E-DRUG: HAI Europe and MIEF's response to the EMA consultation on the identification of Commercially Confidential Information and Protection of Personal Data
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Dear E-druggers ,
HAI Europe and the Medicines in Europe Forum have published a joint
response to the HMA/EMA Guidance document on the identification of
Commercially Confidential Information and Protection of Personal Data
within the structure of the Marketing Authorisation (MA) Dossier.
HAI Europe and MIEF welcome the initiative to comment on the HMA/EMA
guidance document on the identification of Commercially Confidential
Information and Protection of Personal Data within the structure of the
Marketing Authorisation (MA) Dossier. We have, however, identified
serious shortcomings in the guidance document.
Public accountability of regulatory decisions is only possible if the
public has access to the evidence on which those decisions are based,
and is provided with a rationale for decisions.
There is an inherent risk that vital information of public relevance,
would remain inaccessible to the public, were such a draft guidance
document to be approved. When medicines agencies fail to publicly
disclose important safety information to potential users and the public
at large, they also fail to fulfil their mandate to contribute to
rational medicine use, safeguarding and upholding public health.
Lack of full public access to the body of available scientific evidence
about the effects of medicines on human health leaves European citizens
at greater risk for otherwise preventable harm. This is unacceptable. A
broad definition of commercial confidentiality that puts commercial
interests before human health is both inconsistent with EU regulations
and almost certain to lead to otherwise preventable harm. Two steps are
needed to prevent future harm: a precise and limited definition of
commercial confidentiality and regulatory procedures that make
transparency the norm and secrecy the exception.
For the full response, please visit:
http://haieurope.org/wp-content/uploads/2011/08/31-August-2011-Joint-HAI
-Europe-MIEF-response-to-EMAHMA-consultation-on-draft-guidance-docum.pdf
Best regards,
Teresa Leonardo Alves
European Coordinator
Health Action International (HAI) Europe
Overtoom 60, II
1054 HK Amsterdam
The Netherlands
Tel: +31 20 683 3684
Mobile: :+31 6 246 867 71
Fax: +31 20 685 5002
Email: teresa@haieurope.org
Website: http://www.haieurope.org
HAI Europe staff blog about recent developments in medicines policy:
www.haieuropestaffblog.blogspot.com/
Health Action International (HAI) is an independent, global network
working to increase access to essential medicines and improve their
rational use through research excellence and evidence-based advocacy.