among the many promises made during the referendum campaign, the most serious is probably the one saying that Britain would regain its true sovereignty after leaving the EU. In fact, it now seems as if the country, the birthplace of the modern parliamentary democracy, will have to accept and apply rules without participating anymore in its making. The largely unfounded fear of imposing regulations from Brussels is ironically becoming true as the UK is quitting the European Union. Indeed, of all the options drawn by legal experts to the EU membership, none can truly reconcile British political aspirations to more “independence” and “sovereignty” with the necessity for the country to keep its economy afloat in an era of free trade and globalisation. Part of those options, for example, being a member of the European Economic Area (like Norway) or negotiating sectorial bilateral agreements with the EU (like Switzerland), would entail applying and respecting an important part of the European legislation decided in Brussels, with no more say in it. That is, only if the UK wants to preserve the free access of its enterprises to the common market. Moreover, the country would still have

to contribute substantially to the EU budget. All these inconveniences would come without the advantages. The rest of the options would entail that the UK fully cuts itself loose of the common market, and is considered by its European trading partners as any other third country. Britain could indeed decide to renegotiate a form of free trade agreement with the continent. First, the UK would have to negotiate with the block of 27 countries, without any picking or choosing. Second, such an agreement could only confer the country a limited access to the continental market, with high tariffs remaining for certain products. Third, it would also mean that the UK would have to renegotiate all by itself and therefore with less weight, all its trading arrangements with non-European countries. Of course, the preferred option of Brexiters would have been a sort of special status for the United Kingdom within the EU, by which Britain could have remained a full member of the common market while being exempted of all other European policies. Such an alternative is, however, made impossible by current treaties. It

was also foolish for us to believe that UK’s partners could find any justification for such a preferential treatment, which would have opened the Pandora box of Europe “à la carte.” The best solution, in the end, would have been for Britain to remain. As a member of the EU, the UK was able to heavily weigh in the shaping of the common market policies, through the legitimacy of its government, its Commissioner and it’s democratically elected MEPs. Outside the EU, it will find itself caught in a difficult situation and will have to choose between applying foreign legislation and cutting access of its companies to the largest consumer’s market in the world


It’s time to rip off the Brexit band-aid

voices of the european parliament

We put on a band-aid as a means of protection; therefore ripping off a band-aid is not easy and often makes one feel uncomfortable. However, a quick rip-off eases ouch factor. Referring to the UK’s exit from the European Union as the world biggest band-aid removal process, Jeppe

Kofod MEP, Leader of the Social Democrats

in the European Parliament, calls for Britain to expedite the process of leaving the European Union

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t’s common knowledge that you need to act fast, while removing a band-aid. If Brexit is the world’s biggest band-aid removal process, it looks like we are in for a painfully slow process. First of all, Prime Minister Theresa May is clearly playing for time, whilst her predecessor, David Cameron announced that the Article 50 should be activated sooner rather than later. The incumbent PM mentioned that the Article 50 would be triggered sometime around 2017. However, now the word is spreading that senior government ministers in the UK are eying the end of 2019 as the new date for exiting the European Union. The reason, apparently being that the UK government is in no shape to actually conduct either Brexit negotiations or the plethora of trade deals that the UK has to have in place with other countries, after Brexit. Leaving aside Britain’s Brexit start-up troubles, what can the UK expect from us? Well, as far as the outlandish promises made by the Leave campaigns, the honest answer is: not much, if anything. I want to be very clear that this has nothing to do with either malice or bruised feelings, as the Brexit-camps and anti-EU populists throughout Europe are keen to portray it. Rather, this is due to some very basic, but tragically often forgotten principles in modern politics, namely that a deal is a deal, that agreed rules must be adhered to and that solidarity is a two-way street. The best example is Britain wanting access to the single market, without adhering to the principles of free movement. Whilst Brexiteers promised the electorate of Britain, all the benefits of EU-membership without any obligations, the political realities of making international cooperation work in practice are far removed from the empty promises of the Leave camp. So where does this leave both the UK and the

EU? There can and should not be any doubt about the fact that the remaining EU members are terribly sad to see the UK leave the European Union. Neither should there be any doubt that we wish the UK every success on its new path and that we will negotiate the practicalities of Brexit in an open, amicable and constructive manner. In doing so, we - the remaining EU member states, must, of course put the concerns, needs and wishes of our own populations and countries first. That is the difference of negotiating within a formal cooperation built on solidarity, which the EU is, and on negotiating with external partners on the basis of a zero-sum relationship, which is the path that the UK has chosen. We cannot allow the UK to enjoy all the benefits of EU-membership, without sharing in the obligations. Neither can we allow the UK access to the common market, without adhering to the same rules and regulations that govern our own access as Danes, Germans or Swedes. Delivering on the promises of the Brexit campaign will, therefore be more than difficult, to say the least. Being painfully aware of this, I can completely understand the UK Government’s wish to play for time.

Government Gazette

manner.

However, I sincerely doubt if this tactic of pushing the actual date of Brexit, will benefit the UK in any

Whether the UK’s new arrangement with the EU will come in the form of EEA, EFTA membership, or in the form of some hitherto unseen deep and comprehensive trade and partnership agreement is far too early to say. But one thing is certain, no-one gains from the uncertainty of the present situation. As time passes, the UK will increasingly be seen as the lame-duck country of the EU. Whilst still a formal member, actual influence will wane with time and patience with the partner who has already announced the break-up but refuses to leave will wear thin. As such, I strongly believe that the UK’s best course of action is to move quickly on activating the Article 50 so that the formal exit-negotiations can start and a new EU-UK relationship can begin in all earnestness

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the dilemma of the post-brexit united kingdom

Can we solve the trade problem while keeping the spirit of Brexit in place? Pondering over the UK’s trade problem and the essence of the Leave camp,

The Rt Hon John Redwood MP, the former cabinet minister,

argues that Britain need not belong to the single market in order to trade with the continent. He also notes that the aim of Britain’s electorate was not to trigger renegotiation with the EU, but to end up with some version of membership which the UK can live with

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he electorate of Britain voted to leave the European Union. They did so because they liked the idea that ‘we take back control of our law making, our borders and our money.’ The Brexit campaign was very clear. The aim was not to trigger renegotiation with the EU, but to end up with some version of membership which the UK can live with. Amidst criticisms of the campaign literature published during the EU referendum campaign, the government was equally clear. It stated in its official communiqué to every voter that voting to leave meant we would leave the EU. The government promised to execute the wishes of the people. There was no stipulation that more than a simple majority was needed, and no provision

for a second referendum. Indeed, the Prime Minister unequivocally ruled that out, in support of both campaign teams. But now some people want to slow down the exit process, or turn it into some new arrangement which ties us into parts of EU law making, requiring us to continue making some financial contributions, and allow freedom of movement between the UK and the EU. None of it is in the spirit of Brexit. All these concerns were strongly debated before the plebiscite, and Leave made clear its wish to leave with no EEA or single market membership. It’s rather surprising that some still continue to think that we need to belong to the single market in order to trade with the continent. Try telling that to China or the USA or India, who trade with the EU on a daily basis, without belonging to the so called single market. I recall only too well, all the meetings I had to attend when I was Britain’s single market minister. Far from the single market being some priceless creation that speeds trade and generates

prosperity, my work told me that it was a “large power grab” by the EU. Using the excuse that it would help trade if more central control was exercised over a wide range of matters, the EU brought forward a complex and voluminous legislative programme that included the environment, health and safety, employment law, transport, energy, communications, competition and much else besides. In many cases, it was difficult to see the relevance of the measure to more trade. In some cases, the draft laws were hostile to enterprise. Most of it went through qualified majority votes, so as Britain’s business minister I had to build alliances to prevent or water down the most damaging proposals. At its best, it created common standards and specifications to make the task of some exporters to the EU a bit easier. At its worst, it locked the EU into product designs and technologies that were not optimal but mandatory. To the extent that it helps exporters to the EU, and that all EU countries have to ask for the same specification of certain goods and products, this is a benefit that applies equally to non members of the EU and single market as well as to members. To the extent that it limits competition, innovation and choice, it slows down the EU, relative to the rest of the world. The UK’s growth rate has been slower in the EU than it was after the war before we entered the EU. There was neither any increase in Britain’s growth rate when the so called single market in goods was created in 1992, nor was there any acceleration in growth since the advent of many more service sector regulations and directives in the century. The UK should get on with the task of leaving the EU, by repealing the 1972 Act and notifying the EU that the UK is leaving under Article 50, using our constitutional procedures. I doubt the other member states will want to impose high tariffs and other barriers in the way of their trade with us. However, they will be limited to the general 3.5% average tariff of the WTO as members of that body. The UK should tell them we are not seeking to place tariff and other impediments on their trade with us, unless they do so, on our exports. The UK is in a strong position, as we import much more than we sell them. We are in a strong position because we make big net contributions, which we need to cancel and spend at home. The sooner we end the uncertainty, the better. The sooner we start spending the £10bn a year we send them and not get back the better for our public services and economic output, the sooner we take control of our borders, the sooner we can limit numbers to reduce pressures on housing, public facilities and transport. The sooner we can also reduce the downwards pressure on low end wages. There will be a boost to our GDP. Meanwhile after complaining, Germany will want to continue selling us her cars tariff-free and France will want to continue selling us wine and cheese tariff-free in order to persist trading with us in a sensible manner


Will there be a second Scottish independence referendum?

the brexit effect

Another Scottish referendum is highly likely if the Government of the United Kingdom fails to protect Scottish interests while exiting the EU. While twothirds of Scots voted to Remain in the European Union and with a vast majority of Germans, French and Danes favouring a Scottish decision to join the EU,

Stephen Gethins MP, member of the Scottish

National Party, argues that honouring Scotland’s decision to stay within the EU, whilst providing distinct solutions appropriate to other parts of the UK, becomes Britain’s democratic necessity

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lmost two thirds of the Scottish electorate – in every local authority area, including those who voted against joining the EU - voted to Remain in the European Union. Scotland chose to be an open, inclusive and outward-looking society where other EU citizens are welcome to live, work and contribute. We voted to protect the freedom and prosperity that comes with our rights to trade and invest, travel, live, work and study in other European countries. Scotland’s future is in Europe and the overriding objective of the Scottish Government and SNP is to protect Scotland’s place in the European Union. EU Nationals make a huge contribution to our communities in Scotland. On the morning after the vote, Scottish First Minister Nicola Sturgeon displayed our corresponding commitment to EU citizens living in Scotland, saying: “you remain welcome here, Scotland is your home and your contribution is valued.” Soon after, she gained the support of the Scottish Parliament, with only the Conservatives abstaining, to visit and make Scotland’s voice heard in Brussels where she met with Presidents Schulz and Junker as well as leading parliamentarians from around the EU. She described the reception she received as sympathetic and we thank all of those who have shown such goodwill towards Scotland. At home, the First Minister has set up a Standing Council on Europe – comprising distinguished figures with backgrounds in diplomacy, the EU institutions, economics and industry - which will advise the Scottish Government on how it can best secure Scottish interests and our relationship with the rest of the EU going forward. It is now time for the UK Government to likewise respect the decision made by the people of Scotland and demonstrate rather than

assert - against evidence to the contrary – that remaining part of the UK can work for Scotland. This will be particularly important in the negotiations that will precede the invocation of Article 50. We expect a negotiation position allowing different parts of the UK to meet their distinct needs and pursue different outcomes whilst respecting the outcome of the referendum in different parts of the UK. The Scottish First Minister has outlined five tests for any negotiation outcome: Scotland’s democratic decision must be upheld; we must retain access to the EU’s single market and funding mechanisms; Scotland must continue to benefit from EU social protections; we must be able to work in solidarity with other EU partners to promote security, tackle global challenges and encourage EU sponsored study exchanges; and Scotland must retain influence by being able to shape the rules of the single market. Whilst the first priority of the Scottish Government and SNP is to ensure these tests are met, it is clear that another Scottish independence referendum is highly likely if the UK Government can’t protect Scottish interests. The manifesto with which the SNP won the Scottish election in May, just 6 weeks before the Referendum, stated: “The Scottish Parliament should have the right to hold another referendum...if there is a significant and material change in the circumstances that prevailed in 2014, such as Scotland being taken out the EU against our will.” In the UK’s parliamentary tradition, it would be unthinkable for the UK Government to refuse a second independence referendum that had the support of the Scottish Parliament and a

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majority of Members of the UK Parliament with Scottish constituencies. There is now growing public support for Independence from those who voted to stay in the UK in 2014 on the basis of the UK remaining in the EU. An increasing number of our fellow European citizens appear to agree. A recent YouGov poll questioned several European countries if they would endorse Scotland’s decision to join the EU, 71% of people in Germany, 61% of people in France and 67% of people in Denmark were in favour. We are pleased to hear Irish Taoiseach Enda Kenny affirm that “Scotland should not be dragged out of the European Union having voted to stay.” The endorsement from Gunther Krichbaum, Chair of the German Parliament’s European affairs committee, favouring a Scottish referendum is also highly welcoming. Honouring Scotland’s decision to stay within the European Union, whilst providing distinct solutions appropriate to other parts of the UK, is in the interests of all the UK’s nations and is a democratic necessity. The sustainability of multinational union-states such as the UK rests on the needs, interests and democratic aspirations of each part being fulfilled. For the EU itself, I can see no greater interest- or purpose - than that of retaining the membership of all nations and peoples committed to working together for peace, prosperity and Europe itself

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uk parliament speaks out

‘Let’s take control of our own destiny’ Explaining why he wants the UK to leave the EU, Sir

David Amess MP, notes that the British membership of the European Union ‘had eroded the country’s national sovereignty to about 45%.’ Highly appreciative of the influence of Britain throughout the world, he is increasingly affirmative of the benefits that Brexit offers

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ver since the late General De Gaulle vetoed Harold Macmillan’s application to join the then Common Market, I have felt that the United Kingdom was very much on the back foot in terms of the reality of our membership. Perhaps, if we had been one of the “founding fathers” everything might have been different. Many UK residents were very pleased that we were eventually given the opportunity to trade our goods and services in a single market, have educational and cultural links and work together in common defence and foreign affairs matters, but became increasingly hostile to closer integration of sovereign states. In essence, the majority of UK residents were never happy with the ultimate concept of what they perceived to be a move towards one government, one currency and pooled sovereignty. So, it was perhaps against all odds and forecasts, in what was a high turnout that a substantial majority of British people voted to Leave the EU. Before that momentous decision had been taken, there was a high level of totally irresponsible scare-mongering, which the common sense of the British people decided to ignore. I believe they’ve already been proved right in their judgement; after all the sky has not fallen on Britain. After the initial reaction to the vote, our financial markets have once again stabilised.

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We now, of course, have a new Prime Minister and she has made it absolutely clear that Brexit means Brexit and that there can be no going back on the decision of the British electorate. The Prime Minister has also been wise enough not to be bullied into triggering Article 50 before everything is in place, to begin the two year renegotiation process. It is in no-one’s best interest to conduct these historic negotiations in an ill-prepared manner. A new Cabinet has been appointed, with key ministers who supported the Leave campaign entrusted with the job of negotiating trade deals and other associated matters. From a British point of view, I believe there will be enormous gains for British businesses from leaving the European Union. We will no longer be restrained by general trade deals, geared for all member states, in the mistaken belief that ‘one size fits all.’ All present members of the EU will be as keen as ever to sell their goods and services to the UK, nothing will change in that regard. But from a British point of view, we will be able to address the adverse consequences which followed our joining the EU in terms of agriculture and fisheries. We will now take the opportunity to ensure that we boost trade with our Commonwealth partners and hopefully conquer new markets in the rest of the world. I see no reason whatsoever, whilst we may no longer be a member of the European Union, not to continue to work in common matters concerning foreign affairs and defence. Indeed, the disastrous British decision to support the Americans in toppling the former regime in Iraq went ahead in spite of EU opposition, particularly from the French. Whilst, as an island, we have a particular advantage to defend our shores, being surrounded by water, we would very much want to help and work with

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our European colleagues in terms of security and the general effort to defeat terrorism. Whilst for me, the fundamental issue was sovereignty; for many of my constituents it was all about immigration, by which I mean too many people arriving in a small island and wanting to live in the south or southeast. Since the referendum, many people have raised the issue of reciprocal rights, i.e., Europeans already living in the UK and British people living in Europe. I am absolutely sure that, with goodwill, the negotiations should secure arrangements, which will satisfactorily accommodate those who are worried about their future. It would be in no-one’s interest to discriminate against what would be perceived as “foreign nationals” living abroad. I am also sure that European workers will continue to be welcomed in the UK, but the number entering our country in future may be strictly monitored, not only in terms of skill mix but also in terms of our country’s safety and security. Many people felt that the UK economy simply could not continue to support a rapidly growing population from overseas and Europe in particular. Finally, for me perhaps the greatest prize of all is the Government of the United Kingdom taking back control of its own destiny. It is absolutely imperative that the British Parliament is sovereign so that when UK residents vote in General Elections they know that the MPs they are sending to Westminster will make all the laws which govern our country. In recent years, our membership of the European Union had eroded our national sovereignty to about 45%, which is a totally unsatisfactory state of affairs. So, in summary, in most people’s lifetime, the British people’s decision in the referendum of June 23rd to Leave the EU is a defining moment in our history. The UK has always been rightly proud of the influence that a relatively small nation has had throughout the world. Brexit has secured what I believe will be a very bright future and will enable us to still enjoy a fruitful and positive relationship with both our European neighbours and the wider world


the future of uk-eu relations

Stepping into the unknown As Britain’s relationship with the European Union hangs in balance,

The Rt Hon Keith Vaz MP, argues that now is the time

for the United Kingdom to stand up to discrimination of all kinds and expose the welcoming nature of the nation. Spelling out the known knowns and the known unknowns of Brexit, he writes that only decisive leadership, a steady nerve and shrewd diplomacy can ensure that Britain will emerge unified, as it steps into the unknown

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n the aftermath of the European Union Referendum, many people have been wondering how Parliament will implement the will of the British people.

The only sure action is to invoke Article 50 of the Treaty of Lisbon, but a vote to leave by a member state is unprecedented, therefore the rules for exit are brief and the strategy for such a move is unstipulated. What is guaranteed is that it will take a minimum of two and a half years before we know what the United Kingdom’s future relationship with the European Union will look like. This is a time of great political, economic and social uncertainty. The country has a new Prime Minister, and it is now Mrs May’s job to lead us through the political storm. The most pressing issue is the economy. The immediate market reaction was concerning. However, the Chancellor Philip Hammond and Mark Carney of the Bank of England have, in the short term, reassured the markets and the economy appears stabilised. The Referendum has shown that the United Kingdom is a nation divided. Divided in its membership; with Scotland and Northern Ireland voting to Remain whilst England and Wales backing Leave. Split between generations, with the youth feeling robbed at a decision overwhelmingly supported by older generations and at odds along class lines, with many working class communities voting to Leave. Then, there is a North-South and a rural-urban divide. Division is also rife within the two main political parties. A vile showing of racism and xenophobia that has seemingly been bubbling under the surface in many communities around the country has also been revealed. The perpetrators of these actions have been indiscriminate, targeting not just EU Citizens, but anybody that could be considered ‘foreign’. By fighting, and winning,

a referendum on the premise of stemming migration, racist and xenophobic thoughts and actions have been given legitimacy. I believe the liability for this lies with the Leave campaign. We now have an opportunity as a country, to stand up to discrimination of all kinds and show the rest of the world, that the United Kingdom is the open and welcoming country that I know it to be. The new Prime Minister is responsible for delivering the wishes of the people and tackling the issue of European citizens remaining in the UK and British citizens living abroad. Migration is therefore the second key issue. There are currently 1.2 million British citizens living in the European Union and 3 million European citizens living in the United Kingdom. The Government has repeatedly refused to confirm their status, and it is widely anticipated that this will not be made clear until after the negotiations have been completed. I cannot begin to imagine how worrying this must be. The nation’s relationship with Europe now hangs in the balance. Planning beyond October 2018 is near impossible. As a nation we are taking a huge step into the unknown. It is only through decisive leadership, a steady nerve and shrewd diplomacy that we will emerge from this unscathed. I am sure that we are up to the challenge. In a real sense it’s “back to the people.”

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reversing brexit

Brexit was a step backwards; our new Prime Minister has the power to reverse it Brexit means Brexit, as Prime Minister Theresa May fondly repeats. While we still don’t have a clue what Brexit really means, once we do, Geraint

Davies

MP, Labour MP for Swansea West, says the electorate

should have a chance to decide whether it really favours that over membership of the EU and argues why the new British government should consider applying the brakes whenever necessary

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s a Labour MP, I’ve spent my career fighting for greater social justice, equality, better environmental protections, more tolerance and inclusion, and more opportunities for people, in particular for those least advantaged. In the 14 years that I’ve been in the UK Parliament, I’ve witnessed a great deal of progress on all of these fronts. Before the Brexit vote, our country was stronger, more inclusive, more diverse and more open. Many people had opportunities previously denied to their parents. Our environment had become cleaner and our streets were safer. But of course, there was still plenty of work to be done which is why voting to Leave the EU was such a bad idea. It’s not simply that it’s taking us back a few steps but that it’s also taking us in a completely different direction. Take race relations, for instance. We thought racial violence was a thing of the past, but immediately after the result of the referendum, police reported a major increase in racially motivated hate crimes. The attack on a Polish centre and racist abuse on primary school children hit news headlines. Or, consider the economy, instead. Latest statistics reveal that in the quarter prior to the vote, UK’s GDP grew by 0.6% - much higher than expected. We were on track to become the largest economy in Europe, overtaking Germany, and unemployment was at a record low. As we know, it all changed in an instant when the UK voted to Leave. We went from being one of the most stable economies in Europe to one of the least, with the GDP of France moving ahead of the UK. As a member of the Parliamentary Environmental Audit Committee, I know

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just how much of our environmental progress came from EU membership. Since the environment is an international issue, protecting it requires international cooperation too, and this is exactly what the EU offers, with a big enough critical mass to lead global advances in sustainability. Without the EU, our Tory government will have to bow down to the pressure from multinationals, who will put their profits before the planet. Thanks to EU regulations, Britain was no longer the dirty man of Europe. Now, I fear that Britain will put back its dirty old clothes and lead on fracking, accelerating climate change, diesel pollution, and already prematurely killing 40,000 people a year. This is why our new Prime Minister, Theresa May, and her team of Brexit ministers have a lot of work to do. I fear that it will be in vain. What Boris campaigned for, and what 52% of the country voted for, was EU market access with lower costs and less immigration, which indeed is a cynical fabrication. What will inevitably emerge is lower market access at higher costs with similar immigration. So, not only will we retreat on numerous issues including diversity and inclusion, the economy and the environment, but what people voted for, will certainly not happen. The exit negotiations are at this stage only informal, but European leaders have made one thing clear: we cannot impose controls on immigration if we want to stay in the single market. Theresa May supported the UK remaining in the EU but she now faces the dilemma of delivering what Leave campaigners promised, and crash the economy, or stay in the market and undermine the reason why most voted to

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leave. At the present moment, she might be enjoying her honeymoon as a new leader, but the false promises of Brexiteers will plague all Tory houses not least her own. In the last few weeks, I have introduced two Bills to the Parliament to protect Britain from the impact of Brexit. The first is to safeguard EU environmental protections by retaining them in British law. The second calls for a referendum on the UK-EU Exit Package. If UK voters feel that the terms of leaving the EU don’t reflect their reasonable expectations when they voted to leave, then they can then reject the deal and remain in the EU. If the promises of a stronger economy with immigration control turn out to be false, the Brits could then vote to come home to the EU. Theresa May has shrewdly put arch-Brexiteers Boris Johnson, David Davis and Liam Fox in charge of the exit negotiations, knowing very well that the political conditions for a second referendum will emerge only when they fail to deliver on Brexit and stir public opinion against themselves and back in favour of the EU. Then, Theresa May will either “offer the people their final say, in light of the facts” to save Britain or accept that the economic uncertainty, political confusion and social regression emerging from the June 23 Brexit plebiscite. I hope she will seize the moment to reverse a referendum that was born of the grubby tactical manoeuvring of her predecessor and resume our place at the table where we can best help shape a stronger, fairer and more sustainable world


security and brexit

The Brexit effect and why strong neighbourhoods matter The United Kingdom is strong only when her neighbourhood is safe and secure, writes Dr Simon J. Smith, Lecturer of International Relations from Staffordshire University. Considering Britain’s long-term security interests from an insider’s perspective, he argues that Brexit might weaken the country’s position in NATO and reduce her ability to influence and guide the future of the European Union

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impact on the UK’s direct security in the short-term. Broadly speaking, this remains the case. The UK remains a strategically relevant actor in the international system. It retains the military, diplomatic and intelligence assets to sustain a relatively high-level of influence on matters of international security and it gains a multitude of advantages from its soft power attractiveness as well.

ccording to Theresa May, ‘Brexit means Brexit.’ Therefore, when the newly-formed British Government decides to trigger Article 50 of the Lisbon Treaty, there will be implications for UK, European and Transatlantic security. In fact, the ramifications of the Brexit referendum are already starting to emerge. To consider this question from a UK-centric position is not only superficial but, paradoxically, also potentially perilous to Britain’s own long-term self-interest.

In addition, the UK possess one of only two ‘full-spectrum’ military capabilities left in Europe, which also includes a nuclear deterrent which the House of Commons recently voted to renew; although this could also be seriously undermined if a vote to Leave unleashed further independence tendencies in Scotland. Even as a member of the EU, the UK is in full control of its borders as it is currently outside the Schengen area. The UK even possesses the right to deny entry to EU citizens under the EU’s 2004 citizenship directive.

That there will be implications is certain, yet the extent of those implications may not be fully realised for some time. Threat perception in the international environment is notoriously difficult as the Russian annexation of Crimea and the rise of Islamic State have both demonstrated recently. When it comes to international security, the shadow of the future is always lurking in the background.

However, cracks in this minimal impact argument have already revealed themselves. In July, Trevor Taylor at RUSI raised ‘major doubts about the affordability of the country’s current defence equipment plans’ due to the sharp decline in the pound, post-referendum. This could mean ‘extra costs of up to £700m a year’ for the UK Ministry of Defense. Furthermore, Spain is also increasing its efforts to regain sovereignty over Gibraltar in the wake of the referendum result. This would have, both political and strategic implications, for the UK.

In the days leading up to the referendum, many security experts argued that withdrawing from the EU was likely to have little noticeable

Government Gazette

It is also something that the United States is watching closely as this could also have strategic implications for them given that Gibraltar ‘is a port for U.S. nuclear-powered submarines in the Mediterranean.’ At the heart of the Leave campaign was a desire to pursue a more global (i.e. ‘liberated from the shackles of EU membership’) economic and security agenda. However, disengaging from European institutions will not, ultimately, support this strategy. The ability to act globally fundamentally depends on stability in our own neighbourhood. It is true that NATO has formed the ‘bedrock of our national defence, and of stability in the Euro-Atlantic area, for almost 70 years’. Yet, security in the UK and Europe is provided for by more than just membership of the NATO Alliance. In reality, the EU and NATO are two sides of the same coin. Membership in the EU and NATO, as well as crucial bilateral relationships, reinforces UK’s current national security strategy; a strategy that is motivated by the so-called ‘comprehensive approach’ which draws on both civilian and military resources. Moreover, although the integrated design of NATO resulted in former European enemies finding it physically problematic to fight one another after the Second World War, progressive and consistent EU political cooperation has resulted in the Clausewitzian notion that ‘war is the continuation of politics by other means’ as simply unfathomable between EU member states at least. In short, the EU has helped provide for security in Europe by evolving both interests and our security cultural identities. In effect, Brexit may weaken the UK’s position in NATO, and the overall solidarity of the Alliance, just as the UK is now putting all its eggs in one basket. Even when it was a potential Brexit, it had already motivated some in the US to maintain that such a move would considerably reduce Great Britain’s ability to ‘influence and guide the future of Europe… as well as to ‘reduce British influence on the world stage’. Brexit, of course, also poses security questions for France and Germany, not to mention the future of the Common Security

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security and brexit

and Defence Policy (CSDP). The argument that leaving will not have a major impact for the UK, what with the country being a leading military and intelligence provider in Europe, is also fundamentally flawed. The UK is only strong if its neighbourhood is strong. The story of Europe after the Second World War has overwhelmingly been one of integration and institution building. The effects of unravelling this process are not likely to contribute to further stability in Europe over the long-term. The current and longer-term challenges facing the UK (and its Western partners) need a range of tools in the toolbox. Put simply, although the US-UK intelligence relationship retains primacy for the UK, membership in the EU

gives the UK unfettered access to even more of these dynamic tools.

as an outsider and with no veto powers.

In turn, this helps bolster wider European security. The vote to Leave the EU will mean a significantly different relationship with its European neighbours and could unleash processes that may have tremendous negative security implications over time.

The UK may well leave the EU but it cannot leave Europe. None of the UK’s domestic, regional or global security challenges will become any easier to manage once the UK leaves the EU. Only time will tell if Brexit incentivised a bolder, more outward looking Britain.

Simultaneously, the process of untangling the UK from the EU will necessitate a tremendous amount of political, diplomatic and economic capital that could be better placed mitigating the current security challenges that Europe faces as a whole. Once this is completed, the UK will still need to devote vast resources towards influencing EU policy, although now

We will also have to wait and see if Brexit produces a more integrated EU; including in the area of defence and security. Yet, at a time when the current international order is being severely tested, the UK’s limited resources will necessitate a level and a manner of strategic planning that has not been seen in London for some time

Understanding the security implications of Brexit Professor Emeritus Malcolm Anderson, Professor

of Politics, University of Edinburgh, analyses the grave implications for the security of Britain and Europe. He notes that Brexit poses specific and general threats to internal and external securities of both the UK and the EU, and highlights that Brexit might have a serious impact on Europe’s intelligence gathering and Britain’s internal security arrangements with EU, which could potentially call for more hard work in countering challenges effectively

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here are two aspects to Brexit and European security - what leaving the EU will mean for UK security and what impact it will have on the remaining 27 members of the Union. There is as yet little firm ground on which to speculate about the impact for two main reasons. First, we do not yet know even the broad outlines of the UK government’s negotiating

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position after it invokes article 50, let alone any indication of the shape of the final agreement between the EU and Britain. UK ministers, but not the Prime Minister, have indicated a preference for “hard” Brexit, namely leaving the single market and negotiating mutually agreed access. Since immigration, and therefore free movement of EU citizens, is the main political issue for the UK, this is the probable but, by no means certain, outcome. Second, security is a very broad field, covering many issue areas from nuclear deterrence to

Government Gazette

neighbourhood security, including all policies which keep us, or allegedly keep us, safe. Some have little to do with Brexit, and others will be affected by it. There can, however, be unforeseeable consequences. In addition, both internal and external securities tend to merge under the impact of globalisation, new technologies, and specific developments such as terrorist outrages and cyber-crime. Governments, including the UK government, continue to treat external and internal security separately, although the strong connections between them have implications for Brexit. Although the EU is increasingly active diplomatically, the development of a common external defence and security policy has been slow and hesitant. It may well accelerate when


security and brexit

the UK leaves the EU because Britain has been the most resistant of member states to any European integration in this field. In internal security the EU has established a series of instruments in the field of justice and home affairs, and the UK government has opted into 35 of the most important. In external policy, the new UK Defence Minister, Michael Fallon, has insisted that Brexit will not modify the British commitment to European security. The UK nuclear deterrent and its commitment to NATO will continue, but so will British reluctance to intervene out of area after the unsuccessful intervention in Afghanistan, Iraq, and Libya. A recent parliamentary paper stated that “The UK’s ability to project military power would be largely unaffected (by Brexit), and any military shortfalls could be compensated by bilateral arrangements. Ensuring the success of Common Security and Defence Policy (CSDP) operations remains in the UK’s interest, but outside the EU, the UK could choose to continue its participation in CSDP operations as a third party state.” But there will be a political downside. The UK would have less or no influence over the development of CDSP. Within NATO, the probable rapid increase in German defence capability, as envisaged by a recent official report, will make Germany, together with France, key European partners for the United States. No significant changes in cooperation between security services are likely since specialists in this field insist cooperation depends on what the parties to cooperation “bring to the table” (the intelligence which they have which others want). However, it also depends on political goodwill and how well existing channels of communication work. In this respect, Pauline Neville-Jones, a former Chairman of the UK Joint Intelligence Committee and Minister of State for Security and Counter Terrorism, issued what is probably an over-emphatic warning that Brexit would put valuable bilateral relations at risk as well as cutting the UK off from key multilateral forms of cooperation. In this field, governments cooperate when they must, and when they want to. Existing arrangements in internal security membership of Europol, Eurojust, European Arrest Warrant (EAW), access to the Schengen Information System and other matters must be re-negotiated. British law enforcement authorities are persuaded of their value. The EAW and Europol are particularly appreciated by the police. According to Sir Hugh Orde, former head of the Association of Chief Police Officers (ACPO), if the UK left the EU, to replace the EAW it would have to renegotiate 27 different extradition agreements and create

a bureaucratic nightmare. This would leave the UK more exposed to terrorism, human trafficking, cyber-crime, drugs and child pornography. Both specific and general threats to security are posed by Brexit. If the Northern Ireland border becomes an EU external border and systematic controls on persons and goods are re-imposed, this would put the Northern Ireland peace process at serious risk, with the possible revival of Republican violence. The UK government has declared that these controls will not be imposed but it is difficult to see how they can be avoided in a hard Brexit. The possibility of secession by Scotland creates a further layer of uncertainty and other European countries could see this as a threat to their own integrity and security. The most serious threat to security is general political and economic instability, and the possibility that countries outside the EU such as Russia, and even the UK, will attempt to exploit divisions between member states for their own advantage and to advance their own policy objectives

The main issues in the security debate fall under the broad categories of intelligence, terrorism, the future of NATO, and internal security. The Joint Committee on the National Security Strategy warns that UK’s defence spending will shrink in real terms despite NATO 2% target and that capabilities of the armed forces would be undermined

The rocky road ahead Defence perspective The UK’s ability to project military power would be largely unaffected by Brexit), and any military shortfalls could be compensated by bilateral arrangements. Intelligence impact Brexit would put valuable bilateral relations at risk as well as cutting the UK off from key multilateral forms of cooperation. In this field, governments cooperate when they must, and when they want to.

Internal security angle If the UK left the EU, to replace the EAW it would have to renegotiate 27 different extradition agreements and create a bureaucratic nightmare. This would leave the UK more exposed to terrorism, human trafficking, cyber-crime, drugs and child pornography. With inputs from Professor Malcolm Anderson

Government Gazette

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economic aftermath

Economic repercussions of a political convulsion The historic plebiscite has tipped many into disillusionment and despair. While the poor, the jobless and the pensioners would face the severity of the Brexit storm, Philippe Legrain, British political economist, journalist and founder of OPEN think tank, says its ripple effects will be felt in every aspect of Britain’s trading relationship with the EU. Making a thorough scrutiny of Britain’s political, economic and trade options, he pinpoints the major economic lessons of Britain’s Leave vote

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he Brexit vote is a political earthquake whose economic aftershocks are likely to be severe.

Britain faces years of political instability, financial turbulence and economic uncertainty that will depress investment and growth. It is likely to end up with a more closed labour market, worse access to European and global markets, lower foreign investment and a more corporatist and protectionist EU on its doorstep – crimping productivity, growth and living standards. For the feeble and fragile eurozone, Brexit is also a dangerous shock. Economies such as Ireland and the Netherlands are highly exposed through trade. Heightened risk aversion and collapsing share prices seem to have brought Italy’s banking crisis to a head. Above all, Brexit exacerbates fears about continued European Union disintegration, giving businesses another reason to postpone investments. Britain’s economy is already on the brink of recession. Business confidence has plunged to its lowest since the 2009 slump. With massive uncertainty about future trade, regulations and demand, many companies are postponing or cancelling investment and employment decisions. Foreign investors are pulling out of deals. Open-ended commercial-property funds are preventing investors from withdrawing their money. Housing prices look set to fall, denting Britons’ principal form of wealth. All this is likely to deter consumers from spending. And with a current-account deficit of 7% of GDP, Britain’s economy is reliant on flighty foreigners to keep financing it. A cheaper pound – down 9% in trade-weighted terms since the Brexit vote by the end of July – is unlikely to help much. As after sterling’s collapse in 2008-9, it may lift inflation, cutting real wages and hence spending, while doing little to boost exports. Few companies will invest in increasing export capacity with global demand weak and trade terms uncertain. Monetary policy can’t help much either. Official interest rates have fallen to a record


the brexit effect

low of 0.25%; negative interest rates have proved counterproductive elsewhere. With UK Treasury bond yields at record lows, reviving quantitative easing (QE) probably wouldn’t provide much stimulus. The downturn will also widen the budget deficit, already 4% of GDP. While fiscal stimulus is feasible, the Conservative government seems unlikely to embark on it. Eventually a poorer Britain will need to cut public spending and raise taxes, compounding the misery. This uncertainty is likely to be prolonged. Extricating Britain, the EU’s second-largest economy, from the Union will be extremely complex. Britain must also negotiate a new trading relationship with the EU, with which it does nearly half of its trade. That could take many more years. Economically, the least-damaging option would be to join the European Economic Area (EEA), with Norway, Iceland and Liechtenstein. Britain would retain almost full access to the £11 trillion EU single market (with opt-outs from EU agriculture and fisheries policies), while gaining the right to strike its own trade deals with non-EU countries. But EEA membership would still involve the return of customs controls and other barriers such as rules-of-origin requirements. Politically, though, the EEA option seems a non-starter. It would involve accepting singlemarket rules and associated EU legislation in areas such as consumer, environmental and social protection, without a say in setting them. It would require continued contributions to the EU budget, without receiving spending in return. And it would entail continued freedom of movement for EU citizens – an economic boon, but a political bugbear. At best, then, EEA membership might be a transitional arrangement. The fallback option is to trade with the EU on the basis of World Trade Organisation (WTO) rules, as the United States and China do. Such a “hard Brexit” would be much more disruptive. It would entail tariffs on UK goods exports to the EU – as much as 10% in the case of cars – as well as non-tariff barriers. It would offer little access to EU markets in services, in which Britain specialises. UK-based financial institutions would lose their “passport” to export freely to the EU. While financial firms might seek continued access on the basis that Britain had “equivalent” financial regulations, which (political) judgement would be up to the EU. Without full access to the single market, foreign investment – and the good jobs tied to it – would be lower. Trade barriers also entail less competition, and so less pressure on companies to innovate and become more productive. And while the UK could restrict EU migration, this would have an economic price. Many businesses and organisations rely

on hard-working EU migrants, who pay more in taxes than they take out in public services and benefits. Their willingness to move around and do jobs that Britons spurn is a key element of the country’s much-vaunted labour-market flexibility. The WTO option would still be tricky and time-consuming. Britain needs to apply for independent WTO membership and agree a schedule of commitments with the 163 other WTO members. Eventually, Britain might negotiate a Canadian-style free-trade agreement with the EU, which is basically WTO-plus. Brexiteers are deluded in claiming that Britain will be able to cherry pick what it likes about the EU: enjoy free trade while keeping out EU citizens. Exports to the EU (13% of GDP) matter more to Britain than exports to the UK (3% of GDP) do to the EU, so the EU will have the whip hand. And for every EU firm keen to maintain access to the UK market, there are others – notably financial centres in Frankfurt, Paris, Amsterdam, Dublin, Luxembourg and elsewhere – keen to steal a competitive advantage. EU governments also have a political incentive to drive a hard bargain, to dent the appeal of anti-EU parties such as France’s National Front and deter other countries from leaving. Any deal would require the consent of all 27 remaining EU governments, each with their own economic demands and political constraints.

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Whatever happens, a postBrexit Britain is set to end up with worse access to EU markets. Brexiteers argue that the UK can make up for lost exports to the EU with increased sales to fastergrowing economies such as the US, China, India and Australia. But in the near term, Britain will lose the benefits of the trade deals with 50-plus countries that the EU has negotiated on its behalf. Since the government has hardly any trade negotiators, it will struggle to strike new deals quickly. And while any future UK trade negotiations won’t be hamstrung by protectionist interests elsewhere in the EU, as a much smaller economy with largely open markets and a government desperate to do deals, Britain will also have much less leverage. And given the protectionist tone of the US presidential election, a trade deal with the

Government Gazette

US is unlikely any time soon. Brexiteers also argue that Britain could boost growth by slashing regulation. But its labour markets are already the least-regulated in the EU and its product markets the secondleast, so any potential gains are likely to be slim. Besides, there is no political appetite for such deregulation. On the contrary, Prime Minister Theresa May has signalled greater state intervention, while the government is committed to raise the minimum wage substantially. Britain is heading for a Brexit bust and beyond that weaker growth. Hardest hit will be the poor, the jobless and pensioners – often Leave voters – who depend on taxpayer largesse. It is tragic

Legrain’s lessons for the Brexiters Britain’s economy is already on the brink of recession Quantitative easing will not provide much stimulus Britain is set to end up with worse access to EU markets EEA option seems to be a political non-starter The WTO option would be tricky and time-consuming Britain can’t cherry pick what it likes about the EU With no good trade negotiators, the British will struggle to strike new deals With inputs from Philippe Legrain. Responsibility for the views expressed herein lies entirely with the author.

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migration and brexit

What does Brexit hold for European nationals living in UK?

Whilst uncertainty still clouds the future of European Union nationals living in Britain, Will Somerville, UK senior fellow at Migration Policy Institute and visiting professor of politics at the University of Sheffield, notes that the Government of the United Kingdom will face several challenges in drafting and implementing a withdrawal agreement, in terms of setting criteria for residency of European nationals, setting cut-off points and implementing whatever is decided. He weighs the different options available and says the devil is the detail It is widely expected that the accord will be negotiated over the next 18-30 months, with the starting gun fired when the UK triggers Article 50 (which initiates a 24-month period of negotiation). Crucially, EU free movement law applies until exit is official. Thus, in the short term, nothing changes. In the longer term, the government will most likely guarantee existing rights for Europeans for legal, practical and political reasons. British Future think tank polling shows that 84 percent of the public favour settlement for European migrants, and in any event unravelling accrued legal rights would be difficult. There are also reciprocal reasons to guarantee rights as many British citizens live across Europe. However, the devil will be in the detail. There are three challenges. The first is setting out the criteria for who qualifies for permanent residence. Current free movement law automatically awards permanent residence after five years of continuous UK residence. Recent analysis by the Migration Observatory at Oxford shows that an estimated 2.6 million EU and EEA nationals have lived in the UK for more than five years.

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rime Minister Theresa May’s political response to the EU referendum— “Brexit means Brexit”—has bought her time. The slogan manages to signal movement without giving away any detail. Yet, for the estimated 3.5 million European Union and European Economic Area (EEA) nationals living in the UK, the details are all important.

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The UK government has promised that European migrants will be ‘properly protected’ but has stopped short of guaranteeing permanent status. Amid the uncertainty, many are voicing concern over their future in the UK. The referendum has also emboldened those vehemently opposed to migration, as shown by a sharp rise in anti-immigrant hate crimes. Though the precise sequencing of Brexit has yet to be announced, we need two agreements: first a withdrawal agreement and then a separate accord codifying the future UK-EU relationship (covering trade, migration and other arrangements). The withdrawal agreement is the most relevant treaty for European nationals living in the UK today, as it will detail their rights of residence.

Government Gazette

The remainder—temporary residents—will thus be a particular point for negotiation, not least as certain nationalities are particularly affected. Social Market Foundation analysis suggests that more than half of people from Romania, Spain, Hungary, Greece, Italy and Bulgaria don’t qualify for permanent residence. The second related challenge lies in setting the cut-off point for when the rules will come into effect. Obvious choices are when the withdrawal agreement comes into force, the date when Article 50 is triggered or the 23 June 2016 referendum date. This has substantial implications. For example, while the UK remains a member of the EU, an additional 435,000 European nationals will accrue permanent resident rights over the next two years. The third and the most difficult challenge ahead is implementing whatever is decided. The current system is rigid and processes just 25,000 applications yearly, turning down 1 in 3 applications, mostly because of insufficient,


trade implications of brexit invalid or incorrect documentation. The processing challenges are immense: the UK does not have a population register and the most obvious proxy (a National Insurance Number) has obvious flaws—for example there are 1.5 million temporary numbers in the system with no way of checking if those with a NINo are residents in the UK. Similarly, three of the four categories of permanent residents (self-employed, self-sufficient and students) require proof of permanent health insurance. One would anticipate that a range of proofs of income and residence will eventually be needed, with all the problems that will entail for government bureaucracy. Turning to future flows, the future UK-EU agreement is unclear. One option is an EEAtype agreement that provides association rights, with a brake on migration. Under such an outcome, the rights of EU nationals would be the same as today. But given that control of immigration was a key motivator for Brexit voters and that it’s implausible EU governments will grant the UK a special status that includes limits on free movement, some sort of EEA agreement seems possible—if at all—only as an interim step. In the longer term or if there is no EEA agreement, a future arrangement will involve a greater degree of control over European nationals. It is logical to assume that it would be based on selection of highly skilled workers and students, perhaps a natural extension of the existing UK Points Based System alongside extending the current regulations on non-EEA family joiners, which are far more restrictive. Under any future agreement, rights accorded to European nationals will be weaker, as is currently the case for non-EEA migrants. While these questions are being resolved, European governments may consider ways to support their nationals. In addition to negotiating the details (fees, streamlining process, etc.), governments could facilitate the process of receiving residency. Consulates could assist with proof of permanent residency (e.g. health insurance), or helping with appropriate citizenship applications or applications for a residence card (or registration certificate for temporary residents), which few European nationals possess but would be an obvious gateway into permanent residence later Will Somerville recently co-authored an MPI report examining the role of immigration in the UK political sphere and call for a Brexit referendum.

A strategy for the UK’s future trade policy The United Kingdom’s future trade policy should certainly start with the EU, its main and most proximal trade partner, writes Mark Manger, a Professor at the University of Toronto and a former consultant to the Governments of Canada and Japan on Free Trade Agreements. Clarifying the intricacies of forming trade agreements with other countries, he notes that retaining the existing European templates of trade for drafting FTAs with other countries would barely cost a thing

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ollowing the vote to Leave the EU, the new British government faces the task of meeting the expectations of an unlikely coalition of voters: from farmers who currently receive EU subsidies and citizens in economically deprived areas worried about immigration to those who hope to light a ‘bonfire of EU regulations.’ The appointments to the new British cabinet suggest that the proponents of free trade and radical deregulation have won the day. The declared aim is to negotiate trade agreements with growing markets in Asia, the Commonwealth, and most importantly the US. At the same time, recent polls confirm that Britons expect net immigration to considerably fall in the aftermath of UK’s exit vote. Notwithstanding statements by disappointed Remain campaigners, many of these objectives can be met: Britain should negotiate a free trade agreement according to Article 24 of the General Agreement on Tariffs and Trade (GATT) and Article 5 of the General Agreement on Trade in Services (GATS) with the EU. In effect, this means that Britain should leave the EU’s customs union as part of the withdrawal agreement, and immediately start negotiating a free trade agreement with the EU. Meanwhile, it is in Britain’s best interest to focus on its trade relations with the EU first, and leave other Free Trade Agreements (FTA) for later. To be sure, such an agreement would never be as economically beneficial as remaining within Europe’s single market. But it is a coherent reading of the referendum outcome that a majority of British voters would

Government Gazette

trade off some economic wealth for limits on immigration from the EU. The freedom to negotiate individual trade agreements with other countries comes at a price: An FTA requires rules for what duties to charge on goods that are made of inputs from different places. These ‘rules of origin’ are among the most complex topics in trade negotiations. They determine whether a good qualifies for tariff-free shipping between members, if it uses inputs from outside the common FTA. In a world of complex supply chains, the rules quickly become complicated, and sometimes make up 2/3rd or more of the text of an FTA. Any such agreement would require British exporters to document that they comply with these rules. All of this quickly adds to the cost of trading. At the same time, there is much common ground between the UK and the EU. No matter the nostalgia for when the UK traded

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rise of the far right

Did Brexit benefit from the far-right?

mainly with its former colonies, empirical research has established beyond doubt that economic size and geographic proximity are the best predictors of how much two entities will trade with each other. Also, given the high level of existing integration, British products use many European inputs already, even when the finished goods are exported elsewhere. Britain would not lose anything by following the existing European templates for rules of origin. And lastly, there is little point in insisting on British standards. Exporters will obviously build products to the requirements of their biggest market — much like cars sold anywhere in the US comply with California’s emissions standards, because it would be more expensive to make separate models. A precondition for this strategy would be for the UK to assume full responsibilities as a WTO member upon leaving the EU. Here, too, detractors have questioned the UK’s ability to fully extricate itself. In fact, the most legitimate position would be to adopt the current EU tariff schedule for goods on a mostfavoured-nation basis and its commitments for services. For agricultural goods, it would be sensible to offer quotas equivalent to the UK’s current imports from non-EU countries, and to likewise adopt any existing EU tariffs as the UK tariff. This position will neither leave any WTO member state worse off in its trade with the EU nor discriminate against anyone. It is unlikely to be challenged successfully in the WTO dispute settlement system—and no matter what some Leave campaigners have asserted, the EU’s external tariffs are already among the world’s lowest in many cases. In this scenario, the UK would surely lose some access to the EU market. Trade in financial services is unlikely to be as free as it is today. Even though 90 percent of additional demand in the next ten years is likely to come from outside of the EU, the EU without the UK will still be a fifth of the global economy. Constrained by global trade rules and voter expectations, the UK would be well served by coherent free trade agreement policy that starts with the EU, its most important partner

Monitoring and analysing the rise in followership of Britain’s far-right groups on Twitter,

Melanie Smith, Researcher,

Institute for Strategic Dialogue, notes that these extremist groups will continue to sow discord and disharmony, both online and offline

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ince the Brexit vote on the 23rd of June, British police, NGOs and researchers have been exploring the impact of the campaign and election result on the rise of racist and xenophobic incidents. The police reported a fivefold increase in reports of hate crime in the five days following the announcement of the vote. In addition to the shocking and tragic murder of Jo Cox MP, there were reports of threatening phone calls to minority community centres, numerous Islamophobic attacks, and Polish families receiving flyers reading ‘Leave the EU, no more Polish vermin.’ Despite the increased media focus on xenophobia and racism, there has been little or no research published on whether the Brexit campaign and vote have actually resulted in a measurable increase in support for far-right street movements or political parties in the UK. Between the 28th May and 28th June, the Institute for Strategic Dialogue (ISD) analysed the social media accounts of several influential UK far-right groups to investigate how these events have impacted their support. Researchers analysed the official twitter accounts of the British National Party (BNP), the English Defence League (EDL), Aryan Revolution UK, Britain First and British Unity. Despite the vast differences in output, popularity and political tone between these groups, some uniform trends were identified. Firstly, all five movements gained followers over this period; Britain First’s Twitter account saw the largest increase with 15%, followed by Aryan Revolution UK and the EDL, with 13% and 5% respectively. Britain First’s 15% increase saw a significant upturn in the days after the murder of Jo Cox, with another, more gradual increase following the EU Referendum result. While followership does not always equal

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Government Gazette

endorsement, these five groups and movements have all gained potential exposure through their new followers’ networks. This exposure can in turn impact the reach of far-right and anti-immigrant material, for example Britain First’s 15% followership increase resulted in a 291% increase in potential impressions for their content. This type of exposure can also galvanise potential offline support and activity. Our analysis revealed that despite the rise in female engagement with extremist movements, the vast majority of contributors to the conversation surrounding these groups are middle-aged males. Geographical analysis showed that North West, Yorkshire & the Humber and Greater London residents - all regions with large migrant communities dominate the discourse around British Unity. ISD also observed that the use of derogatory xenophobic terms between April and June showed a continued focus on anti-Muslim or Islamophobic sentiment. Research into Islamophobic crime over the course of several years does indicate rapidly escalating levels of verbal and physical abuse, including a 300% increase in ‘offline’ incidents in 2015. However, our analysis revealed that terms such as ‘gypsy’, ‘poles’ and ‘paki’ became more prominent towards the end of the data collection period, perhaps indicating a surge inspired by the referendum. The rise of these derogatory terms online was mirrored in recent official reports, coupled with incidents reported through hashtags like #PostRefRacism and #PostBrexitRacism, which indicated a surge in hate crime toward ethnically Polish, Romanian and Greek communities. Perhaps most interestingly, our analysis revealed that there were large spikes in derogatory terms around May 6th-7th, the date of the election of Sadiq Khan as Mayor of London, but the greatest spike occurred around the 12th of June, the day of the terrorist attack in Orlando. This is perhaps unsurprising, given the far-right often exploits Islamist-inspired attacks – as well as presenting events such as the election of


security and brexit

Mayor Khan as examples of ‘Islamisation’ – to shape and disseminate their propaganda. While the long-term effects of the vote to Leave the EU on the activities of UK far-right groups remain to be seen, the events that took place between the 28th of May and the 28th of June appeared to measurably increase support for the online presences of these movements. With growth in followership and potential impressions, comes increased visibility for groups like Britain First, British Unity and the BNP, thus enacting a feedback loop where exposure often leads to general – if slight – increases in support. Managing diversity and integration is one of the biggest challenges currently facing governments throughout Europe. Failure to cope with these challenges is debatably at the root of the Brexit vote, and is reflected in the rise of xenophobic speech, hate crime, and the online followership of far-right groups. However, these challenges will not be solved simply by leaving the European Union and closing borders. Far-right groups will continue to sow discord and disharmony, both online and offline. While monitoring xenophobia is essential, understanding if and how these sentiments translate into support for these movements is vital to preventing the rise of farright groups in the UK

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europe’s renewable revolution

The earth is not flat, it is urban!


By 2050, nearly 70% of global population will be urban. This unprecedented wave of urbanisation is leading to a great number of challenges. However, cities are where the greatest climate change challenges and opportunities lie. Many city Mayors have taken initiatives to change the environmental behaviour of their citizens and businesses. To understand the core processes and benchmarks that can transform cities and make them more resilient and sustainable, Government Gazette interviews Mayors and senior policy makers in cities across Europe, including Basque, Aalborg, Helsinki, Stockholm, Cologne, Warsaw, Rome, San Sebastiรกn, Rotterdam and Ghent


europe’s renewable revolution

Why Europe should strengthen cooperation between cities

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mart city solutions can be the answer to many of the challenges faced by European cities, including better safety, better healthcare, better traffic management, less air pollution or more efficient public administrations. But becoming a smart city requires scale. According to estimates, only a third of EU cities and towns are of adequate scale to carry out the necessary strategic planning and to attract sufficient investment on their own. Others depend on working together to develop affordable solutions and to attract financing. This is why we have to strengthen cooperation between cities. Cities need to think about joined-up planning, market research, tendering and procurement. This is what the European Innovation Partnership on Smart Cities and the Horizon2020 Smart Cities lighthouse projects are aiming at: fostering stronger cooperation between cities beyond research towards implementation and deployment. 21 European cities already participate directly in these projects with a focus on energy, mobility, digital solutions and smart applications. They typically involve reducing carbon emissions and energy consumption, and improving urban mobility.

In order to tackle the current challenges of European cities, Roberto Viola, Director-General of European Commission’s DG CONNECT says ‘cities need to think about joined-up planning, market research, tendering and procurement.’ Two examples illustrate this initiative. First, 40 industry players have committed themselves to develop interoperable solutions for smart cities. These solutions help building interoperable platforms, the hardware and software that is needed to manage data at city level and allow for new and better services. In turn, 80 cities have agreed to cooperate on this topic with industry. They have already developed and tested joint requirements for platforms and are working towards a fast rollout of this key enabling technology (KET) in their cities. Second, there are cities in four European regions that cooperate on smart networked lamp posts including features like e-charging, sensors, Wi-Fi and of course LED upgrades for lighting. Currently such products are still extremely expensive and the added value for cities remains often unclear. By cooperating, cities get a better understanding of the market. They jointly carry out feasibility studies and procurement preparations, which should eventually bring down the cost of such projects. Making smart cities happen in Europe is a priority. Our EU policies directly help

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technological innovation, interoperability and standards. The Digital Single Market (DSM) strategy is our strong political anchor for this but we also support the smart cities market in Europe by linking the DSM with the Energy Union and the EU Urban Agenda. Our challenge at the EU level is to simultaneously engage all stakeholders and in particular city authorities, urban infrastructures operators, the ICT sector and major investors. To this end, we will launch a single online entry point, as a first action under the EU Urban Agenda, that will bring together all relevant contacts, provide access and information on policy, funding and finance to boost investment in cities. The challenges for cities have increased drastically over the last few years but the digital tools at their disposal have never been better. A strategic approach with a clear focus on their individual needs can make their efforts pay off. However, only joint action and demand aggregation can offer cities faster, better and cheaper solutions with improved returns and benefits. We have to encourage all actors in Europe to cooperate even more and reap the benefits of the potential that smart cities offer


europe’s renewable revolution

Cities lead by example and go renewable renewable. Frederikshavn uses a variety of local renewable energy sources to pave the way for this societal transformation, such as solar heating, heat pumps, wave energy and wind turbines. Moreover, it creates synergies with nearby industries (such as the maritime industry anchored in Frederikshavn harbour, for which it will provide sustainable biofuel) and partnerships with renowned academic institutions like Aalborg University. The Danish municipality’s clear, concise and cross-cutting take to secure the energy future of its citizens has attracted significant private investment, and has subsequently enabled it to stay on track for its ambitious target: reducing GHG emissions by more than 50% compared to 2007 levels.

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approach to tackle mitigation and adaptation to climate change. Over 6,600 cities, representing more than 200 million citizens, translate their political commitment into bold action through the development and implementation of local action plans with clearly defined, tangible measures.

n the aftermath of the global climate Paris agreement, the focus now shifts to taking action to limit the impacts of climate change and stabilise global warming. Local authorities involved in the Boosting local renewable energy is a key Covenant of Mayors for Climate & Energy, element of most actions plans of Covenant of heralded by European Commissioner Arias Mayors signatories. In Kaunas, the secondCañete as the “world’s biggest urban initiative,” largest city in Lithuania, a multitude of are at the forefront of these efforts, as they are measures defined in the city’s local action plan driving the shift towards aims at increasing local renewable renewables to secure a energy production. By 2020, Kaunas “After COP21, the sustainable energy future. plans to use biomass to cover all of focus has shifted to its heating needs, and is therefore In 2015, global investment stabilising global investing in the construction of in renewable energy broke warming and limiting several new biomass boilers. The city new records and outpaced has also efficiently tapped into many the impact of climate investment in fossil fuels other locally-available renewable change” by 2 to 1, according to energy sources, such as hydropower Bloomberg New Energy or biogas from wastewater treatment Finance. At the same time, facilities. Kaunas’ strong will to decrease GHG more and more cities worldwide are expressing emissions has put the city well on track to go their ambition to make their territories “100% “100% renewable.” In 2013, the Lithuanian renewable” by fully tapping into their local city was already half-way through to this goal, energy potential. thereby outpacing its own country, which Many of these cities are signatories of the should achieve this benchmark only in 2016. Covenant of Mayors for Climate & Energy, Covenant of Mayors cities often prove to be an avant-garde bottom-up initiative that more ambitious than national governments, brings together local and regional authorities when it comes to fostering an energy system voluntarily committed to implementing the based on renewable energy sources (RES). EU climate and energy objectives on their Another example is the Danish municipality territory. Covenant of Mayors signatories of Frederikshavn, which signed the Covenant share a vision of decarbonised and resilient in 2012. Investing in local renewable cities where citizens have access to secure, sustainable and affordable energy. They commit electricity and heat production is a cornerstone of Frederikshavn’s local action plan and to reducing GHG emissions by at least 40% by its “Master plan for Renewable Energy 2030 through investments in renewables and 2030,”where the municipality has laid out a energy efficiency, and shall adopt an integrated precise framework and roadmap to go 100%

Government Gazette

In territories where less RES are available, it is important to use a diversified approach to be able to go 100% renewable. The German financial metropolis and Covenant signatory Frankfurt-am-Main does exactly that, as it aims to go carbon free and fully renewable by 2050. Frankfurt’s strategy follows a threefold approach to achieve these goals: reducing energy consumption by 50%, and covering the remaining 50% by locally-produced RES for the first half, and by RES purchased from external suppliers for the other half. Frankfurt’s local RES are solar (photovoltaic and thermal), wind power, organic waste and highly-efficient cogeneration plants (combined heat and power). The German city has also benefited from close collaboration with the Frankfurt/Rhine/Main region, the regional association and the federal state of Hessen, as all these stakeholders have helped Frankfurt develop and implement its ambitious vision for a sustainable energy future. The inspiring examples of the Covenant of Mayors cities of Kaunas, Frederikshavn and Frankfurt show that going renewable is a challenge that can be effectively tackled by cities of all sizes and resources. It demonstrates that the Covenant of Mayors for Climate and Energy is key to offer citizens a high quality of life in sustainable, resilient and vibrant cities David Donnerer,Communications Officer, Covenant of Mayors for Climate & Energy

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europe’s renewable revolution

Leading the sustainable revolution CITIZEN-POWERED CITY Basque, Spain

Š Gobierno Vasco 2016

The Basque Country has positioned itself among the leaders of local sustainability and its environmental policy has a proven track record dating three decades back. In an exclusive interview with Janani Krishnaswamy, Commissioning Editor, Government Gazette, Ana Oregi, Minister for Environment and Territorial Policy of the Basque Government, shows a firm commitment to improving the environment and tells us what European cities should learn from the Basque Country

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uropean Cities will have to find sustainable solutions to current challenges and create social and economic value for the benefit of the local population.

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How can this value be captured in Europe today?

I believe that the answer to that question is through open participation, collaboration, solid funding, circular economy principles and a strong awareness of the need to change the current social and economic model. Cities need a socio-economic transformation so as to boost the local economies, create small scale investment opportunities and jobs, apply new innovative approaches to financing, and prioritise the purchase of products and services with high environmental performance, among others.

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In the Basque Country we have a strong model of participation that includes some good examples of value capturing. Such is the case of the Udalsarea 21 network, working with over 200 municipalities to implement and monitor transversal public policies on sustainable effective development; the Ner group, an initiative where local companies share knowledge and experiences. They support each other financially, so as to change the current relations model in the private sector from a human development and sustainability perspective; or the Koopera Reusing Center, a private-public partnership project that works on the integral management of local solid waste, based on environmental co-responsibility, social inclusion, and community-based economy. We are confident that cities are valuable centres of economic growth, and we trust that local value will be reflected in the transformative actions of European cities and organisations.

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The Basque country’s newly adopted Environmental Programme for 2020 shows a firm commitment to improving the environment and also aligns with current European strategies on job creation, enhancing standards of living and building a low-carbon economy. What are the major highlights of your latest strategy?

Government Gazette

As the Minister for Environment and Territorial Policy, I am proud to say that the major highlight of the Environmental Programme for 2020 is that our society and citizens are at the core of the strategy. We are convinced that obtaining an advanced, modern and prosperous society is only possible by protecting and respecting our natural resources and by scrupulously preventing the environmental risks for the health and quality of life of everyone. One of the main goals of the Basque Government is to leave for future generations a territory that is more pleasant, more sustainable and with greater development potential. The Basque Government understands the environment as the key concept that gathers all the factors that condition human life, natural, cultural, economic or social. Thus, our Administration has incorporated the environment in all its policies as a crosscutting element that decisively contributes to wellbeing, creation of green jobs, development of a future-looking and strong economy, as well as building a fairer and more equitable society. In this context, we are working on: protecting our natural capital as a source of wellbeing and quality of life; moving towards a new energy model to face climate change; promoting public health and its interdependence with


towards an index of urban sustainability the environment; fostering a circular economy and a competitive territory; developing an education system that prioritises commitment to future generations; and leading a governance model based on co-responsibility.

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The Basque Country has positioned itself among the leaders of local sustainability and its environmental policy has a proven track record dating three decades back. Can you explain how the Basque Country has continued to make significant progress, and what do you think other European cities should learn from the Basque Country? Four decades ago the environmental performance of the Basque Country was rather poor: there were very few urban water purification infrastructures; we did not have networks to control the quality of the air or water masses; and there was no expertise and experience regarding environmental policies among the Public Administration, companies or citizens. In the 90s, we started working towards reverting this situation. So we invested in innovation and R&D, the heavy industry was restructured towards a more sustainable and efficient model, the unemployment rate began to drop steadily, and environmental indicators began to evolve positively. In 2002 the Basque Network of Municipalities

for Sustainability, Udalsarea 21, was created to facilitate inter-institutional coordination and the intervention of municipalities in this change process. As of today, 97% of Basque citizens live in towns and cities with Local Agenda 21 plans of action. We have a trajectory of over 30 years now and we have developed a coordinated and participative governance system, we have prioritised the environmental actions within the government budget, and we have introduced sustainability as the key factor in the economic activities of our production model, and that is the key to the transformation of our region. The Basque Country is nowadays among the advanced European regions leading environment-linked policies and instruments, as it was shown at the COP21 in Paris with the participation of the Basque Government, municipalities and companies that presented 12 examples of excellence and transformative programmes to combat climate change, as an opportunity to produce goods and services with lower emissions, and train co-responsible and well-informed citizens.

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With both the EU Urban Agenda and the Habitat III New Urban Agenda to be adopted in 2016, cities will continue to be in the focus of international policy processes. How do you think these two agendas interrelate with the political reality in European cities? What guidance can they

provide for cities, and what do city leaders expect from them? City leaders are asked to design and shape the transformation of our countries in a context of financial and economic crisis in Europe, and the challenges of unemployment, regional conflicts, economic and social divide, as well as the increased migration that is one of their consequences. The EU Urban Agenda and the UN New Urban Agenda aim to be frameworks for sustainable urban development that will foster cooperation between local and national governments and international organisations, and will enable the integration of urban policies and cohesion of actions. I understand that both tools promote a new working method to ensure maximum utilisation of the growth potential of cities and successfully tackle the social challenges. However, I would say that in addition to a reference framework, cities expect to see a multilevel governance and implementation mechanism: supportive legal and programmatic framework conditions; financial programmes to generate and increase urban value; and strategic urban planning and design guidelines with a focus on citizens and aiming at driving sustainable development and an equitable society

Š Gobierno Vasco 2016

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europe’s renewable revolution

Boosting cooperation between cities to fight climate change Mayors and policy makers of more than forty countries from Europe recently gathered in the Basque Country for the 8th European Conference on Sustainable Cities & Towns. The meeting was an opportunity for scaling up further cooperation and action plans on how best to create productive, sustainable and resilient cities for a liveable and inclusive Europe. In an interview with Janani Krishnaswamy, Commissioning Editor, Government Gazette, Wolfgang Teubner, Regional Director for Europe, ICLEI – Local Governments for Sustainability, outlines his vision for a smarter and sustainable Europe

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towards an index of urban sustainability

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mart and sustainable cities are becoming commonplace, with people getting more responsible to reduce global carbon emissions. Q Can you explain how Europe aims to achieve the smartness and sustainability in cities? From my perspective, the topics or buzzwords are commonplace but we are far from reaching a common understanding about the transformations we will have to undergo to become sustainable. If we would like to reach the goals of the Paris Agreement, we have to reduce our CO2 emissions to 2t per capita or below. Currently we are quite far away from the benchmark and are substantially overusing the resources. Smartness was originally quite strongly linked to information and communication technology, big data and the combination with infrastructural hardware. Thereby, it is a means to achieve certain goals that might or might not be sustainable although many had the implicit intention that it should lead to more sustainability. This tension between means and ends and the moving away from a purely technologybased definition is a hot discussion issue at the moment.

Q What is the significance of hosting a conference on sustainable cities in the Basque Country? Can you elaborate further on the Basque Declaration and its 15 pathways to move towards a more sustainable and inclusive Europe? I think the significance of hosting a European Sustainable Cities and Towns Conference in the Basque Country is the city’s ambitious sustainability goals. The conference focused on transformation towards sustainability and inclusiveness and the Basque Country had gone through a massive transformation in the past 20 years in this direction, and therefore offered many practical examples as well as intellectual inspiration. The 15 pathways point at the wellknown need to achieve sustainable societies and that we often focus on technological and infrastructure development. However, a large part of the necessary transformations are of a socio-cultural and socio-economic nature, which need a comprehensive new thinking. This particularly addresses the activation of the civil society, both in the planning and implementation of change, governance models and education, as

well as its economic involvement and the share of resources and opportunities in our societies. To this end, and also with the help of new technologies, we have to decentralise many structures as far as possible and build from the ground. This will also make energy production and distribution more resilient in the mid and long-term.

Q How do you think sustainable solutions can be shared between cities? What do you think should be the focus of future debate on sustainability? Until recently, the sustainability debate has been focussing on expansion and growth as the solution and less on distribution. As soon as we move away from permanent growth, the distribution question comes up much more prominently and it needs to be addressed. This is exactly the point where we need the socioeconomic and socio-cultural transformation. Of course, we are aware that this is an evolution and not a revolution, although the political developments in Europe indicate that the patience of people is not endless and a lot of awareness raising and education has to be done.

Q What in your opinion is the role of local governments in contributing to national governments to reach the Sustainable Development Goals of the United Nations? All goals will have to be implemented on the local level somehow. In an urbanised world, the lives of people are shaped by their urban environment. Therefore cities and urban regions will have to play a key part. Again, the SDGs are thought to be the means to address development and quality of life within the global resource boundaries and are, consequently, in line with an integrated sustainable urban development that we have always promoted.

Q Do cities need to be more involved in policymaking at regional, national and EU level? With the Committee of the Regions, we already have a formalised body of participation in EU policymaking that also involves cities. However, I think we need more specific occasions for a non-institutional open dialogue on specific topics and issues where local government representatives are really heard and messages are taken into account. The gap is often between the European Commission, who partly has these dialogues, and the national governments, who are largely influencing the decision but are not necessarily highly represented in such dialogues. There are some emerging good examples that could potentially be replicated, such as the interministerial council on urban development in Germany. Therefore, yes, cities should be more involved in policymaking but it needs to be ensured that their efforts are also reflected in the resulting rules and legislation. Of course, involving the local level can also help to bring people closer to Europe in the end. With the Pact of Amsterdam this is decided for now. In line with what I said before, we will have to see how it will work in practice and how effective the participation will be and what kind of results can be achieved

The critical point is that cities have a high level of implementation power but comparatively little legislative power, and only limited sources of financing. It is for this reason that it is highly important that the legislative frameworks and financial mechanisms are adapted where necessary in order to be supportive of the SDGs and their local implementation. It is a bottom-up exercise to challenge the relevant layers of government in that respect, as well as a top-down exercise to motivate regional and local governments and trigger action. Towards the end, only a well-organised multilevel governance effort will yield substantial results however, I am sure, there will be strong initiative and push from the local level.

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europe’s renewable revolution

Investing in cities for a green future

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round three quarters of the European population live in urban areas and even more Europeans are expected to move to cities in the years ahead. Cities are often the centre of economic, social and cultural life in Europe, contributing to quality of life. At the same time, city authorities face a long list of problems including long daily commutes, traffic congestion, social exclusion, and air pollution, all of which have a negative impact on that same quality of life. Cities have an important role to play in tackling these challenges. They also need to anticipate and prepare for other challenges linked to climate change and demographic changes. Human health, well-being and the prosperity of cities are closely linked to the environment. A healthy environment — clean air, clean water, productive forests, land and seas — is an essential element that also influences our quality of life, from our standard of living to our public services and education. Acting as hubs for food, water, housing, energy and transport, urban areas have a key role to play in addressing this situation. Cities can be designed to be more resource-efficient and energy-efficient, reducing the impacts to ecosystems, minimising pollution and acting to mitigate and adapt to climate change. Despite significant improvements, air pollution remains a major environmental health risk in European cities, contributing to respiratory and cardiovascular diseases, lung cancer and other health effects. Exposures to particulate matter, ozone and carcinogenic benzo(a)pyrene are of high concern. Congested urban traffic conditions and frequent short journeys result in higher air pollution emissions per kilometre compared to free-flowing longer journeys.

There is no simple formula for converting a sprawling, polluted, congested 20th century metropolis into a clean, freeflowing, low-carbon urban utopia. However, well managed, well planned and well governed cities can be a positive game changer. Hans Bruyninckx, Executive Director, European Environment Agency, presents his recipe for a greener future populations. The challenges we face underline the need for action to reconfigure systems of production and consumption so that they operate within our planetary limits and thereby ensure the well-being of current and future generations. This need has long been recognised in the European Union: the EU’s longer-term policies increasingly call for sustainability and greening the economy.

Noise pollution is also a challenge. At least 125 million people in Europe were exposed to high levels of road traffic noise in 2012. Exposure to environmental noise has been estimated to contribute around 10,000 cases of premature deaths due to coronary heart disease and stroke each year. Almost 90% of the noise-related health impacts are associated with road traffic noise.

The EU and its member states are already putting in place several measures to facilitate a transition toward a truly sustainable society. Different EU funds are clearly earmarked and spent on making this green transition happen. This combination of measures and a coordination framework between different governance levels is essential for enabling city authorities to take action on the ground. So are knowledge and know-how. The European Environment Agency’s work also focuses on urban issues to inform decision makers on how cities can become cleaner and more resourceefficient. It is clear that Europe needs to invest in greening its economy, and thereby its cities.

There are also less known problems, which can lower the quality of life. For example, urban sprawl can increase car dependency, which in turn increases the risk of obesity. More cars on the road can increase commuting stress and wasted time. Similarly, inadequately connected cities can present a risk of isolation for ageing

More concretely, cities can work on waste management, promoting recycling and re-use of materials, and avoiding waste by better organisation. They can also develop integrated urban planning and management, which will eventually minimise the use of natural resources, energy, and the loss of biodiversity.

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Similarly, urban planners can focus on the ‘greenification’ of city areas, with ample green and blue spaces which contribute to clean air and less noise. These areas encourage physical activities, improve mental health and social interaction. Planners can also look at improving mobility, making transport infrastructure modern and more efficient, with more walkable and cyclable neighbourhoods and by making access to local services easier. Such green planning can also contribute to local climate regulation to reduce heat in core built-up areas of cities. Our intensive consumption in Europe has put excessive pressures on the environment and it is clear that a ‘business as usual’ approach is no longer a viable development path for Europe. The burden on our environment in Europe and abroad represents a growing threat to future advances in living standards and increasingly raises questions about the fairness of the wealthy imposing disproportionate burdens on the global environment. Well managed, well planned and well governed cities can be a positive game changer. Urban areas already serve as magnets for talent and innovation and are well placed to lead the way to a greener future. Cities are a source of problems, but at the same time they also have a huge potential to develop solutions towards a resource-efficient economy and a low-carbon society


the smart cities challenge

Put citizens first for a successful smart city CITIZEN-POWERED CITY Ghent, Belgium

Building a successful smart city requires a city-led and citizen focussed approach. Smart cities need to have smart citizens to be fully inclusive, innovative and sustainable. The city of Ghent strongly focuses on its smart citizens, and actively enables them to become smarter. Daniel Termont, Mayor of Ghent explains his vision for an inclusive, smart and child-friendly city, which will be a better place for everyone to live, work and enjoy

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n Ghent, we combine our historical facades with a forward looking vision. By 2020, I want my city to be open, inclusive, smart and child-friendly. Key to this vision is our citizens: we want to build the Ghent of the future together, a better place for everyone to live, work and enjoy. Discussions around smart cities are too often driven by technology and industry. I believe cities – and their citizens – are at the core of the smart city transition. Technology is an important ingredient of course: we are looking

to cutting edge solutions to better manage our energy and transport systems, process and visualise data and make life easier for citizens. We’re not overlooking the low tech solutions that complement these: well-organised bike paths, for example, and vertical farming. Technology for us is a means not an end, and becoming smarter is about a whole lot more. We need to find new ways of working together so we can make the most of everyone’s expertise. Public administrations, citizens, businesses and research institutes: we are all part of the same urban ecosystem and we all have something to offer. By pooling our resources, we can create better solutions that

Government Gazette

truly address our challenges and are owned by the entire city. In Ghent, we have several tools to make this cooperation happen, like the Ghent Climate Alliance, which is behind our vision of becoming climate neutral. We bring everyone together to discuss, debate and explore the path to climate neutrality. And our Ghent Living Lab is an innovative platform where citizens, developers, researchers and businesses can cocreate their city. Smarter cities rely on data, so opening up data is an important initiative for Ghent. Students and developers can use it to work on new solutions, including apps that make life easier

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the smart city challenge for residents, like a waste collection calendar and an app to locate free parking spaces. We’ve even turned it into a competition: our annual hackathon, Apps for Ghent, invites developers to turn our open data into exciting new apps. We’ve seen examples such as Studio Dott’s Popbike, which allow users to calculate the best bike route and share bikes, and Ghendetta, a game that encourages users to explore and conquer city districts.

EU-funded projects are important for testing and scaling up new solutions. Ghent is involved in several projects, including the Green Digital Charter, through which we commit to reducing our carbon footprint through smart ICT.

While these projects are important, we are noticing that competition between cities to win EU-funded projects is on the rise. Applying for these opportunities is demanding on administrative and staff Ofcourse there are limitations. “In becoming smarter, we will capacity, and there is learn lessons and encounter One of the challenges many no guarantee of success. cities face with opening data What’s more, it is often challenges along the way. is protecting citizens’ privacy. A direct dialogue with the national or regional Citizens need to be able to governments that allocate European Commission would the share of funding access, use and manage their enable us to address these data, and for this they need that local authorities adequate digital skills. This can receive. This means challenges as and when they is a priority for Ghent, as we arise. The new urban agenda that the opportunities want to make sure technology at EU level don’t always for the EU provides a suitable match our local needs, is accessible to everyone. All of our citizens need to be part framework for this” so I would strongly of this transition. recommend giving cities direct access to EU funding. It is essential then that we create a level playing field, so local businesses and entrepreneurs As a mayor, I know every corner of my city and can benefit. We need common and open have the daily contact with the citizens. From standards and better interoperability between street to strategic level, this knowledge is crucial systems. Not only would this open the market for making smart city solutions work. to more actors, especially locally, but it would Working with cities means working with bring down costs and maximise the release, citizens, so by strengthening the links between accessibility and usability of data, helping the European institutions and cities, we are businesses grow. building a stronger Europe, one that is closer to In becoming smarter, we will learn lessons and its citizens encounter challenges along the way. A direct dialogue with the European Commission would enable us to address these challenges as and when they arise. The new urban agenda for the EU provides a suitable framework and the tools for this cooperation.

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europe’s renewable revolution

Why Aalborg’s triple helix works? Aalborg has been historically involved in championing sustainable development in Europe. Having launched the European Sustainable Cities & Towns Campaign in 1994, the city has played a key role in defining what a sustainable European city should look like. In an exclusive interview with Government Gazette, Thomas Kastrup-Larsen, Mayor of Aalborg sets out the city’s sustainable commitments and offers best pathways to create resilient and sustainable cities

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nternationally, cities and businesses pose a significant challenge to sustainable development, both environmentally, socially and economically. In the future, up to 70-80% of the world population will live in cities, and thus it is important to handle the challenges they pose.

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How can European cities become smart and sustainable?

To us, sustainability means balancing the needs of the city and the citizens with responsible use of available resources. We wish to ensure that our children will have the same standard of living that we have, which means that the fulfilment of our own needs should not come at the expense of future generations. Therefore, we strive to create strong links and partnerships from all across Aalborg Municipality to make the city more efficient, thereby minimising our resource consumption. In general, I think that a strong focus on creating a “circular” city is of immense importance for European cities. To become “circular,” we need to be able to redevelop our city systems in partnership with the different sectors in our city. The redevelopment of the systems has to be designed so that they can deliver integrated and holistic solutions. Our smart city initiatives are designed to support this.

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As Aalborg is one of the cities having a great influence on the European cities’ work with sustainability, can you elaborate more on the city’s sustainability strategy? Aalborg’s sustainability strategy is based on the “green transition” while also focusing

© Lars Horn/Aalborg Municipality

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CIRCULAR CITY Aalborg, Germany

on education, business and social actions. We believe that only strong policies, which combine and integrate policy areas, will help develop lasting sustainable cities – where people thrive. Aalborg is known for its strong collaboration between education, business and government (triple helix), which leads to innovation, growth, prosperity and more jobs. Aalborg, for example, has a very strong position when it comes to renewable energies (wind, biomass and solar) that create green jobs, reduce the climate impact and create a strong economy in the municipality. Another focus this year is to create more green social enterprises where people outside the labour market will have a chance for a job within the green transition. This includes the waste area where waste products are recycled, up-cycled and included in the circular economy. The municipality has set up a Centre for Green Transition with the main purpose of creating a green transition in cooperation with citizens, companies, NGOs, etc. Some examples of projects are the Network for Sustainable Business Development, our yearly Sustainability Festival and our Green Agents. The latter is a project designed to engage citizen involvement by making it easier for citizens to be greener in their daily lives, supporting them with their green ideas.

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What are some of Aalborg’s newest pathways to create productive, resilient and sustainable cities for an inclusive Europe? We want cities, companies and individuals to endorse the newly adopted Basque Declaration on Sustainable Cities & Towns

Government Gazette

and want cities to use our common platform, www.sustainablecities.eu, to share their transformative actions and through them inspire others to engage in the green transition. This campaign will continue on the path that was laid down in 1994 with the Aalborg Charter and continued in 2004 through the Aalborg commitments. Locally, we have – among other things – established a council for Green Energy with the purpose of setting up strategies on becoming CO2 neutral and we are currently working on creating the framework for an integrated energy system entirely based on renewable energy sources.

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How can smart city concepts enable reducing the divide among citizens, and address the challenges posed by the escalating refugee crisis? As a social democratic city for more than 100 years and an active player in the development of the Nordic welfare model, the city has a long and strong tradition for prioritising welfare policies, activities and city planning styles that minimise the divide among citizens. With the development of the “smart” city activities in Aalborg, the city council has decided to focus on sustainability, job creation and engagement of us all. Therefore, I believe that our “smart” city activities give us an excellent opportunity to maintain a strong focus on decreasing the divide between our citizens. We need to think outside the box and find innovative ways to engage our civil societies in sustainable actions

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europe’s renewable revolution

Driving the transition to sustainable procurement The city of Helsinki has committed to act as a global and regional champion of sustainable public procurement. In an interview with Government Gazette, Pekka Sauri, Deputy Mayor of Helsinki, explains how important sustainable procurement is in making European cities smarter, more resilient and sustainable

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very procurement decision we craft has an immediate effect on our environment, economy and the society.

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As Helsinki is currently pushing to drive a transition to sustainable consumption and production by purchasing sustainably, can you elaborate on Helsinki’s current sustainable procurement strategies and explain how it aims to achieve 100% sustainable procurement by 2020? The City of Helsinki attaches great importance

to its environmental program. Since 2012, the City Council has had an environmental policy in place to tackle topics such as climate protection, environmental awareness and material efficiency. We see sustainable procurement as a key tool in implementing this policy and achieving our long-term goals. Clearly, responsible public procurement represents a tremendous opportunity not only to make our societies more sustainable, but also to ensure social justice and fair treatment. In 2013, we established an internal working group dedicated to making our procurements more environmentally friendly. The group aims to reinforce cooperation and information exchange between the different departments in charge of the city’s procurements. The group has worked on a number of topics, including the definition of environmental criteria for use in Helsinki’s tenders and the monitoring of contracts once they have been awarded. In 2015, we published a city guide for sustainable procurement which contains

EFFICIENT CITY Helsinki, Finland

concrete instructions and examples on how environmental criteria can be used in various procurement processes. Last year, 50% of the city’s procurement processes included environmental criteria. This year, it is 60%, and we will continue until we reach 100% in 2020. To achieve this goal, we are providing training to all city departments and subsidiaries on how to purchase sustainably.

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Can you provide some examples or case studies on how environmental criteria can be utilized in various procurements? One of the keys to ensuring the long term success of sustainable procurement is to be able to monitor the impact of including sustainable criteria within tenders. Helsinki’s Procurement Centre was an associate partner in the GPP 2020 project, which ended earlier this year. Through this project, we were able to measure the impact of our low carbon tenders in terms of tonnes of carbon dioxide and fuel equivalent. One very successful example of this was a framework contract for the purchase and renewal of IT equipment. After engaging with the market to determine an appropriate ambition level for the criteria, the invitation to tender specified long lifecycle products which met the latest energy star criteria as a minimum. Extra points were awarded for lower energy usage and a clear recycling process. This tender achieved energy savings of 27% and cost savings of 72,000 euros over the lifetime of the products.

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How does Helsinki’s procurement policies and practices benefit local businesses? Sustainable and innovative procurement are drivers for boosting green growth and contribute to the development of SMEs. We encourage local business to develop innovation and sustainable solutions that can be bought by the City. Engaging with the market as early as possible is an important way of ensuring they are prepared when the tender is launched. As described in the previous example, we work hard to understand what is currently available and ensure that suppliers are aware of what we are looking for in terms of sustainability criteria. In this way, we hope to move the market and open up our tenders to smaller businesses.

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© City of Helsinki

As one of the leading cities on sustainable procurement, how do you intend to accelerate the implementation of sustainable procurement worldwide?

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Helsinki has committed to act as a global

Government Gazette


and regional champion of sustainable public procurement (SPP) and this is a responsibility we take very seriously. One of the best ways for cities to get engaged in sustainable procurement is by learning from the experiences of others. I am currently Chair of the Procura+ European Sustainable Procurement Network, which brings together more than 40 European public authorities to share information and best practice on sustainable and innovation procurement. We are also a founding participant of the Global Lead City Network on Sustainable Procurement, where we are leading from the front by setting very ambitious sustainable procurement targets that can be replicated by others.

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How important is sustainable procurement in making European cities smarter, more resilient and sustainable? Sustainable procurement is smart procurement. It’s about making good use of citizens’ money to make the city a better place for them. Every single purchasing decision of the City of Helsinki has an impact on the environment, on our economy and on our city. Often, the smartest procurement can be the one you did not make. Taking a considered and holistic approach can lead to better decisions, such as reusing products, procuring jointly to increase

efficiency gains or investing in a different model – for example, leasing rather than purchasing products. By first deciding whether or not we need to buy certain products or to contract certain services, and afterwards by introducing smart and sustainable criteria in our tenders, we move towards smartness, resilience and sustainable development. Local governments can and must link their purchases to their broader goals, and this is what Helsinki is doing. If we want to improve energy efficiency, we might need to engage with companies to explain what our needs are and learn what solutions they can provide. If we want to become more resilient, we can address GHG emissions, raw material usage and the management of natural resources by introducing the right criteria in our tenders. If we want to boost sustainability, procurement is essential to achieve social, economic and environmental value for money.

towns over the world are finding themselves facing more complex needs with limited budget capacity. Sustainable procurement is a very important method of ensuring we don’t overstep the ecological boundaries which face us. But if we are to win the economic argument, we also need to show that it is financially sound. This is why the circular economy is such an important concept right now. By finding ways to decrease our consumption and reuse our waste, we will both reduce our ecological footprint and make sure that we are securing an environmentally and financially sustainable future

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What do you see as key considerations for the future of sustainable procurement? We live in a world which is increasingly conscious of the finite nature of the resources at our disposal. On top of this, cities and

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the smart procurement challenge


europe’s renewable revolution

Why cities are a solution to climate change

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hat makes a great city Currently, cities are facing a variety of interrelated economic, climatic, demographic and social challenges. However, they can transform into great places to live and work by achieving smart growth, doing more with less. Here is a review of the steps city mayors and senior policy makers across Europe take to achieve smart growth and transform their cities into resilient and sustainable spaces Š City of Warsaw/the Warsaw Tourism Organization


the sustainable city challenge

Gustaf Landahl

Coordinator of GrowSmarter, Dept. Head City of Stockholm biogas from organic household waste will help increase material recycling and the production of renewable vehicle fuel. By collecting the waste in a pneumatic system, the need for waste collection vehicles decrease, thereby reducing residential noise and local emissions from vehicles. Smarter lighting and heating

© City of Stockholm

The street-lights will become smarter by making it possible to dim them when no one is present and also using the poles for the increased need for transmitters for wireless communication. They will also tell the maintenance teams when the lamps need to be replaced. Opening up the district heating system for, and buying surplus heat from server-halls and grocery-refrigerators will create a new business model for the district heating company. Increasing the use of the big data collected in the project to implement new solutions will be demonstrated. Stockholm also plans to develop new tools for better traffic planning, using information from the actual flow of traffic collected from smart-phones. Smart mobility

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weden’s Stockholm is the fastest Sustainable pathways growing capital city in Europe and The city of Stockholm is currently involved has been working on climate change in the process of renovating more than 30 adaptation since the 1990s. Stockholm thousand square meters of primarily residential has envisioned to be the smartest city in the buildings, co-funded by GrowSmarter project. world by the year 2040. The city has shown The buildings, built in the 1960-70ies, used that economic development and greenhouseindustrialised building technologies and are gas emissions can be decoupled. The city’s currently in need of renovation as is the case in quick growth and thriving most European cities. By economy has gone hand in “Stockholm is now putting building in cost efficient hand with the reduction of even more efforts into its work energy efficiency measures, greenhouse gas emissions smart information systems on smart sustainability to by 44 % per capita during and other services, the keep ahead. The work in the the last 20 years. tenants receive better city has been reorganised to Green index services.

reach even higher ambitions

Ericsson has named the and a programme for digital The city housing company city of Stockholm as the aims to reduce the need for renewal has been produced” top-ranking city in the energy by over 60% and sustainable development the tenants will have the part of the Networked Society Index in 2014 possibility to better follow their energy use in and 2016. The city is also a widely acclaimed real-time through information systems in the smart city. This global ranking of cities apartments. These measures therefore have a measures the cities from both sustainability great potential to be replicated in other cities. (economic, social and environmental) and ICT By using locally produced solar electricity maturity. together coupled with reduced energy use and the charging of electrical vehicles, peak loads Stockholm is now putting more efforts into can be cut and a smarter use of electricity its work on smart sustainability to keep ahead achieved. of the race. The work in the city has been reorganised to reach even higher ambitions Organic waste collection and a programme for digital renewal has been Collecting waste in different coloured bags and produced. optically sorting these and producing more

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Building material accounts for 30% of all goods transported in Stockholm. By introducing a building logistics centre and a building material terminal for the reconstruction works, much energy can be saved while also improving the working conditions at the site. More people are buying goods on the internet. By introducing delivery boxes right by the entrance of residential building, tenants can easily collect their goods and reduce the need for travel. By using cycle transport for the last part of the delivery chain, emissions are even further reduced. Stockholm has a long tradition of using renewable fuels. As part of the European Commission’ Horizon 2020 funded GrowSmarter project, more filling stations for biogas and also electric charging points will be built and demonstrated. The city will initiate car and cycle sharing facilities in suburban areas shortly. Giving signal priority to buses and lorries for construction work will support these smarter solutions even further. To find out more please visit www.grow-smarter.eu


towards an index of urban sustainability

Leszek Drogosz

© City of Warsaw/the Warsaw Tourism Organization

Director of Infrastructure Department, Deputy Chairman of Climate Protection Team City of Warsaw

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lmost a decade ago, the City of Warsaw, aspired to become the “green metropolis” and set itself a prospective goal of ensuring a high standard of living for its inhabitants in conditions of sustainable development. Barring a few initial challenges, the city joined the Covenant of Mayors in 2009, and adopted the resulting Sustainable Energy Action Plan in 2011. In 2015, Warsaw adopted the LowCarbon Economy Plan, envisaging expenditure of 4 billion euros for investments improving both air quality and energy efficiency. Some of its sustainable solutions include production of clean energy (also from waste), in particular in cogeneration; creating energy-efficient buildings and districts; sustainable transportation, including e-mobility; preserving green spaces and conservation of wildlife. Sustainable solutions Warsaw has implemented several measures in order to achieve its current strategic goals. For example, extension of the existing municipal solid waste incineration plant will give the city an additional source of renewable electricity and heat. Since plans predict another such plant, both investments combined will lead to solid waste satisfying 8% of our energy demand.

Moreover, projects conducted in publicprivate partnerships and energy performance contracting provides significant savings. A project has been started on the modernisation of street lighting, which will cover at least 22,000 lamps. This will allow the city to save about 57% of energy costs, reducing CO2 emissions by 20,000t per year. Another PPPEPC project will cover thermal retrofits of schools.

The largest challenges that the city is currently facing are connected with waste management and air pollution, mainly resulting from private cars. The waste management belongs to competences of Polish municipalities only since a couple of years, so it takes time to implement and perfect the system, especially in a city as large as Warsaw, which produces more than 700,000t of municipal waste a year. However, the situation has been improving in this field.

The largest investments have been dedicated to public transportation, including construction of the first stage of the next metro line for more than 1 billion euro. The city highlights its pro-environmental policies of MZA municipal bus operator, which purchased 4 hybrids, 35 gas buses and 10 electric buses. The company’s plans for 2020 envision at least 130 EVs/HEVs, which shall make it one of the largest European operators of clean buses.

The city is tackling this challenge by further strengthening and prioritising the public transportation system. Warsaw has also become friendlier for bikers and pedestrians. An example of this, is a successful Veturilo public bike system, covering more than 200 stations and 3,000 bikes. Currently, the city is preparing a similar car-sharing system

Thanks to the EU project Sharing Cities – SHAR-LLM, Wawsaw will learn how to implement complex smart cities solutions, which will assist the city in preparation of a low-carbon area. Project ADAPTCITY aims to help the city create a comprehensive strategy of adaptation to climate change, making it truly resilient.

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the sustainable city challenge

Paula Verhoeven

Director of Urban Development City of Rotterdam internationally acclaimed economic strategist, Rotterdam is developing the Roadmap Next Economy in a metropolitan context. This roadmap describes in five transition paths the way in which Rotterdam, together with its regional partners in a triple helix context, is planning to shape the transition to a sustainable and modern economy, resulting in an implementation agenda. Naturally an implementation agenda is part of the Roadmap, as the future is starting today. Zero-on-the-meter

© Peter Schmidt and Joep Boute, City of Rotterdam

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s a harbour city with a large petrochemical industry, climate change affects the economy of the city of Rotterdam to a great extent. As a consequence, there is a large awareness that energy transition has to be quickly achieved. The city of Rotterdam has the ambition to lead Europe’s sustainable revolution and plans to connect its climate adaptation strategies

and ambitions to a strong economy and the collaborative process to become the most sustainable world port city. As an innovator in climate change strategy, including green energy production and CO2 storage, the city is committed to the knowledge sharing process at the regional and international level. Together with Jeremy Rifkin, the

For decades, the city of Rotterdam has been known to have a practical approach to challenges. Practical examples of this are the innovative water storages in order to catch waste rainwater via so-called water squares, parking garages with water storages and the overflow areas near the canals. The installation of thousands of charging stations for the charging of electric cars and the installation of solar panels on (public) buildings are contributing to this. And for new houses a great deal of effort has been invested in ‘zeroon-the-meter’ (no energy bills). Rotterdam is now a home base for many young companies which are working on groundbreaking innovations. Together with them the city will keep building its knowledge and is willing to share it with the world! Rotterdam will be collaborating with Glasgow and Umea over the next five years on the RUGGEDISED project, demonstrating a series of 32 smart solutions aimed at creating urban spaces powered by secure, affordable and clean energy, smart electro-mobility, smart tools and services

“If we are not taking action now, climate change will have an enormous impact on the city of Rotterdam which is situated entirely below sea level. A sustainable energy transition is the goal, but also hopes are pinned on the chances and challenges the Internet of Things is offering” © Peter Schmidt and Joep Boute, City of Rotterdam

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towards an index of urban sustainability

Dr Barbara Möhlendick

Climate Protection Co-ordinator, Project Director City of Cologne

Every year, the Mayor of Cologne invites organizations, companies and start-ups involved in smart and resilient projects to meet at the city hall for the annual SmartCity Day. This year’s motto was “A Good Climate for Cologne.” It was a very successful event “While leading the transition with participation from various to more sustainability stakeholders and within our city, we see more parties involved.

© KölnTourismus GmbH - Dieter Jacobi

efficient and more intelligent solutions as well as increased knowledge exchange between new partners. As a key component in succeeding with this task of transition, we are fostering the opportunity for more transparency and more understanding between citizens, the industry and administration. Rethinking the city from the vision of the citizens enables us to see through different lenses and create more quality of life in multiple ways”

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lthough many steps are still to be taken, the city of Cologne is well on its way to sustainability. Cologne is the first German city to be awarded the title of “Lighthouse City” with the EU funded GrowSmarter project. For the city of Cologne, a key component of a sustainable city is the two-way approach: top-down and bottom-up are both simultaneously necessary to make sustainability happen. It is important to support strong leadership in the Mayor’s office, the city council and all levels of administration to demonstrate sustainable ideas. At the same time, it is crucial to involve citizens and allow for sustainability to happen from the bottom up. Another key element is the topic of investments. On the way to becoming a sustainable city, capital expenditures need to be reinvested into sustainable infrastructure. Because of recent budgetary difficulties and changing priorities, the city had to suspend a number of projects. A mid-and long-term plan is now underway to reinvigorate sustainable investment. The city believes in the need to engage the entire community in order to ensure that not only citizens, but also corporations, organizations, universities, schools etc. will implement sustainability goals and therefore turn our city into a sustainable city. The city offers a platform to companies, organizations and individuals to test sustainability projects, intelligent ideas and technologies of the future.

Citizen-centered solutions Cologne’s green and smart approach attracts intelligent, creative, young people and companies who are important players on the path of a sustainable revolution. Cologne especially promotes citizen participation. Enabled by its participatory budget, the city encourages citizens to comment on problems or inspire solutions by providing an app on the city website, therefore fostering co-creation with each citizen. To engage and excite all parties, the city believes it is important to create a vision for itself. This needs to happen in collaboration with experts, politicians and citizens. At the same time, the administration needs to leave behind the outdated form of thinking in silos and instead cooperate across departments, cross-linking and integrating with each other. We need to think outside the box. The city can instigate and help create that atmosphere and process of restructuring the way we operate. A practical example for the city’s sustainable pathway is the SmartCity platform, where diverse sustainability projects, intelligent ideas and technologies of the future are developed to make the City of Cologne even more liveable, step by step. Anyone can join: private citizens, corporations, associations, initiatives etc. The EU project GrowSmarter as well as the neighborhood project Climate Street are just two examples within SmartCity that demonstrate smart and resilient projects.

Government Gazette

Opportunities and challenges While the city finds opportunities with many groups involved, it worries that challenges arise in the same context: The dialogue between different actors, such as citizens, companies and the city administration is not always easy when diverging objectives like city design or smart devices that are potentially “ugly” are in discussion.

Another challenge for innovation is national or regional legislation, for example fire protection laws, procurement regulations and road traffic regulations, to name just a few. To the city of Cologne, the transition and path to more sustainability is not as much about technology as it is about governance and people coming together, talking and working with their joint goal of sustainability in mind. It is about increasing the quality of life in a city with its many facets. Smart initiatives With the GrowSmarter project, the city tests integrated solutions and a neighborhood management system that will allow for management of multiple data sources, including energy management from apartment buildings such as photovoltaics, battery storage devices and home energy use as well as from electric cars at the mobility charging stations, and a virtual power plant. It is designed to be replicable in other neighbourhoods in Cologne and other cities. Together with multiple other projects, these ventures foster the green revolution in Cologne

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the sustainable city challenge lighting), mobility (promotion of electric vehicles: coaches, cars/taxis, motorbikes, etc.) and ICT (smart information management platform for the city, improved connectivity, and so on). All these initiatives, carried out in the district of Txomin, were aimed at its being a zero-emission district in the near future and to improve a variety of issues in the city at large. Opportunities and challenges

© San Sebastián Turismo

The city of San Sebastián has focused on local knowledge and capacities to identify problems, design solutions and obtain more sustainable results. This requires participation and cooperation, and so it may affect internal coordination within and between institutions, local agents and external actors. They are complex processes indeed, demanding great efforts but having outcomes that are worth `while.

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n Europe, about 75% of the population live in cities. By 2030, 60% of the global population will live in urban areas, which means we need to make urban development sustainable. Urban sustainability means avoiding environmental damage while ensuring high living standards for citizens. The concept, which has economic, political and scientific implications, can only be implemented by taking a comprehensive approach to it, for the challenges we face in urban areas – economic, environmental, climatic, social, demographic, and so on – are intertwined. Furthermore, if we are to reach an acceptable sustainable urban development level, we must get citizens and the civil society involved, along with the local economy and institutions. San Sebastián has already embarked on this journey, implementing a process that requires the participation of city authorities, local

Eneko Goia

Mayor of San Sebastián

economic agents and citizens to design and carry out sustainable projects. Sustainable projects A series of projects are being carried out in the city framed within the 7th European Framework Programme – Systems Thinking for Efficient Energy Planning (STEEP) and the Donostia-San Sebastián Smart Plan 20162020. For instance, SmartKalea (Smart Street), whereby government agencies, businesses, shops and citizens work together to make a wiser use of the resources (mainly energy and water), improve street infrastructure and create opportunities for local companies (tech testing, e.g. small living lab). There is also Replicate, the EU Lighthouse project (Horizon 2020) that got the highest evaluation marks from the Committee in 2015. These projects have led to the development of several initiatives to be implemented at city or district level in the areas of energy management (housing rehabilitation, district heating, smart

© San Sebastián Turismo

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The planning and development of smart city projects must be led by the local city government, implementing participatory processes on the basis of public-private partnerships and getting citizens involved while striking a balance between the interests of the city and those of private corporations, and optimising technology investments through the promotion of socialisation. At the European level, connections should be encouraged between experiences and cities, along with coordination between different institutions. Likewise, city governments should get funding and ties strengthened between businesses and technology centres. Replacing the 7th European Framework Programme with Horizon 2020 was a good idea, resulting in a closer relationship between the technological and industrial spheres on the one hand and the needs of cities on the other, and enabling us to work on real-life developments. There are but a few significant comprehensive experiences in cities undergoing this kind of processes based on intangibility and socialisation. We have to bear this in mind


towards an index of urban sustainability

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he City of Rome has joined the Covenant of Mayors in 2010. Since then, Rome is strongly engaged in sustainability policies, including, for example, the adoption of rules on air quality indicators that are often more strict than those utilised in many other European cities. Moreover, Rome is in fact currently building up its resilience index and is involved in sustainable solutions relating to energy and water management and critical infrastructures. The current participation of Rome in several projects focused on sustainability/resilience aim to creat a “Resilience Office” of the city of Rome. This work unit, under the responsibility of the City Council, would contribute to consolidate all the policies and guidelines that respond to the challenges the city is facing. An example of a challenge that this work unit would face is water management at city level, today a commitment of different authorities operating independently, thus creating at times obstacles and reciprocal interferences.

Claudio Bordi and Patricia Hernandez City of Rome

Resilience projects Through these projects, Rome is currently implementing a comprehensive knowledge of sustainability/resilience issues gained and accurately evaluated in terms of: 1. Outlining the “big picture” of challenges faced, 2. Stakeholder identification and subsequent involvement, 3. Better definition of the challenges and their delimitations, 4. Scenario analysis for the next 20-30 years, 5. Definition of a Field of Opportunities deriving from the correct identification of the challenges faced by the city. Rome is currently undertaking three outstanding initiatives on this theme: 100 Resilient Cities – 100RC (the programme launched by the Rockefeller Foundation for its centennial) and two H2020 projects, Smart Mature Resilience – SMR and Smarticipate. The three projects are aimed at defining the resilience level of urban areas by means of innovative modeling of many interlinked variables. In particular, SMR and 100RC make use of slightly different methodologies to measure the general level of urban resilience, while Smarticipate is focused on the re-use of abandoned properties, by strongly involving the participation of the public by means of the new ICT applications Claudio Bordi, Patricia Hernandez and Pierluigi Potenza, belong to the EU Projects team of Risorse per Roma SpA, which is an in-house company of the City of Rome collaborating with the Urban Planning Department of the City.

© City of Rome

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europe’s renewable revolution

Sustainability engine: Resource efficient and resilient cities Cities are where most of the consumption and production happen today. With growing urbanisation, Dr. Arab Hoballah, UNEP Chief of Sustainable Lifestyles, Cities and Industry says the importance of city-level actions will be reinforced, making cities primary players to deliver sustainable solutions in the production of goods and enable responsible consumer choices

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ost policy and decision makers, public and private, as well as citizens, are increasingly aware of the importance of cities for economic growth and sustainable development. Generally perceived as sources of problems, cities can be where solutions will come from.

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At times of increasing shocks and stresses, not least due to climate change and natural resource constraints, it is imperative to adopt a system’s perspective and be innovative so as to change our current unsustainable consumption and production patterns, and inefficient management of the planet’s limited resources. This will require a fundamental “structural” change in the way of designing and implementing policies, aiming at smart, low-carbon, resource efficient and resilient

Government Gazette

investments and actions, to reduce economic, social and environmental risk for the natural and built infrastructure assets. In this context, urban infrastructures must take into account the long-term flows of strategic resources, which require linking urban systems to the wider regional flow of ecosystem services and natural resource extraction. The global community has increasingly realised the importance of and necessity for


towards an index of urban sustainability

changing our unsustainable consumption and production patterns if to eradicate poverty and deliver sustainable development. This has resulted in the adoption at Rio+20 of the 10 Year Framework of Programmes for Sustainable Consumption and Production/SCP, and the inclusion in the set of 17 Sustainable Development Goals/SDGs of SDG 11 and SDG 12 on Cities and SCP together with related targets in most of the other goals, showing their cross-cutting nature in support of the sustainable development. Cities are where most of the consumption and production happen today; with growing urbanisation, the importance of city-level actions will be reinforced, making cities primary players to deliver sustainable solutions in the production of goods and enable responsible consumer choices. Delivering SCP through city-level action starts with buildings, the low hanging fruit for energy efficiency and reduction of CO2 emissions. Besides buildings, it is critical for government and local authorities to consider the flow of resources that constitute the metabolism of a city in relation with its population and consumption needs. Cities are complex networks of interlocked infrastructures that bring resources in, use the resources to provide services, generate wealth, and dispose of the waste that is generated by consumption. More circular urban metabolism that treats outputs from one as inputs to another would help cities decouple resource use from the provision of better services, economic opportunities and environmental impacts. Analysis of material flows can help set priorities and inform policies and measures. Establishing targets for desired resource flows per capita based on the economic and ecological context of any given city can provide a coherent framework for assessing progress towards more sustainable resource use. Targets for water, energy consumption, and carbon emissions are being used in some cities already. Many of the problems that are attributed to cities are consequences of economic growth and consumer behaviour. In this context, it is particularly important to take into consideration the growing global middle class who are not only expected to live longer due to improvements in health care but are also characterized by their increased purchasing capacity. With the expected additional middle class of about 3 billion in some 30 years, the cities can be characterized as the “industries of the three-quarters” in the sense that, as an order of magnitude, cities will host about three quarters, between 70% and 90% depending on sector and region, of the population, the GDP, resources use, waste production and CO2 emissions. This is to say that there could be no sustainability if not at city level and with resource efficient cities with the aim to deliver sustainable consumption and production.

understanding of resource flows to and within cities. Considering the huge pressures cities will be facing from a resource supply and demand perspective, there is a need to support cities and their networks in better identifying and realising the economic, social and environmental benefits of resource efficiency and sustainable consumption and production. And this will result in improved resilience of cities and thereon of countries from resulting climate mitigation actions. Ultimately, resource efficient cities combine greater productivity and innovation with lower costs and reduced environmental impacts, making them the engines to sustainability. To that end, it is essential that all countries, starting with leading economies such as the EU countries and those under G20, get engaged more pro-actively in an objective and responsible low carbon agenda, bringing government, central and local, together with business in a long term strategic alliance with the aim at delivering the badly needed transformative change in policy frameworks and actions, in market evolution and lifestyles, towards responsible and sustainable consumption and production patterns for delivering sustainability. And it is in this same spirit that the COP21 Paris Agreement has highlighted that sustainable lifestyles and sustainable patterns of consumption and production, with developed countries taking the lead, play an important role in addressing climate change. The New Urban Agenda, prepared through the ongoing Habitat III process, should provide an opportunity to focus on vertical and horizontal integration and the implementation of the SDGs at the city level. Promoting resource efficiency at city level will increase their economic resilience, contribute to climate mitigation, reduce waste and associated costs, while also improving quality of life. Finally, as long as the global community, with the EU taking the lead, does not reverse the current situation of subsidies for unsustainable consumption and production patterns, characterised by use of fossil energy sources and unsustainable food systems, and induce adequate supporting measures and incentives for promoting resource efficiency and sustainable consumption and production, as long as detoxifying, decoupling and decarbonising economic development, sustainable development will remain a “wishful thinking”

However this requires knowledge about and

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europe’s renewable revolution

How cities can power their economic engines with renewable energy City planning and management need to take full account of climate change, simply because exposed cities equal large parts of any countries’ population and infrastructure exposed to the threats of climate change. Exclusively writing for Government Gazette, Daniele Violetti, Chief of Staff, UNFCC says cities not only need to adapt to climate change, they also have a major role to play in mitigating its impact.

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towards an index of urban sustainability

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he year 2015 was a historic year for two reasons: first, for the first time in history, the nations of the world agreed a universal climate change agreement – the Paris Agreement – which sets an ideal temperature increase threshold of 1.5C. The agreement also strengthens the drive to adapt to the consequences of climate change and embraces the national climate action plans (the nationally determined contributions “NDCs”) mainly towards the reduction of greenhouse gases that countries made. It not only calls for action, it also boosts action. 2015 also saw agreement on new sustainable development goals which boost climate action. For the first time in history, more people on this planet lived in cities than outside of them. Globally, urbanisation is occurring in leaps and bounds with no sign of abating. So too in Europe, where from over 72% today, around 80% of Europeans will be living in urban areas by 2020. In some countries this may be as much as 90%. This unprecedented wave of urbanisation is leading to many new challenges. For example, in 1990, there were ten “megacities” with 10 million inhabitants or more, and now there are 28 mega-cities worldwide, home to 453 million people. Another example of a new challenge is in Europe, where cities have expanded on average by 78%, whereas the population has grown by 33%. This has been largely due to low density suburban development over the past 20 years, which, similar to the mega-cities, necessitates infrastructure with increased connectivity and transport and other logistical challenges to meet the needs of urban populations. As if these challenges were not large enough, they are also taking place in the era of climate change. This means climate change impacts such as floods or sea-level rise that we are already locked into given current levels of greenhouse gases in the atmosphere on the one hand, and the absolute necessity to reduce greenhouse gases as we move forward on the other. City planning and management need to take full account of climate change because in the context of growing urbanisation, exposed cities equal large parts of any countries’ population and infrastructure exposed to the threats of climate change. Cities not only need to adapt to climate change, they also have a major role to play in mitigating its impact. The rapid expansion of cities means that greenhouse gas reduction measures have to be taken today to help tackle climate change. Yet, acting on climate change for the sake of acting on climate change is a view that inadequately captures what it is all about. Climate action isn’t just about greenhouse gas emissions and adapting to climate change impacts. Rather, climate action goes handin-hand with sustainable development. Implementing the new sustainable development

goals and the Paris Agreement will lead to a myriad of co-benefits for people.

combined with the unabatedly strong trend of urbanisation and expanded cities, means that cities need to have an ever increasing role in meeting their country’s national climate action plans through their own climate smart development.

Climate action can increase liveability, reduce public health costs, improve community, strengthen sustainable development and create business opportunities. For example, policies to ensure cleaner air in cities have a positive In this way, cities can play a key role in the impact on the climate, but they also have a implementation of their country’s climate decidedly positive impact on people as they action plans, and at the same time enable them lead to fewer respiratory complications and to raise their overall level of ambition when lower public health costs. Climate action at it comes to the reduction of greenhouse gas the city level means that local leaders have the emissions. opportunity to create jobs, “Cities not only need to adapt This would be a key ensure people have access to contribution to the water, food and energy and to climate change, they also implementation of the increase the resilience that have a major role to play in Paris Agreement and safeguards communities from mitigating its impact. The sustainable development climate impacts. goals and would boost rapid expansion of cities To deliver these benefits to the breakthrough in means that greenhouse gas citizens, careful planning is climate action and required. Cities can transform reduction measures have to sustainability that the be taken today to help tackle agreements promote. their local growth dynamics by powering their economic climate change. Yet acting on This contribution would engines with renewable climate change for the sake not be a one-way street. energy, shifting their transport In 2015, the UNFCCC of acting on climate change systems to low-carbon or climate change is a view that inadequately by creating cycling and captures what it is all about” secretariat launched pedestrian infrastructure. the NAZCA portal Cities can look at all systems (http://climateaction. residents rely on – land use, unfccc.int/), an online platform to showcase building codes, waste management, water the massive mobilization of cities, regions, management and infrastructure investment business and investors in moving towards and – and align these systems with a sustainable implementing climate change solutions. The future. Paris Agreement explicitly recognises the efforts Cities around the world have started taking made by cities and other non-state actors and inspiring action. calls for a scaling up of these efforts. - In Lima, a bus rapid transit system helps people get to work, to school and to their doctors more quickly and at reasonable cost, while avoiding transportation emissions. - In New York, resilient infrastructure ensures mobility and productivity in the face of climate impacts. And ambitious targets guide building and transportation policy.

Many cities have entered their climate change goals on NAZCA and we urge many more to do so. 2015 was a historic year. The key now is to turn the upcoming years into a historic phase: a phase of unprecedented climate action spurred by co-benefits, and supported by the Paris Agreement and sustainable development goals

- In Beijing, a regional carbon market is being tested alongside seven other markets to bring a national carbon market to China, a move that benefits public health and encourages green jobs. - In Paris, a transformational shift in energy generation and use is now incorporated into city planning and policy, and it is already creating clean energy jobs. These types of actions should increase around the world. To achieve this, cities can partner together to proliferate best practices and share lessons learned so that all cities can be enabled and empowered in the transition to climate smart development and sustainability. Actually, the absolute need to keep average global temperature increases to 1.5C

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Cyber Security Europe Roundtable 2016 Engage with Europe’s security policy makers This roundtable meeting will bring together EU policy makers, academic experts, and public & private sector representatives from Operational and IT backgrounds, leading cyber security authorities and some of the world’s most influential IT solution providers

Wednesday 12th October 2016


on the road to 2030

Decarbonising Europe’s roads is not merely a whimsical thought

2016 is a crucial year for the future of European transport with the European Commission due to publish its communication on decarbonising transport later this summer. Miriam Dalli MEP evaluates the current transport scenario and says decarbonisation of road transport is not an unachievable Utopia, we can make it happen, and we can make it our reality.

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here are some in Europe who think that the decarbonisation of Europe’s roads is some form of unachievable Utopia – dreamt about by a handful of (overly) idealistic environmental activists. Such an opinion is not just limited in scope but also very dangerous. It is dangerous not simply because it goes counter to inconvenient truths about air quality and vehicle emissions, but perilous as it disregards findings from various EU cities. A recent study on the air quality of London conducted by R. Howard in collaboration with King’s College London shows that 25% of children and 44% of workers in this major European capital are exposed “to levels of air pollution that exceed legal and healthy limits.” If current policy and decision makers do not care about the present, some thought and consideration must be given to future generations of European citizens as well as of the rest of the planet.

“Europe needs a strategy for air quality that is further reaching and more ambitious than the one we have today. We must give serious consideration to the electrification not just of public transport, but also other major polluters such as delivery vehicles and construction machinery” Given the recent failings of Volkswagen to adhere to strict emissions limits for diesel engines I believe that the European Union needs to undertake a detailed review of the current regime that guides and governs the emissions of our cars used on Europe’s roads. By delivering on a successful reform of the EU vehicle type approval system and on the

Government Gazette

effective implementation of more stringent limits of pollutant emissions (such as, carbon dioxide, nitrogen oxides and particulate matter) plus by speeding up the introduction of electric vehicles, the European Union would make a major step towards progressive medium and long-term policies that truly manage to improve air quality in our cities. Desperate times call for desperate measures and it is high time that European Vehicle Emission Standards get tougher. To bolster this initiative, the level and strictness of enforcement must match tough new emission standards. One initiative could include a moratorium period whereby car owners will be encouraged to exchange their older vehicles for newer, cleaner models. Although similar ‘scrappage schemes’ have been introduced in various member states their uptake have been somewhat slow. An official European scheme could include tax incentives to green car manufacturers, fiscal incentives to public transport authorities that decide to go electric as well as other smaller

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on the road to 2030

scale but widespread schemes that would percolate throughout the European society.

Thankyou, Volkswagen!

Logic dictates that any form of decarbonisation plans must be coupled with increased monitoring of emissions and, just as importantly, a completely new form of testing and test procedures. Should a car manufacturer choose to benefit from any European tax initiatives linked to the research and development of low emission vehicles it must be willing to undertake new test procedures. Volkswagen has taught us that laboratory emission tests can be doctored and are therefore dubious at best. What is required at the moment are ‘real-drive’ emission tests with results being closely scrutinised by independent officials and specialists. Any major failings will mean the loss of any current tax initiatives and of any similar schemes that the errant company would have benefited from. When planning for future budgets, the European Union must put its money where its mouth is. By dedicating increased funding to research and development in the automotive sector, Europe will be working towards a future with less vehicle emissions whilst establishing itself as a world leader in the field. Europe can also lead by example by ensuring that all its employees and beneficiaries are incentivised to ‘turn electric.’ We must also give serious consideration to the electrification not just of public transport, but also other major polluters such as delivery vehicles and construction machinery. Europe needs is a strategy for air quality that is further reaching and more ambitious than the one we have today. Certainly, there are some key actions to take in this sense: test cycles must be improved and real world emissions testing using Portable Emissions Measurement Systems must be introduced without delay, the EU type approval system for new vehicles must be made more consistent and new, Euro 7 standards must be developed in order to achieve further emissions reductions when developing new generations of cars. But decarbonising transport is not only in the heart of Europe’s health and environment policies, it is also a crucial part of our climate change mitigation strategies. The electrification of light vehicles, such as bicycles and motor bikes, cars, vans and buses would significantly help the EU and the member states to meet the greenhouse gas reduction targets for 2030. In all, decarbonising Europe’s roads is not merely a whimsical thought but a duty that we have to future generations of Europeans. It is about the air they will breathe and the climate they will be living in. The decision is on us today, and the time for action is now. Decarbonisation of road transport is not an unachievable Utopia, we can make it happen, and we can make it our reality.

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Although the shift towards sustainable transportation seems to be painfully slow in EU strategies and initiatives, Merja Kyllönen MEP says that the revolution doesn’t have to wait for EU regulators to be pioneers

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hank you Volkswagen: if we ever thought we were on a straight path to sustainable mobility, it has now become clear that the road is bumpier than expected. The problems in monitoring and enforcement are of such a scale, that I won’t even dare to think about the real carbon footprint of transportation. A European Environment Agency (EEA) report published in November 2015 estimates that air pollution is responsible for more than 430,000 premature deaths in Europe. Urban air quality is greatly affected by road-traffic emissions which come from a number of sources. Emissions consist of exhaust pipe emissions as well as friction processes and resuspended road dust which is especially a significant springtime problem in Sweden and in Finland. Air pollution caused by road traffic is a complex mixture of particles and gaseous pollutants, all of which cause health effects. The main pollutants are nitrogen oxides (nitric oxide and nitrogen dioxide), carbon monoxide (CO) and volatile organic compounds (VOC). In addition road transport is responsible for about 20% of the EU’s total emissions of carbon dioxide (CO2). Thus it is clear, that air pollution harms both human health and the environment. Another factor to this complex air quality issue was added in September 2015 when the US Environment Protection Agency (EPA) issued a Notice of Violation of the pollution rules applicable to Volkswagen and Audi. This came after a non-governmental organisation, International Council on Clean Transportation, ICCT, carried out a study on the nitrogen oxide (NOX) emissions of diesel vehicles.

Government Gazette

The Notice of Violation alleges that fourcylinder Volkswagen and Audi diesel cars from model years 2009-2015 include software that circumvents EPA emissions standards for certain air pollutants. This results in cars that meet emissions standards in the laboratory or testing station, but during normal operation emit nitrogen oxides up to 40 times the standard. Up to 40 times! And it was only thanks to an NGO that this came up! Events in the USA lead the European Parliament to establish a Committee of Inquiry in January 2016, that will investigate the alleged contraventions and maladministration in the application of EU law in relation to emission measurements in the automotive sector. Comprehensive measures needed “In technology we trust.” This seems to be unanimous religion of European regulators when it comes to measures for reducing the harmful environmental impact of transport. The current scandal on automotive industry shows that 97% of diesel cars on European market are actually emitting much more NOX than the official limit. This and many other cases have revealed problems in monitoring and enforcement. I won’t even dare to think about the real carbon footprint of transportation. The decision makers in different institutions find it much easier to invent limits for manufacturers than introduce measures that would have a direct effect on people and their behaviour: fostering the use of public transportation, walking and cycling, introducing the low-emission zones


driving road decarbonisation with traffic restrictions or setting price elements based on the environmental externalities of mobility. Is it because we politicians don’t want to tell our voters what to do? While advances in renewable power generation and propulsion technology will deliver significant progress, this will not suffice. I would really like to see more comprehensive and holistic policy and measures. It cannot be the technology alone. On the contrary, we will need brave visions and straight-forward steps on every single field: improved spatial planning highly relying on the use of public transportation, better information services for travel planning and comparison, and incentives towards more responsible choices.

It’s good that our eyes have finally been opened – thanks to Volkswagen. While urban mobility is a massive contributor to CO2 emissions and also a producer of a huge amount of nitrogen oxides and harmful particles, it’s also a field where these questions are easiest to solve by promoting the attractiveness of public transport and by improving the conditions for walking and cycling.

It is also worth noting that smart and sustainable mobility is definitely not of interest only to the big cities or metropolises in Europe. Instead, in many cases, it is precisely the smaller cities and towns which have the privilege of shorter distances and thus can easily promote sustainable solutions based on local conditions.

“It’s good that our eyes have finally been opened – thanks to Volkswagen. While urban mobility is a massive contributor to CO2 emissions and also a producer of a huge amount of nitrogen oxides and harmful particles, it’s also a field where these questions are easiest to solve by promoting the attractiveness of public transport and by improving the conditions for walking and cycling”

Also persistent work to introduce new environmentally-friendly energy sources and strong effort to foster the electrification of transport are still needed. Decarbonisation it is We have been fighting the constant growth of CO2 emissions since early 1990s, yet the CO2 emissions from transportation are still growing in Europe. Since 1990 CO2 emissions from transport has grown by 29% in OECD countries and by 89% in non-OECD countries. The European Commission is now preparing its communication on decarbonising the transport sector. It is something I look forward to with excitement but also with trepidation. I really hope that the Commission’s attitude is ambitious enough. The “Project Europe” has recently been sailing from crisis to crisis and this has done harm to the decision-making ability of European institutions. There are some indications that the College of Commissioners lead by Jean-Claude Juncker is becoming more and more careful: the Commission tries to safeguard that their proposals will be adopted and all troublesome measures and objects of possible political resistance are highly avoided. This might be a politically risk-free way forward but it is not the way to transform Europe’s transport system to a new, zero-carbon era or to protect ourselves from ever increasing pollution from transportation. It certainly isn’t the way to save our planet. Revolution can start from grass root level Although the shift towards greener and more sustainable transportation seems to painfully slow in EU strategies and initiatives, it is worth remembering that the revolution doesn’t have to wait for EU regulators to be pioneers. There is a human being in every single car. Lots can be done on individual, municipal and regional level, just by re-thinking our own choices as individuals, as members of households and as residents.

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save the dates

Engage with Europe’s healthcare policy makers These high-level roundtables are a unique way to bring together key healthcare policy makers and stakeholders to ensure stronger action on health and reach an EU-wide consensus for improved diagnosed accuracy, management and care

Lung Cancer Europe 2016 Tuesday, 27th September 2016 www.lungcancer.parlicentre.org

Breast Cancer Europe 2016 Tuesday, 29th November 2016 www.breastcancer.parlicentre.org

Prostate cancer Europe 2017 Tuesday, 24th January 2017 www.pca.parlicentre.org

Diabetes Europe 2017 Tuesday, 4th April 2017

www.diabetes.parlicentre.org

Bladder cancer Europe 2017 Monday, 19th June 2017

www.bladdercancer.parlicentre.org


Government Gazette

HEALTH REPORT

Recommendations to reshape policy making

Beating the diabetes challenge in Europe the brexit impact 02 Julie Girling MEP

european commission 04 Vytenis Andriukaitas, Commissioner for Health & Food Safety

holistic management 06 Jane Griffiths, Group Chairman, Janssen Europe, Middle East and Africa 07 Dr Nicola Guess, Division of Diabetes and Nutritional Sciences at King’s College London 08 Francesca Colombo, Head, OECD Health Division 10 Prof Sehnaz Karadeniz, Chair, IDF Europe 11 Arvind Venkataramana, Research Director, ICPS 13 Dr Carine de Beaufort, Secretary General, International Society for Pediatric and Adolescent Diabetes 15 A viewpoint from AstraZeneca


the brexit impact

Navigating the rocky road ahead

What impact does Brexit have on the NHS and our health? Julie Girling MEP looks at the pros and cons and says the impact largely depends upon what the United Kingdom’s new Prime Minister adopts for its relationship with the EU

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t gives me no pleasure to say it - but we face a rocky road ahead, following the Brexit vote in the EU referendum last month.

It may be that we eventually emerge from the approaching negotiation with some form of agreement on trade that mitigates harm to our economy, but I see no reason for great optimism over that. In the meantime, I fear we face uncertainty, stagnation and underinvestment. The healthcare sector will face broadly the same challenges caused by Brexit as other parts of the economy. Some of those challenges will cast an even deeper shadow over health than other sectors. As I write the pound has just hit a thirtyyear low against the dollar and stock-market volatility continues, especially in bellwether sectors such as building and property. The Governor of the Bank of England has said that his predictions of problems caused by a Leave vote are largely playing out. Investment decisions are delayed and the housing market has slowed. Of course the longer term is what matters and I do believe that the inherent strength of our

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economy will prevail. We will pull through, but I believe our future success will be forever diminished by the decision to leave.

Expect food prices to rise and thus place pressure on household budgets. Wages will go less far.

When we leave, it is likely we will be shutting ourselves off from a single-market of 500 million. The Leave camp has no plans for how to address that, and the Government will struggle to piece one together.

Meanwhile in the healthcare sector, research grants are likely to be harder to come by if we lose access to the EU’s highly valuable Horizon 2020 funding pool.

Some claim that we can keep access to the single market without paying money in and without accepting free movement; but why would the remaining 27 countries give us a better deal outside the club than anybody has inside it? If I were Mrs Merkel or Mr Hollande, I would not fancy selling that to my electorate. It may be the bigger businesses that benefit most from the single market, but thousands of smaller concerns are indirectly affected as part of the supply chain or through having the larger firms’ employees as customers. On top of that, our farmers will be in limbo as they wait to see what replaces the single farm payment. They also face uncertainty about the labour market if they are prevented from employing migrant workers at harvest and other busy times.

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The NHS depends more than any other organisation I can think of, on skills and labour supplied by nationals from elsewhere in the EU. At present, there is no guarantee that those staff will be allowed to stay in the UK. Instead, there is the prospect of them becoming bargaining chips in the negotiation. Rather than waiting for that outcome, many may vote with their feet - just as they did when they once saw the great attraction of coming here to help us. I am very happy that the new Prime Minister is now in place and a new structure is beginning to emerge. I am sure that Theresa May will move rapidly towards resolving the issues and ending the uncertainty. However, I do not underestimate the difficulty of the task. I wish her luck


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tackling the diabetes challenge

Let’s put the evidence into practice

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ccording to the World Health Organisation, from 1980 to 2015 the number of adults living with diabetes rose from 153 million to 415 million. By 2030, diabetes is expected to be the 8th leading cause of death worldwide. It is therefore no wonder that this year’s World Health Day was dedicated to a disease that is increasing so dramatically in prevalence. Currently in the European Union, nearly 30 million people are living with diabetes. More than just a number, this translates on average to at least one of your neighbours, one of your children’s school friends or someone who you see on the bus to work every day suffering from the consequences of this disease.

‘At least one of your neighbours, one of your children’s school friends or someone who you see on the bus to work every day might be suffering from the consequences of diabetes milletus. In order to reverse this alarming trend, what we need is a behavioural change.’ Vytenis Andriukaitis, European Commissioner for Health and Food Safety, encourages member states to deploy all tools at their disposal, ranging from education to awareness campaigns and from advertising to taxation and town planning, to reduce the prevalence of the deadly disease physical activity are ingrained in habit from a young age, we will raise a generation of children who are ‘fat for life,’ and therefore at greater risk of developing a number of preventable diseases. To foster healthy habits, we need to create conditions that make healthy food and physical exercise easily available and affordable to everybody, and unhealthy options less accessible.

Experience has shown that simple changes in lifestyle can be effective in preventing or delaying diabetes type 2. These include maintaining a normal weight, regular physical exercise and a healthy diet.

To succeed in this endeavour, I encourage member states to deploy all tools at their disposal across policies ranging from education to awareness campaigns and from advertising to taxation and town planning. If we want our children to eat well, we need to provide healthy food in schools, get rid of vending machines selling sweets or sugary drinks in schools, make food low in salt, sugar and fat.

We need behavioural change. One in five school children is obese or overweight already, and this number is on the rise. Unless we start raising a generation where healthy food and

Naturally, we must also continue addressing Type 1 diabetes. Here, I am working towards more concrete actions to improve the lives of people living with diabetes by increasing

But every cloud has a silver lining. Firstly, in many cases type 2 diabetes is preventable. Secondly, it is also possible to reverse it.

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patient access to quality care across Europe and supporting research for finding new and more effective treatments. New eHealth solutions enable, for example, diabetic patients to monitor their own blood glucose, transmitting the information electronically to their healthcare specialist. eHealth being one of the 10 domains identified by the Commission as key priorities of standardisation, I will make it my personal priority to continue this work with my colleagues in the Commission, our stakeholders and member states, to maximise the potential of eHealth solutions. I am the Commissioner for Health not the Commissioner for Sickness. Therefore my deepest wish is to see a radical shift from treatment of diseases towards promotion of good health. We have solid evidence that this works. I need your help to put this evidence in practice


act on diabetes now

The war against diabetes rages on... 442 million

adults were living with DIABETES in 2014 and that is 314 million more than what was the case in 1980 52 million adults are living with diabetes in Europe

What should the EU START, STOP and ACT DIFFERENTLY in relation to diabetes policy making? Europe must start taking a series of actions in order to reduce the impact of the condition, such as addressing key gaps in diabetes knowledge, prioritising obesity prevention from an early age and improving diagnosis and management of primary healthcare. The easy solution is for all of us to exercise and eat healthy. Several Northern European countries have an increased focus on prevention, and are currently using several policy levers to facilitate effective management of the disease. In Denmark, for example, more exercise was introduced in schools. In eastern European countries, more attention is given to improving healthcare systems. In Slovenia, many diabetes-related deaths have been prevented, thanks to a relatively high level of investment. It’s important for governments to set specific targets for reducing the number of people suffering from diabetes, and replicate the preventive efforts of their fellow European countries.

68.9 million adults are forecast for 2035

Europe has the highest number of children diagnosed with Type 1 diabetes

A soda tax is one of the top recommendations of global health experts. Several European countries including France and United Kingdom have some version of tax, however the rest of Europe should act immediately and regulate the fat and sugar content of foods to ensure that there were healthy options available.

“In particular, we need much better nutritional labelling to enable people to make healthier choices about the food they eat.”

Glenis Willmott MEP

Diabetes is currently the 8th biggest killer in the world, accounting for at least 1.5 million deaths a year. It is forecasted to grow globally by 55% over the next 20 years.

TYPES OF DIABETES TYPE 1 2.2 million deaths were caused by higher-than-optimal blood glucose

“It is of paramount relevance to develop a more effective mass screening tool to prevent blindness in those suffering from diabetes, as ‘deabetic retonopathy’ is the second largest cause of blindness in Europe.”

Comodini Cachia MEP © Recommendations have been compiled from media reports

TYPE 2 3.7 million deaths have been caused by high blood sugar levels and Type 2 diabetes

5,49,000 people haviwng Type 2 diabetes are currently undiagnosed and obesity is the most important risk factor for such high rates © Data: World Health Organization

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tackling the diabetes challenge

Janssen in diabetes: a lifelong commitment With the alarming nature of the human cost of diabetes and the increasing prevalence,

Jane Griffiths, Group Chairman, Janssen

Europe, Middle East and Africa, Janssen Pharmaceutical Companies of Joohnson & Johnson, reiterates the commitments of the Johnson & Johnson family of Diabetes, and points out that it is critical that industry and policy makers look into new and creative approaches to address the full continuum of the cardiovascular and metabolic disease

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he World Health Organization estimates that in 2014, 422 million people had diabetes globally, with the prevalence of the disease having doubled since 1980. (1) European statistics are just as alarming with 60 million people estimated to have diabetes (type 1 and 2) in the European Region, equating to 10.3% of men and 9.6% of women aged 25 years and over. (2) More than 600,000 people die annually as a result of diabetes in Europe, equating to 11% of all deaths in people aged 20-79 years old. (3) Statistics suggest that diabetes is an ever growing epidemic, with projections indicating that over 1 billion people will be living with or at high risk of diabetes globally by 2035. (4) Beyond the human cost of diabetes, the broader economic impact is considerable. (5) According to the International Diabetes Federation, health expenditure for diabetes was estimated at USD105.5 billion in the European Region: the equivalent of 10% of the European healthcare budget. With such alarming future projections, effective management and prevention of diabetes has never been more important. Few companies are as uniquely positioned as Janssen to address the different aspects of the disease. The Johnson & Johnson Family of Diabetes Companies today touch more than 10 million people with diabetes and share a vision of “Creating a world without limits for people with diabetes.” As a unified, integrated global entity, it has the opportunity to address unmet needs in diabetes and support people living with diabetes and their families. The Janssen Pharmaceutical Companies of Johnson & Johnson, aim to stimulate the advancement of knowledge about the disease

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and develop new treatment approaches to potentially prevent the progression of diabetes or cure it. Janssen has already developed important medicines that are currently

“Janssen’s long term commitment to diabetes is further demonstrated through on-going clinical trials, such as the CANVAS, CANVAS-R, and CREDENCE studies” improving the lives of millions of patients, including those with type 2 diabetes. Despite recent reports noting that simple lifestyle changes can dramatically lower the chances of developing type 2 diabetes, obesity is still driving the diabetes epidemic in Europe and is estimated to account for approximately 65–80% of new cases of type 2 diabetes. (2) It is also estimated that by 2025, 58.6 million people will have prediabetes in Europe. (6) Early intervention is key in preventing diabetes in high risk populations; however lifestyle changes alone are not always enough. Janssen is therefore focusing on the development of treatments to manage obesity and to prevent diabetes.

Government Gazette

Janssen currently has marketing authorisations for canaglifozin (Invokana®) (an SGLT2 inhibitor) and canaglifozin/metformin hydrochloride (Vokanamet®) (a fixed dose combination of SGLT2 inhibitor and metformin) and has recently completed a series of key acquisitions and collaboration agreements to expand the diabetes portfolio, demonstrating a commitment to exploring new therapy areas and driving partnerships. In November 2015, Janssen obtained worldwide rights, excluding China and Korea, to develop and commercialise oxyntomodulinbased therapies, of which some are showing potential to treat diabetes and obesity. Just a month later, in December 2015, Janssen entered into a research collaboration agreement with Intrexon to discover and develop ActoBiotics® therapies to treat type 2 diabetes, obesity and/or metabolic disorders related to energy dysregulation. Janssen’s long term commitment to diabetes is further demonstrated through on-going clinical trials, such as the CANVAS, CANVAS-R, and CREDENCE studies, and driving public awareness through projects such as the Janssen Diabetes in the Downturn report. (7) As the prevalence of diabetes continues to


act on diabetes now increase, it is critical that industry and policy makers look to new and creative approaches to address the full continuum of cardiovascular and metabolic disease, from risk and screening to diagnosis and treatment. It is also crucial that industry and healthcare systems work together to provide access to the right medicines and long term support programmes to help prevent diabetes in the first instance, and optimise patient outcomes in the long term To know more on Diabetes and on Diabetes & Obesity: http://www.diseaselens.com/v2/index.php and http://www. janssen-emea.com/health-policy-centre/topic/diabetes

References: 1. World Health Organization. Global report on diabetes. Available at http://apps.who.int/iris/ bitstream/10665/204871/1/9789241565257_ eng.pdf?ua=1 Last accessed May 2016 2. World Health Organization Europe. Diabetes data and statistics, Available at: http://www.euro.who.int/en/health-topics/ noncommunicable-diseases/diabetes/data-andstatistics Last accessed May 2016 3. Jakab, Z., WHO Regional Director for Europe. Delivering for Diabetes in Europe. Plenary Meeting of the European Parliament’s EU Diabetes Working Group, 8 December 2010. Available at: http://www.euro.who. int/__data/assets/pdf_file/0007/128059/RD_ speech_Diabetes_Brussels_Dec_2010.pdf?ua=1 Last accessed May 2016 4. International Diabetes Federation. 2014 Annual Report. Available at:http://www.idf.org/ sites/default/files/IDF-2014-Annual-Reportfinal.pdf Last accessed May 2016 5. World Health Organization Europe. Diabetes epidemic in Europe. Available at: http://www.euro.who.int/en/health-topics/ health-determinants/social-determinants/news/ news/2011/11/diabetes-epidemic-in-europe Last accessed May 2016 6. Pre-diabetes highlighted as problem in Europe. Available at: http://www.diabetes. co.uk/news/2006/Jan/Pre-diabetes-highlightedas-problem-in-Europe.html Last accessed May 2016 7. Janssen. Diabetes in the Downturn report. Available at: http://www.janssen-emea.com/ diabetes-in-thedownturn Last accessed May 2016

How food tax policies can lower the risk of Type 2 Diabetes Diabetes prevention programs are an effective individual-level approach to prevent type 2 diabetes in those at high-risk. Dr Nicola Guess, Division of Diabetes and Nutritional Sciences at King’s College London, says food taxation policies are needed to prevent type 2 diabetes at a macro level

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supermarket shelf primarily consists of highlyprocessed foods, which, rather than promote satiety, may override the body’s natural appetite feedback mechanisms.

he current epidemic of prediabetes and type 2 diabetes (T2D) is largely driven by overweight and obesity. The prevalence of T2D in people at More critically, once a person is overweight, a a normal weight is 2%, rising to 13% in those variety of physiological feedback mechanisms who are obese. Each additional 1 kg increase combine to drive that person towards weight in body weight increases regain. New evidence a person’s risk of T2D by suggests that in addition “A sugar-tax implemented 4.5-9%. It is also clear to an increase in hormones in Mexico in 2014 reduced that losing 5-7% of body which promote hunger, the average consumption of weight can reduce the weight loss also causes risk of developing T2D in sugar-sweetened beverages by the body’s metabolic people with prediabetes. up to 17% by the end of the rate to reduce, and these unfortunate changes in year, while consumption of While a common view on plain bottled water increased appetite and metabolism weight gain is that it is a remain altered up to 7 result of will-power and by 4% However, tax policies years after a person loses poor choices, in reality need to be coherent, in order weight. the causes of weight gain

to maximise success” are multifactorial and Such responses to weight complex. Consider schoolloss are likely a remnant of children leaving a class on nutrition only to our hunter-gatherer genetics, formed during find 3 or 4 fast-food outlets on the high street, thousands of years where food was scarce, where 850 kcal can cost only £1.85. Or where and during a time where losing weight easily instead of unprocessed, high-fibre cereals which would have resulted in the extinction of our are known to send satiety signals to the brain, a species. Reducing overweight and obesity in

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an already overweight and obese population is therefore not a feasible proposition. Put it in this context, the challenge to reduce T2D in our populations is immense. A two-pronged approach is needed by which 1) T2D is prevented or delayed in people who are already at high-risk of T2D and 2) obesity is prevented by combined taxation and educational policies. The first approach is exemplified by the NHS Diabetes Prevention Programme in the UK. This programme is an implementation of the irrefutable evidence that moderate weight loss following a lifestyle programme prevents T2D by up to two-thirds. Importantly, even 10 years after these programmes finish, participants’ risk of T2D is still reduced even if they regain the weight. However, these programmes are expensive and labour-intensive. There are currently an estimated 6 million people in the UK with prediabetes. Unless the obesity crisis is addressed, this number may rise to 8-10 million by 2025. Therefore, while the NHS Diabetes Prevention Programme will help prevent T2D in people already at-risk, we must prevent

as many people as possible from becoming high-risk in the first place. This will require preventing obesity by changes in tax policy and education at the macro-level. A “sugar-tax” implemented in Mexico on January 1st 2014 reduced the average consumption of sugar-sweetened beverages by up to 17% by the end of the year, while consumption of plain bottled water increased by 4%. In a small study in a school cafeteria, halving the price of fruit and salad tripled their consumption. When the cafeteria reintroduced the original price of fruit and salad, consumption reduced again. Similarly, halving the price of low-fat items in a vending machine increased their consumption by 93%. However, here is an example where tax policies need to be coherent, and where nutrition education can maximise success: Lowfat cereal bars may be sweetened with sugar and contain an abundance of refined starch. By taxing high-sugar and high-fat products together, a person is “nudged” to make a truly healthier choice. Secondly, someone who has received education on nutrition in school is equipped to recognise a truly healthy choice.

Educational policies aimed at children and their families appear to be the most effective approach at changing dietary and exercise habits. In a study in Greece, a one-year educational programme increased the consumption of fruits, lowered the consumption of fats, oils, sweets and sugary drinks and reduced body weight and blood pressure after one year. While long-term evaluation of similar programmes shows that people revert to unhealthier habits over time, with food taxation policies which support healthy dietary changes, their long-term effectiveness can be optimised. In summary, T2D can be prevented in individuals with prediabetes by lifestyle programmes to improve diet and exercise habits. Changes in food taxation policy are urgently needed to support these healthy dietary habits long-term. More importantly, such changes in the food landscape are needed to halt the obesity crisis which is driving the T2D epidemic

Let’s take ownership of this public health challenge We will never entirely eradicate diabesity, but we can at least prevent a large portion of it. Francesca Colombo, Head, OECD Health Division, says it’s time we took ownership of this public health challenge as a starting point

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ublic health experts call it “diabesity” – the rapidly rising prevalence of obesity and type 2 diabetes impeding efforts to reduce the global burden of cardiovascular disease. The failure of health systems to curb this new epidemic has led to the deaths and disability of millions of people. Much of this is highly preventable. Every OECD (Organisation for Economic Co-operation and Development) country has become more obese in recent years. Across OECD, the proportion of obese adults rose from 15% to 18% between 2000 and 2013. The United States is home to the OECD’s most obese population, which comprises more than

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a third of adults in the country. Obesity and a sedentary lifestyle are recognised risk factors for type 2 diabetes, that are inflating the prevalence of the disease. Globally, an estimated 415 million adults have diabetes. This is almost 9% of the world’s population. (1) The United States also has the OECD’s highest number of adults with diabetes, and is the world’s biggest spender on diabetes-related prevention and care. (1) These numbers are expected to swell further in the coming years, unless more decisive action is taken. The health consequences of diabetes are many, and can be catastrophic. Among them are foot

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and leg amputation due to damaged nerves, loss of sight, and renal failure requiring highly invasive and costly interventions like dialysis and kidney transplantation. In pregnancy, poorly-managed gestational diabetes increases the risk of miscarriage, premature birth, foetal death and other complications. There are also economic costs. In the United States, the total estimated cost of diagnosed diabetes was USD 245 billion in 2012, including USD 176 billion in direct medical costs and USD 69 billion in reduced productivity. (2) An OECD analysis shows there can also be labour market consequences,


act on diabetes now

with diabetes associated with a lower probability of employment, lower wages, and lower labour productivity. (3)

with the cure. In times of economic austerity, it may be tempting for governments to make prevention the first casualty in health budgets, in the misguided belief that it is One of the most common consequences of inconsequential compared with curative diabetes is cardiovascular disease, which persists care. OECD data as the leading cause of death in indicates that “The United Kingdom is the OECD countries, accounting while the biggest latest country to announce for almost one-third of all deaths target for health a sugar tax on soft drinks. in 2013. The good news is that savings has been deaths caused by cardiovascular Though these taxes have a pharmaceuticals, disease have been declining in stronger effect on low-income prevention has not most OECD countries. The been immune. The groups, it may not have the frustrating news is that rising intended effects if consumers OECD average levels of obesity and diabetes are annual growth rate hampering our efforts to capitalise divert their consumption to of health spending on this and achieve further other unhealthy products” for prevention was mortality reductions. 5.6% between 2005 and 2009. However, this was followed by an If we are to get serious about addressing average annual decline of 0.3% between 2009 cardiovascular disease, we need to tackle the and 2013. It is indeed a sizeable cut when global burden of diabesity with urgency. A considering that budgets for prevention are multi-faceted approach should combine hard usually modest to begin with. regulatory measures with softer tools such as education and health promotion campaigns. We will never entirely eradicate diabesity, but we can certainly try to prevent a large portion An OECD analysis suggests greater access to of it. All of us should take ownership of this healthcare resources improves outcomes. (4) public health challenge. As a starting point, Strengthening primary care and enhancing think of the millions of deaths we could prevent the role of general practitioners and nurses in coordinating care pathways is fundamental to optimising the prevention, diagnosis and management of diabetes. Primary care also needs to be data-driven, to monitor patient care and performance, improve adherence to evidence-based care, and help gauge an understanding of variation in the quality of care. High out-of-pocket costs and poor education may deter the more disadvantaged from seeking necessary care, leading to deterioration and avoidable complications and more costly care later.

if each person was armed with the tools they need to take better care of their own health References: 1. International Diabetes Federation (2015), IDF Diabetes Atlas – Seventh edition, 2015. http://www.diabetesatlas.org/ 2. American Diabetes Association (2013), “Economic costs of Diabetes in the US in 2012”, Diabetes Care, 36(4):1033-1046. doi: 10.2337/dc12-2625 3. Devaux, M. and F. Sassi (2015), The Labour Market Impacts of Obesity, Smoking, Alcohol Use and Related Chronic Diseases, OECD Health Working Paper No. 86. 4. OECD (2015), Cardiovascular Disease and Diabetes: Policies for Better Health and Quality of Care, OECD Publishing, Paris. doi: http://dx.doi. org/10.1787/9789264233010-en 5. OECD (2010), Obesity and the Economics of Prevention: Fit not Fat, OECD Publishing, Paris. doi: http://dx.doi. org/10.1787/9789264084865-en

Some countries have experimented with a sugar tax and/or fat tax to reduce the prevalence of diabetes. These taxes serve the public health goal of reducing the consumption of food containing high content of sugar and fat. These taxes have a stronger effect on low-income groups, which stand to benefit the most due to higher prevalence of obesity and risk factors. However, such taxes may not have the intended effects if consumers divert their consumption to other unhealthy products. France, Hungary and Mexico are among the countries that have imposed such taxes to various degrees.(5) The United Kingdom is the latest country to announce a sugar tax on soft drinks. Other policy measures governments have at their disposal include regulation of food advertising to children, and compulsory food labelling. Softer policy levers include incentives and education programmes to make healthier choices more appealing. A combination of policies is likely to be most effective in reducing diabesity. It is often said that prevention is better than cure. Yet health systems remain obsessed

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tackling the diabetes challenge

We need stronger political mobilisation and investment Despite several political engagement efforts and the work of international and national diabetes associations across Europe,

Prof Sehnaz

Karadeniz, Chair, IDF Europe,

believes that the gravity of the situation is not fully understood by many of our national and European politicians

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t is too late to consider diabetes as a health issue alone. It has become an economic and social issue, too. The World Economic Forum has considered diabetes and other non-communicable diseases a clear threat to development and economic growth several years back, and the numbers of diabetes cases continue to grow beyond predictions. The alarming scale of the diabetes pandemic has also been recognised at a global level by the 2006 UN Resolution, as well as the UN Summit on Non-Communicable Diseases in 2011. At the European level, several texts have been adopted, including the European Council conclusions on type 2 Diabetes (June 2006) and a European Parliament (EP) Resolution on addressing the diabetes epidemic (March 2012). In April 2016, the EP adopted, with 405 signatures, a written declaration on diabetes, urging the European Commission and the European Council to prioritise diabetes in EU health policy, to encourage member states to develop national diabetes plans and, crucially, calling on the European Commission and European Council to develop an EU diabetes strategy through an EU Council Recommendation on diabetes prevention, diagnosis and control. All these resolutions and declarations, however, will make a positive change in the everyday lives of people with diabetes or people at risk for diabetes, only if national governments “internalise” them and take necessary actions in line with them. This can only be achieved by political will, structured diabetes programs and their implementation, with monitoring being an essential component. The International Diabetes Federation European Region (IDF Europe) organises awareness-raising activities mainly on the occasion of World Diabetes Day (14 November, an official United Nations Day), takes part in several platforms and participates in debates at

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“Initiatives such as the Diabetes Europe Roundtable 2016 “Reaching a consensus to prevent and control the prevalence of diabetes,” organised on 6 April by the International Centre for Parliamentary Studies, are very important to keep the political debate on diabetes on the agenda” the EU and pan-European level to contribute to the lives of the 60 million people living with diabetes in Europe, 32 million of which in the EU, and to prevent diabetes in people at high risk for the disease.

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At the same time, initiatives such as the Diabetes Europe Roundtable 2016 “Reaching a consensus to prevent and control the prevalence of diabetes,” organised on 6 April 2016 by the International Centre for Parliamentary Studies, are very important to keep the political debate on diabetes on the agenda. Politicians at the national and European level must be more engaged Despite these political engagement efforts and the work of international and national diabetes associations across Europe, we believe that the gravity of the situation is not fully understood by many of our national and European politicians. New and innovative approaches are urgently required across national policy, in care and management of diseases such as diabetes which


act on diabetes now are chronic by nature, and for healthcare delivery systems to adopt a more holistic approach to diabetes prevention and its management in affected people. As IDF Europe, an inclusive and multicultural organisation of 70 national diabetes associations in 47 countries across Europe, 44 of which are based in the 28 EU countries, we believe we have an important role to play in achieving this goal. Together with our members, as civil society we wish to work more closely with politicians and policy makers to increase awareness, encourage health improvements and promote the exchange of best practices at national and European levels.

Policy recommendations for improved treatment of diabetes

Through IMPACT diabetes, the Initiative to Mobilise Parliamentarians to Act, Prevent, Care and Treat diabetes, IDF Europe wishes to strengthen the mobilisation role of civil society, reinforce the knowledge of policy makers and position diabetes where it should be: high on the national and European agenda. With IMPACT diabetes, we wish to contribute to a more informed political environment, where knowledge and understanding are provided by people living and working with diabetes so that effective policies for people with diabetes and those at risk are developed, adopted, financed, implemented and evaluated. By reinforcing the role of and synergies with civil society, and by strengthening communication and advocacy skills, IMPACT diabetes aims to identify and disseminate successful national advocacy practices and contribute to putting diabetes at the centre of national and European policy making. Links to the European Union and the European office of the WHO increase the sustainability of outcomes and of investment in diabetes for all Europeans. By sharing experiences about the successes and pitfalls of advocating for diabetes in different countries and regions, IMPACT diabetes aims at creating a network of diabetes campaigners and politicians across the European region with the capacity, skills and tools to mobilise policy measures, investment and political will to tackle the rising burden of diabetes. In 2014, for example, 30 out of the 47 countries in Europe had national diabetes plans or were addressing diabetes with a plan for noncommunicable diseases (NCDs). The implementation of these plans have to be monitored and evaluated for their impact. Countries where there are no plans in place must be encouraged to take similar steps to mobilise resources for diabetes. By channelling the political will and the expertise of civil society, IDF Europe will continue to positively IMPACT the prevention of diabetes and the care for people living with the condition across Europe For more information about IDF Europe, please visit www.idf-europe.org

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

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ccording to the World Health Organisation (WHO), 60 million people in the EU are affected by diabetes, which directly translates to 10.3% of all men and 9.6% of all women over the age of 25 in the region. Research has shown that the prevalence of the disease is increasing among all ages due to the general population becoming overweight and obese due to poor diets and lack of physical activity. The WHO has also warned that high blood glucose is killing about 3.4 million people annually with about 80% of these deaths occurring in low and middle income countries and half of them are affecting people under the age of 70. The WHO projects that diabetes deaths will double between 2005 and 2030. With a view to proposing policy recommendations to the EU on effectively managing the disease, John Bowis OBE and the International Centre for Parliamentary Studies brought together Members of the European Parliament, senior representatives from the European Commission, diabetologists, endocrinoligists, patient groups, as well as leading pharmaceutical and technology providers to a senior level roundtable in Brussels on the 5th of April, 2016. EU Policy – Current state of affairs and scope for change The meeting began on a sombre note with tributes, condolences and messages of solidarity from participants to the people of Brussels, who were subject to the terror attacks on the city on the 22nd of March. This was followed by a presentation by IDF Europe’s Chair, Prof Sehnaz Karadeniz who highlighted the fact

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that over 32 million people in the EU, which is equivalent to the population of the 6th largest country in the continent. On a positive note, EU spending on tackling the disease had increased year on year and the IDF’s 70 associations across 40 countries had established a clear roadmap to bring about better outcomes for patients in the future. At the roundtable, one of the most common criticisms of current EU policy was that it was too geographically focussed and that it ignored other, more important demographics of patients. Additionally, there is no EU policy on the type and volume of data that needs to be consistently collected in member states. As current policy tends to be more focussed on Type 2 Diabetes, more needs to be done on both types, independent of each other. Impact of diabetes on patient wellbeing The discussion then moved to the implications of diabetes on mental health – more support needs to be provided for patients who suffer from depression as a result of diabetes. Future policy should also take into consideration psychiatric treatment, self-help as well as patient education and empowerment to reduce instances of diabetic patients suffering from depression and other mental health issues. Assessing the ‘true’ cost of diabetes The consensus was that assessing the cost of diabetes should go beyond treatment – the EU should take into account the cost to treat diseases resulting from diabetes, the cost to set up preventative measures, education as well as costs incurred outside the healthcare sphere, including local governments. This will provide us better visibility on the potential far reaching consequences of the disease and could facilitate informed policy making.

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tackling the diabetes challenge

Diabetes treatment and care, ten years from now

Technologies and treatment Although there were important technological breakthroughs in the treatment of Type 1 Diabetes and improved treatments for Type 2, more should be done by the European Parliament (EP) and the European Commission (EC) to ensure these developments are brought to patients quickly. The EU needs to be more proactive in bringing treatments to patients faster than before. During the roundtable, Christel Schaldemose MEP, Co--chair of the EU Diabetes Working Group, highlighted the importance of bringing developments to EU policy makers more regularly as most policies are currently at the risk of being developed using historical data. More needs to be done to ensure there is a constant stream of information flowing through the EP and EC to facilitate future policies to reflect on the most recent developments and breakthroughs

The participants of this meeting laid out a few important policy recommendations and also gave their predictions on how they see diabetes in ten years’ time

The EU should have a multi-disciplinary approach when devising healthcare policy for diabetes

Annual budgets to address a lifelong disease isn’t the most efficient funding model – the EU should develop 5-10 year budgets to facilitate longterm research

The EU should remove unnecessary barriers between research findings and bringing it to the market

There should be a greater focus on education and health literacy in order improve prevention and reduce the cost of treatment

Current trends indicate diabetes will grow significantly in the next ten years unless EU steps in to tackle obesity

In ten years’ time, there will be a cure for Type 1 Diabetes

The EU should encourage more patient help centres and key stakeholders need to come together to build a strong case for finance ministries to approve them

Basic clinical research is key and the EU needs to back more funding for it

Tele-health and eHealth will play a key role in patient care

Data and information interchange within the EU should be stringent and better guidelines should be put in place for this

Treatment outcomes should focus on patient experience and quality of life

Participants of the Diabetes Europe Roundtable 2016 Global Government Affairs & Policy Area Head, Western & Eastern Europe, Russia, Turkey, Abbott Laboratories, Consultant Endocrinologist & Diabetologist, Algemeen Ziekenhuis Alma VZW, Global Head Market Access & Policy, Ascensia Diabetes Care, Director of Medical, Clinical and Scientific Affairs EU/EMEA/LATAM/APAC, Ascensia Diabetes Care, Director Global Government Affairs and Patient Relations CVMD, AstraZeneca, Director of Marketing & Development CoE Diabetes Care, B.Braun, President, Bulgarian Diabetes Association, Policy Manager, Diabetes UK, External Engagement Lead for Europe & Canada, Eli Lilly, EU Liaison Officer, European Association for the Study of Diabetes, Policy Manager, European Chronic Diseases Alliance - European Kidney Health Alliance, MEP (Austria) and Co-Chair of the EU Diabetes Working Group, European Parliament, Chief Executive, Input Diabetes, President Elect, IDF Europe, Regional Manager, IDF Europe, Secretary General, ISPAD - International Society for Paediatric and Adolescent Diabetes, EMEA Medical Devices Leader, Government Affairs & Policy, Johnson & Johnson, Professor of Nutrition & Dietetics, King’s College London, Market Access Manager, Roche Diabetes Care, Chief Medical Officer, The Finnish Diabetes Association, Director, Laboratory of Experimental Medicine, Universite Libre de Bruxelles (ULB), Chair and Professor of Medical Psychology, VU Medisch Centrum, Netherlands, EU Representative, World Health Organisation

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Children and adolescents with diabetes need continuous surveillance Childhood diabetes is a lifelong challenge with high risk for severe chronic complications. Dr Carine de Beaufort, Secretary General, International Society for Pediatric and Adolescent Diabetes, says continuous surveillance with frequent benchmarking is required to optimise outcomes through best practice

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henever there is a mention about diabetes mellitus, most people think of the obesity related type 2 diabetes mellitus (T2DM) in adults after their 40s. In Europe, this form of diabetes represents over 90% of the adults with diabetes. Initial treatment consists of oral medication and lifestyle changes. In case of late diagnosis or of not achieving treatment targets, it is likely to result in a high cost, due to its severe long term complications with high medical costs and loss of productivity. Due to the obesity epidemic, the prevalence and frequency of T2DM in adolescents worldwide has increased rapidly. Until 10 years ago, T2DM accounted for less than 3% of all cases of new-onset diabetes in adolescents. At present 45% of cases are attributed to it. (1,2) Furthermore, T2DM in youth seems to be less frequent in Europe (1-2 % of youth with diabetes) compared with the United States or Asia (3), although the presence of impaired glucose tolerance in obese children should not be underestimated (12.4 % in obese adolescents in an Italian region). Late diagnosis

may be associated with higher frequency of complications. (4, 5) This reinforces the importance of good data collection in this field.

T1DM in children up to 14 years increases by 2% annually, with an expected doubling in the number of children below 5 years in the next 10 years (7) T1DM is one of the most frequent chronic non-communicable diseases in childhood and it touches all populations across the world.

Recent studies demonstrate that this disease in youth shows a more aggressive pathway and rapid decline of metabolic control, and thus a higher risk of complications (eye, kidney, high blood pressure) at a very young age. (6) Without insulin injections, the child can not Obesity and sedentary lifestyle play a major survive. When the disease is first diagnosed in role. In order to a child at around 5 years of age, reduce the number he/she faces a lifelong sentence “Currently, there is neither of complications, of over 140,000 subcutaneous a harmonised longitudinal Europe should start insulin injections. Under or monitoring of outcome supporting healthy overdosing will lead to high or indicators, nor a cross-border low blood glucose values, both lifestyles from an early childhood. with neurocognitive symptoms continuous data collection, and acute physical complaints evaluating the impact However, no (even seizures and coma) and prevention is of different therapeutic both with long term risk. possible for the most approaches� frequent form of Careful continuous glucose diabetes in children monitoring and continuous and adolescents, insulin dependent type 1 insulin adjustment are required in order to diabetes mellitus (T1DM). More than 90% of prevent complications. This adds just as many children with diabetes suffer from this form, (>140,000) finger pricks for blood glucose which leads to death when untreated. The measurements over the lifespan of a person cause of T1DM is still unknown, although with T1DM. Long term survival may be genetic predisposition and multiple hits by complicated by blindness, end stage renal environmental factors seem to be involved. failure, neuropathy, cardio – cerebrovascular In most European countries, the incidence of disease. These late complications, however,

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tackling the diabetes challenge can be prevented by a good glucose control. However, meeting treatment targets in toddlers, children and adolescents is a challenge for patient, family and healthcare professionals. Although current ISPAD Clinical Practice Consensus Guidelines state that an optimal blood glucose control is needed in all ages, the implications remain uncertain when these targets are temporarily not met. (8) New technology is offered for those who can afford it. Although they seem to improve outcome, long term follow up and outcome are required. Currently, in Europe, there is neither a harmonised longitudinal monitoring of outcome indicators, nor a cross-border continuous data collection, evaluating the impact of different therapeutic approaches over time and beyond the research setting. Several countries have created national age specific registries, but do not ensure the continuum from 0 – 100 y. The Diabetes Patienten Verlaufsdokumentation (DPV), Danish and Swedish registries are currently the best known prospective registries with longitudinal data. But even these registries do not provide data over the lifespan of a person with diabetes and thus cannot address key questions on best therapeutic approaches. Access to essential medication (insulin) and regular monitoring in combination with age appropriate education, is the first step to improve survival, metabolic outcome and quality of life. The next step should address the long term morbidity/mortality in relationship with treatment factors that really count. Many studies suggest best practice, but only few provide long term follow up data, taking all previous years of living with diabetes into account. (6, 7) A continuous prospective longitudinal EU wide (or cross border) data registry is the need of the hour.

The SWEET consortium, partnering with ISPAD and DPV, collects data on treatment and outcome of youth with diabetes, twice a year. (9) Benchmarking, based on the data, stimulates the discussion on outcome parameters and current practice. Extending this initiative to cover all age groups would allow long term evaluation of different treatment regimens in diabetes, taking into account the full picture. Therapies can be improved to ensure the best outcome in children with diabetes, only with an ongoing collection of robust data on treatment and outcome References: 1. Pinhas-Hamiel O, Zeitler P. The global spread of type 2 diabetes mellitus in children and adolescents. J Pediatr 2005;146:693– 700pmid:15870677 2. Pinhas-Hamiel O, Zeitler P. Acute and chronic complications of type 2 diabetes mellitus in children and adolescents. Lancet 2007;369:1823–1831pmid:17531891 3. Dabelea D, Bell RA, D’Agostino RB Jr, et al; Writing Group for the SEARCH for Diabetes in Youth Study Group. Incidence of diabetes in youth in the United States. JAMA 2007; 297:2716–2724

Med. 2012 Jun 14;366(24):2247-56 7. Patterson C, Guariguata L, Dahlquist G, Soltész G, Ogle G, Silink M Diabetes in the young - a global view and worldwide estimates of numbers of children with type 1 diabetes. 8. ISPAD Clinical practice Consensus Guidelines Pediatric Diabetes 2014 , 15 S20 1-290 9. Pirart J, Lauvaux JP, Rey W. Blood sugar and diabetic complications. N Engl J Med. 1978 18; 298(20):1149 SWEET (www.SWEETproject.eu) was originally an European project (April 2008 – March 2011) based on a joint initiative of established national, European and international diabetes organisations: ISPAD, IDF Europe, FEND and PCDE and co-funded by the European Union in the framework of the Public Health Program with additional funds from corporate partners and foundations. It is currently an international consortium. ISPAD is the international professional organisation that brings together all healthcare professionals and researchers to improve treatment of children, adolescents and young adults and their families afflicted with diabetes throughout the world. (www.ISPAD.org)

4. Brufani C, Ciampalini P, Grossi A, et al. Glucose tolerance status in 510 children and adolescents attending an obesity clinic in Central Italy. Pediatr Diabetes 2010;11:47–54 5. Haines L, Wan KC, Lynn R, Barrett TG, Shield JP. Rising incidence of type 2 diabetes in children in the U.K. Diabetes Care 2007;30:1097–1101 6. TODAY Study Group, Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F.A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J

Around the world, by 2040, one in 10 adults will have diabetes © Data: IDF Europe

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act on diabetes now

Making it easier to do the right thing

AstraZeneca believes there is an urgent need for active political action and evidence based policy solutions in treating diabetes milieus. AstraZeneca elaborates on its policy forums and activities to address patients’ unmet needs

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lobal and national policies have spend resources on a public health policy that reaps benefits in the long term. As an example, failed to stop, and in many cases have contributed to, the increasing take national prevention programs in diabetes: diabetes prevalence that we witness Why have less than a handful of European at the moment. (1) In the area of diabetes, countries implemented these when we know alarming numbers of people suffer from and that 1) increasing numbers of people develop are at risk of developing the disease in Europe. and suffer from diabetes and its complications (2) Sadly, in the arena of public health, where in Europe (6); 2) the cost of treating diabetes changes are required to avert this situation, and its complications is spiralling ever higher political action is limited and often insufficient. (7) and 3) that prevention programs are costAt AstraZeneca, we believe this can change effective, and can save lives through multi-stakeholder and tax payers’ money (8)? “The AstraZeneca supported efforts in translating The same could be said about campaign on ‘Early existing evidence into best other much needed policy practices for political and Action in Diabetes,’ areas in diabetes, such as earlier clinical action. launched in November diagnosis and treatment where Political inertia? 2015 will host national we have the evidence but still see little action on the ground. The World Health Organization policy workshops in around 15 European first put focus on ‘neglected How can we help? chronic diseases’ in 2005 (3), countries – with a At AstraZeneca, we are active and most recently facilitated further 20 policy across many chronic disease broad commitment behind areas to advocate for more workshops around the the new Sustainability policy action to address world” Development Goals (SDGs) patients’ unmet needs. As in September, 2015 in New one of numerous examples York. (4) Critics flagged that of this, we work with the International the 17 goals with 169 targets of the SDGs Diabetes Federation (IDF), Primary Care is a wish-list underpinning political inertia Diabetes Europe (PCDE) and the World rather than a much needed action plan. (5) Heart Federation (WHF) to advocate among And while widespread government spending policy makers for translating current evidence cuts may further reduce chances of successful from global literature into real action on the SDG action, it is still too early to assess the ground. We call the campaign “Early Action extent to which European governments may act in Diabetes,” and it focuses on prevention, individually or with EU support, particularly diagnosis and management of diabetes. It was in areas of strengthening chronic disease launched in November, 2015 in Barcelona, prevention and management. and during 2016, we will host national policy Too often though, we hear from stakeholders workshops in around 15 European countries – that the needed political visions – and with a further 20 policy workshops around the budgets – are not to be expected. One of world. The outcome of these will be presented the most fundamental explanations for this at a global policy forum in Berlin, December is the duration of the political cycle. With 13th and 14th, 2016, which will be organised governments and politicians sitting only for 4 with global partners, currently including the or 5 years, it takes courage and commitment to IDF, PCDE and the WHF.

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This forum provides policy makers and policy advocates a common platform to gather and share better practices in policies supporting prevention, diagnosis and management of diabetes. More than 35 countries will be present, and we invite you to approach us if you are interested in learning more and perhaps participating at this crucial global forum. With partners, we anticipate a followup global forum in 2017 in Rome to review the status of development and implementation of policies that will have a real impact on the ground References: 1. Raising the Priority of Preventing Chronic Diseases: A Political Process, The Lancet, Vol. 376, No. 9753, p1689-1698, 13 Nov 2010 2. International Diabetes Federation, IDF Diabetes Atlas Seventh Edition, 2015, p.74 3. The Neglected Epidemic of Chronic Diseases, Volume 366, No. 9496, p1514, 29 October 2005 4. Transforming our world: the 2030 Agenda for Sustainable Development, https:// sustainabledevelopment.un.org/post2015/ transformingourworld 5. Experts Divided over Value of UN Sustainable Development Goals, Financial Times, Sep 15th, 2015. 6. International Diabetes Federation, IDF Diabetes Atlas Seventh Edition, 2015, p.74 7. International Diabetes Federation, IDF Diabetes Atlas Seventh Edition, 2015, p.74-75 8. The Diabetes Epidemic and its Impact on Europe, P.10-11, https://www.oecd.org/els/ health-systems/50080632.pdf

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HEALTH REPORT

Recommendations to reshape policy making

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


european commission 77 Marianne Thyssen, European Commissioner for Employment, Social Affairs, Skills and Labour Mobility 79 Antoni Montserrat Moliner, Senior Expert for Cancer and Rare Diseases, Directorate of Public Health, European Commission 86 Dr Emanuele Crocetti,Public Health Policy Support Unit, Institute for Health and Consumer Protection, Joint Research Centre, Ispra (Italy), European Commission

european parliament 78 Daciana Octavia Sarbu MEP

prevention 80 Prof James W.F. Catto, Professor of Urology at the University of Sheffield 92 Prof Morgan RouprĂŞt, Professor, UniversitĂŠ Paris

management & care 82 Dr Anne E. Kiltie, Associate Professor, Department of Oncology, University of Oxford 84 Dr Anne Postulka, Senior Director, Medical and Economic Value, Europe, Cepheid 87 Prof Hein Van Poppel, Adjunct Secretary General - Education, European Association of Urology 88 Dr Laurent Fossion, MD, Head of Urology, Maxima Medisch Centrum 94 Dr Zenichi Ihara, Health Economics Manager, Commercial Excellence, Olympus 100 Dr Gregory Adams, Steve Hurley, Dr Glen MacDonald, Viventia

cost & economics 91 Dr J. Alfred Witjes, Department of Urology, Radboud University Nijmegen Medical Centre

policy action 83 Louise de Winter, Chief Executive, The Urology Foundation 90 Rik Bryan and Jeannie Rigby, Action on Bladder Cancer 95 Mihaela Militaru, Director, European Cancer Patient Coalition 96 Pablo Perez-Moreno and Elzbieta Zawisla, Roche 98 Arvind Venkataramana, Research Director, ICPS


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beating bladder cancer

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EU acts against work related cancer The most common cause of work-related deaths in the EU is cancer and bladder cancer was one of the first cancers to be linked to occupation. The European Commission recently proposed changes to the Carcinogens and Mutagens Directive to limit exposure to 13 cancer-causing chemicals in the workplace.

Marianne

Thyssen, European

Commissioner for Employment, Social Affairs, Skills and Labour Mobility, explains how workers are currently protected under the EU legislation and elaborates on the latest proposal

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ancer is the single biggest health risk to workers in the European Union. While cancer is no doubt a disease with complex causes, our response, at least, should be simple. We should reduce or eliminate the exposure of workers to chemicals that lead to the disease.

My primary goal is to protect the health and safety of European workers. But this proposal will also benefit employers, member states, and the economy as a whole. As a result, employers will be able to protect their workers better – which I believe is what most of them genuinely want to do.

That is why I have proposed to introduce new exposure limits for 13 cancer causing-chemicals at the workplace.

Employers will now have concrete, measurable yardsticks against which they can ensure compliance. And they will be able to hold on to their healthy, skilled workforce for longer. Member states benefit because the proposal will reduce the healthcare costs related to cancer treatment and rehabilitation. And the economy as a whole will benefit from improved labour

Currently, around 20 million EU workers are exposed to at least one of these chemicals. My proposal can save 100,000 lives in the next 50 years, and protect many more from the suffering and economic costs caused by cancer.

Government Gazette

productivity and a lower burden on public finances. Zero-risk does not exist: not in life and not at work. But where we can reduce the risk and save workers’ lives, it is our duty to act. I am doing so with this proposal and I will continue to work, as a matter of priority, on new exposure limits for additional chemicals. I want Europe to continue to set the world standard on health and safety at work, based on scientific evidence and intense dialogue with our social partners

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beating bladder cancer

Reducing risk factors for bladder cancer: the legislator’s role

Discussing the legislator’s role in beating bladder cancer, Daciana

Octavia Sarbu MEP says a broader strategy including,

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s research accumulates, we can be more certain about risk factors for different cancers and develop policies to reduce them. Some are easier to identify than others, and it may take decades before clear links are established between exposure and a particular cancer. However, over time, it has become clear that preventing bladder cancer specifically means tackling at least two key risk factors: occupational exposure to carcinogens and smoking. Legislators can and must play an important role in this process. Reducing exposure to carcinogens and mutagens in the workplace is critical because in some industries this represents the second biggest risk factor for bladder cancer. EU health and safety rules address some of these workplace risks, but critics argue that the legislation is too weak. Three key problems can be identified. Firstly, exposure limits are defined at European level for only a small number of potentially harmful substances, which means different levels of protection in different member states. Secondly, the length of time between exposure and onset of disease means that the financial cost of ill-health is mainly paid by healthcare

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emissions from road traffic and pesticide limits is equally important if we are to control risk factors for major chronic diseases and enact serious, prevention-based health policies systems later on in a person’s life. This creates little incentive for industry to take preventative action for current employees. Thirdly, the European Commission reports serious problems with implementation of the rules, particularly for small and medium-sized enterprises (SMEs). The current and long-awaited revision of health and safety legislation may help. Applying exposure limits to a wider range of industrial chemicals in a single directive would increase minimum standards across the EU. Obligatory post-employment monitoring of employees and provision of medical care could improve detection, diagnosis and treatment. Such changes could bring great benefits, especially for those working in large-scale operations with the resources to implement them. But the balance between protecting workers and making legislation realistic for SMEs may prove hard to strike. Bureaucratic complexity, insufficient guidance from national authorities, and a lack of awareness of responsibilities have already made the laws problematic for small businesses. This is relevant to the discussion about bladder cancer because several higher-

Government Gazette

risk professions are those in which people are often self-employed or work for SMEs, such as hairdressers, drivers, mechanics, and painters. In these cases, workplace rules may not provide the necessary protection. Closing the gaps in health and safety legislation alone will not be enough. With smokers being up to four times more likely to contract bladder cancer than nonsmokers, tobacco use is still a bigger risk factor than any occupational exposure. The EU and member states have taken important steps on tobacco use in recent years. Most work places and many indoor public places are now smoke-free following a 2009 Council recommendation. More recently, the EU Tobacco Products Directive introduced standardised packaging for cigarettes, including mandatory pictorial and text warnings (the tobacco companies recently failed in their bid to overturn this law in the courts). This is important for governments because it reinforces the health messages around smoking which makes it easier to introduce laws for smoke free environments. Research now shows high public support for smoking


health report bans in places such as bars and restaurants. smoke-free environments. The effects on Those governments which have not yet enacted other tobacco-related diseases like cancer such bans should take will be slower to emerge advantage of this popular The current and long-awaited and perhaps harder to support to fully implement quantify, but smoke-free the 2009 recommendations revision of health and safety environments are clearly legislation could bring and reap the health, social associated with decreasing and economic benefits that smoking rates. This can great benefits, especially for smoke free environments only have a positive impact those working in large-scale bring. In some member on health, including a operations with the resources reduced incidence of states, the health benefits to implement them have been immediately bladder cancer. apparent, such as fewer EU policy has gone some hospital admissions for way in addressing the risks of occupational heart attacks soon after the introduction of

diseases such as bladder cancer and the wider health risks posed by smoking. Experience has shown that legislation can create healthier environments - whether by introducing smoke free public places or limiting exposure to carcinogens at work. Regular reviews and strengthening of health and safety rules are vital to increasing protection, but this alone is not enough to cover all the professions at risk. A broader strategy including, for example, emissions from road traffic and pesticide limits is equally important if we are to control risk factors for major chronic diseases and enact serious, prevention-based health policies

European Commission’s fight against cancer grows stronger The European Commission aims to reduce the burden of cancer through the Joint Action CANCON (European Guide on Quality Improvement in Comprehensive Cancer Control), European Code Against Cancer and by heavily investing on research. Antoni

Montserrat Moliner,

Senior Expert for Cancer and Rare Diseases, Directorate of Public Health, European Commission, elaborates on the EU fight against cancer

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ladder cancer is the ninth most common cancer worldwide. Despite significant advances in the treatment of bladder cancer, it remains a growing problem in the European Union. Based on key statistics published in the International Agency for Research on Cancer for 2012, the crude annual incidence of bladder cancer in the European Union is 16.3 per 100,000 of population with 123,000 new cases per year. The mortality in the EU is 4.7 per 100,000, meaning that 40,300 people in the

EU die from bladder cancer annually, nearly 30,000 men and 12,000 women respectively. There are some differences in the occurrence of bladder cancer across Europe. Bladder cancer occurs mainly in older people. Roughly 9 out of 10 people with this cancer are over the age of 55. The average age at the time of diagnosis is 73. Men are about 3 to 4 times more likely to get bladder cancer during their lifetime than women. According to the American Cancer Society, the overall chances of men developing bladder cancer during their life is about 1 in 26. For women, the chance is about 1 in 88. Action on cancer

Government Gazette

The European Commission aims to reduce the burden of cancer in the EU in several ways. It aims to increase survival rates and reduce cancer mortality by improving quality of patient care, ensure better quality of life for cancer patients and helps reintegration and palliative care through two main tools, namely the Joint Action CANCON (European Guide on Quality Improvement in Comprehensive Cancer Control) and European Code Against Cancer. The former serves as the official European guide on quality improvement in comprehensive cancer control, and facilitates discussion among member states. It provides an extraordinary

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beating bladder cancer opportunity to address all the topics directly related to bladder cancer, such as quality-based cancer screening programmes, comprehensive cancer network organisations, communitybased cancer care and survivorship. The active participation of bladder cancer stakeholders in these discussions will constitute a remarkable input to respond to the needs of patients in a broad and cooperative European context, taking into account that a comprehensive cancer control policy should focus not only on the general aspects of cancer control but also on those that specifically correspond to different cancer sites, as is the case for bladder cancer. The 4th version of the European Code Against Cancer, produced by the European Commission in close collaboration with the IARC (International Agency for Research on Cancer) in October 2014, provides essential recommendations for preventing cancer to the general public in a friendly, easy-to-read format. The Code is a key communication tool used in the prevention of all cancers, and constitutes the major tool for disseminating preventive measures and contributing to definitively change the perception of cancer around its two very clear messages: one, that certain cancers may be avoided and that health in general can be improved by adopting healthier lifestyles; and two, that cancers may be cured, or the prospects of being cured are high, if detected at an early stage. The messages of the Code are essential to prevent bladder cancer: avoid tobacco smoking and incriminated occupational exposure and regularly eat fresh

fruit and vegetables. In addition, prevention and control of urinary tract infections should be recommended for bladder cancer prevention.The active involvement of bladder cancer stakeholders in the promotion and dissemination of the Code will be essential.

and bioinformatics to identify and validate biomarkers that hint at a recurring bladder cancer.

The Luxembourgish Centre de Recherche de la Santé (CRP-Santé) joined forces with researchers and clinicians from other member In May 2016, the European Commission states to develop a simple test to detect proposed amending the overarching this. The European Union Horizon 2020 Occupational Safety and Programme for research “Research is essential in Health (OSH) Framework is supporting the project Directive 89/391/EEC and ‘Multimodal, Endoscopic better understanding the other Directives specifically Biophotonic Imaging mechanisms of bladder dealing with chemical of Bladder Cancer for cancer. A total of 16 projects, Point-of-Care Diagnosis,’ risks. Based on input from scientists, employers, workers, with a total investment of led by the Technical representatives from the University of Denmark 25 million euros, have been different member states and the Frederiksberg supported by EU Research and labour inspectors, the Hospital, which will Programmes” Commission has proposed provide robust, easylimit values for 13 priority to-use, cost-effective chemical agents identified through the optical methods with superior sensitivity and consultation process, including o-Toluidine, specificity to enable a step-change in point-ofwhich is considered as a carcinogen provoking care diagnostics of bladder cancer. bladder cancer and primarily used in the Large and ambitious initiatives like these manufacture of dyes. can only be implemented through the type Research funding of cooperation that the existing European programmes permit. It is a challenge to Research is also essential in better mobilise common resources and the expertise understanding the mechanisms of bladder of European, national and regional authorities cancer. A total of 16 projects, with a total as well as scientific partners and patient investment of 25 million euros, have been organisations. It’s a big challenge indeed – but supported by EU Research Programmes. our commitment to organise the efficient and The European FP7 project DeCanbio appropriate coordination of these efforts at a brought together a consortium of clinicians European level is even bigger and researchers in genomics, proteomics

Industries at risk within Europe Several occupations have an elevated risk of bladder cancer. The highest risks occur in workers within tobacco manufacture, dye and rubber production, nurses, hairdressers and radiation workers. Prof James W.F. Catto, Professor of Urology at the University of Sheffield, surveys the occupations at risk of developing bladder cancer and those at risk of death

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ladder cancer (BC) is the fourth commonest malignancy worldwide and one of the most prevalent in the European Union. (1). The incidence of BC varies greatly around EU member states reflecting patterns of exposure to the main two risk factors; namely tobacco smoke and occupational exposure to cancer forming agents (carcinogens). (1,2) Around half of all BC is caused by tobacco smoke. The impact of smoking upon an individual’s risk of BC varies with the directness of their exposure

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(self-smoking or inhalation of environmental tobacco smoke), the type of tobacco (black or blonde), gender and the inherited genetic profile (3,4). Legislation to prohibit smoking in public and workplaces is likely to reduce the rate of BC that arise through this route. (2) The second most common cause of BC is exposure to carcinogens through occupational tasks. This route has been known for many years and has been reduced through workplace health and safety regulations, such as European Union directives (e.g. 90/394/EEC and 98/24/ EC) and the 2002 Control of Substances Hazardous to Health Regulations in the UK. The fraction of BCs that arises through


health report occupational carcinogens is estimated to be around 5.3% in total and 7.1% for males. (5) This is lower than the 10% estimated by Doll and Peto in 1981 (6) and fits the estimated 2030 year latency from exposure to cancer. (7, 8) Historical occupational bladder cancer Bladder Cancer was one of the earliest cancers to be linked to occupation. For example, it was known in the 1920s that workers in the rubber industry had an elevated risk of BC. (9) Subsequent evidence identified the antioxidant-naphthylamine (2-naphthylamine) as a bladder carcinogen and lead to its restriction and replacement in rubber manufacture. (8,10) Similar observations were made in the dye, textile and printing industries, and lead to restrictions in the use of Benzidine and 4-Aminobiphenyl. The rubber, dye, textile and printing industries were characterised by high exposures of workers to aromatic amines, usually through the skin contact or inhalation. (7) Workplace legislation and changing manufacturing processes (e.g. digital publishing rather than printing presses using mineral oils and benzidine pigments, robotic automation within car manufacture) have now reduced aromatic amine exposures and BC risk in these industries. However, current workers still appear to have a higher than expected rate of BC, probably through either unknown agents (11) or continued exposure to known carcinogens (e.g. in recycled tyres). (12) Contemporary occupational bladder cancer Given changes in manufacturing and workplace health and safety, we recently undertook a systematic review of occupational BC from 1930 to 2010. (13) We reported outcomes in 5 million persons and found significantly elevated BC risks in 42 occupational classes. More worryingly, we also saw an increased risk of mortality from BC in 16 occupational classes. Occupations at risk varied and appeared to differ for BC incidence (new cases) and BC mortality (death from BC). Occupations at risk Many occupations have an elevated risk of BC. The highest risks occur in workers within tobacco manufacture, dye and rubber production, nurses, hairdressers and radiation workers. The causative chemicals differ between aromatic amines, polycyclic aromatic hydrocarbons (PAHs) and radiation. Tobacco workers are exposed to aromatic amines such as 2-napthylamine, 4-aminobiphenyl (4-ABP). Dye manufacture, leather and textile workers contact aromatic amines used as dyes and pigments (such as 2-napthylamine, 4-ABP, nitrobiphenyl, benzidine, direct black 58 and blue 6). (14, 15). BC risk in Hairdressers has declined from 3.2-9.15 fold (14, 16), compared to 1.25 fold [13] following the removal of 4-ABP in hair products. Nursing staff are exposed to PAHs through coal tar dressings and the medical use of radiation.

Plastic manufacture uses a variety of urothelial carcinogens (e.g. 1,1-dichloroethane is a solvent for 1,1,1-trichloroethane production, MBOCA is a curing agent in polyurethane production and 4,4’-methylenedianiline is used to make polyurethane foams or epoxy resins). Occupations at risk of death from bladder cancer The risks of BC in the rubber, dye and chemical industries has lead to health education and worker screening programs of ‘at risk’ workers in various countries. (17) These measures appear successful, as elevated BC risks do not necessarily transfer into higher mortality rates. Similar observations occur in medical staff, suggesting rapid BC diagnosis can alter its prognosis. In contrast, there appears to be a number of occupations, e.g. metal, aluminum and glass manufacture, with higher than expected risks of BC death. (13) Many of these workers are exposed to PAHs through inhalation of atmospheric pollutants or skin contact from lubricants. PAHs are recognised carcinogens graded according to composition (e.g. naphthalene (IARC 2b), benzo[a]pyrene (IARC 1)) and exposure.(18) Metal, machine and automobile workers are exposed to mineral oil metalworking fluids (MWFs), solder/welding fumes, solvents, paints and greases. MWFs are colorless, odorless, light alkane mixtures from a non-vegetable (mineral) source (often a distillate of petroleum), and include paraffinic oils (based on n-alkanes), naphthenic oils (based on cycloalkanes) and aromatic oils (aromatic hydrocarbons). Mineral oils are known (IARC 1) carcinogens due to their high PAH content. (5, 14) BC risk increases proportionally with the intensity, duration and accumulation of exposure, (19) and the type of mineral oil: straight (high-risk) versus soluble/synthetic fluids (low-risk) [20]. PAH exposure during aluminum manufacture arises from coal tar/pitch anode evaporation during electrolysis to produce benzo[a]pyrene vapour (IARC 1) (18). PAH inhalation also occurs in firefighters and bar/entertainment industries staff. Many workers are exposed to diesel fumes, known to contain PAHs and other mutagenic particles [21], including drivers, miners, marine workers and seamen. (22-24) The toxicity of fume inhalation is enhanced by the low volumes of fluid drunk by drivers and the high prevalence of cigarette smoking within these occupations. (25) Conclusion Many workers are at elevated risks of BC. Geographic patterns will reflect local industries, e.g. Italy, Bulgaria, Greece, Spain and Poland are the main tobacco manufacturers (26), metal workers in the Netherlands, Germany and the UK, and smoking patterns. Health improvement measures should be targeted to workers with higher BC mortality, such as those exposed to PAHs and diesel fumes References

Government Gazette

1. Chavan S, Bray F, Lortet-Teulent J, Goodman MM, Jemal A. International Variations in Bladder Cancer Incidence and Mortality. Eur Urol. 2014: 66:59-73 2. Islami F, Stoklosa M, Drope J, Jemal A. Global and Regional Patterns of Tobacco Smoking and Tobacco Control Policies Eur Urol Focus. 2015: 1:3-16 3. Burger M, Catto JW, Dalbagni G, et al. Epidemiology and risk factors of urothelial bladder cancer. European urology. 2013 Feb: 63:234-41 4. Cumberbatch MG, Rota M, Catto JW, La Vecchia C. The Role of Tobacco Smoke in Bladder and Kidney Carcinogenesis: A Comparison of Exposures and Meta-analysis of Incidence and Mortality Risks. Eur Urol. 2015 Jul 3: 5. Rushton L, Bagga S, Bevan R, et al. Occupation and cancer in Britain. Br J Cancer. Apr 27: 102:1428-37 6. Doll R, Peto R. The causes of cancer: quantitative estimates of avoidable risks of cancer in the United States today. J Natl Cancer Inst. 1981 Jun: 66:1191-308 7. Reulen RC, Kellen E, Buntinx F, Brinkman M, Zeegers MP. A meta-analysis on the association between bladder cancer and occupation. Scand J Urol Nephrol Suppl. 2008 Sep:64-78 8. Golka K, Wiese A, Assennato G, Bolt HM. Occupational exposure and urological cancer. World J Urol. 2004 Feb: 21:382-91 9. Case RA, Hosker ME. Tumour of the urinary bladder as an occupational disease in the rubber industry in England and Wales. Br J Prev Soc Med. 1954 Apr: 8:39-50 10. Zheng T, Cantor KP, Zhang Y, Lynch CF. Occupation and bladder cancer: a populationbased, case-control study in Iowa. J Occup Environ Med. 2002 Jul: 44:685-91 11. Noon AP, Pickvance SM, Catto JW. Occupational exposure to crack detection dye penetrants and the potential for bladder cancer. Occup Environ Med. 2012 Apr: 69:300-1 12. Wallace DM. Occupational urothelial cancer. Br J Urol. 1988 Mar: 61:175-82 13. Cumberbatch MG, Cox A, Teare D, Catto JW. Contemporary Occupational Carcinogen Exposure and Bladder Cancer: A Systematic Review and Meta-analysis. JAMA Oncol. 2015 Dec: 1:1282-90 14. Teschke K, Morgan MS, Checkoway H, et al. Surveillance of nasal and bladder cancer to locate sources of exposure to occupational carcinogens. Occup Environ Med. 1997 Jun: 54:443-51 15. Serra C, Kogevinas M, Silverman DT, et al. Work in the textile industry in Spain and bladder cancer. Occup Environ Med. 2008 Aug: 65:552-9

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beating bladder cancer 16. Dryson E, t Mannetje A, Walls C, et al. Case-control study of high risk occupations for bladder cancer in New Zealand. Int J Cancer. 2008 Mar 15: 122:1340-6 17. Larre S, Catto JW, Cookson MS, et al. Screening for bladder cancer: rationale, limitations, whom to target, and perspectives. Eur Urol. 2013 Jun: 63:1049-58

Managing bladder cancer in the elderly

18. Boffetta P, Jourenkova N, Gustavsson P. Cancer risk from occupational and environmental exposure to polycyclic aromatic hydrocarbons. Cancer Causes Control. 1997 May: 8:444-72 19. Bourgkard E, Wild P, Courcot B, et al. Lung cancer mortality and iron oxide exposure in a French steel-producing factory. Occup Environ Med. 2009 Mar: 66:175-81 20. Friesen MC, Costello S, Eisen EA. Quantitative exposure to metalworking fluids and bladder cancer incidence in a cohort of autoworkers. American journal of epidemiology. 2009 Jun 15: 169:1471-8

‘At the present point, only about half of all MIBC patients are in a position to be fully cured of their cancer 5 years after diagnosis.’ Dr Anne E Kiltie, Associate Professor, Department of Oncology, University of Oxford, details the management of bladder cancer in the elderly and explains why there is an urgent need to improve current treatment strategies

21. Silverman DT, Hoover RN, Mason TJ, Swanson GM. Motor exhaust-related occupations and bladder cancer. Cancer Res. 1986 Apr: 46:2113-6 22. Porru S, Aulenti V, Donato F, et al. Bladder cancer and occupation: a case-control study in northern Italy. Occup Environ Med. 1996 Jan: 53:6-10 23. Colt JS, Baris D, Stewart P, et al. Occupation and bladder cancer risk in a population-based case-control study in New Hampshire. Cancer Causes Control. 2004 Oct: 15:759-69 24. Boffetta P, Silverman DT. A meta-analysis of bladder cancer and diesel exhaust exposure. Epidemiology. 2001 Jan: 12:125-30 25. Jain NB, Hart JE, Smith TJ, Garshick E, Laden F. Smoking behavior in trucking industry workers. American journal of industrial medicine. 2006 Dec: 49:1013-20 26. European Commision. Raw tobacco: Production and trade. 2015 [cited 20th April 2016]; Available from: http://ec.europa.eu/ agriculture/tobacco/

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ladder cancer is the 4th most common cancer in UK males (14th in females), with 10,341 new cases diagnosed in 2013 and 5,242 deaths in 2012. (1) Three-quarters of patients are men and more than half are over 75 years of age. Around a quarter of patients with the disease suffer from bladder cancer that has invaded the muscle wall. Other patients present initially with the superficial disease confined to the lining of the bladder, but this can progress to muscle-invasive bladder cancer (MIBC) in a proportion of patients. Logically speaking, up to one third of all patients may have muscleinvasive disease at some point. At the present point, only about half of all MIBC patients are in a position to be fully cured of their cancer 5 years after diagnosis, so there is an urgent need to improve on current treatment strategies. In Europe, the ‘gold standard’ treatment for MIBC is removal of the bladder and adjacent organs (prostate in men, uterus, ovaries and anterior vaginal wall in women) and lymph nodes. However, there has been a long history of use of radiotherapy for treatment of bladder cancer in the United Kingdom. Results appear similar from both approaches; although there has been no successful randomised controlled comparison between the two, as patients often die of metastases, when the disease spreads to other parts of the body (including lungs, bones, brain). Patients who are fit enough and with adequate kidney function are also offered a short course of cisplatin-based chemotherapy before their definitive treatment, which

Government Gazette

improves the survival rates by 5%. More recently the use of ‘chemoradiation’ has become a standard of care, where radiotherapy is accompanied by the use of drugs which make the radiation more effective. Chemoradiation is more effective at killing tumour cells than radiation alone, but this may be at the expense of causing increased side effects to the local normal tissues, including the bladder and the adjacent bowel and rectum which inevitably receive some radiation dosage from the treatment fields. The median age of patients treated with radical radiotherapy, where the treatment intention is to cure the patient rather than just provide symptom relief, in our joint uro-oncology clinic over the past five years was 81 years, which seems quite elderly. However, an 81 year old man in the UK is currently expected to live an additional 7.7 years and an 81 year old woman 9.0 years, so these patients would have been expected to live to nearly 90 years old had they not developed muscle-invasive bladder cancer. (2) A rather shocking statistic is that competing mortality only accounts for one-third of deaths in patients with MIBC over the age of 80 years. (3) This means that two-thirds of these patients are dying of their bladder cancer rather than another cause, reflecting the low numbers receiving radical treatment (12% vs 52% of under 60 year olds). Patients in their 80s can be treated by cystectomy but in this age group the mortality rate from the operation rises sharply from the 3% expected in younger patients. The median age at cystectomy is 68 years and only a small number of procedures are carried out in the


health report UK over the age of 80 years. (4) This means that such patients are often offered radiotherapy treatment if they are considered radically treatable, and such treatment is well tolerated in patients of this age group. However, the 2015 National Institute for Health and Clinical Excellence bladder cancer guidelines (5) recommend that patients are offered radiotherapy with a radiosensitiser rather than radiotherapy alone when radical therapy is suitable. Unfortunately, patients over the age of 75 years generally do not have adequate renal function to receive cisplatinbased chemotherapy and the median age of patients in the two recent randomised trials of non-cisplatin radiosensitisers, namely BCON (6) and BC2001 (7), were 74 years (oldest 90 years) and 71.9 years (oldest 76.2 years) respectively. Therefore, clinical trials do not address the issue of treatment of the elderly directly. There is an urgent clinical need to find radiosensitising treatments that are suitable for elderly patients, so that they can also receive the current standard of care. These should be easy to administer with minimal toxicity to the normal tissues, whilst improving tumour control. It is unlikely that we will be able to find an effective agent that confers no additional toxicity, so it is also important to identify biomarkers, either in the patient’s blood or within their tumour that could identify individuals most likely to benefit from adding a radiosensitiser. Biomarkers should also identify those patients who are unlikely to benefit, so that they can avoid the additional potentially harmful treatment and receive radiotherapy alone. In an era where the population is aging but people in their 80s have a good quality of life and life expectancy, it is important to find suitable radiosensitising agents to add to their bladder cancer radical radiotherapy treatment, so that this cohort of patients can receive standard of care and treatment similar to their younger counterparts Anne is also Honorary Consultant Clinical Oncologist, Oxford University Hospitals NHS Foundation Trust.

References: 1. Bladder Cancer Statistics, Cancer Research UK 3. Br J Cancer (2003) 108:1534-40. 4. Luke Hounsome, Predictors of use of orthotopic bladder reconstruction after radical cystectomy for bladder cancer, National Cancer Intelligence Network, 2011 5. Bladder cancer: diagnosis and management, National Institute for Health and Care Excellence, 2015 6. J Clin Oncol (2010) 28:4912-8 7. New Engl J Med (2012) 366:1477-88

What should Europe start, stop and do collectively with bladder cancer? By Louise de Winter, Chief Executive, The Urology Foundation detection of bladder cancer in patients. • Assess new technologies such as Hyperthermia and electromotive drug administration.

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n the UK, around 98,000 people are living with bladder cancer and over 10,000 new cases are diagnosed every year with 5,000 deaths. In the EU, there are approximately 123,135 new cases and 40,252 deaths attributed to bladder cancer per year. It is the fifth most common cancer in Western societies but receives a fraction of the research and awareness funding of other cancers. The field is characterised by a lack of scientific advancement. There is therefore an urgent need to overhaul most aspects of bladder cancer management so that improvements in long-term outcomes can rival those seen in other common malignancies. Bladder cancer is also the costliest lifetime cancer to treat per patient, as patients have to be constantly monitored for potential recurrence, so more efficient and cheaper diagnostic tests need to be developed. In England alone bladder cancer accounts for a total annual cost to the NHS of circa £65million. Early diagnosis means there is greater chance of survival. Research and clinical trials are vital to unlocking markers for diagnostic tests and drugs for treatment and cures. Mortality rates for bladder cancer in the UK have not really changed since the NHS was created. Meanwhile, five year survival rates for prostate and kidney cancers have significantly improved in this timeframe. Living in the UK also means that people’s chances of survival are lower than those in other European countries with comparable incidence rates, with overall deaths from the disease higher in England, and the rate appears to be getting worse, not better.

• Develop prognostic and predictive biomarkers to identify patients who may benefit from chemotherapy or radiotherapy along with surgery. • Investigate surveillance intervals with an aim to improve quality of life for patients. • Improve the management of the disease that positively impacts on survival. Collaboration – both pan-EU and, more broadly, international – is fundamental to research. Where EU grants facilitate collaboration, it can help the member states to achieve better results than if they were acting in isolation. Second, we need to be better at coordinating and using patient data to help innovative treatments to be brought more quickly to patients. The UK is fortunate in that the cradle-tograve care provided by the NHS to our socially and ethnically diverse large population provides opportunities for research which are unparalleled internationally. Analysis of patients’ data – such as clinical care data or data from clinical trials and observational studies (among others) - has underpinned our understanding of the disease and enabled development of new treatments and diagnostics, improving outcomes for patients and the wider population

So what could or should we be doing collectively across the EU that will also help to improve survival and outcome rates in the UK? First, bladder cancer has always been a ‘Cinderella’ cancer in the UK. Even Cancer Research UK has not designated this a priority cancer, despite the lack of new treatments. Charities such as The Urology Foundation are doing what we can to fund research but a more concerted drive is necessary to achieve significant breakthrough in diagnosis and prognosis. We desperately need more research to: • Develop new tests which will enable earlier

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Non-muscle invasive bladder cancer and the hope for urinary marker tests As a result of the persistent risk of recurrence and progression, patients with low, intermediate and high risk of recurrence of bladder tumours need to be followed up regularly at different intervals. Until now, no urinary marker could replace cystoscopy during follow-up or help to lower cystoscopic frequency in routine fashion.

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o date, no non-invasive methods can replace endoscopy. Therefore, follow-up is based on regular cystoscopy. These repeated invasive procedures pose a huge burden on patients and the healthcare systems. Many workgroups and researchers have attempted to identify urinary markers that could detect recurrence before the tumours are large and numerous. The limitation of those urinary markers available is that they still miss a significant portion of tumours found by cystoscopy and therefore cannot be relied upon.

What are the characteristics of a good bladder cancer marker? Technically as simple as possible Easy to perform, with a short learning curve Preferably a point-of-care test, with readily available results Reliable and reproducible Highly specific to avoid unnecessary workup because of false-positive results Highly sensitive to avoid the risk of missing a tumour

Considering the frequency of cystoscopy for follow-up, markers for recurrent urothelial cancer would be especially useful because patients prefer less invasive measures and minimum time spent inside healthcare environments. According to the discussion at Bladder Cancer Europe 2016 Roundtable organised by the International Centre for Parliamentary Studies in Brussels in June 2016, such biomarkers are impatiently awaited by the urologist and patient community. It seems that promising new markers will be available soon. Respective studies, e.g. UroFollow in Germany, are expected to receive a lot of attention. By Dr

Anne Postulka, Senior Director, Medical and Economic Value, Europe, Cepheid


With a cancer diagnosis, time is the critical factor. Gaining early insight can dramatically impact the efficacy of patient action plans, from quality of life to outcome. Cepheid’s innovative oncology program will bring molecular testing closer to patients to optimize treatment plans from the start. When time matters, early insight means better patient management. Come join our journey at www.cepheidinternational.com Vira Solelh | 81470 Maurens-Scopont, France

|

PHONE

+33.563.82.53.00 |

FAX

+33.563.82.53.01 |

EMAIL cepheid@cepheideurope.fr


beating bladder cancer

Epidemiology of bladder cancer in Europe The European Commission’s Joint Research Centre is spearheading the development of a harmonised cancer information system for Europe in collaboration with the European Network of Cancer Registries. Dr Emanuele Crocetti, MD, Joint Research Centre, Public Health Policy Support Unit, Institute for Health and Consumer Protection, European Commission, explains the role of the ongoing collaboration and presents data relating to epidemiology of bladder cancer

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131,000 (103,000 men and 28,000 women), and new cases are expected to increase to 141,000 in 2020.

he European Commission Joint Research Centre (JRC) in Ispra, Italy, has recently extended its capacity in connecting research and policy with a recently established activity, the setting-up of an integrated and comprehensive cancer information system for Europe. The goal is to improve access to, and availability of updated and reliable information on the cancer burden in Europe. The information system includes data on both primary and recurrent cases, on geographical patterns, and on temporal trends in incidence, mortality, prevalence and survival. Such information is required to support health policy interventions and, at a later stage, enable evaluation of their effectiveness.

Within the European Union, there is huge variability in incidence rates; among men – from the age-adjusted rate (on the World standard population, ASR) of 31.0, for Belgium, to the lower rate of 9.2 for the UK; and for women, rates range from 7.4, for Hungary, to 2.5 for Cyprus.

To achieve these aims, a strong collaboration has been established between the JRC and the population-based cancer registries (CR), all over Europe, because of their invaluable role as raw data collectors. Since 2013, the JRC has hosted the Secretariat of the European Network of Cancer Registries (ENCR), a scientific network of over 150 European registries.

With regards to cancer mortality, in the European Union, bladder cancer represents the ninth most frequent cause of cancer death, with around 40,000 deaths (3% of total cancer deaths,) estimated in 2012, and nearly 43,000 estimated for 2015. Mortality from bladder cancer has decreased over time throughout Europe, among men, while it is relatively stable and/or sometimes decreasing among women.

In the European Union (EU-28), according to estimates from the International Agency for Research on Cancer (IARC), bladder cancer ranks fifth among the most frequently diagnosed cancers, with about 124,000 new cases predicted in 2012 for both sexes, representing around 5% of all the incident cases. Among men, with 97,000 new diagnoses estimated for 2012 bladder cancer represents around 7% of all new cancer cases, ranking fourth after prostate, lung, and colorectal cancers. Among women, it is the thirteenth most frequently diagnosed tumor, with 27,000 new cases per year, representing around 2% of all new cancer cases. In 2015, estimated new cases were about

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The epidemiology of bladder cancer is related to the main risk factor: smoking. Therefore, the temporal trend of age-standardised incidence rates has followed the changes in the prevalence of smokers in the population. Indeed, in many countries, there was a long standing increasing trend (especially among men) in previous years, followed by a more recent decrease and/or a flattening of trends.

Approximately 324,000 EU citizens are estimated to have had a bladder cancer diagnosis in the last five years (five-year prevalence). In other words, around 9% (around 3,700,000) of all European citizens who have had a previous (5-year) cancer diagnosis, and are not deceased, had a bladder cancer diagnosis. These patients require clinical follow-up and the assistance of urologists. As regards survival indicators, the EUROCARE project has compared cancer survival data among European countries for decades, and currently the 6th edition will benefit from fruitful collaboration and coordination with the ENCR-JRC project.

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The most recent data from the EUROCARE-5 project has shown that the 5-year relative survival for bladder cancers, diagnosed between 2000 and 2007, is, on average, around 69% varying from 75% in Northern European countries to 65% in Eastern Europe. Some of these differences are presumably related to the stage at diagnosis. In fact, after one year from diagnosis the probability of surviving an additional 5 years not only improves substantially – it is on average 81%, but the geographical differences decrease from 85% in Southern Europe to 80% in Central Europe. Finally, unlike many other tumors, bladder cancer survival is higher in men (European agestandardised 5-year relative survival 69%) than in women (66%). Bladder cancer registration represents a challenge for CR staff due to its complex biology. This includes both non-invasive and invasive tumors and the use of different grade and stage definitions. Moreover, this cancer is typically characterised by multifocal onsets and recurrences. Therefore, comparable and reliable information, collected at EU-28 level, will only be achieved if common classifications and rules are correctly applied in order to ensure that data refer to equivalent lesions. Indeed, the decision to include or exclude non-invasive papillary or flat tumors may affect incidence and survival estimates, making comparisons unreliable. Current ENCR recommendations to European cancer registries recommend full registration (all histological type and stages) of bladder tumors. To achieve the goal of harmonised European bladder cancer information, ongoing collaboration between the Joint Research Centre and the European Network of Cancer Registries is vital, as well as a strong collaboration with urologists and oncologists, to keep in contact the data collection with all the relevant scientific innovations


health report

How to improve outcomes in Muscle Invasive Bladder Cancer Muscle invasive bladder cancer is a complex disease that requires aggressive treatments. Due to the aggressive nature of the disease, timely diagnosis and prompt treatment is required. However, nearly 50% of bladder cancer patients die despite aggressive surgery. Prof

Hein

Van Poppel, Adjunct Secretary General -

Education, European Association of Urology, addresses ways to improve outcomes.

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n the last 30 years, we have not been able to improve the survival rates of our muscle invasive bladder cancer patients. Although we have better surgical and anesthesiological tools, and that there was a dramatic decrease in mortality of cystectomy, bladder cancer continues to kill and about 50% of patients die from the disease despite aggressive surgery. The success of cystectomy in bringing cure depends on the timely indication. Once invasive bladder cancer cannot be controlled with BCG and once the tumor has invaded the muscular layer, a cystectomy should be proposed and conservative measures are not allowed when the patient is fit for surgery. The cure rates are indeed significantly better in organ confined disease compared to extravesical extension and lymph node invasion. (1) Moreover, unlike in prostate cancer for instance, surgery is relatively urgent since postponing surgery more than 3 months from the diagnosis of muscle invasion has a significantly worse outcome. (2) Although bladder sparing approaches (transurethral resection, systemic chemotherapy and radiotherapy) can obtain good results in selected patients, a Cochrane database analysis of individual trials shows a benefit of radical surgery over radiation. (3) In the male bladder, extirpation means a radical cystoprostatectomy with eventually simultaneous urethrectomy when the prostatic urethra is invaded. In the female, it equals an anterior exenteration with hysterectomy, ovariectomy, anterior colpectomy and cystourethrectomy. Obviously, a cystectomy must achieve negative surgical margins since positive surgical margins decrease the 5 year cancer specific survival from 69 to 26.4 %. Performance of minimal invasive techniques (laparoscopic and robot

assisted cystectomy) are therefore not the optimal approach for advanced bladder cancer. (4) Moreover, it has become clear from multiple studies that an extended lymph node dissection should accompany the cystectomy. Probably the lymph node clearing should encompass the external and internal iliac vessels, the obturator fossa and the common iliac artery up to the ureteral crossing. (5) A super extended lymphadenectomy up to the aorta and vena cava did not provide a benefit versus the extended dissection (6). Since the publication of the neo-adjuvant chemotherapy studies, it has become clear that this treatment strategy before cystectomy improves the 10 year survival by nearly 6% (7) and therefore it is actually mentioned in the EAU Guidelines on Muscle Invasive Bladder Cancer that neo-adjuvant cisplatin containing combination chemotherapy should be offered in muscle invasive bladder cancer irrespective of further treatment. It is obviously not recommended in patients with a poor performance status or impaired renal function. (8) Also adjuvant chemotherapy, analysed in a meta-analysis showed a survival advantage (Advanced Bladder Cancer Analysis Collaboration) (9). A recent analysis of an international intergroup randomised phase III trial comparing immediate versus deferred chemotherapy after cystectomy in pT3, pT4 and/or N+ bladder cancer showed a significant improvement in progression free survival, most obvious in node negative patients (10). It is likely that the EAU Guidelines about adjuvant chemotherapy will need to be updated since

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this recent data. The last important point is to concentrate the cystectomies in high volume centers. As shown by Barbieri et al, (11) there is a significant reduced mortality in centers that perform more than 60 cystectomies per year. Another study showed that a number of annual procedures favors high volume versus low volume centers. (12) In conclusion, radical cystectomy with extended pelvic lymph node dissection is the treatment of choice for muscle invasive bladder cancer. Cure implies timely indication for muscle invasive bladder cancer. Cure implies timely indication in performance of cystectomy while bladder sparing and less aggressive approaches must be carefully selected. It is likely that more cisplatin based chemotherapy will ultimately make the difference and this needs a mind change in the urological community and finally surgery is best done in experienced high volume centers References: 1. JP Stein, G. Lieskovsky, R. Cote et al. Radical cystectomy in the treatment of invasive bladder cancer: Long-term results in 1054 patients. J Clin Oncol 2001; 19: 666 2. RF Sanchez – Ortiz, WC Huang, R Mick et al. An interval longer than 12 weeks between the diagnosis of muscle invasion and cystectomy is associated with worse outcome in bladder carcinoma. J Urol 2003; 169: 110-115. 3. M Shelley. Surgery versus radiotherapy for transitional cell carcinoma. Cochrane database systematic reviews 2002

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4. G Novara, V Ficarra, S Mocellin, et al. 5. Systematic review and meta-analysis of studies reporting oncologic outcome after robot-assisted radical prostatectomy. Eur Urol 2012;62:382-404

neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial. J Clin Oncol. 2011;29: 21712177.

6. NB Dhar, EA Klein, AM Reuther, et al. Outcome after radical cystectomy with limited or extended pelvic lymph node dissection. J Urol 2008; 179: 873-878.

9. A Stenzl, NC Cowan, M De Santis et al. Treatment of muscle-invasive and metastatic bladder cancer: update of the EAU Guidelines. Eur Urol 2011; 59: 1009-1018.

7. P Zehnder, UE Studer, EC Skinner et al. Super extended versus pelvic lymph node dissection in patients undergoing radical cystectomy for bladder cancer: a comparative study. J Urol 2011; 186: 1261-1268.

10. Adjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis of individual patient data Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Eur Urol 2005; 48: 189-201

8. International phase III trial assessing

11. C. Sternberg, I Skoneczna, JM Kerst et al.

Immediate versus deferred chemotherapy after radical cystectomy in patients with pT3-pT4 or N+ M0 urothelial carcinoma of the bladder (EORTC 30994): an intergroup, open label, randomised phase 3 trial. Lancet Oncology 2015; 16: 76-86 12. CE Barbieri, B Lee, MS Cookson et al. Association of procedure volume with radical cystectomy outcomes in a nationwide database. J Urol 2007; 178: 1418 13. LS Elting, C Pettaway, BN Bekele et al. Correlation between annual volume of cystectomy, professional staffing, and outcomes: a statewide, population based study. Cancer 2005; 104: 975-984.

Why do bladder cancer patients still receive open surgery in 2016?

Laparoscopic, minimal invasive surgery has proved to be a fair alternative for open radical cystectomy, and has reduced preoperative blood loss, intensive care admission, postoperative recovery and hospital stay dramatically. Dr

Laurent

Fossion, MD, Head of Urology, Maxima Medisch Centrum

discusses the effectiveness of various surgery options available for bladder cancer patients

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ladder cancer is the second most common urologic malignancy after prostate cancer. It is most frequently diagnosed among people aged 75-84 yrs, and has the highest risk to be lethal in this age category. (1) At the time of initial diagnosis, 19% of patients with bladder cancer present with muscle-invasive bladder cancer

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(MIBC). In the absence of distant metastasis, the treatment of choice for MIBC is radical cystectomy (= removal of the bladder), pelvic lymphadenectomy and urinary diversion. (2,3) Minimal invasive surgery instead of open surgery The first laparoscopic radical cystectomy (LRC) for bladder cancer was performed by Sanchez

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in 1993. (4) Since then several centres have started performing LRC. First published data were single centre/surgeon based and suggested reduced blood loss and faster recovery after laparoscopic surgery in comparison with open radical cystectomy (ORC). Proved oncologic equivalence Recently, a large European multicentre study,


health report

coordinated by the European Association of Urology Section of Uro-Technology (ESUT), has confirmed the equivalence in oncologic outcome comparing LRC with the standard of care (i.e. ORC). The ESUT gathered nine bladder cancer centres enrolling 503 patients undergoing LRC for bladder cancer prospectively between 2000 and 2013. This study, the largest to date, showed long-term recurrence free survival, cancer specific survival and overall survival rates after LRC comparable to those reported in current ORC series. (5,6,7) Advantages of LRC over ORC and RARC The first randomised control trial (RCT) has now showed the advantages of the LRCtechnique over the alternatives: less early complications and faster return to oral intake in comparison with open surgery (ORC) and a significantly shorter operative time and significant reduced cost aspect in comparison with robot assisted surgery (RARC).(8) The effect of less blood loss in oncologic surgery There are different studies in the last decades focussing on and the impact of perioperative blood transfusion (PBT) in cancer patients’ survival. Most of them have supported an independent association between PBT and worse survival in those with solid tumor malignancies. Moreover PBT is associated with significantly increased risks of cancer recurrence and mortality following ORC. This supports the choice for minimal invasive surgery in bladder cancer surgery. (9). LRC safe in elderly Radical cystectomy in the elderly population (> 75 yrs) is an aggressive surgical treatment with a significant complication rate, hospital readmission and perioperative mortality rate. Accordingly many urologists are reluctant to perform RC in elderly. LRC has showed new perspectives for the elderly. Thanks to the advantages of minimal invasive surgery, the elderly have now become candidates for curation of their malignancy. This is of extreme importance as our life expectancy grows and elderly count for the majority of our bladder cancer patient population. (10) LRC is the cheapest technique The total costs of radical cystectomy comprise a significant part of the total costs of bladder cancer treatment. Total costs may be very high for a cystectomy with complications. Peri-operative blood loss seems to be the most important factor associated with high total hospital costs for ORC. If the amount of bleeding can be influenced then substantial reductions in the total costs of cystectomy would seem possible. Robotic assisted radical cystectomy (RARC) is associated with a significant higher financial cost than the open approach (ORC). LRC has shown equivalent costs as for ORC, even in our learning curve. One can imagine LRC experts

have meanwhile obtained reduced financial costs since their experience (i.e. 180 LRCprocedures in our series). (11) Quality improvement and centralisation of cystectomies in centres of excellence Several countries have introduced minimal requirements regarding the number of radical cystectomies performed per year and regarding the infrastructure of the hospital (ICU-level, ER-level) to improve the quality of care in bladder cancer surgery. This is based on the principle that high volume centres (e.g. > 20 cystectomies per year) show better outcome and less mortality. The same principle counts specifically for the surgeon/urologist and his bladder cancer team, as the more experience the urologist and his team obtain, the better his knowledge and surgical skills will become. Performing cystectomies in expert centres will allow to improve the outcome results. (12) Conclusion Laparoscopic radical cystectomy (LRC) seem to be the best candidate to become the new golden standard for curative treatment for muscle invasive bladder cancer. Equivalence in oncologic outcome, reduced blood loss and faster recovery after laparoscopic surgery has been confirmed in comparison with the standard of care: open radical cystectomy. LRC shows a significantly shorter operative time and significant reduced cost aspect in comparison with robot assisted cystectomy (RARC). Elderly can benefit from this technique References: 1. SEER Stat Fact Sheets: Bladder Cancer in the US. 2009-2013. 2. Guidelines on bladder cancer. Oosterlinck W1, Lobel B, Jakse G, Malmström PU, Stöckle M, Sternberg C. Eur Urol. 2002 Feb;41(2):105-12. 3. EAU guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2013 guidelines. Witjes JA, Compérat E, Cowan NC, De Santis M, Gakis G, Lebret T, Ribal MJ, Van der Heijden AG, Sherif A. Eur Urol. 2014 Apr;65(4):778-92. doi: 10.1016/j. eururo.2013.11.046. Epub 2013 Dec 12. 4. Radical cystectomy and laparoscopic ileal conduit. Sánchez de Badajoz E, Gallego Perales JL, Reche Rosado A, Gutiérrez de la Cruz JM, Jiménez Garrido A. Arch Esp Urol. 1993 Sep;46(7):621-4. 5. Long-term analysis of oncological outcomes after laparoscopic radical cystectomy in Europe: results from a multicentre study by the European Association of Urology (EAU) section of Uro-technology. Albisinni S, Rassweiler J, Abbou CC, Cathelineau X, Chlosta P, Fossion L, Gaboardi F, Rimington P, Salomon L, Sanchez-Salas R, Stolzenburg JU, Teber D, van Velthoven R. BJU Int. 2015 Jun;115(6):937-45. doi: 10.1111/bju.12947.

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Epub 2014 Dec 18. 6. Critical Analysis of Early Recurrence after Laparoscopic Radical Cystectomy in a Large Cohort by the ESUT. Albisinni S, Fossion L, Oderda M, Aboumarzouk OM, Aoun F, Tokas T, Varca V, Sanchez-Salas R, Cathelineau X, Chlosta P, Gaboardi F, Nagele U,Piechaud T, Rassweiler J, Rimington P, Salomon L, van Velthoven R. J Urol. 2016 Jan 18. pii: S0022-5347(16)00037-9. doi: 10.1016/j. juro.2016.01.008. 7. The morbidity of laparoscopic radical cystectomy: analysis of postoperative complications in a multicenter cohort by the European Association of Urology (EAU)Section of Uro-Technology. Albisinni S, Oderda M, Fossion L, Varca V, Rassweiler J, Cathelineau X, Chlosta P, De la Taille A, Gaboardi F, Piechaud T, Rimington P,Salomon L, Sanchez-Salas R, Stolzenburg JU, Teber D, Van Velthoven R. World J Urol. 2016 Feb;34(2):149-56. doi: 10.1007/s00345-0151633-1. Epub 2015 Jul 2. 8. A single-centre early phase RCT three-arm trial of open, robotic and laparoscopic radical cystectomy (CORAL). Khan MS, Gan C, Ahmed K, Ismail AF, Watkins J, Summers JA, Peacock JL, Rimington P, Dasgupta P. Eur Urol. 2016 Apr;69(4):613-21. doi: 10.1016/j. eururo.2015.07.038. Epub 2015 Aug 10. 9. The impact of perioperative blood transfusion on cancer recurrence and survival following radical cystectomy. Linder BJ, Frank I, Cheville JC, Tollefson MK, Thompson RH, Tarrell RF, Thapa P, Boorjian SA. Eur Urol. 2013 May;63(5):839-45. doi: 10.1016/j. eururo.2013.01.004. Epub 2013 Jan 11. 10. Perioperative and survival outcomes of laparoscopic radical cystectomy for bladder cancer in patients over 70 years. Fontana PP, Gregorio SA, Rivas JG, Sánchez LC, Ledo JC, Gómez ÁT, Sebastián JD, Barthel JJ. Cent European J Urol. 2015;68(1):24-9. doi: 10.5173/ceju.2015.01.498. Epub 2015 Mar 13. 11. What about conventional laparoscopic radical cystectomy? Cost-analysis of open versus laparoscopic radical cystectomy. Hermans TJ, Fossion LM. J Endourol. 2014 Apr;28(4):4105. doi: 10.1089/end.2013.0550. Epub 2013 Dec 30. 12. Volume outcomes of cystectomy--is it the surgeon or the setting? Morgan TM, Barocas DA, Keegan KA, Cookson MS, Chang SS, Ni S, Clark PE, Smith JA Jr, Penson DF. J Urol. 2012 Dec;188(6):2139-44. doi: 10.1016/j. juro.2012.08.042. Epub 2012 Oct 18.

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Path to an upgraded EU policy on bladder cancer By Rik

Bryan and Jeannie Rigby,

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n Western societies, bladder cancer (BC) is the fourth most common cancer in men and ninth most common in women, (1) with a rising number of newly-diagnosed patients globally (2,3). In the UK, the disease accounts for approximately 10,000 new cases and 5,000 deaths per year. (4) Despite high incidence and prevalence, the treatment of BC has changed very little over the past 25-years and outcomes have not improved. (5,6) There is a lack of improvement, even deterioration, in age-standardised mortality rates since the 1980s; and this picture is reflected across Europe. (7) Furthermore, bladder cancer is one of the most expensive malignancies to manage on a per patient basis from diagnosis to death, (8) and does not perform well in the National Cancer Patient Experience Survey. (9) Bladder cancer is thus common, expensive to treat, has experienced little improvement in outcomes, and there is a pattern of poor experiences for patients across the UK – bladder cancer is a forgotten or “Cinderella” cancer. Patient pathways are complex, prolonged, and practiced in various permutations at every stage. (10) A view shared by many clinicians and academics in the bladder cancer field is that the key contributor to this disappointing scenario is a considerable lack of research funding. (5) We don’t actually have the robust evidence from fundamental research, translational research and clinical trials to support a lot of what we do as clinicians (10), thus contributing to a lack of progress and a direct negative impact for bladder cancer patients. If we are to address bladder cancer and improve outcomes, as have been achieved for prostate and kidney cancer, then we need to obtain more funding for clinical trials, translational science and health services research. We also need to tackle the poor awareness of bladder cancer among the general public and the non-urological scientific community (5-7), and there is a necessity for better understanding within primary care. In addition, without a national screening programme (due to lack of accurate and reliable diagnostic tests), bladder cancer is often diagnosed late with a comparatively high percentage of patients diagnosed only upon emergency admission, resulting in a negative effect on longer-term outcomes. (11) And where are bladder cancer’s new drugs (10,12)? It feels as though the pharmaceutical industry has deserted the disease (10) - no new

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on behalf of Action Bladder Cancer UK

drugs have emerged into clinical practice for over 20-years. (5,12). More urgently, there is a desperate need to find an alternative to one of the most commonly-used and effective treatments – BCG (TB vaccine, administered into the bladder (13,14) has been plagued by an unreliable global supply and shortages for 5 years, leaving patients and clinicians in a quandary (15), yet very little appears to be on the horizon as an alternative. (10) This shortage has been compounded by a lack of research in this setting, such that we have poor insight into which patients benefit most from BCG therapy (which is often poorly tolerated), and which patients might be optimally treated by surgery to remove the bladder altogether (cystectomy). (14,16)

progression of disease in non-muscle-invasive bladder cancer: from epidemiology to treatment strategy. Eur Urol 2009: 56(3):430-442.

Crucially, cancer research is currently in the midst of a “genomics revolution.” The first sequenced human genome cost almost USD 3 billion and had taken 13 years when completed in 2003. Today, this same achievement costs USD 1000 and takes a few days. (17). This technology is therefore rapidly becoming a reality for the clinic and should enable genuine precision medicine in the cancer setting – identifying which patients will benefit most from which treatments (e.g. BCG, chemotherapy, radiotherapy, etc).

8. Svatek RS, Hollenbeck BK, Holmang S, Lee R, Kim SP, Stenzl A et al. The Economics of Bladder Cancer: Costs and Considerations of Caring for This Disease. Eur Urol 2014.

Accompanying this is the potential for early diagnosis and less invasive monitoring by sequencing fragments of abnormal DNA in bodily fluids such as blood or urine. (18) Without funding for the underpinning research in bladder cancer, our patients will miss out on these innovations and we will be impaired in our ability to improve outcomes and reduce the burden of the disease.

11. National Cancer Intelligence Network. Routes to Diagnosis http://www.ncin.org.uk/publications/ routes_to_diagnosis. 2013.

Action Bladder Cancer UK is often told by bladder cancer patients that they are angry, feel overlooked, and question why such a serious and common condition is so neglected. By turning the spotlight on bladder cancer, and providing the investment demanded by incidence and prevalence, we strongly feel that improvements in outcomes (and streamlining of treatment pathways and related expenses) could emulate that of other cancers References: 1. Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P et al. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol 2013: 63(2):234-241. 2. Ploeg M, Aben KK, Kiemeney LA. The present and future burden of urinary bladder cancer in the world. World J Urol 2009: 27(3):289-293. 3. Van Rhijn BW, Burger M, Lotan Y, Solsona E, Stief CG, Sylvester RJ et al. Recurrence and

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4. Cancer Research UK. Cancer Statistics for the UK http://www.cancerresearchuk.org/health-professional/ cancer-statistics. 2016. 5. Boormans JL, Zwarthoff EC. Limited Funds for Bladder Cancer Research and What Can We Do About It. Bladder Cancer 2016: 2(1):49-51. 6. Fillon M. Urology meeting highlights prostate, bladder cancers. J Natl Cancer Inst 2012: 104(18):1348-1349. 7. Marcos-Gragera R, Mallone S, Kiemeney LA, Vilardell L, Malats N, Allory Y et al. Urinary tract cancer survival in Europe 1999-2007: Results of the population-based study EUROCARE-5. Eur J Cancer 2015.

9. Saunders CL, Abel GA, Lyratzopoulos G. Inequalities in reported cancer patient experience by socio-demographic characteristic and cancer site: evidence from respondents to the English Cancer Patient Experience Survey. Eur J Cancer Care (Engl ) 2015: 24(1):85-98. 10. Bryan RT, Kirby R, O’Brien T, Mostafid H. So Much Cost, Such Little Progress. Eur Urol 2014.

12. Bryan RT, James ND. Bladder cancer: time for a rethink? Oncology (Williston Park) 2011: 25(10):965, 968. 13. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Comperat E et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2013. Eur Urol 2013: 64(4):639653. 14. Liu X, Dowell AC, Patel P, Viney RP, Foster MC, Porfiri E et al. Cytokines as effectors and predictors of responses in the treatment of bladder cancer by bacillus Calmette-Guerin. Future Oncol 2014: 10(8):1443-1456. 15. Mostafid AH, Palou RJ, Sylvester R, Witjes JA. Therapeutic options in high-risk non-muscleinvasive bladder cancer during the current worldwide shortage of bacille Calmette-Guerin. Eur Urol 2015: 67(3):359-360. 16. Thomas F, Rosario DJ, Rubin N, Goepel JR, Abbod MF, Catto JW. The long-term outcome of treated high-risk nonmuscle-invasive bladder cancer: time to change treatment paradigm? Cancer 2012: 118(22):5525-5534. 17. Hayden EC. Technology: The $1,000 genome. Nature 2014: 507(7492):294-295. 18 Togneri FS, Ward DG, Foster JM, Devall AJ, Wojtowicz P, Alyas S et al. Genomic complexity of urothelial bladder cancer revealed in urinary cfDNA. Eur J Hum Genet 2016.


health report

How to reduce economic costs of bladder cancer?

Did you know that bladder cancer is the most expensive to treat, owing to the inefficient screening mechanisms?

Dr J. Alfred Witjes, Department of Urology, Radboud

University Nijmegen Medical Centre, says there is a lot to be improved in bladder cancer prevention, diagnosis and treatment. Though there are new developments in markers and therapy, he says better awareness of the economic burden would be a great step forward.

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ne of the first reports dealing with the economics of bladder cancer was published in 2003. (1) Botteman et al. performed a critical systematic review on the health economics of bladder cancer in developed countries. They also tried to identify opportunities or interventions to improve effectiveness of bladder cancer care and thereby reduce burden and costs. Although bladder cancer was identified as the fifth most expensive cancer in total medical care expenditures, per patient costs from diagnosis until death were highest of all cancers, ranging from 96-187 k$ in the US. A similar conclusion for the European situation is difficult to draw. Sievert et al. looked at the European economic aspects and identified 2 interesting aspects. (2). The first was the impact of the fact that bladder cancer has two different entities. Non muscle-invasive bladder cancer (NMIBC) is treated with local resection (transurethral

resection, TUR) of the tumor and subsequent intravesical instillations in the bladder to reduce recurrence rates of the tumor. In spite of this adjuvant treatment, although also depending on the risk category of the tumor, recurrences rates are as high as 61% within one year after TUR in the highest risk group. (3,4). Muscle invasive bladder cancer (MIBC), on the other hand, is treated after diagnosis by TUR with a combination of chemotherapy and surgery (removal of the bladder, radical cystectomy), which is clearly a totally different therapy and with a different outcome and impact on health related quality of life. Sievert et al. reported that two-thirds of bladder cancer costs were related to the TUR procedure for NMIBC. A second interesting point is that costs and benefits in Europe differ significantly per country and health care system. TUR costs, for example, differed between €845 in France as compared to €2,231 in Germany. Radical cystectomy, on the other hand, ranged between €3,867

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in the UK and €15,419 in Germany. The overall economic burden of bladder cancer in the European Union (EU) was addressed in 2016 by Leal et al. (5) For the year 2012, €4.9 billion was spent on bladder cancer in the EU. Health care (expenditures on primary, outpatient, emergency, and inpatient care, as well as medications) accounted for €2.9 billion (59%), which represented 5% of total health care cancer costs in the EU. Also taking into account estimation of other costs (23% for productivity losses and 18% for informal care), bladder cancer accounted for 3% of all EU cancer costs, representing an annual healthcare cost of €57 per 10 EU citizens. Again, however, costs varied >10 times between the country with the lowest cost, (Bulgaria, €8 for every 10 citizens), and highest cost (Luxembourg, €93). In summary, bladder cancer is a very costly disease, and costs differ significantly throughout Europe.

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Reduction of costs In 2003, Botteman et al. already identified several points where costs might be reduced. Screening of bladder cancer is not efficient, due to the low incidence rate, not even in high risk patients, and due to the low performance (urinary cytology), costs (cystoscopy) or absence (markers) of diagnostic tests. Especially good urinary markers might improve diagnosis and reduce burden and costs. Currently used therapies, both for NMIBC and MIBC are introduced decades ago, and have not really improved. For NMIBC current therapies have not proved to be cost effective, since they have not consistently demonstrated survival benefits, nor have been able to prevent radical cystectomies. One small step forward has been the introduction of blue light cystoscopy, which has proven to be clinically effective and cost-effective for diagnosis and treatment of NMIBC, indeed reducing economic burden. (6) Follow up of bladder cancer patients is not evidence based and predominantly expert opinion. Less frequent and less invasive monitoring will be cost effective, but is difficult to test in the clinical setting. Another potential cost saving strategy is centralization of for example radical surgery. Several reports have shown that the surgical volume is clearly related to morbidity (and costs) and mortality due to the disease and the procedure. Leow et al., for example, found that surgeons performing >7

radical cystectomies had a 45% lower odds ratio of major complications and a cost reduction of $1,690. (7) There was a striking difference in 90-day median hospital costs between patients without complications as compared to those with a major complication ($43 965 vs $24 341; P < 0.001). A clearly defined cut-off for a minimal yearly number of cystectomies, however, remains to be defined. Finally, even though there are guideline recommendations on treatment and follow up, these are not followed well throughout the urological community. (8) In all there is still a lot to be improved in bladder cancer prevention, diagnosis and treatment, both for NMIBC and MIBC. There are new developments in markers and therapy, but better awareness of the economic burden of bladder cancer for patients, healthcare providers and policy makers would certainly be a step forward References: 1. Botteman MF1, Pashos CL, Redaelli A, Laskin B, Hauser R. The health economics of bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003;21:1315-30. 2. Sievert KD, Amend B, Nagele U, Schilling D, Bedke J, Horstmann M, Hennenlotter J, Kruck S, Stenzl A. Economic aspects of bladder cancer: what are the benefits and costs? World J Urol 2009;27:295–300 3. Sylvester RJ, van der Meijden AP,

Oosterlinck W et al. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol 2006;49:466-477. 4. Fernandez-Gomez J, Madero R, Solsona E et al. Predicting nonmuscle invasive bladder cancer recurrence and progression in patients treated with bacillus CalmetteGuerin: the CUETO scoring model. J Urol 2009;182:2195-2203. 5. Leal J, Luengo-Fernandez R, Sullivan R, Witjes JA. Economic burden of bladder cancer across the European union. Eur Urol 2016;69:438-47 6. Witjes JA, Babjuk M, Gontero P, Jacqmin D, Karl A, Kruck S, Mariappan P, Palou Redorta J, Stenzl A, van Velthoven R, Zaak D. Clinical and cost effectiveness of hexaminolevulinateguided blue-light cystoscopy: evidence review and updated expert recommendations. Eur Urol. 2014;66:863-71 7. Leow JJ, Reese S, Trinh QD, Bellmunt J, Chung BI, Kibel AS, Chang SL. Impact of surgeon volume on the morbidity and costs of radical cystectomy in the USA: a contemporary population-based analysis. BJUI int 2015;115:713-21 8. Chamie K, Saigal CS, Lai J, Hanley JM, Setodji CM, Konety BR, Litwin MS. Compliance with guidelines for patients with bladder cancer. Cancer 2011, 117:5392-401

Screening for bladder cancer: rationale and perspectives Bladder Cancer screening is currently not recommended in routine practice partly because of low overall incidence. However, Prof Morgan Roupret, Professor, Université Paris, believes that rational screening policies for smaller groups of people based on the presence of risk factors are most likely to benefit from screening

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creening is a strategy used in a population to identify an unrecognized disease in individuals without signs or symptoms. Screening allows for “early detection” of the disease before it has been revealed by any symptoms. An efficient screening program, thus, impacts the specific mortality of the disease, and the benefit risk/ cost must be clearly established. There is one major disease in the field of

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urologic oncology for which the opportunity of a screening programme could and should be considered: bladder carcinomas (BCa). With the unpleasant clinical outcomes of patients dying from advanced and metastatic BCa, and the recognition that this disease is indeed a public health problem, a logical assumption is that early detection would reduce mortality and morbidity from this disease. (1) From a general health policy perspective, screening for a specific disease in the general population is useful, contingent upon the fact that five conditions are met. 1. The disease must be a threat to the general population due to its epidemiology (incidence and prevalence) and its specific mortality. 2. There is an effective screening test for the disease.

of smoking of ≥ 40 pack-years revealed a significant proportion (3.3%) of individuals with malignancy. In a screening trial in a recent study, the optimal high-risk population most likely to benefit from screening was men older than 60 years, with a smoking history of >30 pack-years; this group had incidence rates of more than 2/1,000 person-years [6]. Thus, a screening strategy for BCa, particularly in smokers, has been previously used, without any convincing data. It is my personal feeling that the future of screening strategy is hidden in DNA. Cancer is a multifactorial disease that arises from the complex interplay between genetic and environmental factors. Genetic polymorphism is defined as the presence of different allele sequences for a single gene; it is sometimes linked to variations in the expression of constitutive DNA.

3. This test is acceptable in terms of its cost and morbidity rate.

Susceptibility means an increased risk conferred by one or “Preventing BCa is more polymorphisms 4. There is an effective treatment for (allele types) of a given certainly the most the disease. gene or genes that important approach 5. This treatment is acceptable in the individual, to reduce its incidence expose terms of its cost and morbidity rate. family or group of and patient mortality. individuals (ethnic/ Does bladder cancer (BCa) meet Until screening tests geographic variations) these five criteria? to the genotoxic effects are available, in my BCa is the sixth most common of environmental opinion, smoking cancer overall, with an estimated carcinogens. Differences 72,570 new cases and 15,210 deaths avoidance and smoking in the ability to activate in 2013 in the United States [1, cessation are the two carcinogens may 2]. BCa is one of the most diffuse contribute to host most important and urological malignancies, and it is the susceptibility and may be most costly in terms of expenditures. realistic policies to associated with the risk of promote in 2016” BCa screening in the general BCa. The environmental population has been studied by risk factors for developing several investigators [3, 4]; however, BCa, such as smoking, are common, although partly because of the low overall incidence of only a fraction of people exposed to these risks BCa (37.5 and 9.3 per 100,000 in men and will eventually develop these diseases. women, respectively), screening is currently not Recently, genome-wide association studies recommended in routine practice. The United (GWAS) have been performed for BCa [7,8]. States Preventive Service Task Force (USPSTF) The GWAS approach allows a search for novel recently concluded that the current evidence susceptibility loci throughout the genome in a is insufficient to assess the risk/benefit ratio hypothesis-free manner. In recent years, GWAS of screening for BCa in asymptomatic adults (http://www.uspreventiveservicestaskforce.org/). have emerged as a powerful approach in the discovery of genetics underlying complex traits, “Opportunistic screening” entails the use such as cancer. Diagnostic tools based on DNA of diagnostic tests upon the request of an alterations and that can provide high specificity individual. Regarding BCa, the strategy is and sensitivity would clearly be of enormous usually to combine cystoscopy (specific) and a benefit to patients. Screening for BCa in urinary test (sensitive). No study has assessed smokers appears to be too broad of a strategy the diagnostic performance of urinary markers in 2016, and the appropriate method is not to for BCa in the context of screening. screen only highly exposed patients (tobacco) but to screen only those patients (with DNA A secondary prevention would be to develop rational screening policies for a smaller group of susceptibility) who are likely to subsequently develop the disease. people based on the presence of risk factors to identify optimal high-risk individuals who are Until these tests are available, in my opinion, most likely to benefit from screening. Cigarette smoking avoidance and smoking cessation are smoking is the best-established risk factor for the two most important and realistic policies to BCa, with a relative risk of 1.5 to 3 in past promote in 2016. Preventing BCa is certainly smokers and a RR of 4 to 5 in active smokers the most important approach to reduce its [5]. incidence and patient mortality. Therefore, Screening a high-risk group with a history

Cancer Prevention Program, the goal of which is to integrate smoking cessation into urological practices as a primary prevention. Whether people are healthy or not, is determined by their circumstances and environment. To a large extent, factors such as where we live, the state of our environment, genetics, our income and education level, all have considerable impacts on health. Thus, smoking avoidance and cessation must remain the main strong messages to send to the population if we want to struggle for a good health policy in Europe References: 1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin 2013;63:1130. 2. Babjuk M, Burger M, Zigeuner R, et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2013. Eur Urol 2013;64:639-53. 3. Chou R, Dana T. Screening adults for bladder cancer: a review of the evidence for the U.S. preventive services task force. Ann Intern Med 2010;153:461-8. 4. Larre S, Catto JW, Cookson MS, et al. Screening for bladder cancer: rationale, limitations, whom to target, and perspectives. Eur Urol 2013;63:1049-58. 5. Freedman ND, Silverman DT, Hollenbeck AR, Schatzkin A, Abnet CC. Association between smoking and risk of bladder cancer among men and women. JAMA 2011;306:73745. 6. Krabbe LM, Svatek RS, Shariat SF, Messing E, Lotan Y. Bladder cancer risk: Use of the PLCO and NLST to identify a suitable screening cohort. Urol Oncol 2014. 7. Fu YP, Kohaar I, Moore LE, et al. The 19q12 Bladder Cancer GWAS Signal: Association with Cyclin E Function and Aggressive Disease. Cancer Res 2014;74:5808-18. 8. Rothman N, Garcia-Closas M, Chatterjee N, et al. A multi-stage genome-wide association study of bladder cancer identifies multiple susceptibility loci. Nat Genet 2010;42:978-84.

the World Urologic Oncology Federation (WUOF) has initiated the Global Bladder

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Measuring the value of care in the management of bladder cancer

How should we define success in disease management and track the level of achievement in order to continuously improve the health care system to be functional and sustainable?

Dr. Zenichi Ihara, Health Economics

Manager, Commercial Excellence, Olympus, offers a few suggestions

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very action we take delivers an outcome and comes at a cost. What are then the tangible outcomes we would like to see delivered in disease management and the cost it takes to deliver them? It sounds like a trivial question to ask, while in many cases there is no answer, or we have not been looking at it correctly. The outcomes and cost determines the value in health care, although an agreement for a meaningful outcome or the causality with the costs and its breakdown are often missing. (1) Bladder cancer management, as in most of the progressive chronic diseases starts with a healthy population: to prevent or delay the onset of the disease. In suspected cases, early detection is vital, as well as effective, efficient, and minimally invasive treatment to be implemented. The cycle of detection and treatment may be iterated before reaching a state of recovery, control, or palliative care. In order to monitor the status and determine the actions within each of these steps and across the entire care pathway, an agreed set of measures of success is needed along with the resource requirement associated so the framework be improved, optimized, and made sustainable. Under the auspices of a European dialogue

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that brought the stakeholders together – such as policy makers, medical and clinical professionals, academic experts, patients, payers, and industry – the open discussion led to a common ground of recognition around the unmet needs and areas for improvement. Some of my key suggestions are as follows. Awareness and endorsement If bladder cancer appreciated less attention in the past compared to the other fields of cancer such as colorectal, lung, or prostate cancer, a systemic approach may be needed to promote the burden of the condition, the current status and future direction. Although the incidence, prevalence, and mortality might be relatively lower than those mentioned above [2], bladder cancer has one of the highest lifetime treatment costs per patient of all cancers, if not the highest [3]. The high recurrence rate and ongoing invasive monitoring requirement are the key contributors. Set standards of health outcomes and track the success of bladder cancer management Also in contrast to those “major” cancer areas where a standard set of health outcome measures are defined and agreed, bladder cancer does not seem to have such KPIs as of

Government Gazette

yet. (4) This should be the priority since any kinds of measurement and monitoring will be dependent on the relevant data determined prospectively. When an intervention is performed, correct implementation becomes important. Early diagnosis involving flexible cystoscopy or minimally invasive procedures such as plasma resection cannot yield the highest extent of benefit unless the operator is trained and maintains the learning curve. Objective assessment of success and clarification for improvement are possible by tracking the agreed measures of outcome. To that end, working on a screening program and focusing on large-scale registry sounds sensible to collect real-world data in view of connecting the outcomes defined and the costs incurred to deliver them. The use of medical devices and outcomes will also be tracked. Cost of care and value proposition of interventions While there is indication of the costs of bladder cancer, most of the evidence is around aggregated macroeconomic figures reported in the health systems that do not relate to the resources used to deliver a particular outcome.


health report (5) Costs associated with certain types of therapy are documented, while this does not say about the particular technology used or the results provided. (6) The funding scheme such as outpatient payment for diagnostic cystoscopy or DRG tariff for resection procedure has at least two limitations: 1) it does not account for all costs involved in the delivery of care, notably the CapEx costs; and 2) it has no clear mechanism to incentivize better outcomes or superior efficiency and penalise worse ones. For instance, a new technological feature (e.g. narrow-band imaging) that improves the diagnostic yield of cystoscopy or reduces the recurrence are reimbursed the same at the provider level today. These intrinsic shortcomings should be brought to the attention of the policy makers so the outcomes and costs are considered together.

Why is bladder cancer neglected?

The economic value should be combined with the outcome measures that optimize operational costs of the healthcare system, provide better socioeconomic outcomes, and save associated costs with preventing expenditure of onset and progression of disease. (7, 8) To look at a solution to a problem through the filter of value (and not only the price) should be a change management all of us should adopt. Conclusion There is much enthusiasm in bringing the focus on the management of bladder cancer. A costly disease has also a big opportunity to improve its status by increasing the awareness, defining and tracking the success, as well as clarifying the costs and managing the funding scheme References: 1. Porter, M.E., What Is Value in Health Care? New England Journal of Medicine, 2010. 363(26): p. 2477-2481. 2. International Agency for Research on Cancer (IARC), GLOBOCAN. 2012, WHO. 3. Sievert, K., et al., Economic aspects of bladder cancer: what are the benefits and costs? World J Urol, 2009. 27(3): p. 295â&#x20AC;&#x201C;300. 4. ICHOM. The International Consortium for Health Outcomes Measurement. 2016; Available from: http://www.ichom.org/. 5. Leal, J., et al., Economic Burden of Bladder Cancer Across the European Union. European Urology, 2016. 69(3): p. 438-447. 6. Svatek, R.S., et al., The Economics of Bladder Cancer: Costs and Considerations of Caring for This Disease. European Urology, 2014. 66(2): p. 253-262. 7. Gerecke, G., J. Clawson, and Y. Verboven, Procurement: The Unexpected Driver of Value-Based Health Care, the Boston Scientific Group, Editor. 2015: bcg.perspectives. 8. MedTech Europe, Economic Value as a guide to invest in Health and Care, MetTech Europe, Editor. 2016.

The European Cancer Patient Coalition recently launched a White Paper on Bladder Cancer. This paper provides a high level overview of the state of play of bladder cancer in Europe, principles for prevention, treatment guidelines available and research gaps. The paper will be translated in five languages and will be used at country level to inform policy-makers and the medical community about current shortcomings and the research needs.

By Mihaela

Militaru, Director, European Cancer Patient Coalition

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n 1985, the European Community launched the first Europe Against Cancer Program. Since then the European Commission has developed policies tackling the main risk factors that increase the burden of cancer. However, to date, not all cancers have been treated equally. The EU has been ambitious in supporting member states in the development of cancer screening programmes accompanied by guidelines for breast, cervical and colorectal cancers. Despite a prevalence of 13.07% in the EU 27, bladder cancer has been thus far overlooked by both decision makers and the pharmaceutical industry. And it is a pity as bladder cancer still claims more than 52,000 lives each year in Europe and although survival rates have improved over the past 30 years, with 50% of people surviving their disease for more than 10 years compared to only a third in the 1970â&#x20AC;&#x2122;s, there is still a lot to be done.

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Action at EU level As bladder cancer is a very common disease in industrialised EU countries and with incidence likely to rise in coming years, there is a need for EU initiatives to reduce the exposure to some chemicals at the workplace as well as more stringent protection of workers, taking into account not only exposure periods but also the mix of chemical and/or toxic substances to which workers are exposed. In this regard, I greatly welcome the recent campaign launched by the European Trade Union Confederation to address workplace use of carcinogens and work-related cancer. The European Cancer Patient Coalition recently launched a White Paper on Bladder Cancer in Brussels, which goes in detail on all actions needed in order to improve patient outcomes in bladder cancer

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Roche confirms its commitment to address the needs of patients with bladder cancer Recognising the need for consolidated focus on bladder cancer patientsâ&#x20AC;&#x2122; needs, Roche supports an opportunity for broad collaboration engaging professional societies, nurses, patient organisations and various European institutions. Pablo

Perez-Moreno, International Medical Director - Oncology and Elzbieta Zawislak, International Health Policy Leader from Roche elaborate on the companyâ&#x20AC;&#x2122;s commitment

Pablo Perez-Moreno

International Medical Director - Oncology

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ealth remains a national competence but European coordination in the fight against cancer has shown that much more can be achieved through coordinated activities. The EU has been effective in supporting EU member states in the development of cancer screening programmes supplemented with guidelines for breast, cervical and colorectal cancer. However, not all cancers have received similar level of attention. Bladder cancer is one of the most common cancers in the western world and the 2nd most frequent malignancy of the urinary tract after prostate cancer, yet it remains outside of health

policy priorities. Raise awareness on bladder cancer in Europe The awareness of bladder cancer is still low in Europe. Despite its prevalence, specific aspects of the disease are often overlooked. In Roche, we believe that now is the right moment to come out and speak, to ensure that at the European level, bladder cancer discourse is being heard. We are devoted to partner in coordinated efforts to bring bladder cancer higher up the EU agenda in hope of improved treatment outcomes for all bladder cancer patients in Europe. Act now to improve the situation Early recognition of symptoms and prevention will play a crucial role in the management of bladder cancer. Healthcare professionals should be taught to identify risk factors and early symptoms so that patients stand a better chance of having access to the right cancer treatment. Further research is needed to address high mortality among women and work-related risks. With smoking seen as the number one cause of bladder cancer more action is needed to reduce tobacco consumption.

Elzbieta Zawislak

International Health Policy Leader

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Due to the complexity of the disease, its higher prevalence among an older population and related comorbidities, effective care requires concerted, multidisciplinary approach, integrating the expertise of urologists, oncologists, radiation therapists, imagining experts and nurses. Until recently, for those people with the advanced disease, prognosis was poor because of the lack of effective treatment options available beyond chemotherapy or radiotherapy. In terminal cases, these treatments are given to relieve symptoms and improve quality of life. Consequently, there is a significant medical need for new treatment options. In Roche, we are committed to exploring treatment solutions to address that need. In recent years, personalised cancer immunotherapies have been investigated in clinical trials to understand their potential for treating bladder cancer by stimulating a patientâ&#x20AC;&#x2122;s own immune system to target and kill cancer cells. The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. This is an exciting and ever-expanding area of research, which may change how we treat cancer in the future. To date we have been extremely encouraged by the outcomes of our research in this field and believe that cancer immunotherapy may have the potential to drive a paradigm shift in cancer care. Thus far, this class of treatments has shown encouraging results for people diagnosed with bladder


act on bladder cancer now cancer. Recognising the growing need to act, Roche supports an opportunity for broad collaboration engaging professional societies, nurses, patient organisations and various European institutions About Roche

Urgent policy action needed More than 175,000 people are diagnosed with Bladder Cancer in Europe each year; and this number is increasing. More people die from BCa than all the UK military deaths in every conflict since 1945. It’s one of the most expensive cancers to treat and affects all genders and age groups.

“We tend to forget that bladder cancer is the fifth most common cancer in Europe, yet resource provision including funding for research and reimbursement of new medicines does not reflect the high disease burden or societal cost”

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Francesco de Lorenzo, President of European Cancer Patient Coalition

“Statistics show that up to half of all people diagnosed with bladder cancer in Europe, will die within five years. Nowadays, the advent of new promising drugs like immunotherapeutic compounds is likely to revitalize the field, and new drugs are expected to become available at new standards. For this reason, the access to new drugs for patients with bladder cancer will be a major concern for European regulators in the next few months.”

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines

Dr Andrea Necchi, oncologist and member of ECPC Expert Group on Bladder Cancer “Whereas many actions need to be implemented at national level, the European Commission should recognise the burden imposed by bladder cancer by promoting the use of guidelines. EAU’s bladder cancer guidelines and its broader use at country level can help to improve clinical outcomes” Prof Hein Van Poppel, Adjunct Secretary General, European Association of Urology

Where should the EU act? to consider initiatives to reduce and monitor the exposure 1. Continue to carcinogenic chemicals and continue efforts to reduce tobacco consumption in Europe, which is the main cause of bladder cancer.

occupational health and safety legislation; encourage the 2. Ensure continuous health surveillance of those at high risk of devoloping

3.

occupational cancers and invest in trials to identify best approaches for early detection. Address lack of resources, increase research funding and ensure all patients have access to multidisciplinary units involving urologists, medical oncologists, radiation oncologists, pathologists, radiologists, psycho-oncologists and palliative care experts.

© Data: European Cancer Patient Coalition

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Bladder Cancer â&#x20AC;&#x201C; The forgotten killer

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

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ccording to the World Cancer Research Fund International, bladder cancer is the 9th most common cancer. The EU has witnessed more cases than any other part of the world, with Belgium having the highest instances for any country. Although cases of bladder cancer have fallen significantly since the 1970s, it has a prevalence rate of 13.07% and over 52,000 lives are lost each year because of it. Patient groups, medical professionals, leading charities and other key stakeholders have expressed the need for policy makers to take further initiatives to ensure bladder cancer is no longer perceived as the forgotten cancer. With that in mind, the International Centre for Parliamentary Studies, in partnership with the European Association of Urology, hosted the Bladder Cancer 2016 Roundtable that took place in Brussels on the 21st of June 2016. This Roundtable

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brought together Members of European Parliament, senior representatives from European Commission, leading urologists, oncologists, patients groups, representatives from non-governmental organisations and representatives from pharmaceutical and technology companies to improve preventative, screening, diagnostics and overall treatment of bladder cancer. Some of their major recommendations have been elaborated below. Registration and data Like many other diseases, bladder cancer data capture, storage and the effective use of it across member states needs to improve significantly across the EU. Populationbased cancer registers were recommended as the most effective data capture tools, but the quality of data at the time of capture has to be consistent across the board. The EU needs to do more to ensure terms like â&#x20AC;&#x2DC;invasiveâ&#x20AC;&#x2122; are defined clearly so there is no

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room for various interpretations. The true cost The true cost of tackling bladder cancer needs to be determined not just by the number of deaths as a result of it, but also the number of patients who were successfully treated. The EU should also budget for preventative measures such as education, fast tracking new and cutting edge treatments and drugs, filling the skills gap in urology, implementing strict guidelines on high quality imaging and research and postmarket studies. There is scope to reassess current funding models and adopt more result-oriented approaches. Joint action from member states is of utmost importance. Improving screening Unlike prostate and breast cancers, bladder cancer does not have an effective screening programme. In addition, screening should


act on bladder cancer now

go beyond just the use of MRIs, as data from radiologists may only provide a one-dimensional view of the existence and severity of the cancer. Again, the EC should work with member states to develop and implement a consistent and effective screening initiative. New technologies and treatments This year’s meeting also discussed new technologies and drugs in the screening and treatment of bladder cancer. A number of drug companies were in phases two and three of drug development, who have so far had promising results. There is a conscious move from mono to combination therapies, improved minimally invasive and non-invasive treatments and a more complimentary, rather than competitive, approach towards new research between drug companies have been observed. Other developments include the use of biomarkers, improved imaging solutions, the future of robotic surgery and other significant changes in technology. Other recommendations for policy makers The following recommendations were made for key policy makers to take into account for the future: - Collection of histology should be an EU – wide policy - Registration should be harmonised, data collected should adhere to strict EU norms and there should be consensus on the nature of data that is to be collected - Member states should agree on common terms on invasive and non-invasive measures - Screening policy needs to be reassessed and should mirror initiatives that have been implemented in Breast and Prostate Cancers

- Policy makers should build consensus on clinical guidelines and a standard for quality cancer care - Bladder cancer should have a multidisciplinary approach in the detection and treatment aspects - The EU needs to have a more ‘open door’ approach towards new treatments and technologies - Access to existing information should be made simple and consistent - The availability of grants and funding for research should be clear and access to them should be clearly earmarked by policy makers - More effort needs to be made on the care and nursing aspects as bladder cancer patients need specialist treatment - Bladder cancer is not high enough on the list of neglected diseases and more should be done to prioritise it - Access to multi-disciplinary teams should be available to citizens of all countries - New research should be funded to explore better diagnostic tools. There is over reliance on retrospective studies – more should be done to encourage new research - Bladder cancer affects certain people who are exposed to specific environments and working conditions – more should be done to educate both, employers and employees - Medical innovations should not be perceived as costs but enablers For more information and for details about the next edition of the Bladder Cancer Roundtable, please visit www.bladdercancer. parlicentre.org or email information@ parlicentre.org

Participants of the Bladder Cancer Europe Roundtable 2016 Urologist, Academisch Medisch Centrum Universiteit van Amsterdam, Medical Director Immuno-Oncology, Europe, AstraZeneca, Assistant Medical Director, Algemeen Ziekenhuis Klina V.Z.W., Chairman of Urology, Azienda Unita’ Sanitaria Locale Di Modena, Director Marketing and Development, B.Braun, Head of EU Global Regulatory Sciences, Bristol-Myers Squibb, Senior Director Medical & Economic Value, Europe, Cepheid, Radiotherapist, Erasmus MC Cancer Institute, Board Member & Senior Urology Consultant, European Board of Urology, ECCO Public Affairs manager, European CanCer Organisation (ECCO), Director, European Cancer Patient Coalition (ECPC), Policy Officer on Cancer and Rare Diseases, European Commission, Scientific Officer in charge of the Cancer area of the Unit for Non-Communicable Diseases, European Commission, Secretary General, Public Health Policy Support, European Commission & the Istituto per lo Studio e la Prevenzione Oncologica, European Coordination Committee of the Radiological, Electromedical & Healthcare IT Industry (COCIR), Chief Physician, Pathology, Fimlab Laboratories, Clinical Nurse Specialist, Ghent University Hospital, Head of Urology, Hospital General Vall d’hebron - Fundacio per a la Recerca, Head of Urology, Institut Jules Bordet, President, International Bladder Cancer Network, Associate Publisher, IOS Press, Urologist - Oncology & Laparoscopy Specialist, Maxima Medisch Centrum, Veldhoven, Director, National Cancer Institute of Lithuania, Professor of Public Health-Head of the Centre for Health Care, National Institute of Public Health of Slovenia, Head of Oncology, Netherlands Cancer Institute, Director, NHS European Office, Health Economics Manager, Olympus, Professor of Formulation Science, University of Reading, Group Medical Director, Roche, Adjunct Secretary General, European Association of Urology, Uro-oncologist, University Hospitals Leuven, Associate Professor and Clinical Group Leader, University of Oxford - CRUK/MRC Oxford Institute for Radiation Oncology, Professor and Chairman of the Department of Urology, University Vienna, General Hospital Währinger Gürtel, Uro-oncologist Specialist & Post Doctoral Researcher, Universitair Ziekenhuis Ghent, Medical Head of Radiology Department, Universitair Ziekenhuis Leuven, Chief Development Officer, Viventia, Technical Officer, World Health Organisation Europe

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Vicinium: A recombinant targeted protein therapeutic for Non-muscle invasive bladder cancer Vicinium is currently being evaluated in a single arm, registrational phase 3 clinical trial in the USA and Canada in patients with high grade Non Muscle Invasive Bladder Cancer (NMIBC).

Dr Gregory Adams, Chief Development Officer and Steve Hurley, Chief Executive Officer and Dr Glen MacDonald, Viventia Bio, write about why Vicinium is expected to be effective in elderly patients with waning immune systems

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he global prevalence of bladder cancer is estimated at 2.7 million with 430,000 new cases of bladder cancer diagnosed and 165,000 deaths in 2012 (5). The opportunity exists to decrease the morbidity and mortality associated with bladder cancer through the development and implementation of more effective interventions employed before the disease invades the muscle lining the bladder and becomes systemic. Vicinium, a targeted therapeutic agent that is currently in phase 3 clinical trial, directly addresses this need. Vicinium Vicinium is a recombinant fusion protein consisting of a single chain antibody fragment (scFv) linked to a truncated form of Pseudomonas exotoxin A (ETA), a potent protein-based toxin that kills cells by inhibiting protein translation. (1) The scFv portion of Vicinium specifically targets epithelial cell adhesion molecule (EpCAM), which is overexpressed in many tumors, including bladder cancer (3), while exhibiting limited expression in normal bladder tissue. EpCAM overexpression often correlates with more aggressive disease and is considered to be a cancer stem cell marker (2). As Vicinium does not cross the cell membrane without first binding to EpCAM, it is not capable of targeting healthy bladder tissue. Vicinium is currently being evaluated in a single arm, registrational phase 3 clinical trial in the USA and Canada in patients with high grade Non Muscle Invasive Bladder Cancer (NMIBC). It is administered in the same manner as BCG, by intravesical instillation, and is therefore easily handled by practicing urologists.

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Dr Gregory Adams Vicinium’s recommended dose of 30 mg per instillation was established in a phase 1 dose escalation clinical trial, which examined doses ranging from 0.1 to 30 mg given weekly for a total of 6 weeks to patients with high grade BCG-refractory or intolerant NMIBC (3). All doses were well tolerated and no dose limiting toxicities or significant systemic exposures were observed. The highest dose, 30 mg, was selected, as it was believed to be associated with the greatest level of tumor exposure to the agent. A total of 64 patients were treated in this study, with a complete response of 41% at three months. Vicinium was next evaluated in a phase 2 trial conducted in the United States and Canada comparing a standard BCG-like regimen of once a week for 6-week induction phase with a longer once a week for 12-week induction phase (3). Both arms were followed by three maintenance cycles of
weekly Vicinium administration for 3 consecutive weeks, every three months (e.g., standard BCGlike schedule). 
Patients (n=46) with BCGrefractory (defined as not achieved disease-free status at 6 months or recurred within 6 months of last BCG treatment cycle) carcinoma in situ (CIS) with or without concurrent Ta or T1 were enrolled in this study. Tumor response was assessed via cystoscopy, urine cytology and biopsies, with a complete response defined by negative urine cytology and the lack of histological evidence of disease at 3 months. While both induction phase regimens were associated with CR rates of 40% at three months, the 12-week induction regimen was associated with higher 12 months CR rates and longer median time to recurrence than the 6-week induction regimen, 17% (408 days median time to recurrence) vs. 13% (272 days median time to recurrence), respectively.

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Chief Development Officer A majority of patients reported at least one side effect, however they were generally mild to moderate local bladder symptoms, including: 
dysuria (painful urination), pollakiuria (frequent urination), hematuria (blood in the urine), nocturia (waking up at night to urinate)
or bladder pain. Overall, Vicinium was found to be safe, well-tolerated and exhibited clinical efficacy with greater efficacy associated with a longer course of induction therapy. Observation of a longer median time to recurrence in the phase 2 trial in the group that was given more drug in the induction phase (e.g., the 12-week induction phase) suggested that increasing the number of doses of Vicinium would lead to even greater and more prolonged CR rates. Therefore, we modified both the induction and maintenance phase dosing in the phase 3 trial such that the induction phase is now 6 weeks of twice-a-week dosing followed by 6 weeks of once-a-week dosing. The frequency of the maintenance dosing was also increased to once every other week for the remainder of the two-year study. We believe that increasing the number of doses in the induction phase may increase the CR rate at 3 three months and that the increased frequency of the maintenance phase dosing will prevent more patients from recurring. Vicinium is the only targeted therapeutics in advanced development for the treatment of NMIBC. As it functions by blocking protein production in targeted cells rather than inducing immune stimulation, Vicinium is expected to be effective in elderly patients with waning immune systems – a population that


act on bladder cancer now can be less responsive to agents like BCG that depend upon a robust immune function References: 1. Biggers, K and Scheinfeld, N. VB4-845, A conjugated recombinant antibody and immunotoxin for head and neck cancer and bladder cancer. Current Opinion in Molecular Therapeutics. 10:176-86, 2008. 2. Brunner, A, Schaefer, G, Veits, L, Bruner, B Prelog, M and Ensinger C EpCAM Overexpression is Associated with High-grade Urothelial Carcinoma in the Renal Pelvis. Anticancer Research, 28:125-8, 2008. 3. Kowalski, M, Entwistle, J, Cizeau, J, Niforos, D, Loewen, S, Chapman, W and MacDonald, GC. A Phase I study of an intravesically administered immunotoxin targeting epcAM for the treatment of nonmuscle-invasive bladder cancer in Bcg- refractory and Bcg-intolerant patients. Drug Design, Development and Therapy. 4:313-320, 2010. 4. Kowalski, M, Guindon, J, Brazas, L, Moore, C, Entwistle, J, Cizeau, J, Jewett, MAS and MacDonald, GC. A Phase II Study of Oportuzumab Monatox: An Immunotoxin Therapy for Patients with Noninvasive Urothelial Carcinoma In Situ Previously Treated with Bacillus Calmette-GueĚ rin 5. Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, and Jemal A. Global cancer statistics, 2012 CA: A Cancer Journal for Clinicians, 65:87-108, 2015.

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electoral technology

Election technology in the Philippines, a success story The Filipinos witnessed their most successful elections this year, where voter turnout hit 81.7% and the winner in the presidential race was known on the voting date with 86% of votes transmitted by election night. The use of technology helped Filipinos all over the country and overseas to make their voices heard. Andres Bautista, Chairman of the Philippine Commission on Elections, elaborates on the success story and says Filipinos can be proud of their countryâ&#x20AC;&#x2122;s position at the vanguard of electoral innovation

A

ny discourse on model elections and democracy invariably veer towards the United Kingdom as one of the worldâ&#x20AC;&#x2122;s oldest democracies, or India, as the largest. One place that may not immediately spring to mind is the Philippines, although its recent May 9 elections broke several records and has been widely-regarded as an outright success.

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With more than 18,000 positions at stake, 44,000 candidates and 35,000 polling stations across the country, this was one of the largest and most complex elections in the world -- demanding meticulous planning and preparation. More than 44 million registered voters cast their ballots. Successful elections are crucial for strengthening

Government Gazette

democracy. But conducting them is not easy in countries like the Philippines, which spreads over more than 7,000 islands and has one of the largest diasporas in the world -- an estimated 10 million Filipinos are working or residing abroad. There is also a vibrant political environment in which every element of the electoral system is scrutinized to the highest degree. That is why the country chose to automate. We worked with Smartmatic, an election technology specialist, to deploy more than 90,000 vote-counting machines across the Philippines and in 18 countries with large overseas Filipino communities. Our investment delivered the Philippinesâ&#x20AC;&#x2122; fastest vote count ever. The winner in the


elections and democracy

presidential race was known on voting day, with 86% of votes transmitted by election night. Faster results mean less political and economic instability, and greater public and business confidence in the outcome. The Philippine peso rose the day after the election thanks to the credibility of the process. Voter turnout meanwhile hit 81.7% -- the highest in almost two decades, and up from 75% in the last presidential election in 2010. The use of technology helped Filipinos all over the country and overseas to make their voices heard. This was also the largest electronic vote count in the country’s history, according to Smartmatic, involving the deployment of the most vote counting machines ever. People may not think much about what happens to their votes after they enter the voting booth, or the technology used to enable the transmission of results. But without these machines it would have been impossible for votes to be counted so quickly and accurately, ensuring credibility in the process. Widely audited Combining technology and human resources, this poll was one of the most transparent and widely audited elections ever. Seven months before the elections, political parties, candidates and election watchdogs were invited to examine the technology and the system to be used. On election day, we created one of the largest paper audit trails in the history of elections, producing more than 44 million ballots and

printed receipts that allowed for votes to be crosschecked. A random manual audit by the respected citizen’s group Namfrel (National Movement for Free Elections) found a 99.8% match between the electronic and the manual counts, leading an obviously pleased statistician (who is this?) to exclaim that the count was “almost perfect!” Of course, no election is without its challenges, and we faced many along the way, including a Supreme Court decision on the eligibility of one of the candidates that required the reconfiguration at a relatively late stage of all the machines. The commission also had to deal with a constant stream of misinformation and unfounded allegations about the abilities and security of the technology.

were essential in ensuring the orderly conduct of the polls. With voter turnout falling across the world, the vibrancy of our electorate is a testament to our nation’s commitment to democracy. This was the third automated election held in the Philippines. Not only did it represent a significant advance over manual elections, where counting takes weeks, sowing uncertainty and instability, but we also saw further major improvements compared with our two previous automated elections. Filipinos can be proud of their country’s position at the vanguard of electoral innovation. I hope we can share our successes and lessons with other countries and help strengthen democracy around the world.

This is why we can be understandably proud of the recognition this election has achieved. The important role that automation played in ensuring speedy, credible and legitimate results has been widely acknowledged by business groups such as the American Chamber of Commerce and the Philippine Stock Exchange, as well as by foreign observers and civil society organizations such as the Parish Pastoral Council for Responsible Voting and NAMFREL. Both played vital roles in scrutinizing the election. Above all, this election reflects the spirit of the Filipino people. They ensured that it was peaceful and orderly. Hundreds of thousands of teachers who acted as voluntary inspectors

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International Electoral Awards 2016 December 2016*

ICPS and ICEP have established an award exclusively for electoral stakeholders, in recognition of their work and to acknowledge their significant contribution to the democratic process beyond the community of electoral professionals, practitioners and experts. The nomination period will start soon. For further information, about the awards, nomination procedure and last yearâ&#x20AC;&#x2122;s winners, please visit the International Electoral Awards website: www.awards.electoralnetwork.org

*

Venue and date to be confirmed shortly


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Elections have the power to give every citizen a voice DQGHOHFWHGRÉ?FLDOV legitimate authority to govern. We help election authorities realize this power.

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Government Gazette September 2016  
Government Gazette September 2016  
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