Digging Medicines Regulation Out of the Brexit Hole

As negotiations between the UK and the remaining 27 members of the European Union commence in the next month or so, questions of trade, IP protection and of free movement will emerge.

The imponderables about Brexit continue to mount up on both sides of the English Channel – and not least for medicines, where the trend towards seamless cooperation across European Union member countries has been crucial to much of the success that the sector has enjoyed over recent decades.
Common customs rules have allowed trade in finished products, samples, ingredients and components to cross borders without ponderous declarations and controls.
Common marketing rules have made it possible to sell a product in all 27 member states on the basis of a single authorization.
Common intellectual property frameworks have eased access to EU-wide protection of trademarks and patents and data.
Common rules for people to move from country to country have permitted a free flow of researchers, managers, technicians and experts in and around the medicines innovation business.
And common approaches to regulation and supervision have been molded by consistent and persistent joint work among Europe's national and regional drug agencies, centered on and stimulated by the European Medicines Agency and its thousands-strong networks of experts across the continent.
What happens to trade, to IP protection and to free movement for people will emerge, for good or for ill, from the negotiations that are scheduled to start in a month or so between the UK government and the remaining 27 EU member states. (The atmosphere at present, in the run-up to these talks, is anything but promising, with Brussels accusing the UK government of self-delusion about the prospects of a happy low-cost outcome, and the UK government repeating ever more loudly that success will flow from strong and determined leadership… The upcoming negotiations will clarify over the next few months how much of this is significant and how much is pre-fight rhetoric.)
But what is much more obvious and immediate is the damage already being done to regulation, and to the options for retaining some form of EU-wide marketing authorizations. In part, this is the collateral damage that Brexit has inflicted on the European Medicines Agency, which will have to relocate away from London, with the inevitable disruption this will entail for such a complex organization. In part, it is the imminent dismemberment - or at the very least the weakening – of the networks that sustain regulation in Europe: UK experts and officials will no longer contribute as they have done in the last 50 years. And in part it is the prospect of discordance emerging over time as one of Europe's largest countries and leading centers for medicines begins to forge its own path in regulation (already some in the UK are talking up the opportunities that Brexit will offer for the country to go its own way on supervision of sensitive areas of scientific research such as regenerative medicine).

The EMA has begun to put plans in place for damage limitation, and at the end of April it held a top-level meeting with the heads of Europe's national drug agencies specifically to discuss the regulatory consequences of Brexit. The principal agenda item was how to split up the work on evaluating and monitoring medicines after the UK withdrawal – now presumed to take place on March 30th, 2019.

This wouldn't be so much of an issue if the UK had not been such a prominent resource for the EMA. It has been one of the most active agencies and supplied many of the experts for the EMA's work for 20 years. So, its departure will leave a gap – a big gap.
The EMA's boss, Guido Rasi – an embattled figure in an embattled institution – made optimistic noises at the end of the meeting. “I am reassured to see the overall commitment of the member states to step up their efforts and to explore the options to take on a bigger share of the workload,” he said. And he offered something of a double-edged sword of consolation: “The expertise available across the network is impressive, and this is an opportunity to streamline the way we work, increase our capacity and work even more efficiently.” Crudely translated, that is the equivalent of: "Houston, we have a problem!"

The "principles" EMA has set out for solving the problem amount to no more than statements of the obvious: ensuring business continuity, maintaining quality of assessments, meeting timelines… So too with the proposed methodologies: mapping expertise in the network and identifying gaps, enhanced training… A further meeting is now scheduled for July to refine the thinking. For everyone around Europe who relies on effective regulation, answers cannot come soon enough.

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