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New UK law means improved safety for medicines – but what about medical devices?

New UK law means improved safety for medicines – but what about medical devices?

The UK government is to introduce a law forcing all researchers to publish results of their clinical trials within 12 months of trial completion.

Any company or university breaking the law will be refused permission to start new trials. This is a major victory for patients in the UK and sets a new global gold standard for transparency.

It is great news for patient safety when it comes to medicines – but what about medical devices like mesh? Our understanding is that results of trials will be made public on a “goodwill” basis.

We know that goodwill or voluntary reporting doesn’t work. For example, two thirds of mesh complications were not logged with the MHRA Yellow Card – which meant the voices of thousands of women suffering effectively fell into a black hole.

The resulting lack of data on harm meant mesh carried on being implanted into women causing untold and irreversible harm – and as campaigners we had no evidence to back up our stories.

Despite our relentless campaigning, the MHRA still refuses to make it mandatory for clinicians to report complications to the Yellow Card system. Which means even today there will be a new mesh scandal going on under everybody’s noses, but there is no data to spot trends of harm and then issue an early warning trigger.

The new law explained

The new UK law will make it mandatory to pre-register trials and for researchers to share their outcomes with participants.

The new legislative agenda follows a public consultation in which the over 2,000 respondents overwhelmingly supported new legislation to require trial registration (97%), rapid results reporting (94%), and sharing of trial findings with participants (91%).

The UK law sets a new global benchmark for transparency in medical research. Comparable disclosure laws in the European Union and the United States only cover some types of trials, and so far remain unenforced.

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