TWN Info Service on Health Issues (Oct24/03)
7 October 2024
Third World Network

WHO: INB11 moved away from developing countries’ needs, Bureau pushed to rush through text

5 October, Kochi (Nithin Ramakrishnan) – The 11^th round of the WHO Intergovernmental Negotiating Body (INB) on the pandemic instrument held last month rushed through the text at the behest of the INB Bureau.

The Bureau pushed Member States to speed up the negotiations and showed reluctance to incorporate substantive text suggestions from delegations, especially from developing countries. INB11 thus moved the draft WHO pandemic instrument away from the needs of developing countries.

The Bureau, instead of aiding Member States to undertake text-based negotiations and real-time on-screen editing, itself entered into negotiations with Member States, questioned text proposals from Member States, invited the WHO Secretariat to comment on the proposals, and seldom made changes to the on-screen text in the name of a streamlining approach. Several provisions relating to equitable access to vaccines, therapeutics and diagnostics are getting diluted to unsustainable levels in this approach.  

For example, in the case of Article 12 on Pathogen Access and Benefit Sharing (PABS), the Bureau again issued a new shortened text in the name of streamlining. The Bureau has categorically ignored the calls for detailed substantive provisions in Article 12 on benefit sharing by the Africa Group and the cautionary calls from the Group of Equity against such a streamlining approach that effectively is a content reduction approach.  (See TWN Analysis on the Bureau’s new streamlined text for PABS, here and report on the negotiations here.)

Developed countries, particularly the E.U., seem comfortable with this content reduction approach and with controlled negotiations aiming for a framework-type convention on pandemic prevention, preparedness and response – this approach does not allow them to make concrete commitments to enable equitable access to health products or technologies. (See TWN’s Analysis of the European Commission’s “reflection paper” on a WHO pandemic framework convention that came out during the early stages of negotiations in 2021).

The reason for this is purportedly an argument that there is “no time for detailed negotiations”. The Bureau is rushing through discussions to adopt the pandemic instrument by December 2024. Even though the 77^th Session of the World Health Assembly gave the INB time till May 2025, negotiators and WHO secretariat staff often cite the Africa Group’s pressure as the reason for the rush. Sources say the Africa Group’s Heads of the State, seem to have called for a WHO pandemic agreement adoption by the end of December 2024 and the delegations are thus pushing for the same.

Several African Member States, on the other hand, clarified with Third World Network (TWN) that their Heads of State want a strong WHO pandemic instrument, not a weak framework agreement.

Compromising equity, citing calls for speedy conclusion

The several pathways to equitable access to vaccines, medicines and diagnostics, as mentioned above are either getting closed, or faced with obstacles through a rushed process to adopt a WHO pandemic instrument. This makes equitable access more elusive for developing countries as can be seen from the current status of the draft text on Articles 9 to 13 (see the following sections).

Several developed countries, developing countries as well as WHO Secretariat officials told TWN the haste is because the Africa Group wants a WHO pandemic agreement by December 2024.

Many Member States said they are confused with what the Africa Group statements convey. A developed country negotiator told TWN that, “We are not clear what they are asking for. It seems like they want more than a framework treaty; we can see such an appetite for a comprehensive treaty at least in some negotiators. But then they need to be flexible with timeline for negotiations and they have to be vocal about it”.

While some African delegations confirmed with TWN that the Group asked for an agreement by 2024, a majority of them reaffirmed that the Group wants a meaningful legal instrument with concrete commitments on equity – “not any shallow framework agreement”.

“It's totally unjustified if we are being blamed for compromising equity in the Pandemic Treaty. We have been constantly reiterating that equity should be central to the treaty, and we haven't asked for a shallow treaty, nor our Heads of States will accept such a treaty without enforceability,” according to a senior African negotiator.

Meanwhile, several persons close to the negotiations also pointed to some powerful countries within the E.U., that hold large collections of biological resources such as gene banks, sequence information databases and research centres, as among those blocking equity under the WHO pandemic agreement. These countries want to retain their ability to control those resources, hence they do not want to adopt concrete proposals on PABS.

A functional PABS system and also a balanced One Health text (Articles 4 and 5) would mean these resources they hold have to be used in an accountable and transparent manner before the international community. Those familiar with the negotiations observe that these developed countries are therefore eager to close INB discussions at the earliest and leave PABS as well as One Health negotiations (both involving subject matters relating to sharing of biological materials and information) to the future.

Article 9 - no guarantee for access after clinical trials or publicly funded research

Article 9 on Research and Development has two key proposals for improving access to vaccines, medicines and diagnostics, in its Paragraphs 3 and 5 on clinical trials and publicly funded research respectively. Developing countries have proposed to include in these paragraphs, concrete commitments on equitable access. However, the negotiations are coming to end with no such concrete commitment.

Paragraph 3 currently reads as follows: “[ALT 3. Each Party shall [, as appropriate], in accordance with their national or domestic circumstances and law, and taking into account relevant national and international ethical guidelines and guidance, promote, during PHEIC and pandemic emergencies, the conduct of well-designed and well-implemented clinical trials in their jurisdiction, including by [ensuring / promoting / enabling] inter alia: (i) representative study populations; (ii) access to safe and effective products that result from these trials for such study populations, including communities; and (iii) access to comparator products as required in the clinical trial to assess candidate pandemic-related health products.]”

The bold font in the above text indicates that an “initial convergence” has been reached on the text. This provision, compared to the earlier versions of the negotiating text, is very short on the conduct of clinical trials. There is no clear commitment made that the entities conducting clinical trials are obliged to make available the effective health products to communities in which study was conducted.

The Bureau and WHO Secretariat seem to have been heavily involved with the textual proposals from developing countries in this paragraph and these text proposals were not reflected adequately in the paragraph before the initial convergence was recorded.

In one instance, an Indonesian proposal for inserting “through pretrial agreements” at the end of clause (ii), giving legal certainty to post trial access through contractual obligations, was not inserted. Instead, the Bureau directed the discussions in a manner such that the debate is now on the word “ensuring” before the three clauses. “Ensuring” is in brackets alongside promoting and enabling, meaning the debate is still on. It is not clear even if the paragraph manages to retain the word “ensuring”, what measures Parties will take to ensure equitable access.

Developed countries are already arguing they cannot ensure access, the only thing perhaps they can do is to take actions that might improve access. According to a developing country delegate, “Improving or ensuring access is not in our hands, they say. At the same time, they are not ready to commit to minimum measures that they can easily undertake. The Secretariat and Bureau keeps buttering this position by asking developing countries - why do we want to limit the measures? and why don’t we trust developed countries and their private sector to take even greater measures than we anticipate?”

Similarly, it was learnt that the Secretariat tried to nudge for deleting clause (iii) on access to comparator products by stating it as a restrictive clause and restraining researchers from conducting trials in a situation where the comparator product is non-existing. 

Paragraph 5 of Article 9 reads: “Each Party shall develop and implement national and/ or regional policies regarding the inclusion of provisions in research and development agreements, particularly publicly funded research of private entities and public-private partnerships, for the development of pandemic-related health products, that promote timely and equitable access to such products, particularly for developing countries, during public health emergencies of international concern including pandemic emergencies, and the [publication of] such [terms or provisions]. Provisions in the R&D agreements may include: (i) licensing and/or sublicensing, particularly to manufacturers of developing countries and for the benefit of developing countries, preferably on a non-exclusive basis; (ii) affordable pricing policies; (iii) technology transfer; (iv) publication of relevant information on clinical trial protocols and relevant research results; and (v) adherence to product allocation frameworks adopted by WHO.”

The first sentence of the above paragraph may seem to improve equitable access conditions by requesting Parties to include equitable access conditions in publicly funded research or public-private partnerships.

However, the challenge is the second sentence, where access becomes discretionary and uncertain with the use of the word “may”. It gives a menu of options to Parties to include in R&D agreements, from which they might choose one or they are free to choose anything outside the indicative list in paragraph 5. Either way, they are discharged of the obligation envisaged under these paragraphs.

Some of the options are themselves questionable. Together they could create an escape clause from concrete obligations.

For instance, “affordable pricing policies” is an option that would be favoured by private entities and Parties may be narrowed down to this only in bilateral contractual negotiations. The option clearly is not practical as the cost of production of health products is treated as confidential information, and affordable prices are not necessarily “equitable”. Nevertheless, choosing this option will discharge the obligation of Parties under the paragraph. More unfortunately, other options like “adherence to WHO allocation frameworks” or “licensing for geographical diversification of production” will be pushed into a vanishing point.

Article 10 – Almost fully “green” article with a big loophole

Colour coding has been introduced at the INB to indicate degrees of negotiation text convergence among Member States. Yellow indicates “initial convergence”, green indicates “initial agreement”, which is one step ahead of “initial convergence” and one step behind “final agreement”.

One of the most lauded successes of INB progress is the near-full greening of Article 10, which calls for international collaboration and cooperation on “sustainable and geographically diversified local production”. However, a closer look at paragraphs 2 and 3 raises doubts in the green text.

Parties and the WHO Secretariat seem to be obliged under paragraphs 2 and 3, respectively, to provide support, and/or strengthen existing or newly created production facilities of relevant health products, at national and regional levels, particularly in developing countries, with a view to promoting the sustainability of such geographically diversified production facilities.

However, paragraph 2 is limited by the phrase “subject to national and/or domestic law”. This conditional language means if there is national or subnational law limiting the types of measures a Party can take to support diversification of production, then the Party is not obligated to take such measures. There is a clear hierarchy established between national law and the provision of the WHO pandemic instrument here, where the former restrains the application of the latter. A developed country Party can also create new national laws to avoid or restrain the application of this provision in multiple ways. 

Similarly, the support from WHO is also limited and kicks in only “upon request from the Conference of Parties”. This means even a single Party can or in general a few countries together can block such requests from being made. The WHO Secretariat also cannot intervene in diversification of the production of novel health products developed post-outbreak of pandemics, if a Conference of Parties meeting is not convened.

(The provision on decision making by the Conference of Parties is still under negotiations at the INB.)

Article 11 - Zero progress on technology transfer; ignores South African call for explanation

Article 11 provides for “Transfer of technology and know-how for the production of pandemic related health products”. However, there is no progress in this Article, although text colours are changing from white to yellow and yellow to green. This is because the major developed countries are adamant on including an overarching clause “voluntary and mutually agreed terms” in paragraph 1(a) which calls to promote or incentivize transfer of technology and know-how.

Paragraph 1(a) currently reads as follows: “1. Each Party shall, in order to enable the sustainable and geographically diversified production of pandemic-related health products for the attainment of the objective of this Agreement, as appropriate: (a) Promote and otherwise facilitate or incentivize transfer of technology, skills and [knowhow] [which may include know-how, as appropriate,] on [voluntary and mutually agreed terms, without prejudice to other measures a Party might take,] for pandemic-related health products, in particular for the benefit of developing countries [and for technologies that have received public/government funding for their development], through a variety of measures such as licensing, capacity building, relationship facilitating, incentives or conditions linked to research and development, procurement or other funding, regulatory policies, and/or fiscal policies;”

[Note: Underlined bold text indicates initial agreement (green text); simple bold text indicates initial convergence (yellow text). Normal font are text without convergence.]

The Bureau in its attempt to remove the contentious words “voluntary and mutually agreed terms” proposed a new paragraph along the lines of the demand made by the United States. The proposal contains a new paragraph 1(a) along with a footnote. The on-screen text now reads thus:

“After agreeing to the definition/footnote on technology transfer and know how, article 11.1 (a) can read:

Promote and otherwise facilitate or incentivize 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/government funding for their development in line with Article 9] through measures which may include, inter alia, licensing, capacity building, relationship facilitating, incentives or conditions linked.

Revised New 1(j) Alt / footnote under Article 11 following consultations on Monday 16 September:

For the purposes of this Agreement, Transfer of Technology means a mutually agreed process where Parties share technology without coercion. This understanding is without prejudice to measures that Parties may take in accordance with their domestic or national legislation and does not affect any rights they may exercise under it, provided that these measures are in line with their relevant international obligations regarding intellectual property rights.”  

[Note: Underlined bold text indicates initial agreement (green text); simple bold text indicates initial convergence (yellow text). Normal font is text without convergence.]

However, the footnote definition of technology transfer makes it clear that there is zero obligation on Parties to ensure the technology held by their nationals are shared with developing countries for geographical diversification of production of pandemic-related health products. The proposal essentially limits the scope of the provision to voluntary sharing or transfers of technology. Even though other measures are available nationally or internationally, Article 11 fails to establish trigger points for some of those measures. This is exactly what developed countries wanted, regardless of whether the word “voluntary” is used or not.

The South African delegation was reportedly deeply dissatisfied with the provision and called on the INB Bureau and developed countries to explain how this proposed language changes anything in the status quo regarding access to technologies for developing countries. The delegation challenged the Bureau and developed countries to develop a non-paper on this question, alongside a compilation of definitions of technology transfer, if included, in any other international legal instruments.

It is reported that while the developed countries shied away from accepting the challenge, the WHO Secretariat has promised to come back with a non-paper on the definition. “It's clear that both the Bureau and developed countries know that there is no merit in their proposal, yet they want to retain it,” a developing country delegate told TWN.

Article 12 - Calls for functional PABS system ignored

On Article 12 on Pathogen Access and Benefit Sharing (PABS), the INB Bureau has come up with an extremely streamlined text, and pushing it against the developing countries’ demands and proposals. Those close to the negotiations observed that the Bureau seems to be partial towards those countries that want to conclude Article 12 with simple headline elements and to push negotiations for a functional PABS system into another negotiating process/body.  (See TWN analysis on the proposed PABS text).

The Africa Group has clearly opposed the Bureau’s proposal, according to many negotiators belonging to the Group, and has stated several times they want to establish a functional PABS system, using detailed annexures, along with the adoption of the WHO Pandemic instrument, as a part of the instrument. In this regard, the Africa Group has also circulated a non-paper containing proposed annexures.

The Bureau has been reluctant to add a reference to “Annexures” to Article 12 Paragraph 2 which would indicate this demand from the Africa Group. To the contrary, the Bureau said it would not like to make the change because a significant part of the text has been made green already, i.e. initial agreement.

Interestingly it is also learnt that the Bureau later attempted to alter a green text under the guise of “enriching” the text to incorporate a Japanese proposal.

A majority of the Africa Group and several other developing countries are struggling hard to get a functional PABS system adopted along with the WHO pandemic instrument, while a few others seem to have given up already and have become silent. Some of them came up with suggestions overtly supporting the Bureau’s streamlined text, making it easier for developed countries and the Bureau to move ahead with postponing developing country demands.

Thus, the Bureau continues to ignore calls for a functional PABS system, as well as for concrete commitments on benefits such as a share of production of live-saving vaccines and medicines.

The Indian delegation’s call for tracing PABS materials and information, improving accountability and transparency, supported by several developing countries, is also pushed aside for future consideration by the Bureau.

These calls were also supported by 94 Civil Society Organizations from all WHO regions.

On the last day during agenda item 4 on the next steps, and ahead of the adoption of the INB11 report, there were several statements which reflected dissatisfaction with the Bureau’s approach towards Article 12, according to delegates. 

Articles 13 and 13bis – Failed attempt to insert text on WHO stockpiles

Articles 13 and 13bis are about global supply chain management, including procurement and distribution of pandemic-related health products. Developing countries and several civil society organisations attempted to highlight that there is nothing concrete in Articles 13 and 13bis, except for a promise that the future Conference of Parties will develop the structure and operational details of a Global Supply Chain and Logistics Network.

There is no clarity on what this network or WHO will do to establish and maintain WHO stockpiles. There is also no explicit mention in the provisions of an obligation on countries to contribute to WHO stockpiles or to share their stockpiles.

The attempt of the Central African Republic to add these obligations into the provisions were ignored by the Bureau on the basis that those are new proposals and the INB does not have time to consider them at this stage.