In a statement, the European Consumer Organisation (BEUC) has said that it will intervene to support the European Medicines Agency (EMA) in the pending proceedings before the European Court of Justice (ECJ).
EMA was sued in February 2013 by pharmaceutical companies AbbVie and InterMune for releasing the clinical trial data for some of their products. After an interim judgement, the EMA halted release on any further data relating to the proceedings, but is continuing to treat other applications on a case-by-case basis. The EMA published proposals for new policies and processes around clinical trial data transparency earlier this year, with a public consultation to close later this month.
BEUC had lodged a request to intervene a few months ago. The news about the application being officially accepted have been freshly delivered.
Monique Goyens, BEUC Director General commented: “This is great news for consumers. Our participation in the Court case will show that the public at large is interested in test results, be they good or bad. The European Medicines Agency chose to stand for transparency, and this is where we stand too.
“Consumers, as patients, carers and potential users of medicines, increasingly want to be involved in the decisions regarding their health. They have the right to access information on clinical trials. Therefore keeping such results confidential boils down to denying this right. We hope our intervention will contribute to make headway towards more open data and serve as a precedent for future cases.
“While waiting for the court ruling, we are concerned about the various delays imposed to the revision of the clinical trials’ legislation. We urge Member States to support the Parliament’s position advocating for more transparent clinical trials results. The ball is now in the European Council’s court. It is time consumers’ concerns were listened to and their safety put on the forefront of negotiations.”