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Drug trial lawyer criticises Michael Gove's comments on scrapping European rules on clinical trials

Lawyer blasts Michael Gove over claims that European regulations such as the Clinical Trials Directive, to safeguard those taking part in trials, could be scrapped following Brexit

27 March 2017

The lawyer who represented some of those affected in the TGN1412 drug trials has criticised comments made by Conservative MP Michael Gove to attendees at an Advertising Week Europe seminar, which suggested that the UK could amend or rescind legislation relating to clinical trials after leaving the European Union.

According to the Independent Mr Gove told those that attended the event on Wednesday that Britain could now get rid of European regulations such as the Clinical Trials Directive.

Mr Gove claimed that European regulations were holding back business, adding:

“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.”

Gene Matthews, partner in law firm Leigh Day’s consumer law and product liability team, said:

“The comments by Mr Gove relating to scrapping the European Clinical Trials Directive are ill-informed nonsense.

“His claim that the UK would benefit by getting rid of EU regulations has no scientific or medical support and, frankly, from a pharmaceuticalbusiness point of view, makes little sense as British pharmaceutical companies will continue to need to meet international ethical, scientific and practical standards (detailed within the Good Clinical Practice document) if the those drugs are to be sold in Europe, America and around the world.

“While the importance of drug trials in developing new medicine to reduce patients’ suffering cannot be underestimated it is crucial that robust regulations are in place to protect those participating against unnecessary serious adverse events.

"Our clients have sadly experienced the impact of when clinical trials go badly wrong and we have recently seen the tragic death of a man in the Phase 1 clinical trial of painkiller BIA 10-2474 that was carried out by Biotrial (a Contract Research Organisation) on behalf of Bial (a Portuguese pharma company). I cannot believe that Mr Gove can seriously be suggesting that volunteers, and the public in due course, would be better served by less safety regulation”

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