WHO: Clarity on next steps expected from stocktaking of pandemic instrument talks

Covid-19

Geneva, 3 May (K M Gopakumar) – The stocktaking of progress on the 5th day of the resumed session of the Intergovernmental Negotiating Body (INB) is expected to provide clarity on the next steps on the pandemic instrument negotiations.

The negotiations have not made any substantial progress towards conclusion as planned.  According to the programme of work of the resumed 9th INB session, the first 5 days (29 April-3 May) were allocated for the negotiation of the pandemic instrument and the next 5 days for the negotiation of the World Health Assembly (WHA) resolution to adopt the instrument.

According to the interim report of the 9th INB meeting the negotiations on the draft negotiating text of the pandemic instrument is to be finished by 5 May. It states: “The INB will work to finalize substantive negotiations on the text of the proposed WHO Pandemic Agreement by 5 May 2024 and will plan to take stock of progress on 3 May 2024 in order to determine the way forward for the Seventy-seventh World Health Assembly”.

The deadline of 5 May had been inserted at the insistence of Switzerland.

The stocktaking is taking place today (3 May) after more than 40 hours of negotiations over the last four days.  However, negotiations are progressing slowly in the formal settings i.e. negotiations in the drafting group and 3 working groups.

There are various Member States that lead the informal process. For instance, the United States has taken initiatives on Articles 12 (pathogen access and benefit sharing system) and 14 (regulatory strengthening). Germany has taken the initiative to insert textual proposals on Article 7 dealing with health and care workers. Mexico coordinated discussions to improve Article 9 dealing with research and development. Argentina facilitated a discussion on technology transfer provisions under Article 11.

On 2 May the EU organised a bilateral lunch time meeting with the Africa Group. There was also some brainstorming on the next steps around the same time. On the 3rd morning Norway had a coffee/breakfast meeting of a few ambassadors to discuss the way forward.

Negotiations so far

Despite the INB Bureau’s declared position against text-based negotiations, especially in the drafting group, on-screen editing of textual proposals took place a few times in both the drafting group and working group sessions. Leaked texts show the lack of convergence on important issues.  The negotiations have to continue in the coming days if the pandemic instrument is to be ready to be adopted at the 77th WHA scheduled from 27 May to 1 June.

Important issues that need consensus are as follows.

Surveillance and One Health: There are three issues that still evade consensus. First, on the scope of surveillance, the leaked text shows that Member States are still negotiating the list of surveillance activities to be included in Article 4.2.

Secondly, there is no consensus on the availability of additional resources required to implement the obligations on surveillance and One Health. Developing countries are arguing that in the absence of committed resources from developed countries it would be impossible to undertake these obligations.

Thirdly, many Member States oppose the proposal under Article 5 on One Health, which proposes a new legally binding instrument on One Health. It reads: “The modalities, terms and conditions and operational dimensions of a One Health approach shall be further defined in an instrument that takes into consideration the provisions of the International Health Regulations (2005) and will be operational by 31 May 2026“.

Developing countries point out that the proposal goes beyond the mandate of the INB and there was no discussion in the past to have such an instrument. Many developing country delegates told TWN that the European Union is championing the proposal for a new instrument, conveying the message to developing countries that the One Health instrument is in exchange for a dedicated instrument on the pathogen access and benefit sharing (PABS) system. The working group on Articles 4 and 5 has met only twice. The second time the negotiations were on Article 4.

Research and development: Mexico has carried out informal consultations on Article 9. However, the only change in the draft negotiating text is the insertion of four words. Paragraph 6 of Article 9 deals with the obligation to develop policies to implement the pro-access conditions in publicly funded research agreements. However, neither the drafting group nor the working group discussed Article 9.

Sustainable and diversified production: The working group discussed Article 10 on the second day and many brackets remain. Many parts of the leaked text are highlighted in yellow with around 56 brackets remaining in the text signifying lack of consensus. Developed countries are inserting many qualifications to limit their obligations to support sustainable and geographically diversified production. Another area which lacks consensus is the provision seeking WHO’s support in the establishment and maintenance of production facilities to supply pandemic-related products at the national and regional levels. The bracketed paragraph reads as follows:

 “WHO shall, upon request of the Parties, provide assistance to the facilities referenced under paragraph 2, including training, capacity building and timely support for development and production of pandemic related products, especially in developing countries, with the aim to achieve geographically diversified production. WHO shall also promote the procurement of the pandemic relate products from the facilities under reference through the network pursuant to Article 13”.

Access and Benefit Sharing: The full day of negotiations had only three hours spent on text-based negotiations and another six hours spent inserting textual proposals from various Member States and groups. After that, there was negotiations on the text.  During the daily briefing the Co-chair informed that a group of countries was working to streamline the text but refused to name those countries. A few delegates told TWN that both the US and EU circulated their version of Article 12 as part of informal discussions.  The Africa Group proposed the following mandatory benefits sharing from manufacturers:

• Sharing of 20% of real-time production of health products like vaccines, therapeutics, diagnostics etc. in the event of public health emergency of international concern (PHEIC) and pandemic with WHO. Out of the 20%, 10% is a donation and 10% is at affordable cost;

• Make health products required for PHEIC or pandemic response to developing countries at affordable price;

• Grant royalty-free technology transfer license to WHO in the event of PHEIC or pandemic;

• Make available the above-mentioned health products to developing countries during an outbreak and to the WHO stockpile at an affordable price.

The United Kingdom opposed the earmarking of a fixed percentage of real-time production.

The US is agreeing to the 20% formula and includes PHEIC as a trigger point for the donation. However, it does not support the mandatory monetary contribution of users of the PABS system.

The EU has a different approach to benefit sharing and propose the decoupling of access from benefit sharing. According to the EU formula, there would be a legally binding obligation on Parties of the PABS system to share pathogen or sequence information but no obligation on users to share benefits. Regarding benefit sharing, the EU proposes legally binding contracts with a few manufacturers who are willing to sign such contracts.

Finance: The main issue regarding finance is the opposition to the establishment of dedicated funds as part of the financial mechanism. While many developing countries are demanding the creation of a new fund to support the implementation of the pandemic instrument, developed countries are of the view that there are many existing sources of financing and therefore there is no need to establish a new fund.

Developing countries point out that these mechanisms are not accountable to the governing body of the instrument and therefore there is no guarantee that there would be alignment of financing priorities of existing facilities with the priorities of the governing body of the pandemic instrument.

Negotiations on Article 11 took place on the 3rd morning but are not expected to reach any consensus.

There was no discussion on Articles dealing with governance. Similarly, the adoption of the pandemic instrument under Article 19 of the WHO Constitution as well as the proposed new instruments on One Health and PABS system and their implications for the fragmentation of the health emergency regime are yet to find a place in the INB discussions.

Next Steps

Realising the need to continue negotiations Member States are weighing various process options. Three options are discussed in the corridors. First, extend the negotiations till 10 May and carry out a further stocktaking.

Second, continue the negotiations till 10 May and beyond till the 77th WHA.

Third, take note of the progress and seek further time to complete the negotiations from the WHA. Many developed and developing country Member States say that is the most rational option at this stage but also admitted that they are waiting for the right opportunity to communicate this option to the INB.

Today’s stocktaking is expected to provide clarity on the negotiation process. - Third World Network