EMA kind of Announces Changes…kind of


For a regulator committed to transparency, the European Medicines Agency has a cryptic way of releasing information about widely anticipated policies.

Yesterday, the EMA issued a statement saying its controversial policy requiring drug makers to disclose clinical trial data should be adopted by its board next month. But instead of disclosing details, as some had expected, the EMA indicated the policy would be disclosed in “due course.” A spokeswoman wrote us that the wording must still be “fine-tuned” and would be available as soon as possible.

The announcement came one day after Guido Rasi, the EMA executive director, released a statement defending what critics anticipate will be an about-face toward greater disclosure. Until recently, the EMA was widely expected to pressure the pharmaceutical industry to release significant amounts of data, including clinical study reports, which collect and summarize trial data.

But last month, the EMA began circulating a draft policy, which was conceived in response to a growing number of scandals in which drug makers were accused of failing to disclose trial data that included safety or effectiveness information. And instead of the forceful approach the EMA had been signaling—and in fact, had begun to put in place two years ago—the contents of the draft suggested a retreat.

In his statement earlier this week, Rasi described this as a “compromise approach.”

This series of events, however, is raising alarm bells among some researchers and policymakers, who worry the EMA is making too many compromises that will thwart transparency. Besides commercial confidentiality, critics are concerned the agency will make it difficult to obtain documents through Freedom of Information requests and researchers will be unable to download, print or save information.

“I’m puzzled as to why the EMA did an about turn,” says European Ombudsman Emily O’Reilly, who had expressed “grave concerns” when she read the EMA draft last month and worried it was in keeping with the “wishes” of the pharmaceutical industry. “EMA has never said publicly why there was such a reversal. And unfortunately, we will not know the consequences until we see the policy in action.”

Interestingly, what some began calling a U-turn occurred not long after the EMA settled a court case with AbbVie, which was hoping to prevent the regulator from releasing data concerning its Humira treatment for rheumatoid arthritis. An AbbVie spokesperson told the medical journal BMJ that the settlement included a decision to redact certain information that was considered commercially sensitive. Another drug maker, InterMune, also filed legal action and that case was settled earlier this month.

O’Reilly remains concerned that the EMA will impose what she calls “broad legal conditions” on gaining access to data and using data, as well as limiting access by allowing “significant” data to be redacted. She says her office has now obtained redacted records from those cases in hopes of understanding the extent to which the redactions pertained to confidential commercial information.

The EMA, meanwhile, says its policy “will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation,” but the agency is actually imprecise about the ability to view data. The new policy will only allow for the “possibility to download, save and print the trial data for academic and non-commercial research purposes,” according to the EMA statement.

This worries Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, who has pushed for greater transparency. “I’ll judge it once I see the fine print, but I did not see unambiguous language that the ‘view-on-screen only’ access method was removed from consideration. He adds that the press release does not address redactions.

Nonetheless, the EMA trumpets the policy for taking the agency “beyond its legal obligations and provides and an unprecedented level of access to clinical trial data that are used as part of decision making for new medicines.”

But the lack of details makes it difficult to know for sure. And if any portion of the policy suggests the EMA has acceded to industry wishes, an outcry is likely to occur.

Originally posted on Phramalot