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.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 06 May 2015 | By Michael Mezher
Members of scientific and expert committees at the European Medicines Agency (EMA) will no longer be able to take part in the evaluation of medicines if they intend to work for a pharmaceutical company.
In 2012, EMA came under fire from the European Court of Auditors (ECA), after an audit uncovered a number of shortfalls in the agency's conflict of interest (COI) policies.
At the time, ECA made recommendations to EMA intended to improve the agency's COI policies and their implementation. The recommendations included pre-screening candidates for COI before appointment and making declaration of interest (DOI) processes more transparent.
ECA also highlighted the need for EMA to address post-employment issues following the controversy surrounding the agency's former Executive Director Thomas Lönngren, who began consulting for the pharmaceutical industry weeks after leaving the agency. Critics contended that EMA failed to uphold EU staff regulations and expressed concern that Lönngren's working knowledge of policies being developed by the agency could "influence the outcome" of the policies.
In response to ECA's recommendations, EMA held a public consultation and workshop on improving its COI operations and policies.
These efforts led to the development of a Best Practice Guide for Staff leaving the Agency in 2013, and a new COI policy, which came into effect on 30 January 2015.
The Best Practice Guide reminds EMA staff of their obligation to "inform the agency of their intention to engage in an occupational activity whether gainful or not … for a two year period following their departure." Additionally, if a current staff member plans on taking a job following their departure from EMA, the agency can restrict them from certain product-related activities.
The new COI policy, EMA/626261/2014, Corr. 1, deals with how the agency handles declarations of interest for its scientific and expert committee members. The policy also introduces a three-tiered system for ranking declared interests, which range from "no interests declared" at level 1 to "direct interests declared" at level 3.
Now, several months after the policy went into effect, EMA has decided it needs to further explain one particular clause, which states:
“Furthermore, if a scientific committee/working party/SAG/ad hoc expert group member intends to be engaged (either solicited or not) in occupational activities with a pharmaceutical company (such as employment) during the term of the mandate, the member shall immediately inform the Agency and refrain from any activities which may have an impact on the pharmaceutical company concerned, and shall comply with any additional conditions or limitations which the Agency may consider appropriate to impose.”
In a new guidance document, EMA clarifies that it is taking a broad interpretation of this clause. Rather than barring committee members from participating in activities which relate to their future employers, EMA says it will "fully restrict the member or alternative immediately from further involvement in any Agency activity from the date of notification.” The agency says it will also conduct a review to "verify the integrity" of any ongoing or past evaluations the member was party to.
EMA Press Release
Tags: Conflict of interest, COI, declared interests