European drug agency’s attempts to improve transparency stalled by legal action from two US drug companies

The European Medicines Agency (EMA) has been forced to put its move to greater transparency on hold in the light of legal advice, after it was taken to court by two US based pharmaceutical companies.

The agency is refusing requests for the release of trial data on drugs that have gone through the approval process after lawyers advised that its general policy of openness could expose it to more legal actions from other companies.

The advice follows an interim injunction in April from the general court of the European Union, ordering the agency not to release clinical study reports on products from two US drug companies, AbbVie and InterMune, pending a hearing that is unlikely to take place before 2014.1 The companies sought the injunction to prevent the EMA releasing “commercially sensitive” information in response to freedom of information requests.2

The London based agency, which had hoped by next year to publish all data on drugs submitted for approval once they had completed the process, initially indicated that it would continue to release information on a case by case basis.

But researchers, who have more than 100 requests pending, have now received letters from the EMA refusing them access to documents it holds from clinical trials of medicines currently used in Europe. The agency says it has been advised that to release the same type of data it has been barred from releasing in the two cases would put it at risk of further legal action from other pharmaceutical companies.

The two US companies are the first to challenge the release of data under a transparency policy adopted by the agency in November 2010, which has seen nearly two million pages of documents released. In both cases, rival drug companies were seeking the information, which in AbbVie’s case relates to its best selling drug Humira (adalimumab) for rheumatoid arthritis.

The legal developments are a setback for the EMA’s plans to begin publishing full clinical trial data from January 2014. The agency said that it was committed to continuing its work on clinical trial transparency and still intended to publish its draft policy by the end of June.

Peter Doshi, a researcher at Johns Hopkins University in the US, said that the agency’s November 2010 policy had “revolutionised the ability of independent researchers to critically examine data.”

He added: “If AbbVie and InterMune win their cases, there is a real chance that the EMA’s revolution in data transparency will come to an abrupt end, returning us to the old status quo of data secrecy.”

Martin Harvey Allchurch, head of communications at the EMA, said that every application was being looked at individually, but the agency had to decline requests for the types of documents involved in the two court cases unless it could be shown that it was in the public interest to disclose them. Previously, under the November 2010 policy, disclosure was presumed to be in the public interest.

Meanwhile, European parliamentarians debating new draft European Union rules for clinical trials have backed a move to greater openness. On 29 May, members of the environment, public health, and food safety committee agreed an amendment to the draft text, to provide that all clinical trials must be registered and summary results published within a year of a trial’s end, with financial penalties for non-compliance.