Entitled "The Pandemic Treaty and International Health Regulations Revision: Ongoing Negotiations and Discussion Points", the 3rd TUPReP Crosstalk examined COVID-19 pandemic responses and the future of international health from the perspective of global health governance. Professor Nishimoto first introduced the current state of negotiations on the Pandemic Treaty and International Health Regulations (IHR) revisions. Professor Ueki then provided an overview of the basic rulemaking principles in the international community. In the discussions that followed, panelists discussed issues with the Pandemic Treaty and the conflict between high-income countries (HICs) and low- and middle-income countries (LMICs).

•Topic 1: “The Pandemic Treaty and the IHR Revision: Ongoing Negotiations and Discussion Points”
Kentaro Nishimoto (Professor, Tohoku University School of Law)
　Within the WHO, negotiations and drafting of the Pandemic Treaty—an international convention that comprehensively defines measures against possible future pandemics—and the revision of the existing International Health Regulations (IHR) are currently underway. Such discussions reflect the challenges and issues experienced during the COVID-19 pandemic, but it is debatable whether the Pandemic Treaty will hold any substantive significance.

　The Pandemic Treaty was proposed by the EU in November 2020 at the suggestion of the European Council President Michel, who raised the need for international rulemaking against pandemics based on lessons learned from COVID-19. The Treaty contains response and reinforcement measures against future pandemics from various angles. Its contents can be divided into two themes: “reinforcement of countermeasures and international cooperation among countries through treaty obligations” and “establishment of new rules and international frameworks.” The latter is particularly important and includes the WHO Pathogen Access and Benefit-Sharing System (PABS), which aims to develop "pandemic-related products" such as vaccines by sharing information on pathogens that could cause a pandemic. PABS also aims to appropriately distribute the benefits among the countries involved in developing such products. The Treaty also includes the establishment and detailed systems of the WHO SCL Network (WHO Global Supply Chain and Logistics Network), an international mechanism focused on the procurement, stockpiling and distribution of pandemic-related products.

　The Pandemic Treaty is drawing attention as a new international framework for post-COVID society. However, there are a considerable number of issues with the Treaty when we consider whether it will truly prepare us for another pandemic. The first issue is that IHR revisions are proceeding in parallel with Pandemic Treaty negotiations and despite the need to make adjustments between the two, some of the Treaty contents currently overlap with the IHR. In addition, while the proposed Treaty is intended to direct the policies of contracting countries via obligating them to formulate national plans and strategies, it does not contain many provisions that require them to decide on the details. Therefore, it is questionable whether the Treaty is truly effective.

　Furthermore, the general focus of the Treaty is on access to "pandemic-related products," such as vaccines. This is based on the "equity issue" raised by the Global South given their COVID-19 pandemic experience. It is easy to imagine, however, that these issues cannot be solved simply with “products.” If we consider the possibility of future pandemics with characteristics different from the COVID-19 pandemic, such as pandemics for which vaccines and drugs cannot be developed, the current Treaty's emphasis on "products" will not be sufficient. The Pandemic Treaty in its current form is also inadequate and ineffective in many other respects, including the fact that it assumes geographically equitable production capacity for the development of pandemic-related products. Additionally, the incentives to develop pandemic-related products under PABS are unattractive to high-income countries (HICs). Furthermore, the Treaty largely disregards issues central to pandemic response, such as the protection of vulnerable populations and prevention of human rights violations.

　To make the Pandemic Treaty effective, an Intergovernmental Negotiating Board (INB) was established, and discussions are underway with the goal of submitting a report at the 77th WHO General Assembly in May 2024. We expect that the repeated discussions will result in truly meaningful international rules for future pandemics.

　On the contrary, the IHR—an existing WHO regulation on pandemics—is based on Article 21 of the WHO Charter. Unlike the Pandemic Treaty is a set of binding rules for all WHO member states, with no need for ratification by each member state. Furthermore, under the IHR, all member states are obliged to maintain "core capacity.” The IHR is also being considered for revision based on lessons learned from the COVID-19 pandemic.

　There are two main points of discussion surrounding IHR revisions: the establishment of a system to ensure IHR compliance and revising the PHEIC (Public Health Emergency of International Concern) declaration system. Regarding the former, although all member states must follow the IHR, the current compliance assurance method has multiple problems. Several countries have made proposals to systematically strengthen compliance assurance, however the African Union, the US, the EU, and other countries are divided on the proposed methods. As for PHEIC recognition methods, currently, the PHEIC declaration is inadequate because it is an overly binary status determined only by "whether or not a phenomenon meets the PHEIC criteria." Thus, some countries proposed the need to create and negotiate the terms of an “intermediate” PHEIC status. The focus is on how to define the "intermediate" status and what kind of regulations should be established for this system.

•Topic 2: “The Basics Principles of International Rule-Making”
Toshiya Ueki (Director/Executive Vice President for Tohoku University General Affairs, Financial Affairs and International Relations; Professor, Tohoku University Graduate School of Law)
　Rulemaking in the international community starts with the principle that "consensus is binding." Unlike domestic rulemaking, where laws passed by the Diet are binding for citizens regardless of individual opinions, in the international community, all sovereign nations have equal status in rulemaking, and a rule becomes binding for a nation only when they agree. Phrased differently, "no agreement, no bindings": a nation has the freedom not to accept a rule if it is disadvantageous to them. This means that even if one attempts to make rules that are favorable only to a particular nation, if other nations that are outside its interests disagree, the rules will be ineffective. Thus, rulemaking entails an extremely complex process: both sides must thoroughly discuss what is acceptable to each other, and then come up with mutually agreeable rules.

　The drafting of the Pandemic Treaty and the IHR revision have been subject to intense conflict between the Global South and high-income countries. This confrontation is groundedin issues of justice and equality. The Global South is proposing provisions favorable to them based on "substantive equality," while high-income countries are refusing to accept them on the basis of "formal equality." In fact, this conflict between substantive and formal equality extends public health as is embedded in all issues of international society, such as environmental issues. If this situation continues, neither the Pandemic Treaty nor the IHR will have any significance as international frameworks for pandemic response. To create effective rules in the international community and find the optimal solution for all, we must return our discussions to the principle of "no agreement, no bindings."

Discussion

•Is the Current Pandemic Treaty Meaningful?
　The fundamental issue with discussions on the Pandemic Treaty is that the discussions focus only on "what to do in the event of a pandemic" and rarely mention "what to do to prevent an outbreak." For example, while the COVID-19 pandemic was under control in Asia at the end of March 2020, a mutant strain rapidly spread to Europe, followed by the East Coast of the US and then the rest of the world. Experts argue that the pandemic could have been prevented if the West had taken adequate countermeasures against infection back then. However, the Pandemic Treaty does address upstream issues like these. In fact, the Pandemic Treaty refers to many pandemic-related products such as vaccines. The G7 also proposed the 100 Days Mission, which aims to "develop diagnostic drugs, vaccines, and therapeutics, obtain approval, and supply them fairly worldwide within 100 days of the declaration of a PHEIC." However, we must remember that in the 1918 Spanish Flu pandemic, most deaths occurred within three months of the first outbreak. Thus, in a future pandemic, it is possible that few lives will be saved even if such a 100-day mission is accomplished. Of course, vaccines are necessary as a last resort in a pandemic. However, upstream measures that prevent the outbreak of a pandemic itself must also be discussed.

　Since the IHR already incorporates a framework for early response to pandemics, the Pandemic Treaty under discussion includes structural issues that overlap with the IHR. However, it is also true that the IHR did not function during the COVID-19 pandemic. For example, core capacity scores specified in the IHR (the minimum capacity at the regional and national level that should be in place for emergency response) correlate inversely with the number of deaths per population in a pandemic: an indication that the IHR did not accurately assess each country's capacity.

　Geopolitical issues, such as the US-Chinese and US-Russian relations, also prevent global containment of infectious diseases. Of course, pandemic prevention—in terms of preventing the spread of infectious diseases—is of common interest, and history shows that it is an area in which people can easily cooperate, even with political conflicts. Nevertheless, we still need an international agreement, such as the Pandemic Treaty, to cover the areas that the IHR cannot. Moreover, this Pandemic Treaty can be considered a "framework treaty," so to speak. In addition to the contents related to pandemic prevention, more specific details regarding incentives for providing information on the surveillance of pathogens and issues concerning One Health will be decided at subsequent Conference of the parties. Another form of modern rulemaking is a flexible approach of holding a series of meetings after concluding a treaty and reiteratively revising it in response to changes in international circumstances. While the current Pandemic Treaty does have its issues, these points must also be kept in mind.

•Distance Between the "Zero Draft" and the Current Situation
　The introduction of the Pandemic Treaty's "Zero Draft," released by the WHO in February 2023, emphasized that the international community made a catastrophic failure in terms of solidarity and equity in the COVID-19 pandemic response and argued that it must begin discussing the Pandemic Treaty as a legally binding treaty based on the lessons learned from COVID-19. Particularly, the use of a strong expression such as "catastrophic failure" had a significant impact on international law, implying a sense of urgency toward the current situation and recognition of the need for a treaty.

　It has been almost a year since the "Zero Draft" was written, but its discussions have made no significant progress. Initially, some LMICs called for support towards allowing the Global South to have a lower level of preparedness than HICs via the inclusion of "common but differentiated responsibilities" in the Pandemic Treaty and the IHR. While fairness and equality among countries are certainly important, the philosophy of the IHR is that each country should have a minimum core capacity; if "common but differentiated responsibilities" allow inadequate preparedness for reasons of low capacity, there is a risk of a pandemic originating in vulnerable countries. Therefore, the current IHR and Pandemic Treaty discussions do not recognize "common but differentiated responsibilities." They only recognize capacity levels differ and adopt the logic that such countries need to be supported to comply with the Pandemic Treaty. As such, negotiations between high-income countries and LMICs are still in progress.

　As for the goal of a "legally binding" treaty, the more the treaty focuses on "legal constraints," the more its provisions tend to be generalized, become subsidiary, or postponed. However, it is of high importance for the WHO to continue claiming that the Pandemic Treaty is "legally binding."

•The Pandemic Treaty Lacks Incentives
　As for the opinion that consensus will be easy to reach in the public health field because it is an area of international interest, there are multiple challenges. For example, if a new virus with pandemic potential emerged within an LMIC, their economy will be severely damaged if they respond based on the Pandemic Treaty. Such rules make consensus difficult to obtain. It is important to institutionalize incentives so that the Pandemic Treaty does not become one where "honest people draw the short straw."　

　Also, regarding the PABS included in the Pandemic Treaty, companies that develop pandemic-related products must pay a certain amount of money to the WHO each year, but neither the amount nor the payment deadline has been decided. Furthermore, the provision, "provide 20% of the actual product to the WHO,” is also unclear. PABS itself was born from the insistence of LMICs; no high-income country would consider PABS necessary under the current circumstances.

　Moreover, the PABS includes an article that allows for a time-limited waiver of intellectual property rights under relevant frameworks, such as TRIPS and WIPO, for supplies needed for accelerated/large-scale manufacturing of pandemic-related products. LMICs made this article from the perspective of fairness and equality. However, many HICs have criticized its institutional design, arguing that there is no incentive at all for them to develop pandemic-related products. Indeed, virologists have criticized that it inhibits information sharing among scientists. Although a coercive provision, such as "in the case of manufacturing a product using the PABS material, which should not be manufactured unless shared access is provided, it is considered as using the PABS," has been proposed as a measure for incentives, HICs are dissatisfied with the one-sided burden.

　In terms of incentives, the Pandemic Treaty is not something that can be readily agreed upon internationally. Institutional design and negotiations that reward the honest and do not impede incentives for development are crucial.

•Comparing of the Investment Effects of the Pandemic Treaty and the Debate over the BBNJ Agreement
　Examining the trend of international cooperation on climate change response, the Kyoto Protocol concluded at COP3 in 1997 -contained extremely strict provisions that stipulated greenhouse gas reduction obligations for its signatory countries, as well as penalties for violation. On the other hand, the Paris Agreement is less binding than the Kyoto Protocol. Adopted at COP21 in 2015, the Paris Agreement requires each country to submit greenhouse gas emission reduction targets as "Nationally Determined Contributions (NDC)," which are then updated and globally aggregated. This agreement could be seen as one that prioritizes the formation of international public opinion to stimulate the investment in the energy industry, rather than legally binding each country.

　While the Pandemic Treaty has a strong legal binding force in designing new systems, such as PABS, other areas of the treaty—although binding-—are weak in terms of responsibilities. On another note, the Nagoya Protocol stipulates that the fair sharing of profits from genetic resources should be based on the criteria agreed by the country in which the genetic resources were discovered. Similar discussions are taking place between HICs and LMICs regarding PABS materials.

　Next, we consider where HICs and LMICs are focusing their debates and what is being done. In June 2023, the BBNJ Agreement was adopted to supplement the UN Convention on the Law of the Sea, but the specifics of how the financial and economic benefits of using marine genetic resources will be decided after the agreement comes into effect. HICs will bear a certain percentage of the treaty budget until then.

　This agreement was the result of two main factors. First, the HICs wanted to avoid any negative impact on development incentives by making the government pay the full price before a monetary framework, which would make individual countries pay. Second, LMICs prioritized marine environmental protection system in the agreement and thought it would be better to compromise with the HICs if they could resolve the conflict financially. The agreement has become a success story for LMICs, making them claim for a similar argument in the PABS. However, for HICs, PABS does not have the same advantages as the BBNJ Agreement, and are therefore unlikely to compromise and likely to remain at odds with HICs.

•Could the Relationship Between International Law of War and International Law in Peacetime Apply to Pandemics?
　Until 1945, International Law consisted of two distinctly different legal norms: International Law of War, which functioned during wartime, and International Law of Peacetime, which functioned during peacetime. However, with the prohibition of war and the renunciation of force in the UN Charter, the legal concept of "war" disappeared from the international legal order after 1945. For that reason, currently, only one international legal system is functioning. Within that system, for armed conflicts—which are regarded as "emergencies"—the International Humanitarian Law exists to prevent unnecessary casualties and to protect human life. When we consider how pandemics should be understood in a unified international legal order, pandemics are like armed conflicts because are emergencies or exceptional situations that can only be effectively handled by a military-like organization. We need rules to prepare for such special emergencies.

•Are High-income Countries Responsible for the Pandemic?
　Within the trend in international cooperation on climate change, Hi-income countries are increasingly acknowledging they historically have a degree of responsibility towards climate change. Their financial contributions to climate change "loss and damage" measures demonstrate this. Low- and middle-income countries have been actively demanding "common but differentiated responsibilities" from HICs concerning the Pandemic Treaty and the IHR revisions. However, for "common but differentiated responsibilities" to be recognized, two grounds are necessary: historical contribution and capacity. Since the former does not apply to pandemics, the "common but differentiated responsibility" is not acknowledged. However, the existence of different capacity levels of each country is recognized, and LMICs are to be supported in building capacity from the perspective of fairness.

•Conflicts of Interest between HICs and LMICs in Categories Outside Pandemic-Related Products
　HICs and LMICs also have conflicting interests regarding the transfer of technology and expertise. Current regulations use the weak term "encourage." More specifically, the term includes the time-limited waiver of intellectual property rights and information disclosure, and LMICs are seeking access based on the unfairness they experienced during the COVID-19 pandemic. For HICs, however, the issue is not so much a conflict of interest between HICs and LMICs, but rather a conflict with their domestic legal systems in terms of respect for intellectual property rights and other issues.

　Not only in pandemic treaties but also in recent treaty negotiations, LMICs have insisted on forced technology transfer and capacity-building assistance. This argument is based on the claim that HICs are obliged to comply with technology transfer between them and LMICS in terms of capital, technologies, and capacities. Competition under the same conditions would widen the gap. On the contrary, HICs accept this logic, but they are making efforts to find a compromise between the two sides, for example, by making the article only a moral obligation, not a legal obligation.

•Restriction of People's Movement during a Pandemic
　The Pandemic Treaty does not contain provisions on travel because the IHR's objectives include maintaining a balance between guaranteeing international travel and public health measures. Legally restricting the movement of people would mean interfering with the immigration control policies of each country. Thus, if an international organization were to step into the domestic jurisdiction and sovereignty of each country and strictly regulate it, countries may push back, making such restrictions difficult to implement. The regulation of human travel should be based in the principle of guaranteeing the free movement of individuals, and there should be discussions on how to create absolutely minimal restrictions.

•The Responsibilities of Low- and Middle-Income Countries
　In the debate over the Pandemic Treaty, HICs and the Global South disagree over the concept of "justice," i.e., the correction of the disparity between HICs and LMICs. However, their argument can also be interpreted as "we won't take risks but want benefits." For example, the PABS, also largely proposed by LMICs, is calls upon HICs to bear all the costs and risks involved in the development of pandemic-related products then distribute them to LMICs. Despite such claims, we cannot ignore that LMICs are not fulfilling their responsibilities in the first place.

　Taking the influenza pandemic as an example, despite the need for countries—including LMICs—to vaccinate against seasonal flu to ensure a market for vaccination and maintain manufacturing capacity for vaccine development against future pandemics, many LMICs are not taking action. HICs are also investing heavily in LMICs, but this investment is contingent on LMICs' commitment to maintaining sustainable vaccine markets. Nevertheless, many LMICs are not investing in areas where HICs, the WHO, and CDC have invested in. Furthermore, even during the COVID-19 pandemic, the Global South claimed inequity in vaccine distribution, but a certain amount of vaccine was provided by COVAX; the issue was rather that many LMICs had not developed their vaccination systems. Furthermore, many LMICs are politically unstable. Even if vaccines were provided, they would likely not have been prepared to vaccinate dissident groups. Although all countries need to invest in pandemic preparedness, LMICs are largely failing to fulfil their responsibilities.

　The Pandemic Treaty includes a provision entitled "Sustainable Production." This provision supports the measures and investments necessary to maintain manufacturing facilities for pandemic-related products in each country, but when considering the perspective of HICs, the provision may be criticized as merely unilateral support to LMICs. "Sustainable Production" intends to ensure that pandemic-related products can be produced and maintained in any country, regardless of how developed it is. Currently, however, there is a discrepancy between the original goal and actual actions and claims.

•Where Will the Debate Over the Pandemic Treaty Lead?
　The Pandemic Treaty is designed to prepare the world for future pandemics. However, many provisions in the treaty are disadvantageous, especially for high-income countries. In future discussions, low- and middle-income countries are expected to firmly oppose truly disadvantageous parts of the Treaty, such as the PABS and the time-limited waiver of intellectual property rights. However, even if those parts are modified, there are many areas in the treaty where high-income countries do not know how they can benefit.

　The benefits to each country of the revising the IHR is more comprehensible as it contributes to realizing a safe international society via each country securing capacity. Unlike the IHR, the ratification of the Pandemic Treaty is left to each country. If the current situation continues, it is possible that few countries will ratify it and the Treaty may result in having little substantive meaning. Unless the Treaty contents are developed to incetivize many countries to ratify it, the Treaty will face difficulties.

　Indeed, the Pandemic Treaty includes the concept of One Health, which is very attractive to high-income countries and may be seen as a benefit of ratifying the Pandemic Treaty. However, One Health may not be directly satisfactory to most LMICs, where agriculture, tourism, and the animal industry are the main sources of revenue. It is difficult to know how serious the WHO will be about One Health.

　Of course, high-income countries are not monolithic; nor are low- and middle-income countries. The countries of the Global South also have various disagreements and conflicting interests. There are some areas where the interests of the HICs and LMICs overlap. We must remember to carefully evaluate the common and conflicting interests of each individual country, rather than simply viewing disagreements as bipolar conflicts between HICs and LMICs.

•Concluding Remarks
　An article published in the Lancet in January 2023 ("Human Rights and the COVID-19 Pandemic: A Retrospective and Prospective Analysis") suggests that the Pandemic Treaty should be founded on the fundamental theory regarding health rights for all. Human rights is an issue that should be currently discussed within the UN framework on human rights guarantees, since such a framework already exists. However, "the issue of human rights under a pandemic" does not receive much attention in human rights discussions in general, although it would make sense to discuss it in the context of the Pandemic Treaty. However, even if we actually get into rulemaking concerning human rights, there are still doubts as to whether it can be truly effective amidst financial issues and the conflicts between HICs and LMICs. Another important question is to what extent this issue of human rights is intertwined with the WHO's concept of "health," and to what extent it can avoid duplication with other specialized agencies such as UNESCO.

　The development of the Pandemic Treaty, given the COVID-19 pandemic, as an interstate treaty that comprehensively outlines responses to possible future pandemics is indeed a major step forward. But there is a good chance that the next pandemic will be completely different than the COVID-19 pandemic. The COVID-19 pandemic was a very protracted pandemic, with deaths mainly among the elderly. Therefore, while there were many victims in high-income countries—where the elderly account for a high percentage of the population and there are many facilities for the elderly—a vaccine was developed and used globally. However, if the next pandemic were to occur in a very short period and most deaths were among young people, including children, it is expected that many people would die in LMICs as well and that vaccines would not be available in time. In fact, most deaths from the 1918 Spanish Flu were among young people in their 20s and 30s, and some papers predict that if a similar pandemic were to occur in modern society, more than 65 million people would die, with 95% of those in LMICs.

　When considering future strategies, basing them solely on what has happened in the past makes the strategies extremely vulnerable. For example, after the Great Hanshin-Awaji Earthquake, disaster prevention focusing on building collapse and fire prevailed throughout Japan. However, the subsequent large-scale disaster, the Great East Japan Earthquake, took many lives because of the tsunami, which was not a part of the Hanshin-Awaji Earthquake. Thus, if we focus on past events, we will not be able to deal with future events. The debate over the current Pandemic Treaty is also largely modeled on the COVID-19 pandemic. With this stance, the next pandemic will be tough to deal with. If an entirely different pandemic were to occur, then a different framework would be needed and discussed. Both HICs and LMICs must consider—with all possible scenarios in mind—what investments can be made and how the world should be structured to create a more resilient society.