HTA GG publishes Guiding Principles on Data Transparency

‍The HTA GG, the Member State Coordination Group on Health Technology Assessment, has published Guiding Principles on Data Transparency. The purpose of the document is to provide general principles to be used when assessing requests for confidentiality from health technology developers within the context of joint clinical assessments within the context of Joint Clinical Assessments (JCA).

The document distinguishes between what it considers Commercially Confidential Information (CCI) and clinical data, including identification of the information that the Group does not consider to constitute CCI. The Guide considers that CCI includes:

• trade secrets (including e.g., formulas, programs, process or information contained or embodied in a product, unpublished aspects of trademarks or CE marking, patents etc);

• structures and chemical analytics;

• development plans of a company for a medicinal product, medical device or an in vitro diagnostic medical device.

The information that the Guide does not consider to constitute CCI includes:

• any information that is already in the public domain;

• clinical trial methodologies;

• all clinical trial results and other clinical data (e.g., patient characteristics, efficacy, safety and health-related quality of life data);

• evidence synthesis approaches taken, including discussions on uncertainties in the results and the underlying information and data used, excluding personal data.

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