The Global Health Agenda in 2023: An Emerging New Architecture, Post COVID-19

1. Context
2. WHO Pandemic Accord
3. Working Group on Amendments to the International Health Regulations (WGIHR)
4. Extension of the Trips Waiver to COVID-19 treatments and diagnostics
5. G7, G20 and its Health Working Group
6. Main Takeaways

Context

The COVID-19 pandemic tested the limits of global healthcare systems and capacity of governments and international organizations to coordinate an effective and timely global response. Governments and international organizations were criticized for the inequality in access to COVID-19 vaccines, diagnostics and treatments. These criticisms, along with other regional and global political trends, have led governments and international organizations to start developing a new global pandemic preparedness framework, with the objective of achieving a quicker and fairer response to the next pandemic.

The creation of this global pandemic preparedness framework is taking place in several forums and led by different international organizations. These discussions will have significant implications on the global health architecture and the way governments will prepare for and respond to the next pandemic; especially in the relationship between low- and middle-income countries (LMICs) and high-income countries (HICs) and their relative access to pandemic countermeasures. These discussions will also impact the healthcare industry, particularly global pharmaceutical and medical device companies, as they have the potential to add requirements and responsibilities to the industry’s role in providing medical countermeasures during pandemics.

The politics across these forums have converged around stated positions of member countries, with discussions at the WTO feeding into positions of the same members at WHO, and vice versa. In recent years, emerging markets have gained influence in these forums while the inequality in access to pandemic countermeasures between LMICs and HICs is reflected in country-level positions on thorny issues around equitable access and intellectual property.

In this blog post, we highlight the three processes that are currently occurring in parallel: the WHO Pandemic Accord negotiations, the Working Group to reform the International Health Regulations of 2005, and the extension of the TRIPS waiver to COVID-19 treatments and diagnostics, with a particular focus on emerging markets and what global healthcare leaders can do to be part of local and regional level discussions that feed into global decisions.

WHO Pandemic Accord

The first process, the WHO Pandemic Accord negotiations, focuses on developing a legally binding agreement to protect the world from future pandemics. The Accord’s draft aims to improve infectious disease monitoring, information sharing, strengthen healthcare systems, and ensure equitable access to medical pandemic countermeasures. The negotiations on the “zero draft” of the Pandemic Accord by WHO members started at the fourth meeting of the Intergovernmental Negotiating Body (INB4) from February 27 to March 3, 2023, and continued onto the fifth meeting (INB5) held between April 3 and 6, 2023 in a hybrid format. Both sessions were treated as one and effectively marked the start of the final negotiation process for a final draft text with the WHO hoping that negotiations will be finalized within a year, and that the legal instrument can be signed at the World Health Assembly to be held in May 2024.

INB5 was mostly held behind closed doors and ended with the announcement that the deadline for member states’ textual submissions was extended from April 14 to 22. Member states also agreed that the INB Bureau will prepare a compilation report of the submissions, an initial “Bureau version” of the Accord, until May 22, with a report on the process due to be made to the World Health Assembly, which starts on 21 May. The next meeting of the INB’s drafting group is scheduled for June 12 to 16, and the sixth INB meeting is set for July 17-21.

In recent weeks, the WHO Director, Tedros Adhanom Ghebreyesus, stated that the Pandemic Accord will not require countries to cede part of their sovereignty, as some sectors fear. “We continue to see misinformation about it in the media and social networks, and the accusations that the agreement will imply a transfer of power to the WHO are simply false,” Dr. Adhanom Ghebreyesus said at a press conference.

“It will be the countries, and only the countries, which decide what the agreement establishes or does not establish, and they will apply it in line with their own national laws, without any country having to cede part of its sovereignty to the WHO”, the director reiterated. Tedros, also acknowledged the tight timeline for negotiations in his remarks during INB5, but it seems that, at this moment, there remains a willingness among most countries to maintain the timeline of having a definitive version of the Accord for adoption by May 2024.

Working Group on Amendments to the International Health Regulations (WGIHR)

Another process currently taking place in the realm of global health discussions is the Working Group on Amendments to the International Health Regulations (WGIHR). This group, established in September 2022, is tasked with developing amendments to the World Health Organization’s (WHO) International Health Regulations (IHR) (2005), with a focus on improving accountability and compliance.

The IHR is a legally binding instrument that provides a framework for countries to report public health events of potential international concern and coordinate responses to outbreaks and other emergencies. The COVID-19 pandemic has highlighted the need for stronger and more effective global health regulations, and the WGIHR aims to address some of the shortcomings of the current system.

The WGIHR has been meeting regularly since its establishment, with member states and other stakeholders discussing potential amendments to the IHR. Some of the issues being considered include the need for stronger reporting requirements, more effective coordination mechanisms, and improved compliance mechanisms to ensure that countries follow the regulations.

The group is expected to submit its recommendations to the WHO in the coming months to start a negotiation process with final reforms to be agreed at the World Health Assembly in May 2024. If adopted, the amendments could have significant implications for how countries report and respond to public health events, and could have stronger enforcement mechanisms than the Pandemic Accord. During negotiations at both the INB and the WGIHR, there have been discussions on the dynamic between these mechanisms and how the IHR can be seen as a “micro” tool and the Pandemic Accord as a “macro” tool.

To bring cohesiveness and avoid duplication of efforts between these two parallel negotiations, member delegates at INB5 decided that “the INB Bureau will explore with the WGIHR Bureau, the possibility of a joint plenary meeting of the two bodies in advance of the June meeting.”

Extension of the Trips Waiver to COVID-19 treatments and diagnostics

The third process currently taking place in the realm of global health discussions is the extension of the TRIPS waiver on COVID-19 treatments and diagnostics. The TRIPS agreement, which is administered by the World Trade Organization (WTO), sets out rules for how intellectual property (IP) rights are protected and enforced.

In October 2020, India and South Africa submitted a proposal to the WTO calling for a temporary waiver of certain TRIPS provisions related to COVID-19 medical products, including vaccines, treatments, and diagnostics. The proposal argued that the waiver would help to ensure that these products are available to all countries, regardless of their level of development or ability to pay. On June 17, 2022, after two years of contentious talks, WTO members reached a decision on a five-year patent-related waiver for COVID-19 vaccines at the WTO’s 12th Ministerial Conference (MC12). This deal did not include a waiver for treatment and diagnostics pushing this extension for at least six months, which raised significant criticism from low- and middle-income countries and several non-governmental organizations.

The decision on whether countries would extend the TRIPS waiver to tests and treatments for COVID-19, continued to stall at the WTO in March 2023, with the process effectively been put on hold pending internal investigations in the United States. Back on February 1, 2023, the U.S. International Trade Commission initiated an investigation into the impact of intellectual property rights on the production, supply, and availability of diagnostics and therapeutics used to detect and treat COVID-19. The Office of the U.S. Trade Representative requested this investigation to inform its position on negotiations over the possible expansion of the TRIPS waiver to COVID-19-related diagnostics and therapeutics.

The WTO TRIPS Council, which is tasked with debating the issue, had its first meeting of the year in March with little progress achieved toward breaking the stalemate with member states pushing the waiver extension decision to the next TRIPS Council meeting scheduled for June.

G7, G20 and its Health Working Group

In addition to these three processes, other global spaces have emerged and strengthened their function as important fora for global health discussions, especially G20. In recent years, the G20 has increasingly focused on global health issues, particularly in the wake of the COVID-19 pandemic. To a lesser extent, the G7 engagement forum has also increasingly covered health topics. As the Pandemic Accord and WGIHR negotiations are now centered at member state-level, inter-governmental engagement forums like G20 and G7 will be vital for the development of member state positioning.

In 2022, the G20 health ministers established a health working group (HWG) to promote cooperation and coordination on global health issues. The HWG is a key negotiation space anticipating official UN meetings, in addition to being more open to industry and civil society advocacy. Of note, last year’s Health Ministerial Meeting Chair Summary confirms “the Ministers support the work of the Intergovernmental Negotiating Body (INB) that will draft and negotiate a legally binding instrument, which should contain both legally binding and non-legally binding elements mindful that the decision will be made by World Health Assembly, to strengthen pandemic PPR. The Ministers also support the working group on the International Health Regulations that will consider Amendments to the International Health Regulations (IHR) (2005).”

The Health Track of the G20 India Presidency will comprise four Health Working Group (HWG) Meetings and one Health Ministerial Meeting (HMM). The 1st Health Working Group meeting under G20 India Presidency was held from 18 – 20 January 2023 in Thiruvananthapuram, Kerala while the second meeting was held between 17-19 April in Goa. The 3rd and 4th HWG meetings and the HMM are yet to be scheduled.

On the G7 front, in the last weeks, different advocacy initiatives were developed by the private sector and civil society in the framework of G7 official engagement groups.

In the context of the C7 Summit (event organized by the Civil 7, civil society official engagement group), an official Communiqué was handed over to Japan’s Prime Minister, G7 Chair and other authorities on April 12, which included a Global Health session with a call to action to G7 to “encourage geographically diversified manufacturing capacity.”

On the other hand, a delegation of 24 CEOs from the Biopharmaceutical CEOs Roundtable (BCR) met with Japanese Prime Minister Fumio Kishida and other officials in Tokyo on April 13-14. The CEOs presented the Tokyo Statement of the BCR, outlining the biopharmaceutical industry’s priorities, such as Universal Health Coverage (UHC) to establish robust healthcare systems and foster a dynamic innovation ecosystem. BCR also presented their proposal “Biopharmaceutical Industry Vision for Equitable Access in Pandemics“, originally shared with the German government during it G7 Presidency. This proposal presented in Germany initially was a response to the start of the WHO Pandemic Accord negotiations.

Main Takeaways

The discussion at INB and WGIHR have highlighted the differences between countries’ vision for the global pandemic preparedness framework. LMICs are pushing harder for enforceable provisions on IP waivers, financing and equitable access to pandemic countermeasures, whereas HICs have preferred watered-down versions of texts much like the initial TRIPS waiver negotiations went on at the WTO.

During INB5, some diplomats from LMICs felt that representatives from HICs were hesitant in moving towards a first draft of the instrument. It has been hinted that some HICs are more invested in the outcomes from the WGIHR, as it is seen as the forum with a higher enforcing power, and that they prefer the WTO as the sole forum for IP discussions.

Instead of positioning this important agenda on a LMICs vs HICs framework, these discussions could present an opportunity for shifting the focus on IP as a barrier to access innovation to a focus on measures to increase R&D, funding and local capacity building tools to improve pandemic countermeasures. Discussion of innovation in healthcare often goes to the point of placing access to innovation vs. intellectual property protection. Considering learnings from pandemic, opening patent of existing products does not necessarily mean immediate capacity to create innovative products. Several COVID-19 vaccine producers either opened their patents or announced that they would not be enforcing patent protection during the pandemic. However, this did not result in a flurry of vaccine manufacturing sites opening across the world. Other factors apart from IP made this difficult. Namely, logistics, supply chain conditions, infrastructure and healthcare workforce capacity/resources. Countries that had experience in generating long term impactful partnerships in science and innovation were the ones that were better prepared for local COVID-19 vaccine production.

Discussions on the Pandemic Accord have seen different leading voices from emerging markets, particularly in pushing for stronger provision on equitable access to treatments. These pushes are guided by high-level political positions in member state Governments and Ministries of Health. Having an acute understanding of local and regional level influences on these positions and opportunities for engagement and policy shaping is vital for healthcare organizations navigating the effects of these global health discussions. In addition, the G7 led by Japan and the G20 led by India, this year, bring their own dynamics and opportunities for engagement into the state of play.

With the public deadline of the WHA77 for the signing of the Pandemic Accord and the reforms to the IHR in 2024, this will be a key year in global health negotiations and their impacts on the healthcare industry. Although most negotiations occur between member state delegations and behind closed doors, positions are formed at the local level and high-level commitments also occur at forums like the G20 Health Working Group where private sector engagement can be more effective. In parallel, health and regulatory authorities in HICs are increasingly aware of the need to participate in international initiatives that promote regulatory harmonization, reliance, and the exchange of health data to make access to innovation more efficient. Speyside can assist healthcare actors in monitoring and strategically engaging with these global health discussions.