European Patient Groups, Pharma And Financing

Given that patient and consumer groups are increasingly involved in as stakeholders and experts in management and scientific committees at the European Medicines Agency, one activist group decided to survey corporate sponsorship and compliance with disclosure requirements.

Health Action International canvassed 23 groups, including those concerned with AIDS, multiple sclerosis, Alzheimer's, Parkinson's, cancer and diabetes, to gauge financial ties between 2006 and 2008. Here is the study and this is what was found...

- Two-thirds of the groups working with the EMA received partial or significant funding from drugmakers or industry associations. All in all, 15 organizations received between 0.2 percent and 99 percent of their annual income from corporate sources, while seven were funded entirely from alternative sources. No financial data or revenue sources were found for one organization.

- The average corporate contribution per sponsored organization rose over the two-year period at a rate greater than inflation. The average donation rose from 185,500 EUR (about $235,500) per sponsored organization in 2006, to 282,090 EUR (about $358,00) in 2007, and to 321,230 EUR in 2008 (about $407,800). In percentage terms, the increases amounted to 47 percent, 51 percent and 57 percent, respectively (please note the dollar figures are expressed in today's values).

- Fewer than half of the 23 groups complied with EMA’s financial reporting guidelines. Just six groups identified their income sources by name and included the corresponding financial contributions relative to their operating budgets. An additional nine groups specified donors by name with their corresponding contribution, but did not cite the donation as a percentage of total income.

In discussing the findings, HAI concludes the EMA "appears to have failed" in monitoring and enforcing its own guidelines on financial transparency.

HAI notes the EMA introduced transparency guidelines in 2005, but by March 2010, 20 of the 23 eligible groups that were surveyed had not yet reported 2006 income online. "Despite the lack of compliance, all organizations were invited to participate in the EMA annual meeting in December 2009," HAI adds. One problem cited: EMA guidelines do not stipulate a reporting deadline or cycle, and so some groups have not yet met requirements established five years ago.

More funding sources for patient groups are needed beyond corporate backing, according to HAI. The activist group points out that patient and consumer groups receive funds from member fees, foundation grants, and funding programs from national governments and European institutions. But such sources are limited. And so here are HAI's recommendations...

The EMA should...  Enforce a precise reporting format outlined in the existing financial transparency criteria;  Clearly define financial contributions to include honorariums, travel fees and other forms of sponsorship;  Set deadlines for submitting financial disclosure reports;  Establish monitoring and enforcement mechanisms to ensure info is publicly available on the EMA website;  Make participation in EMA activities conditional on the fulfilment of all eligibility criteria, with particular regard to financial transparency.

And patient and cosnumer groups should...  Include references to their funding policies in financial reports;  Provide full disclosure of all financial contributions, including honorariums and travel fees;  Post regular and easily accessible financial reports on their websitesr.