Síle Lane from Sense About Science discusses the recent European Court injunction on clinical trial data.
The European General Court has issued an injunction to prevent the European medicines regulator from releasing information from clinical trials conducted by AbbVie and InterMune at the request of the two companies. While yesterday’s ruling pertains to two particular cases it has ramifications for all.
The Court’s decision puts the European Medicines Agency into conflict with its own policy, announced in 2012, to proactively release data from clinical trials supporting the authorisation of medicines being used by patients all over Europe. The Clinical Study Reports that EMA has made available since last year were one of the few ways that researchers could access otherwise withheld material. Their release was instrumental in spotting serious flaws in the evidence for Roche’s drug Tamiflu, for example, which the UK government alone spent £500m on in one year.
More importantly the Court’s decision at the request of AbbVie and InterMune puts it into conflict with the interests of patients. When GSK joined the AllTrials campaign and promised to publish all the CSRs available since its formation as a company they said that they owe this to the patients who have taken part in their trials. Two hundred other organisations including more than 100 patient groups and 50,000 people have signed up to the campaign calling on regulators worldwide to do everything they can to secure registration and publication of the results of clinical trials.
So we’re on the brink. Patients and researchers all over the world have started pushing for historic change. GSK has shown that it’s not beyond the reach of pharma companies to agree to that change. The EMA has tried going some way to delivering on that change.
But, EMA now has to decide if the European Court’s ruling will divert them from their policy to publish trial information. We will be sending the EMA the AllTrials petition. We will be asking them to continue their fight for transparency and showing them that tens of thousands of people are asking why they don’t have access to the evidence behind the medicines they use, prescribe and research. Will you help us today at www.alltrials.net? Please, ask your colleagues and friends to add their voices and ask them to forward this to others when they have.
The European Court has indicated that it is on the wrong side of history. The EMA now has to show that arguments in favour of secrecy no longer hold.
Síle Lane is director of campaigns at Sense About Science
The European Court is on the Wrong Side on Patient Safety by PLOS Blogs Network, unless otherwise expressly stated, is licensed under a Creative Commons Attribution 4.0 International License.