There is no lack of criticisms frequently levelled against the international pharmaceutical industry (Big Pharma): excessive profits, dubious or even dishonest practices, exploiting the sick and selective use of research data. Neither is there a shortage of examples used to support such opinions. A recent book by Brody (Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry, 2008) provides a précis of the main areas of criticism, adopting a twofold strategy: (1) An assumption that the special nature and human need (...) for pharmaceutical medicines requires that such products should not be treated like other commodities and (2) A multilevel descriptive approach that facilitates an ethical analysis of relationships and practices. At the same time, Brody is fully aware of the nature of the fundamental dilemma: the apparent addiction to (and denial of) the widespread availability of gifts and financial support for conferences etc., but recognises that ‘Remove the industry and its products, and a considerable portion of scientific medicine’s power to help the patient vanishes’ (Brody 2008, p. 5). The paper explores some of the relevant issues, and argues that despite the identified shortcomings and a need for rigorous and perhaps enhanced regulation, and realistic price control, the commercially competitive pharmaceutical industry remains the best option for developing safer and more effective medicinal treatments. At the same time, adoption of a broader ethical basis for the industry’s activities, such as a triple bottom line policy, would register an important move in the right direction and go some way toward answering critics. (shrink)

Public discussions of ethical issues related to the biotechnology industry tend to treat “biotechnology” as a single, undifferentiated technology. Similarly, the pros and cons associated with this entire sector tend to get lumped together, such that individuals and groups often situate themselves as either “pro-” or “anti-” biotechnology as a whole. But different biotechnologies and their particular application context pose very different challenges for ethical corporate decision-making. Even within a single product category, different specialty products can pose strikingly different ethical (...) challenges. In this paper, we focus on the single over-arching category of “genetic testing” and compare tests for disease susceptibility and drug response. We highlight the diversity of ethical challenges – grouped under the broad categories of “truth in advertising” and “protecting intellectual property” – raised by the commercialization and marketing of these technologies. By examining social and technical differences between genetic tests, and the associated corporate ethics challenges posed by their commercialization, our intent is to contribute to the nascent business ethics literature examining issues raised by the development and marketing of genetic tests. (shrink)

Public discussions of ethical issues related to the biotechnology industry tend to treat "biotechnology" as a single, undifferentiated technology. Similarly, the pros and cons associated with this entire sector tend to get lumped together, such that individuals and groups often situate themselves as either "pro-" or "anti-" biotechnology as a whole. But different biotechnologies and their particular application context pose very different challenges for ethical corporate decision-making. Even within a single product category, different specialty products can pose strikingly different ethical (...) challenges. In this paper, we focus on the single over-arching category of "genetic testing" and compare tests for disease susceptibility and drug response. We highlight the diversity of ethical challenges - grouped under the broad categories of "truth in advertising" and "protecting intellectual property" - raised by the commercialization and marketing of these technologies. By examining social and technical differences between genetic tests, and the associated corporate ethics challenges posed by their commercialization, our intent is to contribute to the nascent business ethics literature examining issues raised by the development and marketing of genetic tests. (shrink)

This paper investigates the fundamental idea at stake in current bioeconomies such as Europe's Bio-Based Economy (BBE). We argue that basing an economy upon ecology is an ambivalent effort, causing confusion and inconsistencies, and that the dominant framing of the damaged biosphere as a market-failure in bioeconomies such as the BBE is problematic. To counter this dominant narrative, we present alternative conceptualisations of bio-economies and indicate which concepts are overlooked. We highlight the specific contradictions and discrepancies in the relation between (...) economy and ecology, and then work towards outlining a genuine and consistent conceptualisation of the BBE. The philosophical perspective of Emmanuel Levinas is employed to develop a more profound understanding of the tensions at stake; Levinas' work is compared with that of Nicholas Georgescu-Roegen's work on bioeconomics, and found to be of complementary value. Our hypothesis is that, rather than the impossible, absolute amalgamation of economy and ecology striven for today, a principal heterogeneity between humankind and nature must be acknowledged if a bioeconomy that truly operates within the carrying capacity of planet Earth is to be achieved. (shrink)

As the rapidly advancing possibilities of biotechnology have outstripped the adaptive capacity of current legal and ethical institutions, a vigorous debate has arisen that considers the boundaries of appropriate use of this technology, particularly when applied to humans. This article examines ethical concerns surrounding the development of markets in a particular form of human genetic engineering in which heterozygotes are fitter than both homozygotes, a condition known as heterozygous advantage. To begin, we present a generalized model of the condition, illuminated (...) by the application to sickle-cell anemia. Next, we propose a typology of related markets, some of which are currently functioning with available products and services, and others that are widely viewed as imminent. We suggest the manner in which perverse incentives may arise for firms that market genetic intervention in circumstances where heterozygous advantage is possible. Finally, we propose that this misalignment of incentives with social welfare has arisen from both ill-conceived market intervention where markets are capable of achieving efficient outcomes and the lack of market intervention where markets have failed. We offer specific legal and regulatory approaches for reform. (shrink)

As the rapidly advancing possibilities of biotechnology have outstripped the adaptive capacity of current legal and ethical institutions, a vigorous debate has arisen that considers the boundaries of appropriate use of this technology, particularly when applied to humans. This article examines ethical concerns surrounding the development of markets in a particular form of human genetic engineering in which heterozygotes are fitter than both homozygotes, a condition known as heterozygous advantage. To begin, we present a generalized model of the condition, illuminated (...) by the application to sickle-cell anemia. Next, we propose a typology of related markets, some of which are currently functioning with available products and services, and others that are widely viewed as imminent. We suggest the manner in which perverse incentives may arise for firms that market genetic intervention in circumstances where heterozygous advantage is possible. Finally, we propose that this misalignment of incentives with social welfare has arisen from both ill-conceived market intervention where markets are capable of achieving efficient outcomes and the lack of market intervention where markets have failed. We offer specific legal and regulatory approaches for reform. (shrink)

In public health, the issue of pharmaceutical pricing is a perennial problem. Recent high-profile examples, such as the September 2015 debacle involving Martin Shkreli and Turing Pharmaceuticals, are indicative of larger, systemic difficulties that plague the pharmaceutical industry in regards to drug pricing and the impact it yields on their reputation in the eyes of the public. For public health ethics, the issue of pharmaceutical pricing is rather crucial. Simply, individuals within a population require pharmaceuticals for disease prevention and management. (...) In order to be effective, these pharmaceuticals must be accessibly priced. This analysis will explore the notion of corporate social responsibility in regards to pharmaceutical pricing with an aim of restoring a positive reputation upon the pharmaceutical industry in the public eye. The analysis will utilize the 2005 United Nations Educational, Scientific, and Cultural Organization’s Universal Declaration on Bioethics and Human Rights to establish implications regarding the societal responsibilities of pharmaceutical companies in a global context. To accomplish this, Article 14 of the UDBHR—social responsibility and health—will be articulated in order to advocate a viewpoint of socially responsible capitalism in which pharmaceutical companies continue as profit-making ventures, yet establish moral concern for the welfare of all their stakeholders, including the healthcare consumer. (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)