E-DRUG: EMA policy on access to data: proactive access to some data with strings attached
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Dear E-druggers
This is a joint statement on the European Medicines Agency's final policy on access to clinical data by Association Internationale de la Mutualité (AIM), Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB), Medicines in Europe Forum (MiEF) and the Nordic Cochrane Centre (NCC).
On 2 October 2014, the European Medicines Agency (EMA) finally adopted its policy on access to clinical data. From 1 January 2015 onwards, the general public will be able to “view on screen” selected parts of trial reports submitted in support of marketing authorizations.
Academic and non-commercial researchers will be allowed to download the data. This policy, unfortunately, also gives pharmaceutical companies the upper hand in deciding the contents of the clinical reports by allowing them to redact [obscure or remove] data on the grounds of “commercial confidentiality”.
Implementation of the policy will need careful monitoring.
The full statement is available at:
http://english.prescrire.org/en/79/207/46302/3839/3303/SubReportDetails.aspx
Christophe Kopp
Editor with Prescrire
for AIM, HAI Europe, ISDB, MiEF, NCC
Christophe KOPP <ckopp@prescrire.org>