Blog: Could the UK Continue To Be A Member of The EMA?

In this blog Brian Cleary looks at the efforts by some members of the British government to remain an active part of the European Medicines Agency.

The hackneyed portrayal of student demonstrations invariably features the call of “What do we want?” and the response “More/Less/No..” or something similar.  Whereas student marchers have a definite response and cause in mind, the British government are very much undecided about what they want Brexit to look like and how they intend to legislate a future outside of the European Union.

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British Prime Minister, Theresa May, speaking at the Conservative Party conference in October 2016. (Image: Sky News)

The latest volte-face comes from the Business Secretary Greg Clark MP who appears determined to ensure that the UK’s life sciences sector remains a part of the European Medicines Agency.  On the surface this is an eminently sensible decision until the world of politics raises its head.  Politics, more than ever, is increasingly conducted in the public eye.  While we have the ability to witness history in the making, it has made it extremely difficult for politicians to change their minds without suffering from some sort of defeat.

British Prime Minister Theresa May stated in October 2016, at the Conservative Party conference, that she would not allow a post Brexit Britain to be under the jurisdiction of the European Courts of Justice.  In doing so she signalled that it would not feature, as a participant in a wide range of pan-European organisations, including the European Medicines Agency.

Now, with the suggestion that the UK could continue to be part of the EMA, there would have to be a role for the European Courts of Justice as the organisation is under the ECJ’s remit.  This would be yet another climb down for Hard Brexiteers (and the Prime Minister) who are intent on devising their own mechanisms for facilitating trade and regulation in the life sciences sector.  Furthermore, and possibly most infuriatingly to Hard Brexiteers, such a move would almost certainly involve a payment to the EU in return for access to the ECJ.  This would certainly infuriate those that have worked hardest to extract the UK from the union.

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Failure to progress with such an arrangement would be damaging to the life science sector and will create uncertainty as an alternative mechanism is constructed.  While World Trade Organisation rules would be invoked they are no match for the friction-less trading arrangement currently in place.

Koen Lenaerts, President of the ECJ with Donald Tusk

Groucho Marx, never a politician, but a man who had the measure of many things said:

“Politics is the art of looking for trouble, finding it everywhere, diagnosing it incorrectly and applying the wrong ideas”.

If the UK wishes to remain part of the network then the red line of the ECJ will have to be crossed in the interests of patient safety, medicine supply, industrial concerns and scientific innovation.  While every sector can lay claim to special requirements, there are few that matter more than medicines.

The possibility of the UK remaining a member of the EMA was first floated in July of 2017 in an open letter to The Financial Times by Greg Clark and Jeremy Hunt (Health Secretary).  While their initial intervention was met with some disquiet, it has now gained wider acceptance following a number of representations from British industry bodies.  The UK government has already accepted that the UK will come under the jurisdiction of the ECJ during any transitional period and therefore it is practical to suggest that the red line of the ECJ be crossed permanently to enable the aviation, chemicals and life science sectors be able to function effectively post Brexit.

This latest episode is, in my opinion, another costly political mistake that has caused inconvenience to manufacturers and MAH’s.  While the Clark and Hunt suggestion is now gaining ground it is clear that a definitive decision needs to be decided on by bother sides sooner rather than later.