03.05.2013 - A Court decision may delay the timely implementation of the EU clinical trials regulation. Two firms have sued the EMA over confidentiality breaches.
The General Court of the European Union ordered the EMA not to provide any raw data on pivotal clinical trials of EU-approved drugs to competitors of originator drugs' developers. Upon request of three biosimilar makers, the EU Agency had disseminated patient-level clinical data on Abbvie's US$9.3bn arthritis blockbuster Humira and InterMune's orphan drug Esbriet, a TGF-beta blocker loosing market exclusivity in 2014. On the day of the Court's decision, the EMA published its final advice on the proactive publication of clinical raw data aimed at creating more transparency towards market authorisation of medicines.
"If the court decides we have to stop the release of data, I think that would be the worst possible boomerang for the industry," EMA chief Guido Rasi told Reuters in an interview. "The most powerful weapon we have to tackle distrust is transparency." After the EU ombudsman three years ago decided that the Agency "may not withhold data from clinical studies referring to commercial confidentiality", the EMA had tabled plans to grant open access to clinical raw data of approved medicines. The rules are a pillar of the new clinical trials regulations.
The General Court, however, ordered the EMA not to provide any documents to the drugmakers which filed the Freedom of Information requests, at least until a final ruling is given. Nonetheless, the agency plans to continue releasing documents on a case-by-case basis, depending upon the outcome of these challenges. The move of of Abbvie and Intermune is backed by the US organisation Phrama, who believes that the EMA's policies fail to respect the principle of responsible data sharing. Since the challenges were filed, the EMA claims to have received more than 30 statements of support. Conversely, US and European pharmaceutical industry trade groups have filed papers supporting the drugmakers.
"The interim ruling must not delay the timetable for introducing a modernised Clinical Trial Regulation for Europe, believes Steve Bates, CEO of the BioIndustry Association (BIA). The BIA said, it welcomes the publication of the EMA's final advice and looks forward to contributing to the consultation on the EMA draft policy."
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