European Union

“Europe has gone from 27 (sic) fragmented, independent, not-talking-to-each-other regulatory authorities in the healthcare space to one. That’s a big deal.”
Andrew Witty, CEO of GSK

Until relatively recently, the pharmaceutical sector has been more or less absent from the Brexit debate. Finally, the silence was broken by the likes of Merck, Eli Lilly and GSK, proving that the lack of noise throughout 2015 should never have been mistaken for a lack of interest by pharma or lack of concern on the issue. In fact, pharma has every reason to be worried about this. In Europe, the pharmaceutical sector will be negatively impacted by a Britain outside of the EU to the detriment of both the business and its patients.

Pharmaceuticals is one of the most highly regulated industries, and quite rightly so. We only have to look at the severity of the consequences of the misuse of medication (loss of trust in healthcare systems, drug resistance and even premature death) to understand why. Without the EU, this ‘regulation’ looks like 28 separate countries creating their own separate rules and consequently differing standards – making authorisation of and patient access to drugs a difficult process. Luckily, thanks to the EU, these 28 separate systems have been pulled under one ‘European Medicines Agency’ umbrella, meaning an authorisation of a drug in Germany, means relatively easy authorisation of a drug in the UK, for example. As a consequence, quicker access to the drug for patients.

Of course, if the UK leaves the EU (which puts into question its membership of the EMA); it is still going to be subject to the EU’s rules and regulations on pharmaceutical products. UK producers will have to abide by these rules to ensure that their products are authorised to be marketed and sold within the EU. Moving forward, not only will we most likely have to continue to abide by these rules, if we chose the EEA option for example after a vote ‘No’, but we will also lose our seat at the table in discussions on the development of further regulation. If we look at countries like Norway and Iceland, as part of the EEA, they’ve had to implement things such as the Falsified Medicines Directive, for better or for worse, without any say in its development. This has included things such as the implementation of electronically authenticating medicines. If the UK were to totally remove itself from the single market, and follow a Swiss model for example, then the UK will of course have to implement its own regulation, so that’s double regulatory burden for pharma companies to deal with and likely a host of complex bilateral deals with other member states. None of this is sounding ideal.

‘Brexit would be “challenging” for Merck’s scientists, who have “benefited from a world where they receive grants from the European Union.”’
Roger Perlmutter, Head of R&D at Merck & Co.

Let’s move away from regulation, the pharmaceutical sector lives or dies by its ability to research and develop new drugs and therapies. Scientists working at huge R&D sites in the UK will likely lose access to cross-European scientific research programmes, such as Horizon 2020 and the Innovative Medicines Initiative (IMI). These programmes are working on some of the world’s most significant health threats such as AMR and oncology. In January 2016, the European Investment Fund made a £24.8m commitment to help commercialise innovations at the University College London, with a specific focus on new medicines, further highlighting how the EU benefits British science. On the topic, just last week, more than 50 biotech and pharmaceuticals chief executives signed a letter putting across the business case for remaining in the EU.

Equally, the free movement of people contributes to the strength of Europe’s knowledge economy. The best researchers are able to travel freely from one member state to the next and collaborate with each other. What will happen to UK research institutions when this movement is restricted or becomes so burdensome it prevents us from hosting Europe’s scientific talents?

If the UK is to leave the EU, it’s going to have to think very carefully about whether or not it deviates away from current EU standards in pharmaceuticals. If it is, then I’d really like to know the rationale as to why. The EU (and the US) is recognised as having the highest standards in pharmaceuticals. If it’s not, it’s going to be subject to the same rules and regulations that it already is, without a seat at the table, potentially complex bilateral deals and perhaps even the burden of double regulation. All meaning one thing – it’s going to take longer for patients inside of the UK to get access to drugs launched in the EU, and vice versa. Furthermore, the UK, which is currently seen as a hub of excellence in scientific research, will likely suffer from a cut in funding and loss of some of its most talented scientists, stifling research and innovation. The impact of Brexit on the pharma sector doesn’t just impact the pharmaceutical business, its impact is likely to be most felt by the patient at the end of the supply chain.

Emma Cracknell, Healthcare Practice.

Brexit is too important to leave just to the British. Yes, of course it will be up to UK voters to decide, but that doesn’t mean that the rest of the EU should stand silently on the sidelines.

Europeans elsewhere than in the UK have much to contribute to the Brexit debate. With the discussion in Britain deteriorating into a dialogue of the deaf, and into internecine political infighting and score-settling, better informed proponents and critics of the European project could do much to lift the debate to a higher and more constructive plane.

Voices from the continent should include those of senior people in the EU institutions. So far, their views have been muted because the EU and its officials avoid involvement – usually termed ‘interference’ – in the domestic politics of a member state.

“Few people throughout Europe doubt that a British exit would be catastrophic”

But Brexit isn’t just about the British, and the issue is in any case far too serious and potentially destructive for that ‘hands off’ formula to apply. Few people in Brussels, or indeed in political and business circles throughout Europe, doubt that a British exit would be catastrophic, not just for the UK but for the EU itself. Some may be exasperated by the way the UK membership issue is sidelining more urgent EU questions, but that doesn’t mean they would welcome Britain’s departure.

The level of debate in Britain has so far been disappointing; it’s much more emotional than rational. A striking feature has been the absence of factual accuracy, even among Prime Minister David Cameron’s supporters now campaigning to stay in the EU. On issues as far-ranging as trade, immigration and military capabilities, Britain’s debaters on both sides of the argument demonstrate daily their ignorance of how the EU works.

On these topics and many others, there’s a wealth of authoritative research at the finger-tips of EU officialdom and key players and politicians around Europe. Instead of remaining aloof, they should be joining the fray and bombarding British media with facts and figures that correct misleading claims. A prime example of this is immigration, where the ill-informed prejudice that EU membership is opening the door to millions of “job stealing” eastern Europeans could easily tilt undecided voters towards Brexit.

The reality pointed out by a recent Eurostat report is that in 2014 the UK topped the EU league for residence permits, granting well over half a million that went overwhelmingly to Americans, Chinese and Indians. The refugee crisis is not a British problem, and the European Union’s spokespeople should be ramming that point home at every opportunity.

“There’s always a risk that hectoring from across the English Channel could prove counter-productive”

Getting the tone of voice right will be important; there’s always a risk that hectoring from across the English Channel could prove counter-productive. On the other hand, informed comment and objective analysis by major corporations that invest and trade in the UK would help to correct the notion that the cost of Brexit would be minimal, involving no more than a quick and painless re-negotiation.

David Cameron’s error has been to frame his demands for EU reform in a purely British context. The multiplying challenges to the EU’s future are highlighting the slowness and divisiveness of its decision-making. So signals from the UK’s European partners that they, too, want to address these problems would do much to reassure British voters while also setting a more positive course for the European project.

IMAGE CREDIT: CC / FLICKR – Jeff Djevdet

The post Brussels: Now add your voice to the Brexit debate! appeared first on Europe’s World.

The EP-Verkhovna Rada high-level conference opened a new era of cooperation between the two parliaments, said lead MEP on capacity-building for the Ukrainian Parliament, Andrej Plenković (EPP, HR) at the close of the event on Wednesday. "We agreed to jointly implement the recommendations of the report of the Needs Assessment Mission and allocate adequate funds for the organisation of the follow up with our Ukrainian partners", he added.
Committee on Foreign Affairs

Source : © European Union, 2016 - EP

The EP-Verkhovna Rada high-level conference opened a new era of cooperation between the two parliaments, said lead MEP on capacity-building for the Ukrainian Parliament, Andrej Plenković (EPP, HR) at the close of the event on Wednesday. "We agreed to jointly implement the recommendations of the report of the Needs Assessment Mission and allocate adequate funds for the organisation of the follow up with our Ukrainian partners", he added.
Committee on Foreign Affairs

Source : © European Union, 2016 - EP

The EP-Verkhovna Rada high-level conference opened a new era of cooperation between the two parliaments, said lead MEP on capacity-building for the Ukrainian Parliament, Andrej Plenković (EPP, HR) at the close of the event on Wednesday. "We agreed to jointly implement the recommendations of the report of the Needs Assessment Mission and allocate adequate funds for the organisation of the follow up with our Ukrainian partners", he added.
Committee on Foreign Affairs

Source : © European Union, 2016 - EP

The Committee of inquiry into Emission Measurements in the Automotive Sector (EMIS) elected its chair and four vice-chairs at a constituent meeting on Wednesday morning, thus officially starting its one-year mandate.
Committee of Inquiry into Emission Measurements in the Automotive Sector

Source : © European Union, 2016 - EP

The Committee of inquiry into Emission Measurements in the Automotive Sector (EMIS) elected its chair and four vice-chairs at a constituent meeting on Wednesday morning, thus officially starting its one-year mandate.
Committee of Inquiry into Emission Measurements in the Automotive Sector

Source : © European Union, 2016 - EP

This is Wednesday’s edition of our Brussels Briefing. To receive it every morning in your email in-box, sign up here.

Europe is waking to news that Donald Trump has taken a huge, bounding leaptowards securing the Republican nomination for US president. It is not yet wrapped up; the Republican race will probably run through to the spring. But Mr Trump could barely have emerged in better shape from Super Tuesday and the Europe’s press are all a bit stunned. Before they could even deploy some withering headlines, Mr Trump beat them to the punch, blasting the bloc on terrorism and migration: “You look at Brussels, look at Sweden, you look at Germany – it’s like a disaster.” With an eye on the presidential race, he at least had the diplomatic courtesy to hold back on attacking Germany’s Angela Merkel, a leader he recently said would “be out if they don’t have a revolution”.

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DRAFT OPINION on the proposal for a regulation of the European Parliament and of the Council establishing an EU common list of safe countries of origin for the purposes of Directive 2013/32/EU of the European Parliament and of the Council on common procedures for granting and withdrawing international protection, and amending Directive 2013/32/EU
Committee on Foreign Affairs
Jozo Radoš

Source : © European Union, 2016 - EP

Plenary sessions : Just over two years after the Euromaidan mass protests resulted in removing President Viktor Yanukovych from power, Ukraine is still at a crossroads between war and peace, between corruption and reform. The entry into force of the EU-Ukraine free trade area on 1 January 2016 was a milestone in relations between the two entities. Our timeline tracks the main events of the past two years, from the annexation of Crimea to the Minsk II peace agreement and more.

Source : © European Union, 2016 - EP

Plenary sessions : Just over two years after the Euromaidan mass protests resulted in removing President Viktor Yanukovych from power, Ukraine is still at a crossroads between war and peace, between corruption and reform. The entry into force of the EU-Ukraine free trade area on 1 January 2016 was a milestone in relations between the two entities. Our timeline tracks the main events of the past two years, from the annexation of Crimea to the Minsk II peace agreement and more.

Source : © European Union, 2016 - EP

http://tvnewsroom.consilium.europa.eu/uploads/council-images/thumbs/uploads/council-images/remote/http_7e18a1c646f5450b9d6d-a75424f262e53e74f9539145894f4378.r8.cf3.rackcdn.com/9c5f3f50-e084-11e5-b3b7-bc764e092fac_157_thumb_169_1456930190_1456930213_129_97shar_c1.jpg

Donald TUSK, President of the European Council, visits countries along the Balkan route and Turkey.

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DRAFT REPORT with a proposal for a European Parliament recommendation to the Council on the 71st session of the United Nations General Assembly
Committee on Foreign Affairs
Andrey Kovatchev

Source : © European Union, 2016 - EP

Implementation and review of the EU-Central Asia Strategy
Source : © European Union, 2016 - EP

It is of crucial importance to continue backing the former Yugoslav Republic of Macedonia's progress towards EU membership, said Foreign Affairs Committee MEPs on Monday. But only if the July 2015 "Przhino Agreement" to pave the way out of the country’s political crisis via elections is implemented in full and if substantial progress is also made on delivering urgent reform priorities, including media freedom, parliamentary control of interception of communications and fighting corruption.
Committee on Foreign Affairs

Source : © European Union, 2016 - EP

It is of crucial importance to continue backing the former Yugoslav Republic of Macedonia's progress towards EU membership, said Foreign Affairs Committee MEPs on Monday. But only if the July 2015 "Przhino Agreement" to pave the way out of the country’s political crisis via elections is implemented in full and if substantial progress is also made on delivering urgent reform priorities, including media freedom, parliamentary control of interception of communications and fighting corruption.
Committee on Foreign Affairs

Source : © European Union, 2016 - EP

It is of crucial importance to continue backing the former Yugoslav Republic of Macedonia's progress towards EU membership, said Foreign Affairs Committee MEPs on Monday. But only if the July 2015 "Przhino Agreement" to pave the way out of the country’s political crisis via elections is implemented in full and if substantial progress is also made on delivering urgent reform priorities, including media freedom, parliamentary control of interception of communications and fighting corruption.
Committee on Foreign Affairs

Source : © European Union, 2016 - EP

On 3 March, SEDE will exchange views with Major General Martin Smith MBE, Operation Commander of EU NAVFOR Somalia. General Smith commands the operation from the Operational Headquarters at Northwood, UK. He plans and conducts the operation in conjunction with the political and military authorities of the EU.
Further information
Draft agenda and meeting documents
Source : © European Union, 2016 - EP