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Producing 'Human Elements Based Medical Technologies' in Biotech Companies: Some Ethical and Organisational Ingredients for Innovative Cooking

机译：在生物技术公司中生产“基于人元素的医疗技术”：创新烹饪的一些道德和组织因素

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This article is based on the findings of an EU-funded qualitative research project, entitled 'From GMP to GBP: Fostering good bioethics practices [GBP] among the European biotechnology industry', which seeks to improve the understanding of bioethical issues through the observation of the daily practices in European biotechnology companies and proposes a methodology approaching ethical issues. The comparative study was carried out in biotech companies in France, Italy, Sweden, Hungary and Belgium which develop a wide range of new technologies, all of them involving human materials or where human subjects participate (in clinical trials). Based on our findings in these local settings, we suggest that the notion of bioethics and the way its production is theorised need to be re-conceptualised. We argue that material practices and moral statements are intermingled in inextricable ways that render the formation of bioethical concerns fully dependent on the organisational landscape in which it is embedded. More precisely, the here presented co-production model of moral statements and organisational practices presents a set of common factors that influence how bioethical discourses are shaped, despite the heterogeneity of their epistemic cultures. For example, the procedural design of cell-based-products, the modes of collecting and storing biological specimen, the relationship between patients and companies and technological transfers to emerging countries are defining components that contribute to the shaping process of bioethical concerns. Thus, the path dependency of bioethical concerns relies on an already existing, specific infrastructure and existing relationships within and outside a company rather than on external judgement subsequently applied to its objects, or a collection of processes of reasoning coming from external institutions.
机译：本文基于欧盟资助的定性研究项目的发现，该项目名为“从GMP到GBP：在欧洲生物技术行业中培养良好的生物伦理规范[GBP]”，旨在通过观察对生物伦理​​问题的理解。欧洲生物技术公司的日常实践，并提出了解决道德问题的方法。这项比较研究是在法国，意大利，瑞典，匈牙利和比利时的生物技术公司中进行的，这些公司开发了各种各样的新技术，这些新技术都涉及人类材料或人类受试者参与的领域（临床试验）。根据我们在这些当地环境中的发现，我们建议对生物伦理​​学及其产生理论的方式进行重新概念化。我们认为，物质实践和道德陈述以不可分割的方式混杂在一起，使生物伦理问题的形成完全取决于其所嵌入的组织环境。更精确地讲，这里提出的道德陈述和组织实践的联合生产模型提出了一系列共同因素，这些共同因素影响了生物伦理话语的形成方式，尽管其认识文化的异质性。例如，基于细胞的产品的程序设计，生物标本的收集和存储方式，患者与公司之间的关系以及向新兴国家的技术转让等都是决定因素，这些因素有助于塑造生物伦理问题。因此，对生物伦理​​问题的路径依赖性取决于公司内部和外部已经存在的，特定的基础结构和现有的关系，而不是依赖于随后应用于其对象的外部判断或来自外部机构的推理过程的集合。

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