Science and Technology CommitteeWritten evidence submitted by Privacy and Clinical Trial Data

1. For trials which have correctly followed protocols, there should be no general privacy-based reason for non-publication of de-identified trial outputs. Where participation in a trial is based in line with protocol (full disclosure of information about the trial, post-trial process, and properly informed consent is obtained from volunteers), the privacy impact of currently required publication should already have been appropriately minimised.

2. Were any organisation conducting a trial to claim privacy as justification for secrecy or failure to publish, this could imply a serious breach of trial protocol. In any such case, a detailed investigation should be made to discover which if any protocols have been broken or improperly applied, and why—and in what other ways the trial might be invalid.

3. For good reason, UK law tightly regulates medical trials. The ability for pharmaceutical companies to use a jurisdiction of choice should not allow them to evade UK regulations on trial publication based upon trial use elsewhere.

February 2013

Prepared 16th September 2013