In perspective: EMA comments on HAI Europe's survey of financial disclosure

The European Medicines Agency's (EMA) response to our research article surveying the effectiveness of the Agency's financial disclosure guidelines, has been reported in the following publications:

• SCRIP Intelligence European regulator rejects study criticising patient organisations' commercial links (18 Aug 2010)

• British Medical Journal Patients must reveal corporate sponsorship, urges campaign (16 Aug 2010)

HAI Europe's comment on the Agency's response:

The European Medicines Agency's transparency criteria do not state that financial information is to be disclosed to the Agency, nor is there an indication of any re-evaluation timeline. We look forward to working with the EMA to further clarify its re-evaluation process, as the data gathered in this research would suggest that EMA re-evaluations have not taken EMA's own transparency criteria into account.

We would also welcome the opportunity to work with EMA on definitions of “transparency”; currently an organisation is regarded as transparent if it submits data which is then held internally by the EMA, rather than in the public domain. The conclusions of the report are therefore based on the transparent and publicly disclosed information available online at the time of data collection, and on data requested directly from the groups themselves, which is in line with the EMA transparency guidelines. This is stated under Data sources in the research article, but HAI did not have access to data which the EMA keeps secret and to which they allude.

Impact of HAI Europe survey results: Two weeks on

Two weeks after publishing HAI Europe's baseline survey of patient and consumer groups' financial disclosure, the findings and conclusions have been reported in media based in at least three European countries, including the British Medical Journal, the Dutch newspaper Trouw, Swedish 'Pharmaceutical World' gazette Lakemedels Varlden, and the international magazine SCRIP, among others.



Broadcast media in the Netherlands widely reported on the results. Dutch journalist Joop Bouma linked the survey results to the national situation in which some patient organisations in dialogue with the drug regulatory authority (CBG) are financed by the pharmaceutical industry. As a result, the Dutch Socialist Party has called for a thorough investigation of patient groups receiving corporate sponsorship and their compliance with the existing code of conduct.



We haven't recieved an official comment from the EMA to date, although their opinion on the survey conclusions is reported in various news articles. We hope to discuss the recommendations in the research article at the meeting of all patient and consumer organisations eligible to work with the EMA in November 2010.

HAI Europe survey reveals new data on financial transparency of patient and consumer organisations

Two-thirds of the patient and consumer organisations working with the European Medicines Agency (EMA) received partial or significant funding from pharmaceutical manufacturers and/or industry associations, which suggests that the pharmaceutical industry is the prevalent sponsor of the patient voice at the EMA.

Fewer than half of the 23 organisations complied with EMA financial reporting guidelines. The EMA appears to have failed in the monitoring and enforcement its guidelines on financial transparency.

These and other main findings are reported in HAI Europe’s recent survey on levels of financial disclosure and transparency among patient and consumer organisations at the European Medicines Agency (EMA).

Read the Research Article and Factsheet on our website www.haieurope.org