“It hasn’t been easy to follow the votes on the clinical trial regulation in the Environment, Public Health and Food Safety Committee in Brussels today but I think we can say that the result isn’t bad, and that we all made a difference.
MEPs accepted compromise amendment 11 which says that all clinical trials must be registered and summary results published within a year of its end, with financial penalties for those who don’t comply.
MEPs rejected consolidated amendment 40 which would have put into law that clinical trial data should not be considered commercially confidential once a marketing authorisation has been granted or the decision-making process on an application for marketing authorisation has been completed. MEPs accepted consolidated amendment 41 which says the same thing but is in the recitals (to help with interpretation of the law). Therefore this is not as strong as we would like it to be, but still important.
Amendment 61 which says that when considering what is commercially confidential, policy makers should adhere to the European Medicines Agency’s guidelines on this and cannot override public health research interests was accepted.
We have heard from a number of MEPs’ offices that your letters made a difference to the votes. The pharmaceutical industry has 350 lobbyists at the European Parliament so in the run up to the vote MEPs were hearing that commercial concerns should trump transparency every day. MEPs told us that your letters, which they received from 100s of members of the public and medical and science organisations, gave them the arguments to make in favour of transparency.
If the regulation became law today it would be a big step forward. We have to say well done to Glenis Willmott MEP and her colleagues for all the hard work that has gone into it.
But the regulation still contains loopholes, inconsistencies and ambiguities that all need to be tidied up, and in front of us are four or five months of negotiations between the Parliament and the EU Member States’ governments where gains could be lost. We’ll let you know about next steps soon.”