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Focus on Regulation

UK to Seek Close Relationship with EMA Post-Brexit

UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the closest possible regulatory equivalence.

He highlighted that, currently, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) carries out over 40% of the EMA’s scientific work, meaning that continued access to the MHRA expertise would also be beneficial for the EMA. He indicated that the UK would be open to automatically recognising marketing authorisations granted in the EU.  Mr Hunt also said that he expects the EU to move the EMA headquarters from London (and indeed, there is a long list of Member States that have expressed an interested in hosting the EMA post-Brexit).

Of course, this will all be subject to the Brexit negotiations between the Member States. However, Mr Hunt’s comments are the clearest indication yet that the UK will have separate regulatory arrangements for medicines post-Brexit, but that these are likely to remain closely aligned with the EU and are unlikely to diverge significantly.