Curtain-Raiser: WHA75; Tough negotiations on the WTO's IP response to the pandemic

Newsletter Edition #138 [The Friday Deep Dives]

Hi,

It is always fascinating to observe how proposals become policies, gaining legitimacy and authority with time, and some strategically deployed pressure. As always, Geneva is a decent barometer on who is making the rules, and who is trying, but not succeeding enough.

Today, we bring to you a curtain-raiser on a few, key issues that will be considered at the 75th World Health Assembly. We hope you find this useful. Do note that some of these resolutions are under “silence procedure” and discussions are still fluid.

I also take this opportunity to urge more member states to speak with us, to enable us to reflect these dynamics as accurately as is possible.

We also have an update on the discussions at the WTO on the intellectual property response to the pandemic. Delegates tell us it is perhaps not entirely accurate to refer to these as TRIPS Waiver discussions. “Nothing is being waived”, a trade diplomat told us this week. Read on!

Consider becoming paid subscribers to absorb some of the reporting costs. This will help us keep pace with fast-moving developments in Geneva.

Next week, we look forward to capture several parallel proceedings in Geneva, as the first in-person Assembly in two years gets underway. Drop me a line if you are in town and want to chat! It is always fun and insightful to meet readers.

It is also my pleasure to moderate a discussion on WHO’s role in the global health architecture on Sunday, May 22 at The Graduate Institute in Geneva, ahead of the Assembly.

Best,

Priti  

Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva

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I. CURTAIN-RAISER: WHA75

The US sets in motion process to amend the International Health Regulations; Developing countries try to restore balance in WGPR discussions

Rules to govern health emergencies continue to dominate the policy discussions at WHO. As the 75th World Health Assembly gets underway in a few days, a crowded agenda awaits member states: from the re-election of the director-general, to the Ukrainian crisis, from formal efforts towards the amendments of International Health Regulations to increasing countries’ assessed contributions to boost sustainable financing of WHO. The first in-person meeting in two years will bring ministers, delegates and other attendees, to Geneva in the backdrop of a darkening geopolitical climate and a worsening food crisis.

Photo by Miguel Á. Padriñán from Pexels

A RESOLUTION FOR A LIMITED AMENDMENT TO THE IHR

It appears the US has convinced countries to introduce a targeted amendment to the IHR, for consideration at the World Health Assembly next week. A resolution led by the US, Strengthening WHO preparedness for and response to health emergencies: Proposal for amendments to the International Health Regulations (2005), suggests an amendment to a specific provision in the IHR.  

The suggested amendment concerns Article 59 of the IHR that governs the timeline to adopt amendments to the IHRs. The suggested amendments of this provision seek to reduce the period of time for the rejection or reservation of the amendment to 9 months from 18 months. It further suggests that amendments must come into force within 12 months. This period currently stands at 24 months.

The text of the resolution has received consensus but is currently under silence procedure when this story went to print.

Diplomatic sources told us that a number of countries had expressed concerns on adopting a single amendment at WHA 75. Other substantial amendments, that need greater deliberation, will be considered in a formal IHR amendment process, potentially under the aegis of a Working Group dedicated to IHR. (See more on this below.)

Other targeted amendments suggested by the US, will be considered along with proposals that have been received, and will be received by a few other member states including Russia, the EU and possibly the African Union. (One African diplomat told us that countries in the African Union remain divided on amendments to the IHR and that, some countries have strong positions on certain aspects of the amendments.)

If this resolution is adopted by the Assembly next week, it will be seen as a win for the US. While the remaining amendments suggested by the US will not be considered by the Assembly, it is still significant, given potential implications of such an amendment. The US had first proposed a set of amendments in late 2021 and these have been discussed in informal consultations.  But other member states have also been keen on bringing their proposals on the amendments, and wanted all proposed amendments to be considered together.

We spoke to a number of Geneva-based global health legal experts to understand the implications of this amendment.

If adopted at WHA 75, such an amendment to Article 59 will come into force at WHA 77. And any subsequent amendments to the IHR that will be decided by member states in the course of the next two years, will be adopted under the revised timeline, experts explained. This means, that any new proposed amendments that could be adopted at WHA 77 (in 2024), will come into force a year sooner than what current provisions state. So any new amendments can take effect by WHA 78 (in 2025) instead of WHA 79 (in 2026), saving one year.

This is important because it would mean that IHR amendments that will be negotiated over the next year or two, will come into force in 2024. This process will run in parallel to the negotiations for a new pandemic accord at the Intergovernmental Negotiating Body. At this point, a new instrument is expected to be adopted at WHA 77 in May 2024. But as experts point out, adoption by the Assembly of any new instrument, does not mean that rules could automatically come into force. Depending on the legal nature of the new instrument (Art. 19 vs Art. 21 of WHO Constitution), it will still need to be ratified by member states.

However, pending clarity on rules in a new instrument, the IHR amendments come into force automatically, unless member states express reservation or consider opting out. (The IHR is an opt-out instrument structured under Art 21 of the WHO Constitution)

As always, details matter. It is not fully clear what the real consequences of the adoption of an amended Article 59 can mean. Some believe that this amendment merely results in “technical adjustments” that seek to provide clarity and consistency, in order to “effectuate” the proposed amendments in Article 59, without altering other provisions in the IHR.

Others caution that amending Article 59 can have deeper implications if it could also substantially affect the way reservations on the amendments can be made by member states. This could have implications on the kinds of amendments that can be incorporated into the IHR, experts say.

Overall, the parallel processes of IHR amendments and work on the new instrument are being seen as a package on new rules for health emergencies.

What is also significant to note is that it now appears that the EU is more engaged than before, on the amendments to the IHR as an approach to govern future health emergencies, sources familiar with these discussions told us. In previous months, this was largely being seen as an American initiative, in opposition to the EU’s emphasis for a new instrument. (The EU has already been working closely with the US on these matters.)

(Also see: Third World Network’s analysis from earlier this month WGPR Draft Report seeks endorsement of US IHR amendment proposals)

AN IHR REVIEW COMMITTEE & THE “WG-IHR”

Health delegates in Geneva have spent a significant part of this month in trying to agree on a final report of the Working group on strengthening WHO preparedness and response to health emergencies. This has been a long and difficult negotiation going well beyond the initial meeting on 4-6 May. Countries have spent many evenings during the past few weeks in trying to reach consensus. Finally, earlier this week, the text of the report was greened. But late one night, the silence procedure was reportedly broken, by Brazil.

Countries had largely agreed on a decision towards a formal Member State-led process to consider amendments to the IHR (2005). But the consequences of further changes to the text as a result of reservations from Brazil, remain unclear by the time this story went to print.

The draft report suggested setting up of a new Working Group on IHR amendments – essentially the current WGPR but with a revised mandate to work exclusively on the consideration of proposed IHR targeted amendments. Countries have suggested rotation of the bureau “as appropriate and if agreed within each region”. (A number of both developing and developed countries that we spoke with, were not happy with the co-chairs of the bureau. Some saw the US as being well-resourced, but too powerful, while others saw Indonesia as being too weak and not taking into concerns by developing countries.)

The report also recommended that proposed amendments should be submitted by 30 September 2022. It also recommends establishing a IHR Review Committee by the Director-General before 1 October 2022. Some developing countries continue to be unsure on the utility of such a committee, that they fear would be overseen by experts from the Global North and could result in a process that may not take their concerns into consideration.

ON EQUITY

Sources familiar with the discussions over the past few weeks were of the view that developing countries particularly Bangladesh, Brazil, China, India and Russia actively shaped the text of the final report to reflect equity considerations including on reference to access and benefits sharing.

“The result is that this is a much more balanced text. However, now that developing countries have managed to write their concerns into the report, efforts have been made by some developed countries to reduce the importance of this report, for example, by calling recommendations as ‘possible outcomes’,” a legal expert who witnessed these discussions told us.

It is learned that some developed countries suggested expanding equity considerations to include access to information. And developing countries wanted specific language on access to technology, know-how and financial resources.

One of the most contentious elements of these discussions was the efforts to reduce the scope of these recommendations to pandemics and not health emergencies. Sources suggested that there was broad consensus on using the term health emergencies and not limiting discussions to pandemics. But it is understood that in an accompanying table, these changes were not reflected. Developing countries pushed for consistency on this throughout the report. Sources spoke about the alleged pressure on the co-chairs of the bureau from developed countries.

WHO’S VISION FOR THE GLOBAL HEALTH ARCHITECTURE

At the Assembly, Director General Tedros Adhanom Ghebreyesus is also expected to present his vision for WHO’s role in the global health architecture. [See: Strengthening The Global Architecture For Health Emergency Preparedness, Response And Resilience (HEPR)]

The document (May 4) outlines the Director-General’s 10 proposals “to strengthen HEPR under the aegis of a new overarching Pandemic Accord that is currently under negotiation.”

The proposals straddle the areas of governance, systems and financing that seek to shape the emerging global health architecture.

Some of the proposals include a Global Health Emergency Council and WHA Committee for Emergencies. He also suggests targeted amendments to the IHR and scaling up the Universal Health and Preparedness Reviews. Others include strengthening a global health emergency workforce, a network of health emergency coordination hubs, and standardize, establishing a Financial Intermediary Fund for pandemic preparedness and response to provide catalytic and gap-filling funding, and to strengthen WHO at the centre of the global HEPR architecture.

An updated document is expected to be published ahead of the Assembly that takes into account consultations with various stakeholders including member states.

A STANDING COMMITTEE ON HEALTH EMERGENCY PREVENTION, PREPAREDNESS AND RESPONSE

The assembly will also consider a proposal for a standing committee on health emergency prevention, preparedness and response. Recall that this was first discussed at the Executive Board meeting in January 2022. A Terms of Reference have now been suggested. It is learned that the proposal has achieved consensus and is now under silence procedure when this story went to print.  

According to the proposal, “The Standing Committee on Health Emergency Prevention, Preparedness and Response shall be composed of 14 members, two from each region, selected from among Executive Board members, as well as the Chair and a Vice-Chair of the Board, ex officio, in line with the principles set out in Rule 18 of the Rules of Procedure of the Executive Board, reflecting a balanced representation of developed and developing countries.”

It also suggests that the committee shall “provide guidance to the Executive Board and advice to the Director-General, through the Executive Board, on matters regarding health emergency prevention, preparedness and response…” when a Public Health Emergency of International Concern is determined  as per IHR. Further, the committee could also make recommendations to the EB on the strengthening and oversight of the Health Emergencies Programme. It also asks the DG to convene an extraordinary meeting of the Standing Committee as soon as reasonably practicable, and ideally within 24 hours following the determination of the PHEIC.

THE SUSTAINABLE FINANCING WORKING GROUP: MOMENT IN THE SUN

The discussion on the working group on sustainable financing is going to be one of the most important items at the Assembly. (See our comprehensive analysis on these discussions here.)  

The recommendations suggest “… that the Seventy-fifth World Health Assembly, recognizing the important role of assessed contributions in sustainably financing the Organization, requests the Secretariat to develop budget proposals, through the regular budget cycle, for an increase of assessed contributions to contribute to financial sustainability of WHO and with its aspiration to reach a level of 50% of the 2022–2023 base budget by the biennium 2030–2031, while aiming to achieve this by the  biennium 2028–2029…”

The report says, “The baseline will be fixed to the base segment of the approved Programme budget 2022–2023 (resolution WHA74.3 (2021)) in order to provide certainty to Member States. This is without prejudice to the adoption of subsequent scales of assessment by the Health Assembly.”

It is also learned that any increase in assessed contributions will be tied to a set of conditions on transparency, efficiency and governance reforms. There could be as many as 40 such conditions to be met, Geneva-based sources familiar with the discussions have indicated.

A RESOLUTION ON CLINICAL TRIALS

Led by UK and Argentina, countries have been negotiating a resolution on clinical trials (Strengthening Clinical Trials to Improve Public Health) that will be considered at the Assembly next week.

Civil society groups such as MSF have pushed to expand the scope of the resolution to all medical technologies and not only to vaccines, for “full transparency requirements, such as sharing of protocols, timely publication of data and public disclosure of research and development (R&D) costs, including the costs of clinical trials, particularly when public funds are assigned to the research”, “Embed access and benefit-sharing principles and conditions in clinical trial management and governance,” among other areas to improve the text.

RUSSIA-UKRAINIAN CRISIS: THE ELEPHANT IN THE ROOM

Geopolitics is no stranger to World Health Assembly. But like no other Assembly in the recent past, will geopolitics dominate the discussions next week. At a special session of the WHO Regional Committee of the European region, earlier this month countries approved a resolution condemning Russia for its invasion of Ukraine (See HPW for more on this).

The resolution will now be considered by all WHO member states. This has pushed WHO to essentially take a political position against a large, influential member state. It calls on WHO to consider relocating the European Office for Noncommunicable Diseases (NCDs) out of Russia.

The Ukrainian crisis adds to a long list of political flashpoints at the WHO, including the US-China dynamic, Ethiopia’s war in Tigray, the coup in Myanmar, Taiwan, and Israel’s occupation of Palestinian West Bank and Gaza.

Earlier this week, it emerged that Russia might unilaterally withdraw from WHO and the WTO. (Also see Think Global Health: Will the WHO Sideline Russia Over Ukraine? Not if Russia withdraws first)

TAIL PIECE: ON PROCEDURE

Seasoned observers have questioned why several contentious discussions on resolutions and reports have resorted to the use of the silence procedure given that in person meetings and consultations between member states have resumed. Some point out there is no clear legal basis for a written silence procedure  that was first developed in the context of COVID- 19.  

Also see: Five Questions for the World Health Assembly - Think Global Health

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II. TRADE AND HEALTH UPDATE

Tough negotiations on the WTO's IP response to the pandemic

WTO members finally got their hands dirty with text-based negotiations on WTO’s intellectual property response to the pandemic. Members met all week, at informal meetings of the TRIPS Council, and in smaller groups to consult and negotiate on the Director-General’s TRIPS COVID-19 text. This text follows the discussions of the quad group that includes the US, the EU, India and South Africa.

Even before the negotiations began, the US fired its first shot, that some say, effectively drew the battle-lines on these discussions.

At the General Council Meeting last week, China had offered to not avail flexibilities in a potential solution as being currently proposed, but rejected the restriction on the eligibility provision that seeks to exclude those countries that exported 10% of the total COVID-19 vaccine doses in 2021.  

Soon after DG Ngozi Okonjo-Iweala was enthused about the constructive move by China.

However, on May 16, US effectively rebuffed the Chinese manoeuvre. Deputy US Trade Representative Maria Pagan told Bloomberg in an interview, “The second-largest economy in the world, which has Covid vaccines and mRNA technology, doesn’t need the waiver… What we want is clarity.”

Sources familiar with the discussions told us that China was clearly not happy with any provision that seemingly excludes it. China’s offer to not use the flexibility in any decision at the WTO, did not cut it with the US. The repercussions of such positions are being felt, and will undoubtedly have implications for any outcome on the WTO IP response to the pandemic.

The US position, many believe, reduces and characterises these negotiations to a geopolitical rivalry that threatens to bulldoze highly nuanced and complex positions on the debate of temporarily waiving IP protections to meet the demands of the pandemic.

One Geneva-based observer said, “The US is trying to make China “The Fall Guy”, in the highly likely event that no deal is made”. To be sure, the text as it stands now has not got endorsement from the US, India or South Africa.

China has highlighted the systemic implications for being excluded out of an agreement. This could also have an overall impact on developing countries at the WTO, in general, experts say.  

Developed countries are keen on having language to address export restrictions during health emergencies in the wider WTO response to the pandemic. But by seeking to exclude China, one of the biggest exporters of vaccines, in any potential solution on a so-called waiver seems ironical.

THE TEXT: HEAVILY BRACKETED

The TRIPS Council chair, Sierra Leone’s Ambassador Lansana Gberie reported that negotiations were held with a group of 30 delegations and group coordinators this week. The deliberations addressed questions on eligibility of members, the use of a single authorization and patent listing, on duration, review and possible extension of the instrument; and on the scope of the decision with respect to therapeutics and diagnostics.

Sources said that although developing countries favor the inclusion of therapeutics and diagnostics, there is pressure from developed countries to stick to the current articulation in the text. According to the current proposal, the expansion of the decision to include these medical products must be taken within six months from the date of the decision.  

Increasingly, the text under consideration is being seen as a set of clarifications for the use of compulsory licensing for the production of vaccines. Some delegates told us that “nothing is being waived. It is no longer a waiver”, suggesting the distance of the current text from the original TRIPS Waiver proposal submitted by India and South Africa in October 2020.

In discussions this week, members also wanted to know more on the legal nature of the text, and whether it would be called a decision or a waiver. They also sought clarification on the WTO law it would be based upon. The TRIPS Council chair is understood to have said that content of the decision would determine the legal form and title of the document.

This week, members wrestled on questions of eligibility. Some members, suggested deletions in the language on the “supply” of vaccines, on “distribution” in the existing text, which, if approved could substantially weaken the text, developing country sources said. There are also suggestions to delete a paragraph on patents listing that is being seen as onerous, that could actually make it more difficult for members to make use of existing provisions in the TRIPS Agreement.

THE PROCESS

Developing country delegates told Geneva Health Files this week, that members have been divided into small groups that have made these negotiations difficult. “Not all countries are invited to these discussions. Delegations have also been split. There is no clarity on who is agreeing to what, and this is being held against us”, one diplomat said.

(See: Green room politics and the WTO's crisis of representation: Progress in Development Studies.)

According to sources closely tracking these negotiations, EU diplomats declared during this week, that they would not be open for new suggestions from outside the existing text. However, both the opponents to the TRIPS Waiver such as the UK, Switzerland, and co-sponsors of the original proposal are keen on bringing their suggestions to the text.

To be sure, TRIPS Council Chair Ambassador Lansana Gberie asked delegations to provide in writing any textual proposals for language in other parts of the text – that does not cover the bracketed text. He said that this can be done through the Secretariat, or through regional group coordinator to allow for structuring of the negotiations.

At the meetings this week, Switzerland is understood to have said that it cannot accept an outcome on IP and TRIPS only because also a meaningful outcome on trade and health is needed.

The UK noted that the timeline proposed to advance negotiations is ambitious and sought flexibility on the deadline. The UK is understood to have said that time pressures must not be used as justification for rushing given the need for substantial discussion of the text.

Tanzania, on behalf of the African Group, stressed its right to contribute to the discussion as any other member and reiterated that whatever outcome is achieved it should be sufficient in duration (a minimum of 5 years) without prejudice of prior manufacturing capacity in Africa. An outcome should result in the diversified production not only of COVID-19 vaccines but also of therapeutics and diagnostics, which should constitute a critical element of the final consensus, Tanzania said in its statement.

Geneva-based observers familiar with the proceedings are also questioning the lack of adequate coordination and engagement between co-sponsors to strategize on these negotiations.

THE WTO UNDER PRESSURE

Statements made by DG Okonjo-Iweala around these discussions suggest that the WTO is under tremendous pressure to deliver on an outcome on these discussions.

“We do not have the luxury of not getting an answer for MC12, it just does not exist, she said. We have ample time really to do it if we work on weekends, so please get your backpacks or your whatever you need to eat, we will be here all weekend, she told delegates,” she is understood to have said this week during the TRIPS Council proceedings.

Some seasoned experts are already ruling out a deal on this text. “One just does not see the kind of momentum which is palpable when an agreement is nearing,” an expert familiar with arduous trade negotiations told us in a late evening call this week.

There will be numerous late evenings and potentially all-nighters for Geneva delegates as the DG ups the ante on delivering a result to save the institution mired in an unlikely set of unfortunate circumstances of a war coinciding with a pandemic.

WTO’s 12th ministerial conference is scheduled for June 12-15th. Negotiators are working round the clock in small group meetings. An informal meeting of the TRIPS council in scheduled for May 24. Small group meetings have resumed at WTO.

A block down the road, not far from the WTO, countries also gather for the World Health Assembly next week. 

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