A court has ordered the European Medicines Agency (EMA) to keep data from two drug companies confidential, running counter to EMA's recent push to share clinical and nonclinical information as widely as possible. The temporary injunction from the General Court of the European Union backs two drug firms on the U.S. side of the pond: AbbVie, headquartered in North Chicago, Illinois, and InterMune in Brisbane, California.
The companies filed independent complaints earlier this year, charging that EMA's policy to release information about therapies it has either approved or rejected would put their commercial interests at risk. "If the EMA makes this knowledge freely available to other companies (in particular to InterMune's competitors) at no cost this could facilitate their development programs and enable them to reach the market and compete with InterMune faster than they would otherwise to be able to do," writes Jim Goff, InterMune's spokesperson, in an e-mail to ScienceInsider, explaining his company's concerns.
The temporary injunction remains unpublished, and the companies' publicly released complaints are bare-boned. (See here and here.) But what's clear is that the challenge is the first time EMA's push for transparency has been successfully torpedoed. The agency, which is the European version of the U.S. Food and Drug Administration, changed its protocols in November 2010. At the time, it had just been through a mirror version of what it's experiencing now: A nonprofit called the Cochrane Collaboration had requested documents about certain drugs, and EMA had refused. The European Ombudsman, a sort of conduct guard for E.U. institutions, "spent quite a lot of time investigating this, and in the end ruled that we had to release the data," says Martin Harvey-Allchurch, EMA's head of communications. As a result of the ombudsman's decision, EMA overhauled its policies and has since honored 613 requests for documents and released 1.9 million pages. About one-third of the requests come from companies. InterMune's Goff writes that the request for his company's data "was made by a potential competitor" and concerned its only available product, pirfenidone, which treats a rare lung condition called idiopathic pulmonary fibrosis. EMA's Harvey-Allchurch explained that one of the requests in question was by a company and another was by an academic.
AbbVie, a much larger entity than InterMune, did not respond to requests for comment from ScienceInsider. The company was formed in January, when the drug giant Abbott split into two entities, one of them being AbbVie.
EMA's goal is not to make it easier for competitors to manufacture drugs by accessing this information, Harvey-Allchurch stresses. It routinely redacts information about manufacturing details or quality assays, as well as protecting the identity of trial participants. But "our position is that clinical trial data cannot, per say, be considered confidential," Harvey-Allchurch says. "There is a legitimate public interest to what we're doing."
Because the ruling applies to only these two cases, EMA plans to keep on releasing other data as individuals and companies request it. It's also moving ahead with plans to post clinical trial data on its Web site for all to see. Whether those efforts continue will depend partly on the General Court's final ruling; it isn't known when that will come. Harvey-Allchurch says that he's received many messages supporting EMA's position on transparency and even interest in joining the case as a party on EMA's side -- including, perhaps not surprisingly, from the European Ombudsman.
In the United States, the Pharmaceutical Research and Manufacturers of America (PhRMA) applauded the European court's decision.
"Biopharmaceutical companies support responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research," said PhRMA Senior Vice President Matt Bennett in a statement. "Unfortunately, the EMA's current and proposed policies fail to respect these principles."