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[e-drug] EMA policy on access to data: proactive access to some data with strings attached

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>

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