[Securing the implantable medical device circuit]. / Arrêté du 8 septembre 2021 : sécurisation du circuit des dispositifs médicaux implantables.

OBJECTIVES: The decree concerning quality management of implantable medical device circuits came into force in healthcare establishments on 26 May 2022. The aim of this project is to assess the level of safety of this circuit within the pharmacy, in order to improve it and bring it into line with this future regulation. METHODS: A grid for compliance with the decree was drawn up, enabling compliance rates to be calculated. A second grid was drawn up in accordance with internal procedures. All these criteria were audited in pairs. Priority areas for improvement were identified and working groups were formed. The action plan was monitored by the Steering Committee. Control audits ensure the implementation and relevance of the action plan, as well as the effective securing of the circuit. RESULTS: The rate of circuit compliance with the decree rose from 58% (initial audits) to 72% (control audits). Over a period of 18 months, six workgroups were set to implement improvement measures allowing to ensure regulatory compliance and circuit security. Obstacles (equipment, IT) nevertheless hindered the presence of the unique identifier for medical devices at every stages of the circuit. CONCLUSIONS: This cross-functional project was carried out in "project mode", thanks to the involvement of field staff. It will be pursued at hospital level by the person in charge of the quality management system.

Towards a Standardized Definition of Medical Nutrition Therapy and Regulatory Reform in Canada.

Various definitions have been proposed to describe Medical Nutrition Therapy (MNT). Broadly, MNT encompasses the provision of nutrition information and advice aimed to prevent, treat, and/or manage health conditions. In Canada, the provision of such information and advice is unregulated, thus allowing anyone to provide MNT services regardless of their education and training. This inevitably poses risks of harm such as the provision of unsafe and/or ineffective nutrition advice as well as delayed evidence-based treatment. Canadian research has further demonstrated that the general public is unable to properly differentiate between regulated, evidence-based nutrition providers (registered dietitians) and those who are unregulated. Therefore, the public is at risk. To reduce nutrition misinformation and ultimately improve the health and well-being of the public, the objective of this paper is, first, to propose a standardized definition of MNT for use across Canada and, second, to propose province- and territory-specific legislative amendments for the regulation of MNT throughout the country. We also present an opposing perspective to the proposed viewpoint. Ultimately, health care regulation across the country requires an overhaul before we expect that nutrition information and advice communicated to the public may be consistently evidence based.

The regulatory landscape of biosimilars: Algeria's efforts and progress made from 2006 to 2021.

Biologics are tremendously efficacious biological molecules that have enabled the treatment of many life-threatening diseases, which have previously been hard to treat. Biosimilars, also known as "follow-on biologics", are highly similar versions of another already approved biologic, called the Reference Product. The European Union has been a pioneer in the regulation of biosimilars. WHO guideline on evaluation of biosimilars published in 2009 was an important landmark in biosimilar regulations worldwide, and several countries have adopted its principles in the development of their own regulatory pathway for the approval of biosimilars. Most countries in the Middle East North Africa (MENA) region still lack official and scientific guidelines for biosimilar approval pathways. This article explores the regulatory situation of biosimilar registration pathways in Algeria and describes the progress made and the regulatory landscape changes for biosimilars in Algeria during the past ten years. Our findings indicate that the development of biosimilar regulation in Algeria went through three major phases between 2006 and 2021, during which there has been much progress in drafting guidance documents for biosimilars. Since 2016, Algeria has used the EMA, FDA and WHO guidelines as the basis for approval of several biosimilars and no national guidelines or regulations have been adopted to date. Additionally, there has been no regulation on substitution/interchangeability. The Algerian regulatory authority has gained considerable experience with approval and use of increasingly complex biosimilars over the past 5 years and has the potential to create its own biosimilar-specific regulatory pathway in the near future.

Emerging regulatory challenges of next-generation synthetic biology.

Cell-free synthetic biology is a rapidly developing biotechnology with the potential to solve the world's biggest problems; however, this promise also has implications for global biosecurity and biosafety. Given the current situation of COVID-19 and its economic impact, capitalizing on the potential of cell-free synthetic biology from an economic, biosafety, and biosecurity perspective contributes to our preparedness for the next pandemic, and urges the development of appropriate policies and regulations, together with the necessary mitigation technologies. Proactive involvement from scientists is necessary to avoid misconceptions and assist in the policymaking process.

[Medico-legal framework for emergency care of a patient with psychiatric conditions]. / Cadre médico-légal des soins en urgence d'un patient à présentation psychiatrique.

The care and referral of patients with psychiatric conditions is a perilous process. It combines the need for care with respect for individual freedom. Knowledge of the different legal frameworks is thus necessary for psychiatric care at the request of a third party, care without request of a third party within the framework of a procedure for imminent danger, and finally for the injunction of psychiatric care on the decision of a State representative. These are necessary prerequisites for practising in an emergency structure.

The future of therapeutic agents in aquaculture.

The implementation and monitoring of fish health regulations vary extensively in aquaculture throughout the world. In the main salmon-producing countries, there is strict regulatory oversight of the use of pharmaceutical drugs. Such controls have supported the sustainable growth of the aquaculture industry and, in Norway, aquaculture has been able to reduce its total consumption of antibiotics by more than 99% between 1995 and today, yet there has been a 20-fold rise in production volume. Other countries on other continents may have less control, with no mandatory prescription regulations and variable quality of the pharmaceutical products available. A good regulatory framework, with control and monitoring systems, should be established in all countries where aquaculture is practised and veterinary medicinal products should only be available under veterinary prescription and supervision. Many drug resistance genes have been identified, and molecular methods should be applied to control drug resistance in the microbial and parasitic populations of all major aquaculture-producing regions.

Les niveaux de mise en place et de suivi des réglementations applicables à la santé des poissons en aquaculture sont extrêmement variables d'une région à l'autre. Les pays où la salmoniculture prédomine pratiquent un contrôle réglementaire strict de l'utilisation de produits médicamenteux. Ces contrôles ont permis une croissance durable du secteur ; ainsi, en Norvège l'aquaculture a pu réduire sa consommation totale d'antibiotiques de plus de 99 % depuis 1995 tout en multipliant par vingt le volume de production. Le niveau des contrôles est parfois moindre dans d'autres pays d'autres continents, où aucune réglementation n'impose l'obligation d'une prescription vétérinaire et où les produits pharmaceutiques disponibles sont de qualité variable. Tous les pays ayant une production aquacole devraient mettre en place un cadre réglementaire solide doté de systèmes de contrôle et de suivi ; par ailleurs, les produits pharmaceutiques vétérinaires ne devraient pouvoir être obtenus que sous prescription et supervision vétérinaires. Plusieurs gènes responsables de résistances aux agents médicamenteux ont été identifiés ; il conviendrait que toutes les régions dédiées à l'aquaculture recourent à des méthodes moléculaires pour contrôler le phénomène de la résistance aux agents médicamenteux dans les populations de microbes et de parasites.

La aplicación de reglamentos de salud piscícola y las actividades de control reglamentario en la acuicultura varían sobremanera según el lugar del mundo de que se trate. En los principales países productores de salmón, el uso de productos farmacéuticos está sujeto a una estricta supervisión reglamentaria. Estos controles han favorecido el crecimiento sostenible del sector de la acuicultura, sector que en Noruega ha logrado reducir su consumo total de antibióticos en más de un 99% entre 1995 y la actualidad, pese a haber multiplicado por veinte su producción. En otros países de otros continentes hay a veces un menor control, debido a la ausencia de reglamentos de carácter prescriptivo y a la irregular calidad de los productos farmacéuticos disponibles. Sería menester que todos los países donde se practica la acuicultura contaran con un buen ordenamiento reglamentario, dotado de sistemas de control y seguimiento, y que en ellos solo se pudieran obtener productos de uso veterinario con receta y bajo supervisión veterinarias. Sabiendo que se han encontrado muchos genes que determinan resistencia a los medicamentos, convendría aplicar métodos moleculares para controlar la aparición de farmacorresistencias en las poblaciones microbianas y parasitarias de todas las regiones que albergan un importante sector acuícola.

The changing nature of aquatic animal production.

Aquaculture will continue to grow, but environmental constraints will interact with changing consumer profiles and regulatory frameworks such that future growth will look somewhat different from the trajectories of the past 30 years. Availability and price of land, fresh water, feeds and energy, and concerns about pollution and the introduction of non-native species will be major constraints to expansion. New technology will evolve in response to these concerns. This new technology will be based on the principle of sustainable intensification so as to reduce the environmental footprint per unit of production and limit volatility in markets precipitated by disease and other production system problems. Markets and consumer demand will be reflected in the economics of the industry under more sophisticated regulatory regimes. More sustainable sources of the proteins and oils in fish diets, improved genetic management, and better health and production systems will continue to underpin the expansion of aquaculture into the 21st century and beyond.

La croissance de l'aquaculture va se poursuivre mais les contraintes environnementales risquent d'interagir avec les mutations des profils des consommateurs et avec l'évolution des cadres réglementaires, de sorte que cette croissance empruntera à l'avenir des voies bien différentes de celles tracées au cours des 30 dernières années. Les principaux obstacles à la croissance concernent la disponibilité et le prix des terres, de l'eau douce, des aliments pour animaux et de l'énergie, les problèmes en lien avec la pollution et l'introduction d'espèces non natives. L'évolution des nouvelles technologies devrait apporter une réponse à ces préoccupations. Ces nouvelles technologies reposeront sur le principe d'une intensification durable de la production afin de réduire l'empreinte écologique par unité de production et de limiter la volatilité accélérée des marchés induite par les maladies ou par d'autres problèmes affectant les systèmes de production. Les exigences des marchés et des consommateurs se répercuteront dans la stratégie économique du secteur en vertu de dispositifs réglementaires plus sophistiqués. Grâce au recours à des sources plus durables de protéines et d'huiles pour l'alimentation des poissons, à une meilleure gestion des ressources génétiques et à des systèmes sanitaires et de production plus performants, l'expansion de l'aquaculture devrait se poursuivre tout au long du xxie siècle et au-delà.

Aunque en el futuro la acuicultura seguirá creciendo, las limitaciones ambientales interactuarán del tal modo con la evolución de las modalidades de consumo y los ordenamientos reglamentarios que este crecimiento se apartará en cierta medida de las trayectorias observadas en los últimos 30 años. La disponibilidad y el precio de terrenos, agua dulce, piensos y energía, junto con las inquietudes por la contaminación y la introducción de especies no autóctonas, limitarán considerablemente la expansión. En respuesta a esas inquietudes surgirá una nueva tecnología basada en el principio de la intensificación sostenible, que servirá para reducir la «huella¼ ecológica por unidad de producción y para poner coto a la volatilidad de los mercados causada por enfermedades u otros problemas del sistema productivo. La demanda de mercados y consumidores incidirá en la economía del sector en forma de ordenamientos reglamentarios más sofisticados. En los primeros compases del siglo XXI, y también más adelante, la expansión de la acuicultura seguirá reposando en el uso de fuentes más sostenibles de proteínas y aceites para alimentar a los peces, en el perfeccionamiento de los procesos de selección genética y en sistemas productivos y sanitarios más eficaces.

[When the law supports the evolution of the profession]. / Quand la loi accompagne l'évolution de la profession.

The scope of practice for nurses has evolved significantly over the past four decades. It is striking to note that this development has been written almost exclusively in a single section of the law, the drafting of which has been completed over time. Knowing accelerations and slowdowns, however, it follows a general trend towards increasing recognition of the major role of nurses in the health system.

[Advanced practice nurse in the United Kingdom]. / Infirmière de pratique avancée au Royaume-Uni.

For twenty years, the author has worked as an advanced nurse practitioner in a large general practice in the north of England. In pioneering times for these new nursing roles, she completed her training at university and alongside her doctor colleagues. In this article she looks back at this highlight of her career and describes the deployment of this practice in the United Kingdom.

Strengthening good governance: exploiting synergies between the Performance of Veterinary Services Pathway and the International Health Regulations (2005).

The ability to minimise the harmful impact of biological threats relies on our capacity to rapidly detect unusual events, including the accidental or deliberate release of pathogenic or toxic agents, and immediately implement control measures. The development of this capacity for each country is the aim of the International Health Regulations (IHR) (2005), a legally binding document adopted by 196 States Parties, including all Member States of the World Health Organization (WHO). Each country's animal health sector contributes to the implementation of the IHR through surveillance, disease reporting and its response to zoonotic diseases, foodborne diseases and other events that emerge at the interface between human and animal health. The World Organisation for Animal Health (OIE) Performance of Veterinary Services (PVS) Pathway allows countries to undertake a comprehensive evaluation of their Veterinary Services and identify areas that need improvement. The OIE and WHO have conducted an in-depth analysis of the differences and synergies between the tools used by WHO to monitor the implementation of the IHR and the OIE PVS Pathway, revealing a wide range of similarities, complementarities and synergies. Taking advantage of the outcomes and outputs from the assessment and gap analysis tools used in the IHR Monitoring Framework and the OIE PVS Pathway, and exploiting the strength of these institutional frameworks, WHO and the OIE have jointly developed methods to facilitate communication between the animal health and human health sectors. This enhanced dialogue improves operational coordination and more efficiently informs policy-makers on strategic investments to strengthen their preparedness for controlling the spread of zoonotic diseases.

La faculté de minimiser l'impact néfaste des menaces biologiques dépend de la capacité des pays à détecter rapidement tout événement inhabituel, en particulier la dissémination accidentelle ou délibérée d'agents pathogènes ou toxiques, et à mettre en œuvre des mesures immédiates pour maîtriser ces événements. Le Règlement sanitaire international (RSI) (2005), un document juridiquement contraignant adopté par les 196 États parties, dont les États membres de l'Organisation mondiale de la santé (OMS) a précisément pour objectif de développer cette capacité dans chaque pays. Le secteur de la santé animale d'un pays participe à la mise en œuvre du RSI à travers une surveillance appropriée, la notification des maladies et l'adoption de mesures en cas de zoonoses, de maladies d'origine alimentaire et de tout autre événement émergeant à l'interface entre la santé humaine et la santé animale. Le Processus relatif aux performances des Services vétérinaires (Processus PVS) de l'Organisation mondiale de la santé animale (OIE) fournit aux pays la possibilité d'entreprendre une évaluation complète de leurs Services vétérinaires et d'identifier les domaines susceptibles d'être améliorés. L'OIE et l'OMS ont analysé de manière approfondie les différences et les synergies entre les outils utilisés par l'OMS pour vérifier la mise en œuvre du RSI, d'une part, et le Processus PVS de l'OIE, d'autre part, ce qui a mis en lumière de nombreuses similitudes, complémentarités et synergies. Sur la base des résultats et des données produites par les outils d'évaluation et d'analyse des écarts du Cadre de suivi du RSI et du Processus PVS de l'OIE, l'OMS et l'OIE ont exploité la puissance de ces cadres institutionnels pour mettre au point conjointement des méthodes visant à améliorer la communication entre les secteurs de la santé animale et de la santé humaine. Ce dialogue renforcé a pour effets d'améliorer la coordination opérationnelle et d'informer plus efficacement les décideurs politiques sur les investissements stratégiques permettant de mettre en place les conditions de préparation nécessaires pour lutter contre la propagation des zoonoses.

La aptitud de reducir al mínimo los efectos perjudiciales de las amenazas biológicas depende de nuestra capacidad para detectar con rapidez episodios inusuales, como la liberación accidental o deliberada de agentes patógenos o tóxicos, e instituir de inmediato medidas de control. El Reglamento Sanitario Internacional (RSI) (2005) es un documento jurídicamente vinculante aprobado por 196 Estados Partes, entre ellos todos los Estados Miembros de la Organización Mundial de la Salud (OMS), que precisamente tiene por objetivo dotar de esta capacidad a todos y cada uno de los países. El sector zoosanitario de cada país contribuye a la aplicación del RSI con actividades de vigilancia, notificación de enfermedades y respuesta ante enfermedades zoonóticas, enfermedades de transmisión alimentaria u otros episodios que puedan darse en la interfaz de la salud humana con la sanidad animal. El proceso de evaluación de las prestaciones de los Servicios Veterinarios (Proceso PVS) de la Organización Mundial de la Salud (OIE) sirve a los países para llevar a cabo una evaluación completa de sus Servicios Veterinarios y determinar aquellos ámbitos en que se requieran mejoras. La OIE y la OMS han analizado a fondo las diferencias y sinergias existentes entre las herramientas que utiliza la OMS para seguir de cerca la aplicación del RSI y el Proceso PVS de la OIE, labor que ha puesto de relieve un buen número de semejanzas, sinergias y aspectos complementarios de diversa índole. Partiendo de los resultados y productos que deparan las herramientas de evaluación y análisis de carencias utilizadas en el Marco de seguimiento del RSI y el Proceso PVS de la OIE, y aprovechando la solidez de estos marcos institucionales, la OMS y la OIE han definido conjuntamente métodos para facilitar la comunicación entre los sectores de la salud humana y la sanidad animal. La existencia de un diálogo más fluido se traduce en una mejor coordinación operativa y permite informar con más eficacia a los planificadores de las inversiones estratégicas necesarias para reforzar las medidas de preparación destinadas a controlar la propagación de enfermedades zoonóticas.

The World Organisation for Animal Health and the World Health Organization: intergovernmental disease information and reporting systems and their role in early warning.

Only two international organisations have a global legal framework that allows them to request, collect, and release global animal or human health information: the World Organisation for Animal Health (OIE), which is responsible for transparently assessing the global animal health situation, and the World Health Organization (WHO), which is responsible for transparently assessing the global human health situation. Legal instruments bind OIE Member Countries and WHO States Parties (OIE's Standards and WHO's International Health Regulations [IHR]) to report certain disease outbreaks and public health events to their respective organisations. OIE Member Countries must report exceptional epidemiological events involving any OIE-listed diseases, including zoonoses. Moreover, they must notify the OIE of any emerging animal diseases. The IHR require WHO Member States to provide notification of events that may constitute a public health emergency of international concern. These include, but are not restricted to, outbreaks of communicable diseases of international concern. In both organisations, in addition to reporting outbreaks and exceptional events, Members also monitor diseases on an ongoing basis and provide regular reports. To complement these passive surveillance mechanisms, the OIE, WHO and the Food and Agriculture Organization of the United Nations track signals from informal sources of outbreaks of animal and zoonotic infectious diseases, thereby increasing the sensitivity of worldwide disease reporting. The formal information collected is disseminated to Members and the general public through various communication channels, so that countries can apply science-based measures to prevent further disease spread. Both the OIE and WHO reporting systems are supported by a range of coordinating activities to ensure the proper flow of information between national and international levels.

Deux organisations internationales seulement disposent d'un cadre juridique mondial permettant de demander, collecter et diffuser des informations sur la santé animale ou humaine dans le monde : il s'agit de l'Organisation mondiale de la santé animale (OIE), qui est chargée d'évaluer de manière transparente la situation zoosanitaire mondiale, et de l'Organisation mondiale de la santé (OMS), qui est chargée d'évaluer de manière transparente la situation de la santé humaine dans le monde. Ces deux organisations ont mis en place des instruments juridiques (les normes sanitaires de l'OIE et le Règlement sanitaire international [RSI] de l'OMS) qui imposent aux Pays membres de l'OIE et aux États parties au RSI de notifier tout événement sanitaire important à leurs organisations respectives. Les Pays Membres de l'OIE doivent notifier tout événement épidémiologique exceptionnel concernant les maladies de la liste de l'OIE, y compris les zoonoses. En outre, ils doivent notifier à l'OIE toute maladie animale émergente. Le RSI impose aux États membres de l'OMS de notifier tout événement pouvant constituer une urgence de santé publique de portée internationale. Cela couvre notamment les foyers de maladies transmissibles importantes au plan international. Outre le signalement des foyers et des événements exceptionnels, les Membres des deux organisations exercent également une surveillance de routine des maladies et communiquent des rapports réguliers. En complément de ces mécanismes de surveillance passive, l'OIE, l'OMS et l'Organisation des Nations Unies pour l'alimentation et l'agriculture (FAO) assurent le suivi de tout signalement provenant de sources non officielles concernant d'éventuels foyers de maladies animales infectieuses et zoonotiques, ce qui accroît la sensibilité du système de notification des maladies à l'échelle mondiale. Les informations recueillies par la voie officielle sont diffusées aux Pays membres et au grand public par divers canaux de communication afin que les pays puissent appliquer des mesures fondées sur la science et empêcher ainsi toute nouvelle propagation. Les systèmes de notification de l'OIE et de l'OMS s'appuient tous deux sur une série d'activités de coordination afin d'assurer la bonne circulation de l'information entre les niveaux national et international.

Solo dos organizaciones internacionales disponen de un mecanismo jurídico de alcance planetario que les permita solicitar, reunir y hacer pública información sanitaria o zoosanitaria de dimensión mundial: la Organización Mundial de Sanidad Animal (OIE), responsable de evaluar con transparencia la situación zoosanitaria del mundo; y la Organización Mundial de la Salud (OMS), que se encarga de evaluar con transparencia la situación mundial en materia de salud humana. Hay instrumentos jurídicos que obligan a los Países Miembros de la OIE y los Estados Miembros de la OMS a notificar a la organización correspondiente todo caso importante de enfermedad (las normas de la OIE, por un lado, y el Reglamento Sanitario Internacional de la OMS [RSI]), por el otro). Los Países Miembros de la OIE deben comunicar episodios epidemiológicos excepcionales en los que intervenga cualquiera de las enfermedades que figuran en la lista de la OIE, zoonosis inclusive. Además, deben notificar a la OIE la aparición de toda enfermedad animal emergente. El RSI obliga a los Estados Miembros de la OMS a notificar todo episodio que pueda constituir una emergencia de salud pública de importancia internacional, como pueden ser, por ejemplo, los brotes de enfermedades transmisibles de importancia internacional. Los Miembros de ambas organizaciones, además de comunicar brotes y episodios excepcionales, deben vigilar continuamente la presencia de enfermedades y presentar informes periódicos. Para complementar estos mecanismos de vigilancia pasiva, la OIE, la OMS y la Organización de las Naciones Unidas para la Alimentación y la Agricultura (FAO) siguen de cerca las señales procedentes de fuentes oficiosas que puedan indicar la presencia de brotes infecciosos de enfermedades animales o zoonóticas, con lo que acrecientan la sensibilidad del dispositivo mundial de notificación. La información oficial así obtenida transita por diversos canales de comunicación para llegar a los Países Miembros y el gran público, de forma que los países puedan adoptar medidas científicamente fundamentadas para evitar la ulterior propagación de los brotes. Los sistemas de notificación de la OIE y la OMS están respaldados por una serie de actividades de coordinación que aseguran la adecuada circulación de información entre los niveles nacional e internacional.

Chiropody/Podiatry: Interprovincial Differences in Profession Formation.

The regulation of foot health care professionals varies across provinces in Canada. In Ontario, the regulated health profession is chiropody. Chiropodists are foot specialists with a limited scope of practice. In contrast, British Columbia and five other provinces regulate podiatrists, who are highly trained foot physicians with an extensive scope of practice. This article explores the history of chiropody/podiatry in Ontario and British Columbia from the early 1900s through the 1980s in order to understand how professional development in this field took such divergent paths within Canada. In so doing, it not only sheds light on a health practice that has received little scholarly attention, but it also highlights the centrality of inter-professional conflict and state actors' agendas to professional regulatory outcomes.

[Complementary medicines in hospitals]. / Les médecines complémentaires à l'hôpital.

It has been a long road for complementary medicines from their use in secrecy just a few decades ago to the first University Congress for Complementary Medicines held in Nice in December 2015. Complementary medicines are now used in hospitals, have been granted a legal framework and recognised training. They are called for by patients.

Need for certification of household water treatment products: examples from Haiti.

OBJECTIVE: To evaluate four household water treatment (HWT) products currently seeking approval for distribution in Haiti, through the application of a recently-developed national HWT product certification process. METHODS: Four chemical treatment products were evaluated against the certification process validation stage by verifying international product certifications confirming treatment efficacy and reviewing laboratory efficacy data against WHO HWT microbiological performance targets; and against the approval stage by confirming product composition, evaluating treated water chemical content against national and international drinking water quality guidelines and reviewing packaging for dosing ability and usage directions in Creole. RESULTS: None of the four evaluated products fulfilled validation or approval stage requirements. None was certified by an international agency as efficacious for drinking water treatment, and none had data demonstrating its ability to meet WHO HWT performance targets. All product sample compositions differed from labelled composition by >20%, and no packaging included complete usage directions in Creole. CONCLUSIONS: Product manufacturers provided information that was inapplicable, did not demonstrate product efficacy, and was insufficient to ensure safe product use. Capacity building is needed with country regulatory agencies to objectively evaluate HWT products. Products should be internationally assessed against WHO performance targets and also locally approved, considering language, culture and usability, to ensure effective HWT.

[Can academic structures improve access to CAR-T cells?] / Les structures académiques peuvent-elles permettre une amélioration de l'accessibilité aux CAR-T cells ?

In France, hospital cell therapy units have not been authorised to routinely produce chimeric antigen receptor T lymphocytes (CAR-T cells), which would then be referred to as academic CAR-T cells. CAR-T cells are classified as advanced therapy medicinal products and correspond to genetically modified T lymphocytes ex vivo. The CAR-T cell production process is complex and requires scientific and technical expertise to meet the acceptance criteria of the pharmaceutical quality system. The most commonly used method for genetically modifying T lymphocytes is viral transduction (lentiviral or retroviral), which requires prior access to a batch of good manufacturing practice (GMP) grade viral vector. Because of its cost, this reagent is the main limiting factor for developing CAR-T cells. A CAR-T cell produced by an industrial company is expensive (around €350,000 per injection) and the time taken by the manufacturer to make it available to the clinician can vary from three to five weeks. By meeting the economic and ecological challenges, can academic structures improve access to CAR-T cells? In this article, we present the elements necessary for the feasibility of setting up CAR-T cell production in an academic structure.

[Seine-et-Marne's health subdirectorate at the heart of prevention]. / La sous-direction santé de Seine-et-Marne au cœur de la prévention.

The health service is closely linked to many entities within the fire and rescue service. This makes it possible to be a force for proposals on the implementation of measures for the safety of all but also on themes related to well-being at work. This facet is exciting with many human and technical interactions.

Economic burden of acute pesticide poisoning in South Korea.

OBJECTIVES: To investigate the magnitude and characteristics of the economic burden resulting from acute pesticide poisoning (APP) in South Korea. METHODS: The total costs of APP from a societal perspective were estimated by summing the direct medical and non-medical costs together with the indirect costs. Direct medical costs for patients assigned a disease code of pesticide poisoning were extracted from the Korean National Health Insurance Reimbursement Data. Direct non-medical costs were estimated using the average transportation and caregiving costs from the Korea Health Panel Survey. Indirect costs, incurred by pre-mature deaths and work loss, were obtained using 2009 Life Tables for Korea and other relevant literature. RESULTS: In 2009, a total of 11,453 patients were treated for APP and 1311 died, corresponding to an incidence of 23.1 per 100,000 population and a mortality rate of 2.6 per 100,000 population in South Korea. The total costs of APP were estimated at approximately US$ 150 million, 0.3% of the costs of total diseases. Costs due to pre-mature mortality accounted for 90.6% of the total costs, whereas the contribution of direct medical costs was relatively small. CONCLUSION: Costs from APP demonstrate a unique characteristic of a large proportion of the indirect costs originating from pre-mature mortality. This finding suggests policy implications for restrictions on lethal pesticides and safe storage to reduce fatality and cost due to APP.