Europe’s Drug Regulators Eye a Post-Brexit Prize

The impact of the “Brexit” referendum and of the UK’s plans for exiting the European Union (EU) has been overshadowed by the equally unexpected election of Donald Trump as the 45th President of the United States. But amid the consequent confusion over what happens next-to everything from the fate of sterling to America’s future relations with Russia-there is a veritable stampede underway among regulatory authorities and politicians in EU countries to secure one of the assets that will be flotsam in the emerging new order: the European Medicines Agency (EMA). 

At the latest count, interest has been expressed by Malta, Bulgaria, Stockholm, Barcelona, Warsaw, Dublin, the Italian cities of Rome and Milan, and the French cities of Paris, Lyon, Strasbourg and Lille. They all see advantages-and massive prestige  -in adopting the highly-regarded agency when it is dislodged from the new building in London’s fashionable docklands where its 1,000 staff currently work-and where hundreds of meetings involving thousands of visiting experts take place every year.

The UK won the privilege of hosting the EMA when it was created back in 1994. At the time, there was little understanding among national politicians of how important an agency it would prove to be, and there were few serious bids to host it. Barcelona and Portugal were also in the running, but the UK was chosen by the heads of EU governments as a sort of consolation prize in a horse-trading deal after Frankfurt was selected as the site of the European Central Bank, created at about the same time.

For the UK and for the EMA-and even for Europe-the choice was a happy one. There was strong synergy between the agency and the acknowledged wealth of life-sciences expertise in the UK, and the EMA grew in stature as its tasks broadened, while Britain’s life-sciences sector benefited from the geographic proximity. The UK was also a major contributor to the agency, both to its full-time staff, and to the pool of experts that composed its committees and rapporteurs. London was a popular location, easy of access from across Europe and beyond, with a high standard of living, so it was easy to recruit the best employees.

With the UK population’s Brexit vote, all that has come to a juddering stop. When the UK departs the EU-and exactly when that will happen is still a very open question-it will also lose its rights to host the EMA. So an alternative will have to be found. And although there are already many candidates, the choice will be no simple matter.

Access is clearly one key consideration, because of the high volume of personnel traffic through the EMA. Most of the current crop of suitors can overcome that hurdle. But connections alone will not be enough. There should also be enough suitable hotel accommodation for the tens of thousands of people attending meetings there every year. EMA’s executive director, Guido Rasi, told the European Parliament in November that he was concerned about the workability of the new location: “We have to bring 40,000 people each year at the right time and we have to have an airport, ground transportation, 350 rooms available per night, five days a week,” he said.

The local environment is also bound to be a factor. London has scientific and pharmaceutical credibility, a good quality of life, adequate social security and medical services and less obvious qualities such as ample schooling and job opportunities for international families and trailing spouses. The promoters of the Lyon bid have been quick to point out that their city is also a major health and science hub-it is the location of major pharma and diagnostics companies and of the World Health Organization’s cancer agency-and highly liveable.

Reliability will also be a factor. Rasi has publicly lamented that the prospect of Brexit has damaged staff morale, and that recruitment has already suffered from the attendant uncertainty. Any alternative site will need to make a convincing case that it can, not only attract the agency now, but can also provide stability, security and support over the long term.

Meanwhile, almost as if in some premature death throes, the agency has been operating at a frantic pace since the Brexit vote last June. Most notably, it has launched its ground-breaking website offering online access to clinical reports submitted in support of marketing authorization applications. And alongside the EMA’s customary work on core tasks such as reviewing marketing authorization applications and monitoring adverse effects, it has become involved in the “first-in-man” debate-following the disastrous Bial trial in France earlier this year-with a proposal to modify its guidance on first-in-human clinical trials. The EMA has been running a series of expert seminars on subjects as diverse as how clinical research networks can support developers of medicines for children, or modeling and simulation in the development of medicines, or how big data can be used for the development and regulation of medicines, or new therapies for spinal muscular atrophy.

The agency has been pushing forward with its discussions on how to make better use of patient registries to collect high-quality data on medicines, or new treatments for rare chronic liver disease, and accelerating the pace of its contacts with patients and healthcare professionals. And the EMA has been fiercely defending its adventurous pilot scheme on early access to medicines for unmet need, against attacks by suspicious consumer organizations and health campaigners who see it as a Trojan horse threatening to erode patient safety and by payers nervous of the possible impact on costs.

As candidates to host the agency jockey for position and chummy up to top EMA personnel, Rasi has made it clear that neither he nor his colleagues can have any influence over where the choice will fall. It is, he has repeatedly said, business as usual as far as possible, with much important business needing to be done, and done now, to ensure the safety and the competitiveness of EU health systems. The decision will be made only by the heads of state or heads of government of the EU’s member countries-and only once the phony war over Brexit gives way to real negotiations.

The uncertainty is all the greater because there are voices being raised in the UK-not least by one of the prime minister’s top advisers, George Freeman-that those negotiations, whenever they do take place, should aim to secure a special deal to keep the agency in London even after the UK leaves the EU. “We’ve got to demonstrate that it’s not in Europe’s interest to take the EMA away,” Freeman said at a recent political meeting.

That may be fanciful. But as the Brexit and Trump votes have demonstrated in recent months, the fanciful is becoming the commonplace this year. Also in the fanciful department, it is still absolutely unclear on what terms the UK will leave the EU, and what relationship the two will have after that split. The fanciful department even contains the possibility, remote though it seems, and hotly denied as it is by the UK government, that negotiations will prove so forbidding that the UK will not in the end leave the EU at all. Right now, all bets are off. Don’t start sending your marketing authorization applications to Valletta yet.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium