A Pandemic Treaty: Learning From the Framework Convention on Tobacco Control

Abstract

The World Health Organization recently began developing a “pandemic treaty” in response to the perceived failures of the global COVID-19 response. The Framework Convention on Tobacco Control, which obligates members to certain global standards in tobacco control, is an example of a global public health agreement that may be used as a model for the pandemic treaty. Several challenges related to the convention, many from the tobacco industry itself, must be addressed if it is to be used as a prototype for a pandemic agreement. These include harm reduction policies, private-sector involvement, and its impact in low- and middle-income countries. A pandemic treaty may encounter similar challenges faced by the Framework Convention on Tobacco Control, particularly from industry groups with financial interests related to infectious disease control and prevention. Addressing challenges at the outset may facilitate the development and implementation of a more robust international instrument.

Introduction

In december 2021, against the backdrop of the ongoing COVID-19 pandemic, the World Health Assembly of the World Health Organization (WHO) agreed to draft an international instrument to strengthen pandemic preparedness and response.¹ The development of this pandemic treaty was a direct response to the perceived failures of the COVID-19 response. In announcing the launch of the effort, WHO director-general Tedros Adhanom Ghebreyesus noted that the COVID-19 pandemic had exposed flaws in the global public health system meant to protect the population from large-scale health emergencies. The global public health community has identified a myriad of shortcomings within the existing directives related to pandemic preparedness and response, such as the International Health Regulations (2005),² which could be remedied by stronger international agreement. Critical issues to address include poor infectious disease surveillance, limited mechanisms for sharing of information across borders, lack of accountability, weak health systems, and inequitable access to pandemic countermeasures.³

The development of a pandemic-specific treaty is complex and uncharted territory, however. The International Health Regulations (2005) are designed to strengthen the capacity of countries to detect and respond to potential health emergencies, but an international treaty coordinating pandemic response would attempt to further integrate international efforts while having few widely implemented precedents to model.² The Framework Convention on Tobacco Control (FCTC), which entered into force on February 27, 2005, is an example of a global public health agreement that may be used as a model for the pandemic treaty.⁴ The FCTC is the only other instance of a legally binding “convention” or “framework agreement” that has been previously implemented by WHO. As such, there is precedent to use it as a model and replicate some of its provisions into the new pandemic treaty. Several challenges related to the FCTC, many from the tobacco industry itself, must be addressed if it is to be used as a prototype for a pandemic agreement. These include harm reduction policies, private-sector involvement, and its impact in low- and middle-income countries (LMICs).

What Is Being Proposed in a Pandemic Treaty?

An intergovernmental negotiating body (INB) was created by the World Health Assembly in December 2021 to develop and negotiate a pandemic treaty.⁵ This INB gathered in early 2022 to begin developing the treaty, with discussions focused on the content of a proposed pandemic agreement and the aim of presenting final proposed text to the World Health Assembly in 2024. Proposed general themes of the agreement include equity, leadership and governance, and finance across the pandemic life cycle (prevention, preparedness, response, recovery). Areas of concern include management of the human–animal interface responsible for the majority of emerging infectious disease threats, transfer of technology and countermeasures, predictable financing for pandemic-related programming, improved biosurveillance and sharing of pathogen and genomic data, enhancement of biosecurity and biosafety directives, bolstering compliance and enforcement of regulations, and health systems strengthening.^3,4,6 Procedurally, a pandemic treaty may be adopted through a variety of mechanisms, including (1) as a legally binding “convention” or “agreement” under Article 19 of the WHO Constitution, (2) as a legally binding “regulation” under Article 21, or (3) as a “recommendation” that is not legally binding under Article 23.⁷

A framework convention under Article 19 has been realized only once before, with the FCTC, and this action requires two-thirds approval by the World Health Assembly, “though adoption by consensus is possible.”^7,8 This latter type of agreement develops a general “framework” of high-level priorities or objectives under which subsequent, more granular guidelines and protocols are developed. A WHO press release indicates that the pandemic agreement will be developed “with a view to adoption under Article 19 of the WHO Constitution, or other provisions of the Constitution as may be deemed appropriate by the INB.”^1,5 Article 19 of the WHO Constitution empowers the World Health Assembly to develop agreements in any area “within the competence of the Organization,” while Article 21 has more limited scope.⁷ In a July 2022 meeting of the INB, it was noted that the agreement may ultimately “contain both legally binding and non-legally binding provisions.”⁷ Another WHO press release from December 2022 noted that “Member States of the World Health Organization today agreed to develop the first draft of a legally binding agreement designed to protect the world from future pandemics.”⁹ A “conceptual zero draft” of the agreement was released at the third meeting of the INB in December 2022.^10,11 This draft “presents a proposed structure of the future accord and is presented as a ‘bridge’ between the working draft presented at the Second meeting of the INB and the future ‘zero’ draft, to be considered at the Fourth meeting of the INB in February 2023.”¹⁰

What Is the FCTC?

In developing a pandemic treaty, the public health community may look to prior global health treaties for guidance, such as the FCTC. The FCTC was adopted as a solution to an overwhelming noncommunicable pandemic: smoking-related disease. With 182 current Parties to the agreement, the FCTC obligates members to certain global standards in tobacco control, which must be implemented through domestic laws targeting various supply- and demand-side elements.^12,13 Demand-side provisions include increasing tobacco product sales tax, creating smoke-free workplaces and public areas, regulating the “contents and emissions of tobacco products” and product packing and labeling, and banning tobacco industry advertising.¹⁴ Supply-side components include prohibiting the illicit tobacco trade and sales to minors, and supporting “economically viable alternatives” for those involved in the production and sale of tobacco products. Additionally, there are provisions related to ensuring tobacco industry liability and promoting tobacco control research. The convention is governed by the Conference of Parties (COP), made up of all members of the FCTC, which establishes guidelines for implementing the guiding principles of the agreement during periodic meetings. Structurally, COP meetings occur every 2 years and a convention secretariat supports the ongoing activities of the COP and implementation of guidelines. Notable impacts of the FCTC include the widespread establishment of tobacco product health warnings, escalation in tobacco taxation, and creation of smoke-free areas.¹²

Key FCTC Challenges a Pandemic Treaty Must Consider

Critics of the FCTC, including those in the tobacco trade itself, highlight several challenges to the agreement, including a limited emphasis on harm reduction, a challenging relationship with industry, and an uneven global impact. A pandemic treaty may encounter similar challenges faced by the FCTC, particularly from pharmaceutical or healthcare industry groups with financial interests related to infectious disease control and prevention. Addressing these challenges at the outset may facilitate the development and implementation of a robust international pandemic treaty that effectively achieves its intended goals.

Harm Reduction

The marketplace for tobacco products has grown increasingly more complex over the past 2 decades, with a variety of “novel and emerging tobacco products” appearing on the market.¹⁵ Novel tobacco products, such as heated tobacco products or electronic nicotine delivery systems, were developed in part to reduce smokers' exposure to toxic chemicals in tobacco smoke, but they pose a unique challenge to the FCTC. Electronic nicotine delivery systems, also referred to as “vapes” or “e-cigarettes,” heat a liquid that generally contains nicotine to form an aerosol that is inhaled, whereas heated tobacco products heat “processed tobacco leaf” for subsequent inhalation.^16,17 The challenge for tobacco industry stakeholders and public health authorities is how to regulate novel tobacco products under the FCTC. Should they be treated as traditional tobacco products or as products that potentially pose less harm?¹⁸ The latter viewpoint is the “harm reduction” position advanced by the tobacco industry, in which actions taken are “aimed at reducing the negative effects of health behaviors without necessarily extinguishing the problematic health behaviors completely or permanently.”¹⁹ This approach has been used in many areas, such as injection drug use, where “harm reduction disentangles the notion that drug use equals harm and instead identifies the negative consequences of drug use as the target for intervention rather than drug use itself.”¹⁹ Certainly, some of the most well-known examples of harm reduction programs have been implemented in the area of substance use, including needle exchange programs, access to overdose-reversal and substitution therapies, and provision of safe spaces for drug consumption.^19,20 Harm reduction programs have been implemented in a wide variety of sectors, however, including provision of preexposure prophylaxis to prevent HIV and regulation of sex workers. Harm reduction policies have been strongly supported by many intergovernmental organizations, such as the Joint United Nations Programme on HIV/AIDS (UNAIDS) and WHO.^21,22 Notably, a 2016 WHO report on electronic nicotine delivery system developed for the FCTC's seventh session of the COP suggested, “If the great majority of tobacco smokers who are unable or unwilling to quit would switch without delay to using an alternative source of nicotine with lower health risks, and eventually stop using it, this would represent a significant contemporary public health achievement.”²³

Many tobacco control experts and stakeholders in the public health field, however, point to a lack of data on the safety of novel tobacco products, particularly in the long term.^24,25 For instance, in 2021, the US Preventive Services Task Force found that “current evidence is insufficient to assess the balance of benefits and harms of electronic cigarettes (e-cigarettes) for tobacco cessation in adults.”²⁶ The FCTC places novel tobacco products in the same regulatory category as traditional cigarettes. In 2018, the FCTC's eighth COP issued a decision that “heated tobacco products are tobacco products and therefore subject to the provisions of the WHO FCTC.”²⁷ In this decision, Parties are urged to “regulate, including restrict, or prohibit, as appropriate, the manufacture, importation, distribution, presentation, sale and use of novel and emerging tobacco products.” Further, “All articles of the WHO FCTC and their guidelines for implementation can be applied to novel and emerging tobacco products, including HTPs [heated tobacco products], and extended to the devices needed for their use if they are not covered by national legislation.”¹⁵

Some governmental authorities and researchers argue for a slightly more nuanced approach to these products. The US Centers for Disease Control and Prevention notes that “e-cigarettes have the potential to benefit adults who smoke and who are not pregnant if used as a complete substitute for regular cigarettes and other smoked tobacco products.”¹⁶ However, it also maintains that “e-cigarettes are not safe for youth, young adults, pregnant adults, as well as adults who do not currently use tobacco products.” A 2021 Cochrane review concluded: “We are moderately confident that nicotine e-cigarettes help more people to stop smoking than nicotine replacement therapy or nicotine-free e-cigarettes,” although the authors noted that “more studies are still needed to confirm this.”²⁸ A 2020 US Surgeon General report on smoking cessation found that “the evidence is suggestive but not sufficient to infer that more frequent use of e-cigarettes is associated with increased smoking cessation compared with less frequent use of e-cigarettes.”²⁹ In the United Kingdom, a Public Health England report from 2021 found that “vaping is positively associated with quitting smoking successfully.”³⁰ Fifteen former presidents of the Society for Research on Tobacco and Nicotine, which describes itself as a “scientific society whose mission is to stimulate the generation and dissemination of new knowledge concerning nicotine and tobacco […] with the ultimate goal of reducing the harms of tobacco and nicotine containing products,”³¹ published a paper in 2021. It noted that “while evidence suggests that vaping is currently increasing smoking cessation, the impact could be much larger if the public health community paid serious attention to vaping's potential to help adult smokers.”³²

No heated tobacco product or electronic nicotine delivery system has been approved as a smoking cessation aid in the United States; however, in 2019 the IQOS heated tobacco product device was approved by the US Food and Drug Administration (FDA) as a modified risk tobacco product, enabling the product to be “marketed with claims that fully switching from regular cigarettes to IQOS can reduce a person's exposure to harmful chemicals.”^17,33 Importantly, the producers of IQOS are not allowed to “claim that using IQOS reduces the risk of disease, that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.”¹⁷ Of note, in 2019 the FDA also issued a modified risk order for various smokeless tobacco snus products made by Swedish Match USA, Inc., allowing the company to sell its products with the following statement: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”³⁴ Conversely, the FDA recently banned the e-cigarette product JUUL (later administratively stayed by the FDA) because its “applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”³⁵

The complex and controversial issue of novel tobacco products offers potential lessons for a pandemic treaty. A pandemic agreement will need to be flexible enough for future technological developments and novel approaches that possibly include harm reduction provisions. Harm reduction methods have been applied successfully in other public health crises such as intravenous drug use and in infectious disease control, most notably with HIV/AIDS.^36,37 The concept of harm reduction has been evident on a community level during the COVID-19 pandemic; for example, “smart masking” or “dynamic masking” in high-risk situations is likely more effective than “universal masking” in all scenarios.^38,39 Harm reduction strategies may be relevant to provisions in a treaty in a variety of areas, including health communication, social distancing, personal protective equipment, and travel and trade restrictions.^40-43 Overly rigid or strict provisions (eg, “abstinence only”) in a pandemic agreement may weaken its impact.

Industry Involvement

The relationship between industry and public health in the area of tobacco control has been thoroughly contentious for many decades. A 2019 WHO publication noted that “the tobacco industry has employed devious tactics to keep generations of men, women and children addicted to cigarettes.”⁴⁴ A 2001 World Health Assembly statement noted that the “tobacco industry has operated for years with the expressed intention of subverting the role of governments and of WHO in implementing public health policies.”⁴⁵ Article 5.3 of the FCTC “requires [p]arties to protect their tobacco control and public health policies from commercial and other vested interests of the tobacco industry.”¹³ The first guiding principle of the Guidelines for Implementation of Article 5.3 states: “There is a fundamental and irreconcilable conflict between the tobacco industry's interests and public health policy interests.”⁴⁶ Similarly, the tobacco industry has issued their own rebukes of the FCTC in a variety of forums.^47,48

In 2018, the “COP decided to require Parties, when designating their representatives to the sessions of the Conference of the Parties […] to indicate that they have observed Article 5.3 of the Framework Convention and have been mindful of the recommendations 4.9 and 8.3 of the Guidelines not to nominate delegates from the tobacco industry (including state-owned tobacco industry) or any entity working to further its interests to attend meetings of the treaty bodies.”⁴⁹ Additionally, intergovernmental and nongovernmental organizations, members of the media, and the general public must complete a declaration of interest to attend meetings, indicating that they are not, or have not, had a financial or professional relationship with the tobacco industry within the past 5 years. As highlighted frequently by the tobacco industry, this stands in contrast to other international agreements, such as the UN Framework Convention on Climate Change, which includes “representatives from business and industry, environmental groups, farming and agriculture, indigenous populations, local governments and municipal authorities, research and academic institutes, labour unions, women and gender and youth groups.”⁵⁰ Although the FCTC views these procedures as necessary to maintaining independence from the reach of tobacco companies, industry makes the argument that measures such as these limit the transparency of the agreement and its implementation.⁵¹

It is a worthwhile question to ask whether there are more collaborative approaches with private industry that can help make a pandemic treaty more effective. The debate over novel tobacco products and their efficacy as a means to smoking cessation has highlighted the challenges of a poor working relationship between industry and a regulatory agreement. Research generated by industry carries little weight with the public health community, and vice versa, which can inhibit open dialogue and effective regulation. On the other hand, a pandemic treaty will likely benefit from robust industry participation in a variety of areas, such as pharmaceuticals and medical equipment manufacturing and delivery, for instance. The FCTC is the first WHO framework convention of its kind, so there are no direct comparisons in other industries; however, the Pandemic Influenza Preparedness Framework includes reference to “the role of industry as an important contributor to technology innovation and transfer in addressing the challenges of pandemic influenza preparedness and response.”⁵²

Technical assistance, financial and material support, and industry supply chains will be needed from the private sector for the development and implementation of such a treaty. Many critical elements of an agreement, from development and distribution of medical countermeasures to management of the human–animal interface, will rely on industry expertise that may have conflicting financial interests. The demand for this expertise will need to be balanced with the obligation of governmental and intergovernmental regulation over private industry, which will naturally advocate for its interests, and the public health goals of the agreement. For example, in response to the INB's release of the conceptual zero draft of the agreement, the International Federation of Pharmaceutical Manufacturers and Associations wrote: “There is no evidence to support many of the policy tools proposed by the Conceptual Zero Draft. […] Time-bound waivers of protection of intellectual property rights would not increase the manufacturing of pandemic response products. Conditionalities on public sector funded research including on technology transfer, costs of production and pricing may slow down time-critical innovation. Measures to limit indemnity or confidentiality clauses can derail or delay supply.”⁵³ The preamble of the conceptual zero draft, with various proposals for language related to intellectual property protection, highlights the challenge of balancing the interests of industry with the development of an effective public health agreement.¹¹

There is some evidence of support for private-sector involvement in the developing agreement at this early stage. A draft outline of the proposed pandemic treaty from June 2022 describes general obligations, including engagement “with communities, civil society and non-State actors, including the private sector, as part of a whole-of-society approach.”⁶ The conceptual zero draft of the pandemic agreement proposes a governance body called the “Enlarged Conference of the Parties,” which is “composed of representatives of any body or organization, whether national or international, governmental or non-governmental, private sector or public sector […,] which, upon nomination by any Party, is supported by a two thirds majority of the COP.”¹

Further, an “informal, focused consultation session, on the topic of intellectual property, production and transfer of technology and know-how,” held in October 2022 to inform development of the agreement, did include industry representation.⁵⁴ A global market undisturbed by a pandemic threat is a benefit to the private sector, and therefore industry has a monetary incentive to strengthen global preparedness and response and support and fund these efforts.³ Deconflicting these public health and financial interests, which may at times compete with one another as currently illustrated by the FCTC, will be critical for the development of an effective pandemic treaty.

Prioritizing Low- and Middle-Income Countries

The FCTC has been adopted widely and has been ratified by 182 countries.¹³ The FCTC has certainly led to increased uptake of tobacco demand-reduction measures, although this impact may be somewhat moderated in LMICs.^55-57 Hiilamo and Glantz noted, “More fragile countries in terms of security, political, economic and social development may not have administrative and technical capacity to implement high tobacco taxes.”⁵⁵ The ultimate goal of the FCTC is to curtail tobacco use to reduce tobacco-associated disease. Although global tobacco use prevalence decreased from 32.7% in 2000 to 22.3% in 2020, it is not clear that the impact of the FCTC is being experienced uniformly.⁵⁸ The reduction in prevalence has not “[kept] ahead of population growth [… and] in four out of six WHO regions, the number of male tobacco users rose between 2000 and 2020.”⁴² A recent study based on Global Burden of Disease data suggested that there has been “little decline in smoking” in most LMICs.⁵⁹ Although several recent country-level and global studies have demonstrated a reduction in smoking associated with the FCTC, this association has not been found universally.^56,60-65 Hoffman et al⁶² wrote that LMICs “showed increased consumption above what would have been anticipated without adoption of the FCTC.” The authors of the study posited that, among other factors, lower governmental capacity in LMICs may be behind this trend.

One principal role of a pandemic treaty will be in the amelioration of the global inequities in pandemic preparedness and response, particularly in terms of diagnostics and countermeasures. Uneven global COVID-19 vaccine distribution has made the need for this evident. Reflecting on the results of studies assessing the impact of the FCTC, it is essential that a pandemic treaty prioritize measures relevant to LMICs and support sustainable technical and financial assistance to implement these measures. The INB appears to recognize this. The preamble of an early draft notes that “equity should remain as a principle, an indicator and an outcome of pandemic prevention, preparedness and response.”⁶⁶ Additionally, a “principle” of the draft states, “Full consideration and prioritization are required of the specific needs and special circumstances of developing country Parties, especially those that (1) are particularly vulnerable to adverse effects of pandemics; (2) do not have adequate conditions to respond to pandemics; and (3) would have to bear a disproportionate or abnormal burden.”⁶⁶

Conclusion

Ultimately, a pandemic treaty will be judged on how well it has performed in reducing morbidity and mortality, social discord, and economic damage associated with an infectious disease threat. Although the FCTC and a pandemic treaty address 2 very different public health threats, there are lessons that can be derived from the FCTC process and implementation. Optimizing the potential pandemic agreement to achieve public health goals should take into account prior treaties that have been implemented. The FCTC is an important but imperfect model for a pandemic treaty. Ultimately, WHO and the global public health community would benefit from understanding and addressing the critiques of the FCTC, which could perhaps serve as the closest structural model upon which to build a pandemic treaty. Undoubtedly, there will be challenges ahead, but the development of a pandemic treaty is a laudable goal that would ultimately serve to make the world a safer place.

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