Brexit Alliance calls for Brexit deal on medicines regulation

The Brexit Health Alliance is again warning that medicines supply in the UK is in danger of being disrupted if the issue of co-operative regulation is not addressed during Brexit negotiations.

“Shared regulatory frameworks at EU level have been crucial in providing patients with faster access to treatments,” stress the authors of a new briefing paper, which argues that “In the global market, separate national systems of regulation of health technologies can slow down treatments for patients.”

In one example, the paper warns that up to 120,000 prostate cancer patients throughout Europe could be affected if negotiations fail to find a solution for future cooperation between the UK and the EU on regulation and trade of medicines and medical devices.

“A prostate cancer medicine, made in a highly sophisticated process in the UK and used in 80 countries including all of Europe, is one of many medicines that risks supply disruption from a “no deal” scenario,” the Alliance said in a statement.

Furthermore, it also warns that the future of research into new medicines and medical technologies could take a hit, with around 750 UK-led clinical trials including multiple EU member states at risk should no plan for their approval or management be in place after March 2019.

“It is critical that UK and EU patients do not lose out on the best treatments and medical devices as the UK leaves the EU,” said the group’s co-chair Niall Dickson. “We want to make sure that patients continue to benefit from early access to new health technologies and cutting-edge medicines, and that includes being able to take part in international clinical trials. This can be achieved if will is there – what patients need is maximum co-operation and alignment between the EU and the UK on the regulation of medicines and medical devices and we very much welcome the UK Government’s commitment to close collaboration with our European partners.”

Aisling Burnand, chief executive of the Association of Medical Research Charities, said: “It is vital that the health of patients is prioritised in the second phase of negotiations. If not, patients in the UK and the EU could face delays in accessing potentially life-saving treatments. Officials on both sides of the negotiating table must have patients’ best interests at heart and ensure safety considerations are paramount.”

“Securing ongoing cooperation on medicines regulation between the UK and EU is the best way of ensuring that patients across Europe continue to have access to safe and effective medicines,” EFPIA director general Nathalie Moll stressed late last year.