European Court is on the wrong side on patient safety
1st May 2013
This is an article for the PLOS Medicine Community Blog and you can read the full piece here.
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.