EMA transparency

In October, the European Medicines Agency (EMA) launched a new database aimed at increasing the transparency of expert advisors' financial ties to industry. The new policy is a reaction to accusations that EMA was not complying with EU legislation that states that members of its scientific committees and expert advisors should not have financial or other interests in the pharma industry that could affect their impartiality. The French government is also considering a law that would fine experts who advise the government on medical treatments up to €30,000 ($40,000) for failing to disclose any conflicts of interest. The US is taking the opposite stand, with the US Food and Drug Administration facing pressure to loosen conflict-of-interest rules (see page 1062). But in Europe, industry and the scientific community largely applaud the new policy. “There is no way other than full transparency,” says Richard Bergström, director general of the European Federation of Pharmaceutical Industries and Associations. The EMA now requires all advisors, and scientific experts serving on any of EMA's committees (and their families) to declare annually any direct or indirect financial ties to industry or any other conflicts of interest. Previously, declaration forms were only available from the agency by request. Now they will be posted on the EMA's website and can be searched alphabetically or by country. But Bergström is concerned over how restrictions will play out in practice. Industry ties don't necessarily represent a conflict of interest, he says. To become an expert in clinical research, for example, one must have been involved in studies that are usually funded by industry, he adds. The agency will rank committee members into risk categories ranging from 1 to 3, with 3 being the highest risk category applicable to experts with direct financial ties to industry anytime within the past 5 years. Being classified in the highest risk category won't necessarily exclude an expert from EMA activities, however, but may severely restrict their participation. Although the risk ranking will not be made publicly available, Tony Mayer, member of the Euroscience Governing Board and specialist in research integrity says, “Assigning risk levels is a reasonable way of managing risk in this situation.” The new database lists approximately 5,000 experts, but so far only about half of the entries include declaration-of-interest forms. EMA expects to publish the remaining forms over the next several months.