english.prescrire.org > Topics > Advancing healthcare policy > Response to HMA/EMA on identification of commercially confidential information (8/2011)

Advancing healthcare policy

Via its policy advocacy, Prescrire acts as a force for change in health policies, first and foremost in the interest of patients.

Advancing healthcare policy

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 Dossier (August 2011)

In their joint response, HAI Europe and the Medicines in Europe Forum identify several serious shortcomings in the HMA/EMA Guidance Document. They argue in favour of a precise and limited definition of commercial confidentiality, along with regulatory procedures that make transparency the norm and secrecy the exception. Read on...

Summary

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is an inherent risk that vital information of public relevance, would remain inaccessible to the public, were such a draft guidance document to be approved.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 fulfill 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.

> Download the joint response (pdf)

- HAI Europe
- Medicines in Europe Forum