As Europe prepares to open its clinical trial data vaults in a move toward greater transparency, the British Medical Journal is criticizing the European Medicines Agency for seemingly backtracking on its promises to make important information available to consumers.
BMJ's critique comes as documents detailing a compromise between the EMA and participating drug companies have been made public.
Big Pharma player AbbVie ($ABBV) was one company that resisted the new initiative. Last year, AbbVie filed a lawsuit claiming that the EMA's plans to disclose its trial results could do "serious and irreparable" damage to the company by revealing commercial secrets. But the two parties came to an agreement recently, leading AbbVie to drop its case against the agency in April.
Now, the terms of that agreement have surfaced in documents shared at an EMA workshop, and BMJ says the European agency is yielding from some of its original goals of its transparency initiative. According to those documents, "clinical study reports (CSRs) and other detailed information will be available only to registered users, and only through 'controlled access' and in a 'view on screen only' mode," writes Trish Groves, BMJ's head of research and Wim Weber, European research editor for the journal.
On May 13, European ombudsman Emily O'Reilly reportedly wrote to the EMA inquiring about the legal basis of the revised policy, questioning how it relates to the right of public access to EU documents. EMA Executive Director Guido Rasi denied that there any legal impediment to changing the policy, saying it was a reasonable compromise between the EMA and participating drug companies, according to the BMJ.
However, even with this "watered down" policy, Groves and Weber note that opening up some clinical trials data to the public is still a step in the right direction.
The EMA's management board is set to meet on June 12 to finalize the nature of the new policy.
- read the BMJ editorial
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