Responses from European health ministers

A number of you who wrote to your European health minister urging them to support clinical trial transparency in Europe have heard back from your health minister or department.

Here are the replies you’ve sent us – please let us know if you’ve received a reply too and we’ll add it below:

Letter from UK Department of Health

Dear XXXX,

Thank you for your email of 22 October to Jeremy Hunt about transparency on clinical trials.  I have been asked to reply.

The Government supports the call for more transparency in clinical trial data. Transparency is important for patients, the public, researchers and the NHS, and can be achieved through ensuring that all clinical trials are registered on a public database such as so that everybody can see what trials are ongoing, the results of all clinical trials are published, and data from all clinical trials is made available.

Before a clinical trial can begin in England it must be approved by an independent ethics committee.  Since 30 September one of the conditions for approval has been that the trial is registered on a publically accessible database.

In its proposal for a Clinical Trials Regulation (2012/0192), the European Commission calls for a publically accessible EU database.  This database will contain details of all trials submitted for authorisation in the EU and summaries of their results within one year after they have ended.  The Government is supportive of these proposals.

In the negotiation of the Clinical Trials Regulation, the European Parliament has opted for even more transparency and would like clinical study reports that have been submitted in support of a marketing authorisation to be published on the EU database by the Marketing Authorisation Holders within 30 days after a regulatory decision has been made.

The Government also agrees with the European Parliament that once a regulatory decision has been made, the data in clinical study reports should not be considered commercially confidential.  The Government thinks it is important that there is clarity about the data that should be included in clinical study reports to ensure that trial sponsors as well as the public can be reassured.

Finally, with regard to the Science and Technology Committee report on transparency, the Government is currently considering the recommendations and will respond by 18 November.

I hope this reply is helpful.

Yours sincerely,

Joe Griephan
Ministerial Correspondence and Public Enquiries
Department of Health