Considerations for applying bioethics norms to a biopharmaceutical industry setting

Abstract

Background: 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.

Main text: 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.

Conclusion: 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.

Keywords: Bioethics norms; Biopharmaceutical industry; Context; Definition; Setting; Specification.

Fig. 1

Bioethics specialties. Biopharmaceutical bioethics utilizes ethics norms from the bioethics specialties of research ethics, clinical ethics and public health ethics, and specifies them for the biopharmaceutical industry context

Fig. 2

Patient categories. There are two patient categories that must be considered when assessing bioethical responsibilities of the biopharmaceutical industry—current and future patients. Within the category of current patients, there are two subcategories—those for which there is not a clinical trial and those for which there is a clinical trial. Within the latter category, there are four additional subcategories. Most biopharmaceutical bioethics deliberations require consideration of at least two or more categories or subcategories