On 16 November 2022, the Bureau of the Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (INB) released the conceptual zero draft in all six official languages for the consideration of the Intergovernmental Negotiating Body at its third meeting.
The Bureau underscores that the “conceptual zero draft is provided as a flexible, “living” document, with a view to moving it towards a zero draft.” The INB (which is composed of WHO member states) requested the INB Bureau to prepare a conceptual zero draft prior to the third meeting of the INB (5-7 December 2022). As a reminder, the INB Bureau is composed of the following persons: Brazil (Ambassador Tovar da Silva Nunes), Egypt (Ahmed Soliman), Japan (Kazuho Taguchi), Netherlands (Roland Driece), South Africa (Precious Matsoso), and Thailand (Viroj Tangcharoensathien). The two co-chairs of the INB are Roland Driece (Netherlands) and Precious Matsoso (South Africa).
The Bureau factored in the following inputs in developing the conceptual zero draft:
- Comments from the second meeting of the INB;
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Written inputs on the working draft from Member States (30), regional submissions (2), and relevant stakeholders (36);
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Input from regional consultations organized during the six regional committee meetings in 2022;
- Outcomes from the four informal focused consultations held by the INB Bureau during the intersessional period between the second and third INB meetings, which addressed the following topics: legal matters; operationalizing and achieving equity; intellectual property, and production and transfer of technology and know-how; and One Health in the context of strengthening pandemic prevention, preparedness and response, with reference to antimicrobial resistance, climate change and zoonoses; and
- Outcomes from the second round of public hearings, conducted in September 2022, by the WHO Secretariat to support the work of the INB.
The conceptual zero draft has eight chapters in addition to a preamble and vision. In terms of the agenda for INB 3, the WHO has provided the following guidance.
First, the INB will be invited to provide overall general comments on the conceptual zero draft, including identifying the key priorities from the areas included in the conceptual zero draft and whether there is a common understanding/ shared view that the paper can be used as a basis to facilitate further discussions and transform the conceptual zero draft into the zero draft for INB4; as well whether the INB agrees not to discuss the Preamble and “Definitions and use of terms” (Article 1) at this stage;
Second, the INB will be invited to provide comments on the Background, Methodology and Approach; Vision; Chapter I. Introduction (aside from Article 1); and Chapter II. Objective(s), principles and scope.
Third, the INB will be invited to provide comments on Chapter III. Achieving equity in, for and through pandemic prevention, preparedness, response and recovery of health systems; and Chapter IV. Strengthening and sustaining capacities for pandemic prevention, preparedness, response and recovery of health systems.
Fourth, the INB will be invited to provide comments on Chapter V. Pandemic prevention, preparedness, response and health system recovery coordination, collaboration, and cooperation; and Chapter VI. Financing.
Fifth, the INB will be invited to provide comments on Chapter VII. Institutional arrangements; and Chapter VIII. Final provisions.
The preamble of the conceptual zero draft contains 44 paragraphs.
Paragraph 41 recognized that publicly funded R&D required conditionalities:
41. Recognizing that publicly funded research and development plays an important role in the development of pandemic response products, and, as such, requires conditionalities;
Paragraph 3 of the preamble stresses that “equity should be a principle, an indicator and an outcome of pandemic prevention, preparedness and response”.
In relation to sovereignty, paragraph 1 reaffirmed the principle of sovereignty of State Parties in addressing public health matters:
1. Reaffirming the principle of sovereignty of States Parties in addressing public health matters, notably pandemic prevention, preparedness, response and health systems recovery;
Paragraph 34 speaks to the concept of “common but differentiated responsibility”.
34. Emphasizing that improving pandemic prevention, preparedness, response and recovery of health systems relies on a commitment to mutual accountability, transparency and common but differentiated responsibility by all States Parties and relevant stakeholders;
The conceptual zero draft frames States’ obligations to international cooperation under a human rights lens:
2. Recognizing the critical role of international cooperation and obligations for States to act in accordance with international law, including to respect, protect and promote human rights;
In relation to the impacts of determinants of health on vulnerable populations, the conceptual zero draft states:
18. Acknowledging the impacts of determinants of health across different sectors and communities on the vulnerability of communities, especially persons in vulnerable situations, to the spread of pathogens and the evolution of an outbreak;
With respect to evidence-based policies and interventions, paragraph 20 notes:
20. Emphasizing that policies and interventions on pandemic prevention, preparedness, response and recovery of health systems should be supported by the best available scientific evidence and adapted to take into account resources and capacities at subnational and national levels;
Antimicrobial resistance is described as an “aggravating factor” and a “silent pandemic:
24. Noting that antimicrobial resistance is often described as a silent pandemic and that it could be an aggravating factor during a pandemic;
Paragraph 29 emphasized the importance of accountability and transparency to enhance global solidarity and effective global coordination:
29. Recognizing the need to enhance global solidarity and effective global coordination, as well as accountability and transparency, to avoid serious negative impacts of public health threats with pandemic potential, especially on countries with limited capacities and resources;
Paragraph 31 underscored the point gross inequities in the COVID-19 response hindered timely access to pandemic countermeasures:
31. Deeply concerned by the gross inequities that hindered timely access to medical and other COVID-19 pandemic response products, notably vaccines, oxygen supplies, personal protective equipment, diagnostics and therapeutics;
In terms of language on WTO TRIPS flexibilities and the Doha Declaration on the TRIPS Agreement and Public Health, there are three paragraphs with unbracketed language (paragraphs 35, 36, and 37).
35. Recalling the Doha Declaration on the TRIPS Agreement and Public Health of 2001 and reiterating that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health;
36. Reaffirming that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health, and, in particular, to promote access to medicines for all;
37. Reaffirming that WTO Members have the right to use, to the full, the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health of 2001, which provide flexibility to protect public health including in future pandemics;
The conceptual zero draft contains four versions of paragraph 38 (all bracketed) with references to the role played by intellectual property rights:
38. [Proposal: Recognizing that protection of intellectual property rights is important for the development of new medical products, but also recognizing concerns about its effects on prices, as well as noting discussions/deliberations in relevant international organizations on, for instance, innovative options to enhance the global effort towards the production of, timely and equitable access to, and distribution of health technologies and know-how, by means that include local production;]
[38. Proposal: Recognizing that protection of intellectual property rights is important for the development of new medicines, and also recognizing concerns about the negative effect on prices and on the production of, timely and equitable access to, and distribution of vaccines, treatments, diagnostics and health technologies and know-how;]
[38. Proposal: Recognizing that intellectual property protection is important for the development of new medicines, and also recognizing concerns about its effect on prices, as well as noting discussions on enhancing global efforts towards the production of, timely and equitable access to,
and distribution of health technologies and products;]
[38. Proposal: Recognizing the concerns that intellectual property on life-saving medical technologies continue to pose threat and barriers to the full realization of the right to health and to scientific progress for all, particularly the effect on prices, which limits access options and impedes independent local production and supplies, as well as noting structural flaws in the institutional and operational arrangements in the global response to the COVID 19 pandemic, and the need to establish a future pandemic prevention, preparedness and response mechanism that is not based on a charity model;]
The fourth proposal, which notes the “structural flaws in the institutional and operational arrangements in the global response to the COVID 19 pandemic” and recognizes concerns that intellectual property rights limit “access options and impedes independent local production and supplies” is the most critical of the current architecture underpinned by international trade rules.
The conceptual zero draft contains two alternatives for paragraph 39 on TRIPS flexibilities.
39. [Proposal: Reaffirming the flexibilities and safeguards contained in the Agreement on Trade Related Aspects of Intellectual Property Rights and their importance for removing barriers to production of, and access to, pandemic response products, as well as sustainable supply-chains for their equitable distribution, while also recognizing the need for sustainable mechanisms to support transfer of technology and know-how to support the same;]
[39. Proposal: Reaffirming the flexibilities and safeguards contained in the Agreement on Trade Related Aspects of Intellectual Property Rights and their importance for ensuring access to technologies, knowledge and full transfer of technology and know-how for production and supply of pandemic response products, as well as their equitable distribution;]
In relation to access and benefit sharing, paragraph 42 the conceptual zero draft states:
42. Underscoring the importance of promoting early, safe, transparent and rapid sharing of samples and genetic sequence data of pathogens, as well as the fair and equitable sharing of benefits arising therefrom, taking into account relevant national and international laws, regulations, obligations and frameworks, including the International Health Regulations (2005), the Convention on Biological Diversity and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity, and the Pandemic Influenza Preparedness Framework, and also mindful of the work being undertaken in other relevant areas and by other United Nations and multilateral organizations or agencies;
Paragraph 43, the penultimate paragraph in the preamble, acknowledges the central role of WHO in the pandemic response, including “the directing and coordinating authority on international health work, and in convening and generating scientific evidence”.
43. Recognizing the central role of WHO in pandemic prevention, preparedness, response and recovery of health systems as the directing and coordinating authority on international health work, and in convening and generating scientific evidence, and, more generally, fostering multilateral cooperation in global health governance;
In terms of the operative parts of the conceptual zero draft, this walkthrough will focus on Chapter III – Achieving equity in, for and through pandemic prevention, preparedness, response and recovery of health systems.
The transparency of cost and pricing of pandemic countermeasures is embedded into Article 6(a)(ii) on the Global supply chain and logistics network.
Article 6(a)(ii) states:
Towards this end, each Party [shall]/[should]: (a) Ensure a concerted and coordinated approach to the availability and distribution of, and equitable access to, pandemic response products, by means that include:
(ii) measures to promote and encourage transparency in cost and pricing of pandemic response products, including development, production and distribution costs
Perehudoff et al. (A pandemic treaty for equitable global access to medical countermeasures: seven recommendations for sharing intellectual property, know-how and technology, British Medical Journal) had the following recommendations on transparency:
A pandemic treaty should have a distinct and ambitious chapter on transparency that addresses the need for transparency on a range of issues including: pathogens; scientific research; R&D funding agreements (in all sectors)*; regulatory standards and procedures*; patent landscapes and regulatory status landscapes*; licences of inventions, data, know-how and biologic resources*; clinical trial designs, outcomes, costs and subsidies*; R&D costs (this could be designed as a requirement for regulatory approval)*; public funding of R&D including grants, research contracts, advance purchase agreement, tax exemptions and credits and other measures of monetary value*; performance data from diagnostic tests*; manufacturing costs*; supplier/manufacturing capacity; country and multicountry procurement contracts including the list and net prices paid for medical countermeasures*; terms of the non-disclosure agreements between suppliers, government and private employers; volumes of vaccines/treatments procured and available nationally/regionally; price structures/components; manufacturing and acquisition costs of diagnostic tests.
With respect to strategic stockpiles, Article 6.2(c) states that each Party [shall]/[should]: “Enhance countries’ and regional logistical capacities to establish and maintain strategic stockpiles of pandemic response products;”
In relation to raw materials and active pharmaceutical ingredients, Article 6.2(d) calls on State parties to:
Allocate supplies, raw materials and other necessary inputs for sustainable production of pandemic response products (especially active pharmaceutical ingredients) including for stockpiling purposes, through the most efficient multilateral and regional purchasing mechanisms, including pooled mechanisms and in-kind contributions, based on public health needs, by means that include:
(i) measures that address the restriction of distribution of pandemic response products
Article 7 of the conceptual zero draft deals with access to technology: promoting sustainable and equitably distributed production and transfer of technology and know-how.
Article 7.1 states:
The Parties [shall]/[should] develop multilateral mechanisms, particularly during inter-pandemic times, that promote and provide relevant transfer of technology and know-how, in a manner consistent with international legal frameworks, to potential manufacturers in developing countries/all regions to increase and strengthen regional and global manufacturing capacity.
Article 7.2 stresses that each Party [shall]/[should] “strengthen local capacity, particularly in developing countries and regional groups, to manufacture pandemic response products through transfer of technology and know-how in order to ensure rapid and equitable access to adequate global supplies that meet surge demand, including by encouraging innovative options, by means that include:
(i) measures to strengthen coordination, including trilateral cooperation among the World Health Organization, the World Trade Organization and the World Intellectual Property Organization, as well as other relevant United Nations agencies, on issues related to public health, intellectual property and trade, including timely matching of supply to demand, and mapping manufacturing capacities and demand
(ii) innovative mechanisms and incentives to promote transfer of technology and knowhow, including through technology transfer hubs and product development partnerships, and to address the short timeframe in which new pandemic response products are developed and needed, by means that include:
(a) measures to incentivise the development of pandemic response products, including incentives targeted at developing countries
(iii) measures to encourage, incentivize, and facilitate participation of private-sector entities in voluntary transfer of technology and know-how through collaborative initiatives and multilateral mechanisms
(iv) measures to support time-bound waivers of protection of intellectual property rights that are a barrier to manufacturing of pandemic response products during pandemics
(v) measures to fully reflect the flexibilities provided in the TRIPS Agreement, including those recognized in the Doha Declaration on the TRIPS Agreement and Public Health and in Articles 27, 30 (including the research exception and “Bolar” provision), 31 and 31bis of the TRIPS Agreement
(vi) measures to ensure an available, skilled and trained manufacturing workforce that is ready to support local production, through scaling up of training and capacity of training institutions, upon request
Article 7.2(b) focuses on strengthening regulatory authorities’ capacities including, “where appropriate, regional regulatory authorities’ capacities, to prepare for and accelerate emergency licensing and approval procedures, grounded in evidence-based procedures and evaluation”.
On the specifics, Article 7.2(b) calls on State parties to engage in:
(i) measures to build and strengthen the capacity of regulatory authorities and increase the harmonization of regulatory requirements at the international and regional level, including through mutual recognition agreements
(ii) measures to build and strengthen country regulatory capacities for timely approval of products for pandemic prevention, preparedness, response and recovery of health systems
(iii) measures to accelerate the process of licensing and approving pandemic response products for emergency use in a timely manner, including the sharing of regulatory dossiers
(iv) measures to monitor and regulate against sub-standard and falsified pandemic response products, through existing Member State mechanisms.
In relation to increasing R&D capacities, Article 8.1 states:
The Parties [shall]/[should] build and strengthen capacities and institutions for innovative research and development, particularly in developing countries, by means that include scientific and technical cooperation, collaboration and communication, consistent with national and international biosafety and biosecurity standards, guidelines and regulations. Publicly funded research and development for pandemic prevention, preparedness, and response [shall]/[should] include conditions on prices of products, allocation, data sharing and transfer of technology, as appropriate.
Paragraph 8.2(a)(iii)(a) of the conceptual zero draft calls for:
measures to support the collective development and use of principles and norms and sets of practices that ensure that public financing of research and development for pandemic response products results in more equitable access and affordability, including through conditions on distributed manufacturing, licensing, technology transfer and pricing policies
In terms of indemnity and liability, Articles 8.2(iii)(b) and Articles 8.2(iii)(c) conceptual zero draft state:
(b) measures to limit indemnity or confidentiality clauses in commercial pandemic response product contracts between countries and manufacturers, taking into account public financing in research and development
(c) measures to ensure that promoters of research for pandemic response products assume part of the risk (liability) when the products or supplies are in the research phase, and that making access to such pandemic response products or supplies conditional on a waiver of such liability is discouraged
With respect to developing “strong, resilient national, regional and international clinical research ecosystems, Article 8.2(c) contains the following provisions:
(i) measures to foster and coordinate national, regional and international high quality clinical research/trials
(ii) measures to ensure equitable access to investment in clinical trials, so that resources are deployed optimally and efficiently
(iii) measures to support the transparent and rapid reporting of clinical research/trial results, to ensure evidence is available in a timely manner to inform national, regional and international decision-making
(iv) measures related to disclosure of disaggregated information on research and development and clinical trials of vaccines, diagnostics, pharmaceuticals and other products relevant to pandemic preparedness and response
Perhaps one of the most consequential provisions in the conceptual zero draft is Article 8(d) on increasing R&D capacities. In particular, the text requests Parties to the Pandemic Treaty to issue “recommendations to make it compulsory for companies that produce pandemic response products to disclose prices and contractual terms for public procurement in times of pandemics.” In addition, the pandemic treaty conceptual zero draft requests Member States to increase transparency through “measures related to the disclosure of information on public funding for research and development of potential pandemic response products and provisions to enhance the availability and accessibility of the resulting work, including freely available and publicly accessible publications and public reporting of the relevant patents.”
This is a robust and welcome implementation of the WHO transparency resolution, WHA72.8.
Article 9 of the conceptual zero draft addresses fair, equitable and timely access and benefit-sharing.
Article 9.1 states:
The Parties [shall]/[should] develop provisions on access and benefit-sharing to promote rapid and transparent sharing, in a safe and secure manner, of pathogens with pandemic potential and genetic sequence data on the one hand, and fair and equitable access to benefits arising from such sharing on the other, by establishing a comprehensive system for access and benefit-sharing, taking into account relevant elements of the Convention on Biological Diversity and its Nagoya Protocol, including by building upon or adapting mechanisms and/or principles contained in existing or previous instruments, such as, but not limited to, the FAO International Treaty on Plant Genetic Resources for Food and Agriculture and the WHO Pandemic Influenza Preparedness Framework.
Article 9.2 refers to ensuring “timely access to affordable, safe, efficacious and effective pandemic response products, including diagnostics, vaccines, personal protective equipment and therapeutics” but the language to operationalize this is somewhat nebulous.
(i) measures to ensure their equitable distribution, in particular to developing countries according to public health risk and need
(ii) measures to develop national plans that identify priority populations and prioritize access to pandemic response products by health care workers, other frontline workers and persons in vulnerable situations, such as, indigenous peoples, refugees, migrants, asylum seekers and stateless persons, the elderly, persons with disabilities, persons with health conditions, pregnant women, infants, children and adolescents
In relation to promoting and facilitating recognition of a specialized system for access and benefit-sharing, Article 9.2(b) states:
(i) measures to engage with all relevant actors in the design, development and implementation of the system for access and benefit-sharing
(ii) commitments to facilitate real-time access by all countries to pandemic response products, based on public health need
With respect to facilitating the rapid, regular and timely sharing of pathogens, genetic sequence data, Article 9.2(c) of the conceptual zero draft states:
(b) Promote and facilitate recognition of the system as a specialized system for access and benefit-sharing, by means that include:
(i) measures to engage with all relevant actors in the design, development and implementation of the system for access and benefit-sharing
(ii) commitments to facilitate real-time access by all countries to pandemic response products, based on public health need