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As Brexit delayed, wannabe next PM wants to slash trial regulations

April 4, 2019
Life sciences

In the middle of a major democratic quagmire over when and how the U.K. should leave the EU, one man (and bookies’ favorite to be the next prime minister) is talking about cutting red tape surrounding clinical trials.

Seems a rather odd choice for Michael Gove, a British conservative member of Parliament and former cabinet minister, given the ongoing deadlock at Parliament.

But Gove, who alongside former London Mayor Boris Johnson is a leading favorite to be the next leader of Britain (as current PM Theresa May appears to be stepping down in the near future), used a recent speech to talk clinical trials and how EU regulations for them can be loosened as a result of Brexit.

Gove pledged leaving Europe would allow the U.K. to “take back control” and scrap “absurd” rules including the EU’s Clinical Trial Directive, which sets the rules for studies across the continent and was overhauled in 2014 to, in fact, make it easier to conduct trials after a marked decline in studies across Europe.

“I’ll mention one in particular,” he said at an event for Advertising Week Europe. “I know that pharmaceuticals is a huge British success story and export, but pharmaceuticals are to an extent held back by the principles of the Clinical Trials Directive, which in some respect inhibits, for example, the development of treatments which could be trialled in a particular way which would both help some of the suffering an advance innovation.”

The former education secretary said slashing these regulations could boost innovation in drug development and help spur on new medicines to relieve “pain and misery”.

The U.K. is still existing under EU rules on drug development and regulation, but the future of these two key proponents for biopharma remains unclear.

Carl Heneghan, professor of evidence-based medicine at the University of Oxford and a GP, wrote in The BMJ that while it is not “inconceivable” the U.K. will have its own human research act, he argues we “won’t be ‘scrapping’ the trials directive.

“Largely, because the directive follows Good Clinical Practice (GCP), something many countries endorse, to protect patients and volunteers and define the different roles for those involved in trials.”

He adds: “Therefore we can expect, post-Brexit, that U.K. trials legislation will largely harmonize with the EU trials directive. The U.K. could adopt measures to speed up low-risk trials and go further on trials transparency. We could remove some of the bureaucratic legislation at the front end of trials, slowing down the speed of getting started, and add some legislation to the back end of trials.”

One of the key things for groups such as AllTrials will be the continued focus on clinical trial transparency, i.e., ensuring all data from all trials, whether commercial or academic, are made available for public consumption, something Europe has been slowly but surely working on in recent years.

By Ben Adams

Source: Fierce Biotech

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