The General Court of the European Union has prohibited the European Medicines Agency from releasing data from two AbbVie and Intermune trials in an interim ruling, part of a challenge by the two drugmakers to the agency’s decision to grant access to information the companies provided as part of their market approval applications.
The challenge is the first to be made to the EMA’s three-year old access-to-documents policy. Since November 2010, the Agency has released more than 1.9 million pages in response to such requests. The legal battle involves documents relating to AbbVie’s rheumatoid arthritis drug Humira and InterMune’s Esbriet, a treatment for idiopathic pulmonary fibrosis, an unexplained chronic and progressive scarring of the lungs. In both cases, competitors of the companies were seeking the data.
“Biopharmaceutical companies support responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research,” says Matt Bennett, senior vice president for the Pharmaceutical Research and Manufacturers of America. “Unfortunately, the EMA’s current and proposed policies fail to respect these principles.”
The ruling comes amid increasing pressure from medical journals and patient advocates on pharmaceutical companies to provide complete transparency and make public all of their clinical trials data. It also comes as the EMA readies implementation of a new policy to proactively publish publication of data from clinical trials supporting the approval of new drugs once a decision has been made. The EMA said it would continue the process of drafting its policy on publication of clinical trial data.
Ben Goldacre, author of “Bad Pharma” and co-founder of the AllTrials campaign, which seeks publication of all results from all clinical trials, called the ruling “a disgrace.” “There is no justification for withholding information about the methods and results of clinical trials from doctors, researchers, payers and patients, who need all the information on a medicine to make truly informed decisions,” he says.
The EMA says it welcomes the opportunity for legal clarification of the concept of commercially confidential information, but expressed “regret” over the decision to grant interim relief to AbbVie and InterMune. It said it is considering whether to appeal the interim decisions.
May 03, 2013