A dispute exists about whether bioethics should become a new discipline with its own methods, competency standards, duties, honored texts, and core curriculum. Unique expertise is a necessary condition for disciplines. Using the current literature, different views about the sort of expertise that might be unique to bioethicists are critically examined to determine if there is an expertise that might meet this requirement. Candidates include analyses of expertise based in "philosophical ethics," "casuistry," "atheoretical or situation ethics," "conventionalist relativism," "institutional guidance," (...) "regulatory guidance and compliance," "political advocacy," "functionalism," and "principlism." None succeed in identifying a unique area of expertise for successful bioethicists that could serve as a basis for making it a new discipline. Rather expertise in bioethics is rooted in many professions, disciplines and fields and best understood as a second-order discipline. (shrink)

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. (shrink)