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Brexit concept

Between now and the UK’s departure from the EU at the end of March 2019, the European Medicines Agency may have to reassign as many as 230 human-use medicines for which the country has acted as rapporteur or co-rapporteur in the centralized approvals procedure. This is just under one in four of the almost 1,000 medicines approved centrally since the current system came into operation in 1995.

There are also questions over how far the UK can continue to be chosen as the lead or co-lead regulator in the evaluation of products submitted for EU-wide approval in the run-up to Brexit.

As of March 29, 2017, the UK had acted as either rapporteur or co-rapporteur for 226 (i.e., over 23%) of the 964 human medicines approved, the EMA told the Pink Sheet. It was rapporteur in 155 cases and co-rapporteur in 71. The EMA’s main scientific committee, the CHMP, is responsible for appointing the rapporteur and co-rapporteur for human medicine evaluations.

The EMA said that while no rapporteurships had yet been reallocated, “on the hypothesis that the UK may no longer participate in the work of EMA and the European medicines regulatory system,” UK rapporteurships and co-rapporteurships “will have to be reallocated at some stage”.

It added: “EMA is looking at various possible redistribution scenarios for the products for which the UK is currently rapporteur/co-rapporteur and will discuss this with CHMP/CVMP [the veterinary committee] and within the European regulatory network. Once the products have been redistributed, marketing authorisation holders will be informed accordingly. This will be done within the two years of the [Brexit] negotiations.”

Pharmaceutical companies “have no involvement or influence in the decision on rapporteurship appointments”, the EMA noted.

UK Tops (Co)rapporteur League

As in previous years, the UK in 2016 was the lead EU/EEA member state in terms of the number of rapporteurships/co-rapporteurships appointed to it. According to the EMA’s annual report for 2016, which has just been published, the UK was appointed rapporteur for 22 initial marketing authorizations and co-rapporteur for 19. Germany also had 22 rapporteurships, but was co-rapporteur in only 12 cases. Some way behind were Sweden (16/5), Spain (12/4) and the Netherlands (11/5).

Once appointed, rapporteurs remain responsible for the products in question during their entire life cycle. (Also see "UK Regulator Has Key Role in One in Four EU-Wide Approvals" - Pink Sheet, 22 Nov, 2016.) If the UK has to pull out of the EU regulatory network as the result of a so-called “hard Brexit,” its rapporteurships would need therefore to be taken over by other member states. As well as leading the initial evaluation – rapporteurs and co-rapporteurs prepare the assessment reports and lead the discussions in the committees – rapporteurs are involved in post-authorization procedures such as applications for variations and annual reassessments.

The reassignment exercise will presumably also need to cover products for which the UK has been appointed rapporteur or co-rapporteur and which are either under evaluation by the EMA, have been accepted for review, or have still to be submitted. The EMA does not provide data on rapporteurships for drugs under review until the evaluation process is complete and so could not say how many products currently under review or about to be submitted would have to be reallocated.

If the UK has to pull out of the EU regulatory network, its rapporteurships will need to be taken over by other member states.

Will The UK Still Be Appointed?

The implications of Brexit for drug regulation were aired at an April 29 forum on Brexit and pharmacovigilance organized by the UK Drug Safety Research Unit. (Also see "Situation Far From Ideal But EU Network Will Survive Brexit" - Pink Sheet, 27 Apr, 2017.) One issue raised was whether the UK would continue to be designated as rapporteur or co-rapporteur between now and when the country leaves the EU.

It would, on the face of it, be a fair assumption that after the Brexit vote – and particularly after prime minister Theresa May made clear the UK would not be staying in the single market – the country has become less of an attractive proposition for the role of rapporteur, and that the number of drugs assigned to the UK may well be tailing off. Any sudden drop would of course have a negative impact on the MHRA’s workload and revenues.

However, there is no evidence to suggest this is happening. The EMA said that between January 2015 and December 2016, the UK was appointed rapporteur for 15% of the products that were up for appointment, and was appointed co-rapporteur in 13% of cases – although it is not clear how many of these appointments were made in the periods before and after the June 2016 EU referendum.

Professor Saad Shakir, director of the DSRU, said it was not known whether the UK would continue to be designated rapporteur in the run-up to Brexit. In an interview with the Pink Sheet, he noted that MHRA has said it is still “business as usual,” but added “you would expect them to say that.”

Shakir said there had been talk “on the grapevine” at the April forum that the MHRA had been in touch with the EMA to ask it not to stop appointing the UK as rapporteur. It was suggested, he said, that there could be a multi-year transitional arrangement post-Brexit to allow more time to reallocate products where the UK continued to be rapporteur.

“Pharmaceutical companies have no involvement or influence in the decision on rapporteurship appointments” – European Medicines Agency

Pharmacovigilance Issues

Another concern among both companies and regulators is what will happen to the EU pharmacovigilance system when the UK leaves the EU, particularly in terms of the MHRA’s key role in building up the EudraVigilance database. “The feeling at our forum was that companies wanted the UK to continue to play a part” in EudraVigilance, Shakir said.

As for the effect of Brexit on the DSRU’s activities and staff, he said it would be affected “like any other part of the economy.” The scientific community in general has voiced the need to continue the exchange of students and researchers, he observed. “We think openness is good.”

From the editors of Scrip Regulatory Affairs.

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