Speakers
•Kentaro Nishimoto (Professor of International Law at Tohoku University Graduate School of Law)
　Lecture: “Challenges and Progress in Global Health Governance”
•Toshiya Ueki (Director of Tohoku University Center for International Law and Policy)
•Hitoshi Oshitani (Professor, Tohoku University Graduate School of Medicine)
　Lecture: “PHEIC Declaration against Mpox, etc.”

●Topic 1 “Challenges and Progress in Global Health Governance”
Kentaro Nishimoto (Professor of International Law at Tohoku University Graduate School of Law)

During the 77th Session of the WHO General Assembly (May-June 2024), discussions on the International Health Regulations (IHR) amendment and the Pandemic Treaty (Agreement) were held. The discussions–based on the COVID-19 experience–were significant steps toward improved preparedness for future pandemics.

〇The IHR Amendment
The IHR is a regulation that mandates a country where a disease originated to immediately notify the authorities when premonitions are detected, or when the disease has spread. The regulation prevents disease outbreaks from being dealt with domestically and covertly. Instead, it allows such occurrences to be communicated to the international community and organizations like the WHO, which can subsequently provide support to the impacted countries. The IHR also plays a role in preventing excessive measures by other countries, which is important in minimizing the impact of outbreaks on international transportation and trade.
　Furthermore, the IHR requires all countries to build and strengthen their public health capacities (“core capacities”) necessary to detect and respond to public health incidents. If necessary, the WHO will issue a non-binding advisory. However, the issue in the case of COVID-19 was that many countries took countermeasures independently.
　The proposed IHR amendments were approved by consensus by the General Assembly. The five main amendments are listed below.

1.The Adoption of a “Pandemic Emergency”
In addition to the existing PHEIC, a new system that allows for the declaration of a “Pandemic Emergency” in the wake of a critical incident has been established. According to the IHR amendment, a Pandemic Emergency is “a public health emergency of international concern that is caused by a communicable disease and (WHO 2024a):
　1.has, or is at high risk of having, wide geographical spread to and within multiple States; and
　2.is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and
　3.is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and
　4.requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches”

The significance of this amendment is that it allows a Pandemic Emergency to be declared based on the four criteria that assess an incident’s severity. However, the response measures that will be practiced based on the declaration will not significantly change: the approval of an incident as a Pandemic Emergency does not grant special authority to WHO or its member states, nor does it introduce new procedures for taking strong measures.

2. Enshrining “Equity” and “Solidarity” to the IHR Principle
　One amendment to the IHR principle is the addition of the phrase, “shall promote equity and solidarity.” While the amendments tend to be conceptual rather than substantive, they may lead to tangible systems. This amendment was made in response to the challenges low- and middle-income (Global South) faced regarding equitable access to vaccines and other related health products during the COVID-19 pandemic. During the pandemic, there were significant disparities in resource access between the Global South and the Global North (i.e., high-income countries). As a result of this amendment, the IHR now explicitly states that it promotes equitable access and international solidarity.
　Furthermore, Article 13 now explicitly states that upon PHEIC declaration, the WHO will facilitate rapid and equitable access to relevant health products. Some suggested methods for the WHO to quickly respond are assessing the availability/access to relevant health products like vaccines; assisting with the geographical diversification of production; sharing product information; and supporting research/development of such products.
Additionally, the IHR amendment stipulates it will reinforce the obligation for mutual cooperation and assistance among participating countries, emphasizing the provision of need-based assistance to the Global South. However, this assistance is non-binding and will only be exercised under “applicable laws and available resources” of each State Party.

3. Accentuation of “Preparedness” for the International Spread of Diseases
The amended IHR purpose now states the need to “prepare for” the international spread of diseases. While the original IHR focused on early detection and reporting of events, the amendment emphasized “preparedness” at a conceptual level. Furthermore, specific articles and provisions on surveillance and public health response were amended to include “prevention.” Many prevention capacities were also added to the list of minimum core capacities required of each country.

4. Establishment of the “Coordinating Financing Mechanism"
The “Coordinating Financing Mechanism” was newly established through the amendment. It is a mechanism to coordinate funds needed to acquire, strengthen, and maintain the core capacities of participating countries, especially the Global South. While the Global South called for the establishment of a new financial mechanism, the parties agreed to make efficient use of existing international aid schemes. The purpose of the Coordinating Financing Mechanism is to leverage and maximize funds, or more specifically, to analyze funding needs and shortages. It will also promote coordination and consistency among multiple funding schemes. However, the amendment only defines the general framework of its objectives and functions, leaving its implementation and operation for further discussion.

5. The Establishment of “The States Parties Committee for the Implementation of the International Health Regulations”
Through the amendment, a committee entitled “The States Parties Committee for the Implementation of the International Health Regulations” was newly established. This committee was established given the need to assess the implementation and effectiveness of the Regulations. The Committee aims to facilitate the effective implementation of the Regulations, particularly Article 44 (Collaboration, assistance and financing) and 44bis (Coordinating Financial Mechanism). However, its actual operation depends on future discussions.
　The main role of the Committee is to promote and support learning, cooperation, and the exchange of best practices among States Parties. The State Parties will meet at least once every two years for this purpose. The details of the Coordinating Financial Mechanism are also planned to be determined by this Committee. While the parties discussed strengthening compliance with the Regulations–given the failure of the IHR to adequately function in response to COVID-19–specific measures to improve compliance were addressed in the amendment. The amendment states that the Committee shall be “facilitative and consultative in nature only, and function in a non-adversarial, non-punitive, assistive and transparent manner.”
　As explained above, in the IHR amendment, functions related to the acquisition of response capacities to a potential PHEIC event were maintained. The system for recognizing “Pandemic Emergencies,” as well as prevention/preparedness of such events were explicitly stipulated. On the other hand, there were no major amendments regarding the prevention of excessive measures by countries not of a disease origin. The amendments mainly focused on reinforcing the preparedness of the Global South and did not add new burdens to the Global North. The effectiveness of the new mechanism requires further discussion.

〇The Pandemic Treaty Negotiations
The Pandemic Treaty negotiations failed to conclude. The participants decided to continue the negotiation in the future.
　Equity is valued in the Pandemic Treaty as it was in the IHR. The purpose of the Treaty is to prevent, prepare for, and respond to pandemics based on equity and principles. The Global South have been advocating for equal access to pandemic-related health products, as well as enhanced cooperation and support for research/development; technology/know-how initiation; production/distribution; and the adoption of new systems.
　A particular area of disagreement is the “Pathogen Access and Benefit-Sharing System,” a system for “multilateral access and benefit-sharing” of pathogens with pandemic potential.
　The Treaty also stipulates the pandemic preparedness system of each country, which requires the development of a routine surveillance plan. However, given the concerns that this system will burden the Global South, the Articles lays out some conditions, such as taking into consideration “national capacities and national/regional circumstances ” (WHO 2024b).
　A major challenge in the negotiations will be reaching a compromise between the Global North and South. In the absence of an agreement, especially on the PABS system, the Treaty will be difficult to conclude. Future negotiations on the Treaty will also address the relationship between the Treaty and the IHR.

●Comments from Professor Ueki
While issues concerning the negotiations, presented by Professor Nishimoto, are specific to public health, similar issues can be seen in the establishment of international regulations, especially when resource allocation is involved. For example, the Global South believe that the Global North may be earning improper benefits from vaccine developments during the pandemic. Thus, the Global South are seeking an international system for equitable vaccine distribution. Furthermore, the Global South are demanding the provision of funding and enforcement of obligations on private companies in the Global North. However, the Global North are reluctant to respond to such demands.
　The concept of “common but differentiated responsibilities” recognizes differences in obligations according to national circumstances. While the Global South claim the necessity of formal inequalities to achieve substantive equality, the Global North have difficulty accepting international legislation based on this logic. These ideological clashes are behind the failure to conclude the Pandemic Treaty. A difference between the Pandemic Treaty and the IHR is that the latter has a mechanism by which member countries can, on notice, be exempted from binding if they cannot comply with certain provisions. If a state cannot accept the WHO Charter or the IHR, it can withdraw from the WHO. The decision to withdraw from the WHO during the Trump administration is an example. Such withdrawals are common not only in public health, but also in global environmental issues, global warming, and marine resource development. I believe that similar conflicts also underlie the IHR amendment and the Pandemic Treaty negotiations.


●Topic 2 “PHEIC Declaration against Mpox and other Diseases”
Hitoshi Oshitani (Professor, Tohoku University Graduate School of Medicine)

〇Emergency Declaration against Mpox
PHEIC was recently declared against Mpox (monkeypox). Mpox was declared a PHEIC once in 2022, then subsequently lifted, but has now been declared again.
　Mpox has been endemic mainly in the Democratic Republic of the Congo (DRC) since it was first confirmed in the 1960s. Since 2022, the disease has spread globally, infecting some Japanese as well. Mpox spread mainly among the gay community, infecting approximately 100,000 people, but resulting in only about 200 deaths. One person died in Japan, but his death was likely associated with immunodeficiency caused by HIV. Only a few people are said to have died from Mpox itself.
　Since the end of 2022, there has been a massive epidemic in the DRC, with at least 20,000 people infected and about 1,200 dead. The current epidemic differs from the one in 2022 as Mpox has infected more women and young children than before. It is spreading particularly through commercial sex workers, who are infecting more children, leading to higher mortality rates.
　The difference in the viral nature is due to the difference in viral strain, which in 2022 was a clade II virus, known to have a low fatality rate. The currently prevalent virus is a clade I virus, which is highly virulent and has a fatality rate as high as 10%. This virus is spreading mainly in the DRC, but a case was recently confirmed in Sweden.
　The smallpox vaccine has been proven to be effective against Mpox. Since there is cross-immunity between smallpox and Mpox viruses, smallpox vaccines provide humans a certain degree of protection against Mpox. Japan has a stock of smallpox vaccine and is considering offering it to the DRC. However, the efficacy is estimated to be about 70%, which may be inadequate, especially against the highly pathogenic clade I virus. Development of a Mpox-specific vaccine is currently in progress, but the smallpox vaccine is the only option as of now.

〇Challenges of Vaccine Development During Pandemics
Discussions on PABS stalled and the Pandemic Treaty was not concluded. The Global South and medical journals based in U.K. have strongly criticized the Global North and pharmaceutical companies. Nevertheless, the impact of the Treaty after its conclusion must also be considered.
　Pandemic vaccines are not necessarily highly profitable. Only two companies, Pfizer (in partnership with BioNTech) and Moderna, have made large profits. Other companies have either failed to commercialize their vaccines or have been unable to achieve widespread usage of their commercialized vaccines. Despite their success, Pfizer and Moderna suffered a huge loss in their vaccine production in 2023. Moderna is now shifting its focus to cancer research rather than vaccines.
　The new GSK tuberculosis (TB) vaccine is expected to be developed but has not yet reached clinical trials, despite adequate funding. While TB is still a major problem in the Global South, GSK's CEO stated that the current priority is the shingles vaccine, since it has a large market in the elderly population of the Global North.
　Because pandemic and TB vaccines should be provided at low cost to the Global South, pharmaceutical companies may withdraw from those fields if they cannot gain profits. One could understand that a company would face difficulty remaining in the vaccine development business if it had to provide a portion of its products/profits, as the Pandemic Treaty may mandate, despite the high risks involved in vaccine development.

〇 Issues Regarding the Definition of a “Pandemic”
The WHO guidance regarding pandemics issued in 2009 clearly defined the term, “pandemic.” According to that guidance, an epidemic would be considered a pandemic if it occurs in two of the six regions where the WHO regional offices are located. However, there were criticisms that the definition had limitations. For example, if an outbreak started in Laos and spread to Thailand, it would be a pandemic by definition, since the ASEAN countries are divided into two WHO regions, but some question whether that example should actually be recognized as a pandemic.
　In 2009, a pandemic caused by the H1N1 influenza virus occurred, which resulted in a low number of deaths. Given the low death toll, the question of when to declare a pandemic became an issue. Based on the guideline, a declaration would have been required at the beginning of May, since infected cases were reported not only in the US and Mexico, but also Spain.
　Furthermore, on May 18, infections were confirmed among high school students in Osaka and Hyogo, Japan. A pandemic declaration was considered, but due to opposition from the Japanese government, the declaration was postponed. Eventually, when the pandemic was declared on June 11, the infection had already spread globally. The delay was thought to be due in part to the fact that negotiations with various countries were required prior to the pandemic declaration, since such a declaration would automatically set border closures and other countermeasures.
　After the H1N1 pandemic, the WHO decided not to clearly define the term, “pandemic.” Thus, when Director-General Dr. Tedros declared the COVID-19 pandemic on March 11, 2020, he used equivocal phrases.
　The delay in declaring PHEIC for COVID-19 and the 2010 Ebola virus outbreak has been criticized. As for COVID-19, while there was a chance to declare COVID-19 a PHEIC one week prior to its actual declaration on January 30, 2020, Dr. Tedros made the declaration only after visiting China.
　While many reports and committees have criticized the WHO for its slow response, the current focus is primarily on pandemic emergencies.

●Discussion

〇The Significance and Challenges of the Consensus Method
The IHR amendments were adopted via the consensus method, in which negotiations are conducted behind the scenes to find a compromise rather than by majority vote. Typically, countries clarify their positions by agreeing, disagreeing, or proposing amendments to treaties and rules but the consensus method ensures that there are no dissenting opinions to reach a consensus. The method allows for an irresolute compromise without bringing conflicting interests of the countries to the surface.
　The IHR amendment included the decision to create a Coordinating Financial Mechanism, but its details and implementation methods were left for future discussion. Whether the mechanism would prioritize the interests of the Global North or South depends on future discussions. Notably, the postponement of such discussions was a key factor in reaching a consensus.
　However, as for the Pandemic Treaty, an agreement was not reached due to the conflicting interests and demands of the Global North and South, as well as pharmaceutical companies. While the IHR amendment was successful, the reason the Pandemic Treaty was not concluded can be attributed to the difficulties in harmonization among the countries and stakeholders.

〇Interpretation of “Human Rights” and “Equity”
　The IHR Principle on equity and solidarity states that the Regulation will be implemented with “full respect for the dignity, human rights and fundamental freedoms of persons.” The mentioned “human rights” is interpreted to include the right to health in addition to conventional human rights such as freedom of movement and action.
　On the other hand, “equity” has a variety of possible interpretations. In the IHR, “equity” means equal distribution of resources among nation-states. However, in the Pandemic Treaty, “equity” includes not only equity between states but also equity between individuals in a state. This definition adopted by the Pandemic Treaty could be considered more radical than the definition in the IHR, as it goes beyond simply eliminating inequities between countries.
　The fundamental reason why the WHO has been accepted by the international community is that it has formed rules and utilized its expertise in issues related to health and public health. For human rights issues, the international community already has a system whereby each specialized agency draws on expert knowledge to formulate rules.

〇Background and Reality of the IHR’s Legally Binding Nature
The Pandemic Treaty is an independent treaty in which each country decides whether to ratify. While it is to be concluded via consensus, subsequent ratification is up to each country. If the Treaty is deemed to have no merit to a nation-state, it may not be ratified.
　The IHR, on the other hand, is adopted in accordance with the WHO Charter and is essentially binding for all WHO member states. The IHR's legally binding nature is unique among international laws since resolutions adopted by international organizations typically only have an advisory effect. Thus, member states must, in principle, accept the binding nature of the IHR, but they may make “reservations” to certain clauses, as is the case with treaties.
　From a historical perspective, the International Sanitary Conference, the predecessor of the WHO, has existed since 1851. The Conference has held early discussions on dealing with infectious diseases. Early documents by the WHO stated that its purpose was to respond to the global spread of infectious diseases, which may be a reason for its legally binding nature.
　International public interest is at the heart of the creation of treaties and rules in the field of international health. Since pandemics involve human lives, countermeasures against pandemics are in the common interest of all countries. Therefore, there is an incentive to grant strong authority to international organizations.
　Recently, however, the interests of nations and companies in providing vaccine assistance to the Global South have become increasingly conflictual, making the creation of common rules more difficult. Some point out that this background has undermined the foundation for rulemaking in the field of international health.

〇How to Effectively Employ International Law
As a principle of international law, treaty obligations cannot be circumvented by domestic law; each country must fulfill its obligations under the international law it has ratified. However, since the method of fulfilling obligations is left to each country, the fulfillment status may vary between countries. Furthermore, although the official IHR documents do not explicitly stipulate it, countries are encouraged to develop national laws in accordance with the IHR. Only about half of the countries have actually done so.
　On the issue of health disparities, international pressure could be used to promote the implementation of treaties. Methods of enforcing international pressure have been discussed, such as the establishment of a compliance committee. While creating direct measures are difficult within the IHR framework, complementary measures, such as utilizing the review system of the WHO or a third-party committee may be possible. To encourage implementation of the treaties, national reviews and reporting, followed by international publicization of the results may effectively pressure each government. Recent international treaties tend to be more flexible and allow for an implementation system based on changing circumstances. It was noted that the WHO could also follow that trend.
　There is no definite answer regarding the operation and composition of the committee that evaluates the implementation of treaties and regulations. The current trend is toward a cooperative and facilitative approach, rather than pressurizing, since the failure of countries to comply is often due to a lack of resources and capacity, rather than intentionality.
　Upon the implementation of treaties and international law, the scope of national jurisdiction differs with time. For the evaluation committee to be effective, there must be a good balance between professionalism and political impartiality. The committee must strengthen its authority by gathering representatives and experts from various countries.
　However, the reliability of the committee’s assessments has been questioned. Some point out that there was an inverse correlation between COVID-19 mortality and the Global Health Security Index, as well as the scores of the Joint External Evaluation (JEE) of the IHR, which assesses the core competencies of each country.

〇PABS and Vaccine Development
Essentially, pathogens are covered by the Access and Benefit-Sharing (ABS) under the Convention on Biological Diversity. However, the Pandemic Treaty will exclude pathogens from that provision and instead, potentially establish its unique system. Specifically, a system in which the WHO manages and distributes a portion of vaccines has been proposed, with a proposed distribution ratio of 10-20%. However, pharmaceutical companies are strongly against this, warning that vaccine development may be delayed if the treaty is enacted.
　While the early release of genomic information during the COVID-19 pandemic led to the rapid development of mRNA vaccines, discussions on PABS have raised the possibility that genomic information may also be subject to regulation, which, if implemented, would make rapid vaccine development more difficult. This is a critical issue that would have a serious impact on the rapid supply of vaccines during a pandemic.

〇Opportunities for Non-State Actors to Participate in the WHO
Although the IHR is legally binding, lacking direct provisions for non-state organizations, and WHO membership is limited to states, some pointed out that there may be opportunities for non-state actors and NGOs to participate in WHO meetings as observers or information providers.

〇Various Stakeholders in Global Health Governance
Following discussions focused on the roles and challenges of not only sovereign states and international organizations, but also pharmaceutical companies, philanthropists, NGOs, and professional organizations, in global health governance.
　Pharmaceutical companies take risks to develop vaccines. However, in the case of Moderna, the company monopolized the patent and refused to grant it to other countries, despite the fact that public funds were invested. In one case, South Africa, with the cooperation of NIH researchers in the U.S., developed its own vaccines via reverse engineering. Pfizer has also been reported to have refused to let other companies conduct clinical trials comparing its vaccine to other vaccine candidates. Oxford University and AstraZeneca's vaccine development was also initially intended to be patent-free, but Bill Gates' opposition is said to have driven commercialization. Thus, conflict between the pursuit of profit and public interest can be seen among pharmaceutical companies.
　The Bill & Melinda Gates Foundation , with a budget comparable in size to that of the WHO, has a significant impact on global health policy. However, because philanthropy is not a governmental institution, it lacks accountability and has the risk of neglecting other issues by focusing too much on specific issues.
　International law mainly disciplines sovereign nations, making it difficult to impose legal obligations on multinational corporations. However, one option is to formulate behavioral guidelines (“Code of Conduct”) as a soft law. For example, a proposal was made on reserving a certain percentage of vaccines for the Global South, in case the Global North attempt to buy them up. Another option discussed was the possibility of mandating companies to invest in public funds and assist the Global South. More specifically, while potential measures against companies–with public funds as a trigger–have been considered, no final agreement has been made.
　Given that the negotiations were conducted behind closed doors by national representatives, some criticized the lack of participation of NGOs and experts. A downside of the negotiations that was shared among the participants was that the final agreement still depends on the nation-states, despite the presence of various stakeholders in global health governance being increasingly recognized.

〇Concluding Remarks: The Importance of Human Resource Development
　The presence of Japan in the field of global health is gradually diminishing. For Japan to contribute in providing expert knowledge in international discussions, including vaccine distribution, we must nurture and effectively employ human resources. We should particularly focus on creating an environment in which Japanese experts can receive training necessary to actively engage in international discussions.
　Furthermore, in international negotiations, the impact of Japan is relatively weakening. We must keep in mind that the impact of a country does not simply depend on its national strength; rather, people from non-developed countries with expertise and innovative ideas often play a significant role. Thus, we must develop a system to assemble expert knowledge to contribute to the international community.
　Japan's international impact has historically relied heavily on its economic strength, but its economic strength is waning. To overcome this challenge, the Japanese should hone their unique characteristics, especially their sincerity and high level of expertise, and be able to practice those skills to play an active role in the international community.

Bibliography
WHO. 2024a. “International Health Regulations.” World Health Organization. https://apps.who.int/gb/ebwha/pdf_files/WHA77/A77_ACONF14-en.pdf.
———. 2024b. “Proposal for the WHO Pandemic Agreement.” World Health Organization. https://apps.who.int/gb/inb/pdf_files/inb9/A_inb9_3Rev1-en.pdf.