UK vote to keep EMA ties will likely instil confidence in industry, says RAPS

By Flora Southey contact

- Last updated on GMT

(Image: Getty/ThorstenSchmitt)
(Image: Getty/ThorstenSchmitt)

Related tags: Brexit, Ema, Fda, European union

The UK has voted in favour of continuing its involvement in the EMA’s regulatory network, once it withdraws from the European Union.

On July 17, the UK Parliament voted 305-391 in favour of amendment NC17 to the Trade Bill, to take “all necessary steps” ​to maintain participation in the European Medicines Agency (EMA) regulatory network

In a joint statement on behalf of its members, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, said:

“Today, Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations. Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way.

“Therefore, it is essential that the UK continues to participate in the EMA after Brexit, as set out in the Brexit White Paper​ and in the Prime Minister’s Mansion House speech​.”

According to the Regulatory Affairs Professionals Society (RAPS), the vote will likely be well received within the industry.

“This new development from the House of Commons is a step forward towards a more aligned UK and EU regulatory landscape and should instil confidence in drug manufacturers for a smoother transition post-Brexit, most importantly safeguarding the continuous supply of vital medicines,” ​said RAPS’ executive director, Paul Brooks.

“Of course, EMA has yet to determine the terms on which the UK could remain part of the agency post-Brexit,” ​he added.

Drugmakers have begun to prepare, both financially and logistically, in the event that a ‘hard Brexit’ threatens drug supply and regulatory approvals. Just this week, AstraZeneca announced plans​ to stockpile 20% more medicines into its UK inventory, for eventual export to the European Union.

The firm also set aside £40m ($52m) to cover potential costs incurred as a result of the UK’s withdrawal from the UK, we were told.

Related topics: Regulatory & Safety, Regulations

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