LONDON, May 8 (APM) - The UK government is considering a deal with the EU on medicines regulation after Brexit, chief executive of UK biotech trade body the BioIndustry Association (BIA) Steve Bates said.
Speaking in a webinar on Friday, Bates highlighted recent remarks made in parliament by Conservative MP Robin Walker, suggesting his party wants to come to a deal for medicines regulation, rather than pursuing a hard-line Brexit.
Walker, who is also undersecretary of state at the Department for Exiting the European Union, said: "In the negotiations, the government will discuss with the EU and member states how best to continue to cooperate in the field of medicines regulation in the best interests of both the UK and EU."
Bates said in the webinar, which is available on YouTube, that this view is at odds with the EMA's tougher stance, after it issued a notice last week that pharma companies operating in the UK need to start planning now for life post-Brexit if they want to maintain the validity of their EU marketing authorisations (APMMA 52926).
Bates said he was unsurprised the EMA has issued such firm guidance because it is an organisation that is at the service of the European Commission, which is itself preparing for various potential outcomes of negotiations.
"Although this documentation seems definitive, it's only preparation for only one possible outcome which I don't think is the potential only outcome of Brexit," he said.
He added: "I think there is room in the communications for a deal, but what would happen in any future deal is not set out."
The issue is compounded by the upcoming UK general election, said Bates, commenting that it is difficult for politicians to come out and state a preferred position on medicines regulation when the nature of the next government is unknown.
"In a sense, you have now got the situation where the EU 27 are preparing for a hard Brexit. And the Brexiteer UK government are postulating the notion of deal."
Despite political uncertainties, Bates said the industry position remains the same; that no matter the future location of the London-based EMA, close alignment on medicines regulation between the UK and EU is in the best interests of both parties.
He highlighted several reasons why the remaining EU member states should not want to lose the UK as a partner on medicines regulations, including the potential for duplication and expensive extra regulation for industry.
It could also be worse for patients as the rest of the EU would lose access to 15% of pharmacovigilance data, while there would be a capability challenge across agencies as UK competency inspectors are replaced.
The EMA's plans for more integration, such as across computer systems, may also be harder to deliver than anticipated in the event of Brexit, said Bates.
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