The classification of ageing as a disease is fundamental to developing new pharmacological strategies that can target said phenomenon. The European Medicines Agency does not do this and maintains a questionable perspective based on the traditional naturalistic argument and the value-free ideal. An alternative is proposed which, inspired by consequentialism, is committed to considering ageing as a disease in European regulatory contexts as long as the ethical consequences are desirable. Within a realistic framework, I show that making this decision (...) would have moderate positive effects such as increased knowledge about antiageing pharmacology or potential greater chances of completing vital projects. Furthermore, we will see that the main arguments used by critics to show that the negative effects outweigh the positive ones are not sound. Therefore, I conclude that it would be beneficial for the European Medicines Agency to change its position on ageing. (shrink)

Based on anthropological fieldwork conducted in the Eastern Cape, the paper explores the interconnections between dreams (amathongo, amaphupha) and medicines (amayeza, imithi, amachiza) as aspects of the Xhosa diviner’s culture, knowledge and experience. Background information is provided in the introduction, inter alia, on the Xhosa patrilineal clan (isiduko), divination (imvumisa, evumiso) and religious and cultural change. The ability to dream, inter alia of the ancestors and medicines, is central to the diviner’s intuition and professional stock-in-trade, which are part (...) and parcel of a religious healing tradition. Examples of dreams involving the ancestors (iminyanya), diviners, clients and medicinal plants are presented and analysed in relation to relevant case material. The ritual significance of dreams is explored in some detail. The distinctions between diviner (igqirha lokuvumisa) and herbalist (ixhwele), and between medicines and charms (amakhubalo), receive attention in the section on medicines. The underlying purpose of traditional Xhosa religious ideology is discussed in the conclusion. (shrink)

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted (...) to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)

“I want my leadership to be judged by the impact of our work on the health of two populations: women and the people of Africa.” This is how Dr. Margaret Chan, the current Director-General of the World Health Organization , described her leadership mission. The reason behind this mission is evident. Women and girls constitute 70% of the world’s poor and 80% of the world’s refugees. Gender violence against women aged 15–44 is responsible for more deaths and disability than cancer, (...) malaria, traffic accidents, and war. An estimated 350,000 to 500,000 women still die in childbirth every year. The negative health implications of absolute poverty are worst in Sub-Saharan Africa and South Asia. Hence, Chan aims to have the biggest impact on the world’s poorest people. (shrink)

This article evaluates New Zealand’s Medicines Amendment Bill 2011. This Bill is currently before Parliament and will amend the Medicines Act 1981. On June 20, 2011, the Australian and New Zealand governments announced their decision to proceed with a joint scheme for the regulation of therapeutic products such as medicines, medical devices, and new medical interventions. Eventually, the joint arrangements will be administered by a single regulatory agency: the Australia New Zealand Therapeutic Products Agency. The medicines (...) regulations in Australia and New Zealand will be updated as part of this process. The Medicines Amendment Bill addresses some of the well-recognised deficiencies in the Medicines Act 1981. However, a comprehensive overhaul of the Act is not being undertaken. I argue that repealing and replacing the Medicines Act 1981 would be preferable and advisable, given the number of legal difficulties with the Act and, in particular, where it does not align with equivalent current international law. (shrink)

Dr Devi Sridhar, Department of Politics and International relations, University of Oxford, All Souls College, High St, OX1 4AL UK, Email: devi.sridhar{at}politics.ox.ac.uk ' + u + '@' + d + ' '//--> Abstract This paper discusses the politics of access to essential medicines and identifies ‘space’ in the current system where health concerns can be strengthened relative to trade. This issue is addressed from a global governance perspective focusing on the main actors who can have the greatest impact. These (...) include developing country coalitions and citizens in developed countries though participation in civil society organisations. These actors have combined forces to tackle this issue successfully, resulting in the 2001 Doha Declaration on Public Health. The collaboration has been so powerful due to the assistance of the media as well as the decision to compromise with pharmaceutical companies and their host countries. To improve access to essential medicines, six C's are needed: coalitions, civil society, citizenship, compromise, communication and collaboration. CiteULike Connotea Del.icio.us What's this? (shrink)

ABSTRACTThe quality of medicines is generally adequately assured by manufacturers and regulatory authorities for well-resourced settings, while the implementation of existing quality standards is challenged in many low- and middle-income countries. This situation of multiple pharmaceutical standards raises the question whether it could ever be ethically justified to compromise on the quality assurance of medicines depending on what individuals, communities, or societies can afford. In this paper, we contend that ethically, any unjustified exceptions to medicines’ quality assurance (...) represents a violation of the principles of beneficence and non-maleficence. Exceptions are only acceptable in exceptional and temporary circumstances, if based on a meaningful quality risk assessment, guided by a rigorous ethical framework built on the principles of independence, technical competence, transparency, and accountability. We also discuss how such exceptional and temporary circumstances should be defined/justified.... (shrink)

In over thirty lines of the Agamemnon I think I discern lurking in the apparatus of modern editions truths unnoticed by recent editors, and needing for the most part merely redivision, repunctuation, or reaccentuation to become recognizable. At a few points I offer alternative interpretations of readings that have been accepted by some at least among modern editors.

Professor Thomas Pogge, Professorial Fellow, Centre for Applied Philosophy, LPO Box 8260, Canberra. Tel.: +61 261255485; Email: tp6{at}columbia.edu ' + u + '@' + d + ' '//--> Abstract I would pay three million to go into space, says the banker to his attorney. — I wouldn't go if you paid me, the latter laughs, for me the French Riviera is quite exciting enough. Ah, I would pay a million for an extra year of life , the elderly tourist effusively (...) tells his lover. — We have never had even a hundred dollars , the Cambodian teenager replies, we are a large family. CiteULike Connotea Del.icio.us What's this? (shrink)

Transparency is a salutary value in our constitutional architecture. It has also been described as a necessary element in promoting accountability in the regulatory aspects of essential medicines. Despite its several incarnations, the Medicines and Related Substances Act (Medicines Act) retains a provision headed 'Preservation of secrecy' (section 34). This contributionseeks to evaluate section 34 in the context of transparency and ascertain whether it is in conflict with other legislation pertaining to the promotion of access to information (...) and, in particular, whether it is consistent with the Constitution of the Republic of South Africa. (shrink)

Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.

This paper deploys Laclau and Mouffe's discourse theory to examine the dispute over intellectual property protection and global HIV/aids medicines access. Over the 1980s and 1990s, major pharmaceutical companies and minority world governments successfully crafted a strong patent protection regime, institutionalized in the World Trade Organization's intellectual property rules. In the early 2000s, a transnational civil society campaign challenged this regime, positioning patents at the centre of a highly publicized dispute. This dispute has been retrospectively identified as a turning (...) point in medicines access discourse, with the 2001–2003 period dubbed the ‘golden window’ for expanded global HIV/aids medicines access. However, this ‘window’ has also been critiqued as an unsustainable aberration to a continuing hegemonic regime that prioritizes patent protection, to the detriment of equitable global medicines access. This paper draws on both political economy analyses and discourse theoretical concepts to examine the processes of rupture and suture in HIV/aids medicines access discourse. (shrink)

The global health crisis in non-communicable diseases (NCDs) reveals a deep global health inequity that lies at the heart of global justice concerns. Mirroring the HIV/AIDS epidemic, NCDs bring into stark relief once more the human consequences of trade policies that reinforce global inequities in treatment access. Recognising distributive justice issues in access to medicines for their populations, World Trade Organisation (WTO) members confirmed the primacy of access to medicines for all in trade and public health in the (...) landmark Doha Declaration on the TRIPS Agreement and Public Health of 2001. (shrink)

This article examines two spheres of global governance in which the World Health Organization (WHO) has sought to exercise international leadership — combating “counterfeit” medicines and illicit trade in tobacco products. Medicines and tobacco products lie at polar opposite ends of the health spectrum, and are regulated for vastly different reasons and through different tools and approaches. Nevertheless, attempts to govern counterfeit trade in each of these products raise a host of somewhat similar challenges, involving normative and operational (...) conflicts that cut across the crowded intersection of health protection and promotion, intellectual property protection, and activity to combat transnational organized crime. As negotiations of an illicit trade protocol to the WHO Framework Convention on Tobacco Control enter their final stages, lessons learned from counterfeit medicines governance need to be applied to ensure that the most appropriate governance arrangements are adopted. (shrink)

In her opening address to the 2011 session of the World Health Organization's governing body, the World Health Assembly, WHO's Director-General, Dr. Margaret Chan, noted that WHO's job was much more straightforward when it was dealing mainly with germs, hygiene, medicines, vaccines and sister sectors, like water supply and sanitation. Today, international public health governance is much more complex. It is not only about forging agreement around shared health problems, but also being concerned with health as an outcome of (...) global policies in areas such as trade, intellectual property, and human rights and, nationally, as an outcome of work in other sectors such as education, agriculture and the environment. Global health governance is increasingly fragmented, and WHO is not the only health game in town. (shrink)

In this paper, we provide an overview of how the outcomes of the Uruguay Round affected the application of pharmaceutical intellectual property rights globally. Second, we explain how specific pharmaceutical policy tools can help developing states mitigate the worst effects of the TRIPS Agreement. Third, we put forward solutions that could be implemented by the World Bank to help overcome the divide between creating private incentives for research and development of innovative medicines and ensuring access of the poor to (...) medicine. Fourth, we evaluate these solutions on the basis of utilitarian considerations and urge that equitable pricing is morally preferable to the other solutions. (shrink)

Radical changes are taking place in the United Kingdom in relation to the classification of, and access to, medicines. More and more medicines are being made available over the counter both in local pharmacies and in supermarkets. The provision of more open access to medicines may be hailed as a triumph for patient autonomy. This paper examines whether such a claim is real or illusory. It explores the ethical and legal implications of deregulating medicines. Do patients (...) benefit? What is the impact on pharmacists? Are the true beneficiaries of change largely the pharmaceutical industries? (shrink)

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)

Nicole Hassoun here makes a philosophical argument for health, and access to essential medicines, as essential human rights, and she proposes the Global Health Impact system as a way to ensure those rights. She reports how life-saving medicines are inaccessible and costly for the global poor, and that rather than focusing on treatments for critical, deadly global health problems, pharmaceutical companies instead invest in more profitable drugs. To address this problem, Hassoun's proposal will rate pharmaceutical companies based on (...) their medicines' impact on the improvement of global health, and will reward highly-rated medicines with a Global Health Impact label. (shrink)

Medicines regulators have generally adopted a scientistic view of medicines evaluation, which they present as an exercise that should—and indeed can—be purely “objective,” based only on knowledge produced through validated research protocols. The growing body of social science literature analyzing the regulation of medicines has questioned this pretense of objectivity and underlined the socio-political construction of evidence on the risks and benefits of medicines. But while the European Medicines Agency has become the dominant regulatory body (...) in Europe and a key player at world level, very few studies have investigated its actual practices. Based on interviews with European regulators, but also on direct observations of several meetings of the European Medicines Agency’s main expert committee, this article aims to analyze how regulatory knowledge is defined and then transformed into regulatory decisions. First, it describes the main characteristics of European medicines regulation and the historical definition of what can count as “objective” evidence on the safety and efficacy of medicines. Second, it demonstrates that experts use many different types of knowledge in building their opinions: the results of studies, but also knowledge about firms’ past and present strategies, about patients’ needs and future behavior, about the state of research and clinical practices, and about legal and policy-making issues. Third, it explains why, in spite of the various forms of knowledge involved, experts manage to produce consensual opinions on medicines and why these opinions are considered genuine decisions in the sector. (shrink)

Dying before one’s time has been a prominent theme in classic literature and poetry. Catherine Linton’s youthful death in Wuthering Heights leaves behind a bereft Heathcliff and generations of mourning readers. The author herself, Emily Brontë, died young from tuberculosis. John Keats’ Ode on Melancholy captures the transitory beauty of 19th century human lives too often ravished by early death. Keats also died of tuberculosis, aged 25. “The bloom, whose petals nipped before they blew, died on the promise of the (...) fruit” is how Percy Bysshe Shelley expressed his grief over Keats’ death. Emily Dickinson wrote So Has a Daisy Vanished, being driven into depression by the early loss of loved ones from typhoid and tuberculosis. (shrink)

In June 2020, Gilead agreed to provide the USA with 500 000 doses of remdesivir—an antiviral drug which at that time was percieved to show promise in reducing the recovery time for patients with COVID-19. This quantity represented Gilead’s then full production capacity for July and 90% of its capacity for August and September. Similar deals are evident around access to proposed vaccines for COVID-19, and such deals are only likely to increase. These attempts to secure preferential access to (...) class='Hi'>medicines and vaccines, so-called vaccine/treatment nationalism, jeopardise supplies of life-saving treatments and vaccines available elsewhere, and jeopardise global equitable distribution of such vaccines/treatments more generally. Much of the focus to date has been on States’ role in negotiating such deals. However, such developments also demonstrate the power patent holders have in controlling access to life-saving healthcare, determining who obtains access first and at what price. This article argues that the extent of control currently given to patent holders for COVID-19 must be questioned. This article demonstrates that patents have significant implications for healthcare acting as private governance tools over patented inventions. It is only by greater probing of patent holders’ role in delivering access to medicines, diagnostics and vaccines for COVID-19 that equitable global equitable access can be achieved. (shrink)

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. Attention to race can make a therapeutic difference, to the point of saving lives. On the other hand, racial distinctions have social meanings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically (...) fixed. I argue in this essay that we should start with a presumption against racial categories in medicine, but permit their use when it might prolong lives or meaningfully improve health. Use of racial categories should be understood as an interim step; follow-up inquiry into the factors that underlie race-correlated clinical differences is important both to improve the efficacy of clinical care and to prevent race in itself from being misunderstood as a biological determinant. If we pursue such inquiry with vigor, the pernicious effects of racial categories on public understanding can be managed. But perverse market and regulatory incentives create the danger that use of race will be “locked-in,” once drugs or other therapies are approved. These incentives should be revisited. (shrink)

In this paper, we provide an overview of how the outcomes of the Uruguay Round affected the application of pharmaceutical intellectual property rights globally. Second, we explain how specific pharmaceutical policy tools can help developing states mitigate the worst effects of the TRIPS Agreement. Third, we put forward solutions that could be implemented by the World Bank to help overcome the divide between creating private incentives for research and development of innovative medicines and ensuring access of the poor to (...) medicine. Fourth, we evaluate these solutions on the basis of utilitarian considerations and urge that equitable pricing is morally preferable to the other solutions. (shrink)

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow.

Today there is a growing wave of demands being placed upon the pharmaceutical industry to contribute to improved access to medicines for poor patients in the developing countries. 1 This article aims to contribute to the development of a systematic approach and broad consensus about shared benchmarks for good corporate practices in this area. A consensus corridor on what constitutes an appropriate portfolio of corporate responsibilities for access to medicines -especially under conditions of 'failing states' and 'market failure' (...) 2 – is not only in the interest of the world's poor, but also of corporations that want to contribute to the solution of one of the most significant social problems of our time. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with inadequate (...) experimental methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

This article explores the social frameworks guiding expert and nonexpert perspectives on medicines safety in the U.K. Scientific experts from the Committee on the Safety of Medicines and the Medicines Commission were interviewed, and three nonexpertgroups, including patients and health professionals, were studied by the administration of questionnaires and focused group discussions. The research examined to what extent these groups subscribed to technocratic or democratic approaches to medicines regula tion and how this might be related to (...) values toward technological risk. The results reveal that there is substantial divergence between expert and nonexpert perspectives on medicines regulation, and that this derives as much from value differences as from any informational deficits. However, there seems to be some scope for shared values between some experts and some nonexperts, especially as regards state secrecy. The article concludes by discussing how those values could be used to foster a new "social contract of expertise" in which scientists are more democratically accountable and patients take more responsibility in governing medical risks. (shrink)

This article analyses the conflicting professional ethical demands imposed on judges to, on the one hand, faithfully apply the existing law of the land and, on the other hand, do justice in the face of urgent global challenges such as ensuring an equal access to life-saving medicines. After establishing the precise nature of the professional ethical duties of judges (as opposed to those of lawyers) and noting the tensions they face when the duty of applying the law prevents them (...) from complying with the duty of delivering material justice in the domain of access to medicines, the article then analyses the way this issue plays out in Latin America, a región where judicially-mandated access to medicines has been common. The article concludes by arguing that the Latin American experience suggests that judges around the world should take seriously the need to find a balance between their duty of deference towards public health authorities in this domain (when this is mandated by legislation), and the duty to do justice to individuals who cannot afford live-saving medicines. (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)

The Pharmaceutical Benefits Scheme, operating in Australia under the National Health Act 1953, provides citizens equal access to subsidised pharmaceuticals. With ever-increasing costs of medicines and global financial pressure on all commodities, the sustainability of the PBS is of crucial importance on many social and political fronts. Direct-to-consumer advertising (DTCA) of prescription medicines is fast expanding, as pharmaceutical companies recognise and reinforce marketing potentials not only in healthcare professionals but also in consumers. DTCA is currently prohibited in Australia, (...) but pharmaceutical companies continuously lobby for the ban to be lifted. There is evidence that such marketing strategies influence consumer behaviour and concerns have been raised about whether DTCA could affect government expenditure on the PBS in Australia. This pharmacy-based study explored Australian consumer attitudes towards DTCA and whether consumer attitudes regarding DTCA differ based on socioeconomic status, measured in terms of income and education. Consumers from different socioeconomic areas in Sydney were asked to respond to a survey about an advertisement created specifically for the promotion of a mock prescription medicine. Their views about the intent, value and reliability of the advertisement were explored. The study found that consumers of lower socioeconomic status were more likely to perceive DTCA as a source of valuable and reliable medical information, and that they were more likely to request an advertised medication from their physician. If DTCA of prescription medicines was to be introduced in Australia, an increase in government expenditure on the PBS would be anticipated. Findings of this study also expose a deficit in respect for patients’ right to autonomy and informed consent which should be based on evidence-based, unbiased, information rather than advertisements. (shrink)

This study aimed to identify the antibiotic-relevant lessons from the controlled drug regimen for narcotics. Whereas several elements of the United Nations Single Convention on Narcotic Drugs could be advantageous for antibiotics, we doubt that an international legally binding agreement for controlling antibiotic consumption would be any more effective than implementing stewardship measures through national AMR plans.

The negotiations of the intergovernmental group known as the ‘IGWG’, undertaken by the Member States of the WHO, were the result of a deadlock in the World Health Assembly held in 2006 where the Member States of the WHO were unable to reach an agreement on what to do with the 60 recommendations in the report on ‘Public Health, Innovation and Intellectual Property Rights submitted to the Assembly in the same year by a group of experts designated by the Director (...) General of the WHO. The result of these negotiations was the ‘Global strategy and plan of action on public health, innovation and intellectual property’ which was approved by the World Health Assembly in 2008. The intention of the Global Strategy and Plan of Action (GSPOA) which was produced by the IGWG was to substantially reform the pharmaceuticals' research and development system in view of the findings that this system, whose purpose is to produce medicines for diseases which affect the greater part of the world population which lives in developing countries, had failed. The intellectual property rights imposed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the recent trade agreements could become one of the main obstacles to access to medicines. The GSPOA makes a critical analysis of this reality, and opens the door to searching for new solutions to this problem. (shrink)