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)

There is no cure or vaccine for HIV/AIDS. The only life-prolonging treatment available is antiretroviral (ARV) therapy. WHO estimates, however, that less than 5 percent of those who require treatment in developing countries currently enjoy access to these medicines. In Africa fewer than 50,000 people–less than 2 percent of the people in need–currently receive ARV therapy. These facts have elicited strongly divergent reactions, and views about the appropriate response to this crisis have varied widely.The intensity of the debate (...) concerning access to life-prolonging medicines for the treatment of HIV/AIDS, and the heated rhetoric with which they are often conducted, suggest that these disagreements may be rooted in deeper disagreements of value. It is not obvious, however, what disagreements of value are at stake in this debate. By analyzing the statements of scholars, public officials, activist organizations, and private sector representatives, each of whom may endorse very different policy recommendations on access to HIV/AIDS drugs, we have identified and created a typology of the different sources of disagreement in the debate. We conclude that the central disagreements concerning access to medicines arise from competing understandings of how responsibilities for bringing remedy to hardships should be allocated to different agents and institutions. A central lesson that emerges from our analysis is that thinking about “health equity” must extend beyond the explanation and justification of goals, values, and ideals, and engage more honestly with the difficult question of how responsibilities for bringing remedy to health crises should be allocated in complex social contexts. (shrink)

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)

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)

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)

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)

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.

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)

“Access to medicines” is a broad concept. After a review of three authoritative frameworks that help to identify its constitutive components, this essay summarizes the actual situation on the ground in low- and middle-income countries on the basis of recent empirical work. An analysis of survey data from 36 countries concluded that developing countries should promote generic medicines as a key policy option for improving access to medicines. Taking an international perspective to that recommendation, this (...) essay reviews the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and, particularly, how this agreement has been applied in practice. As shown by the experience of Thailand, Brazil, and the Philippines, in order to deal effectively with international pressures for an excessive application of the TRIPS Agreement, some sort of conversion experience appears to be required, which then leads to a switch from a private enterprise, supply-driven approach to a public health vision that insists on universal and affordable access. But moral conviction is not sufficient. In order to muster and sustain the political will to face down international forces, civil society and government offices must be able and ready to show the costs and other adverse consequences of the TRIPS-based model for medicines. This calculation needs to reach beyond the health sector and calls for new alliances, nationally as well as internationally. (shrink)

Our Viewpoint argues that expanding access to less effective or more toxic treatments is supported not only by utilitarian ethical reasoning but also by two other ethical frameworks: those that emphasise equality and those that emphasise giving priority to the patients who are worst off. The inadequate resources available for global health reflect not only natural constraints but also unwise social and political choices. However, pitting efforts to reduce inequality and better fund global health against efforts to put available (...) resources to their best use mistakes complementary objectives for conflicting ones. (shrink)

When 47-year-old Simba Abalo, an unemployed retired soldier in Lomé, Togo, found out that he had AIDS in September 2007, he was unable to receive government-supplied antiretroviral drugs: “CAMEG [the state’s central medicines purchasing organization],” he said, “told me they were not taking any new cases for six months because they had run out of drugs.Stocks of antiretrovirals had become depleted after the Global Fund to Fight AIDS, Tuberculosis and Malaria suspended part of its grant to Togo in 2006 (...) and failed to approve a new grant request in 2007, reportedly because of oversight irregularities. “Even if they had the drugs,” said Abalo, “I could not have paid more than US$4 a month since I had just lost my job as a security guard earning US$70 a month.”. (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)

Companies increasingly seek to strategically integrate social objectives in commercial activities to address societal challenges, yet little is known about how companies can sustain such a commitment over time. To address this question, we conduct a case-based, abductive study of two pharmaceutical companies widely considered industry leaders in facilitating access to medicine over a 20-year period (2000–2019). We identify product and operation-level integration as distinct types of integration efforts enacted by these companies. Tracing the intraorganizational dynamics associated with these (...) efforts, we theorize that sustained integration is contingent on companies’ ability to respond to and address the challenges specific to product and operation-level integration. The theoretical framework we develop contributes to an emerging debate on the potential of companies to make progress on societal challenges by strategically integrating social objectives, including but not limited to those related to global health. (shrink)

There is evidence of persistent inequalities in household financial protection of health and drugs spending in Latin America. Despite the expansion of coverage, strong inequalities persist in access to health and family spending on drugs in the region. Out-of-pocket spending in medicines is regressive in greater need for affordable medicines.

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)

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.

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)

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)

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)

Cancer is a major burden on populations and health systems internationally. The development of innovative cancer medicines is seen as a significant part of the solution. These new cancer medicines are, however, expensive, leading to limited or delayed access and disagreements among stakeholders about which medicines to fund. There is no obvious resolution to these disagreements, with stakeholders holding firmly to divergent positions. Access to cancer medicines was recently explored in Australia in a Senate (...) Inquiry into the Availability of New, Innovative, and Specialist Cancer Drugs in Australia. We analysed the resultant Senate Report to identify competing stakeholder values. Our analysis illustrates that there are four main “goods” prioritized by different stakeholders: 1) innovation, 2) compassion, 3) equity, and 4) sustainability. We observe that, with the exception of sustainability, all of these “goods” put pressure on payers to provide access to cancer medicines more quickly and based on less rigorous evaluation processes. We then explore the consequences of giving in to such pressure and suggest that deconstructing the implicit values in calls for “enhanced access” to cancer medicines is necessary so that more nuanced solutions to the challenge of providing access to these high cost medicines can be found. (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)

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...

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)

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.

Patients who search for a better treatment, an increased quality of life, or even a chance to preserve life itself may claim to have an interest in accessing investigational medicinal products (IMP), particularly when no validated treatment for their disease or condition exists. For many, awaiting the uncertain and time-consuming process of converting an IMP into an approved drug may not appear a realistic option, as prognoses may be grim and a dramatic outcome may seem hard to avert. Gaining (...) class='Hi'>access to an IMP, however, often proves to be a difficult enterprise with a highly uncertain outcome. In addition, the process of seeking access to IMP is surrounded by various ethical issues that will be explored in this article. This paper explores the ethical concerns in two potential tracks of seeking access to IMP for minors: on an individual basis, or collectively, as a patient organisation. In this discourse, several unique ethical and regulatory concerns related to the direct negotiation of access to IMP for minor patients are identified, with a focus on product safety, the recruitment of research subjects, the unnoticed entry of market mechanisms in the recruitment of research subjects, and the sidelining of third parties in the recruitment process. The paper concludes with a concise reflection on the way forward. The quest for access to investigational drugs is particularly relevant to paediatric practice, in which a significant share of the drugs prescribed has never been tested in children or labelled for use in the paediatric population. (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)

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)

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)

The United States' pursuit of increasingly TRIPS-Plus levels of intellectual property protection for medicines in bilateral and regional trade agreements is well recognized. Less so, however, are U.S. efforts through these agreements to influence and constrain the pharmaceutical coverage programs of its trading partners. Although arguably unsuccessful in the Australia- U.S. Free Trade Agreement (AUSFTA), the U.S. nevertheless succeeded in its bilateral FTA with South Korea (KORUS) in establishing prescriptive provisions pertaining to the operation of coverage and reimbursement programs (...) for medicines and medical devices, which have the potential to adversely impact future access in that country. More recently, draft texts leaked from the current Trans Pacific Partnership Agreement (TPPA) negotiations show that U.S. objectives include not only AUSFTA-Plus and KORUS-Plus IP provisions but also ambitious inroads into the domestic health programs of its TPPA partners. This highlights the apparent conflict between trade goals — pursued through multilateral legal instruments to promote economic “health”— and public health objectives, such as the development of treatments for neglected diseases, the pursuit of efficiency and equity in priority setting, and the procurement of medicines at prices that reflect their therapeutic value and facilitate affordable access. (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)

The United States’ pursuit of increasingly TRIPS-Plus levels of intellectual property protection for medicines in bilateral and regional trade agreements is well recognized. Less so, however, are U.S. efforts through these agreements, to directly influence and constrain the pharmaceutical coverage programs of its trading partners. The pursuit of increasing levels of intellectual property protection in successive bilateral and regional trade agreements has been driven, at least in part, by a U.S. desire to achieve standards of protection it anticipated from (...) the TRIPS Agreement, but failed to secure. Despite the conclusion of a global agreement on IP standards that would establish significant protections in countries that had hitherto declined them, the U.S. pharmaceutical industry viewed TRIPS as falling well short of its objectives — particularly in light of the delayed introduction of patent protection in countries that are key suppliers of generic medicines, such as India. (shrink)

ABSTRACT Medicines 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 (such as HIV/aids and tuberculosis) 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 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)

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 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)

The (B) case summarizes GSK’s response to pressures to increase access to essential medicines in developing countries and subsequent developments.

This article argues that to advance the struggle for access to essential medicines, it is necessary to identify the global and local regimes that shape the rules that give impetus to particular policy options, while undermining others. In exploring the role of law and politics in this process, the author first outlines the globalization of a standardized, corporate-inspired, intellectual property regime. Second, the author uses the example of the HIV/aids pandemic to demonstrate how the stability of this new (...) regime came under pressure, both locally and globally. Finally, it is argued that while the global HIV/aids pandemic and the social movements that emerged in response to government inaction have effectively challenged the TRIPS regime, this complex contestation has reached an unsustainable stalemate in which development aid, corporate, and non-governmental philanthropy is simultaneously providing increased availability to drugs while precluding a more lasting solution to the crisis of access to essential medicines in developing countries. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and (...) Harvard University (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

The (B) case summarizes GSK’s response to pressures to increase access to essential medicines in developing countries and subsequent developments.