E-DRUG: Civil society organisations worry about the EMA Publication and Access to Data Policy
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We invite you to read our press release (available at http://english.prescrire.org/en/79/207/46302/3624/3303/SubReportDetails.aspx).
Several civil society organisations outline their concerns about the EMA Publication and Access to Data Policy, due to be adopted at the EMA management board through written procedure (early July).
In this press release, we encourage the EMA not to succumb to pressures from pharmaceutical companies and the European Commission. We explain why commercial agreements (TRIPS) do not prevent the public from accessing data.
We call upon EMA to ensure its final clinical-data policy improves public access to scientific evidence about the effects of medicines on human health.
We urge EMA to:
- postpone the adoption of this policy pending the outcome of the Ombudsman’s enquiries;
- refuse the privatization of pharmaceutical knowledge;
- reject the release of censored documents, a practice which will prevent citizens from accessing original documents under the European Freedom of Information Act (Regulation (EC) N°1049/2001);
- ensure that access to data is guaranteed to the wider public, not only researchers and academics.
Best regards,
Christophe Kopp
Editor with Prescrire (english.prescrire.org)
on behalf of:
Association Internationale de la Mutualité (AIM)
Health Action International (HAI) Europe
International Society of Drug Bulletins (ISDB)
Medicines in Europe Forum (MiEF)
Nordic Cochrane Centre
Christophe KOPP <ckopp@prescrire.org>