How post-Brexit regulation may affect healthcare – Med-Tech Innovation | Latest news for the medical device industry

Failing to maintain regulatory alignment with the European Union could mean that the UK could be part of fewer, if not excluded, from clinical trials, according to Professor Tamara Hervey from the University of Sheffield.

Speaking at the University of Manchester’s School of Law event on healthcare disparities, Hervey used the time it takes to license new drugs as a potential problem that means the UK could fall behind in the field of biomedical research.

She said: “We know even now it takes a long time for a new drug to become available on the NHS. Just licensing it isn’t enough for a patient necessarily to be entitled to it, but at the moment at the least the drug is licensed. A patient with a rare disease could be part of a clinical trial or a doctor could put in an individual patient request.

“If the UK no longer has regulatory alignment with the EU then those new drugs won’t be licensed in the UK. That will mean UK patients will no longer be able to be part of clinical trials.

“Trials are of the best current treatment versus the new in the UK, and that means the UK will start to fall behind in biomedical research.”

The effects of Brexit on health will be felt most in the UK, including on the NHS, but not evenly across the population.

Hervey suggested that some of the worst affected areas could see problems exacerbated by the UK’s withdrawal from the EU – with newly installed Prime Minister Boris Johnson pledging to leave the bloc on 31 October with, or without, a deal.

“In other words, broader Brexit effects on health will exacerbate existing geographical health disparities and inequalities. There are also implications for those who are particularly vulnerable such as older people, people in clinical trials, people with rare diseases and so on.

“The effects on the NHS and health differ significantly depending on the types of Brexit. In brief, the withdrawal agreement is much less harmful than a no-deal Brexit.”

When it comes to regulation surrounding medical devices and healthcare following Brexit, Henriette Roscam Abbing, emeritus professor of health law at the University of Utrecht, suggested the UK’s position could be similar to Norway’s once any future trade arrangements are in place.

In her presentation on health technologies and patient safety, she said: “In my opinion the United Kingdom will have to take account of the common European norms and this will be the same in the case of Norway and the European Union.”