A court ordered the European Medicines Agency (EMA) to keep confidential data from two pharmaceutical companies, in contravention of the recent surge in the EMA to share clinical and clinical information as widely as possible. The temporary injunction EU Court supports two pharmaceutical companies on the US side of the pond: AbbVie, headquartered in North Chicago, Illinois, and InterMune in Brisbane, California.
The companies filed separate complaints earlier this year, charging that the EMA policy to disclose information on therapies it is approved or rejected would put their commercial interests at risk. "If the EMA makes this knowledge freely available to other companies (including competitors to InterMune) toll this could facilitate their development programs and allow them to reach the market and compete with InterMune faster than they otherwise would be to be able to do it, "writes Jim Goff, spokesman for InterMune, in an e-mail to science Insider, explaining his company's concerns.
the temporary injunction remains unpublished, and made public complaints of businesses are bare-boned. (See here and here.) But what is clear is that the challenge is the first time the thrust of the EMA for transparency was successfully torpedoed. the agency, which is the European version of the Food and Drug Administration of the United States, changed its protocol in November 2010. at the time, he had just gone through a mirror version of what he knows now: called the Cochrane Collaboration nonprofit requested documents about certain medicines, and EMA refused. The European Ombudsman, a sort of conduct to guard E.Ü. institutions, "spent a lot of time investigating this, and in the end decided that we should release the data," said Martin Harvey-Allchurch, head of EMA communications. Following the decision of Ombudsman, EMA revised its policies and has since honored 613 requests for documents and released 1.9 million pages. About a third of requests from companies. InterMune Goff wrote that demand for his company's data "was made by a potential competitor "and regards its only product available, pirfenidone, which treats a rare lung disease called idiopathic pulmonary fibrosis. Harvey-Allchurch EMA explained that one of the requests in question was by a company and another was by a university.
AbbVie, a much larger entity that InterMune, did not respond to requests for comment from Science Insider. The company was founded in January, when pharmaceutical giant Abbott divided into two entities, one of them being AbbVie.
The aim of EMA is to not make it easier for competitors to manufacture drugs in accessing this information, Harvey-Allchurch said. He regularly redacts information on the manufacturing details or quality testing, as well as protection of the identity of trial participants. But "our position is that clinical trial data can not, for example, be considered as confidential," says Harvey-Allchurch. "There is a legitimate public interest in what we do."
Because the decision applies only to these two cases, EMA plans to continue to release other data that individuals and businesses demand. It is also moving forward with plans to send clinical trial data on its website for all to see. That these efforts continue partly depend on the final decision of the Tribunal; we do not know when it will come. Harvey-Allchurch said he has received many of the EMA position messages of support on transparency and same interest in joining the case as part of the side of the EMA - including, perhaps without surprise, the European Ombudsman.
In the United States, the Pharmaceutical Research and Manufacturers of America (PhRMA) applauded the decision of the European Court.
"Biopharmaceutical companies support sharing data responsibility to protect 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, current and proposed policies EMA fail to respect these principles."
0 Komentar