Patient and public involvement in the benefit–risk assessment and decision concerning health products: position of the Scientific Advisory Board of the French National Agency for Medicines and Health Products Safety (ANSM)

Introduction In France and Europe,1–4 medicine and healthcare products regulatory agencies have been proactively engaging in health democracy for the last decade. Since 2002, the French legislation has evolved to guarantee the rights of healthcare system’s users.5 Thus, eligible patients and health...

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Veröffentlicht in:BMJ global health Jg. 8; H. 5; S. e011966
Hauptverfasser: Belgodère, Laëtitia, Pougheon Bertrand, Dominique, Jaulent, Marie Christine, Rabeharisoa, Vololona, Janssens, Walter, Rollason, Victoria, Barbot, Janine, Vernant, Jean Paul, Oualikene Gonin, Wahiba, Maison, Patrick, Ankri, Joel, Barouki, Robert, Bastos, Henri, Bellissant, Éric, Druml, Christiane, Ezan, Éric, Houssin, Didier, Monteiro, Maria Emilia, Bertrand, Dominique Pougheon, Sautou, Valérie, Ankri, Joël, Jaulent, Marie-Christine, Vernant, Jean-Paul
Format: Journal Article
Sprache:Englisch
Veröffentlicht: England BMJ Publishing Group Ltd 01.05.2023
BMJ Publishing Group LTD
BMJ Publishing Group
Schlagworte:
Advisors
Breast milk
Caregivers
Commentary
Decision making
Democracy
Health care
Health care policy
health policy
health systems evaluation
Humanities and Social Sciences
Humans
Legislation
Medical personnel
Participation
Patient safety
Pharmacovigilance
Professional ethics
Public Health
Public involvement
Regulation
Regulatory agencies
Risk Assessment
treatment
Whistleblowing
health systems evaluation
treatment
health policy
public health
ISSN:2059-7908, 2059-7908
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Zusammenfassung:Introduction In France and Europe,1–4 medicine and healthcare products regulatory agencies have been proactively engaging in health democracy for the last decade. Since 2002, the French legislation has evolved to guarantee the rights of healthcare system’s users.5 Thus, eligible patients and health system user organisations are systematically represented in French health agencies as in some other countries.6 Beyond the integration of their representatives as members of committees and as part of its transparency policy, the French National Agency for Medicines and Health Products Safety (ANSM) is striving to involve patients at the various stages of the assessment and decision-making processes, but also all people concerned with health products. The assessment processes are driven by patient risk management, enabling the Agency to make decisions in a public health policy. In some scientific committees, it is more difficult to recruit patients’ representatives because of the topics covered (eg, microbiological controls of breast milk from lactarium). Besides integration of patients into national committees, patients are involved at the European Medicines Agency (EMA) level through their participation as members of the management board and scientific committees for European regulatory decision-making.11 Furthermore, in addition to the decision-making committees, two other types of committees have been set up: a Health Products Information Committee to promote public communication and the dissemination of information, and an ad hoc committee to strengthen the partnership between the Agency and patient organisations and health system users. [...]the following collection methods have been implemented: Since 2011, pharmacovigilance declaration allowing the detection of signals is available to patients and their organisations (38.36% of adverse reaction reports registered in the French pharmacovigilance database were declared by patients in 2021).15 To facilitate this measure, an online portal for reporting adverse health events was set up in 2017 (www.signalement-sante.gouv.fr).
Bibliographie:SourceType-Scholarly Journals-1
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ISSN:2059-7908
2059-7908
DOI:10.1136/bmjgh-2023-011966