Eyebrows are sure to be raised following the publication of a report which shows that two-thirds of the patient and consumer organisations working with the European Medicines Agency received “partial or significant funding from pharmaceutical manufacturers and/or industry associations”.
A research article from the independent Netherlands-based Health Action International Europe notes that patient and consumer organisations are "increasingly involved as stakeholders and experts in the management and scientific committees at the EMA". They are all asked to disclose their sources of income and the corresponding financial contributions relative to their operating budget.
HAI Europe says that “complete disclosure is important because it provides a qualitative and quantitative evidence base from which to assess potential conflicts of interest”. Any “competing interest could influence the decision-making process around medicines regulation and as a result, have an impact on public health”.
Given this scenario, HAI Europe surveyed levels of “corporate sponsorship” between 2006 and 2008 among the 23 patient and consumer organisations eligible to work with the EMA. It found that 15 organisations received between 0.2%-99% of their annual income from corporate sources, whilst seven were funded entirely from alternative sources. No financial data could be retrieved for one of the 23.
The report goes on to note that the average corporate contribution per sponsored organisation “continued to rise over the period studied at a rate greater than inflation”. The average donation rose from 185,500 euros in 2006, to 282,090 euros in 2007, and to 321,230 euros in 2008 - 47%, 51% and 57% of the average annual revenue of an organisation, respectively.
Worryingly, fewer than half of the 23 organisations met the EMA’s financial reporting guidelines, HAI Europe found. Nine of them specified donors by name with their corresponding contribution, but did not express the donation as a percentage of total income.
EMA fails to enforce transparency guidelines
The report says that “the EMA appears to have failed in the monitoring and enforcement of its guidelines on financial transparency”. These were introduced in 2005, but by March 2010, 20 of the 23 eligible
groups had not yet reported their 2006 income online. “Despite the lack of compliance, all organisations were invited to participate in the EMA annual meeting in December 2009”.
HAI Europe believes that “there are insufficient public and non-corporate funding sources to support the valuable work of patient and consumer organisations, particularly at the regulatory level”. Therefore, “this contributes to the prevalence of pharmaceutical industry sponsorship of the patient voice at the EMA”.
The authors of the report acknowledge that its study “has already contributed to greater disclosure by the eligible groups, particularly as a result of requests to individual organisations for financial data in the EMA format”. They add that in several cases, “organisations updated their websites and financial records immediately after receiving our request”, which “facilitated the data collection and contributed greatly to this study”.
However, HAI Europe insists that more needs to be done and has made a number of recommendations for the EMA. These include establishing a clear definition of “financial contributions” that includes honorariums, travel fees and other forms of sponsorship, ensuring that the information is publicly available, “potentially on the EMA website,” and making participation in EMA activities “conditional on the fulfilment of all eligibility criteria, with particular regard to financial transparency”.
For HAI Europe's full article, which details the amounts received by the 23 organisations, follow the link below.