Demands for access to experimental therapies are frequently framed in the language of rights. This article examines the justifiability of such demands in the specific context of surgical innovations, these being promising but non-validated and potentially risky departures from standard surgical practices. I argue that there is a right to access innovative surgery, drawing analogies with other generally accepted rights in medicine, such as the right not to be forcibly treated, to buy contraceptives, and to choose (...) to have an abortion, including a post-viability abortion where the mother's life or health is threatened by the pregnancy. I argue that we accept these rights because we believe that people are entitled to try to preserve their lives and health and to make choices of an important and intensely personal kind, and I suggest that a person's choice of medical treatment should be seen in the same light. However, since few rights are absolute, I also consider the circumstances in which it may be justifiable to limit the right to access innovative surgery. In discussing this question, I apply the human rights standard of proportionality, comparing the importance of the reasons for limiting the right with the severity of the invasion on liberty. (shrink)

On September 30–October 2, 2005, a group of individuals drawn from civil society organizations, governments, international agencies, and academic institutions came together in Montréal, Québec, Canada, for an international workshop entitled “Human Rights and Access to Essential Medicines: The Way Forward.” At the conclusion of the workshop, we drafted the “Montréal Statement on the Human Right to Essential Medicines.” This “Statement” is reprinted at the end of this comment, which offers some background on the problem addressed (...) at the workshop. (shrink)

Using the case of Ebola Virus Disease as an example, this paper shows why patients at high risk for death have a defensible moral claim to access unregistered medical interventions, without having to enrol in randomized placebo controlled trials.A number of jurisdictions permit and facilitate such access under emergency circumstances. One controversial question is whether patients should only be permitted access to UMI after trials investigating the interventions are fully recruited. It is argued that regulatory regimes should (...) not prioritise trial recruitment over patient access, even if this results in drug research and development delays.We describe how the moral duty to rescue impacts on others' duties to oblige patients seeking emergency access to unregistered medical interventions. The view that eligible patients are owed the provision of access to UMI regardless of their willingness to enrol in a randomised controlled trial is defended. (shrink)

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)

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 human right to health, insofar as it is widely recognized, is typically thought to include the right to fair access to adequate healthcare, but the operating conception of healthcare in this context has been under-defined. This lack of conceptual clarity has often led in practice to largely Western cultural assumptions about what validly constitutes “healthcare” and “medicine.” Ethnocentric and parochial assumptions ought to be avoided, lest they give justification to the accusation that universal human rights are (...) mere tools for Western imperial agendas. At the same time, a right to healthcare that is not also explicitly the right to effective healthcare rapidly loses meaning. This paper strives to provide an account of medicine with the flexibility to accommodate cultural difference in forms of practice, while also aiding in the articulation of a minimum for medical systems to meet the standards set out in a human right. (shrink)

Even in the Netherlands, where the practice of physician-assisted death (PAD) has been legalized for over 20 years, there is no such thing as a ‘right to die’. Especially patients with extraordinary requests, such as a wish for PAD based on psychiatric suffering, advanced dementia, or (a limited number of) multiple geriatric syndromes, encounter barriers in access to PAD. In this paper, we discuss whether these barriers can be justified in the context of the Dutch situation where PAD (...) is legally permitted for those who suffer unbearably and hopelessly as a result of medical conditions. Furthermore, we explore whether there are options to address some of the barriers or their consequences, both within the Dutch legal framework or by adjusting the legal framework, and whether these options are feasible. We conclude that although there are insufficient arguments to overrule the doctor’s freedom of conscience in the Netherlands, there are ways to address some of the barriers, mainly by offering support to doctors that would be willing to support a request. Moreover, we believe it is morally required to reduce or mitigate where possible the negative consequences of the barriers for patients, such as the long waiting time for those who suffer from psychiatric disorders, because it is unlikely the adjustments suggested to the system will ensure reasonable access for these patient groups. (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)

The failure of the Canadian pharmaceutical company Biolyse Pharma to obtain authorization under Canada’s Access to Medicines Regime to produce 15 million badly needed doses of a generic copy...

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)

ABSTRACTMedicines that are vital for the saving and preserving of life in conditions of public health emergency or endemic serious disease are known as essential medicines. In many developing world settings such medicines may be unavailable, or unaffordably expensive for the majority of those in need of them. Furthermore, for many serious diseases these essential medicines are protected by patents that permit the patent‐holder to operate a monopoly on their manufacture and supply, and to price these (...) class='Hi'>medicines well above marginal cost. Recent international legal doctrine has placed great stress on the need to globalise intellectual property rights protections, and on the rights of intellectual property rights holders to have their property rights enforced. Although international intellectual property rights law does permit compulsory licensing of protected inventions in the interests of public health, the use of this right by sovereign states has proved highly controversial. In this paper I give an argument in support of states’ sovereign right to expropriate private intellectual property in conditions of public health emergency. This argument turns on a social contract argument for the legitimacy of states. The argument shows, further, that under some circumstances states are not merely permitted compulsory to license inventions, but are actually obliged to do so, on pain of failure of their legitimacy as sovereign states. The argument draws freely on a loose interpretation of Thomas Hobbes's arguments in his Leviathan, and on an analogy between his state of War and the situation of public health disasters. (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)

In an article in this journal, Christopher Cowley argues that we have ‘misunderstood the special nature of medicine, and have misunderstood the motivations of the conscientious objectors’. We have not. It is Cowley who has misunderstood the role of personal values in the profession of medicine. We argue that there should be better protections for patients from doctors' personal values and there should be more severe restrictions on the right to conscientious objection, particularly in relation to assisted dying. We (...) argue that eligible patients could be guaranteed access to medical services that are subject to conscientious objections by: removing a right to conscientious objection; selecting candidates into relevant medical specialities or general practice who do not have objections; demonopolizing the provision of these services away from the medical profession. (shrink)

In this paper, I argue that disabled people have a right to assistive technology, but this right cannot be grounded simply in a broader right to health care or in a more comprehensive view like the capabilities approach to justice. Both of these options are plagued by issues that I refer to as the problem of constriction, where the theory does not justify enough of the AT that disabled people should have access to, and the problem (...) of overextension, where the theory cannot adequately identify an upper limit on the AT that people have a right to. As an alternative to these justificatory frameworks, I argue that disabled people are owed access to AT at the expense of nondisabled people as a matter of compensatory justice. That is, I defend the position that disabled people are owed AT as part of due compensation for the harms they experience from being disadvantaged by society’s dominant cooperative scheme and the violation of their right to equality of opportunity that such disadvantage entails. I also propose a method for identifying an upper limit to what this right to AT requires. In this way, I argue that compensatory justice avoids both the problem of constriction and the problem of overextension. (shrink)

As the authors of the Millennium Development Goals Gap Task Force have noted, access to medicines is a vital component of realizing the human right to health. Without reliable access to drugs, the highest attainable standard of health cannot be achieved.

Do terminally ill patients who have exhausted all other available, government-approved treatment options have a constitutional right to experimental treatment that may prolong their lives? On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, held “Yes.” The plaintiffs, Abigail Alliance for Better Access to Developmental Drugs and Washington Legal Foundation, sought to enjoin the (...) Food and Drug Administration from refusing to allow the sale of investigational new drugs that had not yet received FDA approval. The terminally ill plaintiffs contended that they quite literally could not wait that long for the drugs. With no other treatment options available, the plaintiffs urged the court to recognize a fundamental, constitutional right to take potentially life-saving or life-prolonging drugs, even though the treatment had not been fully tested through human trials for safety and effectiveness and could not be legally marketed to the public. (shrink)

In 2006, a WHO survey found evidence of a substantial increase in patient-led litigation against health authorities and funders over access to medicines around the world. New Zealanders have seldom litigated denials of access to health care. Part of the explanation lies in the fact that New Zealand has a legislated patients' "bill of rights", with enforcement through a complaints mechanism. Although the separate regime does not afford patients substantive legal protection in respect of complaints about lack (...) of access to care, this form of alternative, low-level resolution of health care disputes does condition disgruntled patients not to turn to the courts for legal redress in relation to their rights. But given the increasing need for prioritization arising from serious concern about the sustainability of the public health system, as well as a trend towards greater explicitness when it occurs, increased disappointment on behalf of patients and the public when care is denied or limited seems inevitable. This may well translate into increased patient-led litigation against health boards and funders. Part 1 provides an overview of the New Zealand health system, with a focus on the points at which resource allocation decisions are made, the identity of the decision-maker, and the methods by which priority-setting occurs. Part 1.1 describes inequalities between population groups in New Zealand, both in health outcomes and in access to health care. Part 2 describes the legal framework surrounding the health and disability sector, and discusses the lack of legislated rights to health and the limited right of access to health care in legislation, despite the existence of a legally enforceable Code of Health and Disability Services Consumers' Rights. (shrink)

Addresses the issues at the heart of international medicine and social responsibility. A number of international declarations have proclaimed that health care is a fundamental human right. But if we accept this broad commitment, how should we concretely define the state’s responsibility for the health of its citizens? Although there is growing debate over this issue, there are few books for general readers that provide engaging accounts of critical incidents, practices, and ideas in the field of human rights, health (...) care, and medicine. Included in the book are case studies of such issues as AIDS among orphans in Romania, organ trafficking, prison conditions, health care rationing, medical research in the third world, and South Africa’s constitutionally guaranteed right of access to health care. It uses these topics to address themes of protection of vulnerable populations, equity and fairness in delivering competent medical care, informed consent and the free flow of information, and state responsibility for ensuring physical, mental, and social well-being. (shrink)

Health care reform that includes universal coverage could lower a major barrier to care for people of color and ethnic minorities—the inability to pay for care. But universal coverage alone, even with comparable fee-for-service payment or appropriately risk-adjusted capitated reimbursement, will not eradicate the racial and ethnic inequities in health care delivery. Restrictive admissions practices, geographic inaccessibility, culture, racial stereotypes, and the failure to employ minority health care professionals will still create barriers to minority health care. In addition to universal (...) financing, health care reform should include new civil rights legislation to address and reduce these noneconomic barriers to minority health care. (shrink)

Is it possible to use the courts - or rights instruments - to advance fair access to health care? This article examines this question within the context of the Norwegian public health care system - one special example of the Scandinavian welfare system. In particular, it asks four basic questions: What are the normative justifications for rights to health care? What were the political processes and concerns leading up to the current Patients Rights Act in Norway? What kind of (...) legal status do these rights have? How can rights to access be implemented?Patient rights do not only concern the right to access to health care; they also include the right to information, the right to participate in decision-making, and informed consent. This article examines only the former aspect, the use of the legal system to secure access to prioritized specialized health care services. (shrink)

The expansion of the corpus of international human rights to include the right to water and sanitation has implications both for the process of recognizing human rights and for future developments in the relationships between technology, engineering and human rights. Concerns with threats to human rights resulting from developments in science and technology were expressed in the early days of the United Nations (UN), along with the recognition of the ambitious human right of everyone “to enjoy the benefits (...) of scientific progress and its applications.” This comment explores the hypothesis that the emerging concepts most likely to follow recognition of the human right to water primarily involve issues of science and technology, such as access to medicines or clean and healthy environment. Many threats to human rights from advances in science, which were identified in the past as potential, have become real today, such as invasion of privacy from electronic recording, deprivation of health and livelihood as a result of climate change, or control over individual autonomy through advances in genetics and neuroscience. This comment concludes by urging greater engagement of scientists and engineers, in partnership with human rights specialists, in translating normative pronouncements into defining policy and planning interventions. (shrink)

Not all intellectual property rights grant the right to exclude that is indicative of “property rules,” as that term was used by Guido Calabresi and A. Douglas Melamed in their seminal article. Some intellectual property rights are “liability rules,” in which the right holder has an entitlement to compensation for use of the protected invention, not a right to preclude the use. Although patent laws normally grant a right to exclude others from use of the protected (...) invention as a default, most countries’ laws allow the government to convert the patent property rule into a liability rule through a compulsory license. It has been noted, for example, that by the end of the 1950s, the U.S. had issued compulsory licenses covering 40 to 50 thousand patents, including substantial portions of the patent portfolios of AT&T, General Electric, IBM, and Xerox. The U.S. Supreme Court recently expressed a willingness to accept liability rules over injunctions in some patent infringement cases. (shrink)

Recent years have seen an increase in the turn to rights discourse within the context of access to health and specifically health care. Developments took place at both the national and global levels, with a significant increase in right to health litigation around the world1 and developments at the international level, such as the appointment of a Special Rapporteur on the Right to Health and the adoption of a “General Comment” on the topic by the UN Committee (...) on Economic, Social and Cultural Rights. (shrink)

We argue for the existence of a state constitutional legal right to language. Our purpose here is to develop a legal framework for protecting the civil rights of the deaf child, with the ultimate goal of calling for legislation that requires all levels of government to fund programs for deaf children and their families to learn a fully accessible language: a sign language. While our discussion regards the United States, the argument we make is based on human rights and (...) the nature of law itself, and can likely be adapted to any country.We begin with an introduction to the biological facts surrounding language acquisition and how these facts impact the deaf child, where lack of language has devastating effects on individuals and negative effects on society in general. (shrink)

The claim that individuals legitimately differ with respect to their values seems to be uncontroversial among bioethicists, yet many bioethicists nevertheless oppose right-to-try laws. This seems to be due in part to a failure to recognize that such laws are intended primarily to be political, not legal, instruments. The right-to-try movement seeks to build political support for increasing access to newly developed drugs outside of clinical trials. Opponents of right-to-try laws claim that increasing access outside (...) of clinical trials would undermine evidence-based medicine. They seek to maximize overall gains to patients by protecting them from adverse drug reactions and ensuring that drugs are more effective on average. In contrast, right-to-try activists have a point that regulatory judgments of drug safety and effectiveness impose one set of trade-offs on all individuals, regardless of their different values. That might be acceptable if determinations of safety and effectiveness were black and white, but that does not seem to be the case. This article argues that judgments of safety and effectiveness are in an important respect normative and reflect the perceived value of those ends relative to others. Such judgments, when universally imposed, harm patients who would readily make do with less knowledge of drug safety and effectiveness in exchange for more time and self-determination. The relevant moral principle is that of respect for individual autonomy. Just as that principle should lead one to substitute collective decisions for individual ones to regulate a natural monopoly, the same principle should lead one to substitute individual decisions for collective ones to avoid a government monopoly on access to newly developed drugs. It is argued that reforms should increase the number of treatment options available to patients outside of clinical trials. The final section of the article discusses ways in which current regulations might be reformed so as to provide more treatment options outside of clinical trials, without undermining evidence-based medicine. (shrink)

Do we have a legal and moral right to health care against others? There are international conventions and institutions that say emphatically yes, and they summarize this in the expression of “the right to health,” which is an established part of the international human rights canon. The International Covenant on Social and Economic Rights outlines this as “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” but declarations such as (...) this remain tragically unfulfilled. According to recent figures, roughly two billion people lack access to essential drugs or to primary health care. Millions are afflicted by infections and illnesses that are easily avoidable or treatable. In the developing world many children die or grow stunted and damaged for lack of available treatments. Tropical diseases receive little or no attention by the major pharmaceutical companies’ research departments. Is this a massive violation of the right to health? And if so, why does it attract so little attention? Is it because our supposed commitment to human rights and the rule of law is hypocritical and hollow? Or is it because the right to health is a special case of a right, so that these tragedies are no violation at all? Jennifer Prah Ruger summarized this puzzle when she wrote: “one would be hard pressed to find a more controversial or nebulous human right than the right to health.” In this essay I discuss three different theories of a right to health care. I conclude by offering my own reconstruction of one such theory. (shrink)

In Global Health Impact: Extending Access to Essential Medicines, Nicole Hassoun argues that the concept of a minimally good life grounds the human right to health, which in turn implies the human right to access essential medicines in developing countries. This article argues that Hassoun's argument must be revised. If the temporal unit of a minimally good life is identified, her argument faces a substantive problem, which undermines an important part of her argument. This (...) article then proposes a solution to this problem. If this proposed solution is accepted, Hassoun's project turns out to be more radical than her argument is supposed to be. (shrink)

Should people have a legal human right to health? And, if so, what exactly does protecting this right require? This essay defends some answers to these questions recently articulated in Global Health Impact. It explains how these answers depend on a particular way of thinking about health and the minimally good life, how quality of life matters at and over time, what various agents should do to help people who are unable to live well enough, and many other (...) things. Moreover, it suggests some ways of improving common metrics for measuring and advancing our collective global health impact. (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.

“Intervention” is not synonymous with “care.” For an intervention to constitute care—which patients should have a right to access—it must be technically feasible and licit. Now these criteria do not prove sufficient; numerous archaic interventions remain feasible and legally permissible, yet are now bywords for spurious care. Therefore, we propound another necessary condition for an intervention to become care: the physician must rationally judge the intervention to be conducive to the patient’s good. Consequently, the right of (...) class='Hi'>access-to-care relies on physicians being free to practice medicine in accord with their consciences, conscience being the rational faculty with which they judge the reasonableness of even mundane medical decisions. Since physicians operate as part of a community, it is further necessary to consider when central bodies may reasonably compel physicians to engage in interventions that the physician believes are not consistent with the patient’s good and/or are not congruent with the purposes of medicine. (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)

Access to care has become a key and contentious issue in the Canadian health care system. In this article, I explore the role of Canadian courts in determining rights to access public health insurance, beginning with a brief overview of the Canadian system and its distinguishing features, and then moving to discuss challenges to governmental limits on publicly-funded Medicare using the Canadian Charter of Rights and Freedoms. I argue that the Canadian courts are not, as is often charged, (...) proactive in this area. I question whether the deference exhibited by courts to governmental limits on Medicare is justified given concerns about the fairness of the principles and processes followed by decision-makers. In sharp relief to the judiciary’s conservative approach to applications for better or timely access to publicly-funded Medicare is the recent Supreme Court of Canada’s decision in Chaoulli v. Quebec which upheld a right to buy private health insurance for “medically necessary” hospital and physician services. (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)

This article argues that universities have duties to negotiate contracts with the pharmaceutical industry that are favourable to the world’s poor, and to do more research into diseases which disproportionately strike the global poor. It is argued that these duties are related to human rights (in particular to a human right to health) and that they are therefore very weighty. Furthermore, these duties are in line with some of the most important things that Universities Allied for Essential Medicines (...) (UAEM), a worldwide group of students and academics, wants universities to do. A number of objections are discussed, among other things to do with safeguarding pharmaceutical innovation, and it is argued that the aforementioned duties should, as UAEM also advocates, often be combined with efforts on the part of universities to work towards more long-term, large-scale institutional arrangements to ensure access to and availability of essential medicines for the global poor. -/- . (shrink)

The right to health is enshrined in the constitution of the World Health Organization and numerous other international agreements. Yet today, an estimated 5.7 million people die each year from treatable infectious diseases, most of which are susceptible to existing antimicrobials if they were accessible. These deaths occur predominantly among populations living in poverty in low- and middle-income countries, and they greatly exceed the estimated 700,000 annual deaths worldwide currently attributed to antimicrobial resistance. Ensuring universal appropriate access to (...) antimicrobials is not only a critical part of realizing the right to health, it is necessary for mobilizing effective collective action against the development and spread of AMR. (shrink)

Hans Morten Haugen offers an analysis of the intersection of intellectual property with health, traditional knowledge and biodiversity against a backdrop of established and emerging human rights. How those rights interface and who decides are among the most difficult issues in international intellectual property, and there is no doubt that there is room for fresh ideas on how to simultaneously achieve the goals of innovation, development and access. 0Also part of series: Library of Human Rights; 2.

Taking people’s longevity as a measure of good life, humankind can proudly say that the average person is living a much longer life than ever before. The AIDS epidemic has however for the first time in decades stalled and in some cases even reverted this trend in a number of countries. Climate change is increasingly becoming a major challenge for food security and we can anticipate that hunger caused by crop damages will become much more common. -/- Since many of (...) the challenges humanity faced in the past were overcome by inventive solutions coming from the life sciences, we are compelled to reconsider how we incentivize science and technology development so that those in need can benefit more broadly from scientific research. There is a huge portion of the world population that is in urgent need for medicines to combat diseases that are currently neglected by the scientific community and could immensely benefit from agricultural research that specifically targets their environmental conditions. At the same time efforts have to be made to make the fruits of current and future research more widely accessible. These changes would have to be backed by a range of moral arguments to attract people with diverging notions of global justice. This article explores the main ethical theories used to demand a greater share in the benefits from scientific progress for the poor. Since life sciences bring about a number of special concerns, a short list of conflictive issues is also offered. (shrink)

Is there any ethical justification for limiting the reproductive autonomy and not make assisted reproductive technologies available to certain prospective parents? We present and discuss the results of an interdisciplinary clinical ethics study concerning access to assisted reproductive technologies (ART) in situations which are considered as ethically problematic in France (overage or sick parents, surrogate motherhood). The study focused on the arguments that people in these situations put forward when requesting access to ART. It shows that requester’s arguments (...) are based on sound ethical values, and that their legitimacy is at least as strong as that of those used by doctors to question access to ART. Results reveal that the three implicit normative arguments that founded the law in 1994, which are still in force after the bioethics law revision in July 2011—the welfare of the child, the illegitimacy of a “right to a child,” and the defense of the so called “social order”—are challenged on several grounds by requesters as reasons for limiting their reproductive autonomy. Although these results are limited to exceptional situations, they are of special interest insofar as they give voice to the requesters’ own ethical concerns in the ongoing political debate over access to ART. (shrink)

As the price of pharmaceuticals and biologicals rises so does the number of patients who cannot afford them. In this article, we argue that physicians have a moral duty to help patients access affordable medicines. We offer three grounds to support our argument: (i) the aim of prescribing is to improve health and well-being which can only be realized with secure access to treatment; (ii) there is no morally significant difference between medicines being unavailable and (...) class='Hi'>medicines being unaffordable, so the steps physicians are willing to take in the first case should extend to the second; and (iii) as the primary stakeholder with a duty to put the individual patient’s interests first, the medical professional has a duty to address cost-barriers to patient care. In articulating this duty, we take account of important epistemic and control conditions that must be met for the attribution of this duty to be justified. (shrink)

We argue that while presidential candidates have the right to medical privacy, the public nature and importance of the presidency generates a moral requirement that candidates waive those rights in certain circumstances. Specifically, candidates are required to disclose information about medical conditions that are likely to seriously undermine their ability to fulfill what we call the "core functions" of the office of the presidency. This requirement exists because (1) people have the right to be governed only with their (...) consent, (2) people's consent is meaningful only when they have access to information necessary for making informed voting decisions, (3) such information is necessary for making informed voting decisions, and (4) there are no countervailing reasons sufficiently strong to override this right. We also investigate alternative mechanisms for legally encouraging or requiring disclosure. Protecting the public's right to this information is of particular importance because of the documented history of deception and secrecy regarding the health of presidents and presidential candidates. (shrink)

This article challenges the widespread contention - promoted by the World Health Organization, the U.N. Human Rights Commission, and certain non-governmental organizations - that health care should be regarded as an individual human right. Like other "post-modern" rights, the asserted individual right to health care is a positive claim on the resources of others; it is unlimited by corresponding responsibilities; and it pertains exclusively to the individual. In fact, an individual human right to health, enforceable against either (...) governments or corporations, does not currently exist in law. If established, such a right would portend a dramatic expansion of government control over health care, with negative consequences for efficiency and patient welfare. Voluntary efforts based on partnership, rather than the imposition of legal requirements, are the most productive means of expanding access to health care while preserving incentives for continued development of innovative health technologies. (shrink)

Taking into consideration the extremely harsh public health conditions faced by the majority of the world population, the Health Impact Fund (HIF) proposal seeks to make the intellectual property regimes more in line with human rights obligations. While prioritizing access to medicines and research on neglected diseases, the HIF makes many compromises in order to be conceived as politically feasible and to retain a compensation character that makes its implementation justified solely on basis of negative duties. Despite that (...) current global health realities make such steps reasonable, the paper looks up the negative effects on one overlooked human right: the right to participate in scientific advancement. (shrink)

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)

This paper examines the recent UK House of Commons Health Committee report on the Influence of the Pharmaceutical Industry in relation to its findings and recommendations concerning access to medicines, and in particular the continuance of cost effectiveness or reference pricing. This mechanism of bargaining down the price of drugs on social justice grounds recently has been targeted by the US Department of Commerce as an unjustifiable non-tariff barrier to trade that should be eliminated in all OECD countries. (...) Concerns have been raised that certain provisions in the AUSFTA may have been designed to achieve this end, in defiance of norms of democratic legitimacy, moral responsibility and the international right to health. Here we examine some implications of the UK House of Commons Report for the PBS in Australia. (shrink)

Abstract:Although the idea of intellectual property (IP) rights—proprietary rights to what one invents, writes, paints, composes or creates—is firmly embedded in Western thinking, these rights are now being challenged across the globe in a number of areas. This paper will focus on one of these challenges: government-sanctioned copying of patented drugs without permission or license of the patent owner in the name of national security, in health emergencies, or life-threatening epidemics. After discussing standard rights-based and utilitarian arguments defending intellectual property (...) we will present another model. IP is almost always a result of a long history of scientific or technological development and numbers of networks of creativity, not the act of a single person or a group of people at one moment in time. Thus thinking about and evaluating IP requires thinking about IP as shared rights. A network approach to IP challenges a traditional model of IP. It follows that the owner of those rights has some obligations to share that information or its outcomes. If that conclusion is applied to the distribution of antiretroviral drugs, what pharmaceutical companies are ethically required to do to increase access to these medicines in the developing world will have to be reanalyzed from a more systemic perspective. (shrink)

Over 45 million Americans are uninsured or underinsured. Those living in poverty exhibit the worst health status. Employment, education, income, and race are important factors in a person's ability to acquire healthcare access. Having established that there are people lacking healthcare access due to multi-factorial etiologies, the question arises as to whether the intervention necessary to assist them in obtaining such access should be considered a privilege, or a right. The right to healthcare access (...) is examined from the perspective of Western thought. Specifically through the works of Aristotle, Immanuel Kant, Thomas Hobbes, Thomas Paine, Hannah Arendt, James Rawls, and Norman Daniels, which are accompanied by a contemporary example of intervention on behalf of the medically needy by the The Johns Hopkins Urban Health Institute. (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)

Any system for the protection of intellectual property rights (IPRs) has three main kinds of distributive effects. It will determine or influence: (a) the types of objects that will be developed and for which IPRs will be sought; (b) the differential access various people will have to these objects; and (c) the distribution of the IPRs themselves among various actors. What this means to the area of pharmaceutical research is that many urgently needed medicines will not be developed (...) at all, that the existing medicines will not be suitable for countries with a precarious health infrastructure or not target the disease variety that is prevalent in poorer regions. Such effects are commonly captured under the rubric of the “10/90 gap” in biomedical research. High prices will also restrict access to medicines as well endanger compliance to treatment schemes. IPRs are mainly held by multinational corporations situated in the developed world, which not only raises egalitarian concerns, but also severely limits the possibilities of companies in poorer countries to realize improvements on existing inventions, as they cannot financially afford to secure freedom to operate, which systematically shrinks the number of potential innovators. Those inequities lead to an enormous burden for the global poor and since no institution is willing to assume the responsibility to fulfil the right to health and the corresponding right of access to essential medicines, we have to analyse alternatives or additions to the actual intellectual property regimes in order to create new incentives to fill this gap. (shrink)

In the Netherlands, access to healthcare has been guaranteed by social health insurance legislation. But since the introduction of the Health Insurance Act in the 1960s, the health insurance system has been in a state of flux. Numerous reforms have changed the system gradually, of which the latest is the introduction of a competitive health insurance scheme for the entire population.Cutting across the various reforms has, however, been the goal of access to healthcare services as defined by international (...) treaty law, including European Union law. In particular the leverage of Community law in strengthening the patient’s right to healthcare is remarkable. Since the European Court of Justice has accepted that healthcare should be considered as a service in terms of the EC Treaty, rights to healthcare have become inextricably linked with the free movement principles and are no longer restricted to the jurisdiction of the country of origin. (shrink)