UK Government Sets Out Vision of Associate Membership of EMA Post-Brexit

We already know that the European Medicines Agency is leaving London to relocate in Amsterdam by the Brexit date in March 2019. But what of the relationship between the UK's regulator, the Medicines and Healthcare products Regulatory Agency, and the EMA? The two regulators currently work very closely together. Is that going to continue or not, post-Brexit?

The industry has been pushing for close regulatory alignment.

In Prime Minister Theresa May's Mansion House speech on 2 March, she set out her vision for a future trading relationship between the UK and EU. That included close regulatory alignment between regulators in certain industries, including with the EMA in the pharma and life sciences sector. She wanted to see the UK become an "associate member" of the EMA, and accepted that that would mean paying in a contribution to the cost of the running of the EMA. The benefits would mean that products would only need to undergo one set of regulatory approvals. It would also mean that the MHRA would be able to continue to provide the EMA with its own expertise.

The Association of the British Pharmaceutical Industry (ABPI), the body representing big pharma in the UK, welcomed the desire to have continued close ties, citing the statistic that every month, 45 million packs of medicine move from the UK to the EU and 37 million go the other way.

In a statement, the ABPI said: "That is why the Prime Minister's commitment to seek cooperation on medicines regulation would be the best outcome for patients, not just in the UK but across Europe. It is now critical that both sides prioritise patient safety in phase two of the negotiations. Delivering close cooperation on the regulation of medicines is only one part of the challenge. Making sure the supply of medicines is uninterrupted is essential to ensure patients in the UK and EU can get the medicines they need from day one of Brexit."

Comment

I welcome this vision. Close regulatory alignment is what the industry has been calling for and makes a lot of sense both for the UK and EU. It would see the UK giving effect to the referendum vote by having independence, but still working closely with the EU regulator in this key area, which would have mutual benefit, and ultimately would be best for patients.

There is no bigger issue facing pharma in the UK at the moment than Brexit. We will be holding our annual PING (Pharmaceutical Industry Network Group) event on 5 June 2018 dedicated to how Brexit is going to affect the pharma industry. Among a wide ranging speakers covering regulation, trade, people and funding and a Bank of England forecast, there will be: MHRA Chief Executive, Dr Ian Hudson, who will address the future relationship between the MHRA and the EMA; and Dr Pete Gough, Executive Director at NSF Pharma Biotech, who will offer some practical steps on how to prepare for the new regulatory environment.

If you are interested in attending the event, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 01923 919 320.