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is an inherent risk that vital information of public relevance, would remain inaccessible to the public, were such a draft guidance document to be approved.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

©Medicines in Europe Forum 31 August 2011