EXCLUSIVE: Next Draft of The Pandemic Agreement Will Likely Have No Fund and No Binding Obligations On Pathogen Access & Benefits Sharing, Defers Modalities to Conference of Parties
Newsletter Edition #80 [Treaty Talks]
Hi,
Today we bring you a preview of a draft version of the new proposed negotiating text from the Bureau of the Intergovernmental Negotiating Body (INB) working towards a Pandemic Agreement.
A new proposal for a negotiating text text is due to be published this week, as early as later today. This draft version that we discuss today is close to what is expected to be presented, sources suggest.
In this edition, we look at a few contentious provisions and bring you the latest formulation - as drafted by the Bureau of the INB. The draft proposal seen and examined by Geneva Health Files, was workshopped in certain regions, and had not yet been officially shared when this story went to print.
We are unable to publish this draft version in these pages ahead of this being shared officially with member states and other stakeholders. Given reader interest, we discuss parts of it here.
On March 29, we reported that the INB may come up with a streamlined text. The current draft version is about 20 pages in its latest form. Whether countries will endorse this version to begin text-based negotiations later this month, is not clear yet.
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I. EXCLUSIVE:
Next Draft of The Pandemic Agreement Will Likely Have No Fund and No Binding Obligations On Pathogen Access And Benefits Sharing, Defers Modalities to Conference of Parties
A draft version of the proposed negotiating text for a Pandemic Agreement, currently being discussed internally, has no reference to a dedicated fund that would help implementation of new obligations on pandemic prevention, preparedness and response. Such a pooled fund previously articulated in a prior text was also meant to help finance existing obligations under the International Health Regulations.
The draft version of a proposed new text from the Bureau of the Intergovernmental Negotiating Body, also merges the provision on technology transfer with the article on sustainable production; and it merges parts of the language on compensation and liability management with the provision on supply chain and procurement.
And importantly, it presents a streamlined version on the Pathogens Access and Benefits Sharing provision with effectively no binding provisions on benefits, and kicks the can down the road, with modalities to be finalised two years in May 2026.
Both on the matters of financing, PABS, Supply Chain Network among other areas, the modalities have been proposed to be left for a future date to be addressed by a Conference of Parties.
In other key changes, the word “waiver” has disappeared but has been replaced with “time-bound suspensions of relevant intellectual property rights” to encourage manufacturing.
This draft version of the negotiating text is effectively about 20 pages in length, streamlined from the 30-odd pages from the version on March 8th. But recall that countries had painstakingly added text to the March 8th version, swelling it more 100 pages. And yet, it appears much of those suggestions did not make the final proposed text from the Bureau. Whether countries will fight back to put their language in, yet again, is not clear.
Sources familiar with the process told Geneva Health Files that the draft version was presented to some regional blocs and certain delegations in recent days. A final version based on this draft, is expected to be shared with member states later today. Initially it was expected that such a text would be published only on April 18th.
We reported earlier, that a streamlined text from the Bureau will be presented, in an effort to coalesce countries to accept what looks like a framework convention approach with broad principles, and details to be hashed out in due course by a Conference of Parties. There are only a handful of negotiating days left to conclude these negotiations.
In this story, we bring you a quick update on this draft, cite and discuss key provisions that have been contentious over the last two years. We only discuss significant omissions over the previous draft, and any additions of note in this new version. (Emphasis in bold ours)
NEW CHANGES IN THE DRAFT
The preambular paragraphs do refer to differences in the level of development, but the principle of Common but Differentiated Responsibilities that existed in a prior version has been dropped.
Under definitions, there is a placeholder for a “digital sequence information” – a new term following the Brazilian proposal on PABS during the previous meeting.
The objective of the agreement is limited to govern pandemics, although there were efforts to broaden the scope.
Under principles, both CBDR, and reference to “respect to international humanitarian law” for PPR have been omitted. (There is reference to “recognizing different levels of capacities and capabilities”)
On surveillance measures
Articles 4,5 and 6 that delve into prevention, surveillance, One Health and preparedness measures, spell out a series of obligations.
See 4.2:
“2. Each Party shall develop, strengthen, implement, periodically update and review comprehensive multisectoral national pandemic prevention and public health surveillance plans that are consistent with and supportive of the effective implementation of the IHR (2005), and in accordance with its capabilities, which cover, inter alia:
(a) collaborative surveillance;
(b) community-based early detection and control measures;
(c) water, sanitation and hygiene;
(d) infection prevention and control;
(e) zoonotic spillover and spillback prevention;
(f) laboratory biosafety and biological risk management, in order to prevent the accidental exposure to, misuse or inadvertent release of pathogens;
(g) vector-borne disease surveillance and prevention; and
(h) antimicrobial resistance (AMR) to address pandemic-related risks associated with the emergence and spread of pathogens that are resistant to antimicrobial agents.”
On One Health, the draft suggests additional time:
“5.4: The Parties shall further define the modalities, terms and conditions, and operational dimensions of prevention and a One Health approach in an instrument, that takes into consideration the provisions of the IHR (2005), and is operational no later than 31 May 2027.”
See 6.4:
“.4. The Parties, collaborating with WHO and relevant international organizations, shall endeavour to identify and promote, in accordance with national law, relevant international data standards and interoperability that enable timely sharing of public health data for preventing, detecting and responding to public health events.”
On Research and Development:
Article 9. Research and development
On R&D, the latest version has language on referring to “developing countries”. On conditionalities to public-funded research, the draft does not propose a binding obligation.
1. The Parties shall cooperate to build, strengthen and sustain geographically diverse capacities and institutions for research and development, particularly in developing countries, based on a shared agenda, and shall promote research collaboration and access to research through open science approaches for the rapid sharing of information and results, especially during pandemics.
2. To this end, the Parties shall promote:
(a) sustained investment in research and development for public health priorities;
(b) technology co-creation and joint venture initiatives, actively engaging the participation of scientists and/or research centres from developing countries; and
(c) participation of relevant stakeholders, consistent with applicable biosafety and biosecurity obligations, laws, regulations and guidance, to accelerate innovative research and development.
3. 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, and facilitating the rapid reporting and interpretation of data from such trials.
4. Each Party shall ensure that government-funded research and development agreements for development of pandemic-related products include provisions that promote timely and equitable access to such products and shall publish the relevant terms. 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.
Merging production and technology transfer:
After scores of informal consultations on technology transfer on what was then Article 11, the draft version has merged this contentious provision with the one on sustainable production.
The text envisages roles of existing entities, also safeguarding prevailing status quo on technology transfer on Voluntary and Mutually Agreed Terms - a much debated standard in the context of these discussions.
Articulation on waivers of IP rights have been replaced with “time-bound suspensions of relevant intellectual property rights”.
Article 10. Sustainable and geographically diversified production, and technology transfer and know-how
“The Parties commit to achieving more equitable geographical distribution and scaling up of the global production of pandemic-related health 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, through voluntary transfer of relevant technology and know-how on mutually agreed terms.
1. The Parties, in collaboration with WHO and other relevant organizations, shall:
(a) take measures to provide support for, maintain and strengthen facilities at national and regional levels, particularly in developing countries that have conducted disease burden studies relevant to pathogens with pandemic potential, with a view to ensuring the sustainability of such investments, for the production, or scaling up of production, of pandemic-related health products;
(b) take measures to identify and contract with manufacturers other than those referenced in paragraph 2(a) of this Article, for scaling up the production of pandemic-related health products, during pandemics, in cases where the production and supply capacity of the production facilities does not meet demand;
(c) actively support, participate in and/or implement, as appropriate, relevant WHO technology, skills and know-how transfer programmes to facilitate strategically and geographically distributed production of pandemic-related health products; and
(d) promote and incentivize public and private sector investments and/or partnerships aimed at creating or expanding manufacturing facilities or capacities for pandemic-related health products, especially facilities with a regional operational scope that are based in developing countries.
2. Each Party, in addition to the undertakings in paragraph 2 of this Article, shall:
(a) promote and otherwise facilitate or incentivize the transfer of technology and know-how for pandemic-related health products, in particular for the benefit of developing countries and for technologies that have received public funding for their development, through a variety of measures such as licensing on voluntary and mutually agreed terms;
(b) publish the terms of its licenses for pandemic-related health technologies in a timely manner and in accordance with applicable law, and shall encourage private rights holders to do the same;
(c) encourage research and development institutes and manufacturers, in particular those receiving significant public financing, to forgo or reduce, for a limited duration, royalties on the use of their technology for the production of pandemic-related health products;
(d) promote the voluntary transfer of relevant technology and related know-how for pandemic-related health products, by private rights holders, on fair and most favourable terms, including on concessional and preferential terms and in accordance with mutually agreed terms and conditions, to established regional or global technology transfer hubs or other multilateral mechanisms or networks, as well as the publication of the terms of such agreements;
(e) encourage holders of relevant patents that received public funding, and where appropriate, other holders of relevant patents for pandemic-related health products, to forgo royalties or otherwise license any relevant patents at reasonable royalties to developing country manufacturers for the use, during the pandemic, of their technology and know-how for the production of pandemic-related health products; and
(f) encourage manufacturers within its jurisdiction to share as appropriate, during pandemics, information that is relevant to the production of pandemic-related health products when the withholding of such information prevents or hinders urgent manufacture of a pharmaceutical product that is necessary to respond to the pandemic.
3. During pandemics consider supporting, within the framework of relevant institutions, time-bound suspensions of relevant intellectual property rights to accelerate or scale up the manufacturing of pandemic-related health products.
4. The Parties that are WTO Members reaffirm that they have the right to use, to the full, flexibilities in the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health of 2001, which provide flexibility to protect public health in future pandemics, and the use of such TRIPS flexibilities shall not be challenged or undermined.
5. The Parties shall, working through the Conference of the Parties, establish regional or global technology and know-how transfer hubs, coordinated by WHO, to increase and geographically diversify the transfer of technology and know-how for the production of pandemic-related health products, by manufacturers in developing countries.”
Pathogen Access and Benefits Sharing
On arguably the most important set of provisions, the language on PABS has been cut down to five broad paragraphs, down from 14 in the previous draft. As we reported yesterday, it does not reflect the nuts and bolts of operationalising the mechanism, and leaves this up for negotiation for a year more.
The trickiest issues of governance, access conditions to users have been left unaddressed, with a nod to open science and sharing information without strings attached. This is, while there are no binding obligations to ensuring benefits.
Article 12. Access and benefit sharing
1. A multilateral access and benefit sharing system for pathogens with pandemic potential, the “WHO Pathogen Access and Benefit-Sharing System” (PABS System), shall be established to ensure rapid, systematic and timely sharing of PABS Material and Information (as such term is defined in this Pandemic Agreement) for public health risk assessment, and, on an equal footing, timely, effective, predictable and equitable access to pandemic-related health products, and other benefits, both monetary and non-monetary, arising from such sharing.
2. The PABS System shall have the following foundations, in addition to the principles set out in Article 3 of this Agreement:
(a) the commitment of Parties to share, on an equal footing, PABS Material and Information and the benefits arising therefrom, considering these as equally important parts of the collective action for global public health;
(b) its universal application for the protection of all people of the world from the international spread of disease;
(c) its implementation in a manner to strengthen, expedite and not impede research and innovation;
(d) its implementation in a manner to ensure mutual complementarity with the Pandemic Influenza Preparedness Framework; the development of a robust, inclusive, transparent, Member State-led, and science-based governance, review, and accountability mechanism(s); and
(e) consistency with the objectives of 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 with a view to providing legal certainty to PABS System providers and users, and recognition of the System as a specialized international access and benefit-sharing instrument within the meaning of paragraph 4 of Article 4 of the Nagoya Protocol.
3. The WHO PABS System shall have, at a minimum, the following components and elements:
(a) The rapid, systematic and timely sharing of PABS Material and Information, and all relevant information, in accordance with modalities, terms and conditions to be determined and agreed; and
(b) The fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS Material and Information, in accordance with modalities, terms and conditions to be determined and agreed, and which shall include, at a minimum, the following:
(i) in the event of a pandemic, real-time access by WHO to 20% (10% as a donation and 10% at affordable prices to WHO) of the production of safe, efficacious and effective pandemic-related health products; and
(ii) annual monetary contributions from PABS System users, based on modalities, terms and conditions to be defined by the Conference of the Parties, and which shall be used by WHO to improve pandemic prevention, preparedness and response, inter alia, for strengthening laboratory, surveillance and regulatory capacities.
(c) A mechanism to ensure the fair and equitable allocation and distribution of the pandemic-related health products in paragraph 3(b) above, shall be developed taking into account public health risks, needs, and demand. Each Party that has manufacturing facilities that produce pandemic-related health products in its jurisdiction shall take all necessary steps to facilitate the export of such products, in accordance with timetables to be agreed between WHO and the relevant manufacturers
4. The PABS System will also have additional benefit-sharing options, which may include:
(a) encouraging manufacturers from developed countries to collaborate with manufacturers from developing countries through WHO initiatives to transfer technology and know-how and strengthen capacities for the timely scale-up of production of pandemic-related health products;
(b) tiered-pricing or other cost-related arrangements, such as no loss/no profit loss arrangements, for purchase of pandemic-related health products, that consider the income level of countries; and
(c) encouraging of laboratories in the WHO coordinated laboratory network to actively seek the participation of scientists from developing countries in scientific projects associated with research on PABS Material and Information.
5. The Parties shall further define the modalities, terms and conditions, and operational dimensions of the PABS System in a legally binding instrument, that is operational no later than 31 May 2026.
See our previous story on this: Principles to Guide the Pathogen Access-and-Benefit Sharing System [PABS] in a Pandemic Agreement; Update: Proposal to Buy More Time to Operationalize PABS by May 2026
While at the face of it, there is greater alignment between countries on the basic principles of a workable mechanism, but there are vast divergences on “how” benefits should be delivered. Diplomats in developed countries argue that it will be very difficult to commit to sharing benefits without burdening the system, that could dissuade the use and uptake of pathogen information particularly for researchers. They argue that scale at which information is shared, will make it impossible to enforce benefits-sharing obligations on all users.
And yet, PABS effectively holds the strings to tie up these negotiations overall. More than 70 developing countries are pushing for stronger commitments for benefits-sharing. Without these, not only will these negotiations get tougher, countries may also walk away from PABS, and turn to domestic laws to tighten the screws on information sharing in future emergencies that would fragment the governance further adding to legal uncertainty to such rules.
Liability, indemnity (Art 15) merged with Supply Chain & Procurement
This provision now reflects language on liability and indemnity highlighted below.
The modalities of a Supply Chain Network has been left to be determined by the Conference of Parties.
Article 13. Supply chain and logistics
1. The Global Supply Chain and Logistics Network (the Network) is hereby established to enhance equitable, timely and affordable access to pandemic-related health products. The Network shall be developed, coordinated and convened by WHO in partnership with the Parties and other relevant international and regional stakeholders. The Parties shall prioritize sharing through the Global Supply Chain and Logistics Network for equitable allocation based on public health risk and need over bilateral donation agreements.
2. 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:
(a) collaboration among the Parties and other relevant stakeholders during and between pandemics;
(b) functions of the Network are discharged by the organizations best placed to perform them;
(c) consideration of the needs of developing countries, and the needs of persons in vulnerable situations, including those in fragile and humanitarian settings;
(d) equitable allocation of pandemic-related health products; and
(e) accountability and transparency in the functioning and governance of the Network.
3. The Parties shall periodically review the operations of the Network, including the support provided by Parties and other stakeholders during and between pandemics.
4. During a pandemic, emergency trade measures shall be targeted, proportionate, transparent and temporary, and do not create unnecessary barriers to trade or disruptions in supply chains.
5. During a pandemic, rapid and unimpeded access of humanitarian relief personnel, as well as their means of transport, supplies and equipment, shall be facilitated in a manner consistent with relevant provisions of international law, including humanitarian law, and in respect of the principles of humanity, neutrality, impartiality and independence for the provision of humanitarian assistance.
6. A multilateral system for managing vaccine and therapeutic related compensation and liability during pandemics shall be considered.
7. 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
1. Each Party shall publish the relevant terms of its purchase agreements with manufacturers for pandemic related health products at the earliest reasonable opportunity and in accordance with applicable laws, and shall exclude confidentiality provisions that serve to limit such disclosure. Regional and global purchasing mechanisms shall also be encouraged to do the same.
2. During a pandemic, each Party in a position to do so shall, within available resources and subject to applicable laws, 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.
3. Each Party shall take appropriate measures to promote rational use and reduce waste of pandemic-related health products.
4. Each Party undertakes to avoid having national stockpiles of pandemic-related health products that unnecessarily exceed quantities anticipated to be needed for domestic pandemic preparedness and response.
5. When sharing pandemic-related health products with countries, organizations, or any mechanism that is facilitated by the Network, such products will be unearmarked and accompanied by all appropriate and relevant conditions, requirements and characteristics, as well as ancillary products, necessary for their distribution, administration and dispensing.
6. Each Party shall endeavour to ensure that, in contracts for the supply or purchase of novel pandemic vaccines, buyer/recipient indemnity clauses, if any, are exceptionally provided and are time-bound.
No Pooled in Financing Provision
There is no mention of a pooled fund in this provision on financing. Developed countries have argued against the creation of another fund, in addition to existing mechanisms.
The text also does not envision an additional fund to be created in the future by the Conference of Parties. Without having a pathway for financing of new and existing PPPR obligations, this will likely make this agreement a difficult sell.
Article 20. Sustainable financing
1. The Parties shall strengthen sustainable and predictable financing, in an inclusive and transparent manner, for implementation of this Agreement and the IHR (2005).
2. In this regard, each Party, within the means and resources at its disposal, shall:
(a) maintain or increase, as necessary, domestic funding for pandemic prevention, preparedness and response;
(b) mobilize additional financial resources to assist, in particular developing country Parties, in the implementation of the WHO Pandemic Agreement, including through grants and concessional loans;
(c) explore, and as appropriate, promote, within relevant bilateral, regional and/or multilateral funding mechanisms, innovative financing measures, including transparent financial reprogramming plans for pandemic prevention, preparedness and response especially for developing country Parties experiencing fiscal constraints; and ; and
(d) 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.
3. Coordinating Financial Mechanism (the “Mechanism”) is hereby established to provide sustainable financing support, strengthen and expand capacities for pandemic prevention, preparedness and response, and necessary for day zero surge response, particularly in developing country Parties. The Mechanism shall, inter alia:
(a) develop every five years a Financial and Implementation Strategy for the Pandemic Agreement, and submit it to the Conference of the Parties for its consideration;
(b) promote harmonization, coherence and coordination for financing pandemic prevention, preparedness and response and IHR (2005) related capacities;
(c) identify all sources of financing that are available to serve the purposes of supporting the implementation of this Agreement, and maintain a dashboard of such instruments and related information, and the funds allocated to countries from such instruments;
(d) 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;
(e) provide advice and support, upon request, to Parties in identifying and applying for financial resources for strengthening pandemic prevention, preparedness and response;
(f) leverage voluntary monetary contributions, free from conflict of interest, from relevant stakeholders, in particular those active in sectors that benefit from international work to strengthen pandemic prevention, preparedness and response; and
(g) conduct relevant analyses on needs and gaps, in addition to tracking cooperation efforts, to inform and support strategic decision making in the development of the Financial and Implementation Strategy.
4. The Mechanism 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 terms of reference for the Mechanism and modalities for its operationalization and governance, within 12 months after the entry into force of the WHO Pandemic Agreement.
5. The Conference of the Parties shall periodically consider, as appropriate, the Financial and Implementation Strategy for the Pandemic Agreement referred to in paragraph 2(a) above. The Parties shall endeavour to align with it, as appropriate, when providing external financial support for the strengthening of pandemic prevention, preparedness and response.
The following has been removed: “..4. 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.”
WHAT NEXT?
In the coming days, a final version, likely based on this text, will be discussed in capitals, and delegations in Geneva are expected to seek more clarity on the process of treating this text in the resumed session of the INB starting April 29th.
This will be preceded by what is scheduled to be the final meeting of the working group to amend the IHR during April 22-26.
If countries assess that the latest draft fails to operationalize equity, there will be pressure on countries to strengthen the content of the agreement in the remaining days ahead of the World Health Assembly. At the time when the ninth meeting of the INB was suspended, countries had agreed to stocktake deliberations by May 3rd, with a view to concluding discussions by May 10th.
There is growing chorus at least by a few countries to demand for an extension of the process in order to secure a meaningful agreement. But it is not clear if such a demand will garner support from most or all member states. Countries have cited concerns on the loss of political momentum beyond May 2024.
We reported earlier that one way of adopting this agreement, was by way of a vote, sources had indicated to us. But adopting an international treaty not by consensus, but by calling a vote would be unusual, it would also leave WHO deeply polarised, diplomats say. Failing to arrive at an agreement, would be “catastrophic” not only for global health, but also for multilateralism, many believe.
Stakeholders including civil society organizations have cautioned that any new agreement should not only not perpetuate status quo, it should definitely “not make it worse”.
Much will depend on the process of conducting negotiations at the resumed meeting of the INB, and the ability of the Bureau and member states to negotiate interests in order to arrive at a consensus in a matter of days.
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