Hunt and Clark look to clarify drug regulation in the UK after Brexit.

EMAJeremy Hunt, Health Secretary, and Greg Clark, Business Secretary, have recently made a bold move to suggest that the UK will consider collaborating closely with the EU in order to navigate drug approvals post-Brexit. The pharmaceutical industry has been insistent since the referendum for clearer indication of the future of drug regulation post 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, maybe welcomed by some but represent a significant change in tack. As negotiation tactics have so far found the Conservative government striving to keep its cards close to its chest but due turbulent time of late, that approach seems to have been abandoned.

“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 stated in their letter.

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

The main cause for worry about this approach is that it would place the UK behind bigger 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.

Source – Pharmafile

Industry News