More daylight on finances

Advocates for a clean slate at EMA have put their money on the table – literally, by scrutinizing every euro and withholding approval of the agency's €230 million annual budget. Under instruction from the European Parliament, the EU Court of Auditors last year initiated a review of the EMA's accounts for the 2010 financial year, with the aim of assessing the effectiveness of procedures to prevent outside interests from influencing critical decisions on market authorization. The Auditor report, released on October 11, exposed a number of gaps in the system, including the practice of not basing payments for services provided to the EMA by national registration authorities on their real cost, and the allowance for carryovers in spending from year to year, which makes it more difficult to trace where and how resources were actually deployed.

The auditors ended up giving the agency passing marks for a good faith effort. Still, their carefully hedged conclusions failed to impress, particularly when no one at the court could explain why release of the report occurred nearly a year after the investigation was completed. Basically, what the report did was just pitch the issue back to the Parliament. In fact, the Parliament's Budget Committee didn't even wait for the auditor report, voting on October 2 to lift the parliamentary veto on the 2010 accounts after citing changes that Rasi had made shortly after taking office, the most important of which was to make public the declarations of interest of the 4,500 outside experts that the EMA relies on in conducting its evaluation work. In February, the EMA extended this open door policy by publishing declarations of interests provided by agency management and staff. The EMA also committed to periodically screen all declarations to keep compliance up to date; to obtain and cross-check declarations provided by experts working with national regulatory agencies; to conduct retroactive legal reviews of the work of employees who leave the agency for "resolving door" positions; and, perhaps most important, to publish on the EMA website by no later than the end of 2013 detailed minutes of meetings of its seven scientific expert committees (three—on pediatrics, orphan drugs, and pharmacovigilance risk assessment—have complied so far).

The full Parliament endorsed the committee report on October 24, formally releasing the EMA from its funding hold. The message to Executive Director Rasi and his team was clear: self-initiate changes to advance trust through transparency, or it will be imposed.

Finding transparency—where it counts

In the drug industry, data is the tangible asset that drives approval and market uptake by clinicians and patients. Precisely because of its value, companies have contested demands for the release of information submitted to the EMA and its scientific committees in pursuit of that all important license to sell. Cracks are appearing in the façade, however, as major companies like GSK move to disclose more such data on their own. Last year, the European Ombudsman ruled that trial data held by drug regulatory agencies could not automatically be determined as commercially confidential. Rasi is now seeking to drop the bar further with a new signature initiative designed to make clinical trial data submitted to the agency more readily available to outside groups. Access to such data will be allowed immediately after a new drug is approved, but the process for obtaining it remains a subject of discussion—and it's not a question of whether to do so, but how.

On November 22, an invitation-only workshop, chaired by Rasi, was held at EMA headquarters in London, to consider ways to channel that access appropriately. It was agreed to fix standards around five key process issues: patient confidentiality; data formatting; rules of engagement with requestors; analytical standards of good practice; and legal jurisdiction. Working groups involving stakeholders will be set up for each of the five; they are due to report in to EMA management with recommendations by April 2013, with the new system of "proactive release" set to start in January 2014. EFPIA Director-General Richard Bergström proclaimed the workshop a success, noting to Pharm Exec that "we have already agreed that almost all clinical data in files should be made public after approval." Trial activists, however, want it all.