TWN Info Service on Health Issues
30 September 2024
Third World Network
www.twn.my

WHO: Africa Group and Group of Equity say “no” to dilution of PABS obligations

Geneva, 30 September (TWN) – In response to the Intergovernmental Negotiating Body (INB) Bureau’s new streamlined text proposal on pathogen access and benefit sharing (PABS), the Africa Group and the Group of Equity said that it is not acceptable for them to continue streamlining of this text that is diluting PABS obligations.

They called for critical elements of the PABS system and concrete benefits to be reflected in the PABS text that is being negotiated under Article 12 of the WHO pandemic instrument.

The INB Bureau had circulated a new streamlined text on 12 September 2024, with a view to push all contentious elements to further negotiations to be undertaken after the adoption of the WHO Pandemic Instrument. The text was taken up for discussion during the second week of the 11th meeting of the INB (INB11) on 17, 18 and 20 September. INB11 could not complete a first reading of the newly proposed text as differences were quite large (see TWN analysis on the Bureau’s proposal.)

Several developing countries expressed discontent with the proposed text, and suggested textual edits and insertions to bring back the critical demands they had submitted earlier in INB process. They were specifically unhappy over the kind of uncertainty the Bureau’s proposal leaves on issues like traceability, and core benefits such as sharing of health products, manufacturing licences and monetary contributions.

Third World Network (TWN) learnt that there were statements from the Group of Equity and the Africa Group that irked the INB Bureau, made during the Drafting Group negotiations on Article 12 and Plenary discussions on Agenda item 4 that considered progress and next steps.

There was considerable back and forth arguments between the developing countries and the Bureau in the Drafting Group. Several developing country Member States reported that they felt they were negotiating with the Bureau, rather than with developed countries.

On the other hand, developed countries seemed quite happy with the proposal of the Bureau to go ahead with a streamlining approach. The European Union, the United Kingdom, Japan, Australia, Canada, Switzerland and the United States, in general, expressed their acceptance of the Bureau’s reductionist approach and pushed to continue negotiations. This is not surprising as such an approach would not require them to make any strong commitments to share benefits fairly and equitably.

A developing country delegate told TWN that “the Bureau’s proposal does not even make framework level commitments. It is merely a process commitment. Forget the benefit sharing commitments, it doesn’t even lay out clearly how access to pathogens and genetic sequence data will be provided. The proposal is not clear about the role and the core functions of laboratories and databases. These are the major intermediaries, alongside WHO, that makes the PABS system work. Our delegation would have perhaps accepted the Bureau’s proposal if there was a clear establishment of framework elements. We would have been open to consider a proposal which leaves only operationalization to the future negotiations. But the current proposal is nothing of that sort and is not acceptable to us”.

Call for Clearer Benefit Sharing Commitments

The Bureau’s text had slashed down the benefit sharing commitment on pandemic-related health products such as vaccines, therapeutics and diagnostics during pandemic emergencies. Although paragraph 4(a) mentions 20% share of the real time production for pandemic emergencies, paragraph 4(b) dilutes the implementation of paragraph 4(a) by providing for “flexible implementation” within a range of 5-20%. As per paragraph 4(b), the only guaranteed share is 5% free of charge real-time production, and the rest can be very little – even as low as 1 to 2%.

The Africa Group and Egypt clearly stated that this is not acceptable and called for at least 20% to be assured for pandemic emergencies, with 10% of charge, and 10% at not-for-profit prices.

Diplomatic sources said that several countries from Africa such as South Africa, Nigeria, Eswatini, Botswana and Ethiopia, spoke in addition to Namibia (which leads on the Africa Group of 47 countries plus Egypt on Article 12) to support the demand. This demand is further supported by developing countries outside the Africa region like Indonesia, Malaysia, Bangladesh and others.

On the other hand, developing countries like the U.K., Japan, and others were keen to remove the references to 20% in paragraph 4(a). They argued that paragraph 4 can simply state there will be “a percentage” that will be shared.  This paragraph can be subjected to future negotiations and consensus – perhaps even on a case-by-case analysis.

The Central African Republic made key efforts to ensure that the text suggested by the Africa Group is adequately reflected in the on-screen text on paragraph 4(a). It called for insertion of the words “at least” before “20%” and an explanation thereafter i.e. “10% free of charge” and “10% at not-for-profit” price.

Japan supported by the U.S. proposed mention of “equity-based tier-pricing” which was immediately rejected by developing countries including China.

Tier-pricing does not necessarily deliver products with affordable prices to a country. An investigation by the U.S. International Trade Commission pointed out that “[t]he affordability of COVID-19 therapeutics has been noted as a significant barrier to access for many LICs and MICs”, “[e]ven though the middle and lowest “best access” prices are well below the highest price points paid by HICs, they may still be untenably high for LICs, LMICs, and UMICs. Indeed, for many countries, the “best access price” exceeds the average annual health care expenditure for LICs ($39 per capita) and is more than half the price of the average annual per capita health care expenditure of LMICs ($137)”.

The discussions on benefit sharing commitments such as sharing of health products during a public health of emergency of international concern (PHEIC) and pre-PHEIC stage, as well as benefits such as manufacturing licences, and monetary contributions did not take place during INB11, as the Bureau struggled hard to complete discussions up to paragraph 4(b).

Some developing country delegations, deeply dissatisfied with the Bureau’s text on paragraphs 5 and 6 which deal with some of the benefits mentioned above, reminded the INB Bureau that they will argue substantively on these paragraphs to make these commitments mandatory in the upcoming negotiations.

Who should accept legally binding terms and conditions and when?

The Bureau’s streamlined text removed language relating to the need for users of the PABS system to sign legally binding contractual agreements prior to accessing the materials and sequence information. Removal of the references boosted the E.U.’s position that all recipients of PABS materials and sequence information need not enter into enforceable contracts; rather the focus should be on ensuring that some manufacturers voluntarily commit to enter into benefit sharing agreements.

The E.U. and some other developed countries also did not want WHO to be a party to such agreements. They instead argued to maintain the reference to the “PABS system” in general as well as the recipient of the health products in paragraph 4(a), as opposed to mentioning “WHO”, as preferred by the Africa Group and other developing countries.

The E.U.’s model of ABS for Pathogens and Sequence Information is to delink access and benefit sharing. Towards that end, the E.U. is not keen to require all users of the PABS system to commit to comply with legally binding terms and conditions, including benefit-sharing commitments, at the point of access. Instead, the E.U. proposes delivering on ABS by negotiating a set number of benefit sharing agreements with some pharmaceutical companies, while allowing all other users (including manufacturers) unhindered, unconditional access to pathogens and sequence information.

This approach undermines the concept of ABS as established by the Convention on Biological Diversity and it’s the Nagoya Protocol, fails to ensure that the shared materials and sequence information are only used based on the terms that have been agreed to by Members, and fails to provide legal certainty of benefit sharing. The E.U.’s approach also allows free-riders to benefit from the PABS system without committing to any terms of use as well as fair and equitable benefit sharing.

However, developing countries resisted this move, and clearly established the need for all users to sign legally binding contracts that set out the terms of use (such as those pertaining to intellectual property, transfer to third parties), as well benefit sharing.

The Africa Group, India, Indonesia, Bangladesh, Malaysia etc. also insisted that benefit sharing is not limited to manufacturers of vaccines, diagnostics and therapeutics, and that other users may also need to undertake obligations to share benefits when deriving such benefits from the use of resources accessed.

Countries like Norway, Australia, Canada, Switzerland and the U.S. on the other hand supported the E.U. position. Surprisingly Brazil and the Philippines told the INB that they were willing to move ahead without the reference to PABS users agreeing to contractual terms as proposed by other developing countries. They argued that these could be elaborated in the future process.

However, Malaysia, supported by Indonesia, Bangladesh and several others, inserted language in the chapeau of paragraph 4, to ensure that the negotiating text reflected the developing countries’ proposals. The paragraph 4 chapeau, with Malaysian proposal (in bold), is as follows:

“The PABS System, as set out in the Instrument referred to in paragraph 2, shall provide, inter alia, the following [benefits to be set out in a legally binding contracts with WHO applicable to users who access PABS materials and/or sequence information]: …”

Namibia also insisted that WHO should be reflected as the primary recipient of the real time production from the manufacturers.  It also pointed out that the PABS system would not have independent legal personality to sign these agreements.

Traceability for an effective PABS system

India, pointing to uncertainty linked with the traceability mechanism mentioned in paragraph 2, called for better language that guarantees that the PABS system will contain traceability mechanisms for both materials and information.

The Africa Group and other developing countries supported the call by India. Some of them, according to diplomatic sources, questioned a potential double standard adopted by the Bureau in reflecting the two competing demands, i.e. for traceability and for open access. Paragraph 2 uses the phrase “consistency with Open Access” as an element, and in a sense, it already indicates open access as a desired element. This is not the case of traceability.

Developing countries clearly explained, even quoting scientists, that traceability is not something conflicting with open access. But then countries like the Netherlands, Germany and the U.K., argued that PhD scholars and scientists will not be able to do their work, if PABS establishes terms and conditions for use of the data.

This claim contradicts how sequences of pathogens with pandemic potential are accessed in practice. Many developed country governments, including Germany, endorse the use of the GISAID database, which operates under a data access agreement, with access to sequences hosted by the database being subject to user registration and acceptance of the data access agreement. Despite concerns about its opaque, oligarchic management, GISAID remains a widely preferred database for researchers, precisely because it offers certain benefits to the registered users – such as recognition and possibilities for collaboration – through its access agreements. GISAID even precludes its users from sharing its data with third parties who are not registered with GISAID.

If GISAID’s system seems to work so effectively, it is hard to believe that PhD students in countries like Germany, the U.K., or the Netherlands would be unwilling to use a similar system for other databases. This demonstrates that traceability and accountability measures, such as data access agreements and user registration, do not deter researchers. Rather, they provide security and encourage collaboration.

Traceability measures, far from being excessive, are necessary to ensure that the PABS system is effective including in the operationalization of benefit sharing obligations under the PABs system and the information is not misused for purposes not covered under the WHO agreement.

(GISAID originally stands for the Global Initiative on Sharing Avian Influenza Data, though its database now contains sequences of other pathogens. It is officially hosted by Germany and its funders include the European Commission.)

Specialized International ABS Instrument (SII) Status for PABS

The adoption of the PABS system as a Specialized International ABS Instrument within the meaning of Article 4(4) of the Nagoya Protocol is one of the key demands of the E.U. and other developed countries.

[Article 4(4) of the Nagoya Protocol states that the Protocol does not apply to SII established for specific purposes and specific genetic resources, “where such instrument is consistent with, and does not run counter to the objectives of the Convention on Biological Diversity and this Protocol”. This also could be extended to mean that Parties to the Nagoya Protocol should not apply national ABS measures based on the Nagoya Protocol to genetic resources covered by the SII.]

Instead of the previous language that called for identifying PABS as an SII within the WHO Pandemic Agreement itself, the Bureau came up with two new paragraphs. One of them avoids application of national ABS measures (Paragraph 2bis), and another states that the PABS system will be developed consistent with and not contrary to the objectives of the Convention on Biological Diversity and the Nagoya Protocol (Paragraph 2ter).

This means the Bureau’s text practically self-asserts that the new instrument will be a SII within the meaning of Article 4(4) of the Nagoya Protocol at its inception.

A developing country delegate responding to the newly proposed paragraphs 2bis and 2ter, stated, “It is surprising that the INB Bureau has proposed this text that not only subjects key benefits, which we are already entitled to get, to a future process, but also compromises the said process by accepting developed country demands, even before the process begins”.

Diplomatic sources also revealed that Turkey was apparently unhappy with the language, as was the Russian Federation, who are not Parties to the Nagoya Protocol. To take into account their concerns a small group was formed and language relating to SII was proposed by the small group as follows: “Having regard to Article 4(4) of the Nagoya Protocol, the PABS Instrument shall be developed to be consistent with, and not run counter to, the objectives of the Nagoya Protocol. For greater certainty, nothing in this paragraph creates new obligations for non-parties to the Nagoya Protocol”.

However, Bangladesh argued that the small group’s text seems to be problematic, because the paragraph should be creating obligations for the Parties to the WHO Pandemic Agreement, regardless of the fact they are Parties to the Nagoya Protocol or not. Bangladesh also questioned if the non-parties to the Nagoya Protocol like the U.S. (also not a Party to the Convention on Biological Diversity) and the Russian Federation are not obliged to implement this paragraph, how can the INB state that PABS Instrument shall be developed consistent to Convention and/or the Nagoya Protocol.

Furthermore, there are current negotiations taking place at the Meeting of Parties to the Nagoya Protocol on the characteristic features of international agreements that could be considered as SII. They might also deliver decisions on these issues very soon.

The Africa Group said that the current text as proposed by the Bureau or small group is not acceptable to them, unless there is clear reference to the decisions of the Nagoya Protocol’s Meeting of Parties in the provision relating to the SII status of the PABS. They also argued that unless the PABS system is fully developed and the design is well examined, Parties cannot be forced to not to apply national ABS measures on pathogens with pandemic potential and their sequence information.

Neglecting these concerns the Bureau marked the texts in paragraph 2ter alt with slight modification (quite insignificant) in yellow, indicating there is an initial convergence.

Africa Group’s Non-Paper on PABS and U.S. Response

Namibia, speaking on behalf of the Africa Group, has clearly expressed to the INB Bureau the Group’s interest in establishing a functional PABS system, alongside the adoption of the WHO Pandemic Instrument.

Namibia reportedly has also circulated a non-paper containing textual suggestions for annexures to be included in the WHO Pandemic instrument. However, the non-paper was not discussed in INB11, due to the prolonged discussions on the Article 12 paragraphs as proposed by the Bureau.

The proposed non-paper is not yet made available to relevant stakeholders. A copy was seen by TWN. The non-paper is titled as Annexures and is divided into four sections, containing core terms and conditions applicable to various participants in the PABS system, when they receive or handle PABS material and sequence information.

The first section proposes terms and conditions applicable to laboratories becoming part of a WHO Coordinated Laboratories’ Network (WCLN), when they receive, use and share PABS materials and Sequence Information amongst themselves.

The second section proposes terms and conditions applicable to recipients outside WCLN receiving the PABS materials and sequence information.

The third section deals with terms and conditions applicable to databases that are willing to participate in the PABS systems and become recognized by WHO.

The fourth section deals with terms and conditions applicable to registered users of the databases participating in PABS system, accessing PABS sequence information.

A source close to the Africa Group confirmed that the Group wishes to add annexures to the WHO Pandemic Agreement to be linked to Article 12.  The Africa Group has reserved paragraphs 2 and 3 of Article 12 to do this.

Interestingly, much ahead of the formal introduction and circulation of the non-paper by the Africa Group, the U.S. acknowledged the existence of the paper informally circulating between a few parties and responded in the Drafting Group to the non-paper. The U.S. argued that the non-paper is a reflection of the idea, perhaps the INB is wrong in rushing through the text of Article 12, because delegations are clinging on to different conceptions of PABS and there are fundamental differences which need to be first resolved.

One of the African countries told TWN the U.S. was right in their approach and honest. “There are fundamental differences regarding the conceptions and design of the PABS system. Without addressing these differences, a decision to address PABS operations in a future process will not do any good to anyone,” the delegate added.

Group of Equity statement before closing of INB11

It was learnt that there were quite a number of countries and groups that made statements during Agenda Item 4 on the Consideration of Progress made and next steps. Many of them cautioned the INB Bureau against rushing through the process and adopting an WHO Pandemic Instrument without concrete commitments to deliver equity in pandemic prevention, preparedness and response. There were also direct references to the PABS negotiations as well.

Notably, the Group of Equity delivered a strong statement, firstly about the process in general and secondly about the PABS system negotiations. Regarding negotiations in general, the Group stated:

“At this stage of negotiation, we would like to remind the floor that the INB is mandated to frame practical actions based on the principles of equity and solidarity to deal with both causes and consequences of pandemics and other health emergencies. Hence, we flag following issues on the modalities and approach in the negotiation:  

First, the PABS System, once called the heart of the treaty, is now stripped to almost a skeleton, with little consensus among the Member States. We cannot allow the critical elements of the System to be left for the future. Frank conversations on the System need to happen sooner rather than later.

Second, while we reaffirm our ambition to conclude the negotiations by the next WHA, we cannot sacrifice the substance, and quality of the agreement in pursuit of speed.

Third, we must give merit-based weight to measures in prevention and surveillance as well as to preparedness and response related measures, and we need strong commitment to equity reflected.

Fourth, we must seriously reflect whether the benefits made available in the current Bureau’s text are sufficient to address the gap in facilitating equitable access to VTDs. We do not believe it is.

Fifth, we strongly encourage the Bureau to refrain from further shortening the text and to give full consideration on important elements raised by all countries, including developing countries and members of the Group for Equity and the Africa Group, over the past two weeks.

And sixth, we also caution against rushing towards greening and different levels of treatments that may not yield a good outcome.”

Regarding the PABS system, the Group of Equity made these four demands:

“First, access to PABS Materials and Sequence Information must be subject to agreed legally binding terms and conditions, including commitment to fair, timely, and equitable sharing of benefits. This has to be clearly reflected in the text. We won’t support any delinking between the two. It is important to ensure consistency with the objectives of the CBD and the Nagoya Protocol, if the instrument is to fall within Article 4.4 of the Nagoya Protocol.

Second, sharing of VTDs has to be clearly spelled out. We reiterate our position that 5% as a floor is not acceptable. We support the proposal that at least 20% of real-time production should be made available during the pandemic emergency. We also need specific percentage set-asides to prevent PHEIC, and during PHEIC, as well as commitments to annual monetary benefit-sharing.

Third, additional benefits are vague and hence to be clearly articulated. We particularly draw attention to the technology transfer and the availability of manufacturing licences for developing countries.

Fourth, there must be a firm recognition of the need for traceability mechanisms to ensure accountability and transparency in the governance of the PABS System and to effectively operationalize fair and equitable benefit-sharing.”