Areas for Improvement
Three groups advocating stricter anticonflict rules insist that EMA could go farther to prevent conflicts. Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB), and the Medicines in Europe Forum (MiEF) say the Parliament must insist on additional conflict-of-interest reforms including:
- rules requiring more staffing and enforcement to ensure EMA’s guarantee that medicines files will at all times be handled by independent regulatory staff;
- systematic and random checks by EMA to verify declarations of interest filed by experts;
- a ban on members of drug-industry-sponsored organizations from participating as patient and healthcare professional representatives on EMA’s management board and/or scientific committees.
With 3,500 experts and some 850 staffers, EMA clearly doesn’t have the in-house capacity it needs. “Some experts acquire their knowledge from their experience in the pharmaceutical industry,” Katrina Perehudoff, project officer for HAI Europe, pointed out to GEN. “In this way, EMA’s reliance on advice from outside its walls can make the agency vulnerable to potential conflicts of interest.”
If Parliament presses for more anticonflict rules, they should be in regulating clinical investigators. Last year, the U.S. Department of Health and Human Services lowered the minimum disclosure threshold for clinical investigators receiving Public Health Service funding from $10,000 to $5,000 and required that any equity interest in private entities must be disclosed.
In the U.S., FDA employees have been barred since 1996 from participating in decisions in which they have a financial interest. In 2008, FDA adopted guidance laying out an 11-step algorithm for determining conflict and eligibility for advisory committee participation. For example, FDA must assess whether the committee meeting in question touches on a matter that may have an effect on the financial interests of an employee, where the combined value of financial interests for an employee, his or her spouse, and children is $50,000 or less (interests of greater than $50,000 are not eligible for waivers).
This March FDA adopted rules that condition participation in advisory committee meetings by regular and special government employees on their acknowledging that their financial interest information and waivers will be made public. But not fully public, since the FDA guidance only requires employees to provide the magnitude of their personal/immediate family interests within four range categories and not the specific amount.
As Europe looks to its own conflict-of-interest guidelines, any new rules will only prove as strong as their enforcement. While Parliament has its oversight role, it will require more people, time, and especially money to fulfill. These are no small concerns as the economies of Europe worsen, and nations face pressure to spend more on domestic needs.