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TWN Info Service on Health and Sustainable Development
19 September 2023
Third World Network
www.twn.my
UNGA: Political Declaration on pandemic pays lip service to equity
New Delhi and Kuala Lumpur, 19 September (K M Gopakumar and Chee Yoke Ling) – The text of the Political Declaration on Pandemic Prevention, Preparedness and Response (PPPR) that will be presented to the United Nations General Assembly (UNGA) High Level Meeting on 20 September pays lip service to equity.
A few developed countries have used their power to reinforce the status quo without accommodating pressing issues raised by developing countries to realise equity in PPPR. Developing countries, collectively through the Group of 77 (G77) and some Member States individually, raised critical issues to enhance their capabilities in PPPR especially equitable access, diversified production of health products, access to finance including debt relief.
The High-Level Meeting (HLM) on PPPR will take place on 20th September at the UN headquarters in New York, with the overall theme of the HLM will be “Making the world safer: Creating and maintaining political momentum and solidarity for Pandemic Prevention, Preparedness and Response”.
TWN learned that the draft Political Declaration was finalised in disregard of objections raised by a few developing countries. In fact, the whole process since June 2023 had frustrated many developing countries as the co-facilitators (the Permanent Representatives of Israel and Morocco to the UN) apparently were so outcome-oriented that Member States were not able to really negotiate the proposals that were submitted. Furthermore, in the last few weeks the positions of a small number of developed countries held more sway with the facilitators.
According to a delegation involved in the negotiations, silence was broken over the “final” text, but the former President of the General Assembly (PGA) Csaba Kőrösi of Hungary decided anyway to send the unagreed text to the Secretariat to be processed for formal adoption at the HLM. This was done shortly before he finished his term. On 5 September the UNGA presidency was taken over by Dennis Francis of Trinidad and Tobago.
[UNGA Decision 74/544 of 27 March 2020 introduced the “silence procedure” due to COVID-19 movement restrictions, titled “Procedure for taking decisions of the General Assembly during the Coronavirus disease 2019 (COVID-19) pandemic”. UNGA resolutions are normally the result after rounds of face-to-face negotiations narrowing disagreement towards consensus. But this was not possible as UN headquarters premises were closed even though on-line meetings were being conducted.
Under this procedure, a draft resolution is circulated to Member States with a timeline to respond. If a country supports a resolution, it does nothing. If it opposes a resolution, it sends an email breaking silence; just one such action stops the adoption of the resolution and could trigger an extension of time for revisions or to resolve the objections.]
The title of the document for the HLM is currently identified as “PGA final text as of 1 September 2023” (1 September text) that contains 29 preambular paragraphs and 49 operational paragraphs.
Paragraph 32 contains a “Call for equity, social justice and social protection mechanisms to ensure universal and equitable access to timely and quality health and social services without financial hardship for all people, particularly for those who are vulnerable or in vulnerable situations, as well as the elimination of the root causes of discrimination and stigma in health-care settings, including during pandemics and other health emergencies”.
However, there is little direction in the rest of the PGA text to realise the above goals.
The following parts of the 1 September text deal with equitable access and diversified production, technology transfer, access and benefit sharing, financing and debt.
Equitable Access
Paragraph 35 seeks to “Promote the supply and distribution of sustainable, fair, equitable, effective, efficient, quality, safe, affordable medicines, including generics, vaccines, diagnostics and other health technologies and innovation, to ensure timely access and delivery of affordable quality health services”.
Towards this end the Doha Declaration on the TRIPS Agreement and Public Health is included, “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.”
Further, paragraph 37 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), which provides flexibilities for the protection of public health and promotes access to medicines for all, in particular for developing countries”.
Many observers including developing country delegates are concerned that mere reaffirmation of the right to use the TRIPS flexibilities is not enough without addressing the various barriers to use of those flexibilities. The most important barrier is the bilateral political pressure from developed countries against the use of TRIPS flexibilities.
Recognising the existence of political pressure UN High Level Panel on Access to Medicine in its Report in 2016 stated: “Governments and corporations sometimes threaten political or economic retaliation as a means of illegitimately pressuring others into forgoing their TRIPS flexibilities. Such actions are against the letter and spirit of the TRIPS Agreement and the Doha Declaration.”
Though there is a change in the US approach to the use of compulsory license since COVID-19 for specific products it is not clear whether this approach will continue. The Special 301 Report on US unilateral intellectual property protection monitoring based on US domestic trade law, the main instrument to exert political pressure against the use of TRIPS flexibilities, now encourages the use of compulsory license in the context of COVID-19. For instance, Special 301 Report 2023 states: “International obligations such as those in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) provide flexibility for trading partners to take measures to address serious public health emergencies and circumstances of extreme urgency within that trading partner’s territory. The COVID-19 pandemic certainly qualifies as such. Consistent with this view, the United States respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions of the TRIPS Agreement and the Doha Declaration”.
Apart from freedom of operation under compulsory license for production of vaccines, antibodies and diagnostics, access to details of production processes to fast track regulatory approval is also required. The regulatory assumption for these products is that the production process is itself the product i.e. any deviation from the originator’s product requires proof of safety and quality through clinical trials. The production process details are often submitted to the regulatory authorities of developed countries and can be shared in the public interest. However, there is silence in this regard in the Declaration.
Apart from the use of flexibilities there are no concrete steps mentioned in the Declaration to promote equitable access through diversified production and technology transfer.
Diversified production and technology transfer
Diversified production is considered as the most efficient way to achieve equitable access. The concentration of production of health products required for PPPR has affected the ability of a large number of countries to respond to COVID-19. According to a WTO report issued in August 2020, “Germany, the US, and Switzerland supply 35% of medical products to the world; The top 10 exporters account for almost three-quarters of world exports”.
A revised report in July 2022 noted that the leading position of Europe and the US in the medical goods trade went unchallenged except for less technologically intensive products like personal protective products, where the share of Asia went up form 35% to 51% in 2020. On technology intensive products such as medicines the Report notes: “Europe remained dominant in medicines production and export, accounting for at least 80 per cent of the world supply in 2019 and 2020. This share slightly dipped in 2021 to 77.7 per cent. Asia’s share in medicines, however, increased from 7.7 per cent in 2019 to 10.9 per cent in 2020”.
In this regard the Global Preparedness Monitoring Board, an independent monitoring and accountability, co-convened by the Director-General of WHO and the President of the World Bank recommended to the UN High Level meeting to:
“Recognize pandemic preparedness as a global public good, agreeing on a path to achieve sustainable equitable access to health emergency medical countermeasures through the pandemic convention, agreement, or other international instrument (also known as the ‘Pandemic Accord’) and other reforms by building research, manufacturing, regulatory and deployment capacity, through knowledge and technology transfers and collaborative capacity building as well as through investment in health systems strengthening and primary health care. The High-Level Meeting must agree on a way to finance this access at the required level to support equitable outcomes”.
The 1 September text fully ignores this public good aspect and the need for diversification of production.
Paragraph 31 provides the following mandate to WHO: “Urge the sustainable, affordable, fair, equitable, effective, efficient and timely access to medical countermeasures, including vaccines, therapeutics, diagnostics and other health products and call on the World Health Organization to coordinate this with relevant partners, ensuring coherence with the ongoing discussions of the Intergovernmental Negotiating Body and the Working Group on Amendments to the International Health Regulations (2005) in Geneva”. (Emphasis added)
Meanwhile, WHO is ignoring the public good recommendation of the Global Monitoring Board, and instead proceeding to establish a multi-stakeholder interim platform for the production and supply of medical counter measures (MCM) with cosmetic change to the existing multi-stakeholder platform established during COVID-19 known as Access to COVID-19 Tools Accelerator (ACT-A).
The MCM interim platform is facing opposition from WHO Members States and the attempt to obtain a clear mandate in various forums like G20 to go ahead with this platform has failed. (See G20 health ministers refuse to endorse establishment of interim MCM Platform).
Many developing countries including Brazil have expressed opposition to the establishment of such an interim platform outside the new pandemic instrument and the International Health Regulations (IHR) both of which are in negotiations phases. Further, there is a trust deficit among WHO Member States with regard to a multi-stakeholder platform especially on its accountability to the WHO governing bodies.
TWN learned that the WHO Secretariat is holding consultations to establish the interim platform citing an imminent need for such establishment and citing the 74th World Health Assembly Resolution on WHO Preparedness for and Response to Health Emergencies (WHA 74.7) as its assertion that there is an existing mandate to establish an interim platform.
[Paragraph 9.19 of the WHA decision states: “… in collaboration with Member States, other international organizations, civil society and the private sector, and based on lessons learned from the COVID-19 response and prior health emergencies, including experience in operationalizing the Access to COVID-19 Tools (ACT) Accelerator and the COVID-19 supply chain system, to propose strategies to enable rapid research, development, production and global equitable distribution of quality, safe, effective and affordable medical and other countermeasures and commodities at national, regional and global levels to respond to future health emergencies”.]
On diversification of production the 1 September text makes two conditional promises. First, paragraph 41 states: “Strengthen local, national and regional innovation and production capacities in developing countries, especially low- and middle-income countries through, inter alia, financial and technical support, technology transfer on mutually agreed terms, in cooperation with, support to and development of voluntary patent pools and other voluntary initiatives, such as the Medicines Patent Pool, and through leveraging innovation, such as investment of Unitaid, to make quality health products available and affordable in developing countries, promoting generic competition in line with the World Health Organization Roadmap for access to medicines, vaccines and other health products, 2019–2023.”
Thus, the whole approach is based on voluntary and mutually agreed terms. This clearly puts the diversification of production based on market dynamics and under the control of the private sector, the exact status quo that led to the COVID-10 vaccine supply crisis and inequitable access.
Second, paragraph 42 makes the following promise without the means to achieve the same: “Make collective effort to strengthen developing countries capacity for increased innovation around local and regional manufacturing and production of medical countermeasures, including vaccines, therapeutics, diagnostics and other health products to ensure sustainability as well as to close the gaps in global distribution of vaccines and medicines”.
Regarding technology transfer, a critical element for the realisation of diversified production of medical products required for PPPR, the 1 September text states: “ Promote the transfer of technology, on mutually agreed terms, 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;
Thus, there is no concrete commitment to transfer technology of public funded R&D. The limited commitment to promote technology transfer is based on conditions like “voluntary license” and “mutually agreed terms”.
Financing
The Global Monitoring Board made the following recommendation to the PPPR declaration negotiation process on financing: “Fully finance national preparedness plans and support international financing needs, including support for preparedness and the socioeconomic impact of health emergencies in LMICs, funding for global common goods, funding for early response, and long-term investments in pandemic prevention, preparedness and response, and identify approaches to fully finance these needs, including through the international and regional financing institutions, and through funding sources other than overseas development assistance.”
However, there is no concrete commitments from the developed countries to provide international finance in the 1 September text.
Paragraph 73 of the text states: “Recognize that health financing requires global solidarity and collective effort and commit to strengthen international cooperation to support efforts to build and strengthen capacity in developing countries, especially African countries and Small Island Developing States, including through enhanced official development assistance and financial and technical support and support to research, development and innovation programs.”
Paragraphs 75 and 76 only are only best endeavour statements on international financing:
“Strengthen international cooperation and coordination and financial and investment commitments to support efforts to build, strengthen and sustain capacity for pandemic prevention, preparedness and response, including research and development capacity in developing countries, including through enhanced official development assistance and adequate surge financing for future responses, and other means of innovative financing while recognizing that all people should be able to receive high quality health care without financial hardship. (paragraph 75)
“Leverage existing financing tools, including multilateral development banks, to mobilize additional timely, reliable, flexible, equitable, predictable and sustainable funding for pandemic prevention, preparedness and response, as well as funding for rapid surge financing for responses in the event of a public health emergency of international concern, strengthening financing mechanisms for global health and other relevant sectors, as well as their roles and responsibilities (paragraph 76)”.
Thus, there is no concrete commitment from developed countries to finance PPPR.
While developed countries refused to change the status quo on PPPR and rejected demands to effectively operationalise equity into the health regime the only consolation for developing countries is the consensus reached to promote fair, equitable and timely sharing of benefit arising from the use of pathogens, sequence and other genetic materials, which are critical to development various medical products required for PPPR.
Paragraph 43 of the 1 September text reads: “Promote the fair, equitable and timely sharing of benefits arising from the use of pathogens, sequences or any other materials, with pandemic potential through a multilateral system taking into account relevant national and international laws, regulations, obligations and frameworks, in line with the work being undertaken in other relevant areas and by other United Nations and multilateral organizations or agencies, particularly the ongoing discussions of the International Negotiating Body and Working Group on Amendments to the International Health Regulations (2005) in Geneva”.
Currently, countries widely share pathogens and sequences to speed up the development of medical products but the benefit arising from the use of such sharing i.e products developed using the pathogens or their sequences such as vaccines, therapeutics, diagnostics have not been shared in a fair and equitable manner. Recognising the problem, the IHR Review Committee in its Report on the Functioning of International Health Regulations during COVID-19 response makes the following recommendation:
“WHO and States Parties should consider the benefits of developing a global convention on pandemic preparedness and response in support of IHR implementation. Such a convention may include provisions for preparedness, readiness and response during a pandemic that are not addressed by the IHR, such as for example, strategies for the rapid and timely sharing of pathogens, specimens and genome sequence information for surveillance and the public health response, including for the development of effective countermeasures; provision for equitable access global to benefits arising from sharing the above; …”
At the WHO, during the ongoing negotiations on the pandemic instrument and amendment of IHR 2005 developed countries including the EU and the US, while accepting the need for sharing of benefits emerging from the use of pathogens or their sequences, attempt to decouple access to pathogens from the corresponding obligations to share benefits. Further, the approach is to minimise the benefit sharing especially denying the predictable access to medical products required for PPPR.
Given the hard positions of developed countries across multiple forums, and the objections raised by several developing countries it would be a setback for multilateralism if the UNGA HLM adopts the 1 September text.+
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