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The first stage of separation for the EMA from the UK came with the decision to relocate its headquarters to Amsterdam, and now the second stage has taken place whereby the EMA has reassigned the MHRA’s role vetting medicines to other countries.
All of this has been brought about by Brexit; the surprise decision to go ahead with uncoupling the EMA’s medicine verification process from the MHRA immediately after the deadline for Brexit will have brought even more uncertainty for UK industry.
It was expected that this decision may have been left until the end of the transition period, which will continue until the end of 2020. However, the EMA has already been swift to react to Brexit – first by announcing immediately that it would be seeking new headquarters and now by preparing early for life possible without the aid of the MHRA by March 2019.
Mike Thompson, Chief Executive of the ABPI, said: “Given that the MHRA assesses up to 20% of EU medicines, it is clearly in the EMA’s interest to continue to draw on its expertise. It would also be disadvantageous for the EU to be unaligned with the UK as the largest biopharmaceutical cluster outside of the US.
“The UK Government has been clear that cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health.”
Theresa May had previously suggested, in a speech at the beginning of March 2018, that her government wanted the UK to be closely linked with the EMA, but this move by the EMA looks to have potentially disrupted that wish.
It could prove to be problematic to industry, if drug approvals are slowed down by the process of other member states learning to cope with new burdens, but the main concern for the UK is that it risks isolating industry based in the country, which includes giants such as GSK and AstraZeneca, as well as many other smaller companies.
The flipside to this equation is that, for the EMA, any uncertainty that is dependent upon political wrangling at the national level could spell disaster for the agency’s work if agreements are not reached. It is therefore understandable that the agency has forged ahead of relocating the 370 medicines that the MHRA and Veterinary Medicines Directorate (also UK-based) are currently rapporteur or co-rapporteur on.