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5 April 2017

What happens when the European Medicines Agency leaves the UK?

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

By Anjuli R. K. shere

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.

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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.”

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