This article argues that effective corporate social responsibility (CSR) of multinational pharmaceutical companies in developing countries should reflect context, opportunity, proximity, time and impact in accordance with the social integration and ethical approaches to CSR. It proposes a CSR model expressed as CSR=COPTI+SI+E, which acknowledges access-to-medicines as a matter in the global public domain, a public choice problem and a moral responsibility issue for multinational pharmaceutical companies. This model recognises the globalisation of the principle (...) of humanity in communities of place and communities of interest as highlighted by the Global Economic Ethic Manifesto 2009 as an integral part of the responsibilities of multinational pharmaceutical companies. The model reflects a global application of the concept of disadvantaged consumer already known to some national laws. The article suggests an access-to-medicines CSR framework for pharmaceutical companies which may include pricing, patents, testing and clinical trials, research and development, joint public private initiative and appropriate use of drugs. (shrink)

This chapter critically explores the extent to which pharmaceutical companies have a moral obligation to assist poor patients in least developed countries who currently have no or inadequate access to lifesaving medications. Focusing on the ongoing HIV/AIDS epidemic in LDCs, the first section of this essay begins with some background information of the disproportionate burden of HIV/AIDS in LDCs. The second section provides a brief overview of some of the salient arguments for holding multinational antiretroviral treatment manufacturers (...) as morally responsible for easing the disproportionate global disease burden. The third section explains that these arguments regarding pharmaceutical companies’ duty to assist are going too far on the one hand by downplaying other non-pharmacological contributors to the slow response, but are also not going far enough on the other hand in upholding reciprocity-based duties. As the international community and researchers battle the reemergence of Ebola in Africa, the fourth section explores how lessons from the HIV/AIDS situation can help to address what pharmaceutical companies may subsequently owe patients in this region and how the international community should respond to ongoing unequal disease burden. (shrink)

New and highly effective treatments against hepatitis C have come on the market in recent years. Their high cost has sparked vociferous debate concerning drug price control, the state’s responsibility towards infected populations and the power of multinational pharmaceutical companies. One possible way to understand these debates is to take into account the particular effects of pharmaceutical capitalism upon the circulation of commodities. Recent protests related to access to treatment identify circulation of medicines as an increasing (...) site of capital accumulation and conflicts. This article defines the notion of ‘logistic regimes’ and shows how such regimes are contested. It analyzes critical ways of engaging with contemporary pharmaceutical logistics, through variations on medical tourism, critiques of patenting and pricing practices, and organization of alternative supply routes. It further proposes to deepen the notion of diversion as a political concept describing specific forms of opposition to the management practices of logistical capitalism. (shrink)

At the end of the 1990s, Brazil was faced with a potentially explosive HIV/AIDS epidemic. Through an innovative and multifaceted campaign, and despite initial resistance from multinational pharmaceutical companies, the government of Brazil was able to negotiate price reductions for HIV medications and develop local production capacity, thereby averting a public health disaster. Using interview data and document analysis, the authors show that the exercise of corporate social responsibility can be viewed in practice as a dynamic negotiation (...) and an interaction between multiple actors. Action undertaken in terms of voluntary CSR alone may be insufficient. This finding highlights the importance of a strong role for national governments and international organizations to pressure companies to perform better. (shrink)

BackgroundIn Pakistan, drug promotion practices, ethical or unethical, have rarely been in the spotlight. We aimed to assess the perception and barriers of medical representatives (MRs) and doctors (MDs) regarding ethical promotion of pharmaceuticals in Pakistan.MethodsA cross sectional survey was conducted in seven major cities of Pakistan for 6-months period. Self-administered questionnaire was used for data collection. Logistic regression and five-point Likert scale scoring was used to estimate the perceptions and barriers.ResultsCompared to national companies (NCs), the medical representatives (MRs) (...) of multinational companies (MNCs) strongly believed that their companies follow World Health Organization (WHO) (OR; 5.31, p = 0.0005), International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (OR; 6.45, p = 0.0005) and national codes of ethics (OR; 5.84, p = 0.0005). MNCs trained their MRs (OR; 6.68, p = 0.0005), provide accurate and valid scientific data (OR; 4.01, p = 0.007) with adequate system of accountability and controls on product samples (OR; 1.96, p = 0.047), while, NCs sponsor social or entertainment activities, seminars and conferences, and all sort of facilitation in form of gifts of their choice and clinic renovation for medical doctors (MDs). MDs perceptions were similar to MRs mentioned above, yet strongly agreed that companies offer cash payments or equivalents to MDs. The MRs of NCs/mncs and MDs agreed/strongly agreed that no external accountability, profiteering, pressure on sale targets, job insecurity, condoning unethical promotion by high-ups’ and business promotion by junior MDs were the predominant barriers.ConclusionIn conclusion, MRs of MNCs and MDs believed that MNCs follow certain codes of ethics in the promotion of pharmaceuticals, while NCs tend to be more profit oriented and even condone unethical promotion. All stakeholders, MRs, MDs and companies, might pose certain barriers, intentionally or unintentionally, in ethical promotion. (shrink)

Sustainable development is often framed as a social issue to which corporations should pay attention because it offers both opportunities and challenges. Through the use of institutional theory and the resource-based view of the firm, we shed some light on why, more than 20 years after sustainable development was first introduced, we see neither the adoption of this business model as dominant nor its converse, that is the total abandonment of the model as unworkable and unprofitable. We focus on (...) class='Hi'>multinational corporations (MNCs) because they were among the organizations first called to take action. In order to illustrate the institutional pressures MNCs face and their strategic response to these pressures, we analysed four major oil and gas multinationals subject to similar sustainable development pressures – climate change, biodiversity, renewable energy development and social investment. We argue that normative and coercive isomorphism does not occur at the global level because sustainable development is largely a stakeholder-driven rather than a broad social pressure. That is, host country interpretation of sustainable development pressures varies across an MNC’s subsidiary network. Based on the analysis of the four major MNCs’ annual reports from 2000 to 2005, we argue that mimetic isomorphism may occur, but since it implies the use of complex and intangible resources, mimetic processes are slow, rare and discretionary. (shrink)

This article systematically reviews published studies of the association of pharmaceutical industry funding and clinical trial results, as well a few closely related studies. It reviews two earlier results, and surveys the recent literature. Results are clear: Pharmaceutical company sponsorship is strongly associated with results that favor the sponsors' interests.

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have (...) been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. (shrink)

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The (...) demand for pharmaceutical products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)

Many medicines currently available on the market are simply too expensive for millions around the world to afford. Many medicines available in the developing world are only available to a small percentage of the population due to economic inequities. The profit-seeking behavior of pharmaceutical companies exacerbates this problem. In most cases, the price reductions required to make drugs affordable to a broader class of people in the developing world are not offset by the resultant increase in sales volume. (...) Simply stated, in most of the developing world, it is more profitable to sell drugs to the very wealthy at high prices than it is to sell cheaper drugs to a greater number of people. As a result, medicines remain unaffordable for the vast majority of people in many parts of the world. While this might be an acceptable outcome for certain commodities, such as luxury goods, it is completely unacceptable for life-saving medicines. Therefore, in order to effectively address the global lack of access to medicines, the role pharmaceutical companies play in the international intellectual property regime must be critically examined. (shrink)

Approximately two billion people lack access to medicines globally. People living with HIV, cancer patients, those suffering from tuberculosis or malaria, and other populations in desperate need of life-saving medicines are increasingly unable to access existing preventative, curative, and life-prolonging treatments. In many cases, treatment may be unavailable or inaccessible for even some of the most common and readily treatable health concerns, such as hypertension. In the developing world, many of the factors that contribute to making the world’s most vulnerable (...) and marginalized populations particularly susceptible to illness also operate to restrict their access to medicines. As a result of dramatic economic inequities and widespread poverty, it is not profitable for most originator pharmaceutical companies to develop new medicines for sale in developing markets or to lower the cost of existing drugs so that they are affordable for the majority of these populations. (shrink)

The objective of the paper is to analyze whether that the pharmaceutical companies producing HIV drugs have moral obligation(s) towards the HIV victims in developing countries who don‟t have access to get drug to reduce their risks. The primary assessment is that the pharmaceutical companies have minimum moral obligation(s) to the HIV patients especially in developing countries. It is because they are human beings and hence they are the subject of moral considerations. The paper argues that (...) from the sense of benevolence, there may be an obligation that will tend pharmaceutical companies to make an opportunity of the concerned HIV patients of developing countries to get drugs. The discussion will be made from the utilitarian point of view. Though it is assumed that, utilitarianism is too demanding, I will show that the too demanding ness of utilitarianism can be minimized and it will not be contradictory with the main theme of utilitarian morality. In this respect the counter examples and arguments will also be analyzed to make the claim stronger. The paper also argues that though the primary aim of the pharmaceutical companies is to make money, the actions that might be taken by the pharmaceutical companies for the welfare of HIV victims will not hamper them in making money for which they are deployed. (shrink)

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These (...) principles require us to look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research. (shrink)

A much‐debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics “pharmascolds.” Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these (...) questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high‐income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. (shrink)

. Undoubtedly, multinational corporations must play a significant role in the advancement of global ecological ethics. Our research offers a glimpse into the process of how goals of ecological sustainability in one multinational corporation can trickle down through the organization via the sustainability support behaviors of supervisors. We asked the question “How do supervisors in a multinational corporation internalize their corporation’s commitment to ecological sustainability and, in turn, behave in ways that convey this commitment to their subordinates?” (...) In response, we created a theoretical framework for supervisor sustainability support behavior based on Stern et al., Human Ecology Review 6(2), 81-97 (1999) value-belief-norm (VBN) theory. We then tested our framework by performing a survey-based field study of supervisors in a multinational pharmaceutical company that has publicly professed a goal of ecological sustainability. (shrink)

All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including development, testing, and manufacturing; fair distribution; sustainability; and accountability. All parties' obligations should be coordinated and mutually (...) consistent. For instance, companies should not be obligated to provide host countries with additional booster shots at the expense of fulfilling bilateral contracts with countries in which there are surges. Finally, any satisfactory approach should include mechanisms for assurance that all parties are honouring their obligations. This assurance enables countries, pharmaceutical companies, global organisations, and others to verify compliance with the chosen approach and protect ethically compliant stakeholders from being unfairly exploited by unethical behaviour of others. (shrink)

Although access to medicines is a vital feature of the right to the highest attainable standard of health (“right to health”), almost two billion people lack access to essential medicines, leading to immense avoidable suffering. While the human rights responsibility to provide access to medicines lies mainly with States, pharmaceutical companies also have human rights responsibilities in relation to access to medicines. This article provides an introduction to these responsibilities. It briefly outlines the new UN Guiding Principles on (...) Business and Human Rights and places the human rights responsibilities of pharmaceutical companies in this context. The authors draw from the work of the first UN Special Rapporteur on the right to the highest attainable standard of health, in particular the Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines that he presented to the UN General Assembly in 2008, and his UN report on GlaxoSmithKline (GSK). While the Guiding Principles on Business and Human Rights are general human rights standards applicable to all business entities, the Human Rights Guidelines for Pharmaceutical Companies consider the specific human rights responsibilities of one sector (pharmaceutical companies) in relation to one area of activity (access to medicines). The article signals the human rights responsibilities of all pharmaceutical companies, with particular attention to patent-holding pharmaceutical companies. Adopting a right-to-health “lens,” the article discusses GSK and accountability. The authors argue that human rights should shape pharmaceutical companies' policies, and provide standards in relation to which pharmaceutical companies could, and should, be held accountable. They conclude that it is now crucial to devise independent, accessible, transparent, and effective mechanisms to monitor pharmaceutical companies and hold them publicly accountable for their human rights responsibilities. (shrink)

BackgroundPatient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research.The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.MethodsThis prospective, multicenter survey consisted (...) in the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research.Logistic regression was used to determine factors contributing to “trust” versus “distrust” group membership and willingness to participate in each category of research.ResultsOne thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study.48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female, inactive in the employment market, and not-knowing the name of one’s disease are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.ConclusionDistrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials. (shrink)

Most major pharmaceutical companies have corporate social responsibility policies that pledge their commitment to improving the health and quality of life of people around the world. Yet these same companies also have difficulty in ensuring that developing countries have access to affordable medications. In the late 1990s, Brazil engaged in a heated battle with large US-backed multinational pharmaceutical companies. Brazil was facing a growing HIV epidemic and was determined to provide treatment to those in (...) need. This required massive price reductions on HIV medications. Although met with resistance, Brazil’s campaign eventually resulted in the negotiation of significant price reductions. Our study examines how Brazil was able to secure these price concessions. We conclude that corporate social responsibility initiatives must be viewed as a dynamic interaction between multiple actors. Our study highlights the importance of governmental action, in both the national and international forums, to negotiate pro-actively with companies to ensure that CSR commitments are met. (shrink)

The Constitution of the World Health Organization affirms that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.” The Universal Declaration of Human Rights lays the foundations for the international framework for the right to health. This human right is now codified in numerous national constitutions, as well as legally binding international human rights treaties, such as the International Covenant on Economic, Social and Cultural Rights.Although medical care and access to (...) medicines are vital features of the right to health, almost two billion people lack access to essential medicines, leading to immense avoidable suffering. Improving access to essential medicines could save 10 million lives each year, four million of them in Africa and South-East Asia alone. Gross inequity is a shocking feature of the world pharmaceutical situation. (shrink)

Most major pharmaceutical companies have corporate social responsibility policies that pledge their commitment to improving the health and quality of life of people around the world. Yet these same companies also have difficulty in ensuring that developing countries have access to affordable medications. In the late 1990s, Brazil engaged in a heated battle with large US-backed multinational pharmaceutical companies. Brazil was facing a growing HIV epidemic and was determined to provide treatment to those in (...) need. This required massive price reductions on HIV medications. Although met with resistance, Brazil’s campaign eventually resulted in the negotiation of significant price reductions. Our study examines how Brazil was able to secure these price concessions. We conclude that corporate social responsibility initiatives must be viewed as a dynamic interaction between multiple actors. Our study highlights the importance of governmental action, in both the national and international forums, to negotiate pro-actively with companies to ensure that CSR commitments are met. (shrink)

In recent years, online direct-to-consumer pharmaceutical companies have been created as an alternative method for individuals to get prescription medications. While these companies have noble aims to provide easier, more cost-effective access to medication, the fact that these companies both issue prescriptions as well as distribute and ship medications creates multiple ethical concerns. This paper aims to explore two in particular. First, this model creates conflicts of interest for the physicians hired by these companies to (...) write prescriptions. Second, the lack of direct contact from physicians may be harmful to prospective patients. After analysing these issues, this paper argues that there ought to be further consideration for regulation and oversight for these companies. (shrink)

The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the (...) development of adequate ethical guidelines to protect human beings that participate in multinational research. In this respect, poor and low-income countries, which lack sustainable control and review systems to deal with the ethical and methodological challenges of complex studies conducted by researchers from affluent countries and funded by large multinational pharmaceutical companies, are particularly vulnerable. The aim of the present paper is to explore critically some of the actual and possible ethical pitfalls of globalisation of clinical research and propose mechanisms for turning transnational clinical research into a more cooperative and fairer enterprise. (shrink)

This study investigates how firms in the gambling industry manage their corporate social disclosures about controversial issues. We performed thematic content analysis of CSDs about responsible gambling, money laundering prevention and environmental protection in the annual reports and stand-alone CSR reports of four USA-based multinational gambling firms and their four Macao counterparts. This study draws on impression management theory, camouflage theory and corporate integrity theory to examine the gambling firms’ CSDs. We infer that the CSD strategies of gambling firms (...) in Macao and the USA did not serve as vehicles for reflexivity about social responsibility or social responsiveness. Instead, the firms camouflaged legitimacy gaps about sensitive topics by adopting assertive or defensive façades, disclaiming ethical responsibility, curtailing disclosure, or offering zero disclosure. Differences between CSD strategies according to topic, location, time, and reporting channel appear to reflect four factors: pressure to report, availability of good news, whether a firm was assuming ethical responsibility for addressing the topic, and the prospective readership. This study extends our understanding of the contextual and topic-specific factors affecting the quantity and character of CSDs by firms in a contested industry. (shrink)

A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study aimed to assess the association of socio-demographic variables with the attitudes of medical students towards pharmaceutical companies and their (...) incentives. (shrink)

To celebrate forty years of publication, we asked people new to bioethics to tell us what should be next on the docket. We received 195 essays. Here are four we especially like. Bioethics has, until now, focused mainly on those who directly influence human health. It worked to establish guidelines for doctors to follow when treating their patients, and it provided a backbone for ethical human research. Bioethics has done a lot of good, but it is time for the field (...) to branch out to things that affect human health in less obvious ways. Of the things that bioethics must turn its focus to, one of the most pressing issues is establishing a duty of care between pharmaceutical companies and the people they .. (shrink)

Financial ties between physicians and pharmaceutical companies are pervasive and controversial. However, little is known about how patients perceive such ties. This paper describes an experiment examining how a national sample of U.S. adults perceived a variety of financial relationships between physicians and drug companies. Each respondent read a single scenario about a hypothetical physician and his financial ties to the pharmaceutical industry; scenarios varied in terms of payment type of and amount. Respondents then evaluated the (...) physician on several dimensions . Findings revealed that perceptions of the physician were more strongly influenced by payment type than by payment amount. Specifically, respondents were quite critical of doctors who owned drug company stock or received industry payments for meals and lodging, but were more forgiving of physicians who received free drug samples or consulting fees . Interestingly, physicians who received no payments, while seen as honest, were also viewed by some respondents as inexperienced or uninformed about new treatments. Implications for public policy and future research are discussed. (shrink)

The advent of new antiretroviral medicines means that the effects of HIV can now be curbed, but only one in twenty infected people have so far benefited. For those living in developing countries, the new treatments are practically unattainable. Governments, UNAIDS and pharmaceutical companies recognise this only too well and have rethought established assumption in order to try and overcome the challenges posed by cost, inadequate health services and unreliable local supply of medicines.

In June 2017, Japanese and Korean authors published the results of the CREATE‐X trial in the New England Journal of Medicine (NEJM). After we identified their inadequate disclosures of Financial Conflict of Interests (FCOIs), the authors made a post‐publication correction of their FCOIs. The purpose of this study is to evaluate the accuracy of the post‐publication corrections by the Japanese authors of the CREATE‐X trial. All the Japanese authors of the CREATE‐X trial were included in the study. We determined the (...) payments received by these authors in 2016 using publicly available data published by 78 pharmaceutical companies based on the stipulated Japanese transparency guidelines. We retrieved the original and revised versions of the FCOI disclosures as published on the NEJM website, and compared the payments reported by the pharmaceutical companies and the original and revised FCOI disclosures of the authors. Of the 12 authors, nine received payments made by the drug manufacturer involved in the CREATE‐X trial. Of these nine, only three (33.3%) originally disclosed their relationships, and another three (33.3%) later disclosed such relationships in the post‐publication corrections. Similarly, of the 11 receiving at least one payment from other manufacturers of breast cancer products, none correctly disclosed the payments in the original or the revised disclosure. In the CREATE‐X trial, FCOIs with pharmaceutical companies were not properly disclosed by 11 of the 12 Japanese authors, even after the post‐publication corrections, which highlights the need to pay more attention to the accuracy of FCOI disclosures in academic publications. (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)

Pharmaceutical companies developed Covid-19 vaccines in record time. However, it soon became apparent that global access to the vaccines was inequitable. Through a qualitative inquiry as the pandemic unfolded (to mid-2021), we provide an in-depth analysis of why companies engaged with the Covid-19 Vaccines Global Access Facility (COVAX), identifying the internal (to the company) and external factors that facilitated or impeded engagement. While all producers of the World Health Organization (WHO)-approved vaccines engaged with COVAX, our analysis highlights (...) the differential levels of COVAX engagement and identifies contractual obligations, opportunities and company strategy, and reputational pressures as key explanatory factors. We discuss our empirical findings relative to the literature on political corporate social responsibility (PCSR). Accordingly, we question whether pharmaceutical companies lived up to their responsibilities as corporate citizens and conclude that they failed to fulfill the implied responsibility of combating inequitable vaccine distribution. We conclude with implications of our research for practice, in relation to the challenges of global access to Covid-19 vaccines and for access to medicines more generally. (shrink)

Financial relationships and business transactions between physicians and the health care industry are common. These relationships take a variety of forms, including payments to physicians in exchange for consulting services, reimbursement of physician travel expenses when attending medical device and pharmaceutical educational conferences, physician ownership in life science company stocks, and the provision of free drug samples. Such practices are not intrinsic to medical practice, but as the Institute of Medicine described in its 2009 report, these relationships have the (...) potential to produce positive collaborations that improve patient care and public health, and most physicians view it as “ethically proper to accept items ranging from drug samples to a lucrative consultantship.”However, financial relationships between physicians and pharmaceutical, medical device and biotechnology companies can also create negative influences on physician judgment that compromise patient care and jeopardize the public’s trust. (shrink)

Aim To ascertain the quantity and nature of gifts and items provided by the pharmaceutical industry in Australia to medical specialists and to consider whether these are appropriate in terms of justifiable ethical standards, empirical research and views expressed in the literature.

There is a strong association between reliance on the promotional activities of pharmaceutical companies and a generally less appropriate use of prescription drugs. Pharmaceutical companies direct some of their promotion towards health workers who do not have the authority to prescribe medicines, such as nurses in certain countries. The aim of this study was to determine the impact that exposure to the marketing methods of pharmaceutical companies has on judgments made by nursing students about (...) health worker—pharmaceutical company relationships. A cross-sectional survey was carried out with 442 nursing students in Istanbul, Turkey. The exposure of students to the marketing methods of pharmaceutical companies, whether it be indirectly through observation or directly by first-hand experience, increases the probability that students will adopt rationales that underlie affirmative judgments of health worker—pharmaceutical company relationships. Based on the pervasiveness and ability of drug promotion to influence the perceptions of students, it is imperative that attempts be made to reduce its negative impact. (shrink)

In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a (...) division between the “medical” (human) and “agricultural” (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention. (shrink)

Pharmaceutical industry funding has transformed much grassroots community activism on health into corporate-sponsored advocacy. This critical commentary outlines recent evidence about industry funding of patient advocacy groups, offers a commentary on the history of grassroots activism appearing in this issue of the journal, and calls for greater scrutiny of the impacts and ethics of such sponsorship.

Background Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conflict of interest (COI) disclosures in authors’ concurrent publications. Methods The investigative journalism organization, ProPublica, compiled the Dollars for Docs database of payments to individuals from publically available data from seven US pharmaceutical companies during (...) the period 2009 to 2010. We examined the cohort of 373 physicians in this database who each received USD $100,000 or more in the reporting period 2009 to 2010. Results These physicians received a total of $52,600,624 during this period (mean payment per physician $141,020). The predominant specialties were internal medicine and psychiatry. 147 of these physicians authored a total of 134 publications in the first quarter of 2011 and 77% (103) of these publications provided a COI disclosure. 69% of the 103 publications did not contain disclosures of the payment listed in the Dollars for Docs database. Conclusions With increased public reporting of industry payments to physicians, it is apparent that large sums are being paid for services such as consulting and peer education. In over two-thirds of publications where COI disclosures were provided, the disclosures by physician authors did not include industry payments that were documented in the Dollars for Docs database. (shrink)

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the (...) appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws. (shrink)

The Ebola epidemic that broke out inWest Africa West AfricaAfrica towards the end of 2013 had been brought under reasonable control by 2015. The epidemic had severely affected three countries. This case study is about a phase I/II clinical trial Phase I/II clinical trial of a candidate Ebola virus vaccine in 2015 in a sub-Saharan AfricanSub-Saharan Africa country which had not registered any cases of the Ebola virus disease. The study was designed as a randomized double-blinded trialRandomized double blinded trial. (...) It was sponsored and funded by one of the biggest Northern multinational pharmaceutical companiesPharmaceutical companies. The protocol received ethics clearance from the relevantNational Ethics Committee national ethics committeeEthics committee. The study was coordinated and managed at the local branch of a big Northern diagnostic laboratoryDiagnostic laboratory and a laboratory of a local regional hospital. The overall study was a multi-countryMulti-country, multi-siteMulti-site trial aimed at recruiting a total of 3,000 research participantsResearch participants across four or five sub-Saharan African countries. For this country, the recruitmentRecruitment sites were two big cities, each aiming to recruit 200 participants: adults at the first site and childrenChildren at the second. The target sampleSample size was almost achieved at the first site but, before the study commenced at the second site, some members of raised the alarm that the governmentGovernment was carelessly risking the health, safetySafety and lives of citizens in the cause of an unproven vaccine that could precipitate a public health disaster. The trial was immediately suspended. A commentary on this case, and on the importance of trustTrust, is provided by Katharine Browne and Doris Schroeder at the end of this chapter. It highlights differences between this case and a phase I Ebola vaccine trial in CanadaCanada in 2014. (shrink)

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)

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)