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After two years of intensive negotiations – including long nights this week – the World Health Assembly (WHA) finally passed amendments to the International Health Regulations (IHR)  and committed to completing pandemic agreement talks within a year. 

After failing to agree on the amendments before WHA opened on Monday, member states have been racing to the finish in a drafting committee during this week in meetings that often went into the early hours.

“Tonight we have all won and the world has won. You have made the world safer,” said a hoarse WHO Director-General Dr Tedros Adhanom Ghebreyesus, who lost his voice during the late-night sessions.

[see full report here]

Note deep disappointment expressed by Nina Schwalbe of Spark Street Advisors that all references to compliance have been dropped in the IHR.

“The amendments do not include any provisions for a compliance mechanism. How can countries be held accountable to their commitments with a compliance mechanism?”

Foreword by Her Excellency Ellen Johnson Sirleaf and The Right Honourable Helen Clark

In May 2021, the Independent Panel for Pandemic Preparedness and Response presented a package of evidence-based recommendations to the World Health Assembly that was urgent, ambitious, and practical. Our goal was to make COVID-19 the last pandemic of such devastation. At the current rate of change, it will not be.

The world now marks time as “before” and “after” the pandemic. Many want to forget the pandemic itself and block the collective trauma. Yet we cannot afford to forget.

Government leaders may have turned their attention to other issues, but they must not neglect their responsibility to act now and unite to safeguard the public and prevent future pandemics.

CEPI has awarded USD 6.5 million to support a Phase 2 clinical study evaluating the immunogenicity and safety of the MVA-BN® non-replicating vaccine in children from 2 years to less than 12 years of age compared to adults aged 18-50 years of age for the prevention of smallpox, mpox and related orthopoxvirus infections. Subject to regulatory approvals, the study plans to enroll a total of approximately 460 healthy individuals in endemic regions without previous mpox infection or poxvirus vaccination, who will receive two doses of the MVA-BN vaccine. Bavarian Nordic will be the sponsor of the trial which will be conducted in one or more African countries with planned initiation later in 2024.

We congratulate the Member States of the World Health Organization (WHO) for their efforts to approve the revisions to the International Health Regulations (IHRs) (2005) at the 77th World Health Assembly (WHA), despite the tensions and pressure that characterized the final phase of the negotiations.

The IHRs adopted in 2005 are legally binding on 196 States Parties. They help to prevent, protect against, control and provide a public health response to the international spread of disease. The World Health Assembly 2024 has agreed to a set of amendments to the IHRs that will strengthen the international cooperation to support health security and equity, while recognising countries’ sovereignty in handling public health events and emergencies that have the potential to cross borders. The International Health Regulations as amended can be found in document A77/A/CONF./14.

Many members on 30 May called for preserving the two-tier dispute settlement system, including the binding Ap pellate Body, to ensure the continuation of a robust enforcement function at the Wo rld Trade Organization, said people familiar with the discussions.

At the first formal meeting on dispute settlement reform at the level of He ads of Delegation (HoD) on 30 May, the new facilitator, Ambassador Usha Dwarka-Canabady of Mauritius, explained the process that she would follow i n the coming days and months.

In an "urgent" email sent to members on 27 May, Ambassador Canabady, who had participated in one or two dispute settlement panels in the past, infor med members that "the focus of the 30 May 2024 DS Reform HoDs meeting should be on how to resolve the questions of appeal/review and accessibility."

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A new report suggests a handful of innovative antimicrobials that could be approved within the next few years could save up to 160,000 lives if made available, and used appropriately, in the low- and middle-income countries (LMICs) where they're most desperately needed.  

But the companies developing these products are not doing as much as they could be to make this goal a reality.

The report from the Access to Medicine Foundation tracks four innovative, late-stage antimicrobial research and development projects, and one recently approved product, that collectively treat a variety of drug-resistant infections, which disproportionately affect people in LMICs. It finds that while the companies developing these products are employing some strategies to increase access and promote stewardship in LMICs, there's much more they could be doing to ensure that these drugs will be available to every patient everywhere.

Did they or didn’t they?

This has been one of the many questions plaguing beleaguered negotiators in Geneva negotiating a Pandemic Agreement at WHO this week, when uncertainty around a Presidential communication from South Africa caused complications exacerbating already difficult circumstances. Conflicting signals from the government of South Africa on the overall position of the Africa Group, a key player in these negotiations, has led to confusion at a critical time in these discussions.

In this story, we try to unpack what has transpired over the last 48 hours, even as uncertainty continues at the time of publishing this edition.

The South African case is illustrative of the pressures faced by governments from different quarters and interest groups as countries negotiate a Pandemic Agreement under difficult circumstances. South Africa heads into election mode next week on May 29th, when the World Health Assembly considers a resolution on the Pandemic Agreement.

The pandemic instrument as a treaty under Article 19 of the WHO Constitution raises concerns on the fragmentation of the health emergency regime, which the Intergovernmental Negotiating Body (INB) has not taken up for discussion.

The draft negotiating text and the draft resolution for its adoption proposes that the pandemic instrument would be adopted under Article 19 of the WHO Constitution as a treaty. Further, some Member States are moving towards the notion of a protocol for the Pathogen Access and Benefit Sharing (PABS) system and for the proposed instrument on One Health Approach.

The rising cost of healthcare is one of the most significant burdens on countries, especially low- and middle-income countries. Research has shown that self-care can be critical in reducing unnecessary expenses for healthcare systems. Global self-care activities generate substantial monetary and healthcare workforce savings, totalling at least approximately $119 billion per year, according to a policy brief published by the United for Self-Care Coalition.

“Increased access to self-care products and services could further alleviate the burden on health systems by freeing up resources and time for healthcare providers to attend to more serious conditions,” explained Judy Stenmark, Director General at the Global Self-Care Federation (GSCF). “Globally, a total of 10.9 billion individual hours and 1.8 billion physician hours are saved every year through self-care practices.”

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In a number of global negotiations on the transfer of technology and knowledge, there are industry-led lobbying efforts to limit such transfers to measures that are on mutually agreed Page 2 of 27 terms (MAT), or voluntary and on mutually agreed terms (VMAT). Sometimes it is asserted that as a practical matter, the transfer of manufacturing know-how can only be provided through voluntary measures, and assertions are sometimes made that there is no legal basis for transfers of know-how, access to materials such as product samples and cell lines, or access to and the use of regulatory filings and data.

This note looks at one type of legal mechanism, competition law, and provides some examples of cases where the United States competition authorities have mandated the transfer of manufacturing know-how and access to materials and regulatory filings.

Read note in full

See also subsequent post by Arianna Schouten, "What measures do US competition authorities refer to in technology transfer mandates"