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What happens when the European Medicines Agency leaves the UK?

EU member states are already bidding for the London-based regulator. 

Scrolling down the London-based European Medicines Agency’s Twitter feed shows you exactly what you would expect: a stream of science and health related posts, promoting recent trials and medical news. And then there's one that throws Brits like me off kilter. Immersed as we are in Brexit, it is strange to see the tweet honouring the 60th anniversary of the Treaties of Rome in March. 

It is a reminder that, while UK doctors are desperately trying to keep membership of the decentralised agency, the negative effects of losing the EMA would not, for the most part, carry over to mainland Europe. 

The EMA's purpose is specifically to evaluate the safety of medical products for the European single market. Health secretary Jeremy Hunt has said he expects that the UK will leave the EMA because it is subject to the European Court of Justice. This revelation was met with outrage and panic from many in the medical and pharmaceutical professions.

Since then-Prime Minister John Major secured London as the EMA’s base in the 1990s, the agency has become invaluable in increasing the efficiency of drug regulation across the EU. Patients in Europe, including (for now) the UK, are able to access new treatments and medications roughly six months to a year sooner than those in Australia and Canada. There is the legitimate worry that saying goodbye to the EMA would mean a hike in both drug prices and waiting times for treatments in the UK, as well as a significant drain on the NHS – a bit of a kick in the teeth for those who voted Leave because of the promise of more money for the health service. 

Then there is the business case. The EMA regulates medicine for the entire EU market - which in turn accounts for a quarter of all global pharmaceutical sales - so losing membership of the EMA would drastically affect British pharma. Non-European companies might also see the departure of the EMA as a sign to leave London. As an unnamed EMA researcher told the New Statesman, the agency’s relocation “may influence industry to seek alternative places to operate”. In a document presented at last year’s G20 summit in China, the Japanese government cautioned that the EMA was crucial to the UK’s reputation as a force of scientific development, and that many Japanese pharmaceutical companies would potentially follow the EMA HQ to its new home. 

Among the many politicians frustrated by the government’s lack of clarity regarding the future of medicine regulation in the UK is Richard Corbett, the Labour MEP for Yorkshire and the Humber. He tells me that the EMA avoids duplication of medicines and thus is "a major cost saver" for all EU members states.

He adds:  “If Britain leaves the agency, it will have two poor choices.

"It could either duplicate the world of the EMA in the UK, at considerable cost, and find ways of converging with the EMA in order to continue to share standards with its European neighbours, or it could simply follow the standards set by the EMA without being a member and therefore lose its say in the standards to which medicines must adhere."

There are already fears that leaving the EU will jeopardise the future of the NHS – unsurprising considering that Hunt does not hold a place on the government cabinet committee overseeing Brexit. In particular, uncertainty surrounding EU citizens right to work in the UK has caused some to quit before they are pushed. potential safeguarding of European medical staff is forcing many to flee before they are pushed. A Channel 4 poll found that two fifths of EU citizens working in the NHS are considering returning to the Continent within the next five years.  

While the impact of ending freedom of movement on frontline medical staff has been well covered, it also affects those in the backrooms. Most of the workers at the EMA HQ in Canary Wharf, London, are EU nationals. They would potentially need visas to continue their work post-Brexit. 

Since hosting the EMA HQ, London has enjoyed an extensive role in planning and chairing medical schemes. The Association of the British Pharmaceutical Industry has argued that the EMA's physical presence in the UK gives its domestic regulators more sway in research and development decisions. That is not to mention the various subcontractors, research organisations, and drug companies that have settled in London in order to be close to the regulatory process.

Predictably, then, there are already a myriad of countries from Romania to Sweden vying to become the EMA’s new home. As well as prestige, the next host stands to gain around 900 new staff, a boost for their pharmaceutical industry, and increased access to expert researchers.

Among the more attractive contenders is Italy – the second largest manufacturer of medical products and also home to the European Food Safety Authority. Portugal, Spain, and Sweden’s capital cities are all jostling to be the best choice of turf. In contrast to London, Lisbon is stressing its commitment to the EU as a key feature of its application.

However, one country that seems to tick all the boxes is the Republic of Ireland. Even before May signed the decree absolute, Irish Health Minister Simon Harris had readied a team to prepare Ireland’s bid. In addition to numerous medicine manufacturing sites in and around Dublin, there are new factories springing up, as if representatives of Irish companies and agencies are already thinking ahead. Undeniably, a factor in the decision about the transition is the expectation that the EMA experiences a smooth changeover. Dublin claims the advantage of English as an official language, on top of a strong scientific research sector that can provide an abundance of trained and highly specialised workers. 

The choice of new abode is out of the EMA’s hands - it instead resides with the EU member states. Whichever country they choose, it seems Brits may have to get used to a lower standard of healthcare. As Corbett, the MEP, bluntly told me: “This is one of many examples of the ignorance and ill considered consequences of a Brexit-at-any-cost."

Anjuli R. K. Shere is a 2016/17 Wellcome Scholar and science intern at the New Statesman

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The Brexit Beartraps, #2: Could dropping out of the open skies agreement cancel your holiday?

Flying to Europe is about to get a lot more difficult.

So what is it this time, eh? Brexit is going to wipe out every banana planet on the entire planet? Brexit will get the Last Night of the Proms cancelled? Brexit will bring about World War Three?

To be honest, I think we’re pretty well covered already on that last score, but no, this week it’s nothing so terrifying. It’s just that Brexit might get your holiday cancelled.

What are you blithering about now?

Well, only if you want to holiday in Europe, I suppose. If you’re going to Blackpool you’ll be fine. Or Pakistan, according to some people...

You’re making this up.

I’m honestly not, though we can’t entirely rule out the possibility somebody is. Last month Michael O’Leary, the Ryanair boss who attracts headlines the way certain other things attract flies, warned that, “There is a real prospect... that there are going to be no flights between the UK and Europe for a period of weeks, months beyond March 2019... We will be cancelling people’s holidays for summer of 2019.”

He’s just trying to block Brexit, the bloody saboteur.

Well, yes, he’s been quite explicit about that, and says we should just ignore the referendum result. Honestly, he’s so Remainiac he makes me look like Dan Hannan.

But he’s not wrong that there are issues: please fasten your seatbelt, and brace yourself for some turbulence.

Not so long ago, aviation was a very national sort of a business: many of the big airports were owned by nation states, and the airline industry was dominated by the state-backed national flag carriers (British Airways, Air France and so on). Since governments set airline regulations too, that meant those airlines were given all sorts of competitive advantages in their own country, and pretty much everyone faced barriers to entry in others. 

The EU changed all that. Since 1994, the European Single Aviation Market (ESAM) has allowed free movement of people and cargo; established common rules over safety, security, the environment and so on; and ensured fair competition between European airlines. It also means that an AOC – an Air Operator Certificate, the bit of paper an airline needs to fly – from any European country would be enough to operate in all of them. 

Do we really need all these acronyms?

No, alas, we need more of them. There’s also ECAA, the European Common Aviation Area – that’s the area ESAM covers; basically, ESAM is the aviation bit of the single market, and ECAA the aviation bit of the European Economic Area, or EEA. Then there’s ESAA, the European Aviation Safety Agency, which regulates, well, you can probably guess what it regulates to be honest.

All this may sound a bit dry-

It is.

-it is a bit dry, yes. But it’s also the thing that made it much easier to travel around Europe. It made the European aviation industry much more competitive, which is where the whole cheap flights thing came from.

In a speech last December, Andrew Haines, the boss of Britain’s Civil Aviation Authority said that, since 2000, the number of destinations served from UK airports has doubled; since 1993, fares have dropped by a third. Which is brilliant.

Brexit, though, means we’re probably going to have to pull out of these arrangements.

Stop talking Britain down.

Don’t tell me, tell Brexit secretary David Davis. To monitor and enforce all these international agreements, you need an international court system. That’s the European Court of Justice, which ministers have repeatedly made clear that we’re leaving.

So: last March, when Davis was asked by a select committee whether the open skies system would persist, he replied: “One would presume that would not apply to us” – although he promised he’d fight for a successor, which is very reassuring. 

We can always holiday elsewhere. 

Perhaps you can – O’Leary also claimed (I’m still not making this up) that a senior Brexit minister had told him that lost European airline traffic could be made up for through a bilateral agreement with Pakistan. Which seems a bit optimistic to me, but what do I know.

Intercontinental flights are still likely to be more difficult, though. Since 2007, flights between Europe and the US have operated under a separate open skies agreement, and leaving the EU means we’re we’re about to fall out of that, too.  

Surely we’ll just revert to whatever rules there were before.

Apparently not. Airlines for America – a trade body for... well, you can probably guess that, too – has pointed out that, if we do, there are no historic rules to fall back on: there’s no aviation equivalent of the WTO.

The claim that flights are going to just stop is definitely a worst case scenario: in practice, we can probably negotiate a bunch of new agreements. But we’re already negotiating a lot of other things, and we’re on a deadline, so we’re tight for time.

In fact, we’re really tight for time. Airlines for America has also argued that – because so many tickets are sold a year or more in advance – airlines really need a new deal in place by March 2018, if they’re to have faith they can keep flying. So it’s asking for aviation to be prioritised in negotiations.

The only problem is, we can’t negotiate anything else until the EU decides we’ve made enough progress on the divorce bill and the rights of EU nationals. And the clock’s ticking.

This is just remoaning. Brexit will set us free.

A little bit, maybe. CAA’s Haines has also said he believes “talk of significant retrenchment is very much over-stated, and Brexit offers potential opportunities in other areas”. Falling out of Europe means falling out of European ownership rules, so itcould bring foreign capital into the UK aviation industry (assuming anyone still wants to invest, of course). It would also mean more flexibility on “slot rules”, by which airports have to hand out landing times, and which are I gather a source of some contention at the moment.

But Haines also pointed out that the UK has been one of the most influential contributors to European aviation regulations: leaving the European system will mean we lose that influence. And let’s not forget that it was European law that gave passengers the right to redress when things go wrong: if you’ve ever had a refund after long delays, you’ve got the EU to thank.

So: the planes may not stop flying. But the UK will have less influence over the future of aviation; passengers might have fewer consumer rights; and while it’s not clear that Brexit will mean vastly fewer flights, it’s hard to see how it will mean more, so between that and the slide in sterling, prices are likely to rise, too.

It’s not that Brexit is inevitably going to mean disaster. It’s just that it’ll take a lot of effort for very little obvious reward. Which is becoming something of a theme.

Still, we’ll be free of those bureaucrats at the ECJ, won’t be?

This’ll be a great comfort when we’re all holidaying in Grimsby.

Jonn Elledge edits the New Statesman's sister site CityMetric, and writes for the NS about subjects including politics, history and Brexit. You can find him on Twitter or Facebook.