HDA UK Media And Political Bulletin – 3 May 2017
UK medicines agency set to lose lucrative EMA work post-Brexit
Richard Staines, Pharma Phorum, 2 May 2017
The European Medicines Agency (EMA) anticipates that the UK will quit its regulatory system in March 2019, and has already begun discussions on which member states will handle work currently done by the UK’s regulator after Brexit. While no details are yet confirmed, this could adversely affect the Medicines and Healthcare products Regulatory Agency (MHRA). The assumption is that the EU won’t allow the MHRA to provide its existing services to the EMA post-Brexit – although this is not the stance taken by UK government ministers.
There is no Parliamentary Coverage.
Richard Staines, Pharma Phorum, 2 May 2017
The European Medicines Agency foresees the UK quitting its system in March 2019, and has already begun discussions on which member states will handle work currently done by the UK’s regulator after Brexit.
While no details are yet confirmed, this looks to be the most likely scenario – and would be a major blow to the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
It currently handles around 40% of the EMA’s decision-making on medicines, making it one of the mainstay’s of the EMA, which operates more as a network co-ordinator of national regulators rather than conducting all of the work itself.
The assumption is that the EU won’t allow the MHRA to provide its existing services to the EMA post-Brexit – although this is not the stance taken by UK government ministers.
In December, then-health minister Lord Prior said of the MHRA “[you can’t] replace that kind of expertise.” – but it seems that is exactly what the EU intends to do.
The EMA work is worth millions of euros, and other national regulators will be happy to take this from the MHRA and share the budget out.
In a statement, the EMA said its management board met with national regulators on Thursday to discuss how regulatory work will be shared between member states when the UK quits the EU.
Negotiations on terms of the UK’s departure have not yet officially commenced and the EMA said it cannot prejudge their outcome.
Nevertheless the regulator said that “work will now start on the basis of the scenario that foresees that the UK will not participate in the work of EMA and European regulatory system as of 30 March 2019”.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is one of the largest and most influential national regulators in the EMA’s network, and plays a major part in evaluations of both novel and generic drugs in Europe.
The EMA made no mention of where its new headquarters will be situated, a key issue as the agency is currently based in London and will almost certainly move as a consequence of Brexit.
A host of cities around Europe are lobbying to become the new base for the EMA, as it could even attract investment from pharma companies wishing to be close to the regulator.
For now, the EMA said its goals are to ensure business continuity and stability, maintain quality and robustness of scientific assessment, comply with legal timelines, and retain knowledge.
All regulators are expected to contribute to EMA activities according to their own capabilities, according to the statement.
The EMA’s committees and working parties, will now assess different options for workload distribution, with a follow-up meeting with member states taking place at the beginning of July.
EMA executive director, Guido Rasi, said: “I am reassured to see the overall commitment of the member states to step up their efforts and to explore the options to take on a bigger share of the workload.”
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