Tuesday, June 25

Access to potentially life-saving clinical trials at risk for 600,000 patients after Brexit



More than 600,000 patients a year could be denied access to potentially life-saving clinical trials after Brexit, medical research organisations have warned.

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.

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, told The Independent: 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 60 million, than it is to go to the whole of the EU, which has a population of 500 million, she said. There’s a risk that people might bypass the UK altogether and just go to Europe.

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 Ms 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 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 mother of a 10-year-old boy with Duchenne muscular dystrophy, a life-limiting condition that affects around 2,500 children in the UK, mainly boys, said her son taking part in a clinical trial had given her a huge amount of hope.

Boys with Duchenne usually only get seen by a consultant every six to eight months, said Emma Hallam. She has been told this is because of the degenerative nature of the condition.

They say, It’s never going to get better, so there’s no point reviewing him more often, because there’s never going to good news, it’s only going to be bad.’ That’s not something you want to hear about your child.