The French National Agency for Health Products (ANSM) is a regulatory and public health agency. Its regulatory, health policing and public health protection activities require a perfect fit with the field and the various people involved in the use of health products. Since 2019, the ANSM has adapted its organisation, procedures and processes to encourage and improve interaction with its stakeholders, as part of its policy of openness towards civil society. To accompany this ambitious change and to support its staff, the Agency has recruited advisors corresponding to the main users of health products: prescribers (doctor's hospital and outpatient), pharmacists and patients. Working as a group or individually, they provide a "lived"user perspective on health products at each stage of the evaluation process. They may be involved in the assessment of dossiers, signals or applications received by the Agency, in the internal validation of reports or in discussions with stakeholders. They are particularly involved when the analysis requires expertise that goes beyond the technical, scientific or regulatory aspects. They may also work with ANSM staff to explain certain processes and difficulties in the field. Advisors help to ensure that regulatory and/or scientific expertise is clear and consistent with user experience. In addition to their scientific and therapeutic aspects, medicines are also economic, social and political issues. Their regulation is therefore particularly affected by the need for health democracy. This requires the active participation of health professionals, patients and, more broadly, civil society in the decision-making process. Civil society is a space occupied by a wide range of actors who exert pressure from different ideological positions to influence the regulation of health products. In this context, taking into account a plurality of viewpoints in the regulation of health products is necessary and complex, but its operation can be facilitated by the collective efforts of the actors and the adaptation of organisations, such as the integration of advisors. (c) 2024 Agence Nationale de Securite du Medicament. Published by Elsevier Masson SAS on behalf of Societe franc,aise de pharmacologie et de therapeutique. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) est une agence réglementaire et de santé publique. Ses actions de régulation, de police sanitaire et de protection de la santé publique imposent une parfaite adéquation avec le terrain et les différents acteurs concernés par l’utilisation des produits de santé. Depuis 2019, l’ANSM a adapté son organisation afin de promouvoir et améliorer ses interactions dans le cadre de sa politique d’ouverture à la société civile. Afin d’accompagner cette ambitieuse mutation et soutenir ses agents, l’Agence a recruté des conseillers reflétant les principaux profils d’utilisateurs de produits de santé : médecins, pharmaciens et patients. En collège ou individuellement, ils apportent un regard du « terrain » à chaque étape des processus de décision. Ils peuvent participer à l’évaluation des signalements et demandes comme aux validations de rapports ou aux instances d’échanges avec les parties prenantes. Ils interviennent notamment lorsque l’analyse nécessite une expertise au-delà des aspects scientifiques ou réglementaires. Ils peuvent aider à prendre en compte certains aspects du soin et les difficultés de terrain. Les conseillers participent à la lisibilité et à l’adéquation entre l’expertise réglementaire et/ou scientifique et le vécu des utilisateurs. Au-delà de l’aspect scientifique et thérapeutique, le médicament est aussi un objet économique, social et politique. Ainsi, sa régulation est particulièrement concernée par le besoin de démocratie sanitaire dont les conseillers sont les facilitateurs. Celle-ci impose une participation active des professionnels de santé, des patients et plus largement de la société civile dans la prise de décision. Dans ce contexte, la prise en compte de la pluralité des points de vue dans la régulation des produits de santé est nécessaire mais complexe. Elle peut être facilitée par l’adaptation des organisations, comme l’intégration de conseillers.

PURPOSE:Cough is a prevalent symptom driving patients to seek medical attention in general practice. Despite its widespread use, the clinical efficacy of oxomemazine, the second most reimbursed molecule in France for symptomatic cough treatment, remains uncertain. This study aims to systematically evaluate the clinical efficacy of oxomemazine in cough. METHODS:A systematic literature review with meta-analysis of randomized controlled trials (RCTs) was conducted according to the Rebuild the Evidence Base (REB) protocol. Clinical trials comparing the efficacy of oxomemazine versus placebo or active comparator in cough were searched for. Trials with insufficient data were excluded. Searches were conducted across major databases (Medline, Cochrane Central Register of Controlled Trials, and Embase) and trial registries (World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov). RCTs comparing oxomemazine versus placebo or active comparators in cough were sought. Risk of bias was assessed using the Cochrane Collaboration's RoB2 tool. The protocol was preregistered on PROSPERO under the number CRD42022345496 (15). This study received no funding. RESULTS:No RCTs were at low risk of bias. Therefore, no meta-analysis was conducted, in accordance to the pre-specified protocol. CONCLUSIONS:This systematic review highlights the lack of evidence regarding the efficacy of oxomemazine in cough treatment and underscores the need for further well-designed clinical trials to inform its clinical utility in primary care settings.

Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including the French National Agency for Medicines and Health Products Safety (ANSM). To highlight perspectives for a better prevention, we described and analyzed the management of shortages in the availability of health products in France over the last 10 years. The supply chain was mapped to identify the main causes of shortages and stakeholders involved in managing shortages throughout the supply chain. National and European initiatives and regulatory measures were reviewed. A retrospective nationwide data analysis from the French reporting system of health product shortage reports was conducted over 10 years for drugs (2013–2022) and over an 18-month period for medical devices, from 1st March 2022 to 31st August 2023. An increase in drug shortage reports was observed, rising from 404 in 2013 to 3,761 in 2022 for drugs, with a relatively constant distribution of affected therapeutic classes. In 2022, the main reported causes of drug shortage risk were insufficient production capacity (27.1%), increased sales volume (21.5%), or lack of supply (13.6%). Over half of the reports on medical devices (55.4%) were objectified as indispensable, and their causes were mainly due to a lack of supply (48.2%), discontinuation of marketing (14.9%), increased sales volume (13.2%), and regulatory reasons (9.6%). ANSM and French authorities have engaged a public health policy for prevention and management of health product shortages including financial penalties, minimum safety stocks for Major Therapeutic Interest drugs, and a shortage management plan. Based on 10 years of experience, four priority measures have been identified to anticipate the risk of heath products shortages based: the importance of a national coordination from raw materials to local market, the implementation of new prevention and management actions in the supply chain, strengthening European cooperation and regulation including the establishment of a list of critical drugs, and promoting transparency and information.

Collège, Agence Nationale de Sécurité duMédicament et des Produits de Santé, Saint Denis, Grand Paris, Institut Godinot, Reims, France, Union Francophone des Patients Partenaires, Faculté deMédecine, Bâtiment Jean Roget, La Tronche, France, General Practitioner, Angers, France, Hospices Civils de Lyon, Lyon, France, General Practitioner, Collège de la médecine générale, Paris, France, Institut Daniel Hollard, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France, Université de Paris, Hôpital Saint Joseph Paris (Médecine Vasculaire), Paris, France, EA 7379 EpiDermE, Paris-Est-Créteil, Créteil, France