Analysis of the World Health Organization’s “Pandemic Agreement”

Introduction

In May of this year, the World Health Assembly, the WHO’s highest decision-making body, ultimately decided to adopt the so-called Pandemic Agreement. It is an international agreement that has been under development for about three years, whose aim is to achieve an adequate level of preparedness, prevention, and control of the spread of infectious diseases (pandemics) on a global scale.

Preamble

In the preamble to the international agreement in question, at the very beginning of the treaty, there is a statement that “States bear the primary responsibility for the health and well-being of their peoples, and that States are fundamental to strengthening pandemic prevention, preparedness and response.” This, in turn, underscored the importance of the role of states in safeguarding the health and well-being of their populations. It also includes a provision under which the WHO acts as the coordinating and leading body for international health activities, particularly in the fight against pandemics. The text of the preamble included a reference to the 1979 Convention on the Elimination of All Forms of Discrimination against Women. At the same time, it is worth noting that the wording that appeared in the previous draft of the treaty, according to which Sustainable Development Goal 5 “aims to achieve gender equality and empower all women and girls by 2030” (point 5), has been dropped, which should be assessed very positively. However, a new provision has been added that refers to a number of other international agreements, including, among others, the 1989 Convention on the Rights of the Child, the 2006 Convention on the Rights of Persons with Disabilities and the 1976 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, emphasizing their relevance in the context of pandemic prevention, preparedness, and response (formerly point 5).

It is worth noting the emergence of wording that speaks of the need to undertake decisive’ anti-pandemic measures as well as to improve “equitable access to pandemic-related health products’ while “respecting States’ rights to implement health measures in accordance with their relevant national law and obligations under international law.”

The preamble also included language emphasizing the importance of “building trust and ensuring the timely sharing of information to prevent misinformation, disinformation and stigmatization.”[1] It is worth noting that, as in the previous draft of the treaty, the definitions of the aforementioned terms were not provided anywhere; therefore, the inclusion of the provision under discussion in the text of the preamble to the international agreement at issue should be assessed negatively.

It should be noted that the provision found in previously published drafts, which stated the sovereign right of states to their biological resources, was also removed from the text of the treaty’s preamble; however, it appeared in Article 12. This approach should be evaluated positively, as placing the wording under discussion in the strictly normative part of the draft of the international agreement in question gives it greater legal force.

It should also be noted that the preamble to the treaty contains language recognizing, among other things, the importance and impact of hunger and climate change on public health.

Legal definitions

In the section of the draft Pandemic Agreement that contains legal definitions, it is worth noting a clearly discernible effort to harmonize the terminology used in the international agreement in question with the definitions set out in the International Health Regulations (IHR). Following this latest regulation, the agreement therefore defines terms such as “Public Health Emergency of International Concern”, “Pandemic Emergency,” and “Public health risk”—respectively, in draft Article 1(c), Article 1(g), and Article 1(h).

It is worth noting that the term “pandemic-related health products” has been defined very broadly, as “relevant health products that may be needed for prevention, preparedness and response to pandemic emergencies.” As examples thereof, following the similar definition of “relevant health products” found in the International Health Regulations, one may cite, among others, vaccines, medical devices, and personal protective equipment (it is worth noting, however, that the text of the treaty omits an illustrative list of products falling within this category).

Purpose and principles

The purpose of the Pandemic Agreement is defined in Article 2. According to this provision, the purpose of the WHO Pandemic Agreement is to prevent, prepare for, and respond to pandemics. Under Article 2(2), the provisions of the WHO Pandemic Agreement apply both during pandemics and in the periods between them, unless otherwise specified. Thus, through the indicated phrasing, it was emphasized that, as a rule, the provisions of the treaty will apply not only during the pandemic but also beyond it.

For its part, Article 3 of the treaty sets out the principles that will guide the parties in implementing the provisions of the international agreement in question and in achieving its objectives. It lays down the principle that, in accordance with the Charter of the United Nations and the principles of international law, the Member States have the sovereign right to enact and implement legislation within their jurisdiction (Article 3(1)).

Article 3(2) of the treaty merits particular attention. Among the values listed in this provision, in addition to full respect for the dignity, human rights, and fundamental freedoms of all persons and the right of every human being to enjoy the highest attainable standard of health, additional values are identified, such as “right to development,” “non-discrimination,” “gender equality,” and “protection of persons in vulnerable situations.”

Health and care workers

In the provisions concerning workers in the broadly defined health sector, language has been introduced under which the States Parties are obliged to take appropriate measures to ensure decent work; to safeguard ongoing safety, mental health, and well-being; and to strengthen the capacity of health and care workers, including, inter alia, by “eliminating all forms of inequalities and discrimination and other disparities, such as unequal remuneration and barriers faced by women” (Art. 7(2)(b)). It is also worth noting that the very concept of “discrimination” has not been defined in any provision of the treaty.

Pathogen Access and Benefit-Sharing System

In Article 12, which regulates matters concerning the pathogen access and benefit-sharing system (PABS), the sovereign right of states to their biological resources is emphasized. In the same provision, a multilateral system was simultaneously established for secure, transparent, and responsible access to PABS materials and sequence information, and for the sharing of the benefits arising therefrom. It was also indicated there that the regulations concerning the details of this system (including, among other things, definitions of potentially pandemic pathogens, procedures, legal nature, conditions and requirements, and operational aspects) will be clarified later in an annex that is to be attached to the treaty at a future date.

Supply chains and logistics

Pursuant to Article 13(1) of the Treaty, the “Global Supply Chain and Logistics Network” is hereby established, hereinafter referred to as the “GSCL Network.” The purpose of the GSCL Network is to strengthen and facilitate efforts and remove barriers, and to ensure fair, timely, rapid, safe, and affordable access to pandemic-related health products for countries in need of assistance during public health emergencies of international concern, including pandemics, as well as to prevent such situations.

Pursuant to Article 13(2), the structure, function, and operational rules of the GSCL Network shall be determined by the Conference of the Parties (treaty body). In addition, the Conference of the Parties shall be responsible for assessing the operation of the GSCL Network and shall therefore be empowered to issue guidelines in this regard (Article 13(4)).

Orders and distribution

It is worth noting the provision under which each Party shall use best efforts, as appropriate, during a pandemic and in accordance with national law and/or national policy, to publish the relevant terms of purchase agreements for pandemic-related products entered into with manufacturers at the earliest reasonable opportunity, and to exclude confidentiality provisions that would restrict such disclosure. In addition, the Parties take steps to encourage regional and global procurement mechanisms to undertake the same actions (Article 14(1)).

Pursuant to Article 14(2), each Party, in accordance with national law and/or national policy, will consider including in publicly funded procurement contracts for pandemic-related health products provisions that promote timely and equitable access, especially for developing countries, such as provisions on donations, supply modifications, licensing, and global access plans.

The addition of the above provisions to the treaty text can be interpreted as a reference to calls for greater transparency in the actions of public authorities in the context of expenditures on anti-pandemic measures, primarily vaccines. In several countries, serious concerns have emerged regarding possible corruption, irregularities, or waste in connection with the procurement of vaccines during the COVID-19 pandemic. Therefore, the inclusion of these formulations in the final version of the treaty should be assessed very positively.

Article 14(4) also merits a positive assessment, as it provides that the Parties recognize the importance of ensuring that measures adopted in the event of a pandemic-related emergency affecting trade are targeted, proportionate, transparent, and temporary, and do not create unnecessary barriers to trade or disruptions in supply chains. This type of wording appeared in the most recent commented-on draft of the treaty from April 2024 (Article 13(4)). The purpose of the provision in Article 14(4) can be understood in the context of the unprecedented disruptions to international trade and the movement of persons that the world experienced during the COVID-19 pandemic, resulting from the often very strict public health measures introduced at the time (such as lockdowns). These measures caused numerous economic and social problems in countries that were, at the time, experiencing the effects of the COVID-19 pandemic.

However, Article 14(6) of the treaty, under which, in the event a pandemic emergency is declared, each of the Parties should avoid maintaining national stockpiles of pandemic-related health products that unnecessarily exceed the quantities anticipated as necessary for preparing for and responding to a pandemic at the national level, may raise serious concerns, as may Article 14(7), which elaborates on this provision. Under that latter provision, the Parties are required, with respect to the sharing of national pandemic-related health products, to make every effort to: supply products that are not designated for a specific use, are equipped with the necessary ancillary components, have a sufficient shelf life, and are tailored to the needs and capacities of recipients; provide recipients with information on expiration dates, required ancillary components, and other similar information; coordinate actions among the Parties and any and all access mechanisms; and supply products in large quantities and in a predictable manner.

The foregoing provision should be framed in the context of the phenomenon known as “vaccine nationalism.” It involves actions by a specific country that, in a public health crisis, seeks to secure certain medical products for itself while being reluctant to share them with other countries. This phenomenon was particularly evident during the COVID-19 pandemic with regard to vaccines and protective masks. The provisions of Article 14(6) and Article 14(7) commented on above should be assessed negatively, as they may infringe upon the sovereignty of WHO Member States with respect to the conduct of national health policies (in this particular case, this concerns control over the broadly defined category of “pandemic-related health products”).

Communication and public awareness

It is worth noting that in Article 16, concerning “communication and public awareness” (formerly Article 18), there are no provisions, as there were in earlier (pre-April 2024) drafts of the treaty, requiring the parties to counter or combat disinformation or other false information. It does, however, contain provisions under which the Parties undertake, among other things, to strengthen scientific knowledge, public health, and pandemic awareness among the population (Article 16(1)). Accordingly, taking into account the earlier proposals, such a wording of the provision under comment should be assessed very positively.

Sustainable financing

Under the provisions of the section of the treaty devoted to financing this international agreement, the Coordinating Financial Mechanism was established. It is worth noting that a mechanism with exactly the same name was established under the amended International Health Regulations. Later in the treaty, it is explicitly stated that the Coordinating Financial Mechanism established under the International Health Regulations will be used as a mechanism for implementing the Pandemic Treaty, in a manner determined by the Conference of the Parties.

The purpose of the Mechanism is to promote sustainable financing for the implementation of the treaty, to support the strengthening and expansion of capacities in the areas of pandemic prevention, preparedness, and response, and to contribute to the rapid availability of the financial resources necessary from day zero, in particular in developing countries that are Parties to the agreement.

Treaty bodies

Among the treaty bodies mentioned is the Conference of the Parties. The tasks of this body include, inter alia, conducting regular reviews of the implementation of the treaty, carrying out a review of its functioning every five years, and taking decisions necessary to promote its effective implementation (Article 19(2)). It may also establish subsidiary bodies, specifying the conditions and procedures for their operation and, if it deems it appropriate, decide to transfer functions to bodies established under other agreements adopted in accordance with the Constitution of the World Health Organization (Article 19(4)).

Pursuant to Article 19(3), the first session of the Conference of the Parties shall be convened by the WHO no later than one year after the provisions of the treaty enter into force. At its first session, the Conference of the Parties shall adopt, by consensus, its rules of procedure and the criteria for the participation of observers in its proceedings (Article 19(8)).

Disclaimers

Pursuant to Article 25, reservations to the present international agreement may be formulated, provided that they are not incompatible with the object and purpose of the WHO agreement on pandemics.

Entry into force

According to the information contained in the text of the World Health Assembly resolution as well as in the provisions of the Pandemic Agreement, the treaty enters into force on the thirtieth day after the date of deposit of the sixtieth instrument of ratification, acceptance, approval, formal confirmation, or accession with the Depositary (Article 33(1)). For each State, the treaty shall enter into force on the thirtieth day after the date of deposit of the instrument of ratification, acceptance, approval, or accession (Article 33(2)).

Ordo Iuris comment:

When evaluating both the final text of the treaty and the work undertaken on the international agreement in question, it is worth noting several key issues.

As a preliminary matter, it should be noted that the vast majority of the most controversial provisions appearing in earlier drafts of the treaty were removed from the final text of the international agreement at issue. As an example, previously published proposals concerning the wording of the current Article 16 (formerly Article 18) may serve here. Earlier drafts proposed imposing on the States Parties an obligation to combat false, misleading, erroneous, or untrue information. In the version of the treaty adopted by the World Health Assembly, the previously proposed wording of the provision under comment was abandoned, with the drafters limiting themselves to including in the preamble a clause that underscores the importance of “building trust and ensuring the timely sharing of information to prevent misinformation, disinformation, and stigmatization.”

It should also be noted that certain provisions of the treaty merit a positive, or even a decidedly positive, assessment. An example of this is the provision of Article 14(4), under which the Parties recognize the importance of ensuring that measures introduced in the event of a pandemic emergency affecting trade are targeted, proportionate, transparent, and temporary, and do not create unnecessary barriers to trade or disruptions in supply chains. This is particularly important in the context of the experiences during the COVID-19 pandemic, when restrictive protective measures in international trade and passenger transport caused far-reaching negative social and economic consequences.

On the other hand, it should be strongly emphasized that, despite the removal from the treaty’s final text of the proposals for provisions that provoked the greatest controversy, it still contains provisions that raise serious doubts. One such example is the provision in Article 14(6) of the treaty, pursuant to which, in the event that a pandemic emergency is declared, each Party should avoid maintaining national stockpiles of pandemic-related health products that unnecessarily exceed the quantities anticipated as necessary to prepare for and respond to a pandemic at the national level. WHO Member States should be free to decide on the rationing of critical supplies of health products in the event of a pandemic outbreak.

The provisions on the Coordinating Financial Mechanism should also be assessed negatively. Due to the lack of clearly defined objectives and the means for their implementation, there is a risk that, in a manner typical of international institutions, the Mechanism may become an instrument of financial pressure, at the disposal of the funding states and international organizations, and serving to subordinate the states receiving funds from it.

It should also be noted that the World Health Assembly’s adoption of the Pandemic Agreement text is a historic event. This is due to the fact that, in nearly 80 years of its existence, the World Health Organization has exercised the authority granted to it under Article 19 of the WHO, which empowers it to propose international agreements, only twice (including the treaty under discussion). Thus, the adoption of the Pandemic Agreement by the World Health Assembly, together with last year’s revision of the International Health Regulations, may be a harbinger of a new trend in which the WHO opts to make increasingly frequent use of legally binding instruments, instead of the nonbinding instruments typical of it (soft law).

It should finally be noted that the ultimate decision on whether to be bound by the provisions of the Pandemic Agreement will rest with WHO Member States, which also applies to Poland. The member states of the World Health Organization will be required to ratify the treaty in accordance with the provisions of their constitutions. In the case of the Republic of Poland, the provisions of the 1997 Constitution of the Republic of Poland concerning the ratification of international agreements shall apply.

Patryk Ignaszaczak – analyst at the Ordo Iuris Center for International Law.

See also:

• Will there be a debate in Poland about leaving the WHO? Ordo Iuris presents a special report

[1] Originally „misinformation”. The English-language literature on the subject distinguishes several concepts related to false information, including the terms “disinformation” and “misinformation“. The first one means “information that is false and deliberately created to harm a person, social group, organization, or country,” whereas “misinformation” is understood as “information that is false but was not created with the intent to cause harm.” See: C. Wardle, H. Derakhshan. “INFORMATION DISORDER: Toward an interdisciplinary framework for research and policy making”. Council of Europe, 2017, p. 20; 162317GBR_Report desinformation.pdf, access: May 15, 2024).