The negotiating text of the pandemic agreement (see below) landed in the inboxes of World Health Organization (WHO) member states last Friday afternoon – 10 days before the penultimate negotiation on 18 March and on the eve of the fourth anniversary of the WHO’s declaration of COVID-19 as a pandemic.

The 31-page draft was also sent to official stakeholders previously excluded, as agreed by the eighth meeting WHO’s intergovernmental negotiating body (INB).

READ: WHO Pandemic Agreement draft – negotiating text

The INB Bureau and staff only had a week to distil a mishmash of often contradictory proposals into the negotiating text, and will brief member states and stakeholders this Friday (15 March) on the revised draft and propose how the final round of negotiations will be structured.

Contested articles contain many caveats, with giveaway phrases such as “where appropriate”, “may” and “voluntary”.

What’s new? Chapter I (Articles 1-3)

Chapter I deals with terminology, aims and guiding principles. According to the note accompanying the latest text, what is new in Chapter I, are “refined textual proposals” as proposed by the INB Bureau in Articles 1, 2, and 3.

The stated objective of the WHO pandemic agreement – no longer referred to as a treaty or accord – “is to prevent, prepare for and respond to pandemics” with “equity as the goal and outcome” and recognising the “common but differentiated responsibilities and respective capabilities” of countries’ health systems.

This chapter also explicitly refers to “the sovereign right of states to adopt, legislate and implement legislation, within their jurisdiction, in accordance with the Charter of the United Nations and the general principles of international law, and their sovereign rights over their biological resources”. 

This is in response to misinformation that the pandemic agreement is a WHO power grab that will enable the global health body to impose, amongst other things, global lockdowns.

Chapter II (Articles 4-20): Site of most disagreement 

The meat of the agreement – and site of most disagreements – lies in this chapter. Its theme is “achieving equity in, for and through pandemic prevention, preparedness and response (PPPR)”.

According to the note accompanying the latest text, Articles 7, 8, 16, 17, and 18 contain refined textual proposals as proposed by the INB Bureau based on INB 8 talks.

Meanwhile, Articles 4,5, 6, 10, 11, 13, 19 and 20 contain refined textual proposals as proposed by the INB vice-chairs and co-facilitators from the work of the drafting subgroups. 

Article 4 addresses countries’ responsibilities in terms of “pandemic prevention and public health surveillance”, with countries committing to “progressively strengthen” these. It outlines  eight key responsibilities for member states to prevent pandemics including providing clean water, sanitation and hygiene; reducing the risks of zoonotic spillover and spillback; laboratory biosafety and managing antimicrobial resistance (AMR).

Article 5 sets out a One Health approach, with assistance to developing countries to prevent zoonotic spillover of diseases from animals to humans. This section has been shortened considerably over previous drafts.

Article 6 addresses health system preparedness and readiness, resilience and recovery – but once again dwells on countries’ responsibilities. Responsibilities related to health system strengthening for PPPR includes “the progressive realisation of universal health coverage”.

Article 7 deals with the responsibility of each country to sustain “an adequate, skilled and trained health and care workforce”. However, it makes a veiled acknowledgement of wealthier countries poaching skilled personnel by including a section where countries agree to “minimise the negative impact of health workforce migration on health systems while respecting the freedom of movement of health professionals”.

Article 8 deals with “preparedness monitoring and functional reviews”. Countries are to report to the WHO every five years on their PPPR.

Activists have pushed for companies that get government research and development (R&D) funding to be compelled to share their findings with countries from the global South and to publish the terms of these agreements with private companies. 

But the strongest that Article 9, which deals with R&D, gets is to state that that countries shall “support the transparent and public sharing of research inputs and outputs” from government-funded R&D pandemic-related products and publish the relevant terms of these.

Article 12: PABS is the biggest bone of contention

The most contested section, Chapter II’s Article 12, addresses pathogen access and benefit-sharing (PABS). The new section contains “structural design elements as proposed by the vice chair and co-facilitators from the work of the drafting sub-group”.

This article was not included in the previous draft at INB 8 but it is virtually the same as the vice-chair’s proposal that was leaked shortly before that meeting.

Article 12 spells out the formation of a “multilateral system for access and benefit sharing for pathogens with pandemic potential: the WHO Pathogen Access and Benefit-Sharing System (PABS system)”. 

Its aim is to “ensure rapid, systematic and timely access to biological materials of pathogens with pandemic potential and the genetic sequence data (GSD) for such pathogens” to facilitate the development of products to control such pathogens.

Countries with access to such pathogens will share biological material “as soon as it is available” to one or more laboratories and/or bio-repositories participating in WHO-coordinated laboratory networks (CLNs)” and its GSD to “one or more PABS sequence databases (SDBs)”.

All users of biological materials and GSD “shall have legal obligations under PABS regarding benefit sharing”.

The WHO shall conclude legally binding standard PABS contracts with manufacturers, taking into account their size, nature and capacities.  

Manufacturers will be expected to pay annual contributions to support the PABS system and relevant capacities in countries. They will also be expected to provide “real-time contributions of relevant diagnostics, therapeutics or vaccines” with 10% free and 10% at not-for-profit prices during public health emergencies of international concern or pandemics.

Manufacturers will also be expected to make voluntary non-monetary contributions “such as capacity-building activities, scientific and research collaborations, non-exclusive licensing agreements, arrangements for transfer of technology and know-how” and implement tiered pricing.

The agreement envisages that a Conference of the Parties (COP) will govern the pandemic agreement (detailed in Article 21), and this will “regularly review the operation, monitor adherence and effectiveness of the PABS system” and “promote and support its effective and sustainable implementation”. 

Article 20: New financial mechanism

Article 13 addresses the establishment of a “global supply chain network” developed and operated by WHO in partnership countries and other stakeholders. This will identify needs during pandemics, aimed at avoiding “competition for resources amongst international procuring entities, including regional organisations and/or mechanisms”.

Article 13 bis is a new addition, dealing with “national procurement- and distribution-related provisions”. It declares that countries “shall publish the terms of its government-funded purchase agreements for pandemic-related products at the earliest reasonable opportunity and in accordance with applicable laws” – but shall “exclude confidentiality provisions that serve to limit such disclosure”. 

Article 14 addresses countries’ regulatory systems strengthening, and Article 15 addresses liability and compensation management.

Article 16, on international collaboration and cooperation, covers support for countries to develop PPPR. Article 17 covers whole-of-government and whole-of-society approaches, and Article 18 addresses communication and public awareness geared to tackling misinformation. Article 19 addresses implementation capacities and support.

Article 20 deals with financing. It proposes the establishment of a “Coordinating Financial Mechanism” to support the implementation of the pandemic agreement and, in a new addition, also the implementation of the International Health Regulations (IHR). 

The mechanism shall include a pooled fund to provide financing to support PPPR, and this  may include “contributions received as part of operations of the PABS System, voluntary funds from both states and non-state actors and other contributions to be agreed upon by the Conference of the Parties”.

Chapter III (Articles 21-37): A Conference of Parties

Chapter III, which deals with institutional arrangements and final provisions, contains “refined textual proposals as proposed by the INB Bureau with respect to Article 21, and as proposed by volunteer delegations regarding the remaining Articles of the Chapter”, according to the INB.

It proposes a Conference of the Parties (COP) to review the implementation of the pandemic agreement every three years, based on the countries’ reports on their pandemic readiness, and take the decisions necessary to promote its effective implementation. However, the COP can also request information from countries.

The first COP will be held within a year of the agreement’s adoption. The WHO secretariat is to provide support for the COP.

The previous draft simply referred to a governing body to review the implementation of the agreement to be run by a secretariat. 

In another clarification to address misinformation, Article 24 states: “Nothing in the WHO pandemic agreement shall be interpreted as providing the Secretariat of the World Health Organization, including the WHO Director-General, any authority to direct, order, alter or otherwise prescribe the domestic laws or policies of any party, or to mandate or otherwise impose any requirements that parties take specific actions, such as ban or accept travellers, impose vaccination mandates or therapeutic or diagnostic measures, or implement lockdowns.”

Reaction: ‘Underwhelming governance’

Nina Schwalbe, CEO of Spark Street Advisors and a keen observer of the negotiations, told Health Policy Watch that “the governance section is truly underwhelming”.  

“While they do call for a Conference of Parties, there is almost no regular reporting let alone any type of monitoring vis a vis states’ compliance with their obligations. It’s not even punted to a future date – it is simply not mentioned,” said Schwalbe

Meanwhile, 58 charities, NGOs, and health experts including the Pandemic Action Network, Oxfam, African Vaccine Alliance, Innovarte, and Public Citizen have called on the US and the European Union to end their “patent hypocrisy” in the pandemic agreement  negotiations.

While US President Joe Biden and President of the European Commission Ursula von der Leyen “have overseen ‘laudable’ proposals to step around intellectual property rules when they prevent Americans and Europeans from securing access to affordable medicines”, they “have shown a ‘double standard’ by stopping lower-income countries from doing the same thing”, according to the groups.

In an open letter coordinated by the People’s Vaccine Alliance, organisations including Oxfam, the African Alliance, Innovarte, and Public Citizen, the groups urge the EU and US leaders to support measures in the pandemic agreement “to enable lower-income countries to overcome intellectual property barriers, to make public funding of R&D conditional upon sharing pharmaceutical technology and know-how with Global South countries, and embed transparency in global health by publishing all government contracts with companies involved in public health”.

They also want the pandemic agreement to “go beyond current proposals to require a small proportion of vaccines and medicines to be set aside for the Global South, and instead ensure those at the highest risk are prioritised regardless of where they live”.

They also want  “an extension of the pandemic flu mechanism”, which guarantees that countries that share pathogen data will receive benefits in return, including “fair access to medicines produced and financial contributions”. 

‘Untenable double standard’ of US and EU

“President Biden is staking his reputation on his ability to take on Big Pharma’s profiteering. While the President is taking crucial steps to stand up to the industry domestically, his administration still holds open a door for pharma companies to profit at the expense of people’s lives in lower-income countries. He must change course from this untenable double standard,” said Peter Maybarduk, Access to Medicines Director at Public Citizen.

“Millions of people in developing countries died at the height of the COVID emergency without access to the NIH-supported mRNA vaccines that made such a difference in the United States. The world has a rare, fragile chance to do better through the Pandemic Accord. The United States has uncommon power, and therefore responsibility, to help make a strong agreement that protects lives and livelihoods at home and worldwide, with some measure of justice.”

Image Credits: WHO.