UPDATE: On Monday, 4 July 2022, a revised version of the Core Group’s access to medicines, vaccines, and other health products resolution (A/HRC/50/L.13) was circulated. The current co-sponsors include: Argentina, Brazil, China, Ecuador,* Egypt,* India, Indonesia, Malaysia, Namibia, Nepal, Paraguay, Peru,* Senegal, and South Africa. The next can be found here:
A_HRC_50_L.13_Rev.1 as received
On Wednesday, 29 June 2022, the Core Group (Brazil, China, Egypt, India, Indonesia, Senegal, South Africa, Thailand) tabled a resolution on “Access to medicines, vaccines, and other health products in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” for consideration by the 50th session of the Human Rights Council in July 2022 The text of the resolution can be found here: https://hrcmeetings.ohchr.org/HRCSessions/RegularSessions/50/DL_Resolutions/A_HRC_50_L.13/L.13%20as%20received.docx
For the previous, REV. 1 version of the text, please see here: Access to Medicines, Vaccines and other Health Products REV1
The 2022 text included references to delinkage, the WHO transparency resolution (WHA72.8), the WHO Cancer resolution (WHA70.12), the WHO Cancer Report, United Nations High-Level Panel on Access to Medicines, and the recent Ministerial Decision on the TRIPS Agreement. On Monday, 27 June 2022, the Core Group convened the third and final informal consultation to review the text; Knowledge Ecology International (KEI) participated in this informal.
Right off the bat, the European Union objected to language describing the “exacerbation of economic and social inequalities within and among countries”.
PP4. Recalling also General Assembly Resolution 74/306 of 11 September 2020, which recognizes that the coronavirus disease (COVID-19) pandemic is one of the greatest global challenges in the history of the United Nations and noting with deep concern its negative impacts on the enjoyment of human rights and the exacerbation of poverty and hunger as well the exacerbation of economic and social inequalities within and among countries, which have reversed hard-won development gains and hampered progress towards achieving the 2030 Agenda for Sustainable Development and all its Goals and targets,
The new text has been modified to accommodate the European Union’s previous objections language referencing the exacerbation of economic and social inequalities “within and among countries”
PP4. Recalling Human Rights Council resolution 41/10 of 11 July 2019 and all relevant previous resolutions and decisions on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health adopted by the Council, the General Assembly and the Commission on Human Rights, including resolutions 44/2 of 16 July 2020, 46/14 of 23 March 2021, 49/25 of 1 April 2022 and 49/19 of 1 April 2022, which highlight the need for ensuring equitable, affordable, timely and universal access for all countries to vaccines in response to the coronavirus disease (COVID-19) pandemic and for promoting and protecting economic, social and cultural rights within the context of addressing inequalities in the recovery from the COVID-19 pandemic,
The REV 1 version of the text had the following text on the WHO transparency resolution:
PP20. 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,
At the request of Argentina, “costs” was inserted into the text to now read “Reaffirming the importance of improving of markets, costs, and supply chain for medicines, vaccines, and other health products across the value chain,”
PP21 Reaffirming the importance of improving the transparency of markets, costs and supply chain 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
In relation to WHO’s 2018 technical report on the pricing of cancer medicines, the REV. 1 text had the following language:
PP36. Considering the report by the Director-General of the World Health Organization on cancer medicines, which, pursuant to resolution WHA70.12, examined the impact of pricing approaches, including transparency, on the availability and affordability of medicines for the prevention and treatment of cancer, and looking forward to a possible update and expansion of this study, which could shed light in raising prices of medicines in the context of the COVID-19 pandemic,
At the informal on 27 June 2022, the United Kingdom of Great Britain and Northern Ireland objected to the last part of this paragraph which read “and looking forward to a possible update of this study, which could shed light in raising prices of medicines in the context of the COVID-19 pandemic”. The United Kingdom asserted that this was an overreach of the HRC’s mandate to “steer WHO member states”. The tabled text now reads:
PP39 Considering the report by the Director-General of the World Health Organization on cancer medicines, which, pursuant to resolution WHA70.12, examined the impact of pricing approaches, including transparency, on the availability and affordability of medicines for the prevention and treatment of cancer, and looking forward to a possible update of this study, which could shed light in raising prices of medicines in the context of the COVID-19 pandemic,
In relation to TRIPS flexibilities, the Doha Declaration on the TRIPS Agreement and Public Health, and the recent 17 June 2022 Ministerial Decision on the TRIPS Agreement, the REV. 1 text stated:
PP30. Recalling that the Doha Ministerial Declaration on the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health confirms that the Agreement does not and should not prevent members of the World Trade Organization from taking measures to protect public health, and that the Declaration, accordingly, while reiterating the commitment to the Agreement, affirms that it can and should be interpreted and implemented in a manner supportive of the rights of members of the Organization to protect public health and, in particular, to promote access to medicines for all, and further recognizes, in this connection, the right of members of the Organization to use to the full the provisions of the above-mentioned Agreement, which provide flexibility for this purpose, including the World Trade Organization Ministerial Decision WT/MIN(22)/W/15/Rev.2 on the TRIPS Agreement, of 17 June 2022,
The United Kingdom requested that “in accordance” preceded reference to the “World Trade Organization Ministerial Decision WT/MIN(22)/W/15/Rev.2 on the TRIPS Agreement”.
PP33 Recalling that the Doha Ministerial Declaration on the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health confirms that the Agreement does not and should not prevent members of the World Trade Organization from taking measures to protect public health, and that the Declaration, accordingly, while reiterating the commitment to the Agreement, affirms that it can and should be interpreted and implemented in a manner supportive of the rights of members of the Organization to protect public health and, in particular, to promote access to medicines for all, and further recognizes, in this connection, the right of members of the Organization to use to the full the provisions of the above-mentioned Agreement, which provide flexibility for this purpose, in accordance with the World Trade Organization Ministerial Decision WT/MIN(22)/W/15/Rev.2 on the TRIPS Agreement, of 17 June 2022,
The final paragraph in the preamble of the REV 1 text contained a reference to “international solidarity”.
PP41. Stressing that the universal realization of the human right to the highest attainable standard of physical and mental health should be guided by a strong spirit of international solidarity and in accordance with the principles proclaimed in the Charter of the United Nations, particularly the recognition of the inherent dignity and of the equal and inalienable rights of all persons.
The European Union and United Kingdom objected to the reference of a “strong spirit of international solidarity” in this resolution before the Human Rights Council. The European Union noted that “international solidarity” is not a “concept of international human rights law” while stressing that “there is no obligation of states to exercise international solidarity”.
Consequently, the new language in the tabled text reads:
PP44 Realizing also that during the time of global pandemics and other health emergencies the fulfillment of the right to the highest attainable standard of physical and mental health should be guided by a strong spirit of solidarity, in particular solidarity with the poorest and with people in vulnerable situations.
With respect to cooperation, it is perhaps worthwhile revisiting paragraph 13 in Committee on Economic, Social and Cultural Rights’ (CESCR) General Comment 3 on the nature of States parties’ obligations (art. 2, para. 1, of the Covenant) which states:
A final element of article 2 (1), to which attention must be drawn, is that the undertaking given by all States parties is “to take steps, individually and through international assistance and cooperation, especially economic and technical …”. The Committee notes that the phrase “to the maximum of its available resources” was intended by the drafters of the Covenant to refer to both the resources existing within a State and those available from the international community through international cooperation and assistance. Moreover, the essential role of such cooperation in facilitating the full realization of the relevant rights is further underlined by the specific provisions contained in articles 11, 15, 22 and 23. With respect to article 22 the Committee has already drawn attention, in general comment No. 2 (1990), to some of the opportunities and responsibilities that exist in relation to international cooperation. Article 23 also specifically identifies “the furnishing of technical assistance” as well as other activities, as being among the means of “international action for the achievement of the rights recognized …”.
Operative paragraph 1 of the Core Group’s tabled resolution states:
1. Recognize that timely, equitable and unhindered access to safe, affordable, effective and quality medicines, vaccines, diagnostics and therapeutics, and other health products and technologies is one of the fundamental elements for the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health and the correspondent objectives of universal health coverage and health for all, without discrimination, with special attention to reaching those furthest behind first,
2. Stresses the responsibility of States to ensure timely, equitable and unhindered access for all, without discrimination, to safe, affordable, effective and quality medicines, vaccines, diagnostics and therapeutics, and other health products and technologies, as well as access to immunization as a global public good,
During the informal on 27 June 2022, the United States of America requested to replace the phrase “timely, equitable, and unhindered” with the word “universal”. The request of the United States was not taken on board. With respect to the word “unhindered”, Canada mentioned that it had “legal redline” with this word; one wonders about Ottawa’s justification for opposing this word. In addition, the United States requested that ‘ensure” be replaced with “promote”. The original wording in operative paragraph 2 had the phrase “securing immunization as a global public good.” However, the United Kingdom and the United States objected to this. The United Kingdom noted that their delegation did not recognize the responsibility of states to secure immunization as a global public good.
In relation to the operative paragraphs on the TRIPS Agreement, the tabled resolution contains the following language:
3. Calls upon States to promote timely, equitable and unhindered access to safe, effective, quality and affordable medicines, vaccines, diagnostics and therapeutics, and other health products and technologies, for all, including through the full use of the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which provide flexibility for that purpose, while recognizing that the protection of intellectual property is important for the development of new and innovative medicines and vaccines, and the concerns about its effects on prices and public health,
4. Also calls upon States to take steps to implement policies and plans to promote access to comprehensive and cost-effective prevention, treatment and care for the integrated management of noncommunicable diseases, including, inter alia, increased access to affordable, safe, effective and quality medicines, vaccines and diagnostics and other health products, including through the full use of TRIPS Agreement provisions and flexibilities,
On delinkage, the resolution states:
5. 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,
Perhaps the most ambitious aspect of the resolution’s operative text is paragraph 6 on technology transfer:
6. 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 towards advancing the realization of the Sustainable Development Goals (based on OP9 res. 46/14), urges States and all relevant stakeholders to:
(a) promote research and capacity-building initiatives, and to enhance international cooperation on and access to science, innovation, technologies, technical assistance, and knowledge sharing, including through pooling initiatives, while appreciating the substantive efforts many states have already made to this end,
(b) take all necessary measures to strengthen regional and local production, by promoting innovative modalities of global partnerships and technology transfers, on mutually agreed terms, and facilitate the trade in medicines, vaccines and other health products,
(c) share data and results in line 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) promote transfer of technology and know-how on mutually agreed terms, and 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) assist in efforts to build capacity through training and financial support to developing countries to produce health technologies, including the mRNA vaccine technology,
(f) explore approaches with the view to establishing a global end-to-end platform to promote equitable access and fair distribution of health products, and
(g) 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.
With respect the role of innovative funding mechanisms, operative paragraph 8 states:
8. 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 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,
In relation to supply chain management, operative paragraph 10 states:
10. Encourages States, in cooperation with other stakeholders, to redouble efforts to achieve a continuous supply of quality, safe, effective and affordable health products through research and development that meets public health needs, for the efficient application and management of intellectual property standards, to carry out evidence-based selection of health products and to seek fair and affordable pricing, to adopt good procurement and supply chain management and to promote appropriate prescribing, dispensing and rational use of health products,
In relation to the work program of the United Nations High Commissioner for Human Rights, the resolution requests the following:
16. Requests the United Nations High Commissioner for Human Rights to enhance its work, within its mandate, including with the support for dedicated capacity to continue to carry out research, organize three expert workshops, and provide technical assistance to States throughout the next three years on the human rights dimension of access to medicines and vaccines in the context of the right of everyone to the highest standard of physical and mental health, including good practices, key challenges and new developments, and to provide a compendium of good practices to the Human Rights Council at its fifty-third session and an analytical study on key challenges at its fifty-sixth sessions with a view to presenting a comprehensive report, including new developments, at its fifty-ninth session, and prepare these in an accessible and easy-to-read format.
The Core Group’s resolution on Access to medicines, vaccines, and other health products in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health will be considered by the 50th session of the Human Rights Council during the week of 4 July 2022 to 8 July 2022.