TWN Info Service on Health Issues (Sept24/03)
14 September 2024
Third World Network

INB Bureau further streamlines text on PABS, presenting weak benefit-sharing commitments

The Bureau of the Intergovernmental Negotiating Body (INB) for a WHO Pandemic Agreement (PA) has released a new text aimed at resolving the bracketed text in Article 12, which addresses the Pathogen Access and Benefit-Sharing (PABS) system.

The document released late afternoon of 12th September, further streamlines text on the PABS system, presenting extremely weak benefit-sharing provisions that are grossly inadequate to address the prevention, preparedness, and response to pandemics.

The INB is currently meeting in Geneva from 9th to 20th September for its 11th session, to reach an agreement on outstanding issues in the Pandemic Agreement negotiations.

Article 12 focuses on the development of a PABS system to operationalize international rules on access and benefit sharing, as established by the Convention on Biological Diversity (CBD) and the Nagoya Protocol on Access and Benefit Sharing (Nagoya Protocol) in the context of sharing pathogens with pandemic potential and related sequence information.

Since the beginning of the INB’s textual negotiations, the Africa Group and other developing countries (about 73 countries) have repeatedly put forward detailed proposals for a comprehensive PABS system including fair and equitable benefit sharing.  

Under pressure to conclude the negotiations by the 2024 World Health Assembly (WHA) in May, the INB Bureau pushed for a streamlined approach, suggesting that the finer details of the PABS system be deferred to another intergovernmental working group (IGWG).

With the negotiations not completed by the 2024 WHA, bracketed text of a PABS system was presented to the WHA. The INB Bureau is now aiming for a December 2024 deadline, once again advocating for further streamlining of the text, with the design and other details of the PABS system to be sorted out in another IGWG.

According to diplomatic sources, on Tuesday (10^th September), during a general discussion on Article 12, several developing countries including the Group of Equity voiced strong concerns about the Bureau’s streamlining approach. They warned that this approach would severely undermine the interests and positions held by a large number of developing nations. These countries emphasized the need for greater certainty regarding the establishment of the PABS system and called for more detailed operational provisions, rather than leaving crucial elements unresolved.

However, the Bureau's further streamlined text appears to have ignored these appeals, disregarding the concerns raised by a significant number of countries.

Access terms and conditions

The essence of access and benefit sharing (ABS) is that access to biological materials and sequence information is subject to prior informed consent (PIC) and mutually agreed terms (MAT) with the provider country. At the national level, PIC and MAT are normally reflected in an enforceable bilateral contract.

At the multilateral level, the terms and conditions of access are reflected by governments agreeing to standard terms and conditions, enforced through a legally binding contract. Any recipient wishing to have access would need to accept these terms and conditions, at the point of access. These terms and conditions outline the terms of use including fair and equitable benefit-sharing commitments of the recipient.

Article 12(4)(a) and (b) text as of May 2024, contained text albeit heavily bracketed, referring to PIC and MAT as well as terms and conditions to be agreed in legally binding contracts. These elements have been removed by the Bureau.

Nowhere does the Bureau’s proposal capture the essence of ABS, in particular the idea that access is subject to the recipient/user of PABS material and sequence information agreeing to a legally binding contract that incorporates standard terms and conditions including benefit-sharing commitments and that actors within the PABS system i.e. the WHO-coordinated laboratory networks and databases hosting PABS sequences will operationalise the same.

Fair and equitable benefit sharing

The subject of benefit-sharing is a major point of contention between developed and developing countries.

The US expressed its preference for benefit-sharing “options” that a manufacturer can choose from. Several developed countries questioned the practicality of specifying specific percentages of vaccines, therapeutics and diagnostics (VTDs) that a manufacturer would have to set aside for WHO to distribute to countries in need.

The UK and Japan argued for flexibility in manufacturers providing benefits, adding that requiring manufacturers to set aside VTDs for WHO undermines the attractiveness of the system for manufacturers. 

In contrast, developing countries have been calling for meaningful benefit-sharing, proportionate to the obligation of sharing biological materials and sequence information, as well as certainty and predictability in the timely availability of VTDs to prevent and respond to public health emergencies of international concern (PHEICs) and pandemics.

Accordingly, the Africa Group and other developing countries have made specific proposals on monetary and non-monetary benefits that should be shared by recipients of PABS materials and sequence information.

Diplomatic sources say that during the Tuesday session, the Central African Republic (CAR), recalled the inequities developing countries had  faced during COVID-19 and other PHEICs like mpox and ebola. CAR made it clear that Article 12 text has to concretise the benefits that are to be provided by recipients of PABS materials and sequence information such as manufacturers of VTDs, adding it could not agree to defer that aspect to the IGWG.

CAR stressed the need for set-aside commitment of VTDs for WHO stockpiles or on the request of the WHO Director-General, as well as during PHEIC and pandemic emergencies. CAR also insisted on the need for manufacturers to provide manufacturing licenses as well as for recipients financially benefitting from the PABS system to make annual monetary contributions.

The Bureau’s proposal on benefits seems to align more closely with the interests of developed countries than the right to health imperative of ensuring that benefits arising from the sharing of materials and sequences can reduce or eliminate the recurring inequities witnessed during past health emergencies. The weak benefit-sharing provisions in the Bureau's proposal are wholly inadequate to achieve the core objective of the Pandemic Agreement—to prevent, prepare for, and respond to pandemics with equity as a guiding principle.

Pandemic Emergency

The Bureau’s proposal reads:

“(a) when a pandemic emergency is determined, rapid access to 20% of real-time production of safe, quality and effective vaccines, therapeutics, and diagnostics for the disease causing the pandemic emergency, to be made available to the PABS System, on a free-of-charge basis or at not-for-profit prices, in accordance with legally-binding contractual arrangements with relevant manufacturers, for allocation on the basis of public health risk and need, with particular attention to the needs of developing countries; and

(b) flexible implementation of the provisions of sub-paragraph (a) in a range of 5-20% to incentivise the conclusion of contractual agreements, with a threshold of no less than 5% of safe, quality and effective vaccines, therapeutics, and diagnostics for the disease causing the pandemic emergency, to be made available to the PABS System free of charge».

The rationale given for the Bureau’s proposal is “The proposal is to determine a percentage for allocation in case of a pandemic emergency that would be significant for public health purposes, while also being viable. At the same time, sufficient flexibility is provided for in terms of the range from 5%-20%, while a floor is established for donations”.

 

While sub-paragraph (a) of the Bureau’s proposal gives the impression that during a pandemic emergency, there will be “rapid access to 20% of real-time production” of VTDs”, analysis of its implementation of sub-paragraph (b) suggests otherwise.

The actual effect of both paragraphs read together is that a manufacturer only needs to provide donations of “no less than 5%” of VTDs. A manufacturer may agree to provide 5% donations and 2% “at not for profit” prices i.e. a total of 7%. 

The suggested benefit is much less than what is provided for in the WHO Pandemic Influenza Preparedness Framework (PIP Framework) which requires a donation of “at least 10% of real-time pandemic vaccine production to WHO” (with a footnote that states “Recognizing that flexibility is important in negotiating with all manufacturers, in a range of 5-20%)”. Under the PIP Framework (which only covers the sharing of one pathogen -influenza virus of pandemic potential), through the standard material transfer agreement (SMTAs), manufacturers have committed to provide 10% to 12.5% of real-time production during an influenza pandemic emergency.

The Bureau’s proposal also falls short of the Africa Group+Group of Equity’s call for the allocation commitment of “at least 20% of real-time production, no less than 10% of production to be provided free of charge and 10% of production at not-for-profit prices”.

Instead, it seems to be accommodating of the US’s proposal of “up to 20%”.   

Further sub-paragraph (a) states that the access commitment is “in accordance with legally-binding contractual arrangements with relevant manufacturers”.

The use of the word "relevant" in the text implies that only certain manufacturers may be required to enter into legally binding contracts, a concept repeatedly advocated by the European Union. This approach undermines the fundamental principle of access and benefit-sharing, that any manufacturer accessing materials and sequences must commit to fair and equitable benefit-sharing, an approach also supported by developing countries.

PHEICs

The Bureau’s proposal states: “When a PHEIC is determined, the PABS System shall also include specific benefit sharing provisions, including, as appropriate, taking into account IHR temporary recommendations, for access to safe, quality and effective vaccines, therapeutics, and diagnostics for the disease causing the PHEIC”.

The Bureau’s rationale reads: “Given the wide range of possible public health scenarios involving PHEICs, flexibility is suggested regarding measures related to vaccines, therapeutics, and diagnostics, while taking into account relevant IHR temporary recommendations.”

The approach taken by the Bureau’s proposal with respect to PHEIC will essentially result in the “status quo” for inequity. No binding commitment is required of manufacturers to set aside VTDs during PHEICs.  Any future proposals “will have to take into account IHR temporary recommendations”. Such recommendations normally follow the declaration of PHEIC and the convening of Emergency Committee meetings. Temporary recommendations also have to be accompanied with “supportive evidence” (according to the latest IHR amendments). Thereafter, a manufacturer may be required to make available VTDS.

The practical effect of the Bureau’s proposal is that, during a PHEIC, providing VTDs to the WHO will be a low priority for manufacturers. Without an upfront commitment to allocate a specific percentage of VTDs for WHO, manufacturers will not reserve supplies, and will instead prioritize supply of advance purchase agreements entered into with wealthier countries. As a result, the inequity between developed and developing countries will persist, further exacerbating access disparities during health crises.

In contrast, the Africa Group and Group of Equity have proposed that manufacturers allocate at least 10%-15% of their real-time production of each VTDs to the WHO. Of this allocation, at least 50% would be provided free of charge, with the remainder offered at "not-for-profit" prices.

This proposal from developing countries ensures that manufacturers consistently reserves a portion of each VTD for distribution by the WHO, prioritizing public health risks and response during PHEICs. It establishes a concrete mechanism to promote equitable access, particularly for nations most in need during health emergencies.

Prevention of PHEIC, Stockpiles & Manufacturing Licenses

To prevent disease outbreaks from escalating into a PHEIC, the Africa Group proposed that the WHO Director-General be empowered to initiate the advance release of VTDs. This proactive measure would help stockpile essential supplies for rapid response and ensure equitable access for countries at risk of an outbreak.

This proposal is particularly urgent given the challenges WHO and other humanitarian agencies have faced in securing timely access to VTDs during recent crises, such as the Ebola and mpox outbreaks.

Unfortunately, this crucial benefit is not explicitly included in the Bureau’s current proposal.

Additionally, no concrete deliverable is outlined concerning granting manufacturing licenses to developing country producers—a critical measure to expand supply capacity during PHEICs or pandemics. Instead, this is relegated to paragraph 5 as a potential option for future consideration alongside other benefit-sharing options, leaving a significant gap in the immediate response framework.

Monetary Benefit Sharing

The bracketed text on monetary benefit sharing as of May 2024 is: “Annual monetary contributions to the WHO from relevant commercial users of the PABS System, including relevant manufacturers of vaccines, therapeutics and diagnostics based on modalities, terms and conditions, to be defined according to paragraph 3 of this Article.”

These limited details on monetary benefit sharing, arising from the sharing of PABS material and sequence information, have also been removed from the Bureau’s proposal, which instead captures this important benefit in more general terms.

Application of national ABS rules

A key demand of developed countries has been to declare the PABS instrument to be developed in the future as a specialised international access and benefit-sharing instrument (SII), expressing concerns about duplicative ABS systems and recipients having to pay benefits to multiple ABS systems. 

All developing countries including Brazil, China, India, Malaysia, Indonesia and others strongly opposed this demand of developed countries. They counterargued that since the Article 12 text only sets out an outline of a possible PABS instrument, it was premature to declare the PABS instrument to be a SII. Further, COP/MOP (meeting of the Parties) of the Nagoya Protocol is the forum to decide whether the PABS instrument meets its criteria of a SII, which has to be set out.

[The Nagoya Protocol allows the development of specialized international access and benefit-sharing instruments for specific genetic resource covered and purpose “provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol” (Article 4.2 of Nagoya Protocol). Where a SII exists, the Nagoya Protocol, and hence national ABS rules will not apply to the party/parties to the Protocol (Art. 4.4 of the Nagoya Protocol). The COP/MOP of the Nagoya Protocol is currently considering a decision on the criteria and process for determining an international instrument to be a SII.]

To address the North-South differences, the Bureau’s text introduces two new paragraphs:

“2bis. The PABS System shall be implemented in a manner to prevent the overlapping of the application of ABS measures and obligations with respect to PABS Materials and Sequence Information shared within the PABS System.

“2ter. The PABS Instrument shall be consistent with, and not run counter to, the objectives of the Convention on Biological Diversity and its Nagoya Protocol, such that the PABS Instrument falls under Article 4.4 of the Nagoya Protocol.”

Both paragraphs directly undermine the positions of developing countries. Paragraph 2ter is framed as a self-defined factual statement i.e. the PABS instrument is going to be consistent with the CBD and the Nagoya Protocol and thus within Article 4(4) of the Nagoya Protocol. This appears to be an effort to position the WHO as a forum for framing the PABS instrument as a SII.

Paragraph 2bis goes even further by preemptively excluding the application of national ABS laws, thereby reinforcing the PABS instrument as an SII. Notably, the language in paragraph 2bis mirrors textual suggestions previously put forward by Japan and the United States, aligning closely with their interests.

Given the absence of concrete details regarding the design and content of the PABS instrument, both paragraphs are premature and risk undermining ongoing processes under the Nagoya Protocol, as well as the integrity of national ABS systems. This could create unnecessary conflicts and weaken existing frameworks for access and benefit sharing.

As of May 2024, WHO Members had already agreed that Article 12 of the Pandemic Agreement would include provisions that the PABS system would be implemented "in a manner complementary to, and not duplicative of, the Pandemic Influenza Preparedness Framework and other relevant access and benefit-sharing instruments where applicable." This streamlined language is sufficient to address the concerns of developed countries.

However, the Bureau still introduced two additional paragraphs in the text to further secure the support of developed countries. These additions, instead of fostering consensus, seem designed to disproportionately favour the interests of wealthier nations and their pharmaceutical industries.

Traceability Mechanisms & Open Access

Developing countries converged around the need to have traceability mechanisms for PABS Materials as well as sequence information, to operationalise fair and equitable benefit sharing, scientific provenance and biosecurity checkpoints, by identifying the recipients of materials and sequence information, ensuring they have committed to the terms and conditions for using the PABS system.

Developed countries, however, are opposed to such mechanisms, except for purposes of biosecurity. Instead, some developed countries insisted on text referring to “consistency with open access to data”.

In response developing countries sought clarification on elements of open access, pointing out that there are different models of open access.

According to various sources, South Africa stressed the importance of traceability for avoiding free riders, also referring to the UNESCO Recommendation for Open Science which speaks of good data governance. It pointed to a letter by more than 290 scientists from 36 countries that have stressed the importance that the governance of sequence data be transparent, accountable and supportive of both science and equity. South Africa also added that scientists have clarified that “Not only are open access to DSI and ABS perfectly compatible, but strong ABS principles are also, in fact, more in line with the spirit of open access to research data than the status quo...Ensuring that ABS principles are respected is not about restraining access to data, but about keeping a record of access for accountability purposes” (referring to the blog by Dr. Timothee Poisot, from Université de Montréal).

Despite the vast support for traceability mechanisms among developing countries, the Bureau’s text merely states “Consideration shall be given to provisions on a traceability mechanism”, further adding that consideration shall also be given to “consistency with open science and open access to data”. The latter part is more obligatory than the former part.