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Transparency Committee

Sections

 

Task

1. Assess medicinal products with Marketing Authorisation (MA) when a pharmaceutical company submits an application for inclusion onto the list of reimbursable medicines (initial listing, listing renewal, new or extended indication) or when a reassessment is requested by either the Ministry or the Transparency Committee (TC).

2. Provide recommendations for medicinal products with respects to reimbursement by the National Health Insurance Fund and/or hospital use, through an assessment of their actual clinical benefit (ACB) and likely clinical added value (CAV) in comparison to available treatments.

3. Contribute to the proper use of medicinal products by publishing relevant and independent scientific information on medicinal products, including their intended role within a therapeutic strategy for a given disease.

The TC recommendations are used by public authorities in the reimbursement decision-making process. They also contribute to improving the proper use of medicinal products by health professionals and patients.

 

Composition

  • Twenty-eight members with voting rights (21 full members, 7 substitutes), selected for their scientific expertise; including the chair (appointed among the Board members) and two vice-chairs;
  • Comprised of expert practitioners (doctors, pharmacists), specialists in methodology and epidemiology and members of patient and consumer associations.
  • Seven members in an advisory role: representatives of the Social Security Directorate, the Directorate-General for Health, the Directorate-General of Care Provision, the National Health Insurance Fund, the French National Agency for Medicines and Health Products Safety.

The TC members are appointed by decree for a three-year term, renewable twice.

 

Rules of Procedure

The Committee’s main task is to assess medicinal products in order to provide recommendations on reimbursement decisions made by the public authorities. The Committee follows a set of rules and principles, defined by the Committee itself, which serve the members in reaching and issuing sound recommendations.

The Committee’s work is based on a regulatory framework, medical data, scientific methodology and sound reasoning, guided by the TC Rules of Procedure.

The standards applied to the assessment process take into account scientific and medical advances.

> Transparency Committee Rules of Procedure (in French only)

 

Assessment Process

French Medicine Assessment System

Schema - French medicines assessment system - CT 

Marketing authorisation may be delivered at the European level by the European Commission following a favourable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), or it may be delivered at a national level by the French National Agency for Medicines and Health Products Safety (ANSM) after a favourable opinion of the Committee for Initial Assessment of Medicines.

Access to reimbursement in France follows French Marketing Authorisation and requires pharmaceutical companies to submit an application file to the HAS Transparency Committee (TC). The TC recommendation is then submitted to the Economic Committee of Healthcare Products (CEPS) and to the National Health Insurance Funds (UNCAM) to determine pricing and level of co-payment, respectively. The final decision for inclusion falls under the jurisdiction of the Ministry of Health and is published in the Official Journal.

 

Issuing a recommendation on a medicinal product

General overview:

  • Analysis of the manufacturer's application file and of published literature by the Medicines Assessment Department at HAS with the drafting of a preliminary document;
  • Assessment of the benefit of a medicinal product by the TC: Actual Clinical Benefit (ACB) and Clinical Added Value (CAV);
  • Hearing phase during which the pharmaceutical company may submit written observations and/or request a hearing with the TC;
  • Issuing of the final recommendation to UNCAM, CEPS and the Ministry of Health with publication on the HAS website.

Documents

Posted on Oct 29 2015

For more information