EMA launches public database on declaration of interests of its scientific experts
This article was originally published in SRA
The European Medicines Agency has launched a new database that allows the public to directly search for declarations of interest by scientific experts nominated to take part in the agency's activities1,2.
The database, the launch of which coincides with the entry into force of new EMA rules on handling conflicts of interests of scientific experts3, replaces the previous means of accessing these declarations of interests, which were available only on request. It replaces the list of European experts that was previously published on the agency's website.
The database of experts currently contains approximately 5,000 names. However, declarations of interest, which are signed electronically, are not yet available for nearly half of them. The EMA says it will continue to update the database over the coming weeks and months so that all experts have a valid and signed declaration of interest published together with their name.
The EMA clarifies that experts cannot be involved in the agency's activities until they have submitted a signed declaration of interest and have been assessed for their risk level.
New rules on handling conflicts of interest
Scientific experts are nominated to take part in the EMA's activities by EU competent authorities. They provide scientific expertise to the EMA through its committees, working parties and other groups. The new EMA rules on handling conflicts of interests of scientific experts aim to improve efficiency and transparency in this area.
Under the rules, the EMA says it will apply a more proactive approach – both in identifying potential conflicts of interests and in searching for alternative experts. The agency says it will screen all declared interests of proposed members of its scientific committees "prior to their formal nomination".
Conflicts of interest are classified as either "direct", "indirect" or "no interests". On the basis of a declaration, the EMA decides whether to include an expert as a member of a working party or other group.
Experts are assigned corresponding risk levels, with direct interests leading to the highest risk level. Depending on the assigned risk level, the involvement of an expert may be restricted or even excluded, taking into account the nature of the interest declared, the time passed since the interest occurred and the type of activity in which the expert will be involved, the agency says.
In areas where conflicts of interests may limit the availability of experts, for example, in relation to some rare diseases, the EMA says it will look proactively for alternative experts using its established relationships with academia and learned societies. The aim is to increase the level of transparency on declared conflicts of interests throughout the whole scientific review process, with the new experts' database as a key element, the agency explains.
Background
The EMA has, in the past, come under fire for its poor management of conflicts of interest. Earlier this year, the European Parliament postponed discharging the agency's budget spending for financial year 2009 in light of, among other things, concerns that there is no proper guarantee of the independence of experts hired to carry out scientific evaluations of human medicines at the agency4.
Before that, the EMA was criticised by public health and transparency campaigners for allowing its former executive director to take up a post in the private sector pharmaceutical industry just weeks after leaving his post at the agency5.
References
1. EMA press release, 30 September 2011, www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/09/news_detail_001352.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1
2. European experts' database, site accessed 30 September 2011, www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/landing/experts.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac058043244a
3. EMA, Handling conflicts of interest, site accessed 30 September 2011, www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000178.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac0580028c78
4. EMA under fire again for poor management of conflicts of interest, Scrip Regulatory Affairs, 10 May 2011
5. Restrictions on business activities of ex EMA head needed to "assure public confidence" in agency, Scrip Regulatory Affairs, 24 March 2011