[Drugs: minors and harm reduction?] / Drogues : mineur-e-s et réduction des risques ?

The use of controlled substances (narcotics and psychotropic substances) poses increased risks for minors. However, minors are generally excluded from existing harm reduction services (e.g. drug consumption rooms, drug checking, exchange of consumption material). Based on public health considerations, the authors recommend the establishment of harm reduction services for minors.

La consommation de substances soumises à contrôle (stupéfiants et substances psychotropes) présente des risques accrus pour les mineur-e-s. Pourtant, ces derniers sont généralement exclus des offres existantes de réduction des risques et des méfaits (par exemple, locaux de consommation, drug checking, échange de matériel de consommation). Sur la base de considérations de santé publique, les auteurs recommandent la création de services de réduction des risques dédiés aux mineur-e-s.

[Therapeutic contracts and opioid agonist treatments: legally and ethically questionable]. / Contrats thérapeutiques et traitements agonistes opioïdes : juridiquement et éthiquement discutables.

In Switzerland, the use of « therapeutic contracts ¼ in the implementation of opioid agonist treatments (OAT) is frequently recommended or even imposed. These documents raise legal and ethical issues, which are presented in this article. The authors recommend that this practice be abandoned. The usual tools of medical treatments (e.g. information document, treatment plan) are sufficient.

En Suisse, l'usage de « contrats thérapeutiques ¼ dans le cadre de la mise en œuvre des traitements agonistes opioïdes (TAO) est fréquemment recommandé, voire imposé. Ces documents soulèvent des problèmes juridiques et éthiques, présentés dans cet article. Les auteurs recommandent l'abandon de cette pratique. Les outils ordinaires de la prise en charge médicale (par exemple, document d'information, plan de traitement) suffisent.

[Assisted suicide: a need for clarification]. / Suicide assisté : un besoin de clarification.

In Switzerland, altruistic assisted suicide is permitted. We present here the federal regulations, the deontological rules, the provisions adopted by the cantons and other requirements applicable to assisted suicide. Given the complexity of these different rules and the legal questions that remain open, we recommend the preparation of brochures for patients, as well as better training and support for people faced with requests for assisted suicide.

En Suisse, l'assistance altruiste au suicide est admise. Nous présentons ici la règlementation fédérale, les règles déontologiques, les dispositions adoptées par les cantons et les éventuelles autres exigences applicables en matière de suicide assisté. Vu la complexité de ces différentes règles et les questions juridiques encore ouvertes, nous recommandons la rédaction de brochures à destination des patients, ainsi qu'une meilleure formation et encadrement des personnes confrontées à des demandes d'assistance au suicide.

[Driving under the influence ]. / Conduite sous l'emprise de .

Prescribing medicines containing controlled substances (SSC : narcotics and psychotropic substances) can have legal consequences as per the Road Traffic Act. We set forth the physician's duties as well as the risks incurred by the patient. We recommend that rules regarding SSC, which can influence the capacity or the ability to drive, be clarified.

Prescrire des médicaments contenant des substances soumises à contrôle (SSC : stupéfiants et substances psychotropes) peut avoir des conséquences en matière de circulation routière. Nous présentons ici les devoirs du médecin et les risques encourus par la personne en traitement, avant de plaider pour une clarification s'agissant de médicaments pouvant influer sur la capacité ou l'aptitude à la conduite.

Switzerland's Dependence on a Diamorphine Monopoly.

In 2021, the manufacturer of diamorphine reported a possible impending shortage for Switzerland and Germany. This led us to investigate this controlled medicine's manufacture, market, and regulatory constraints. Based on our analysis of legal texts and gray literature in the form of reports and documents, we propose recommendations to prevent and address diamorphine shortages in Switzerland. Diamorphine, also known as pharmaceutical "heroin," is used medically to treat persons with severe opioid use disorder in a handful of countries. The controlled medicine is manufactured from morphine, which, in turn, is extracted from opium poppies. Studying data from the International Narcotics Control Board for 2019, we find that Switzerland accounts for almost half of the worldwide medical consumption of diamorphine. It manufactures more than half of the worldwide total and keeps the largest stocks. Moreover, Switzerland is dependent on a sole supplier of diamorphine (monopoly). As a niche product, diamorphine has an increased risk of shortage. Such a shortage would immediately threaten a valuable public health program for around 1,660 Swiss patients. We believe it is urgent to curtail the monopoly and ensure a stable supply for the future.

Switzerland's Narcotics Regulation Jungle: Off-Label Use, Counterfoil Prescriptions, and Opioid Agonist Therapy in the French-Speaking Cantons.

The word "narcotic" is often first associated with "illicit drugs". Yet, many "narcotic" and psychotropic substances are, in fact, medicines. Controlled medicines (CM) are products that meet the legal definition of both a "narcotic" under the Swiss Narcotics Act and of a medicine under the Therapeutic Products Act. We aim to examine how similar and how different, respectively, the implementation of CM regulations is throughout French-speaking Switzerland. Based on a legal analysis of the cantonal regulations, we conducted semi-structured interviews with cantonal pharmacists and cantonal physicians. We asked them how they perceive and implement the federal legal requirements. We find that some of these requirements have fallen into disuse, notably the federal duty to notify off-label use of CM. We observe that counterfoil prescriptions in their current paper format are a veritable data graveyard in the sense that they are not actively used to monitor or supervise the market. Moreover, we detect different conditions for opioid agonist treatment authorization. Some cantons require additional physicians' training or written commitments by the person treated. Our mapping of the CM regulation implementation can serve as a basis for cantons to review their practices.

Agonist Treatment for Opioid Dependence Syndrome: The Impact of Current Understanding upon Recommendations for Policy Initiatives.

The provision of opioid agonist treatments (OATs), as a standard approach towards opioid dependence syndrome, differs widely between countries. In response to access disparities, in 2014, the Council of Europe's Pompidou Group first brought together an expert group on framework conditions for the treatment of opioid dependence. The group used a Delphi approach to structure their discussions and develop guiding principles for the modernisation of OAT regulations and legislation. The expert group identified some 60 guiding principles, which were then the subject of wide public consultation. Endorsed by Pompidou Group member states, the final report identified four key recommendations: (1) Prescription and delivery without prior authorisation schemes; (2) Effective removal of financial barriers to access to care; (3) Coordination and follow-up by a national consultative body; and (4) Neutral, precise and respectful terminology. During meetings, the expert group hypothesised that inequalities in OAT access are likely to be linked to underlying rationales which in theory are contradictory, but in practice co-exist within the different political frameworks. The present article considers the perceived influence upon different regulatory frameworks. Discussion is centred around the potential impact of underlying rationales upon the effective implementation of a modernised framework.

[Benzodiazepines, addiction and cantonal authorization : legal framework and clinical implications.] / Benzodiazépines, addiction et autorisation cantonale : cadre juridique et implications cliniques.

Use of benzodiazepine and Z-drug is common in Switzerland, also for prolonged periods of time. Physical dependence, psychological dependence and a syndrome of dependence may ensue. Related to a lack of well-established medical guidelines, current clinical practices are subject to debate. Also controversial is the need to request an authorization from the cantonal health authorities before starting treatment with these controlled substances. The present article describes the limited circumstances in which such prior authorization is required.

La prescription de benzodiazépines et de Z-drugs (zolpidem, zopiclone, zaléplone) est fréquente en Suisse, y compris en traitement de longue durée. Il peut s'ensuivre une dépendance physique ou psychologique, et plus rarement un syndrome de dépendance. En l'absence de directives reposant sur des évidences scientifiques consolidées, les pratiques effectives des professionnels de la santé sont sujettes à débat. L'est également l'obligation d'obtenir une autorisation cantonale préalable à la mise en place d'un traitement contenant ces substances soumises à contrôle. Le présent article décrit les conditions dans lesquelles une telle autorisation est requise ou non.

[Modernising the framework conditions for medicine treatments in opioid dependence syndrome]. / Moderniser les conditions-cadres des traitements médicamenteuxdu syndrome de dépendance aux opioïdes.

Opioid medicines prescribed on a long-term basis for opioid dependence syndrome have historically been deemed « substitution treatments ¼ and misunderstood as involving the "replacement of an illicit drug by a legal drug". Prior authorisation schemes, in addition to ordinary procedures for authorising medicines and supervising professionals, interfere with access to treatment. In order to guide the countries in their efforts to modernise their regulations, the Pompidou Group mandated a group of health and legal experts, who identified 62 guiding principles and developed four strategic recommendations : 1) the removal of prior authorisation schemes, 2) the removal of financial barriers, 3) supervision by a national consultative body and 4) The adoption of neutral, precise and respectful terminology.

Les médicaments opioïdes prescrits à long terme dans le cadre du syndrome de dépendance aux opioïdes ont longtemps été qualifiés de « traitements de substitution ¼ et compris à tort comme « remplacement d'une drogue de rue par une drogue d'Etat ¼. Des régimes spéciaux d'autorisation en sus des procédures ordinaires d'homologation du médicament et de supervision des professionnels entravent l'accès au traitement. Afin de guider les pays dans leurs efforts de modernisation de leur réglementation y relative, le Groupe Pompidou a mandaté un groupe d'experts de la santé et du droit qui ont défini 62 principes directeurs et avancé quatre recommandations stratégiques, à savoir : 1) la suppression des régimes d'autorisation, 2) la suppression des barrières financières, 3) le suivi par une instance nationale consultative et 4) l'adoption d'une terminologie neutre, précise et respectueuse.

Medical research using governments' health claims databases: with or without patients' consent?

Taking advantage of its single-payer, universal insurance system, Taiwan has leveraged its exhaustive database of health claims data for research purposes. Researchers can apply to receive access to pseudonymized (coded) medical data about insured patients, notably their diagnoses, health status and treatments. In view of the strict safeguards implemented, the Taiwanese government considers that this research use does not require patients' consent (either in the form of an opt-in or in the form of an opt-out). A group of non-governmental organizations has challenged this view in the Taiwanese Courts, but to no avail. The present article reviews the arguments both against and in favor of patients' consent for re-use of their data in research. It concludes that offering patients an opt-out would be appropriate as it would best balance the important interests at issue.

The Swiss regulatory framework for paediatric health research.

Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.