Suggestions to EMA include hiring more regulatory staff, enacting random checks, and tightening criteria for board/committee members. [© Mopic - Fotolia.com]
Over the past 18 months, a pair of potential conflict-of-interest cases has prompted European politicians to revisit the long-spinning revolving door through which drug regulators have shuttled between industry and government.
The European Parliament last month refused to sign off on the budget management “discharge” procedure for spending by the EMA and the European Food Safety Authority (EFSA) in 2010, citing the need for tighter conflict-of-interest laws; discharge equates to approval of how the European Commission implemented the budget in that financial year and the closure of that budget. Parliament postponed the normally routine budget discharge for both agencies along with the European Environment Agency until October. By that time it hopes to see rules in place that will lessen the cozy relationship between regulators and industry. The action holds up approval of EMA’s €239.1 million (roughly $298.8 million) budget for 2013.
In EMA’s case, the Euro Parliament brushed aside a series of anticonflict policies enacted since Thomas Lönngren’s December 31, 2010, resignation as EMA’s executive director. Lönngren’s resignation came two months after he incorporated Pharma Executive Consulting. That touched off an EMA board inquiry that concluded, unsurprisingly, that none of Lönngren’s activities constituted a conflict of interest. Yet hoping to satisfy reformists, EMA’s board also curbed Lönngren’s consulting work by barring him for two years from taking managerial and executive positions in the pharmaceutical industry and from providing product-related advice on activities subject to agency scrutiny: “Mr. Lönngren should neither have contacts with agency staff or committee members in the context of his professional activities nor represent or accompany third parties at meetings with the agency.”
EMA’s head of communications, Martin Harvey Allchurch, told GEN, “We believe that we have introduced significant improvements to our processes for handling conflicts of interest. There is no intention at this stage of introducing any further revisions to the conflicts of interest rules since the latest revisions, which were not fully taken into account in the discharge decision, were only introduced in April,” Allchurch said. “We are currently working to show that our revised rules, introduced before the Parliament’s decision, satisfy their expectations.”
Monica Macovei, a European Parliament member from Romania, blocked the sign-off on EMA’s 2010 budget. Parliament’s immediate trigger seems to be less EMA than the May 8 resignation of the chair of EFSA’s management board. Diána Bánáti, Ph.D., director general of Hungary’s Central Food Research Institute, drew criticism for joining the European branch of the International Life Sciences Institute (ILSI) as full-time executive and scientific director. ILSI is a nonprofit whose research and risk assessments are funded by industry sources that include pharmaceutical companies.
EFSA cited anticonflict rules it adopted in June 2011 that bar scientific experts from “participating in scientific work related to services provided to products, their development and/or assessment methods carried out on behalf of trade associations or other bodies with an interest in this subject matter.”
Revisions to Conflict Rules
In September 2011, EMA published an online list of European experts and their declarations of interests, updated on February 29, 2012. In January 2012, EMA requested access to declarations of interests submitted to drug regulatory authorities in EU member states to cross check information given to the agency and national drug review agencies.
This February the agency started requiring employees to file public declarations of interests and be assessed for conflict risk. For example, employees must not hold or seek to acquire some direct interests such as current personal financial interests or patent ownership or should dispose of them prior to the start of employment with the agency. And employees who inherit stock or otherwise passively acquire direct interests must disclose them, then dispose of them within six months.
A month later EMA extended its anticonflict policy for scientific experts to its Management Board. The policy declares pharmaceutical industry employment, a strategic advisory role, a consultancy, or financial interests as incompatible with board activities, adding “the requirements are stricter for chair/vice-chair.” Members must declare their interests for up to five years but need not update their declarations immediately, since EMA allows annual updates.
Then in April EMA took aim at advisory committee members. The guidelines, which replaced rules adopted just last September, bars experts from agency activities until they sign a declaration of interests and the agency has assessed their risk level. Earlier this month, EMA’s Management Board approved a new agency policy to address “suspected breaches of trust,” such as incorrect or incomplete declarations of interests by experts and committee members.
EMA’s latest anticonflict measure was approved in March and took effect on May 15. It is a revised standard operating procedure (SOP) governing how the agency’s employees are to be investigated for potential conflicts of interest. The SOP puts employees in one of three conflict-risk classifications: Level 1 for no conflicts; Level 2 for minor, likely indirect conflicts, which may preclude the employee from full participation in some decisions; and Level 3 for employees with direct conflicts of interest. The executive director may grant exceptions case-by-case to Level 2 or 3 employees.
More significantly, the SOP extends conflict-of-interest rules to managers, scientific advice administrators and other scientific administrators, product/project team members for pre- and postauthorization and maintenance procedures, orphan and pediatric disease coordinators, legal and regulatory affairs advisers, and even press officers and web editors.
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.