Access to health products
Precedents
2022 WTO Ministerial Decision on the TRIPS Agreement
“Notwithstanding the provision of patent rights under its domestic legislation, an eligible Member may limit the rights provided for under Article 28.1 of the TRIPS Agreement (hereinafter “the Agreement”) by authorizing the use of the subject matter of a patent required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic, in accordance with the provisions of Article 31 of the Agreement, as clarified and waived in paragraphs 2 to 6 below.” (paragraph 1)
“For greater clarity, an eligible Member may authorize the use of the subject matter of a patent under Article 31 without the right holder’s consent through any instrument available in the law of the Member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not a Member has a compulsory license regime in place.” (paragraph 2)
“An eligible Member may waive the requirement of Article 31(f) that authorized use under Article 31 be predominantly to supply its domestic market and may allow any proportion of the products manufactured under the authorization in accordance with this Decision to be exported to eligible Members, including through international or regional joint initiatives that aim to ensure the equitable access of eligible Members to the COVID-19 vaccine covered by the authorization.” (paragraph 3(b))
“No later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics.” (paragraph 8)
2021 WHA Resolution on Strengthening Local Production to Improve Access
“Urges Member States, where appropriate, based on the national context: to apply a holistic approach in strengthening local production by considering, for example, promoting research and development, transparency of markets for medicines and other health technologies, regulatory systems strengthening, access to sustainable and affordable financing, development of skilled human resources, access to technology transfer on voluntary and mutually agreed terms for production and needs-based innovation, the aggregation of national and regional demand, and appropriate incentives for private-sector investment, particularly in the context of achieving universal health coverage.” (paragraph 1(5))
“Urges Member States, where appropriate, based on the national context: to engage in global, regional and subregional networks related to promoting sustainable local production of quality, safe, effective and affordable medicines, and to further enhance multistakeholder collaboration.” (paragraph 1(6))
“Urges Member States, where appropriate, based on the national context: to further engage in North–South and South–South development cooperation, partnerships and networks to build and improve the transfer of technology related to health innovation on voluntary and mutually agreed terms and in line with their international obligations.” (paragraph 1(7))
“Urges Member States, where appropriate, based on the national context: to take into account the rights and obligations in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), including those affirmed by the Doha Declaration on the TRIPS Agreement and Public Health, in order to promote access to medicines and other health technologies for all.” (paragraph 1(8))
2021 Political declaration on equitable global access to COVID-19 vaccines
“We call for the rapid scaling up and expansion of vaccine production globally, including in developing countries, through appropriate dissemination of technology and know-how, e.g., licensing in accordance with World Trade Organizations rules, using TRIPS flexibilities if necessary, sharing knowledges, and data related to COVID-19 health technologies.” (paragraph 18)
2021 UNESC Resolution on UNAIDS
“Calls for urgent action and partnership by Member States, the United Nations system, civil society, local communities, the private sector and other stakeholders to scale up evidence-based HIV prevention, testing, treatment, care and retention services, including access to safe, effective, quality and affordable medicines, including generics, to ensure that those services reach the people who need them the most, including adolescent girls and young women as well as key populations that epidemiological evidence shows to be globally at higher risk of HIV infection, and children living with HIV, who have poorer HIV treatment coverage than adults and comprise a higher relative proportion of AIDS-related deaths.” (paragraph 4)
“Urges Member States to urgently remove, where feasible, obstacles that limit the capacity of low- and middle-income countries to provide affordable and effective HIV prevention and treatment products, diagnostics, medicines and commodities and other pharmaceutical products.” (paragraph 5)
2021 Political declaration on HIV and AIDS
“Reaffirm that access to safe, effective, equitable and affordable medicines and commodities for all, without discrimination, is fundamental to the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, yet note with grave concern the high number of people without access to medicine and that the sustainability of providing lifelong safe, effective and affordable HIV treatment continues to be threatened by factors such as poverty and underscore that access to medicines would save millions of lives.” (paragraph 42)
2021 CSW Report on women and HIV/AIDS
“The Commission may wish to encourage the United Nations system and other international actors to advocate for the removal of obstacles that limit the capacity of low-and middle-income countries to provide affordable and effective HIV prevention and treatment products, diagnostics, commodities and other pharmaceutical products tailored to or that are more appropriate for women and to support access to safe, effective, quality and affordable medicines, including generics, to ensure that they reach the people who need them the most, especially adolescent girls and young women.” (paragraph 58(e))
2021 HRC resolution on human rights in the context of HIV and AIDS
“Urges States to bring their laws, policies and practices, including their strategies for implementing the HIV- and other health-related Sustainable Development Goals, fully into compliance with their obligations under international human rights law, and to review or repeal those that are discriminatory or that adversely affect the successful, effective and equitable delivery of, and access to, HIV prevention, diagnosis, treatment, care and support programmes for all persons living with, presumed to be living with, at risk of or affected by HIV, including key populations.” (paragraph 7)
2019 Political declaration of the HLM on UHC
“The high prices of some health products, and inequitable access to such products within and among countries, as well as financial hardships associated with high prices of health products, continue to impede progress towards achieving universal health coverage.” (paragraph 12)
2019 UNESC Resolution on UNAIDS
“Calls for urgent action and partnership by Member States, the United Nations system, civil society, local communities, the private sector and other stakeholders to scale up evidence-based HIV prevention, testing, treatment, care and retention, including access to safe, effective, quality and affordable medicines, including generics, viral load testing in pursuit of achieving viral load suppression, and tuberculosis preventative treatment, to ensure that those services reach the people who need them the most, including key populations that epidemiological evidence shows to be globally at higher risk of HIV infection, adolescent girls and young women, and calls for reinvigorated efforts to protect human rights and promote gender equality and to address social risk factors, including gender-based violence, as well as social and economic determinants of health.” (paragraph 4)
“Urges Member States to urgently remove, where feasible, obstacles that limit the capacity of low- and middle-income countries to provide affordable and effective HIV prevention and treatment products, diagnostics, medicines and commodities and other pharmaceutical products.” (paragraph 5)
2019 WHA Resolution on antimicrobial resistance
“Requests the Director General to support Member States to mobilize adequate predictable and sustained funding and human and financial resources and investment through national, bilateral and multilateral channels to support the development and implementation of national action plans, research and development on existing and new antimicrobial medicines, diagnostics, and vaccines, and other technologies, and strengthening of related infrastructure, including through engagement with multilateral development banks and traditional and voluntary innovative financing and investment mechanisms, based on priorities and local needs set by governments and on ensuring public return on investment.” (paragraph 4(6))
2018 Political declaration of the HLM on the fight against TB
“Commit to promoting access to affordable medicines, including generics, for scaling up access to affordable tuberculosis treatment, including the treatment of multidrug-resistant and extensively drug-resistant tuberculosis, reaffirming the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as amended, and also reaffirming the 2001 World Trade Organization Doha Declaration on the TRIPS Agreement and Public Health, which recognizes that intellectual property rights should be interpreted and implemented in a manner supportive of the right of Member States to protect public health and, in particular, to promote access to medicines for all, and notes the need for appropriate incentives in the development of new health products.” (paragraph 19)
2018 Political declaration of the third HLM on NCDs
“Promote increased access to affordable, safe, effective and quality medicines and diagnostics and other technologies, reaffirming the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as amended, and also reaffirming the 2001 Doha Declaration on the TRIPS Agreement and Public Health, which recognizes that intellectual property rights should be interpreted and implemented in a manner supportive of the right of Member States to protect public health and, in particular, to promote access to medicines for all, and notes the need for appropriate incentives in the development of new health products.” (paragraph 36)
2018 HRC Resolution on human rights in the context of HIV and AIDS
“Reaffirms that access to safe, effective and affordable medicines, diagnosis and treatment for all, without discrimination, in the context of epidemics such as HIV and AIDS, is fundamental to the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.” (paragraph 9)
2017 Resolution on international cooperation to address and counter the world drug problem
“Urges all Member States to enact comprehensive measures aimed at stemming the abuse of prescription drugs, in particular through the establishment of awareness-raising initiatives targeting the general public and health-care providers.” (paragraph 45)
“Calls upon Member States to continue efforts to identify and monitor trends in the composition, production, prevalence and distribution of new psychoactive substances, as well as patterns of use and adverse consequences, and assess the risks to the health and safety of individuals and society as a whole and the potential uses of new psychoactive substances for medical and scientific purposes, and on that basis to develop and strengthen domestic and national legislative, regulatory, administrative and operational responses and practices by domestic and national legislative, law enforcement, judiciary, social and welfare, educational and health authorities.” (paragraph 55)
“Invites Member States to target the illicit cultivation of crops used for the illicit production and manufacture of drugs and address related factors by implementing comprehensive strategies aimed at alleviating poverty and strengthening the rule of law, accountable, effective and inclusive institutions and public services and institutional frameworks, as appropriate, and by promoting sustainable development aimed at enhancing the welfare of the affected and vulnerable population through licit alternatives.” (paragraph 56)
2016 Resolution on Women, the Girl Child and HIV and AIDS
“Address barriers, regulations, policies and practices that prevent access to affordable HIV treatment by promoting generic competition, in order to help to reduce the costs associated with lifelong chronic care and by encouraging all States to apply measures and procedures for enforcing intellectual property rights in such a manner as to avoid creating barriers to the legitimate trade in medicines and to provide for safeguards against the abuse of such measures and procedures.” (paragraph 13(b))
2014 Resolution on efforts to control and eliminate malaria by 2015
“Urges the international community, inter alia, to support the Global Fund to Fight AIDS, Tuberculosis and Malaria to enable it to meet its financial needs and, through country-led initiatives with adequate international support, to intensify access to affordable, safe and effective antimalarial treatments, including artemisinin-based combination therapies, intermittent preventive therapies for pregnant women, children under 5 and infants, adequate diagnostic facilities, long-lasting insecticide-treated mosquito nets, including, where appropriate, through the free distribution of such nets and, where appropriate, to insecticides for indoor residual spraying for malaria control, taking into account relevant international rules, including the Stockholm Convention on Persistent Organic Pollutants standards and guidelines.” (paragraph 13)
“Recognizes the importance of the development of safe and cost-effective vaccines and new medicines to prevent and treat malaria and the need for further and accelerated research, including into safe, effective and high-quality therapies, using rigorous standards, including by providing support to the Special Programme for Research and Training in Tropical Diseases, through effective global partnerships, such as the various malaria vaccine initiatives and the Medicines for Malaria Venture, where necessary stimulated by new incentives to secure their development, and through effective and timely support for the pre-qualification of new antimalarials and their combinations.” (paragraph 20)
“Calls upon the international community, including through existing partnerships, to increase investment in and efforts towards research to optimize current tools, develop and validate new, safe and affordable malaria-related medicines, products and technologies, such as vaccines, rapid diagnostic tests, insecticides and their delivery modes, to prevent and treat malaria, especially for at-risk children and pregnant women, and testing opportunities for integration in order to enhance effectiveness and delay the onset of resistance.” (paragraph 21)
“Reaffirms the right to use, to the fullest extent, the provisions contained in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the Doha Declaration on the TRIPS Agreement and Public Health, the decision of the General Council of the World Trade Organization of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, and, when formal acceptance procedures are completed, the amendment to article 31 of the Agreement, which provide flexibilities for the protection of public health, and in particular to promote access to medicines for all and to encourage the provision of assistance to developing countries in this regard, and calls for the broad and timely acceptance of the amendment to article 31 of the Agreement, as proposed by the General Council of the World Trade Organization in its decision of 6 December 2005.” (paragraph 23)
2009 ECOSOC Resolution on UNAIDS
“Urges Governments to prioritize and expand access to the prevention and treatment of HIV-related opportunistic infections, to promote access to and the effective use of safe and effective antiretroviral drugs of assured quality, at affordable prices, and to support both biomedical and socio-economic research on new products to prevent HIV infection, including those controlled by women, diagnostics, medicines and other treatment commodities and technologies related to HIV.” (paragraph 11)
“Reaffirms the right to use, to the full, the provisions contained in the Agreement on Trade-related Aspects of Intellectual Property Rights, the Doha Declaration on the Agreement on Trade-related Aspects of Intellectual Property Rights and Public Health, and the decision of the World Trade Organization General Council of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, and, when formal acceptance procedures are completed, the amendment to article 31 of the Agreement, which provide flexibilities for the protection of public health, and, in particular, to promote access to medicines for all, and also calls for a broad and timely acceptance of the amendment to article 31 of the Agreement on Trade-related Aspects of Intellectual Property Rights, as proposed by the World Trade Organization General Council in its decision of 6 December 2005.” (paragraph 9)
2007 WHA Resolution on tuberculosis control: progress and long-term planning
“Urges all member states to develop and implement long-term plans for tuberculosis prevention and control in line with the Global Plan to Stop TB 2006–2015, in the context of overall health development plans, in collaboration with other programmes (including those on HIV/AIDS, child health and strengthening of health systems), and through national Stop TB partnerships where appropriate, with the aim of controlling the emergence and transmission of multi-drug-resistant tuberculosis, including extensively drug-resistant tuberculosis, by ensuring the high-quality implementation of the DOTS strategy and by prompt implementation of infection-control precautions.” (paragraph 1(1)(d))
“Urges all member states to develop and implement long-term plans for tuberculosis prevention and control in line with the Global Plan to Stop TB 2006–2015, in the context of overall health development plans, in collaboration with other programmes (including those on HIV/AIDS, child health and strengthening of health systems), and through national Stop TB partnerships where appropriate, with the aim of: if affected, immediately addressing extensively drug-resistant tuberculosis and HIV-related tuberculosis as part of the overall Stop TB strategy, as the highest health priorities.” (paragraph 1(1)(e))
“Requests the director-general to strengthen urgently WHO’s support to countries affected by multidrug-resistant tuberculosis and especially extensively drug-resistant tuberculosis, and to countries highly affected by HIV-related tuberculosis.” (paragraph 2(3))
“Requests the director-general to support Member States in developing laboratory capacity to provide for rapid drug-susceptibility testing of isolates obtained from all persons with culture-positive tuberculosis, to develop consensus guidelines for rapid drug-susceptibility test methods and appropriate measures for laboratory strengthening, and to mobilize funding.” (paragraph 2(3))
2007 WHA Resolution on progress in the rational use of medicines
“Requests Director General in collaboration with governments and civil society, to strengthen WHO’s technical support to Member States in their efforts to establish or strengthen, where appropriate, multidisciplinary national bodies for monitoring medicine use, and implementing national programmes for the rational use of medicines.” (paragraph 2(2))
2006 Political Declaration on HIV/AIDS
“Reaffirm that the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights does not and should not prevent members from taking measures now and in the future to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, reaffirm that the Agreement can and should be interpreted and implemented in a manner supportive of the right to protect public health and, in particular, to promote access to medicines for all including the production of generic antiretroviral drugs and other essential drugs for AIDS-related infections. In this connection, we reaffirm the right to use, to the full, the provisions in the TRIPS Agreement, the Doha Declaration on the TRIPS Agreement and Public Health and the World Trade Organization’s General Council Decision of 2003 and amendments to Article 31, which provide flexibilities for this purpose.” (paragraph 43)
2005 Resolution on the World Summit outcome
“To provide, with the aim of an AIDS-, malaria- and tuberculosis-free generation in Africa, assistance for prevention and care and to come as close as possible to achieving the goal of universal access by 2010 to HIV/AIDS treatment in African countries, to encourage pharmaceutical companies to make drugs, including antiretroviral drugs, affordable and accessible in Africa and to ensure increased bilateral and multilateral assistance, where possible on a grant basis, to combat malaria, tuberculosis and other infectious diseases in Africa through the strengthening of health systems.” (paragraph 68(i))
2003 WHA on global health-sector strategy for HIV/AIDS
“Exhorts Member States, as a matter of urgency to reaffirm that public health interests are paramount in both pharmaceutical and health policies, to recognize the difficulties faced by developing countries in effective use of compulsory licensing in accordance with the Declaration on the TRIPS Agreement and Public Health (Doha Declaration), and, when necessary, to use the flexibilities in the TRIPS Agreement in order to meet the needs of developing countries for drugs against HIV/AIDS.” (paragraph 2(5))
2000 WHA on HIV/AIDS: confronting the epidemic
“Urges Member states to increase access to treatment and prophylaxis of HIV-related illnesses through measures such as ensuring the provision and affordability of drugs, including a reliable distribution and delivery system; implementation of a strong generic drug policy; bulk purchasing; negotiation with pharmaceutical companies; appropriate financing systems; and encouragement of local manufacturing and import practices consistent with national laws and international agreements acceded to.” (paragraph 1(16))
“Urges Member States to ensure that blood transfusion services do not constitute an HIV risk factor by ensuring that all individuals have access to safe blood and blood products that are accessible and adequate to meet their needs, are obtained from voluntary, nonremunerated blood donors, are transfused only when necessary, and are provided as part of a sustainable blood transfusion programme within the existing health care system.” (paragraph 1(7))
Expert precedents
2021 Report of the Special Rapporteur on the right to health
“The Special Rapporteur recommends that biomedical artificial intelligence (AI) technologies must not perpetuate racism, sexism, ableism or discrimination based on sexual orientation or gender. States must eliminate social and political inequalities in order to bridge the gendered digital divide, taking into account the needs of people with disabilities, which includes offering protections from discrimination and violence related to utilization of digital tools and technology.” (paragraph 87)
2016 General Comment No.22 on the Right to Sexual and Reproductive Health
“States parties should ensure, in compliance with their Covenant obligations, that their bilateral, regional and international agreements dealing with intellectual property or trade and economic exchange do not impede access to medicines, diagnostics or related technologies required for prevention or treatment of HIV/AIDS or other diseases related to sexual and reproductive health. States should ensure that international agreements and domestic legislation incorporate to the fullest extent any safeguards and flexibilities therein that may be used to promote and ensure access to medicines and health care for all. States parties should review their international agreements, including on trade and investment, to ensure that they are consistent with the protection of the right to sexual and reproductive health, and should amend them as necessary.” (paragraph 51)
2009 Report of the Special Rapporteur on the right to health
“Developing countries and LDCs should establish high patentability standards and provide for exclusions from patentability, such as new forms and new or second uses, and combinations, in order to address evergreening and facilitate generic entry of medicines.” (paragraph 100)
“Developing countries and LDCs should adopt the principle of international exhaustion and provide for parallel importation with simplified procedures in their national laws.” (paragraph 101)
“Developing countries and LDCs need to incorporate in their national patent laws all possible grounds upon which compulsory licences, including government use, may be issued. Such laws provide straightforward, transparent procedures for rapid issue of compulsory licences. There is also a need to revisit the 30 August decision and provide for a simpler mechanism.” (paragraph 102)
“Developing countries and LDCs should specifically adopt and apply pro-competition measures to prevent the abuse of the patent system, particularly in regard to access to medicines.” (paragraph 103)
“LDCs and developing countries should actively promote the participation of individuals and communities in decision-making processes relating to TRIPS and TRIPS flexibilities and conduct impact assessments of the same.” (paragraph 107)
“Developing countries and LDCs should not introduce TRIPS-plus standards in their national laws. Developed countries should not encourage developing countries and LDCs to enter into TRIPS-plus FTAs and should be mindful of actions which may infringe upon the right to health.” (paragraph 108)
“Flexibilities were included in TRIPS to allow States to take into consideration their economic and development needs. States need to take steps to facilitate the use of TRIPS flexibilities.” (paragraph 96)
“The Special Rapporteur therefore recommends that developing countries and LDCs should review their laws and policies and consider whether they have made full use of TRIPS flexibilities or included TRIPS-plus measures, and if necessary consider amending their laws and policies to make full use of the flexibilities.” (paragraph 97)
Evidence
2021 WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring
“The lack of access to appropriate antifungal therapies and in vitro diagnostics for rapid detection of histoplasmosis and the co-occurrence of other infectious diseases, especially TB, may affect clinical outcomes and underlie the high mortality of disseminated histoplasmosis among people living with HIV.” (p. 216)