AstraZeneca: Retaining current regulatory procedures crucial, post-Brexit

By Dan Stanton contact

- Last updated on GMT

Image: iStock/Nerthuz
Image: iStock/Nerthuz

Related tags: European medicines agency, United kingdom, European union

AstraZeneca says it will be critical to avoid duplicated regulatory efforts and costs once the UK leaves the European Union.

Last month, the UK voted to leave the EU in a historic referendum which has – on top of negatively impacting global markets and causing the value of the pound to plummet – left the pharma industry with an uncertain future​ in the country.

AstraZeneca CEO Pascal Soriot said last week it is too early to know the impact of Britain’s exit (‘Brexit’) from the single-market, but believes any resulting changes to regulatory processes in the UK could be costly for the industry.

He said while discussing Q2 2016 results there is currently a single process for regulatory submissions and processes through the European Medicines Agency (EMA).

“We would hope that it is retained or at least, at the very least a very effective process of mutual recognition, so we don't have to duplicate efforts to get approval in the UK​. That simply adds costs and delays and doesn't help anybody, the patients and other payers and the rest of the industry.”

Soriot described the regulatory uncertainty as “one aspect that is really critical for us,” ​and said while it's too early to know, “we hope that everybody is going to be practical about those things.”

Following the referendum in June, Sophie Labbé, a spokesperson from the EMA – based in London - told this publication as no country has ever decided to leave the EU, there is no precedent for this situation.

“The people in the UK have taken their vote and it is now up to the UK government to decide how to act upon the outcome of the referendum,”​ Labbé said, adding it would be business as usual in the meantime.

Investments

Soriot’s comments came in the same week fellow UK-based drugmaker GSK said it was investing £275m​ in three manufacturing sites in England and Scotland.

With the UK’s economic news being somewhat bleak since the June vote, some pro Brexit campaigners​ jumped on the announcement as evidence the UK is still an attractive place for industry.

GSK refused to comment on whether Brexit had played a role in its decision to invest.

But Stephan Rau, an expert in the life science sector and a partner in law firm McDermott Will and Emery, told this publication the GSK investment was good news for the UK and the pharma industry as a whole.

“It is good to see that a company like GSK still decides to make significant investments in the UK despite Brexit, which will likely cut off the UK from the European market.”

“It might,”​ he speculated, “also be the consequence of indications that the UK is likely to continue to accept EMA licenses and decisions made by EMA once EMA has relocated to another EU State.”

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