Human path blog

March 14, 2024

NINTH MEETING OF THE INTERGOVERNMENTAL NEGOTIATING BODY TO DRAFT AND NEGOTIATE A WHO CONVENTION, AGREEMENT OR OTHER

INTERNATIONAL INSTRUMENT ON PANDEMIC PREVENTION, PREPAREDNESS AND RESPONSE

A/INB/9/3

Provisional agenda item 2

13 March 2024

Revised draft of the negotiating text of the WHO Pandemic Agreement

The Parties to the WHO Pandemic Agreement,

Recognizing that the World Health Organization is fundamental to strengthening pandemic prevention, preparedness and response, as it is the directing and coordinating authority on international health work,

Recalling the Constitution of the World Health Organization, which states that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition,

Recognizing that the international spread of disease is a global threat with serious consequences for lives, livelihoods, societies and economies that calls for the widest possible international cooperation in an effective, coordinated, appropriate and comprehensive international response, while reaffirming the principle of sovereignty of States in addressing public health matters,

Deeply concerned by the gross inequities at national and international levels that hindered timely and equitable access to medical and other coronavirus disease (COVID-19) pandemic-related products, and the serious shortcomings in pandemic preparedness,

Recognizing the critical role of whole-of-government and whole-of-society approaches at country and community levels, and the importance of international, regional and cross-regional collaboration, coordination and global solidarity in achieving sustainable improvements in pandemic prevention, preparedness and response,

Recognizing the importance of ensuring political commitment, resourcing and attention across sectors for pandemic prevention, preparedness and response,

Reaffirming the importance of multisectoral collaboration at national, regional and international levels to safeguard human health, including through a One Health approach,

Reiterating the need to work towards building and strengthening resilient health systems, with skilled and trained health and care workers, to advance universal health coverage and to adopt an equitable approach to mitigate the risk that pandemics exacerbate existing inequities in access to health services,

Recognizing that the protection of intellectual property rights is important for the development of new medical products, and recalling that intellectual property rights do not, and should not, prevent Member States from taking measures to protect public health, and further recognizing concerns about the effects of intellectual property rights on prices,

Recognizing Member States’ sovereign rights over their genetic resources and underscoring the importance of promoting the early, safe, transparent and rapid sharing of samples and genetic sequence data of pathogens with pandemic potential, as well as the fair and equitable sharing of benefits arising therefrom, taking into account relevant national and international laws, regulations, obligations and frameworks,

Acknowledging that unequal development in different countries in the promotion of health and control of disease, especially communicable disease, is a common danger that requires support through international collaboration, and that pandemic prevention, preparedness and response at all levels and in all sectors, particularly in developing countries, requires predictable, sustainable and sufficient financial, human, logistic and technical resources,

Have agreed as follows:

Chapter I. Introduction Article 1. Use of terms

For the purposes of the WHO Pandemic Agreement:

“biological materials” means clinical samples, specimens, isolates and cultures, either original or processed, of a pathogen;
“genetic sequence” means the order of nucleotides identified in a molecule of DNA or RNA, and contains the genetic information that determines the biological characteristics of an organism or a virus;

“genetic sequence data” means the order of nucleotides found in a molecule of DNA or RNA;¹

“manufacturer” means any entity that produces, for commercial purposes, including by means of licensing agreements, diagnostics, therapeutics or vaccines for infectious diseases;
“One Health approach” means an integrated, unifying approach that aims to sustainably balance and optimize the health of people, animals and ecosystems. It recognizes that the health of humans, domestic and wild animals, plants and the wider environment (including ecosystems) is closely linked and interdependent;
“PABS sequence databases” means publicly accessible databases that meet and agree to legally binding terms of reference that include arrangements to notify users of benefit-sharing provisions under the PABS system;

“pandemic-related products” means products that are needed for pandemic prevention, preparedness and response, which may include, without limitation, diagnostics, therapeutics, vaccines and personal protective equipment;
“Party” means a State or regional economic integration organization that has consented to be bound by this Agreement, in accordance with its terms, and for which this Agreement is in force;

“pathogen with pandemic potential” means any pathogen that has been identified to infect a human and that is: novel (not yet characterized) or known (including a variant of a known pathogen), potentially highly transmissible and/or highly virulent with the potential to cause a public health emergency of international concern;

“persons in vulnerable situations” means individuals, groups or communities with a disproportionate increased risk of infection, severity, disease or mortality in the context of a pandemic;

1 Definition might need to be adjusted following finalization of the negotiation within CBD on the scope of Digital Sequence Information, DSI, that, in addition to DNA and RNA, might include proteins and metabolites.

“regional economic integration organization” means an organization that is composed of several sovereign states and to which its Member States have transferred competence over a range of matters, including the authority to make decisions binding on its Member States in respect of those matters;¹
“relevant diagnostic, therapeutic or vaccine” means a diagnostic, therapeutic or vaccine that is prequalified by WHO or has received a positive WHO Emergency Use Listing assessment or an authorization from a national regulatory authority for treatment, diagnosis or prevention of a disease in relation to which WHO has declared a public health emergency of international concern or characterized as a pandemic;
“universal health coverage” means that all people have access to the full range of quality health services they need, when and where they need them, without financial hardship. It covers the full continuum of essential health services, from health promotion to prevention, treatment, rehabilitation and palliative care; and
“WHO-coordinated laboratory network” means laboratory alliances or networks coordinated by WHO in which each laboratory meets WHO standards and agrees to legally binding terms of reference that include arrangements to notify users of biological materials for pathogens with pandemic potential of benefit sharing provisions under the PABS system.

Article 2. Objective

The objective of the WHO Pandemic Agreement, guided by equity, and the principles and approaches set forth herein, is to prevent, prepare for and respond to pandemics.

Article 3. Principles

To achieve the objective of the WHO Pandemic Agreement and to implement its provisions, the Parties will be guided, inter alia, by the following:

full respect for the dignity, human rights and fundamental freedoms of all persons, and the enjoyment of the highest attainable standard of health of every human being;
the sovereign right of States to adopt, legislate and implement legislation, within their jurisdiction, in accordance with the Charter of the United Nations and the general principles of international law, and their sovereign rights over their biological resources;
equity as the goal and outcome of pandemic prevention, preparedness and response, ensuring the absence of unfair, avoidable or remediable differences among groups of people;
common but differentiated responsibilities and respective capabilities in pandemic prevention, preparedness, response and recovery of health systems;
solidarity, transparency and accountability to achieve the common interest of a more equitable and better prepared world to prevent, respond to and recover from pandemics; and
the best available science and evidence as the basis for public health decisions for pandemic prevention, preparedness and response.

1 Where appropriate, “national” will refer equally to regional economic integration organizations.

Chapter II. The world together equitably: achieving equity in, for and through pandemic prevention, preparedness and response

Article 4. Pandemic prevention and surveillance

The Parties commit to take measures to progressively strengthen pandemic prevention and coordinated multisectoral surveillance, taking into account national capacities and national and regional circumstances.

The Parties shall undertake to cooperate:

in the implementation of the provisions of this Article, in particular through enhancing financial and technical support to developing countries; and

in support of relevant global and/or regional initiatives aimed at preventing pandemics, in particular those that improve surveillance, early warning and risk assessment; promote evidence- based actions, risk communication and community engagement; and identify settings and activities presenting a risk of emergence and re-emergence of pathogens with pandemic potential.

Each Party commits to progressively strengthen pandemic prevention and coordinated multisectoral surveillance, taking into account its national capacities, including through:

coordinated multisectoral surveillance: (i) detect and conduct risk assessments of emerging or re-emerging pathogens, including pathogens in animal populations that may present significant risks of zoonotic spill-over, in accordance with the International Health Regulations (2005); and

(ii) share the outputs of relevant surveillance and risk assessments within their territories with WHO and other relevant agencies;

community-based early detection and control measures: leverage community capacities, networks and mechanisms to detect unusual public health events and contain them at the source;
water, sanitation and hygiene: strengthen efforts to ensure access to safe water, sanitation and hygiene, including in hard-to-reach settings;

infection prevention and control: implement active infection prevention and control measures in all health care facilities and institutions, in line with relevant international standards and guidelines;

zoonotic spill-over and spill-back prevention: (i) identify settings and activities that create or increase the risk of disease emergence and re-emergence at the human–animal–plant–environment interface; (ii) take measures to reduce risks of zoonotic spill-over and spill-back associated with these settings and activities, including measures aimed at safe and responsible management of wildlife, farm and companion animals, in line with relevant international standards and guidelines;

laboratory biosafety and biological risk management: develop, strengthen and maintain biosafety and biological risk management, in particular with regard to laboratories and research facilities, in order to prevent the accidental exposure, misuse or inadvertent release of pathogens, consistent with applicable international and national rules, standards and guidelines;

vector-borne disease surveillance and prevention: develop, strengthen and maintain capacity to conduct risk assessments of vector-borne diseases that may lead to pandemic situations; and

antimicrobial resistance (AMR): take measures to address pandemic-related risks associated with the emergence and spread of pathogens that are resistant to antimicrobial agents, including through the development and implementation of national and, where relevant, regional antimicrobial resistance action plans, taking into account relevant international guidelines, and with the aim of facilitating affordable and equitable access to antimicrobials.

To implement the provisions in this Article, each Party shall:

taking into account national capacities, ensure that relevant national, and where applicable regional, action plans, policies and/or strategies, include comprehensive, coordinated and multisectoral pandemic prevention measures and surveillance;
develop, strengthen and maintain pandemic prevention capacities to complement the core capacities for surveillance, prevention and response as set out in the International Health Regulations (2005); and

take into account recommendations, guidelines and standards developed and adopted by WHO and other relevant intergovernmental organizations or bodies, in the development of relevant national and, where applicable, regional policies, strategies and measures to prevent pandemics.

The Parties recognize that environmental, climatic, social, anthropogenic and economic factors increase the risk of pandemics and endeavour to identify these factors and take them into consideration in the development and implementation of relevant policies, strategies and measures, including by strengthening synergies with other relevant international instruments and their implementation.

The Conference of the Parties may adopt, as necessary, guidelines, recommendations and standards, including in relation to pandemic prevention capacities, to support the implementation of this Article.

Article 5. One Health approach to pandemic prevention, preparedness and response

The Parties commit to promote a One Health approach for pandemic prevention, preparedness and response that is coherent, comprehensive, integrated, coordinated and collaborative among relevant actors and sectors.

For this purpose, each Party shall, taking into account its national circumstances and capacities, take measures to:

implement relevant national policies, strategies and measures that reflect a One Health approach;

promote the effective and meaningful engagement of communities in the development and implementation of policies, strategies and measures to prevent, detect and respond to zoonotic outbreaks; and

promote or establish, as necessary, One Health workforce training and continuing education programmes for public health, animal health and environment sectors, to build complementary skills, capacities and capabilities.

The Parties shall contribute to the further development and updating of international standards and guidelines to detect, reduce risks of, monitor and manage zoonotic spill-over and spill-back, in collaboration with WHO and relevant intergovernmental organizations.
The Parties shall develop and implement or strengthen, as appropriate, bilateral, subregional, regional and other multilateral mechanisms to enhance financial and technical support, assistance and cooperation, in particular in respect of developing countries, in relation to promoting and taking measures towards One Health.

Article 6. Preparedness, health system resilience and recovery

Each Party commits to develop, strengthen and maintain its health system, including primary health care, for pandemic prevention, preparedness and response, taking into account the need for equity and resilience, with a view to the progressive realization of universal health coverage.

Each Party commits, in accordance with applicable laws and regulations, to strengthen and reinforce health system functions, including by adopting and/or developing policies, plans, strategies and measures, as appropriate, for:

sustaining and monitoring the timely provision of, and equitable access to, quality routine and essential health services during pandemics with a focus on primary health care, routine immunization and mental health care, and with particular attention to persons in vulnerable situations;

developing, strengthening and maintaining health infrastructure as well as public and animal health institutions, including academic and research centres, at national, regional and international levels;

developing post-pandemic health system recovery strategies;

developing, strengthening and maintaining, as necessary, public health, animal health and environmental laboratory and diagnostic capacities, and associated national, regional and global networks, through the application of relevant standards and protocols for laboratory biosafety and biological risk management;
developing, strengthening and maintaining: health information systems for early detection, forecasting, and timely information sharing; civil registration and vital statistics; and associated digital health and data science capacities; and

promoting the use of social and behavioural sciences, risk communication and community engagement for pandemic prevention, preparedness and response.

The Parties commit to cooperate, within means and resources at their disposal, and with the support of the WHO Secretariat and other relevant organizations, in order to provide or facilitate financial, technical and technological support, assistance, capacity-strengthening and cooperation, in particular in respect of developing countries.

The Parties shall identify and promote relevant international data standards and interoperability that enable timely sharing of public health data for preventing, detecting and responding to public health events.

Article 7. Health and care workforce

Each Party, in accordance with its national circumstances, commits to take, where appropriate, the necessary measures to safeguard, protect, invest in, retain and sustain an adequate, skilled and trained health and care workforce, with the aim of strengthening capacities for pandemic prevention, preparedness and response, while maintaining quality essential health services and essential public health functions during pandemics. To this end, each Party commits, where appropriate, to:

protect the safety and security of the health and care workforce, including through strengthening decent work conditions, addressing mental health and well-being, ensuring priority access to necessary tools and supplies, including to pandemic-related products during pandemic emergencies, as well as addressing harassment, violence and threats against health and care workers;

address disparities, inequalities, discrimination, stigma and bias, including issues related to gender and youth and unequal remuneration and opportunities, such as barriers faced by women to reaching leadership and decision-making roles, within the health and care workforce particularly during health emergencies, to support the meaningful representation, engagement, consultation, participation and empowerment of all health and care workers;

establish and maintain national workforce planning systems and strategies to rapidly, effectively and efficiently deploy health and care workers to maintain quality essential health services and essential public health functions, prior to and during pandemics;

take measures to ensure self-sufficiency in health and care workforce education, employment and retention in advance of public health emergencies; and
strengthen, pre- and in- service competency-based education and training, deployment, remuneration, distribution and retention, including in rural and hard-to-reach areas, of the health and care workforce.

The Parties commit to assist and provide financial and technical support within means and resources at their disposal to other Parties in need, with special attention to the needs of countries that are particularly vulnerable to the adverse effects of pandemics, in order to strengthen and sustain a skilled and competent health and care workforce capable of maintaining quality essential health services, essential public health functions and emergency preparedness and response, at subnational, national and regional levels.

The Parties commit to collaborate, where appropriate, through multilateral and bilateral arrangements and consistent with the WHO Global Code of Practice on the International Recruitment of Health Personnel and other applicable international norms, codes and standards, promoting ethical, international recruitment principles and equity, to minimize the negative impact of health workforce migration on health systems while respecting the freedom of movement of health professionals.

The Parties, building on existing bilateral and multilateral networks, shall invest in establishing, sustaining, coordinating and mobilizing a skilled and trained multidisciplinary global public health emergency workforce that is able to manage health emergencies closest to where they start. For this

purpose, Parties shall invest in designating, at national and where appropriate regional level, interdisciplinary emergency health teams to ensure the essential functions and surge capacities necessary to deploy in a pandemic emergency and to support Parties upon request. Parties having established emergency health teams should inform WHO thereof and make best efforts to respond to requests for deployment by Parties affected by a pandemic emergency to which they are not able to fully respond with their national resources.

The Parties shall develop or strengthen, leveraging or building on existing national and regional education institutions, centres of excellence and networks, a skilled and competent health and care workforce at subnational, national and regional levels, with the capacity to maintain quality essential health services, essential public health functions and to respond rapidly to public health threats of pandemic potential.

Each Party commits to take the necessary steps to ensure decent work conditions and a safe and healthy environment for other essential workers that provide essential public goods and services during pandemics.

Article 8. Preparedness monitoring and functional reviews

The Parties shall, building on existing and relevant tools, develop and implement an inclusive, transparent, effective and efficient pandemic prevention, preparedness and response monitoring and evaluation system.

Each Party shall assess, every five years, with technical support from the WHO Secretariat upon request, the functioning and readiness of, and gaps in, its pandemic prevention, preparedness and response capacity, based on the relevant tools and guidelines developed by WHO in partnership with relevant organizations at international, regional and subregional levels.

Article 9. Research and development

The Parties shall cooperate to build, strengthen and sustain national, regional and international capacities and institutions for research and development, particularly in developing countries, and shall promote scientific collaboration for the rapid sharing of information and access to research results and outcomes, including through open science approaches.

To this end, the Parties shall promote:

sustained investment in research and development for public health priorities, including for pandemic-related products, and support for research institutions and networks that can rapidly adapt and respond to research and development needs in the event of a pandemic emergency;

technology co-creation and joint venture initiatives that engage the participation of, and international collaboration among, scientists and/or research centres, particularly from developing countries, including from the public and, as appropriate, private sector;

innovative research and development, including community-led and cross-sector collaboration, for addressing pathogens with pandemic potential;

equitable access to research knowledge, evidence synthesis, knowledge translation and evidence-based communication tools, strategies and partnerships, relating to pandemic prevention, preparedness and response;

capacity-building programmes, projects and partnerships, and substantial and sustained support for research and development, including basic and applied research, such as early-stage research, product discovery, pre-clinical and translational research;

international collaboration and coordination, including with the private sector, to set common objectives, research goals and priorities, to develop pandemic-related products for diverse populations and settings, with a central role for WHO;
access for scientists and researchers, particularly from developing countries, to relevant international scientific research programmes, projects and partnerships, including those referred to in this Article, as well as scientific publications;

the sharing of information on national research agendas, capacity-building activities, and research and development priorities during pandemic emergencies; and

research on the causes and effects of pandemics, on their prevention and management, including: (i) the epidemiology of emerging diseases, factors driving disease spill-over or emergence, and behavioural science; (ii) public health and social interventions used to control pandemics and their effect on the spread of disease and the burden imposed by these measures on society, including its economic cost; and (iii) relevant health products, with the aim of promoting equitable access, including their timely availability, affordability and quality.

The Parties shall, in accordance with national circumstances and mindful of relevant international standards, take steps to strengthen international coordination and collaboration to support well-designed and well-implemented clinical trials, by developing, strengthening and sustaining clinical trial capacities and research networks at the national, regional and international levels.

The Parties shall support new and existing mechanisms to facilitate the rapid reporting and interpretation of data from clinical trials, to develop or modify, as necessary, relevant clinical trial guidelines, including during a pandemic.
Each Party shall, in accordance with national law, support the transparent and public sharing of research inputs and outputs from research and development of government-funded pandemic-related products, including scientific publications with data shared and stored securely.

Each Party shall develop national policies to:

include provisions in government-funded research and development agreements for the development of pandemic-related products that promote timely and equitable global access to such products during public health emergencies of international concern and pandemics. Such provisions may include: (i) licensing and/or sublicensing, preferably on a non-exclusive basis;

(ii) affordable pricing policies; (iii) technology transfer on voluntary terms; (iv) publication of relevant information on research inputs and outputs; and/or (v) adherence to product allocation frameworks adopted by WHO; and

publish relevant terms of government-funded research and development agreements promoting equitable and timely access to such products during a pandemic emergency.

Article 10. Sustainable and geographically diversified production

The Parties commit to achieving a more equitable geographical distribution and scaling up of the global production of pandemic-related products, and increasing sustainable, timely, fair and equitable access to such products, as well as reducing the potential gap between supply and demand during pandemics.

The Parties, in collaboration with WHO and other relevant organizations, shall:

take measures, in cooperation with regional organizations, to provide support, maintain and strengthen production facilities at national and/or regional levels, particularly in developing countries, and to facilitate scaling up of production of pandemic-related products during emergencies, including through promoting and/or incentivizing public and private investment aimed at creating or expanding economically viable manufacturing facilities of relevant health products;

facilitate the continuous and sustainable operations of the facilities referred to in subparagraph 2(a) of this Article, including through promoting transparency of relevant unprotected information on pandemic-related products and raw materials across the value chain;

facilitate the transfer of relevant technology, know-how, and licences pooled in relevant mechanisms (as referred to in Article 11), including during interpandemic times, to ensure the sustainability of the facilities referred to in subparagraph 2(a) of this Article;

take measures, and encourage international organizations, to establish long-term contracts and make investments, especially in developing countries’ facilities preferably with a regional scope of operation, to ensure regular production of pandemic-related products produced by local and regional manufacturers;

facilitate and support authorization of pandemic-related products produced by the facilities referred to in subparagraph 2(a) of this Article; and

support and/or facilitate skills development, capacity-building and other initiatives for production facilities.

Each Party shall promote public and private sector investments aimed at creating or expanding manufacturing facilities for pandemic-related products, especially regional manufacturers based in developing countries.

Article 11. Transfer of technology and know-how

In order to enable sufficient, sustainable and geographically-diversified production of pandemic-related products each Party, taking into account its national circumstances, shall:

promote and otherwise facilitate or incentivize the transfer of technology and know-how for both pandemic-related and routine health products, including through the use of licensing and collaboration with regional or global technology transfer partnerships and initiatives, and in particular for the benefit of developing countries and for technologies that have received public funding for their development;

promote the timely publication by private rights holders of the terms of licensing agreements and/or technology transfer agreements for pandemic-related products, in accordance with national laws;

make available licences, on a non-exclusive, worldwide and transparent basis and for the benefit of developing countries, for government-owned pandemic-related products, and shall publish the terms of these licences at the earliest reasonable opportunity and in accordance with national laws; and

provide, within its capabilities, support for capacity-building for the transfer of technology and know-how for pandemic-related products.

The Parties shall develop and strengthen, as appropriate, mechanisms coordinated by WHO with the participation of other relevant technology transfer mechanisms as well as other relevant organizations, to promote and facilitate the transfer of technology and know-how for pandemic-related products to geographically diverse research and development institutes and manufacturers, particularly in developing countries, through the pooling of knowledge, intellectual property, know-how and data to all developing countries.

During pandemics, in addition to the undertakings in paragraph 1 of this Article, each Party shall:

encourage holders of relevant patents regarding pandemic-related products, in particular those who received public funding, to forgo or otherwise charge reasonable royalties to developing country manufacturers for the use, during the pandemic, of their technology and know-how for the production of pandemic-related products; and
consider supporting, within the framework of relevant institutions, time-bound waivers of intellectual property rights to accelerate or scale up the manufacturing of pandemic-related products to the extent necessary to increase the availability and adequacy of affordable pandemic-related products.

The Parties that are WTO Members recognize that they have the right to use to the full, the flexibilities inherent in the TRIPS Agreement as reiterated in the Doha Declaration on the TRIPS Agreement and Public Health of 2001, which provide flexibility to protect public health including in future pandemics, and shall fully respect the use thereof by others.
Each Party shall, as necessary and appropriate, review and update its national legislation in order to ensure the implementation of such flexibilities referred to in paragraph 4 of this Article in a timely and effective manner.

The WHO Secretariat shall work towards the improvement of access to pandemic-related products, especially during pandemic emergencies, through transfer of technology and know-how, including through cooperation with relevant international organizations.

Article 12. Access and benefit sharing

The Parties hereby establish a multilateral system for access and benefit sharing for pathogens with pandemic potential: the WHO Pathogen Access and Benefit-Sharing System (PABS System).
The PABS System aims to ensure rapid, systematic and timely access to biological materials of pathogens with pandemic potential and the genetic sequence data (GSD) for such pathogens, which

contributes to strengthened global surveillance and risk assessment, and facilitates research, innovation and development of health products; and on an equal footing, equitable, fair and rapid sharing of monetary and non-monetary benefits, including timely, effective and predictable access to relevant diagnostics, therapeutics or vaccines, based on public health risks, needs and demand, contributing to the rapid and timely control of public health emergencies of international concern and pandemics.

When a Party has access to a pathogen with pandemic potential, it shall, using applicable biosafety, biosecurity and data protection standards:

share with WHO any pathogen sequence information as soon as it is available to the Party;

as soon as biological materials are available to the Party, provide the materials to one or more laboratories and/or biorepositories participating in WHO-coordinated laboratory networks (CLNs), which meet the legally binding terms of reference, as referenced below, with an electronic label of “PABS biological material” which will follow through to the end products and/or publications, and shall notify users of biological materials of the benefit-sharing provisions under the PABS System, recognizing that each Party may also share such biological materials to entities outside the CLNs. All users of biological materials shall have legal obligations under PABS regarding benefit sharing; and

as soon as pathogen GSD is available to the Party, upload the GSD and relevant metadata to one or more PABS sequence databases (SDBs) which meet the legally binding terms of reference, as referenced below, an electronic label of “PABS GSD” which will follow through to the end products and/or publications, and shall notify the users of GSD of the benefit-sharing provisions under the PABS System, recognizing that each Party may also share such GSD outside the SDBs. All users of GSD shall have legal obligations under PABS regarding benefit-sharing.

The Parties consent to the further transfer and use of biological materials and GSD provided to the CLNs and SDBs, with an electronic label of “PABS biological material” or “PABS GSD”, in accordance with the provisions of this Article including on benefit sharing, as well as applicable biosafety, biosecurity and data protection standards. Parties agree that intellectual property rights may not be sought on such materials and GSD.

The Parties agree that WHO shall develop, in accordance with the relevant templates to be developed by the Parties, as referenced in paragraph 11 of this Article, as well as consistent with the WHO regulations for study, scientific groups, collaborating institutions and other mechanisms of collaboration, legally binding terms of reference for the CLNs and SDBs with arrangements to notify the users of biological materials and GSD of the benefit-sharing provisions of the PABS system.

WHO shall conclude legally binding standard PABS contracts with manufacturers to provide the following, taking into account the size, nature and capacities of the manufacturer:

annual monetary contributions to support the PABS System and relevant capacities in countries; the determination of the annual amount, use, and approach for monitoring and accountability, shall be finalized by the Parties;
real-time contributions of relevant diagnostics, therapeutics or vaccines produced by the manufacturer, 10% free of charge and 10% at not-for-profit prices during public health emergencies of international concern or pandemics, to be made available through the Network established under Article 13 for use on the basis of public health risks, needs and demand; and

voluntary non-monetary contributions, such as capacity-building activities, scientific and research collaborations, non-exclusive licensing agreements, arrangements for transfer of technology and know-how in line with Article 11, tiered pricing for relevant diagnostics, therapeutics or vaccines.

The Parties agree on the following benefit-sharing provisions to be applied to users of biological materials and GSD shared through the CLNs and SDBs:

entities that use biological materials and GSD shared through the CLNs and SDBs for commercial purposes, other than for the manufacture of diagnostics, therapeutics or vaccines, are to support the PABS System through voluntary contributions, taking into account the size, nature and capacities of the entity, such as monetary contributions, capacity-building activities, non-exclusive licensing agreements, arrangements for transfer of technology and know-how in line with Article 11, and/or scientific and research collaborations; and

entities that use biological materials and GSD shared through the CLNs and SDBs for non-commercial purposes are to acknowledge the providers of the biological materials and GSD in relevant presentations or publications; contribute to public dissemination and transparency of research results; and, as appropriate, taking into account the size, nature and capacities of the entity, actively engage in scientific and academic collaborations, training and capacity-building activities, and consider voluntary monetary contributions to support the PABS System.

Each Party, in respect of such a user operating within its jurisdiction, shall take all appropriate steps, in accordance with its relevant laws and circumstances, to encourage such a user to provide benefits in accordance with subparagraphs (a) and (b) of this Article.

The Parties shall cooperate and take appropriate measures, such as conditions in public procurements or on public financing of research and development, prepurchase agreements, or regulatory procedures, to encourage and facilitate as many manufacturers as possible to enter into standard PABS contracts as early as possible.
During a pandemic, each Party in a position to do so shall, within available resources and subject to applicable laws and in line with Article 13, set aside a portion of its total procurement of relevant diagnostics, therapeutics or vaccines in a timely manner for use in countries facing challenges in meeting public health needs and demand for relevant diagnostics, therapeutics or vaccines.
To support operationalization of the PABS System, WHO shall maintain updated lists of CLNs and SDBs, as well as of known pathogens that are pathogens with pandemic potential. WHO shall report regularly to the Parties on the conclusions of standard PABS contracts, and shall make such contracts public, while respecting commercial confidentiality. WHO shall use measures such as prequalification and the WHO Emergency Use Listing procedure to promote the PABS System and encourage manufacturers to conclude standard PABS contracts.

Templates for the standard PABS contracts and for legally binding terms of reference agreements with CLNs and SDBs shall be developed by the Parties.
The Parties who are Parties to the Convention on Biological Diversity and its Nagoya Protocol recognize that the PABS System, when fully operational, is consistent with and does not run counter to the objectives of the Nagoya Protocol; shall function as a specialized international access and benefit-sharing instrument; and is the applicable access and benefit-sharing system for biological

materials and GSD for pathogens with pandemic potential. Accordingly, each such Party shall take effective legislative, executive, administrative or other measures at the appropriate government level to give effect to this recognition. Parties who are not Parties to the Convention on Biological Diversity and its Nagoya Protocol shall take such measures with respect to any relevant domestic legislation to ensure alignment with the objectives and implementation of this provision.

The Parties shall cooperate to support the effective operation of the PABS System, including by taking all necessary steps to facilitate the shipment of biological materials, and the export of necessary health products during a public health emergency of international concern or pandemic, in accordance with applicable international law.

The Conference of the Parties shall regularly review the operation, monitor adherence and effectiveness of the PABS System and shall take the decisions necessary to promote and support its effective and sustainable implementation.

Article 13. Supply chain and logistics

The Global Supply Chain and Logistics Network (the Network) is hereby established. The Network shall be developed, coordinated and convened by WHO in partnership with the Parties and other relevant international and regional stakeholders, and shall be guided by the principles of equity, transparency, inclusivity, timeliness, fairness and consideration of public health needs. The Network shall pay particular attention to the needs of developing countries, including those in fragile and humanitarian settings.

The Conference of the Parties shall, at its first meeting, define the structure and modalities of the Network, which shall aim at ensuring the following:

collaboration among the Parties and other relevant stakeholders during and between pandemics;

assignment of functions to stakeholders based on competencies and expertise; and

accountability and transparency in the functioning of the Network.

The Parties shall periodically review the operationalization of the Network, including the support provided by Parties and other stakeholders during and between pandemics.

The functions of the Network shall include:

identifying the types of pandemic-related products and estimating the quantities needed and anticipated demand for robust pandemic prevention, preparedness and response;
identifying the sources of safe, effective and quality assured pandemic-related products, including raw materials and potential surge capacities as well as developing and maintaining a tool for this purpose;

identifying, assessing, keeping under review and facilitating the most efficient means of procuring quality pandemic-related products, potentially including pooled procurement and/or advance purchase agreements, to enhance equitable, timely and affordable access to these products;

promoting transparency in cost, pricing and other relevant data on products, including raw materials, across the value chain;
promoting and coordinating within the Network to avoid competition for resources among international procuring entities, including regional organizations and/or mechanisms;
collaborating with relevant national authorities and organizations/institutions, as appropriate, and taking into account national and regional circumstances to establish, strengthen and maintain national, regional and/or international stockpiles of various pandemic-related products, including stockpiles earmarked for humanitarian settings, as well as to maintain related logistic capacities and assess them at regular intervals;

facilitating the equitable allocation of pandemic-related products, including those procured through the facilitation by the Network, acquired through the PABS or donated by countries as referred to in Article 13bis, paragraph 2, based on public health risks and needs, and taking into account factors, such as population size, demographic structure, epidemiological situation and health system capabilities of beneficiary countries and their readiness and capacity to utilize such products;

facilitating the most efficient delivery and distribution of pandemic-related products, including, as appropriate, through regional stockpiles, consolidation hubs and staging areas, while taking into account specific requirements for these pandemic-related products, including in humanitarian settings; and

assisting countries in meeting the requirements for the effective utilization of specific pandemic-related products, as needed and requested.

The WHO, as the convenor of the Network, shall report regularly to the Conference of the Parties on all matters relevant to the implementation of this Article.

Article 13bis: National procurement- and distribution-related provisions

Each Party shall publish the terms of its government-funded purchase agreements for pandemic-related products at the earliest reasonable opportunity and in accordance with applicable laws, and shall exclude confidentiality provisions that serve to limit such disclosure. Each Party shall also encourage [regional and global purchasing mechanisms] to do the same.

Each Party, in accordance with national laws, shall include provisions in government-funded purchase agreements for pandemic-related products that promote timely and equitable global access to such products, such as provisions that:

permit the donation of such products outside of its territories;

facilitate potential modifications in order to address supply gaps around the world;

incentivize or otherwise encourage licensing and other transfer of technology, in particular for the benefit of developing countries; and

incentivize or otherwise encourage the formulation and sharing of global access plans for the products.

The Parties recognize the importance of ensuring that any emergency trade measures designed to respond to a pandemic are targeted, proportionate, transparent and temporary, and do not create unnecessary barriers to trade or unnecessary disruptions in supply chains.

The Parties commit to ensure rapid and unimpeded access of humanitarian relief personnel, as well as their means of transport, supplies and equipment, in accordance with international humanitarian law, and to respect the principles of humanity, neutrality, impartiality and independence of recognized humanitarian organizations for the provision of humanitarian assistance.

Whenever possible, each Party shall take appropriate measures to promote rational use and reduce waste of pandemic-related products, including through the sharing of products, and taking into account the circumstances of recipient countries.
Each Party shall ensure that any national stockpiles do not unnecessarily exceed quantities needed for domestic public health emergency preparedness and response.
Whenever possible, when sharing pandemic emergency response with countries, organizations, or any mechanism that is facilitated by the Network, each Party shall abide by the following:

The selection and shelf life of pandemic emergency response-related products are data driven and in alignment with identified needs and the distribution and administration/dispensing timelines and capabilities of the recipients;

Prospective recipients are made aware of any expiration dates, availability of the products, and required ancillaries as far in advance as possible;
As appropriate, sharing Parties coordinate with each other and with other global or regional access mechanisms, to maximize allocation to populations with the highest risk and greatest public health need and to facilitate rapid absorption/administration;

Products shared with global or regional access mechanisms are unearmarked for greatest effectiveness and to support long-term planning;

Sharing Parties release products in large volumes and in a predictable manner, in order to reduce transaction costs and facilitate recipient planning; and

Shared products are accompanied by essential ancillaries and coordinated with the availability of support for distribution and administration, to ensure rapid allocation and absorption.

Each Party shall facilitate the effective distribution, delivery and administration of pandemic-related products in its domestic market.

Article 14. Regulatory systems strengthening

Each Party shall strengthen its national and, where appropriate, regional regulatory authority responsible for the authorization and approval of pandemic-related products, including through technical assistance and/or cooperation with WHO, other Parties and relevant organizations, as appropriate, with the aim of evaluating and monitoring the quality, safety and efficacy of such products.

Each Party shall take steps to ensure that it has legal, administrative and financial frameworks, as appropriate, in support of:

issuing emergency authorizations and approvals for pandemic-related products and/or, as appropriate, regulatory reliance processes for the timely authorization and approvals of such products, consistent with national law, as well as systems to provide oversight of the quality, safety and efficacy of those products; and
monitoring adverse events of such products through effective pharmacovigilance and post-marketing surveillance.

The Parties shall, as appropriate, monitor and strengthen rapid alert systems against substandard and falsified pandemic-related products.
Each Party shall, consistent with national laws, encourage manufacturers of pandemic-related products, as appropriate, to generate and submit in a timely manner, relevant data and diligently pursue regulatory authorizations, approvals and/or prequalification of pandemic-related products with WHO, WHO listed authorities and other authorities as appropriate.

Each party shall, in accordance with national laws, with the aim of enhancing transparency and regulatory reliance, make publicly available and keep updated in a timely manner:

information on national and, if applicable, regional regulatory processes for authorizing or approving use of pandemic-related products; and

information on the pandemic-related products that it has authorized or approved, based on quality, efficacy and safety, and any other information on which the decision was based.

The Parties encourage WHO to facilitate access to the information referred to in this paragraph.

Each Party shall endeavour to, subject to national laws:

adopt, where needed, regulatory reliance processes in its national regulatory frameworks for use during pandemic emergencies, taking into account relevant guidelines;

converge and/or align and, where possible, harmonize relevant technical and regulatory requirements, in accordance with applicable international standards and guidance; and

provide support to help strengthen national regulatory authorities’ and regional regulatory systems’ ability to respond to pandemic emergencies, as appropriate, through efforts such as technical assistance, capacity-building, training and information exchange consistent with national law.

Each Party may consider adopting, within the limits of its national legislation, policies and legal practices, guidance and technical documents concerning medical products from relevant international regulatory harmonization initiatives or organizations and other relevant global or regional regulatory forums.

The Parties shall undertake to cooperate, to the extent possible, directly or indirectly and/or through relevant international bodies including WHO and other relevant partners, to support and

improve regulatory capacity with the goal of enhancing the maturity level of the regulatory bodies, as assessed by WHO, and facilitating equitable geographical distribution and scaling up of the global production of medical products.

Article 15. Liability and compensation management

Each Party shall consider developing, as necessary and in accordance with applicable law, national strategies for managing liability in its territory related to pandemic vaccines and shall make such strategies publicly available. Strategies may include, inter alia, legal and administrative frameworks; no-fault compensation mechanisms, potentially funded by private sector contributions; policies and other approaches for the negotiation of procurement and/or donation agreements.

The Parties, within the framework of the Conference of the Parties, in collaboration with relevant entities and multilateral organizations, as appropriate, shall develop recommendations for the establishment and implementation of national, regional and/or global no-fault compensation mechanisms and strategies for managing liability during pandemic emergencies, including with regard to individuals that are in a humanitarian setting or vulnerable situations.

Article 16. International collaboration and cooperation

The Parties shall collaborate and cooperate in global coordinated actions, with WHO and other relevant international organizations, as well as among themselves, in pandemic prevention, preparedness and response, and in the implementation of this Agreement.

The Parties shall:

promote global, regional and national political commitment, coordination and leadership for pandemic prevention, preparedness and response;
ensure that policy decisions are science- and evidence-based;

promote equitable representation as well as equal and meaningful participation in national, regional and global decision-making processes; and
provide support to countries, upon request, through multilateral and bilateral partnerships that focus on developing capacities for effectively addressing health needs for pandemic prevention, preparedness and response; and develop measures aimed at preventing the stigmatization of, and promoting solidarity with, countries that report public health emergencies.

Article 17. Whole-of-government and whole-of-society approaches

The Parties are encouraged to adopt whole-of-government and whole-of-society approaches, including to empower and enable community ownership of, and contribution to, community readiness for and resilience to pandemic prevention, preparedness and response.

Each Party shall establish or strengthen, and maintain, a national coordination multisectoral body for pandemic prevention, preparedness and response.

Each Party shall, taking into account its national circumstances, promote the effective and meaningful engagement of communities, and other relevant stakeholders, as part of a whole-of-society approach in planning, decision-making, implementation, monitoring and evaluation, and shall also provide effective feedback opportunities.

Each Party shall develop, in accordance with national context, comprehensive national pandemic prevention, preparedness and response plans that address pre-, post- and interpandemic periods that, inter alia:

identify and prioritize, as appropriate, populations, based on public health risk and need, for access to pandemic-related products and health services;

support the timely and scalable mobilization of the multidisciplinary surge capacity of human and financial resources, and facilitate the timely allocation of resources to the frontline pandemic response;
review the status of stockpiles and the surge capacity of essential public health and clinical resources, and surge capacity in the production of pandemic-related products;
facilitate the rapid and equitable restoration of public health capacities and routine and essential health services during and following a pandemic; and

promote collaboration with relevant stakeholders, including the private sector and civil society, avoiding all forms of conflicts of interest, in a transparent manner.

Each Party, based on national capacities, shall take the necessary steps to address the social, environmental and economic determinants of health and shall work to prevent or mitigate the socioeconomic impacts of pandemics.
Each Party shall take appropriate measures to strengthen national public health and social policies to facilitate a rapid, resilient response to pandemics, especially for persons in vulnerable situations, including by mobilizing social capital in communities for mutual support.

Article 18. Communication and public awareness

Each Party shall promote timely access to credible and evidence-based information on pandemics and their causes, effects and drivers, with the aim of countering and addressing misinformation or disinformation, particularly through risk communication and effective community-level engagement.
The Parties shall, as appropriate, promote and/or conduct research and inform policies on factors that hinder or strengthen adherence to public health and social measures in a pandemic, as well as trust in science and public health institutions and agencies.

The Parties shall promote and apply science- and evidence-based approaches to effective and timely risk assessment, and culturally appropriate public communications.

The Parties shall exchange information and cooperate, in accordance with national law, in preventing misinformation and disinformation, and endeavour to develop best practices to increase the accuracy and reliability of crisis communications.

Article 19. Implementation and support

The Parties shall cooperate, directly and/or through relevant regional or international bodies, to sustainably strengthen pandemic prevention, preparedness and response capacities in countries, particularly developing countries, which are Parties to the WHO Pandemic Agreement or the International Health Regulations (2005) (hereinafter referred to collectively as “Cooperating Parties”),

taking into account especially the needs of developing countries, while closely coordinating support provided under this Article with the provision of support under the International Health Regulations (2005). Such cooperation shall promote the sharing or transfer of technology and technical, scientific and legal expertise, as well as financial assistance and support for capacity-strengthening to those Cooperating Parties which lack the means and resources to implement the provisions of this Agreement.

The Parties shall, upon request, facilitate the provision of technical assistance and support for those Cooperating Parties that have requested such assistance or support, in particular developing countries, either bilaterally or through relevant regional and/or international organizations.

The WHO Secretariat supporting the WHO Pandemic Agreement and the International Health Regulations (2005), following the guidance of the governing bodies, in collaboration, as appropriate, with relevant regional and international organizations and other relevant bodies, shall provide assistance to all countries that so request, particularly developing countries, and organize the technical and financial assistance necessary to address such gaps and needs in implementing the commitments agreed upon under the WHO Pandemic Agreement and the International Health Regulations (2005).

Article 20. Sustainable financing

The Parties commit to working together to strengthen sustainable financing for health emergencies as well as for pandemic prevention, preparedness and response. In this regard, each Party, within the means and resources at its disposal, shall:

prioritize and maintain or increase, as necessary, domestic funding for pandemic prevention, preparedness and response, without undermining other domestic public health priorities including for: (i) strengthening and sustaining capacities for the prevention, preparedness and response to health emergencies and pandemics, in particular the core capacities of the International Health Regulations (2005); (ii) implementing national plans, programmes and priorities; and (iii) strengthening health systems resilience;

mobilize financial resources through all sources, including existing and new bilateral, subregional, regional and multilateral funding mechanisms, to assist in particular developing country Parties, in the implementation of the WHO Pandemic Agreement, including through grants and concessional loans;

promote, within relevant bilateral, regional and/or multilateral mechanisms, innovative financing measures, including but not limited to debt relief, based on transparent financial reprogramming plans for pandemic prevention, preparedness, response and recovery of health-system related actions, for affected countries whose debt payment might affect expenditures on pandemic prevention, preparedness and response, and in the case of pandemics, take measures for debt relief, including the suspension of debt servicing and debt cancellation; and

encourage governance and operating models of existing financing entities to minimize the burden on countries, offer improved efficiency and coherence at scale, enhance transparency and be responsive to the needs and national priorities of developing countries.

The governing bodies of the Cooperating Parties shall adopt, every five years a Financial and Implementation Strategy on pandemic prevention, preparedness and response. The Parties, particularly those providing financial support for the strengthening of pandemic prevention, preparedness and response, shall align with the Financial and Implementation Strategy while financing the relevant funding mechanisms, both within and outside WHO.

A Coordinating Financial Mechanism (the “Mechanism”) is hereby established to support the implementation of both the WHO Pandemic Agreement and the International Health Regulations (2005) in a sustainable, predictable, inclusive and transparent manner and accountable to the governing bodies of the Cooperating Parties. The mechanism aims to increase the effectiveness and efficiency of existing and future financial mechanisms, including by providing additional financial resources to strengthen and expand capacities for pandemic prevention, preparedness and response in Cooperating Parties, in particular in developing country Parties.

The Mechanism shall include a pooled fund to provide financing to support, strengthen and expand capacities for pandemic prevention, preparedness and response, and as necessary for day zero surge response, in Cooperating Parties that require financial support. The fund may include sources from monetary contributions received as part of operations of the PABS System, voluntary funds from both States and non-State actors and other contributions to be agreed upon by the Conference of the Parties.

The Mechanism will also promote harmonization and coordination for financing pandemic prevention, preparedness and response and International Health Regulations related capacities.

The Mechanism shall, inter alia:

identify financing instruments and mechanisms that are available to serve the purposes of pandemic prevention, preparedness and response, and maintain a dashboard of such instruments and related information such as eligibility criteria, modalities and levels of funding available, priorities and process requirements, including financial contributions made by Parties and non-State actors, as applicable, to such instruments, and the funds allocated to countries from such instruments;

establish, as necessary, following a mandate from the Conference of the Parties, working arrangements with relevant identified financing instruments and entities to facilitate their alignment with the Financial and Implementation Strategy;

provide advice and support, upon request, to Cooperating Parties in identifying and applying in order to obtain access to financial resources in accordance with national pandemic prevention, preparedness and response priorities and identified needs;

assess the availability of funds, and support the mobilization of financial resources free from conflict of interest; and

conduct relevant analyses on needs and gaps, in addition to tracking cooperation efforts, to inform the development of the Financial and Implementation Strategy, guide Cooperating Parties and recommend course corrections as necessary.

The Mechanism, including its fund, shall function under the authority and guidance of the Conference of the Parties and be accountable to it. The Conference of the Parties shall adopt modalities for the operationalization of the Mechanism, including eligibility criteria and the establishment of a governing board of the Mechanism, with balanced representation of WHO regions and developed and developing country Parties, within 12 months after the entry into force of the WHO Pandemic Agreement.

The Conference of the Parties shall periodically review the effectiveness of the Mechanism, such as policies, operational modalities and activities, and its first revision should be carried out no less than two years after its establishment.

Chapter III. Institutional and final provisions Article 21. Conference of the Parties

A Conference of the Parties is hereby established.

The Conference of the Parties shall keep under regular review, every three years, the implementation of the WHO Pandemic Agreement and take the decisions necessary to promote its effective implementation. To this end, it shall:

consider reports submitted by the Parties in accordance with Article 23 and adopt regular reports on the implementation of the WHO Pandemic Agreement;
oversee any subsidiary bodies, including by establishing their rules of procedure and working modalities;

promote and facilitate the mobilization of financial resources for the implementation of the WHO Pandemic Agreement, in accordance with Article 20;

consider and review developed countries’ reports on their contribution to the implementation of the WHO Pandemic Agreement or any other assistance offered towards developing countries and reports submitted by such parties or countries on receiving such offers, their acceptance, rejection or implementation, both submitted pursuant to Article 19 and provide specific recommendations to the parties concerned on enhancing such cooperation and assistance;

invite, where appropriate in order to strengthen the implementation of the WHO Pandemic Agreement, the services and cooperation of, and information provided by, competent and relevant organizations and bodies of the United Nations system and other international and regional intergovernmental organizations and nongovernmental organizations and bodies;

promote, including by establishing appropriate processes, cooperation and coordination with and among relevant legal instruments and frameworks and relevant global, regional, subregional and sectoral bodies, with a view to promoting coherence among efforts for pandemic prevention, preparedness and response;

provide guidance to the WHO Director-General and to Parties, on effective implementation of the WHO Pandemic Agreement including the matters considered in subparagraphs 2(a) and 2(d) of this Article; and

consider other actions, as appropriate, for the achievement of the objective of the WHO Pandemic Agreement in the light of experience gained in its implementation.

The first session of the Conference of the Parties shall be convened by the World Health Organization not later than one year after the entry into force of the WHO Pandemic Agreement. The Conference of the Parties will determine the venue and timing of subsequent regular sessions at its first session.

Extraordinary sessions of the Conference of the Parties shall be held at such other times, as may be deemed necessary by the Conference of the Parties, or at the written request of any Party, provided that, within six months of the request being communicated in writing to the Parties by the Secretariat, it is supported by at least one third of the Parties.

The Conference of the Parties shall adopt by consensus its Rules of Procedure at its first session.

The Conference of the Parties shall establish the criteria for the participation of observers at its proceedings.

The Conference of the Parties shall by consensus adopt financial rules for itself as well as governing the funding of any subsidiary bodies it may establish as well as financial provisions governing the functioning of the Secretariat. At each ordinary session, it shall adopt a budget for the financial period until the next ordinary session.

The Conference of the Parties may establish subsidiary bodies, as it deems necessary, and on terms and modalities to be defined by the Conference of the Parties.

Article 22. Right to vote

Each Party to the WHO Pandemic Agreement shall have one vote, except as provided for in paragraph 2 of this Article.

A regional economic integration organization that is Party to the WHO Pandemic Agreement, in matters within its competence, shall exercise its right to vote with a number of votes equal to the number of their Member States that are Parties to the WHO Pandemic Agreement. Such a regional economic integration organization shall not exercise its right to vote if any of its Member States exercises its right to vote, and vice versa.

Article 23. Reports to the Conference of the Parties

Each Party shall submit to the Conference of the Parties, through the Secretariat, periodic reports on its implementation of the WHO Pandemic Agreement.
The frequency and format of the reports submitted by all Parties shall be determined by the Conference of the Parties.
The Conference of the Parties shall adopt appropriate measures to assist Parties, upon request, in meeting their obligations under this Article, with particular attention to the needs of developing country Parties.

The reporting and exchange of information under the WHO Pandemic Agreement shall be subject to national law regarding confidentiality and privacy. The Parties shall protect, as mutually agreed, any confidential information that is exchanged.

Article 24. Secretariat

Secretariat functions for the WHO Pandemic Agreement shall be provided by the WHO Secretariat.

Secretariat functions shall be to:

provide technical, administrative and logistic support to the Conference of the Parties and its subsidiary bodies as may be established under the WHO Pandemic Agreement or by the Conference of the Parties for the purpose of the implementation of the WHO Pandemic Agreement;

make arrangements for the sessions of the Conference of the Parties and its subsidiary bodies and to provide them with services, as required;

transmit reports and other relevant information regarding the implementation of the WHO Pandemic Agreement received by it pursuant to the WHO Pandemic Agreement;

provide support to the Parties, upon request, particularly developing country Parties, in implementing the WHO Pandemic Agreement, including the compilation and communication of information required in accordance with the provisions of the WHO Pandemic Agreement or pursuant to requests of the Conference of the Parties;

prepare reports on its activities under the WHO Pandemic Agreement under the guidance of the Conference of the Parties, and to submit them to the Conference of the Parties;
ensure, under the guidance of the Conference of the Parties, the necessary coordination with the Secretariats of other competent international organizations, regional intergovernmental organizations, and other bodies;

enter, under the guidance of the Conference of the Parties, into such administrative or contractual arrangements as may be required for the effective discharge of its functions; and

perform other secretariat functions specified by the WHO Pandemic Agreement and such other functions as may be determined by the Conference of the Parties or assigned to it under the WHO Pandemic Agreement.

Nothing in the WHO Pandemic Agreement shall be interpreted as providing the WHO Secretariat, including the WHO Director-General, any authority to direct, order, alter or otherwise prescribe the domestic laws or policies of any Party, or to mandate or otherwise impose any requirements that Parties take specific actions, such as ban or accept travellers, impose vaccination mandates or therapeutic or diagnostic measures, or implement lockdowns.

Article 25. Settlement of disputes

In the event of a dispute between two or more Parties concerning the interpretation or application of the WHO Pandemic Agreement, the Parties concerned shall seek through diplomatic channels a settlement of the dispute through negotiation or any other peaceful means of their own choice, including good offices, mediation or conciliation. Failure to reach a solution by good offices, mediation or conciliation shall not absolve the parties to the dispute from continuing to seek to resolve it.

When ratifying, accepting, approving, formally confirming or acceding to the WHO Pandemic Agreement, or at any time thereafter, a Party may declare in writing to the Depositary that, for a dispute not resolved in accordance with paragraph 1 of this Article, it accepts, as compulsory ad hoc arbitration in accordance with the Permanent Court of Arbitration Rules of 2012.

The provisions of this Article shall apply with respect to any protocol as between the Parties to the protocol, unless otherwise provided therein.

Article 26. Relationship with other international agreements and instruments

The interpretation and application of the WHO Pandemic Agreement shall be guided by the Charter of the United Nations and the Constitution of the World Health Organization.
The Parties recognize that the WHO Pandemic Agreement and the International Health Regulations should be interpreted so as to be compatible.
The provisions of the WHO Pandemic Agreement shall not affect the rights and obligations of any Party under other legally binding international instruments to which it is party.

Article 27. Reservations

Reservations may be made to the WHO Pandemic Agreement unless incompatible with the object and purpose of the WHO Pandemic Agreement.
Notwithstanding paragraph 1 of this Article, no reservation may be made to Article XX, Article YY, or Article ZZ of the WHO Pandemic Agreement.

Article 28. Declarations and statements

Article 27 does not preclude a State or regional economic integration organization, when signing, ratifying, approving, accepting or acceding to the WHO Pandemic Agreement, from making declarations or statements, however phrased or named, with a view, inter alia, to the harmonization of its laws and regulations with the provisions of the WHO Pandemic Agreement, provided that such declarations or statements do not purport to exclude or to modify the legal effect of the provisions of the WHO Pandemic Agreement in their application to that State or regional economic integration organization.

A declaration or statement made pursuant to this Article shall be circulated by the Depositary to all Parties to the WHO Pandemic Agreement.

Article 29. Amendments

Any Party may propose amendments to the WHO Pandemic Agreement, including its annexes and protocols. Such amendments shall be considered by the Conference of the Parties.
The Conference of the Parties may adopt amendments to the WHO Pandemic Agreement. The text of any proposed amendment to the WHO Pandemic Agreement shall be communicated to the Parties by the Secretariat at least six months before the session at which it is proposed for adoption. The Secretariat shall also communicate proposed amendments to the signatories of the WHO Pandemic Agreement and, for information, to the Depositary.

The Parties shall make every effort to adopt any proposed amendment to the WHO Pandemic Agreement by consensus. If all efforts at consensus have been exhausted and no agreement has been reached, the amendment may as a last resort be adopted by a three-quarters majority vote of the Parties present and voting at the session. For the purposes of this Article, Parties present and voting means Parties present and casting an affirmative or negative vote. Any adopted amendment shall be communicated by the Secretariat to the Depositary, which shall circulate it to all Parties for acceptance.

Instruments of acceptance in respect of an amendment shall be deposited with the Depositary. An amendment adopted in accordance with paragraph 3 of this Article shall enter into force, for those Parties having accepted it, on the ninetieth day after the date of receipt by the Depositary of an instrument of acceptance by at least two thirds of the Parties to the WHO Pandemic Agreement.

An amendment shall enter into force for any other Party on the ninetieth day after the date on which that Party deposits with the Depositary its instrument of acceptance of the said amendment.

Article 30. Annexes

Annexes to the WHO Pandemic Agreement shall be proposed, adopted and shall enter into force in accordance with the procedure set forth in Article 29.
Annexes to the WHO Pandemic Agreement shall form an integral part thereof and, unless otherwise expressly provided, a reference to the WHO Pandemic Agreement constitutes at the same time a reference to any annexes thereto.

Article 31. Protocols

Any Party may propose protocols to the WHO Pandemic Agreement. Such proposals shall be considered by the Conference of the Parties.
The Conference of the Parties may adopt protocols to the WHO Pandemic Agreement. In adopting these protocols, every effort shall be made to reach consensus. If all efforts at consensus have been exhausted and no agreement has been reached, the protocol may as a last resort be adopted by a three quarters majority vote of the Parties present and voting at the session. For the purposes of this Article, Parties present and voting means Parties present and casting an affirmative or negative vote. In the event that a protocol is proposed for adoption under Article 21 of the Constitution of the World Health Organization, it shall further be considered for adoption by the Health Assembly.
The text of any proposed protocol shall be communicated to the Parties by the Secretariat at least six months before the session of the Conference of the Parties at which it is proposed for adoption.
States that are not Parties to the WHO Pandemic Agreement may be Parties to a protocol, provided the protocol so provides.
Any protocol to the WHO Pandemic Agreement shall be binding only on the Parties to the protocol in question. Only Parties to a protocol may take decisions on matters exclusively relating to the protocol in question.
The requirements for entry into force of any protocol shall be established by that instrument.

Article 32. Withdrawal

At any time after two years from the date on which the WHO Pandemic Agreement has entered into force for a Party, that Party may withdraw from the Agreement by giving written notification to the Depositary.
Any such withdrawal shall take effect upon expiry of one year from the date of receipt by the Depositary of the notification of withdrawal, or on such later date as may be specified in the notification of withdrawal.

A State shall not be discharged by reason of the withdrawal from the obligations which accrued while it was a Party to the WHO Pandemic Agreement, nor shall the withdrawal affect any right, obligation or legal situation of that State created through the execution of this Agreement prior to its termination for that State.
Any Party that withdraws from the WHO Pandemic Agreement shall be considered as also having withdrawn from any protocol to which it is a Party, unless the said protocol requires its Parties to formally withdraw in accordance with its relevant terms.

Article 33. Signature

This Agreement shall be open for signature by all States, and by regional economic integration organizations.
This Agreement shall be open for signature at the World Health Organization headquarters in Geneva, following its adoption by the World Health Assembly at its Seventy-seventh session, from XX May 2024 to XX June 2024, and thereafter at United Nations Headquarters in New York, from XX June 2024 to XX June 2025.

Article 34. Ratification, acceptance, approval, formal confirmation or accession

The WHO Pandemic Agreement shall be subject to ratification, acceptance, approval or accession by all States and to formal confirmation or accession by regional economic integration organizations. This Agreement shall be open for accession from the day after the date on which the Agreement is closed for signature. Instruments of ratification, acceptance, approval, formal confirmation or accession shall be deposited with the Depositary.

Any regional economic integration organization that becomes a Party to the WHO Pandemic Agreement, without any of its Member States being a Party shall be bound by all the obligations under the WHO Pandemic Agreement. In the case of those regional economic integration organizations for which one or more of its Member States is a Party to the WHO Pandemic Agreement, the regional economic integration organization and its Member States shall decide on their respective responsibilities for the performance of their obligations under the Agreement. In such cases, the regional economic integration organization and its Member States shall not be entitled to exercise rights under the WHO Pandemic Agreement concurrently.

Regional economic integration organizations shall, in their instruments relating to formal confirmation or in their instruments of accession, declare the extent of their competence with respect to the matters governed by the WHO Pandemic Agreement. These organizations shall also inform the Depositary, who shall in turn inform the Parties, of any substantial modification in the extent of their competence.

Article 35. Entry into force

This Agreement shall enter into force on the thirtieth day following the date of deposit of the fortieth instrument of ratification, acceptance, approval, formal confirmation or accession with the Depositary.

For each State that ratifies, accepts or approves the WHO Pandemic Agreement or accedes thereto after the conditions set forth in paragraph 1 of this Article for entry into force have been fulfilled, the WHO Pandemic Agreement shall enter into force on the thirtieth day following the date of deposit of its instrument of ratification, acceptance, approval or accession.

For each regional economic integration organization depositing an instrument of formal confirmation or an instrument of accession after the conditions set forth in paragraph 1 of this Article for entry into force have been fulfilled, the WHO Pandemic Agreement shall enter into force on the thirtieth day following the date of deposit of its instrument of formal confirmation or of accession.

For the purposes of this Article, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by Member States of that regional economic integration organization.

Article 36. Depositary

The Secretary-General of the United Nations shall be the Depositary of the WHO Pandemic Agreement and amendments thereto and of any protocols and annexes adopted in accordance with the terms of the WHO Pandemic Agreement.

Article 37. Authentic texts

The original of the WHO Pandemic Agreement, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary-General of the United Nations.

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