Lisa Forman and Jillian Kohler, “Introduction: International law, access to medicines and pharmaceutical companies” (2012) (original) (raw)
Related papers
Access to medicines is shaped by the obligation of states to observe the right to health, the pharmaceutical industry raising price of medicines to protect intellectual property rights, as well as civil society discourse. This paper evaluates how civil, public and corporate actors interact using Ruggie's framework (2014) for international governance to achieve effective - or not - remedies and due diligence to ensure accessibility, availability, acceptability and quality of access to essential medicines in emerging economies and developing countries. We conclude that obligations and responsibilities are not automatically satisfied by state or multinationals to meet the growing need for access to medicines and that the contribution of civil discourse to striking a balance in the communication of costs and benefits for humanity arising from this tri-sector collaboration, remains a work in progress required to shift more towards evidence-based positions on policy.
It is a vast understatement to say that the problem of access to medicines in developing countries is complex. Access is limited by a range of factors including inability to pay, a lack of infrastructure, and corruption in some countries. Surrounding and exacerbating these structural and technological problems is the layer of legal rights created by patents and their licensing that complicate and render more expensive the preparation and delivery of needed medicines, particularly those that need to be adapted to the social, health and cultural environment of developing countries. This article provides a survey of innovative strategies that aim at maximizing the potential of patents to facilitate the development and delivery of medicines against diseases, the burden of which falls principally on developing country populations. To understand the context in which these strategies are being proposed and implemented, the article reviews the battles over access to medicines beginning in the late 1980s. It then surveys some of the principal suggestions put forward to better direct innovation systems in addressing the critical health needs of the world’s majority including advance market commitments, patent buy-outs, prize funds, public–private partnerships and patent pools.
Submission to the United Nations Secretary General's High Level Panel on Access to Medicines
2016
Much of the current debate on health care goals, medical innovation and trade rules focuses on the misalignment between the need to provide incentives to innovation – mainly through a tight intellectual property (IPR) regime – and the resulting negative consequences in terms of access to medicines. While this clash is certainly crucial, this contribution focuses on a different aspect of the misalignment between innovation and access, concerning essential drugs and generics rather than brand new, innovative drugs. This contribution argues that the promotion of domestic drug production and innovative capabilities in low and middle income countries, and notably on the Sub-Saharan African subcontinent, can may constitute an important step towards achieving significant improvements in public health – as a human right that includes access to essential medicines. We provide background and evidence for this argument. We then draw out policy implications, arguing that increased policy cohere...
Overcoming Obstacles To Enable Access To Medicines For Noncommunicable Diseases In Poor Countries
Health Affairs, 2015
The modern access-to-medicines movement grew largely out of the civil-society reaction to the HIV/AIDS pandemic three decades ago. While the movement was successful with regard to HIV/AIDS medications, the increasingly urgent challenge to address access to medicines for noncommunicable diseases has lagged behind-and, in some cases, has been forgotten. In this article we first ask what causes the access gap with respect to lifesaving essential noncommunicable disease medicines and then what can be done to close the gap. Using the example of the push for access to antiretrovirals for HIV/AIDS patients for comparison, we highlight the problems of inadequate global financing and procurement for noncommunicable disease medications, intellectual property barriers and concerns raised by the pharmaceutical industry, and challenges to building stronger civil-society organizations and a patient and humanitarian response from the bottom up to demand treatment. We provide targeted policy recommendations, specific to the public sector, the private sector, and civil society, with the goal of improving access to noncommunicable disease medications globally.
Improving Access to Medicines in Low-Income Countries: A Review of Mechanism
Journal of World Intellectual Property, 2015
Individuals in low-income countries ("LICs") often lack access to appropriate medicines. The multidisciplinary nature of this problem requires a holistic approach. Whereas, other writings on the topic tend to focus on one or a small number of issues, often from the perspective of a single discipline, this paper seeks to consider the major issues from a multidisciplinary perspective. It first considers mechanisms for improving the availability of medicines in LICs, through grants, prizes, treaties, advance market commitments, priority review and product development partnerships to incentivize and fund R&D for neglected diseases. The paper then assesses mechanisms for improving affordability of medicines in LICs, such as differential pricing mechanisms, monopsonies, patent law flexibilities and human rights obligations. Next, the paper reviews mechanisms for improving the efficacy of medicines in LICs, including authentication, criminalization, international and national enforcement and communication and education. Finally, the paper examines mechanisms for improving the obtainability of medicines in LICs, through low-cost intervention, task-shifting, efficient regulation, grassroots service provision and education. The paper concludes by identifying areas warranting further research. The multidisciplinary nature of the problem of access to medicines in LICs requires a holistic approach, especially one that identifies and examines the areas where cross-disciplinary collaboration is valuable. The need for such a discussion was the primary reason for convening the Roundtable. The Roundtable proceedings included presentations on all participants' areas of expertize, reflections across
Access to Medicines and Human Rights
2017
Access to Medicines 10.3 therapy 5 , 6), and the prevailing R&D model has us ill-prepared to respond to emerging infectious diseases such as Zika and Ebola; to neglected tropical diseases (NTDs) that predominantly affect populations with little purchasing power; 7 and to neglected populations, such as people living with rare diseases and children. The human rights-based approach put forth by this chapter will provide recommendations to resolve this incoherence between innovation and access by realigning global public health priorities and global health technology innovation. This chapter intends to develop the current understanding of a human rights-based approach to access to medicines: it outlines the challenges that many populations face in accessing medicines (Section 1, part I), explains what understanding access to medicines through a human-rights based lens means (part II), summarizes human rights elements necessary for the realization of access to medicines (part III), and examines the tension between intellectual property (IP) rights and international human rights commitments (part IV). Part V focuses on key populations that encounter specific challenges within the broad landscape of enabling access to medicines, and Part VI recommends rights-based interventions and practices. After a tabular overview of the most relevant international and regional human rights standards related to the topic (Section 2), Section 3 discusses relevant human rights-based approaches to advocacy, litigation, and programming. Section 4 highlights specific country examples that have been successful in advancing the right to health and access to medicines for all, and the final section offers a glossary for further reading. What are the issues and how are they human rights issues? I. An overview of the international human rights framework Access to essential medicines, nested in the right to the highest attainable standard of health, is well founded in international law. The 1946 Constitution of the World Health Organization and the 1948 Universal Declaration of Human Rights (UDHR) both expressly recognize the right to health. The 1966 International Covenant on Economic, Social, and Cultural Rights (ICESCR), which has 164 states parties, elaborates that the right to health includes "access to health facilities, goods, and services." In General Comment 14 (2000) on the right to health, the Committee on Economic, Social and Cultural Rights (CESCR) interprets the normative content of article 12 of the ICESCR. 8 Although the ICESCR only requires the progressive realization of the right to health in the context of limited resources, there is a core set of minimum obligations which are not subject to progressive realization, including access to essential medicines. 9 The WHO, numerous national court cases and resolutions of the Human Rights Council, and the Doha Declaration on TRIPS and Public Health reaffirm access to essential medicines as a human right that must be available "for all." While states hold the core responsibility for essential medicines provision, these responsibilities are shared with other non-state actors. For example, pharmaceutical companies have human rights responsibilities described by the former UN Special Rapporteur on the Right to Health, including the duty to take all 5 United Nations (UN), "Goal 3: Ensure healthy lives and promote well-being for all at all ages," SDGs fact sheet, http://www.un.org/ sustainabledevelopment/health/. 6 While access to treatment for HIV/AIDS is still a challenge for many, "new HIV infections in 2013 were estimated at 2.1 million, which was 38 per cent lower than in 2001." United Nations (UN), "Goal 3: Ensure healthy lives and promote well-being for all at all ages," SDGs fact sheet, http://www.un.org/ sustainabledevelopment/health/. 7 In 2014 alone NTDs affected an estimated 1.7 billion people. However, insufficient R&D is invested in treating and preventing NTDs, "further amplified by the fact that many [of these diseases] require chronic and costly care.