HAI Europe research on financial disclosure and transparency of patient and consumer organisations at European Medicines Agency

In 2005, the European Medicines Agency (EMA) established guidelines requiring financial disclosure and transparency from patient and consumer organisations involved as political stakeholders and experts in the work of the Agency. These "Criteria to be fulfilled by Patients` and Consumers` Organisations involved in EMA Activities" require organisations to disclose their financial data, including the names of income sources, and the relation of those financial contributions to the organisations` operating budget.

In its study, HAI Europe examined the financial disclosure practices of patients and consumers`organisations working with EMA as well as the nature of organisations` sponsorship between 2006 and 2008.

HAI Europe established that:

 between 2006 and 2008 two-thirds of all patients and consumers` organisations involved in EMA`s work received substantial financial sponsorship from corporate sources, meaning pharmaceuticals or medical devices` manufacturers as well as industry associations;

 between 2006 and 2008 the average financial contributions from aforementioned sponsors to the organisations` operating budget rose from 47% to 57%;

 fewer than half of all organisations eligible to work with the Agency met the requirements set in the "Criteria to be fulfilled by patients`and consumers` organisations involved in EMA Activities".

Based on these findings, HAI Europe concluded that it is justified to say that EMA failed to properly monitor and enforce its guidelines on financial transparency. Another important conslusion is the fact that there seem to be insufficient public and non-corporate funding sources to support the work of patients` and consumers` organisations, in particular at the regulatory level.

For more information

 HAI Europe Research Article: Patient and Consumer Organisations at the European Medicines Agency - Financial Disclosure and Transparency.

 HAI Europe issue fact sheet on the article.

 HAI website.