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[e-lek] Fwd: [e-drug] E-Drug: Joint open letter on access to clinical study reports

---------- Forwarded message ---------
From: Rita Kessler <ritakessler@gmail.com>
Date: Thu, 19 Dec 2019 at 04:09
Subject: [e-drug] E-Drug: Joint open letter on access to clinical study
reports
To: <e-drug@healthnet.org>


E-DRUG : Joint open letter on access to clinical study reports
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https://english.prescrire.org/en/79/207/46302/6241/5953/SubReportDetails.aspx

At the initiative of Prescrire, over 30 organisations representing
independent drug bulletins, researchers, healthcare professionals, health
technology assessment (HTA) bodies as well as patient, consumer and public
health organisations expressed their concerns in a joint open letter in
view of an expected European Court ruling in January 2020. It is about a
lawsuit filed by pharmaceutical companies against the European Medicines
Agency which threatens public access to Clinical Study Reports. A legal
opinion published by an Advocate General in September 2019 supported the
company's arguments, setting off alarm bells among patient and transparency
advocates.

The co-signing organisations stress that EMA's transparency and access to
document policy must not be watered down: instead it deserves greater
attention as it is a cornerstone of enlightened research and decision
making, as well as public scrutiny and trust in the European regulator.

Access to Clinical Study Reports allows for independent research,
assessment of trial reporting and bias, detailed evaluations of harms and
adverse events, trial re-analyses and their integration in systematic
reviews and meta-analyses. Disclosure of clinical data, including Clinical
Study Reports, is of vital interest for patients, and also needed for
researchers, HTA bodies, independent drug bulletins, healthcare payers and
the global health community.

Full transparency - not secrecy - is the way forward!

The joint open letter is available here:
https://english.prescrire.org/en/79/207/46302/6241/5953/SubReportDetails.aspx

For further information please contact:
Rita Kessler, European Advocacy Officer, Prescrire
rkessler@prescrire.org
Rita Kessler <ritakessler@gmail.com>
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