France

Health systems in transition France 43
consumption. Implementation has not been smooth because of both technical
and patient privacy concerns. As a result, by June 2013, fewer than 400 000
patients had DMPs (see section 4.1.4).
National information system on health professionals
The national Automated Directory of Health Professionals (Automatisation
des listes; ADELI) provides information on gender, geographical distribution,
specialty, type of practice (employed, self-employed, both), starting practice
date, etc.) of all practising health professionals.
2.7.2 Health technology assessment
Governance and organization of health technology assessment (HTA;
évaluation des technologies de la santé) are defined by the government and
SHI. The major HTA body in France is the HAS, which has in-house expertise
as well as the authority to commission assessments from external groups such
as academic centres or professional societies.
All medical procedures and technologies (drugs, devices, equipment,
reagents and tests) are assessed at the request of manufacturers or, in the case
of procedures, professional societies. For technologies, regulatory approval
is based on safety and may be supranational, for example undertaken by
the European Medicines Agency (Agence européenne des médicaments)
for medicines. The second assessment aims to inform coverage and pricing
decisions and is specific to the French health care system.
Assessments are performed by ad hoc committees. Drugs are assessed by
the Transparency Commission (Commission de la Transparence), while devices
and procedures are assessed by the National Commission for the Evaluation of
Medical Devices (Commission nationale d’évaluation des dispositifs médicaux
et des technologies de santé; CNEDIMTS).
In order to be listed in one of the positive lists and covered by SHI, all new
drugs, devices and procedures must undergo an assessment. This assessment
is prior to market launch and is used directly to determine the coverage rate
and less directly the price (statutory tariff). For new technologies, assessment
is based on the documents provided by the manufacturer. The studies are
critically appraised by two reviewers and discussed by the committee. There
is a two-tier procedure.
Is the technology effective? Assessment of the level of medical benefit of
the technology reflecting its clinical efficacy and its possible side-effects, the
severity of the disease it is indicated to treat and the public health relevance