Access to health products
Definition
Access to health products is a human right, intrinsically linked with the right to health. Under the right to health framework, health products must be available, accessible, acceptable, and of good quality. This right covers small molecule drugs, biologics, vaccines, diagnostics, and other types of health tools such as gene- and cell-therapies. While some precedents mention access to “essential medicines,” this right includes health products beyond those formally recognized in the World Health Organization (WHO) list of essential medicines. It also covers access across diseases, including HIV, malaria, tuberculosis, other infectious diseases, and non-communicable diseases. The right to access covers products indicated for preventive and prophylaxis healthcare. Access to health products must be guaranteed during and also in the absence of emergencies.
Access to HIV treatments and other health products continues to be disturbingly uneven in many places, with poorer health outcomes for women and girls, children, minorities, indigenous populations, persons living in poverty, queer people, persons with disability, migrants, stateless persons, and others experiencing marginalization. Improving access to health products could save millions of lives every year. Intellectual property is often recognized as a critical legal barrier impeding the generic manufacture of health products, leading to lack of access and excessive pricing.
The Doha Declaration on the TRIPS Agreement and Public Health and several other subsequent precedents have recognized that the TRIPS agreement should be interpreted and implemented in a manner supportive of the right to protect public health, in particular to promote access to health products for all. Many of the precedents reflected under the term access to health products reaffirm the right to protect public health over intellectual property rights, including by making full use of the flexibilities under the TRIPS agreement and other international commitments. Nevertheless, these recognitions should only be considered as a baseline and not a ceiling.
Other policy interventions required under a right to health framework to ensure access to health products include facilitating technology transfer, enhancing local and regional manufacturing capabilities, ring fencing domestic resource allocation, and exploring and implementing alternative incentives for encouraging research and development. An increasing number of precedents are recognizing the need for these policy interventions to protect the right to health, and they are reflected in this Language Compendium under the access to health products term and also under alternative R&D models, local and regional manufacture, and technology transfer.
Precedents
2022 Resolution on industrial development cooperation
“Encourages the promotion of South-South cooperation, triangular cooperation and the transfer, diffusion and adoption of technology on mutually agreed terms in building their engagement in international trade through the development of micro-, small and medium-sized enterprises” (p. 10)
“Stressing also that the creation, development and diffusion of new innovations and technologies and associated know-how, including the transfer of technology on mutually agreed terms, are powerful drivers of economic growth and sustainable development” (p. 5)
“Encourages regional, subregional and interregional cooperation as a platform for international industrial cooperation aiming to promote investments and technology transfer on mutually agreed terms, to disseminate inclusive and equitable policies and practices, as well as to foster opportunities for high quality and decent work, including for youth and women” (p. 9)
2022 Resolution on elevating pandemic prevention, preparedness and response to the highest level of political leadership
“Recognizing the need to support developing countries in building expertise and in developing local and regional manufacturing capacities for tools, including by building on efforts under the COVID-19 Vaccine Global Access (COVAX) Facility, with a view to developing improved global, regional and local manufacturing, handling and distribution capacities while further enabling the increased use of health technologies and the digital transformation of health systems” (p. 3)
“Emphasizing the need to improve access to quality, safe, effective and affordable vaccines, therapeutics, diagnostics and other health technologies, inter alia, through building capacity for local and regional production, especially in low- and middle-income countries, technology transfer on mutually agreed terms, cooperation with, support to and the development of voluntary patent pools and other voluntary initiatives, such as the World Health Organization COVID-19 Technology Access Pool and the Medicines Patent Pool, and promoting generic competition in line with the World Health Organization road map for access to medicines, vaccines and other health products, 2019–2023” (p. 4)
“Calls upon Member States to promote the transfer of technology and know-how and encourage research, innovation and commitments to voluntary licensing, where possible, in agreements where public funding has been invested in research and development for pandemic prevention, preparedness and response, to strengthen local and regional capacities for the manufacturing, regulation and procurement of needed tools for equitable and effective access to vaccines, therapeutics, diagnostics and essential supplies, as well as for clinical trials, and to increase global supply through facilitating transfer of technology within the framework of relevant multilateral agreements” (p. 6)
“Calls upon Member States to promote the transfer of technology and know-how and encourage research, innovation and commitments to voluntary licensing, where possible, in agreements where public funding has been invested in research and development for pandemic prevention, preparedness and response, to strengthen local and regional capacities for the manufacturing, regulation and procurement of needed tools for equitable and effective access to vaccines, therapeutics, diagnostics and essential supplies, as well as for clinical trials, and to increase global supply through facilitating transfer of technology within the framework of relevant multilateral agreements” (p. 6)
2022 HRC Resolution on access to medicines, vaccines and other health products
“Reaffirming the importance of improving the transparency of markets, costs and supply chains for medicines, vaccines and other health products across the whole value chain, and taking into consideration resolution WHA72.8 of 28 May 2019, adopted by the World Health Assembly at its seventy-second session” (p. 3)
“Recognizing also the need for States, in cooperation with regional and international organizations and civil society, including non-governmental organizations, philanthropic foundations, academic and research institutions and the private sector, involved at all stages of the pharmaceuticals value chain, including research and development, manufacture, distribution and supply of pharmaceutical products, to create favourable conditions at the national, regional and international levels to ensure the full and equal enjoyment of the right of everyone to the highest attainable standard of physical and mental health” (p. 4)
“Seriously concerned also that the supply of health products and technologies is dependent on manufacturing facilities concentrated in few countries and that the lack of adequate infrastructure and logistics expertise to store, distribute and deliver diagnostics, medicines, vaccines and other health products and technologies, particularly in developing countries, among other factors, hampers efforts to achieve diagnosis, treatment and vaccination targets for several diseases, at the right time, safely and efficiently, especially in the context of health emergencies” (p. 4)
“Deeply concerned about the loss of lives and livelihoods and the disruption to economies and societies caused by the COVID-19 pandemic, and its negative impact on the enjoyment of human rights around the world, particularly for women and girls, and recognizing that the COVID-19 pandemic has highlighted the critical need to prevent and prepare for potential disruptions of the supply chain for essential medicines and other health technologies, including through the strengthening of local production, and therefore welcoming resolution WHA74.6 of 31 May 2021, adopted by the World Health Assembly at its seventy-fourth session, on strengthening local production of medicines and other health technologies to improve access” (p. 5)
“Recognizing the need to appropriately address challenges, gaps, market failures and opportunities regarding the research and development of health technologies, availability and affordability to treat, inter alia, rare and neglected diseases, as well as infectious diseases, and to respond to the growth of emerging challenges, such as antimicrobial resistance and pathogens with pandemic potential, among others, with a view to adequately addressing public health needs and protecting, respecting and fulfilling human rights, and taking into account the necessity to promote frameworks that meet public health needs, while adequately rewarding innovation” (p. 5)
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Urges States and all relevant stakeholders, in order to ensure timely, equitable and unhindered access for all persons to safe, affordable, effective and quality medicines, vaccines, diagnostics and therapeutics, and other health products and technologies with a view to advancing the realization of the Sustainable Development Goals:
(a) To promote research and capacity-building initiatives, and to enhance international cooperation on and access to science, innovation, technologies, technical assistance and knowledge-sharing, including by pooling initiatives, while appreciating the substantive efforts many States have already made to this end;
(b) To take all measures necessary to strengthen regional and local production, by promoting innovative modalities of global partnerships and technology transfers, on mutually agreed terms, and to facilitate trade in medicines, vaccines and other health products;
(c) To share data and results in accordance with internationally agreed principles, including sharing of pathogens, samples and genetic sequencing data, and ensure the fair and equitable sharing of benefits that arise from their utilization, in accordance with international access and benefit-sharing instruments;
(d) To promote the transfer of technology and know-how on mutually agreed terms, and to encourage research, innovation and commitment, where possible, to voluntary licensing in all agreements in which public funding has been invested in research and development;
(e) To assist in efforts to build capacity through training and financial support for developing countries to produce health technologies, including mRNA vaccine technology;
(f) To explore ways to promote equitable access and fair distribution of health products, including the possible establishment of a global end-to-end platform;
(g) To advance the health and care workforce investment agenda, with a special focus on the primary health-care workforce and employment of women at all levels;
(h) To take measures to ensure accessible and affordable access to health-care systems for persons with disabilities;
” (p. 7)
“Reiterates the call upon States to continue to collaborate, as appropriate, on models and approaches that support the delinkage of the cost of new research and development from the prices of medicines, vaccines and diagnostics for diseases that predominantly affect developing countries, including emerging and neglected tropical diseases, so as to ensure their sustained accessibility, affordability and availability and to ensure access to treatment for all those in need” (p. 7)
“Recognizes the innovative funding mechanisms and arrangements that contribute to the availability of vaccines and medicines in developing countries, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Gavi Alliance, Unitaid, the Access to COVID-19 Tools (ACT) Accelerator initiative and the COVID-19 Technology Access Pool (C-TAP), especially for those living in poverty, children and other persons in vulnerable situations, and calls upon all States, United Nations agencies, funds and programmes, in particular the World Health Organization, and relevant intergovernmental organizations, within their respective mandates, and encourages relevant stakeholders, including companies involved in the research and development, manufacture, importing, distribution and supply of pharmaceuticals, while safeguarding public health from undue influence by any form of real, perceived or potential conflict of interest, to further collaborate to enable equitable access to quality, safe and effective medicines and vaccines that are affordable to all, including those living in poverty, children and other persons in vulnerable situations” (p. 8)
“Urges all States, United Nations agencies, funds and programmes, and relevant intergovernmental organizations, especially the World Health Organization, within their respective mandates, and encourages non-governmental organizations and relevant stakeholders, including pharmaceutical companies, to promote innovative research and development to address health needs in developing countries, including access to safe, effective, quality and affordable medicines and vaccines, in particular with regard to diseases disproportionately affecting developing countries, and the challenges arising from the growing burden of non-communicable diseases, while taking into account the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property of the World Health Organization” (p. 9)
2022 HRC Resolution on ensuring equitable, affordable, timely and universal access for all countries to vaccines in response to the coronavirus disease (COVID-19) pandemic
“Stressing the importance of improving the transparency of markets for medicines, vaccines and other health products across the whole value chain, and taking note of World Health Assembly resolution WHA72.8 of 28 May 2019” (p. 4)
“Encourages States to work in partnership with all relevant stakeholders to increase research and development funding for vaccines and medicines, leverage digital technologies and strengthen the scientific international cooperation necessary to combat COVID-19 and to bolster coordination, including with the private sector, towards the further development, manufacturing and distribution of diagnostics, antiviral medicines, personal protective equipment and vaccines while adhering to the objectives of quality, efficacy, safety, equity, accessibility and affordability” (p. 5)
“Reaffirms the right of States to use the provisions of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the flexibilities therein, as reaffirmed in the Doha Declaration on the TRIPS Agreement and Public Health, in which it is recognized that the agreement should be interpreted and implemented in a manner supportive of the right of States to protect public health, in particular to promote access to medicines for all, to facilitate access for all to COVID-19 vaccines and to bolster coordination, including with the private sector, towards the rapid development, manufacturing and distribution of vaccines while adhering to the objectives of transparency, efficacy, safety, equity, accessibility and affordability” (p. 5)
“Calls upon States and all relevant stakeholders to promote research and capacity-building initiatives and to enhance cooperation on and access to science, innovation, technologies, technical assistance and knowledge-sharing, to ensure universal, equitable and affordable access for all persons to COVID-19 vaccines, including through improved coordination among mechanisms, especially with developing countries, in a collaborative, coordinated and transparent manner and on mutually agreed terms, in response to the COVID-19 pandemic and towards advancing the realization of the Sustainable Development Goals” (p. 5)
“Reiterates the call for States to continue to collaborate, as appropriate, on models and approaches that support the delinking of the cost of new research and development from the prices of medicines, vaccines and diagnostics for diseases, to ensure their sustained accessibility, affordability and availability and to support access to treatment for all those in need” (p. 5)
“Encourages States and other stakeholders to voluntarily share technology and support the development of voluntary patent pools, such as the World Health Organization COVID-19 Technology Access Pool (C-TAP)” (p. 6)
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 HRC Resolution on ensuring equitable, affordable, timely and universal access for all countries to vaccines in response to COVID-19
“Recognizing further that universal health coverage implies that all people have access without discrimination to nationally determined sets of needed promotive, preventive, curative, palliative and rehabilitative essential health-care services and essential, safe, affordable, effective and quality medicines and vaccines, while ensuring that the use of these services does not expose users to financial hardship, with special emphasis on the poor, vulnerable and marginalized segments of the population” (p. 2)
“Stressing the importance of improving the transparency of markets for medicines, vaccines and other health products across the whole value chain, and taking note of World Health Assembly resolution WHA72.8 of 28 May 2019” (p. 2)
“Emphasizes the urgent need to ensure the right of everyone to the enjoyment of the highest attainable standard of physical and mental health and to facilitate the development of robust health systems and universal health coverage, encompassing universal, timely and equitable access to all essential health technologies, diagnostics, therapeutics, medicines and vaccines in response to the COVID-19 pandemic and other health emergencies, in order to ensure full access to immunization for all, in particular persons and groups in vulnerable situations, as a matter of global priority for all States” (p. 4)
“Encourages States to work in partnership with all relevant stakeholders to increase research and development funding for vaccines and medicines, leverage digital technologies and strengthen the scientific international cooperation necessary to combat COVID-19 and to bolster coordination, including with the private sector, towards the further development, manufacturing and distribution of diagnostics, antiviral medicines, personal protective equipment and vaccines while adhering to the objectives of quality, efficacy, safety, equity, accessibility and affordability” (p. 4)
“Requests all States, international organizations and relevant stakeholders to commit to transparency in all matters relating to the production, distribution and fair pricing of vaccines, in accordance with national and regional legal frameworks, and urges States to take immediate steps to prevent speculation and undue export controls and stockpiling that may hinder affordable, timely, equitable and universal access for all countries to COVID-19 vaccines” (p. 5)
“Reiterates the call for States to continue to collaborate, as appropriate, on models and approaches that support the delinking of the cost of new research and development from the prices of medicines, vaccines and diagnostics for diseases, to ensure their sustained accessibility, affordability and availability and to support access to treatment for all those in need” (p. 5)
“Calls upon States and all relevant stakeholders to promote research and capacity-building initiatives, and to enhance cooperation on and access to science, innovation, technologies, technical assistance and knowledge-sharing, to ensure universal, equitable and affordable access for all persons to COVID-19 vaccines, including through improved coordination among mechanisms, especially with developing countries, in a collaborative, coordinated and transparent manner and on mutually agreed terms, in response to the COVID-19 pandemic and towards advancing the realization of the Sustainable Development Goals” (p. 5)
“Reaffirms the right of States to use the provisions of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the flexibilities therein, as reaffirmed in the Doha Declaration on the TRIPS Agreement and Public Health, in which it is recognized that the agreement should be interpreted and implemented in a manner supportive of the right of States to protect public health, in particular to promote access to medicines for all, to facilitate access for all to COVID-19 vaccines and to bolster coordination, including with the private sector, towards the rapid development, manufacturing and distribution of vaccines, while adhering to the objectives of transparency, efficacy, safety, equity, accessibility and affordability” (p. 5)
2021 Resolution on science, technology and innovation for sustainable development
“Reaffirming that the creation, development and diffusion of new innovations and technologies and associated know-how, including the transfer of technology on mutually agreed terms, are powerful drivers of economic growth and sustainable development” (p. 3)
“Recognizing also the importance of supporting policies and activities of developing countries in the fields of science, technology and innovation through North-South, South-South and triangular cooperation in the areas of financial and technical assistance, capacity-building and technology transfer on mutually agreed terms” (p. 4)
“Underscores the need to adopt science, technology and innovation strategies as integral elements of national sustainable development plans and strategies that help to strengthen knowledge-sharing on mutually agreed terms and collaboration and scale up investment in science, technology, engineering and mathematics education, and enhance technical, vocational and tertiary education and training” (p. 6)
“Also encourages Member States to promote local innovation capabilities for inclusive and sustainable economic development by bringing together local scientific, vocational and engineering knowledge, mobilizing resources from multiple channels, improving information and communications technology and supporting infrastructure development” (p. 7)
2021 HRC Resolution on the human rights of migrants
“Also calls upon all States to promote and protect the right of everyone, without discrimination of any kind, to the enjoyment of the highest attainable standard of physical and mental health, and encourages them to promote equitable access to health services, disease prevention and care for migrants, including equitable access for all migrants to COVID-19 diagnostics, treatment and vaccines” (p. 4)
2021 Resolution on ensuring equitable, affordable, timely and universal access for all countries to vaccines in response to the coronavirus disease (COVID-19) pandemic
“Recognizing that the COVID-19 pandemic requires a global response that is people-centred, gender-responsive, with full respect for human rights, multidimensional, coordinated, inclusive and innovative, based on unity, solidarity and multilateral cooperation, to ensure that all States, in particular developing States, including the least developed countries, have unhindered, timely, fair and equitable access to safe diagnostics, therapeutics, medicines, vaccines and essential health technologies and their components, as well as equipment, bearing in mind that immunization against COVID-19 is a global public good for health in preventing, containing and stopping transmission, and in bringing the pandemic to an end” (p. 5)
“Encourages States to work in partnership with all relevant stakeholders to increase research and development funding for vaccines, medicines, therapeutics and diagnostics, leverage digital technologies and strengthen the scientific international cooperation necessary to combat COVID-19 and to bolster coordination, including with the private sector, towards the further development, manufacturing and distribution of diagnostics, antiviral medicines, therapeutics, personal protective equipment and vaccines while adhering to the objectives of quality, efficacy, safety, equity, accessibility and affordability” (p. 6)
“Urges States to facilitate the trade in, acquisition of, access to and distribution of COVID-19 vaccines as a crucial element of their responses to the pandemic, to ensure the right of everyone to the enjoyment of the highest attainable standard of physical and mental health and to support the administration of vaccines to address the pandemic, in line with the Sustainable Development Goals and in accordance with the relevant international legal frameworks, including international human rights obligations, taking into account the principles of non-discrimination and transparency” (p. 6)
“Reiterates the call for States to continue to collaborate, as appropriate, on models and approaches that support the delinking of the cost of new research and development from the prices of medicines, vaccines and diagnostics for diseases, to ensure their sustained accessibility, affordability and availability and to support access to treatment for all those in need” (p. 6)
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)
2020 Resolution on international cooperation to ensure global access to medicines, vaccines and medical equipment to face COVID-19
“Encourages Member States to work in partnership with all relevant stakeholders to increase research and development funding for vaccines and medicines, leverage digital technologies, and strengthen scientific international cooperation necessary to combat COVID-19 and to bolster coordination, including with the private sector, towards rapid development, manufacturing and distribution of diagnostics, antiviral medicines, personal protective equipment and vaccines, adhering to the objectives of efficacy, safety, equity, accessibility, and affordability” (page)
2020 Resolution on consolidating gains and accelerating efforts to control and eliminate malaria in developing countries, particularly in Africa, by 2030
“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 the latest amendment to article 31 of the TRIPS Agreement, which came into effect in January 2017, which provides 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, while recognizing that the protection of intellectual property is important for the development of new medicine” (p. 10)
“Calls upon the international community to support ways to expand access to affordable, effective and safe products and treatments, such as vector control measures, including indoor residual spraying, long-lasting insecticidal nets, including through the free distribution of such nets, adequate diagnostic facilities, intermittent preventive therapies for pregnant women, children under 5 and infants, and artemisinin-based combination therapy for populations at risk of falciparum malaria infection in endemic countries, particularly in Africa, including through additional funds and innovative mechanisms, inter alia, for the financing and scaling up of artemisinin production and procurement, as appropriate, to meet the increased need” (p. 11)
“Calls upon Member States to promote access to medicines, and emphasizes that access to affordable and quality medicines and medical care in the event of sickness, as well as in the prevention, treatment and control of diseases, is central to the realization of the right to the enjoyment of the highest attainable standard of physical and mental health” (p. 9)
2020 Resolution on comprehensive and coordinated response to the coronavirus disease (COVID-19) pandemic
“Calls upon Member States and all relevant stakeholders to promote research and capacity-building initiatives, as well as to enhance cooperation on and access to science, innovation, technologies, technical assistance and knowledge- sharing, including through improved coordination among existing mechanisms, especially with developing countries, in a collaborative, coordinated and transparent manner and on mutually agreed terms in response to the COVID-19 pandemic and towards advancing the Sustainable Development Goals” (p. 11)
“Encourages Member States to work in partnership with all relevant stakeholders to increase research and development funding for vaccines and medicines, leverage digital technologies, and strengthen scientific international cooperation necessary to combat COVID-19 and to bolster coordination, including with the private sector, towards rapid development, manufacturing and distribution of diagnostics, therapeutics, medicines, including antiviral medicines and medical science-based treatment protocols, and vaccines, and personal protective equipment, and explore ways to consider integrating, as appropriate, safe and evidence-based traditional and complementary medicine services, according to national context and priorities, adhering to the objectives of efficacy, safety, equity, accessibility, and affordability, while taking into account and supporting existing mechanisms, tools and initiatives, such as the Access to COVID-19 Tools Accelerator, and relevant pledging appeals” (p. 7)
“Reaffirms the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) as amended, and also reaffirms 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” (p. 7)
2020 Resolution on industrial development cooperation
“Stressing also that the creation, development and diffusion of new innovations and technologies and associated know-how, including the transfer of technology on mutually agreed terms, are powerful drivers of economic growth and sustainable development” (p. 4)
“Encourages regional, subregional and interregional cooperation as a platform for international industrial cooperation aiming to promote investments and technology transfer on mutually agreed terms, to disseminate good policies and practices, as well as to foster decent work, including for youth and women” (p. 8)
“Encourages the promotion of South-South cooperation, triangular cooperation and the transfer, diffusion and adoption of technology on mutually agreed terms in building their engagement in international trade through the development of micro-, small and medium-sized enterprises” (p. 9)
2020 Resolution on global health and foreign policy: strengthening health system resilience through affordable health care for all
“Reaffirming 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), which provides flexibilities for the protection of public health and promotes access to medicines for all, in particular for developing countries, and the Doha Declaration on the TRIPS Agreement and Public Health, which recognizes that intellectual property protection is important for the development of new medicines and also recognizes the concerns about its effects on prices” (p. 5)
“Reaffirms the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) as amended, and also reaffirms 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” (p. 7)
“Calls upon Member States to ensure access to medicines as one of the fundamental elements of a robust health system based on universal health coverage, and reaffirms that States have the primary role and responsibility to determine and promote their own path towards achieving universal health coverage that ensures universal and equitable access to quality essential health services and access to safe, effective, quality and affordable essential medicines, vaccines, diagnostics and other health technologies for all, without discrimination” (p. 7)
“Calls upon Member States to enhance and build constructive engagement and stronger partnership with relevant stakeholders from the public and private sectors, civil society and academia to pursue access to universal health coverage by improving the availability, affordability and efficiency of health products through increasing transparency of prices of medicines, vaccines, medical devices, diagnostics, assistive products, cell- and gene-based therapies and other health technologies across the value chain, including through improved regulations, in accordance with national and regional legal frameworks and contexts, to address the global concern about the high prices of some health products, and in this regard encourages the World Health Organization to continue its efforts to biennially convene the Fair Pricing Forum with Member States and all relevant stakeholders to discuss the affordability and transparency of prices and costs relating to health products as one of the fundamental features of a robust health system based on universal health coverage” (p. 7)
“Encourages Member States, international organizations and other relevant stakeholders to work collaboratively at all levels to develop, test and scale up production of safe, effective, quality, affordable diagnostics, therapeutics, medicines and vaccines, inter alia and as appropriate through the use of existing mechanisms, such as the Medicines Patent Pool, to promote equitable, affordable and timely access to medical products and health technologies in health emergencies” (p. 8)
2019 Resolution on science, technology and innovation for sustainable development
“Noting that the 2019 Global Sustainable Development Report identifies science, technology and innovation as one of the levers for transformation to accelerate progress in achieving the Sustainable Development Goals and that its strategic deployment has the potential to resolve and minimize trade-offs among the Goals and targets, and recognizes that technology transfer to developing countries on mutually agreed terms will be critical to scale up and accelerate the implementation of the 2030 Agenda for Sustainable Development” (p. 2)
“Reaffirming that the creation, development and diffusion of new innovations and technologies and associated know-how, including the transfer of technology on mutually agreed terms, are powerful drivers of economic growth and sustainable development” (p. 3)
“Recognizing also the importance of utilizing science, technology and innovation in a manner relevant to specific national and local situations and needs” (p. 3)
“Recognizing also the importance of supporting policies and activities of developing countries in the fields of science, technology and innovation through North-South, South-South and triangular cooperation in the areas of financial and technical assistance, capacity-building and technology transfer on mutually agreed terms” (p. 4)
2019 WHA Resolution on improving the transparency of markets for medicines, vaccines, and other health products
“Noting the importance of both public- and private-sector funding for research and development of health products, and seeking to improve the transparency of such funding across the value chain” (p. 2)
“Seeking to progressively enhance the publicly available information on inputs across the value chain of health products, the public reporting of the relevant patents and their status, and the availability of information on the patents landscape covering a particular health product as well as its marketing approval status” (p. 2)
“1. URGES Member States in accordance with their national and regional legal frameworks and contexts:
(1) to take appropriate measures to publicly share information on the net prices2 of health products;
(2) to take the necessary steps, as appropriate, to support dissemination and enhanced availability of, and access to, aggregated results data and, if already publicly available or voluntarily provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring patient confidentiality;
(3) to work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives;
(4) to facilitate improved public reporting of patent status information and the marketing approval status of health products;
(5) to improve national capacities, including through international cooperation and open and collaborative research and development and production of health products, especially in developing countries and low- and middle-income countries (LMICs), including health products for the diseases that primarily affect them, as well as for product selection, cost-effective procurement, quality assurance, and supply chain management” (p. 2)
2019 HRC Resolution on access to medicines and vaccines
“Reaffirming the importance of improving the transparency of markets for medicines, vaccines and other health products across the whole value chain, and taking into consideration resolution WHA72.8 adopted by the World Health Assembly at its seventy-second session” (p. 2)
“Recognizing that universal health coverage implies that all people have access without discrimination to nationally determined sets of needed promotive, preventive, curative, palliative and rehabilitative essential health-care services, and essential, safe, affordable, effective and quality medicines and vaccines, while ensuring that the use of these services does not expose users to financial hardship, with special emphasis on the poor, vulnerable and marginalized segments of the population” (p. 3)
“Expressing deep concern at recent outbreaks of highly infectious pathogens with pandemic potential, which demonstrate the potential vulnerability of populations to them, and in this context reaffirming and underscoring the importance of research into and development of new and innovative medicines and vaccines and of ensuring access to safe, affordable, effective and quality medicines and vaccines to all, including new and innovative medicines, and of building and/or strengthening health system capacities, including primary health care, for detecting, preventing and responding in a timely manner to outbreaks, epidemics, pandemics and other health emergencies” (p. 4)
“Reiterates the call upon States to continue to collaborate, as appropriate, on models and approaches that support the delinkage of the cost of new research and development from the prices of medicines, vaccines and diagnostics for diseases that predominantly affect developing countries, including emerging and neglected tropical diseases, so as to ensure their sustained accessibility, affordability and availability and to ensure access to treatment for all those in need” (p. 4)
“Seriously concerned about the high prices of some health products and the inequitable access within and among Member States, as well as the financial hardships associated with high prices, which impede progress towards achieving universal health coverage for all” (pp. 2–3)
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)