Abstract
BackgroundThe 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.Main textAny 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.ConclusionUnderstanding 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.
Highlights
Any institution with a scientific or healthcare mission should engage bioethics norms to navigate ethi‐ cal issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs
Using Beauchamp and Childress’ perspective on ethics specification as a springboard, this paper presents a definition and scope for biopharmaceutical bioethics, and describes five bioethically relevant contextual factors that are generalizable to a biopharmaceutical industry setting
We propose that the scope of the biopharmaceutical enterprise and the distinct contextual factors of a biopharmaceutical industry setting necessitate focused bioethics consideration, and that an understanding of this setting is foundational for application of bioethics norms
Summary
Definition and scope of biopharmaceutical bioethics We define 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.”. The commercialization phase of a biopharmaceutical healthcare product involves post-approval activities; including product marketing, safety surveillance, expansion of approved uses (i.e., new indications), and commitments made to regulatory bodies or payers to conduct further studies of safety, efficacy, health outcomes or real-world evidence All of these activities can have issues that relate to the bioethics specialties of research, clinical or public health ethics. Clinical trial activity is prioritized, current clinical patients with verified medical needs can suffer Another illustration is that of early access to investigational biopharmaceutical healthcare products. The number of stakeholders with interests in this issue is extensive and highlights the need to delineate industry’s role and responsibility(s) to provide treatment outside of clinical trials [68] Both of these examples underscore an inherent strain between research and public health ethics and clinical ethics. It is our hope there will be continuing collaborative development of biopharmaceutical bioethics because of the definition and contextual scope and factors presented in this paper
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