Van Campen Luann E, Poplazarova Tatjana, Therasse Donald G, Turik Michael
Ethics Matters, LLC, 5868 E. 71st Street, E-125, Indianapolis, IN, 46220, USA.
Eli Lilly and Company, Indianapolis, IN, USA.
BMC Med Ethics. 2021 Mar 25;22(1):31. doi: 10.1186/s12910-021-00600-y.
The biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.
Any institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context "specification" substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.
Understanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society.
生物制药行业处于生命科学、临床研究、临床护理、公共卫生和商业的交叉领域，带来了独特的运营和伦理挑战。这种情况值得进行专门的生物伦理考量，以补充法律合规和商业伦理方面的努力。然而，应用于生物制药行业背景下的生物伦理往往要么被解释得过于宽泛，要么过于狭隘，而很少对其适当范围进行审视。
任何具有科学或医疗使命的机构都应遵循生物伦理规范，以应对生物医学研究、临床护理提供或公共卫生项目实施过程中出现的伦理问题。可以合理假设，虽然生物伦理规范必须保持不变，但其应用将因特定背景的特征而有所不同。背景“具体化”从实质上完善了特定学科或背景下的伦理规范，是一项预期的、必要的且不断发展的伦理活动。为了使这项活动有意义，需要界定和认识生物伦理应用的范围以及背景中的相关背景因素。本文将生物制药生物伦理定义为：将生物伦理规范（概念、原则和规则）应用于生物制药医疗产品的研究、开发、供应、商业化和临床使用。本文对这一定义进行了评论，并提出了在将生物伦理规范应用于生物制药行业背景时需要考虑的五个背景因素：（1）双重使命；（2）及时且务实的指导；（3）资源管理；（4）多个利益相关者；（5）运营复杂性。
理解生物制药企业的范围以及生物制药行业背景的背景因素是应用生物伦理规范的基础。建立生物制药生物伦理的通用语言和方法将促进讨论的广度和深度以及后续实施，从而使患者、医疗系统和社会受益。
