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Revue de livres. 书评
Christian Byk
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引用次数: 0
Recommandations aux auteurs. 给作者的建议
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引用次数: 0
Chapitre 1. Essais cliniques et bioéthique en Inde. 第 1 章:印度的临床试验与生物伦理。
Pub Date : 2024-01-01 DOI: 10.3917/jibes.343.0011
Philippe Frouté

Since the 1990s, the pharmaceutical industry has been a major contributor to the economic growth of India. India is the world’s largest vaccines producer, and it attracts foreign direct investors who are relocating production capacities and research activities to develop new drugs in India. India, however, suffers from a lack of trust due to repeated scandals over clinical trials. Some of these scandals have led to economic sanctions, such as the withdrawal of hundreds of generic drugs from consumption in Europe in 2015. These measures followed irregularities detected in clinical trials carried out on volunteers. While India has taken steps to reform the bioethical institutions responsible for the control of clinical trials, we show in this contribution that loopholes persist. Two periods can be distinguished. The first period, between the early 2000s and 2013, gathers a significant growth in the number of clinical trials with a growth in bioethical scandals. It led the Indian government, under pressure from the civil society and the Supreme Court, to take action to curb clinical trials and to reform bioethical institutions. The second period, from 2013 to 2021, is characterised by an increase in the number of clinical trials in a context of strengthening the efficiency of bioethical institutions. We show that the increase in clinical trials is mainly due to the implementation of the TRIPs agreements on generic drugs. This development put another pressure on national vigilance authorities which remain undersized with respect to the magnitude of the Indian clinical trials market. It also highlights again the structural frailties of the Indian Federal System.

自 20 世纪 90 年代以来,制药业一直是印度经济增长的主要贡献者。印度是世界上最大的疫苗生产国,吸引着外国直接投资者将生产能力和研究活动转移到印度开发新药。然而,由于临床试验丑闻不断,印度缺乏信任。其中一些丑闻导致了经济制裁,如2015年欧洲撤消了数百种仿制药的消费。这些措施是在对志愿者进行的临床试验中发现违规行为后采取的。虽然印度已采取措施改革负责控制临床试验的生物伦理机构,但我们在这篇论文中指出,漏洞依然存在。可以分为两个时期。第一个时期是 2000 年代初至 2013 年,临床试验数量大幅增长,生物伦理丑闻也随之增加。这促使印度政府在民间社会和最高法院的压力下采取行动,遏制临床试验并改革生物伦理机构。第二阶段(2013 年至 2021 年)的特点是,在加强生物伦理机构效率的背景下,临床试验的数量有所增加。我们的研究表明,临床试验数量的增加主要是由于《与贸易有关的知识产权协议》(TRIPs)中关于非专利药协议的实施。与印度临床试验市场的规模相比,国家警戒机构的规模仍然不足。这也再次凸显了印度联邦制度的结构性缺陷。
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引用次数: 0
Chapter 3. How agroecological science has been incorporated into agricultural law and policy. 第 3 章.如何将生态农业科学纳入农业法律和政策。
Pub Date : 2024-01-01 DOI: 10.3917/jibes.344.0041
Luc Bodiguel

Agroecology has become a trendy word in political and media discourse and the subject of international debates, but its meaning remains unclear. This article defines this experimental science and explains its substance, and then goes on to examine how and to what extent agricultural law has allowed it to enter the political arena. It explains why agricultural Frenc Law and UE agricuktural Policy struggles to offer a secure and comprehensive framework for agroecology whereas this multi-disciplinary, complex and systematic science is looking to the future and aims to protect future generations.

生态农业已成为政治和媒体话语中的时髦词汇和国际辩论的主题,但其含义仍不明确。本文对这一实验科学进行了定义并解释了其本质,然后探讨了农业法如何以及在多大程度上允许其进入政治舞台。文章解释了为什么法国农业法和欧盟农业政策难以为生态农业提供一个安全、全面的框架,而这门多学科、复杂、系统的科学却着眼于未来,旨在保护子孙后代。
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引用次数: 0
Centre de recherche de l’Académie militaire de Saint-Cyr Coëtquidan et la Croix-Rouge française, Les enjeux de l’autonomie des systèmes d’armes létaux, Pédone, Paris, 2022. Saint-Cyr Coëtquidan 军事学院研究中心和法国红十字会,《Les enjeux de l'autonomie des systèmes d'armes létaux》,Pédone,巴黎,2022 年。
Pub Date : 2024-01-01 DOI: 10.3917/jibes.343.0082
Christian Byk
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引用次数: 0
Chapitre 3. Inégalités dans le dépistage et la prévention du VIH/SIDA. 第 3 章:艾滋病毒/艾滋病筛查和预防中的不平等现象。
Pub Date : 2024-01-01 DOI: 10.3917/jibes.343.0047
Nonvignon Marius Kêdoté, Anne-Marie Duguet, Joseph Giovanni Agbahoungba, Flore A Gangbo

Despite progress in the detection and treatment of the Human Immunodeficiency Virus (HIV), major challenges remain in developing countries due to insufficient resources and infrastructure. The number of people living with HIV who do not know their serostatus has fallen worldwide. However, a number of existing obstacles stand in the way of better results. The socio-cultural context in Africa hampers knowledge and understanding of the disease, leading to stigmatizing attitudes, reluctance to undergo screening and poor access to treatment.Inequalities also exist within the countries of the North, as in the case of the French West Indies, which benefit from a policy to combat HIV/AIDS, with results that fall short of those in mainland France. For this reason, we have chosen to compare the situation in the West Indies with that in Benin, in the context of African culture.Our analysis takes stock of the issues and prospects linked to the accessibility and use of screening care in sub-Saharan Africa and the French Departments of America (DFA).In both cases, fear of the disease, stigmatization, fear of a positive HIV test result and fear of disclosing the test result limit preventive and treatment actions for an effective fight against HIV.In sub-Saharan Africa, women are more likely to accept a screening test than men. Certain populations, including adolescents and homosexuals, are in a vulnerable position. The comparison reveals similar attitudes and suggests actions or recommendations in both countries that have produced results.Innovative strategies and specific programs must be implemented to turn the tide in the fight against the HIV epidemic.

尽管在检测和治疗人类免疫缺陷病毒(HIV)方面取得了进展,但由于资源和基础设施不足,发展中国家仍面临重大挑战。全世界不知道自己血清状况的艾滋病毒感染者人数已经下降。然而,现有的一些障碍阻碍了取得更好的成果。非洲的社会文化背景阻碍了人们对艾滋病的认识和了解,导致了轻蔑的态度、不愿接受筛查和难以获得治疗。北方国家内部也存在不平等现象,例如法属西印度群岛,这些国家受益于防治艾滋病毒/艾滋病的政策,但结果却不如法国本土。在这两种情况下,对疾病的恐惧、污名化、对艾滋病毒检测结果呈阳性的恐惧以及对公开检测结果的恐惧,都限制了为有效防治艾滋病毒而采取的预防和治疗行动。某些人群,包括青少年和同性恋者,处于弱势地位。比较显示了两国类似的态度,并提出了已见成效的行动或建议。
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引用次数: 0
Chapitre 5. From individuals to social: The needs for a global ethics overview in pharmacogenomics. 第 5 章.从个人到社会:药物基因组学全球伦理概览的需求。
Pub Date : 2024-01-01 DOI: 10.3917/jibes.343.0085
Anastasia Constantin, Alfonsina Faya Robles, Emmanuelle Rial-Sebbag

As a part of personalized medicine, pharmacogenomics (PGx) allows practitioners to provide the right drug for a given patient, in accordance with the result of a genetic test. This practice raises many ethical issues that are discussed in the literature, sometimes within the larger context of personalized medicine. This article is based on a literature review that is original insofar as it is interdisciplinary and based on an approach that articulates individual and social rights. Here, we propose to reconsider some classic ethical issues, such as informed consent, incidental findings and data protection which are raised by genetic testing and also by PGx in the same or in a different way. We also analyse broader collective issues around racialization and health equality. Our purpose is to contribute in drawing links and parallels between individual rights and collective rights using a social approach. This analysis discusses these ethical issues in research and in clinical setting, understanding the treatment of the individual in his dual quality of patient and research participant.

作为个性化医疗的一部分,药物基因组学(PGx)允许医生根据基因检测结果为特定患者提供合适的药物。这种做法引发了许多伦理问题,文献中对此进行了讨论,有时是在个性化医疗的大背景下进行讨论。本文以文献综述为基础,具有独创性,因为它是跨学科的,并以阐明个人和社会权利的方法为基础。在此,我们建议重新考虑一些经典的伦理问题,如知情同意、偶然发现和数据保护,这些问题由基因检测和 PGx 以相同或不同的方式提出。我们还分析了围绕种族化和健康平等的更广泛的集体问题。我们的目的是采用社会方法,在个人权利和集体权利之间建立联系和平行关系。本分析讨论了研究和临床环境中的这些伦理问题,理解了个人作为病人和研究参与者的双重身份所受到的待遇。
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引用次数: 0
Chapitre 2. L’autonomisation des comités nationaux d’éthique de la recherche en Afrique : perspective historique et enjeux actuels. 第 2 章.增强非洲国家研究伦理委员会的能力:历史视角与当前问题。
Pub Date : 2024-01-01 DOI: 10.3917/jibes.343.0029
V Martin-Schmets, O Bah-Sow, M Boko, F Gangbo, C Giquel, E Ouattara, D Pathé, L Penali, V Pirard, A-L Morin

Since the 60s, and particularly after various scandals in the 90s, national research ethics committees in Africa have established themselves as key players in the field of international clinical research. Notably based on the principle of double ethical review, their existence has historically been aimed at preventing a form of ethical dumping, a temptation that still exists today on the part of some research promoters. While the international framework of “soft” law has favored their emergence and legitimacy, a legal and regulatory framework of “hard” law is also necessary at local level for each national research ethics committee, to ensure its proper functioning and the optimal fulfillment of its missions. The aim of this article is to analyze the similarities and differences between three national ethics committees in Africa, specifically the CNERS of Guinea, the CNERS of Benin and the CNESVS of Côte d’Ivoire, in terms of status, missions, legal or regulatory ground and, more generally, autonomy. This analysis will enable us, on the one hand, to take account of common logistical difficulties and, on the other, to go beyond differences in legal status and missions to define what enables this type of committee to fully exercise its role(s). Finally, this article proposes to model the various elements that contribute to the autonomy and resilience of a national research ethics committee, around a notion proposed on this occasion: the “circles of autonomy”.

自 20 世纪 60 年代以来,特别是在 90 年代的各种丑闻之后,非洲的国家研究伦理委员 会已成为国际临床研究领域的主要参与者。特别是在双重伦理审查原则的基础上,这些委员会的存在历来旨在防止某种形式的伦理倾销,而这种诱惑在今天对某些研究促进者来说依然存在。虽然国际软法框架有利于伦理委员会的出现和合法化,但在地方一级,每个国家的研究伦理委员会也需要一个硬法的法律和监管框架,以确保其正常运作并以最佳方式履行其使命。本文旨在分析非洲三个国家伦理委员会,特别是几内亚的 CNERS、贝宁的 CNERS 和 Côte d’Ivoire 的 CNESVS,在地位、使命、法律或监管依据以及更广泛的自主权方面的异同。这种分析一方面使我们能够考虑到后勤方面的共同困难,另一方面使我们能够超越法律地位和任务方面的差异,确定是什么使这类委员会能够充分发挥其作用。最后,本文建议围绕本次会议提出的一个概念:"自治圈"(“circle of autonomy”),对有助于国家研究伦理委员会自主性和复原力的各种因素进行建模。
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引用次数: 0
Revue de livres. 书评
Christian Byk
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引用次数: 0
J-F Delfraisy, C. Kirchner, Questions d’éthique au temps de la Covid-19, La Documentation française, Paris, 2023. J-F Delfraisy, C. Kirchner, Questions d'éthique au temps de la Covid-19, La Documentation française, Paris, 2023.
Pub Date : 2024-01-01 DOI: 10.3917/jibes.343.0082b
Christian Byk
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Journal international de bioethique et d'ethique des sciences
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