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)

Just As it is, I believe, a legitimate philosophical enterprise to engage in a “rational reconstruction” of some term or concept in ordinary language, which will, although similar in many ways to the original concept, be a better concept than the original, in that it will, among other things, be free of ambiguities, vagueness and philosophically irrelevant associations of the parent concept, so there is, I believe, a similar enterprise in the history of philosophy. Here, it is legitimate to reconstruct (...) a philosopher's views about some matter the philosopher has written on in such a way as to defend it from certain criticisms so long as the reconstruction remains faithful to the main thrust of the views in question. In particular this is so when the philosopher is acknowledged to be a very great and influential one, and if the criticisms, were they correct, would be inconsistent with the philosopher's acknowledged greatness. The defence of the philosopher from such criticisms is even more legitimate if it can be shown that although the philosopher has written in places in a way that makes the criticism in question seem correct, he has written elsewhere in a way which makes the criticism seem mistaken. (shrink)

It has been customary among analytic philosophers not to think highly of, and even to denigrate Kierkegaard. Their view is exemplified by the late Henry Aiken who writes that that Kierkegaard ‘usually does not argue for his position: he merely presents it’. Or that, as according to Aiken, one ‘distinguished Oxford philosopher’ is reported to have remarked, ‘Kierkegaard is not one of those philosophers on whom you can sharpen your wits’. It seems to me on the contrary, that Kierkegaard does (...) indeed present arguments for his views. What follows is an example of this. (shrink)

It is, by now, a common-place, to point out that contemporary philosophy under the influence of Moore and Wittgenstein is concerned with language rather than with the ‘world’ There is, no doubt, a great deal of room to niggle at this rather broad characterization of recent philosophy, but anyone familiar with recent philosophical history in Britain and America will agree that such a generalization is as true as such generalizations can be. Thus, J. J. C. Smart points out that.