Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 14 April 2014 | By Alexander Gaffney, RAC,
EU regulators have released a new "best practices" guide intended to steer the European Medicines Agency (EMA) clear of the types of perceived conflicts of interest that plagued the agency's former leader.
In 2012, EMA was publicly chided by the European Court of Auditors (ECA), which said it had inadequately managed situations involving conflict of interest (COI).
While those COIs spanned a wide number of areas, among the most critical identified was the need to address "post-employment issues."
Just prior to the ECA's report, EMA's former leader, Thomas Lönngren, was accused of "setting up a consultancy while still in office," raising concerns about COIs at the highest levels of the agency. Lönngren left EMA two months after forming his consultancy, but critics said at least nine pharmaceutical companies seeking regulatory approval had ties to the company Lönngren's consultancy was affiliated with.
In the aftermath of ECA's report, EMA and its new leader, Guido Rasi, moved to dramatically increase the transparency of its operations and COI policies.
Now EMA is out with a short "best practice guide" intended to help its staff comply with its rules, even as they're planning to leave EMA to pursue other opportunities.
Those staff are required under EMA staff regulations to inform the agency of their intent to "engage in an occupational activity, whether gainful or not," the guide states. The regulation also applies for "every such activity intended to be undertaken for a two-year period following their departure from the Agency."
Those policies are intended to prevent COIs-either real or perceived-from impacting the operations or image of the agency. For example, EMA might prevent a regulator from going to work for a company whose product was recently evaluated by the regulator, as that might create the perception that the regulator "went easy" on the company's product in return for a job. Regulators are required to inform EMA of any jobs taken within two years of leaving the agency.
Accordingly, once EMA staff intend to take up employment following their departure from EMA, they are required to inform EMA of this intent "as soon as possible" and "in advance of accepting any employment offer." EMA said it will treat this employment information as confidential.
This information also allows EMA to restrict any COIs while the employee is still at the agency, it said. "For example, if a staff member intends to work in the pharmaceutical industry dealing with products for which the Agency is responsible, the Agency may consider restricting product relating activities with which the staff member is currently involved, prior to the staff member leaving the Agency."
The document does not indicate what penalties, if any, exist for failing to comply with the guidelines.
EMA Best Practices Document
Tags: Best Practices Guide, COI, Conflict of Interest, Transparency, Latest News, EU
Regulatory Focus newsletters
All the biggest regulatory news and happenings.