The European Medicines Agency (EMA) has launched an internal review of the transparency criteria that patient and consumer organisations need to fulfill in order to be eligible to work with the Agency.
Read the eligibility criteria approved in 2005 (transparency guidelines are on page 2)
HAI Europe proposes these changes to the transparency criteria (added text in bold):
Transparency: The organisation should publicly disclose its sources of funding both public and private by providing the name of the public and/or private bodies and their individual financial contribution both in absolute terms and in terms of percentage of the organisation budget. This information should be updated on an annual basis. The organisation should provide the EMA with a link to its website where this information can be found.[1] Any relationship with corporate sponsorship should be clear and transparent. Any conflict of interest[2] should be publicly disclosed and submitted to the EMA. The reference to private bodies does not include private individuals unless this presents a potential conflict of interest as referred to above.
In case of umbrella organisations the list of member associations should be made available.
EMA encourages organisations to be as transparent as possible, e.g. by regularly publishing, on the organisation website the financial information as specified above as well as a report of the activities undertaken.
[1] This link will be included under the Organisation’s description on the EMA’s webpage titled ‘Organisations involved in the Agency’s Activities’
[2] A conflict of interest is defined as a direct or indirect interest in the pharmaceutical industry, in line with definition established in the ‘European Medicines Agency policy on the handling of conflicts of interests of Scientific Committee members and experts’ published on 13 October 2010.
Stay tuned to find out what final text is agreed in 2011.