Patient groups must reveal corporate sponsorship, urges campaign group

An international pharmaceutical campaign group is urging the European Medicines Agency to tighten its rules that require patient and consumer bodies that work with the agency to disclose any corporate funding they receive. This follows the group’s research findings that two thirds of the bodies advising the agency received “partial or significant” funding from pharmaceutical manufacturers or industry associations.

At the same time, fewer than half of these bodies met the agency’s own financial reporting guidelines, the report by Health Action International Europe shows.

The campaign group investigated the funding and disclosure of 23 organisations that were eligible to work with the agency from 2006 to 2008. This showed a 70% increase in the average annual corporate funding and “low compliance” with the agency’s 2005 guidelines on financial transparency, designed to avoid any possible conflict of interest.

Fifteen organisations received between 0.2% and 99% of their annual funding from corporate sources. In six of these, the figure was over 75%. The average corporate contribution was €185 500 (£152 000; $238 000) in 2006, rising to €321 230 in 2008; these contributions represent 47% and 57% respectively of average annual revenue. Only six organisations fulfilled the agency’s requirements to identify both the source of income and how it corresponded to their operating budget.

Seven other organisations, including Health Action International, were funded entirely from sources that were not pharmaceutical manufacturers or industry associations. In one case, no financial information was available.

Health Action International argues that the European Medicines Agency has failed to enforce its transparency guidelines covering financial contributions. With no reporting deadline, it found that by March 2010, 20 of the 23 organisations had not yet reported their 2006 annual income online. Yet all organisations were invited to attend the agency’s annual meeting in December 2009.

Health Action International is now calling on the agency to fix annual deadlines for financial disclosures, establish a clear definition of financial contributions, and enforce a precise reporting format.

It concludes: “The lack of a unified and detailed reporting system hinders complete public disclosure of the nature and extent of corporate sponsorship of these organisations.”

One of the report’s authors, Katrina Perehudoff, said: “Patient and consumer groups do very valuable work in contributing to policy decisions, but knowing the financial support base fuelling these organisations is crucial for making an accurate assessment about whether a conflict of interest exists. What is clear is the need for fixed deadlines for reporting and unambiguous measures in cases of non-compliance to give these guidelines more teeth.”

The agency disagreed with the report’s conclusions, which it said were based only on information found on the internet. In a statement the agency said it requests financial statements from patient groups, including specific donors and their contributions. Each organisation is re-evaluated every two years. “All organisations currently working with the agency have been judged to have fulfilled the criteria.”