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Le concept de race : serpent de mer de la pratique médicale 种族概念:医疗实践汪洋中的一条蛇
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-09-11 DOI: 10.1016/j.meddro.2024.07.002
Dr Alexandre Geoffroy M.D.
The Medical modernism pattern, eagerly promoting the fairest, the most personalized care, exploits the field of ethnicity and raciality. If assuming the utmost adapted care, as close as possible to the expectations of the patient and as close as possible to the ethical imperatives of conscientious, dedicated care based on data acquired from science dominates, it comes up against the main principles of non-discrimination assessed by the Constitution.
现代医学模式热衷于推广最公平、最个性化的医疗服务,并利用了民族和种族问题。如果在科学数据的基础上,最大限度地根据病人的期望和道德要求提供尽职尽责的护理,那么这种护理就违背了《宪法》规定的不歧视的主要原则。
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引用次数: 0
Parcours de soins rénové, e-santé et maillage officinal : une réponse complexe à la pénurie de médecins 改革护理路径、电子健康和药房网络:应对医生短缺的复杂对策
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-09-11 DOI: 10.1016/j.meddro.2024.07.003
Marie-Catherine Concé Chemtob (Maître de conférences à l’UFR Santé, université Rouen Normandie)
The number of doctors in France today is far too low to meet the growing demand for patient care. An ageing population, a growing number of chronic pathologies and inequalities in access to care across the country are just some of the issues to be considered. By optimizing the care pathway, and promoting interdisciplinarity; by integrating digital health developments, such as shared medical records, new digital tools and telehealth; and by relying on the territorial network of pharmacies, banking on the dispensing pharmacist as a local public health player, France is seeking to make its healthcare system more efficient in the regions, thereby making up for the shortage of doctors.
如今,法国的医生数量远远不能满足日益增长的医疗需求。人口老龄化、慢性病日益增多、全国各地医疗服务不平等,这些都是需要考虑的问题。通过优化医疗路径,促进跨学科发展;通过整合数字医疗发展,如共享病历、新的数字工具和远程医疗;以及通过依靠地区药房网络,将配药药剂师作为当地公共卫生的参与者,法国正在努力提高地区医疗系统的效率,从而弥补医生短缺的问题。
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引用次数: 0
La loi du 10 mai 2024 contre les dérives sectaires : application dans le domaine de la santé : séparer le bon grain scientifique de l’ivraie charlatanesque 2024 年 5 月 10 日的反宗派反常现象法:在卫生领域的应用:从江湖骗子中分离出科学小麦
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-08-31 DOI: 10.1016/j.meddro.2024.08.001
Bruno Py (Professeur de droit privé et sciences criminelles)
To combat toxic health messages the new law criminalizes provocation to therapeutic abandonment but also a new behavior, the provocation to a dangerous treatment presented as salutary. It also creates a new case of exemption from professional secrecy by allowing the reporting of information relating to placement in a state of psychological subjection.
为了打击有毒的健康信息,新法将挑衅放弃治疗的行为定为刑事犯罪,但也将一种新的行 为,即挑衅以治疗为名的危险治疗的行为定为刑事犯罪。该法还规定了一种新的职业保密免责情形,允许报告与心理受控状态下的安置有关的信息。
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引用次数: 0
The quest for the Benjamin Button effect in Silicon Valley: Bioethical and ecological issues posed by the longevity and immortality industry 硅谷对本杰明-巴顿效应的追求:长寿和永生产业带来的生物伦理和生态问题
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-08-01 DOI: 10.1016/j.meddro.2024.05.001

The attainment of longevity and immortality, long a theme of fairy tales and myths, has now become a real-world quest. Scientists, innovators, and elite Silicon Valley entrepreneurs are engaged in an epic mission to transcend mortal limits and defeat death using innovative biomedical technologies. From cryonics and plasma infusion to genetic editing and mind uploading, the development of such technologies has been gaining momentum in recent years. Such biomedical advances in longevity and immortality, if successful, will have implications not only for individuals but also for society. Given their exponential growth as a target of commercial investment, it is crucial to address the potential bioethical and ecological issues these technologies pose within the ecosystem.

实现长寿和不朽,长期以来一直是童话和神话的主题,如今已成为现实世界的追求。科学家、创新者和硅谷的精英企业家们正在进行一项史诗般的任务,利用创新的生物医学技术超越人类的极限,战胜死亡。从低温冷冻、血浆灌注到基因编辑和意念上传,近年来这些技术的发展势头日益强劲。长寿和永生方面的生物医学进步如果取得成功,不仅会对个人产生影响,也会对社会产生影响。鉴于其作为商业投资目标的指数级增长,解决这些技术在生态系统中可能带来的生物伦理和生态问题至关重要。
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引用次数: 0
Les enjeux de la substitution des biosimilaires comparée à celle des génériques et des hybrides 用生物仿制药替代仿制药和混合药的挑战
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-08-01 DOI: 10.1016/j.meddro.2024.01.001

The market of biological drugs is constantly expending, increasing healthcare costs. Facing the expensive cost of the high cost of these drugs, biosimilar drugs have gradually emerged. They are “similar” to the originator drug but less expensive, as they do not have to bear patent and R&D costs. However, these treatments present a high risk of immunogenicity, and are subject to a strict marketing authorization. It also raises the question of their interchangeability, to ensure a high penetration rate. Nevertheless, the mechanism of permutation by the prescriber is well developed. Their substitution by the pharmacist continues to be debated. Legislative and regulatory developments have constantly fluctuated between authorizing substitution and rejecting it. The latest Social Security Financing Act 2024 of December 26th, 2023 should have marked a clear broadening of the conditions for substitution, but the legislator opted for an unambitious solution. These reversals demonstrate the tensions surrounding the issue of biosimilar substitution. On one hand, patients’ fears of any potential adverse effects needs to be acknowledge by healthcare professionals; on the other, the substantial economic stakes involved underline the need to speed up the process. The question of marketing and substituting biosimilar drugs is here addressed in a comparative approach with generic and hybrid drugs. Because biosimilars, like generics and hybrids, are a fantastic opportunity to save funds and reinvest in research, while maintaining the same therapeutic excellence.

生物药品市场不断扩大,医疗成本不断增加。面对高昂的成本,生物仿制药逐渐兴起。它们与原研药 "相似",但价格较低,因为无需承担专利和研发费用。然而,这些治疗方法具有很高的免疫原性风险,需要经过严格的市场授权。这也提出了它们的互换性问题,以确保高渗透率。尽管如此,开处方者的换药机制已得到很好的发展。药剂师对其替代性的争论仍在继续。立法和监管方面的发展一直在授权替代和拒绝替代之间徘徊。2023 年 12 月 26 日颁布的最新《2024 年社会保障融资法》本应明确扩大替代的条件,但立法者却选择了一个不雄心勃勃的解决方案。这些逆转表明了围绕生物仿制药替代问题的紧张关系。一方面,患者对任何潜在不良反应的担忧需要得到医疗专业人员的承认;另一方面,所涉及的巨大经济利益强调了加快这一进程的必要性。本文通过与仿制药和混合药的比较来探讨生物仿制药的营销和替代问题。因为生物仿制药与仿制药和混合药一样,都是节省资金和重新投资研究的绝佳机会,同时又能保持同样的卓越疗效。
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引用次数: 0
Fractures anciennes du scaphoïde. La difficile question de l’imputabilité 陈旧性肩胛骨骨折。难以归咎的问题
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-08-01 DOI: 10.1016/j.meddro.2024.02.002
Clotilde Rougé-Maillart (Professeur de médecine légale et droit de la santé, expert près la cour d’appel d’Angers) , Florence Mallard (Chirurgien de la main)

Scaphoid fractures are difficult fractures to diagnose. They are often revealed at a late stage, or even at a very early stage of pseudarthrosis. Pseudarthroses may be asymptomatic and the fracture will be revealed when a new, more recent trauma occurs. For the expert physician, the question of a previous condition or pathological predisposition must be posed. Using two clinical cases of an old scaphoid fracture revealed by a recent trauma, the authors propose to study clinical and radiological elements in order to analyze imputability and discuss a possible previous condition or pathological predisposition.

肩胛骨骨折很难诊断。它们往往在晚期,甚至在假关节的早期阶段才被发现。假关节可能没有任何症状,当发生新的、较近的创伤时,骨折才会显露出来。对于专业医生来说,必须提出以前的情况或病理倾向的问题。作者通过两例因近期创伤而显露的陈旧性肩胛骨骨折的临床病例,建议研究临床和放射学要素,以分析不可归责性,并讨论可能的既往症或病理倾向。
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引用次数: 0
À propos du diagnostic préimplantatoire des aneuploïdies (DPI-A). Les inconvénients de mots inappropriés et d’une réglementation inadaptée 非整倍体植入前诊断(PGD-A)。用词不当和规定不合适的弊端
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-07-26 DOI: 10.1016/j.meddro.2024.05.003
Pierre Jouannet
Finding biological markers to assess the ability of embryos to develop is a major objective of research being carried out to improve the results of in vitro fertilization (IVF). Among these markers, the chromosomal content of embryonic cells has been the subject of numerous studies to identify euploid embryos which will be transferred as a priority into the uterus. In France, a clinical research program funded by the Ministry of Health was undertaken to evaluate the benefit of this strategy when IVF is carried out in women aged 35 to 41. This program was interrupted because its authorization was canceled by a court on the grounds that the search for aneuploidy in the embryo is a preimplantation genetic diagnosis (PGD) and that this type of analysis is not provided for in the governing law. The law says in fact that a PGD can only be carried out if “has been previously and precisely identified, in one of the parents or one of their immediate ascendants in the case of a seriously disabling illness, with late revelation and prematurely endangering the vital prognosis”. But the chromosomal analysis provided for in the research protocol is not a diagnosis, it is a test which identifies the embryos most capable of developing. Like all other techniques with the same goal, this test is not the responsibility of the law but of the good practice guide. Studies seeking to improve the results of IVF for the benefit of couples who use it should not be prevented.
寻找评估胚胎发育能力的生物标记物是提高体外受精(IVF)效果的一项主要研究目标。在这些标志物中,胚胎细胞的染色体含量一直是众多研究的主题,目的是确定优先移植到子宫中的优倍体胚胎。在法国,卫生部资助了一项临床研究计划,以评估 35 至 41 岁女性在进行体外受精时采用这一策略的益处。这项计划被中断了,因为法院取消了对它的授权,理由是在胚胎中寻找非整倍体属于胚胎植入前遗传学诊断(PGD),而这种分析在相关法律中没有规定。事实上,法律规定,只有 "在父母一方或其直系尊亲属患有严重致残性疾病,并在晚期才显现出来,过早地危及重要预后的情况下,先前已被准确鉴定",才能进行胚胎植入前遗传学诊断(PGD)。但是,研究方案中规定的染色体分析并不是诊断,而是确定最有能力发育的胚胎的试验。与所有其他具有相同目标的技术一样,这种检测不是法律的责任,而是良好操作指南的责任。不应阻止为使用体外受精的夫妇的利益而改进体外受精结果的研究。
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引用次数: 0
Prescription et dispensation de médicaments en dehors des recommandations du dossier d’autorisation de mise sur le marché. Responsabilités des praticiens. L’exemple des fluoroquinolones 处方和配发非市场授权档案中推荐的药品。从业人员的责任。以氟喹诺酮类药物为例
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-07-19 DOI: 10.1016/j.meddro.2024.07.001
Valérie Siranyan (professeure de droit pharmaceutique et d’économie de la santé) , Mathieu Guerriaud (maître de conférences en droit pharmaceutique et de la santé, pharmacovigilance et iatrogénie)
Some complaints were filed in 2023 by several patients, victims of serious adverse effects related to treatment with fluoroquinolones. These procedures thus raise questions about the possible consequences of the choice to prescribe and dispense therapeutics outside the recommendations of the indications in the marketing authorization dossier and the health safety agencies. In terms of indemnity liability, prescribing and dispensing antibiotic therapy require to explain potentially serious adverse events such as tendinopathy or neuropsychic impairment, in the respect of law. In this case, the decision to undertake a therapy that is not completely proven or that presents significant health risks will involve to consider all available options, on the basis of clinical documentation validated and recognized by the entire scientific community.
2023 年,几名患者因使用氟喹诺酮类药物治疗导致严重不良反应而提出投诉。因此,这些程序提出了一些问题,即在市场授权档案和卫生安全机构建议的适应症之外选择处方和配发治疗药物可能产生的后果。在赔偿责任方面,处方和配发抗生素疗法需要依法解释潜在的严重不良事件,如肌腱病或神经精神损伤。在这种情况下,在决定采用一种尚未完全证实或具有重大健康风险的疗法时,需要根据经整个科学界验证和认可的临床文件,考虑所有可用的方案。
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引用次数: 0
La rigueur scientifique de l’approche expertale 专家方法的科学严谨性
IF 0.1 Q4 MEDICINE, LEGAL Pub Date : 2024-07-14 DOI: 10.1016/j.meddro.2024.06.001
Ridouan Hammouch Professeur Maître de Conférence - Docteur en Droit Privé , Yamna Fatmi Professeure universitaire - P.E.S.
Experts are crucial in legal disputes that involve technical matters beyond a judge's competence. Procedural requirements and the judge's assessment of an expert's conclusions provide control guarantees to ensure the reliability of scientific expertise. Experts are obligated to follow objective and rigorous investigation processes, with a professional duty to accuracy and logical approaches. This article examines how judges can control the scientific rigor of experts’ approaches.
在涉及超出法官权限的技术问题的法律纠纷中,专家至关重要。程序要求和法官对专家结论的评估为确保科学专业知识的可靠性提供了控制保障。专家有义务遵循客观、严谨的调查程序,对准确性和逻辑方法负有专业责任。本文探讨了法官如何控制专家方法的科学严谨性。
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引用次数: 0
Le médecin confronté à l’IA (Intelligence artificielle) : Éthique et responsabilité 医生面对 AI(人工智能):伦理与责任
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2024-06-01 DOI: 10.1016/j.meddro.2024.02.001
Cécile Manaouil , Sylvain Chamot , Pascal Petit

Artificial intelligence (AI) is developing at an impressive speed in the field of health. AI paves the way for new practices in diagnostic assistance, preventive medicine, individualized patient follow-up, support in choosing a therapy, assistance in interpreting the results of additional examinations, etc. Far from being a magic bullet, delegating tasks to AI raises many ethical questions relating in particular to the supervision of algorithms, equal access to innovation and the use of patient data. It is still difficult to predict whether AI will remain a “safety net” for the doctor or if it will supplant him. France and Europe have laid down the principle of “human guarantee” in the interpretation of diagnostic and therapeutic results, implying that the machine cannot act alone and enshrining the responsibility of the health professional. This article aims to understand how complex AI is to regulate legally at the risk of neglecting its secrecy, whether at the individual or collective level.

人工智能(AI)在医疗领域的发展速度令人印象深刻。人工智能为诊断辅助、预防医学、个性化患者随访、治疗选择支持、辅助解释其他检查结果等方面的新实践铺平了道路。将任务委托给人工智能远非灵丹妙药,但也会引发许多伦理问题,特别是与算法监督、平等参与创新和使用患者数据有关的问题。现在还很难预测,人工智能是继续为医生提供 "安全网",还是取代医生。法国和欧洲在解释诊断和治疗结果时规定了 "人的保证 "原则,这意味着机器不能单独行动,并规定了医疗专业人员的责任。本文旨在了解,无论是在个人层面还是在集体层面,人工智能在法律上的监管是多么复杂,同时又有可能忽视其保密性。
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引用次数: 0
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Medecine & Droit
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