The first stage of the human embryonic stem(ES) cell research debate revolved aroundfundamental questions, such as whether theresearch should be done at all, what types ofresearch may be done, who should do theresearch, and how the research should befunded. Now that some of these questions arebeing answered, we are beginning to see thenext stage of the debate: the battle forproperty rights relating to human ES cells. The reason why property rights will be a keyissue in this debate is simple and (...) easy tounderstand: it costs a great deal of money todo this research, to develop new products, andto implement therapies; and private companies,researchers, and health professionals requirereturns on investments and reimbursements forgoods and services. This paper considersarguments for and against property rightsrelating to ES cells defends the followingpoints: (1) It should be legal to buy and sellES cells and products. (2) It should be legalto patent ES cells, products, and relatedtechnologies. (3) It should not be legal tobuy, sell, or patent human embryos. (4) Patentson ES cells, products, and related technologiesshould not be excessively broad. (5) Patents onES cells, products, and related technologiesshould be granted only when applicants statedefinite, plausible uses for their inventions. (6) There should be a research exemption in EScell patenting to allow academic scientists toconduct research in regenerative medicine. (7)It may be appropriate to take steps to preventcompanies from using patents in ES cells,products, and related technologies only toblock competitors. (8) As the field ofregenerative medicine continues to develop,societies should revisit issues relating toproperty rights on a continuing basis in orderto develop policies and develop regulations tomaximize the social, medical, economic, andscientific benefits of ES cell research andproduct development. (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Developing and applying a framework for understanding the complexities of economic and legal considerations in two recent Supreme Court rulings was the focus of this research. Of especial concern was the protection of intellectual property in the pharmaceutical industry. Two cases from 2013 were selected: FTC v. Activis and Association for Molecular Pathology v. Myriad Genetics, Inc.. Part of the rationale for the selection was the importance of the Supreme Court rulings and the importance of the pharmaceutical sector. A qualitative (...) content analysis of the Court’s reported decision in each case was analyzed. Since ethical considerations may or may not be consistent with efficiency considerations of plaintiffs, defendants, or the courts, both efficiency and ethical arguments were included. Equally important to the understanding of the economic and ethical issues in the two above- mentioned cases was the development of a rationale for including and excluding a variety of ethical theories, ultimately influenced by Markkula Center For Applied Ethics Of Santa Clara University and Schumann :93–111, 2001). The refinement and use of a levels analysis approach portrays societal, organizational, and individual impacts, and allows for deeper understanding of litigated cases, irrespective of the country in which the litigation takes place :385–393, 2004; Foss et al., J Manag Stud 47:455–482, 2010). A rationale for this framework is the societal and organizational impacts on the myriad of stakeholders in the pharmaceutical sector. We suggest that this framework can be applied to other industries and other complex conflicts among stakeholders as well. (shrink)

Many people believe that the research-based pharmaceutical industry has a ‘special’ moral obligation to provide lifesaving medications to the needy, either free-ofcharge or at a reduced rate relative to the cost of manufacture. In this essay, I argue that we can explain the ubiquitous notion of a special moral obligation as an expression of emotionally charged intuitions involving sacred or protected values and an aversive response to betrayal in an asymmetric trust relationship. I then review the most common arguments used (...) to justify the claim that the pharmaceutical industry has a special moral obligation and show why these justifications fail. Taken together, these conclusions call into question the conventional ideologies that have traditionally animated the debate on whether the pharmaceutical industry has special duties of beneficence and distributive justice with respect to the impoverished in dire need of their products. (shrink)

There are individuals, including children, dying needlessly in poverty-stricken third world countries. Many of these deaths could be prevented if pharmaceutical companies provided the drugs needed to save their lives. Some believe that because pharmaceutical companies have the power to save lives, and because they can do so with little effort, they have a special obligation. I argue that there is no distinction, with respect to obligations and responsibilities, between pharmaceutical companies and other types of companies. As a result, to (...) hold pharmaceutical companies especially responsible for saving lives in third world countries is unjustified. (shrink)

Many people believe that the research-based pharmaceutical industry has a ‘special’ moral obligation to provide lifesaving medications to the needy, either free-of-charge or at a reduced rate relative to the cost of manufacture. In this essay, I argue that we can explain the ubiquitous notion of a special moral obligation as an expression of emotionally charged intuitions involving sacred or protected values and an aversive response to betrayal in an asymmetric trust relationship. I then review the most common arguments used (...) to justify the claim that the pharmaceutical industry has a special moral obligation and show why these justifications fail. Taken together, these conclusions call into question the conventional ideologies that have traditionally animated the debate on whether the pharmaceutical industry has special duties of beneficence and distributive justice with respect to the impoverished in dire need of their products. (shrink)

This seminal collection on the ethical issues associated with infectious disease is the first book to correct bioethics’ glaring neglect of this subject. Timely in view of public concern about SARS, AIDS, avian flu, bioterrorism and antibiotic resistance. Brings together new and classic papers by prominent figures. Tackles the ethical issues associated with issues such as quarantine, vaccination policy, pandemic planning, biodefense, wildlife disease and health care in developing countries.

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical (...) research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund. (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)

Direct-to-consumer advertising (DTCA) of prescription drugs has been a heavily contested issue over the past decade, touching on several issues of responsibility facing the pharmaceutical industry. Much research has been conducted on DTCA, but hardly any studies have discussed this topic from a corporate social responsibility (CSR) perspective. In this article, we use several elements of CSR, emphasising consumer autonomy and safety, to analyse differences in DTCA practices within two different policy contexts, the United States of America and the European (...) Union (EU). Doing so results in an alternative analysis of the struggle between proponents and opponents of DTCA from a CSR perspective, adding an alternative view on this debate. (shrink)

Primary care givers commonly interpret shortages of time with patients as placing them between a rock and a hard place in respect of their professional obligations to fairly distribute available healthcare resources (justice) and to offer a quality of attentive care appropriate to patients’ states of personal vulnerability (compassion). The author argues that this a false and highly misleading conceptualisation of the basic structure of the ethical dilemma raised by the rationing of time in clinical settings. Drawing on an analysis (...) of the Aristotelian virtue of nemesis, or “the sense of justice”, it is argued that, far from being a moral orientation distinct from justice, compassion is a justice response insofar as it is conceptualised as a rational, appropriate response to others’ adversity. The author then proceeds to point out that the perspective on justice and compassion as attributes of healthcare professionalism suggests a novel critical viewpoint on the ethics of managed forms of clinical rationing and the “scarcity paradigm” they engender: clinical conditions where primary care givers’ time is intentionally rendered a commodity in chronically short supply run a deficit of justice, because they fail to make adequate accommodations for the provision of the quality of care human beings deserve in situations of illness and injury, and when they are dying. (shrink)

With over 2 billion people lacking medicines for treatable diseases and 14 million people dying annually from infectious disease, there is undeniable need for increased access to medicines. There has been an increasing trend to benchmark the pharmaceutical industry on their corporate social responsibility (CSR) performance in access to medicines. Benchmarking creates a competitive inter-business environment and acts as incentive for improving CSR. This article investigates the corporate feedback discourses pharmaceutical companies make in response to criticisms from benchmarking reports. It (...) determines whether these responses are part of a healthy process in increasing access to medicines or a barrier to improvement. A qualitative analysis on the feedback the industry provided was performed, and the responses seen in these statements were grouped by analysing the language used, the ideas portrayed and atti- tudes of the companies. Increasing transparency through benchmarking is a powerful tool which reveals the industry’s shortfalls to the public, affects the decisions of socially responsible investors, and is a risk to their financial bottom line. This article demonstrates the importance of benchmarking and transparency in creating inter-business competition and the translation of these responses to actual access to medicine practices. (shrink)

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...) Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)

This paper uses John Rawls' theory of justice to defend the patent system against charges that it has an unfair effect on access to medications, from the perspective of national and international justice. The paper argues that the patent system is fair in a national context because it respects intellectual property rights and it benefits the least advantaged members of society by providing incentives for inventors, investors, and entrepreneurs. The paper also argues that the patent system is fair in an (...) international context, provided that developed nations take steps to help disease-stricken countries secure internal justice. Fairness in a national or international context also requires that the patent system should include emergency exceptions to deal with short-term inequities. (shrink)

ABSTRACTThis module examines ethical debates about the level of care that should be provided to human research participants. Particular attention is placed on the question of what should be considered an ethically acceptable control arm. You will also learn what relevant international and domestic regulatory documents say about standards of care.

This paper observes that a substantially large moral duty of dealing with the AIDS situation in Africa has been placed on the drug co.

The moral responsibility of pharmaceutical companies is often invoked when discussing the difficulties faced by developing countries regarding their access to medication. In this article, I wish to criticize one strategy of attributing responsibility to pharmaceuticals, according to which moral responsibility originates from the analogy between enterprise and individual moral agent. I will propose an alternative strategy linking responsibility to the functions of the enterprise using a distinction between the organizational and occupational functions of a pharmaceutical company. Despite its interest, (...) the mitigated success of this proposition will bring me to reconsider the overall relevance of attributing, in such a targeted manner, moral responsibility to pharmaceuticals. (shrink)