Agence nationale de sécurité du médicament et des produits de santé

The Agence nationale de sécurité du médicament et des produits de santé (ANSM) (German: National Agency for the Safety of Medicines and Health Products ) is the French authority for drug safety based in Saint-Denis . It has existed since May 2012 and is the successor agency of the Agence française de sécurité sanitaire des produits de santé ( Afssaps ) (German: French agency for the safety of health products ). The Afssaps in turn was founded in March 1999th The ANSM is subordinate to the French Ministry of Health and has the rank of Établissement public . When Afssaps was founded , the French public was under the impression of infections caused by HIV-contaminated blood products .

The ANSM has taken over all rights, tasks and duties of the Afssaps , but at the same time some new tasks have been assigned to it. Their means and possibilities have been improved compared to the Afssaps .

tasks

The Afsapps (now ANSM) building in Paris

The ANSM took over its tasks from the Afssaps and the latter had taken over from the former Agence du médicament . One of the main tasks of the Agence du médicament was the recording and assessment of health risks and adverse drug effects that can arise from the use of drugs . This core task of the old agency was expanded for the Afssaps to include active ingredients , medical devices , in-vitro diagnostics , biotechnological products , blood products , organs , tissues and cells ( gene therapies and cell therapies ), homeopathic remedies and cosmetics . Together with the Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail and the Institut de veille sanitaire , it was responsible for the implementation of a law of July 1, 1996, which regulates the monitoring of all aspects of public health regulates. As part of this task, the agency ensured that the safety, effectiveness, quality and correct use of health care products were guaranteed.

Article L-5311-1 of the law provides the following core tasks for the agency:

Scientific medical-economic evaluation

Surveillance of laboratories and public health

Inspections and audits of healthcare product manufacturers

Information from specialist groups and the public.

The ANSM is responsible for the implementation of a law of December 29, 2011. Your core tasks are:

To give all patients fair access to innovations.
To ensure the safety of health products throughout their product life cycle, from the development stage to monitoring during their approval.

Organizational structure

Full front of the Afsapps building (today ANSM)

The agency's general manager is Dominique Martin.

The agency consists of 15 permanent scientific committees or expert commissions :

Committee on Unstable Blood Products and Blood Donors
Committee on Cardiovascular Therapies and Risks
Committee on Dermatological Medicines
Committee on diagnostic and nuclear medicine drugs
Committee on Oncology and Hematology
Medicines Safety and Quality Committee
Committee on Safeguarding the Use of Medicines
Committee on Reproduction , Pregnancy and Lactation
Committee on Pediatrics
Committee on Psychotropic Substances , Narcotics and Addiction
Monitoring and Pharmacovigilance Committee
Hemovigilance Committee

Committee on Materiovigilence and Reaktovigilanz

Committee on Liaison with the Toxicovigilance Network

Medical Device Quality Control Committee

There is also the Health Product Information Committee, Liaison Committees, Temporary Committees and the French Pharmacopoeia Committees .

Cooperation with other authorities

The ANSM works closely with various other European authorities to implement EU-wide directives and laws. So she reports to the European Medicines Agency . But it also cooperates with other authorities such as the Federal Institute for Drugs and Medical Devices in Germany, the Medicines and Healthcare products Regulatory Agency or the Irish Medicines Board . Outside the EU, the United States' Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labor and Social Affairs are cooperation partners.

criticism

In a book entitled Santé, mensonges et propagande , Thierry Souccar and Isabelle Robard criticized the conflict of interests of Afssaps employees. Of 675 people surveyed, 415 (62.4%) admitted that they had already been contacted by pharmaceutical companies, cosmetics manufacturers and other lobbyists . The authors concluded that the agency was run by commercial, not public interests.

In the worldwide scandal over breast implants by the French company PIP , allegations against Afssaps of inactivity were raised, since the US agency FDA acted as early as 2000. This refers to other legal regulations as well as the responsibility of TÜV Rheinland for the CE marking .