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Advancing healthcare policy

Transparent, independent health authorities

Advancing healthcare policy

Transparent, independent health authorities: Actions vis-à-vis regulatory agencies
Legal obligations for transparency at the European Medicines Agency: Prescrire’s assessment over four years (September 2009)

Prescrire and the Medicines in Europe Forum contributed jointly to reinforcing the transparency rules that apply to EU drug regulatory agencies, now enshrined in the 2004 Directive and Regulation. Prescrire assessed how the European Medicines Agency (EMEA) implemented its legal obligations for transparency over a four-year period.

Abstract

Between 2005 and 2008, Prescrire submitted 81 requests for four main types of documents or complementary information: documents that should have been made publicly available on the EMEA website, but that were missing (mainly European Public Assessment Reports (EPARs) and their updates); internal documents that the Agency was not legally required to post on its website (mainly the full reports on which EPARs are based); documents held by the Agency but produced by a third party (mainly drug companies and regulatory agencies of EU member states); and various types of non-documentary information.

As a result of our requests for information, many EPARs and revisions were posted on the EMEA website more rapidly, and a number of anomalies were rectified. Moreover, some pharmacovigilance data that would have otherwise remained hidden were made public. We also reminded the EMEA of its legal obligation to publish the conflict of interest statements made by all experts serving on its committees.

Overall, our experience shows just how reluctant the EMEA is to divulge information, how slow it is to respond, and how it stonewalls when asked for clinical data contained in national agency reports and drug company documents, such as periodic safety update reports (PSURs).

Some sections of documents containing important scientific information are simply censored, in the name of commercial confidentiality, further confirming that EMEA is failing in its duty to protect the health and safety of European citizens.

©Prescrire 24 September 2009

Source: "Legal obligations for transparency at the European Medicines Agency: Prescrire's assessment over four years", Prescrire Int 2009; 18 (103): 228-233.

> Click here to download the full article (pdf, 517 Ko).

> Click here to download the complete facsimile of the blacked-out report (pdf, 620 Ko).

In brief
Why it matters
Actions vis-à-vis regulatory agencies

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The worldwide debate on access to data

European Directive on trade secrets: A threat to access to public health data (2/2015)
WHO statement on public disclosure of clinical data: joint response (11/2014)
EMA's final policy on access to clinical data (10/2014)
Clinical trials regulation: a major advance in transparency (9/2014)
EMA's new policy on access to clinical data (6/2014)
Backpedalling on EMA’s "proactive publication of clinical-data" draft policy (5/2014)
The US-EU Trade Agreement Proposals by the pharmaceutical industry undermine European public policy making and public health (3/2014)
Transparency in the public interest: How the EMA policy on publication and access to clinical-trial data could help save lives (9/2013)
Clinical trials regulation: choose transparency! (4/2013)

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Advancing healthcare policy

Transparent, independent health authorities

Advancing healthcare policy

Transparent, independent health authorities: Actions vis-à-vis regulatory agencies Legal obligations for transparency at the European Medicines Agency: Prescrire’s assessment over four years (September 2009)

Transparent, independent health authorities: Actions vis-à-vis regulatory agencies
Legal obligations for transparency at the European Medicines Agency: Prescrire’s assessment over four years (September 2009)