European Regulator’s Last Ditch Attempt at Transparency

The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials - a policy it initially aimed at introducing from the beginning of this year.

The latest twist in this long-running saga is that the agency will, at the beginning of May, launch “a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical trial data.”

Since late 2010, the agency has been releasing clinical trial reports on request, as part of its policy of providing access to documents. But that was never enough to satisfy outside demands for information. Nor was it enough to meet the more ambitious approach favoured by Guido Rasi since he became the agency’s executive director in late 2011. He set out his view clearly in early 2012, in a position paper stating that the agency did not consider these data to be commercially confidential-while recognizing that the publication of full sets of raw data might breach patient confidentiality.

So in June 2013, just eighteen months after Rasi took over, the agency released a draft policy on the proactive publication of clinical trial data for the medicines it assesses. In the interim, Rasi had strong-armed some of the reluctant stakeholders-in national authorities as well as in the pharmaceutical industry-into accepting the principle of greater transparency. But because he knew how sensitive the issue was, he allowed a three-month public consultation. In particular, the agency recognized that issues of commercial confidence could not be ignored.

Treading carefully through the minefield, the agency set out to “further clarify and fine-tune the proposed rules to achieve the broadest possible consensus,” and the next step was a set of key principles that was agreed by the agency’s management board last December. The still-nascent policy was discussed again by the management board last month, and it was agreed that the final policy and an implementation plan would be presented to the management board for endorsement at its June 2014 meeting.

Last week’s new consultation is designed, the agency says, to “give key stakeholders and the agency the opportunity to address any outstanding issues before the final policy is presented.” It is intended to “clarify and fine-tune specific aspects and achieve the broadest possible consensus and understanding of the policy.” The discussions will focus on the principles for any redaction of the clinical study reports that are to be published-in other words, what can be defined, exceptionally, as commercially confidential information, and how marketing authorization holders will be consulted before publication of their clinical study reports.

The “key stakeholders” are organizations representing patients, academia, and the pharmaceutical industry, as well as the European Commission and the European Parliament. Unsurprising as a choice. But incendiary as a group. Some patient groups are fearful of breaches of privacy. Others-and particularly those with a strong health campaigning agenda-accuse the agency of going soft in admitting any possibility of exceptions being made on grounds of commercial considerations.

Many in academia also want maximum access, so as to be able to conduct further analysis of data. But companies are deeply skeptical. Industry has been backed into a corner from which it cannot say it opposes transparency. But it is fighting tooth and nail to maximize the scope for exceptions and to limit casual access.

The agency is well aware of the divergent views. But it says it is “committed to pursuing the objective of full transparency regarding clinical trial data because it believes that the release of data contributes to establishing trust and confidence in the system.” Between now and June it is going to make a last-ditch attempt to establish that trust and confidence among the stakeholders as a necessary prerequisite to making the system work.