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.