Drug firms take legal steps to prevent European regulator releasing dataBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1636 (Published 12 March 2013) Cite this as: BMJ 2013;346:f1636
A leading US pharmaceutical company, AbbVie, has taken legal action against Europe’s medicines regulator to try to prevent it from releasing data it holds on the safety and efficacy of one of its drugs.
If successful, the action could jeopardise the European agency’s plans to begin publishing from January 2014 all clinical trial data once it has decided whether to approve a drug for use across the European Union.1
AbbVie has sought an injunction to stop the European Medicines Agency (EMA) from releasing detailed information that it holds on its drug Humira (adalimumab) for rheumatoid arthritis. The move follows two freedom of information requests from Belgian pharmaceutical company UCB in late 2012 for patient level data on the drug’s side effects and efficacy.
Since November 2010, it has been possible for anyone to request access to “any document originated, received, or held by the agency,” including clinical data submitted by companies seeking marketing authorisation for their products.
In the first two years of the policy, the agency released more than 1.6 million pages of documents that were previously treated as confidential—three quarters of those requested.2 Most requests (33%) came from the drug industry.
Dirk Van Eeden, senior director of public affairs at AbbVie, said that the company’s actions sought “to protect AbbVie’s confidential and commercially sensitive information.”
He said that the company posts all of its clinical trial results on clinicaltrials.gov and supports the transparency of data that benefit patients and doctors. He added, “We do not support the disclosure of CCI [confidential clinical information] that does not meaningfully contribute to the scientific review or evaluation of our products.”
A Californian biotech company, InterMune, launched a similar legal action against the agency in February.
The European Federation of Pharmaceutical Industries and Associations and its sister association in the US, PhRMA, have asked the court whether they can submit their views on this issue because they believe that the legal basis on which agency is operating is unclear, and that legal clarification would benefit all stakeholders.
A spokesman for the federation told the BMJ that it supports efforts to increase transparency, but that “the principle of transparency must take into account the need to protect commercially sensitive information so as not to undermine incentives for future innovation to meet unmet need. Key to achieving the appropriate balance is the need for the EMA to consult with the dossier owner before providing access to clinical data.”
Robert Steinbrook, adjunct professor of internal medicine at Yale School of Medicine, told the BMJ that he was not surprised by the legal challenge to the release of documents submitted to the EMA. He warned: “If the current legal challenges, or future legal challenges, are successful, the agency’s plans could be derailed.”
Commenting on the legal action, Tracey Brown, director of Sense About Science, said: “This demonstrates the urgency of moving to a situation where every trial is registered and the findings published. This will create a trustworthy knowledge base for the benefit of patients, researchers, and regulators. It will also create a level playing field for industry and reduce this kind of activity in the courts.” In January, she helped to set up the AllTrials campaign (www.alltrials.net), together with the BMJ and others, for all clinical trials to be registered and reported in full.3
MPs on the House of Commons’s Science and Technology Committee begin their inquiry into clinical trials4 on 13 March, when they will question Michael Rawlins, chair of the Medical Sciences Regulation and Governance Review; Keith Bragman, president of the Faculty of Pharmaceutical Medicine; and Fiona Godlee, editor in chief of the BMJ.
Cite this as: BMJ 2013;346:f1636