Hospital Dr News

Brexit: “UK must collaborate with EU on research to develop new medicines and devices”

Brexit negotiators must prioritise patient safety in the next round of negotiations, a report by the Parliamentary Health and Social Care Committee urges.

The report welcomed the Government’s stated intention to maintain regulatory alignment with the European Medicines Agency (EMA).

The entire supply chain of pharmaceuticals, from research and development through to the product being available on a pharmacy shelf, will be adversely affected by regulatory divergence and seriously so in the event of a ‘no deal’ Brexit, the report warned.

It is also vital that the UK life sciences sector is able to continue to participate in Europe-wide clinical trials.

If the UK does not adopt the new clinical trials regulations and is unable to access the EU infrastructure developed within the EU to underpin them, difficulties for patients and the life science industry could emerge, the report warns.

The UK should also seek mutual recognition of pharmacovigilance mechanisms by the MHRA and the EMA as a priority in the next round of negotiations, as the failure to do so could affect patient safety both in the UK and the EU.

The report says it is also in the best interests of patients for the UK to continue membership of all of the major EU pharmacovigilance systems and databases, including the European Database on Medical Devices (EUDAMED) and Eudravigilance.

Chair of the Committee, Dr Sarah Wollaston MP, said: “In order to minimise harm to their citizens, both the UK and the EU-27 should look to secure the closest possible regulatory alignment in the next round of the Brexit negotiations.

“Failure to do so would signal a triumph of ideology over the best interests of patients.”

The report says the Government should assess the impact of the loss of parallel imports, and it recommends further contingency planning should be undertaken on the impact on the supply chain of a failure to achieve free and frictionless trade in pharmaceutical products.

Dr Andrew Dearden, BMA treasurer, said: “There are many sensible recommendations in this report – while Brexit will fundamentally alter both the UK and the EU, it must not threaten patient safety.

“Establishing a regulatory regime for clinical trials that diverges significantly from EU standards would increase the burden on UK researchers and pharmaceutical companies. This would make the UK a less appealing destination to conduct trials, particularly for rare diseases, while also creating barriers to collaborating and sharing expertise and facilities.

“It is crucial that the UK continues to work collaboratively with the EU on research to develop new medicines and medical devices.”

Read the report.

Bookmark and Share

Post a Comment

Enter this security code

Submit Comment for Moderation