European Healthcare Confronted with a Brexit Mouse


Applied Clinical Trials

The British government has at last set out its ambitions for cooperation on medicines post-Brexit.

The British government has at last set out its ambitions for cooperation on medicines post-Brexit. It has been a long gestation-it is more than two years since a slender majority of UK voters chose "leave" the EU rather than "remain", in a referendum that is coming under increasing scrutiny over alleged interference from Russia and abuse of private data to swing opinion.

And with only eight months to go until the scheduled date for Britain's 46-year membership to come to an end, the birth of these plans-after their long and difficult delivery from the faltering government of Theresa May-does not come a moment too soon. There it is at last: a so-called white paper entitled "The Future Relationship Between the United Kingdom and the European Union." But, as Aesop related, "the mountain heaved, and brought forth a mouse".    

The document is little more than a repetition of the same unrealistic wishes and presumptions, which has been the government's approach to the challenge of negotiating a withdrawal treaty with the EU ever since May uttered the promise back in mid-2017 that "Brexit means Brexit". Despite the EU's consistent message that a pick-and-choose membership is just not on the menu, the current paper, as well as the sections on medicines, display just that same argument.
The document produces-like a rabbit from a conjurer's hat-a magic formula for solving all the problems of the border that from early next year will separate the UK from the EU. It says "a common rulebook" should be enough to remove the need for regulatory checks at the border and "reassure the UK and the EU that goods in circulation in their respective markets meet the necessary regulatory requirements". This magic common rulebook would also ensure interoperability between UK and EU supply chains, and avoid the need for manufacturers to run separate production lines for each market, it promises.
A common rulebook is what the EU already has, for all its member states. That is how they are able to operate as a Union, because it governs cross-border trade in goods and services and free movement of people and capital. The UK's suggestion is that a new rulebook should be created just to allow it to duck out of the bits of the EU that it doesn't like, while remaining in the bits it does like. That may well suit the UK as a theory. It is less likely to suit the other 27 member states.
The UK wants manufacturers to face only one series of tests in either market, in order to place products in both markets-"supported by arrangements covering all relevant compliance activity." "Arrangements" is a strikingly vague word for something so critically important to the debate. It is hardly spelled out any more clearly in the UK’s claim that its proposal "would cover all of the compliance activity necessary for products to be sold in the UK and EU markets", including Good Laboratory Practice and Good Manufacturing Practice, and "bespoke provisions for human and animal medicines which reflect their unique status, including the release of individual batches by a qualified person based in the UK or EU, and the role of the qualified person for pharmacovigilance." All necessary of course. But how is this to be agreed? That is largely excluded from the equation.
And such specifics as the document offers are also wrapped in vagueness. The UK is seeking a link with the European Medicines Agency "as an active participant, albeit without voting rights", with the declared intention to "ensure that all the current routes to market for human and animal medicine remain available, with UK regulators still able to conduct technical work, including acting as a ‘leading authority’ for the assessment of medicines, and participating in other activities like ongoing safety monitoring and the incoming clinical trials framework." A noble aspiration. But in present circumstances, about as meaningful as an offer of free money for everyone for the rest of their lives.
The heads of the Association of the British Pharmaceutical Industry and the UK BioIndustry Association both gave the white paper a cautious welcome as an expression of objectives-but the hollowness at the heart of the plan is clearly perceivable in their statement: "Today’s approach depends on agreement from both sides," they politely point out.


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


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