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)

⇒ The European regulatory agencies for medicine and healthcare products are committed to a health democracy approach.⇒ The patient could be involved at the various stages of the assessment of the benefit-risk balance of health products and decision-making processes: (1) integration of patients' representatives as stakeholders in decision-making committees, (2) coconstruction of benefit-risk assessment with patients' views and(3) patients' experience and feedback as inputs to the assessment of the benefit-risk balance.⇒ The contributions and competencies of different profiles such as users, caregivers, patients, patient representatives, victims, support organisations and patient partners should be taken into account.Their profiles and objectives should be adapted to the different levels of participation.⇒ Experiential knowledge is complementary to medical and scientific expertise.Patient and expert participations must follow the same principles and rules, particularly in terms of ethics and links of interest.⇒ Support should be provided to raise their awareness of the regulatory agency environment and offer them continuous capacity-building.