MEPs back new clinical trial rules

New rules will require greater transparency.

MEPs voted in Brussels today to back a European Commission proposal to increase transparency and harmonisation of Europe’s clinical trials on medicines. MEPs voted 594 to 17 to back a deal reached with member states in December.

Under the new legislation, which will come into effect in 2016, all past and future clinical trials will have to be registered and their results reported. Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database.

The new rules will make it easier for these companies and academics to share information about new medicines across borders. Most importantly, the legislation aims to reduce bureaucracy so that clinical trials can be larger, more viable and more reliable.

“The new law will also offer hope to the millions of people in Europe suffering from rare diseases, by making cross-border trials much easier to conduct,” said centre-left British MEP Glenis Willmott, who led negotiations on behalf of the Parliament. “There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases. By working at EU level we can reduce the huge cost and burden of conducting trials across borders.”

Member states agreed to the MEPs’ demand that detailed summaries be published in a publicly-accessible EU database, including full clinical study reports to be published once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn. Fines would be imposed on sponsors who do not comply with these requirements.

In a separate vote, MEPs locked in a first reading position on a proposal to overhaul EU rules on invasive medical devices – those that go inside the human body. Member states remain divided on the controversial subject and have as yet been unable to agree a common position.

With no agreement with member states possible before the end of the parliamentary term, MEPs needed formally to adopt the position agreed in the environment and health committee in September, if they are to bind the next Parliament to work on that basis. MEPs voted 549 to 13 to lock in their position.

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