Possible Problems With European Union Medical Conflicts of Interest

Unfortunately, what I’ve been able to find out about this is pretty much an interagency version of ‘her word against hers.’  Nature is reporting that the European Parliament’s budgetary committee is recommending against signing off on the 2009 accounts of the European Medicines Agency (EMA).  This signoff releases the relevant managers from their responsibility for managing those accounts for that year.  In other words, it would signify that the European Parliament considers the job to have been done without incident.

The committee’s concerns are over the independence of the experts obligated to evaluate medicines for use in the EU.  There is a specific drug at issue, but the general idea is that some of the experts involved may have had some kind of gain based on the decision to use or not use particular drugs.  And, of course, this could all be a matter of an appearance of a conflict of interest.  Whether the members of the European Parliament that complained are concerned about an appearance of a conflict, or are persuaded of an actual conflict based on an appearance of one is something I can’t tell without a trip to Brussels.  I raise the possibility of an appearance based on the reactions of the EMA, which seem to suggest the agency thinks all the concerns (both from the committee and from a report issued in February) have been addressed.  The EMA has also apparently found no violation of its rules for experts issued late last year.  However, those were not expected to be in force until the second quarter of this year, so I’m not persuaded.  Additionally, these rules do not address what would happen in the case of allegations of conflicts that are made after the EMA signs off on particular experts.  It’s a bit of a hole in the EMA’s rules.

Once again, we have a situation where the attempts to address allegations of conflicts do give an appearance of not taking theme seriously.  Even if there is reason for the EMA to not take them seriously, addressing the allegations could certainly be done in a more effective manner.  The full Parliament will vote on the discharge matter next month.