How Will UK Drug Regulation Be Affected by Brexit?

Now that the UK has voted to leave the European Union (EU), there are many questions being asked, Tracy Staton of FirePharma pointed out. The UK had been home to the EU’s European Medicines Agency (EMA) for most of their participation in the union, but that is no more with Brexit.

The UK’s life sciences minister, George Freeman, is helping the UK navigate regulatory breakup negotiations with the EU. Freeman wants to ensure that the voices of the industry are heard during the negotiation process. They will be joined by the Association of the British Pharmaceutical Industry and the Biotech Industry Association for support.

Industry insiders are worried about how the regulatory outlook will look in 2 years’ time. Companies and associations are worried about the development of a separate regulatory system. One fear is cost, the second is that the UK would not obtain new medicines until after the EU. The generic and biosimilar medicines industry has urged the UK to “do everything possible” to maintain its current European marketing authorization and wants to stick with the centralized oversight provided by the EU.

One of Freeman’s ideas is to put regulatory authority in the hands of Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) to separately regulate biopharma. Freeman would also like to implement an Accelerated Access Review project in order to bring new treatments to the UK.

The MHRA will need to work more closely with the National Institute for Health and Care Excellence to speed up coverage for new drugs.

Freeman promises that Britain will retain its influence within life sciences but needs to at least consider an alternative, independent regulatory body in the likely event that negotiations break down. The steering group is set to converge in September to unveil their recommendations for regulation, intellectual property, research, and trade according to the UK Bureau of Industry and Security. Their main goal is to prevent a mass “brain drain” of scientists and executives from relocating.

These reassurances come after great fallout from Brexit including the weakened Pound, economic challenges posed by exiting conglomerates, and even concerns in India about the future of the UK’s drug market. The EU is also reeling and will need to find a new home for the EMA.

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