by ANCEL.LA SANTOS QUINTANO
In late November, the European Medicines Agency (EMA) published a revised policy on conflicts of interest. For many, the revised policy came as a bit of a surprise, not least because its Management Board had endorsed it about eight months earlier,
by Ancel.la Santo Quintano
Following its management board meeting on 12 June, the European Medicines Agency (EMA) announced that it had agreed on a “more user-friendly” policy on the publication of clinical trial data. The policy, according to the EMA, will enable the Agency to “proactively publish clinical trial data that are submitted as part of marketing authorisation applications” and provide “the possibility [for users] to download,
Previously, the EMA appeared committed to passing a policy that would grant full public access to clinical trial data—a move that is critically important for protecting public health.
Public health and transparency advocates ask the European Commission if rules regarding conflicts of interest have been sufficiently and duly respected in light of the EMA’s decision to allow its former Executive Director to work within the private pharmaceutical sector just weeks after leaving his position with the drug regulatory agency.
Read the joint open letter
Read the joint press release
HAI Europe’s latest research has established a link between patient and consumer groups’ perspectives on EU medicines policies and the funding they receive from the pharmaceutical industry.
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.
The physicians’ magazine Deutsches Aerzteblatt highlights HAI Europe’s research on financial dislcosure & transparency of patient and consumer groups in an article examining European politicians’ call for greater transparency of the relationships between European patient organisations and the pharmaceutical industry
Read the article Europäische Patientengruppen: Fragwürdiges Finanzgebaren (in German)
18 October 2010 – The European Medicines Agency (EMA) has taken a step in the right direction by adopting an improved policy to handle potential conflicts of interest among its scientific committee members and experts. Independence in scientific and expert advice is crucial to balanced decision making. Conflicts of interest (CoI) can bias regulatory affairs,