uk exits ema

In draft guidelines prepared by the President of the European Council, and published on 7 March 2018, the European Council has downplayed the likelihood of the United Kingdom staying in the regional regulatory network after Brexit. Previously, British Prime Minister Theresa May had been vocal in promoting the mutual benefits of the UK becoming an associate member of the EMA, and had won strong support from the biopharma industry, by calling for the UK to continue paying into and taking its lead from EMA.

However, the EU’s willingness to countenance this model has now been called into question. As stated in the above-referenced guidelines “The European Council further reiterates that the Union will preserve its autonomy as regards its decision-making, which excludes the participation of the United Kingdom as a third-country to EU institutions, agencies or bodies”.
 

 Although draft, this statement looks to preclude the UK from continuing to participate in EMA after Brexit.
Other sections of the guidelines also have negative implications for the UK and its biopharma industry. The guidelines state the anticipated free trade agreement between the UK and EU “cannot offer the same benefits as membership and cannot amount to participation in the single market or parts thereof,” suggesting it will become harder to move goods across the UK-EU border.

If negotiations progress as foreseen in these guidelines, the UK will need to have its own regulatory infrastructure in place by this time next year, or later if a transition period is agreed. Prior to the vote on EU membership, Sir Michael Rawlins, chair of the Medicines and Healthcare products Regulatory Agency, said the UK was “certainly not” equipped to operate independently of EMA.

The European Council thus appears to have rejected the UK’s desire to maintain the status quo on the licensing and trade of pharmaceutical products.  Is the UK Health Industry (in particular the MHRA) prepared for the 30th March 2019?  

Peter Embley, PGDPRA, MTOPRA Senior Director, Regulatory Science, Drugs & Biologics

Peter Embley, PGDPRA, MTOPRA

Peter brings over 19 years applied industrial and commercial biopharmaceutical experience to his role, including seventeen years in Regulatory Science; working within the Generic, R&D and CRO industries. Peter has a strong grounding in EU legislation and filing strategies and has developed both regional and global strategic perspectives coupled with commercial acumen and experience working within multicultural project teams.

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