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UK regulator attempts to ease fears of impending access abyss

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced that there would be no sudden changes to the UK regulatory framework in the event of a no-deal following Brexit negotiations. It went on to confirm that it would provide “adequate notice to industry and ensure that companies had sufficient time to implement any changed requirements.” (January 16, 2018)

P4A thoughts

The  MHRA’s announcement is aimed at calming down industry fears of a potential “cliff” in the event of a no-deal with the EU.  It also provided an ambiguous indication of its future course of action emphasising on “adequate notice’’ and “sufficient time” for the industry to adjust to new measures.

The industry is seeking clarity and certainty as it prepares for Brexit and the MHRA statement lacks both. The ABPI in its reaction also underpins this ambiguity noting that a no-deal scenario will “ require further detail, and further highlights why a realistic implementation period needs to be urgently agreed’’.

Implications for a No-deal scenario: If the MHRA decides not to reapply to the EMA, pharmaceutical companies would have to submit separate marketing authorisation applications for both the E.U. and the U.K. Given the difference in size between the two markets, this extra work may make them more likely to prioritise EMA approval and less likely to apply for market access in the U.K. This might lead to a reduction in the supply of new innovative drugs to the U.K. It would also put extra strain on the MHRA, slowing the regulatory process and further reducing the number of innovative drugs available.

At the moment, the MHRA handles approximately 30% of the EMA’s caseload. With the absence of MHRA, the EMA would have to prepare for additional resourcing potentially involving other member states. This could lead to some delays initially in the EMA approval process, leading to potentially wide-ranging consequences for patients.

If the U.K. does not decide to join the European Economic Area (EEA), it would have wide ramifications on the pharmaceutical and life sciences industry. This industry is directly responsible for 220,000 jobs in the UK, of which around 7% are filled by non-British E.U. citizens. Potential restrictions in the freedom of movement for workers could result in a decline in workforce productivity and reduce the U.K.’s ability to attract foreign talent. This in turn could decrease investment in the U.K. and have a negative impact on the economy. It could also have an impact on cross-border collaboration, particularly in terms of research and commercial joint ventures between U.K. and non-U.K. based companies.

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