British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The trade groups found fault with proposals for how the Medicines and Healthcare products Regulatory Agency (MHRA) will handle orphan drugs, regulatory fees, the Falsified Medicines Directive and other issues if Britain crashes out of the European Union.
MHRA spent last month gathering feedback on proposals for how the United Kingdom should adapt its drug regulations and legislation to mitigate the impact of it exiting the EU without a deal in March. The consultation sought to gauge industry views on MHRA’s handling of key questions posed by the prospect of a no-deal Brexit.
Joint feedback from the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) suggests MHRA is some way from coming up with a set of changes that satisfy drug developers and manufacturers. ABPI and BIA agreed with with many of the proposals, in some cases with notable caveats, but also found fault with MHRA’s response to some of the biggest issues facing the agency and the companies it regulates.
Points of disagreement between MHRA and the trade groups include how to convert the licenses for products authorized at the EU level into authorizations that are valid in the UK after Brexit. MHRA is proposing to automatically convert centrally authorized products to UK marketing authorizations the day Britain leaves the EU. The agency would not charge a fee for the conversion…