EU Parliament To Vote On Compulsory Publishing Of Clinical Trial Data

The European Parliament is scheduled to vote on 3 April on amended draft legislation that would oblige pharmaceutical companies to publish all clinical trial data in a publicly accessible database.

Specifically, one amendment states “in general the data included in clinical study reports should not be considered commercially confidential once a marketing authorisation has been granted.”

The EP’s Legislative Observatory website shows that the draft legislation was debated and amendments approved by the EP’s Committee on Environment, Public Health and Food Safety in 2013.

The amendments to be put forward to the EP for debate and a vote in plenary in April are available here. The legislation will still need to be approved by the Council of Ministers before implementation.

The plenary debate had been scheduled for 12 March, but was postponed to 2 April, according to ClinDev, among other sources.

The proposed legislation will “lead to safer medicines and therefore to safer prescribing. Disclosure also serves the true interests of advancing collective knowledge, allowing the science underpinning drug development to flourish,” according to the New Scientist magazine.

Currently, pharmaceutical companies do not have to publish all clinical trial data concerning their products. This means that a lot of data showing negative results or possible harmful effects of medicines not made publicly available, with dangerous consequences. The New Scientist article claimed that “every year millions of people die or are harmed by adverse reactions to medicines, drugs prescribed in good faith by their doctors.”

If the legislation is passed, pharmaceutical companies will have to register all clinical trials carried out in the EU before starting on them, and publish the results within two years of trial completion.

The draft also includes provisions for clinical trials to be carried out on vulnerable groups to assess the impact of medicines on these groups, improved conditions of clinical trials for participants, and harmonisation of the rules on protection of patients and informed consent.