The EMA has announced it has completed the reallocation of the medicines that the UK’s national regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), currently regulates.
Despite efforts from the UK to remain linked to the EMA for a transition period until the end of 2020, this decision means that the UK will now be excluded from drug approval after the UK leaves the EU in March 2019.
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The EMA said in a statement that ‘the MHRA and VMD [Veterinary Medicines Directorate] will no longer be able to engage in centralised regulatory procedures’.
The EMA will now ‘explore options for a robust allocation of the workload across the European medicines regulatory network’ meaning that other member states, plus Norway and Iceland, will take on the role the MHRA currently has in drug regulation. The EMA has already appointed new rapporteurs and co-rapporteurs, which will be communicated before the end of this month.
The Association of the British Pharmaceutical Industry (ABPI), the trade association for UK pharmaceutical companies, has expressed concerns over the EMA’s decision, stating that the move could be disadvantageous for both sides.
ABPI chief executive Mike Thompson 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.”
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By GlobalDataIn a speech made in March, UK Prime Minister Theresa May expressed her intention for the UK to become an ‘associate member’ of the EMA and other agencies after Brexit. However, with the UK likely to leave the single market post-Brexit, the 27 EU members involved in Brexit negotiations have reiterated that the UK will be unable to ‘cherry pick’ aspects of EU membership.
Post-Brexit drug regulation has been a key concern for the British and European pharmaceutical industry and medical community, given the centralised nature of medicine approval and clinical trial regulation in the EU. The MHRA currently plays a lead role in drug regulation, but future differences in regulation could slow down approvals and restrict access to medication, with the risk of the UK being ‘deprioritised’ by pharmaceutical companies due to additional regulatory hurdles.
It is unclear whether the UK will align with other regulatory bodies or if the MHRA will exist independently as a regulator.
Whether the UK will be able to negotiate a degree of participation in EU regulation and partake in the free trade of medical supplies also remains uncertain. The MHRA has not yet made a final decision concerning a future relationship with the EMA.
Yesterday, the UK Government committed to aligning the UK with EU clinical trials regulation after the issue was raised in parliament.
