Liberal Democrat MEPs in the Environment Committee today backed an important piece of legislation which will set the bar for transparency in medical research for years to come. The vote at committee stage on the Clinical Trials Regulation saw key amendments relating to transparency of clinical trial data adopted. This will require detailed clinical trial data on medicines to be published once the medicine is authorised.
Lib Dem European health spokesperson Rebecca Taylor MEP commented after the vote:
“Doctors should have access to vital safety and efficacy information on the medicines they prescribe to patients. In the past, that has not been the case. Today is the start of a sea change in data transparency that will lead to important clinical trial data being made publicly available as never before.
While I believe that it is necessary to publish detailed data for authorised medicines, some flexibility should be allowed in relation to non-commercial (academic) clinical trials, in order to encourage research and innovation rather than create barriers.
MEPs will now enter negotiations with national governments before a final vote on the legislation in the autumn.
For more information have a look at Rebecca’s blog.