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Ministers move to clarify drug regulation Post-Brexit

Published on 04/07/17 at 09:11am

Jeremy Hunt, Health Secretary, and Greg Clark, Business Secretary, have made a bold move to suggest that the UK will look to collaborate closely with the EU to navigate drug approvals post-Brexit. The pharmaceutical industry has been pressing since the referendum for a clearer indication of the future of drug regulation in light of the Brexit decision and welcomed the move to indicate a future direction in negotiations.

The strategy by Hunt and Clark to announce their aims prior to full discussions with the EU through a letter to the Financial Times will be welcomed by some areas but represent a significant change in tack; negotiation tactics thus far have found the Conservative government striving to keep its cards close to its chest but, after a turbulent time of late, that seems to have been dropped.

"The UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety…Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data," Hunt and Clark wrote in their letter.

 In the letter, the ministers also seem to suggest that if cooperation with the EMA is no longer possible after Brexit then the UK will move to form its own regulatory agency. This would mean extending the remit of the MHRA to include the processes currently carried out by the EMA.

The principal worry about this approach is that it would place the UK behind much larger markets for pharmaceutical companies to sell their products, especially as the UK’s NICE is known to drive a hard bargain for pharmaceutical companies.

The ABPI’s Chief Executive, Mike Thomson, commented on the release: “This letter is a welcome recognition that the future of medicines regulation is a key priority for the Government as we negotiate a new relationship with the EU. It also signals a readiness to take a pragmatic approach to Brexit negotiations that puts people’s health first. This is a great first step and we look forward to seeing more detail in the coming weeks and months.”

The ABPI has been urging for clarity for some time amid a feeling within the regulatory side of drug affairs that it had been side-lined or not considered at all prior to negotiations beginning.

Ben Hargreaves

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