More than 600,000 UK patients a year could be denied access to potentially life-saving clinical trials after Brexit, medical research organisations have warned in The Independent.
New regulations are set to make it significantly easier for drug companies to test pioneering new treatments in EU countries – sparking concerns the UK will be “bypassed altogether” when it leaves the bloc.
The report says many patients, including those with cancer, diabetes and rare diseases, benefit greatly from access to drugs in late stages of testing that are not yet available on the NHS. But Beth Thompson, senior policy adviser at the Wellcome Trust, which funds medical research, is quoted in the report as saying: “There is a real risk that patients will miss out” when the new EU rules come into operation late next year. “It’s going to become more complicated to run a trial here, with our population of around 60m, than it is to go to the whole of the EU, which has a population of 500m,” she said. “There’s a risk that people might bypass the UK altogether and just go to Europe.”
The report says the new regulations, which the UK helped to draw up, aim to streamline the application process for clinical trials through a single approval system for all 28 countries. They will replace the current system, which has been criticised as slow and bureaucratic and requires separate and often very different applications for each member state.
“The risk is definitely there that when the UK leaves the EU, and with it leaves that harmonised framework, that it will reduce the number of trials that happen in the UK,” said Thompson. “We don’t know yet what the UK’s future relationship with the EU will look like in terms of these trials. We’d really like to see the UK seeking to harmonise with the clinical trials regulation and seeking access to the IT infrastructure that underpins it.”
The fears about drugs trials follow warnings that the introduction of new licenced medicines in the UK could also be delayed after Brexit, with cancer drugs likely to be particularly badly affected, the report says.
The UK is expected to leave the European Medicines Agency, which regulates medicines within the EU, Health Secretary Jeremy Hunt has said, leading to concerns Britain could join the “back of the queue” after Japan, the US and the EU when new drugs are introduced.
Clinical trials can be “vital” for patients with rare diseases, said Aisling Burnand, head of the Association of Medical Research Charities (AMRC). “By the nature of rare diseases, no single country will have enough people with a particular condition to undertake clinical trials of significance,” she said. “Involving the larger EU population not only means that clinical trials can take place, but the EU’s regulatory process also makes it cost-effective to bring innovative new therapies to rare disease patients.”
The prospect of tough negotiations ahead means huge uncertainty remains about what leaving the EU will mean for the drugs industry and clinical trials – which could be detrimental to current research, said Alastair Kent, head of Genetic Alliance UK. “If there is uncertainty about the future trial regime post-Brexit, then companies who have a choice will potentially hedge their bets,” he said. “There’s an important need for government to make clear its intentions on how it sees these proceedings.”
A spokesperson for the JDRF, which funds research into new treatments for type 1 diabetes, also said current uncertainty could cause problems because the timelines involved in planning research can be so long.
Paul Workman, head of the Association of Medical Research Charities (AMRC) said in the report: “Any regulatory barriers to working collaboratively with colleagues in the EU would limit our opportunities to take part in and lead these trials, which would have an impact on both research and patients. The outcome of the Brexit negotiations must ensure the UK remains competitive in a very tough environment.”The Independent report