Tobacco harm reduction and the FCTC: issues and challenges at COP11

Introduction

From 17–22 November 2025 in Geneva, Switzerland, government delegations from around the world will meet to discuss tobacco and nicotine policy, at the Eleventh Meeting of the Conference of the Parties (COP) to the Framework Convention on Tobacco Control (FCTC).

To understand more about what the FCTC is, what COP meetings are, how they operate and who attends, please see the accompanying GSTHR Briefing Paper, ‘The Framework Convention on Tobacco Control (FCTC) and the Conference of the Parties (COP): an explainer’.

This Briefing Paper will touch on whether the FCTC is meeting its objectives and some of the issues with the COP process. It will also consider the discussions likely to take place at the upcoming eleventh Conference of the Parties (COP11) related to safer nicotine products (SNP) and tobacco harm reduction (THR).

How effective has the FCTC been in reducing tobacco use?

The overarching objective of the FCTC, as set out in Article 3, is to “to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke.”[1] This was quantified at COP6 in 2014, when the COP called on Parties to adopt a global voluntary target to reduce tobacco use by 30% by 2025.[2] That target has been missed by a considerable margin.

When the FCTC came into force in 2005, the WHO estimated there were 1.3 billion tobacco users globally.[3] In 2024, WHO figures revealed this number had remained almost unchanged in just under two decades, at 1.25 billion tobacco users worldwide in 2022.[4] Prevalence data released by WHO in 2025 shows the percentage of men who smoke worldwide fell from 36.8% in 2007 to 28.1% of men in 2023.[5] This decrease – just 8.7% over 16 years – leaves 1 in 4 men around the world still exposed to the health consequences of smoking.

One study, published in the British Medical Journal in 2019, indicated “no significant change […] in the rate at which global cigarette consumption had been decreasing after the FCTC’s adoption in 2003.[6] For many high income countries, the prevalence of smoking had already been in decline for decades before the FCTC, although the same cannot be said for the low- and middle-income countries (LMIC).

In a Lancet article in 2022, Robert Beaglehole and Ruth Bonita, Emeritus professors at the University of Auckland, global experts on the prevention of non-communicable diseases (NCDs) and former employees of the WHO, wrote:

“Four out of five of the world’s smokers are in LMIC. In these countries where most of the eight million deaths caused by tobacco occur each year, rates of tobacco use are falling only slowly. [...] The FCTC is no longer fit for purpose, especially for low-income countries.”[7]

How does the FCTC influence global access to SNP?

Consumer access to SNP, such as nicotine vapes (e-cigarettes), snus, nicotine pouches and heated tobacco products, is crucial to realise the public health potential of tobacco harm reduction in the global fight against tobacco-related death and disease. But global regulation and control of SNP is very varied. Governments have responded to use of these products with everything from outright bans (sometimes using existing tobacco control laws) to a range of regulatory frameworks. In countries where there has been no official response, a regulatory vacuum has developed.

There is a growing body of evidence that shows SNP are significantly safer than combustible cigarettes and are already helping millions of people quit smoking.[8] Nevertheless, the WHO seems resolutely set against THR. In recent years, WHO and numerous influential organisations and funders associated with it have explicitly called for countries to either ban SNP outright, or to heavily and prohibitively regulate and tax SNP. The Indian health minister who led the country’s decision to ban e-cigarettes in 2019 was given a WHO Director-General’s commendation award.[9]

Despite this, not all countries are falling into line. While legally binding, the FCTC has no enforcement consequences for non-compliance and tobacco control remains a domestic policy issue.

Two FCTC Parties have adopted partial tobacco harm reduction policies, endorsing quitting smoking by switching to vaping. Both have reaped significant public health rewards. New Zealand has seen smoking fall from 28.9% in 2000 to 10.9% in 2021, with vaping rising to a projected 13% in 2025. The UK has seen smoking fall from 24% in 2005 to 10.8% in 2025, with vaping rising to 10%.[10] In addition, in many countries without an ‘official’ THR policy stance, including Czechia, Italy, Germany, Hungary, Japan, Lithuania, Norway, Slovakia and South Korea, market data shows evidence of substitution effects, as consumers switch from cigarettes to SNP. Tobacco harm reduction is already flourishing in spite of the WHO’s opposition. But how many millions more would quit risky tobacco if the WHO officially integrated harm reduction into its approach – as it did on HIV/AIDS and substance use?

Why are Parties with state-owned tobacco companies at the COP table?

The transnational tobacco industry, and any individual or organisation with any links to it, however tangential or historical, are barred from attending the COP.

Yet paradoxically, several Parties to the Convention have either monopoly or substantial stakes in their own domestic or state-owned tobacco companies. These countries still attend COP meetings. China’s fully state-owned China National Tobacco Corporation (CTNC) is the world’s largest tobacco company by revenue, accounting for 46% of global cigarette sales.[11] The Japanese government owns a 37.5% stake in Japan Tobacco International (JTI), one of the top five companies by revenue.[12] Other Parties with full or significant state tobacco holdings include Thailand, Vietnam, Egypt and Iran.

Is the FCTC Secretariat’s funding structure working?

The FCTC Secretariat receives funding from Parties to the Convention, both in the form of assessed contributions for mainstream Secretariat work, and extrabudgetary (or voluntary) contributions for specific projects.

In 2024–2025, the FCTC’s overall budget was $19,498,888.[13] The proposed 2026–2027 budget is $20,115,895.[14] The amount of each Party’s assessed contributions is calculated using a formula related to the country’s gross domestic product (GDP). The amount owed by each Party is published annually by the FCTC Secretariat, as well as any money that is outstanding. Contributions are made in US dollars.

The total expected annual income from assessed contributions has remained stable at $8,801,093 since 2020–2021.[15] During this period, the dollar has undergone a period of volatility on international markets and, in 2025, has weakened against other major currencies.

Furthermore, the budgetary shortfall, from Parties not paying what they are expected to, increased from 2.2% of the total in 2020–2021 to 5.1% in 2022–2023. As of 31 March 2025, the outstanding balance for the expected assessed contributions in the 2024–2025 fiscal year stood at 42% ($3,700,348), suggesting many Parties were late to make their contributions.

Given budgetary shortfalls, the fluctuating value of the dollar and delays in the payment of assessed contributions, extrabudgetary contributions are increasingly important to the FCTC Secretariat. They made up 55% of its total budget ($10,697,795) in 2024–2025 and are expected to make up 56% ($11,314,802) in 2026–2027.[16]

The reliance on extrabudgetary contributions comes at what cost?

There is little information available about the sources of extrabudgetary contributions. A webpage (accessed September 2025) states “We are grateful to the Parties and entities that provided extra-budgetary support in the biennium 2022–2023 to the Secretariat for the implementation of the workplan adopted by the Conference of the Parties and the Meeting of the Parties”. No information is provided for the period after 2022–2023.[17] While some Parties are named and thanked explicitly for donations, there is no information on which other “entities”, in addition to Parties, supported the work of the Secretariat.

For some time, concerns have been expressed over the WHO’s reliance on voluntary contributions, not just in tobacco control, but throughout its work. One study found that voluntary contributions made up 75% of the WHO’s total budget in 2010, rising to 88% in 2021. This type of funding tends “to be earmarked for donor-specified programmes and projects”, leading to concerns that this has “diverted focus away from WHO’s strategic priorities, […] undermined WHO’s democratic structures and given undue power to a handful of wealthy donors.”[18]

Philanthropist Michael Bloomberg is a generous contributor to tobacco control, via donations to multiple NGOs and also through direct donations to support the work of the WHO. Since 2005, $1.6 billion of Bloomberg funding has been committed to the issue.[19]

In 2016, Mr. Bloomberg was appointed WHO’s Global Ambassador for Noncommunicable Diseases (NCDs) and Injuries, a post he retains at the time of writing.[20] The Bloomberg Initiative to Reduce Tobacco Use has provided millions of dollars of support for the implementation of MPOWER measures as outlined in the FCTC, most of which has been concentrated in low- and middle-income countries.[21][22] In 2025, Bloomberg Philanthropies funded the WHO Global Tobacco Epidemic Report.[23]

Founding members of the Framework Convention Alliance, before it rebranded to the Global Alliance for Tobacco Control (GATC), included the Campaign for Tobacco Free Kids (CTFK) and the South East Asia Tobacco Control Alliance. Both are long-term recipients of Bloomberg funding. Although it is difficult to ascertain which other organisations are members of the GATC, it is likely that many are fellow beneficiaries.

Bloomberg funding has long been used to support policies that restrict or ban SNP, rather than regulating them. In the US, funds have been used by partners to facilitate “the passage of 103 state and local bans on flavoured e-cigarettes”.[24] In other countries, through the activities of the CTFK, Bloomberg funds have been used to influence or even draft legislation to ban SNP. This political interference has come under scrutiny in both the Philippines and Mexico.[25]

Many low- and middle-income countries rely on Bloomberg funds to implement the tobacco control measures outlined in the FCTC. The WHO itself relies on Bloomberg funds for much of its work. This reliance is leading to an outsize influence on policy at both a national and international level and is preventing a clear-sighted, objective assessment of the role that tobacco harm reduction could play – is already playing in many countries – in reducing smoking rates.

Why are COP meetings held behind closed doors?

Funding is only one aspect of the transparency issues facing international tobacco control. When the FCTC was being negotiated (2000–2003), and at the first three COP meetings, the public gallery was open so that anyone could witness the deliberations. Over time, the general public and the media have been excluded from all but the opening day plenary, by a decision of the Parties.

The majority of the proceedings are not publicly streamed or shown for subsequent viewing. Members of the media must now apply for accreditation no less than 60 days before the meeting and declare that they have no financial, employment or professional relationships with the tobacco industry or any entity working to pursue its interest. Since 2021, when the meeting was held virtually due to the pandemic, the opening and closing plenaries have been broadcast online.[26] However, these sessions are formalities, consisting of pre-prepared statements from the Parties.

After the official opening, no other proceedings are broadcast to the public, nor is any transcript made available. This means that any substantive discussions take place behind closed doors, accessible only to Parties and accredited observers approved by the FCTC Secretariat.

The level of secrecy and control around the COP would be unacceptable to Parties to other conventions.[27] It differs from the way other UN agency meetings are conducted, including the Commission on Human Rights, the Commission on Narcotic Drugs, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and the COP meeting on Climate Change.

The meetings of these Conventions facilitate the engagement of numerous civil society organisations and affected groups: for example, by 2024, the COP on Climate Change had given observer status to 3,782 NGOs and 174 IGOs. According to the Framework Convention on Climate Change website, the NGOs “represent a broad spectrum of interests, and include representatives from business and industry, environmental groups, farming and agriculture, indigenous populations, local governments and municipal authorities, research and academic institutes, labor unions, women and gender and youth groups.”[28]

By contrast, the FCTC COP has given observer status to just 28 NGOs and 28 IGOs.[29] To date, no advocacy groups representing people directly affected by tobacco control measures have been considered eligible for observer status or membership of the GATC, including independent groups representing people who use safer nicotine products. It appears that the presence of THR advocates in Panama City, attending meetings held to coincide with COP10, did not go unnoticed by the WHO. Panamanian authorities raided several hotels in search of ‘t-shirts and pamphlets advertising harmful products.’[30]

A significant proportion of the FCTC COP’s funding is from public money donated by the Parties. It follows that there needs to be public accountability and transparency. At present, this is lacking, and the absence of transparency at the COP should be raised with government accountability departments.

What discussions are likely to happen at COP 11 about harm reduction and SNP?

The Agenda for COP meetings are driven by discussion of reports requested at previous COPs, as well as potential new proposals presented by the Parties. The COP Bureau is responsible for preparing the agenda.

The provisional COP11 agenda, published on 17 June 2025, includes a discussion about safer nicotine products at item 4.5.[31] It reads:

“4.5 Implementation of measures to prevent and reduce tobacco consumption, nicotine addiction and exposure to tobacco smoke, and the protection of such measures from commercial and other vested interests of the tobacco industry in light of the tobacco industry’s narrative on “harm reduction” (Articles 5.2(b) and 5.3 of the WHO FCTC)”

Harm reduction is an evidence-based public health strategy that is incorporated into wider WHO and UN responses to drug use and HIV/ AIDS. And according to the FCTC preamble in Article 1(d), harm reduction is one of three strategic pillars of tobacco control. However, the agenda bypasses the preamble, referring instead to Article 5.2(b) to introduce harm reduction.

The wording of Article 5.2 states that “each Party shall … adopt and implement effective legislative, executive, administrative and/or other measures and cooperate, as appropriate, with other Parties in developing appropriate policies for preventing and reducing tobacco consumption, nicotine addiction and exposure to tobacco smoke.”

Introducing harm reduction through the lens of Article 5.2, and placing the term in scare quotes, implies that the approach is an invention of the tobacco industry. It is only presented as a threat, allowing no recognition that safer nicotine products could offer many benefits to public health.

By focusing on Article 5.2, the Secretariat is prioritising the issue of nicotine use and addiction over and above reducing combustible tobacco consumption and exposure to tobacco smoke. By enabling people to quit risky tobacco use, access to safer nicotine products can reduce harm from smoking and eliminate tobacco smoke. The agenda is an attempt to frame all nicotine use as harmful, ignoring the harm reduction potential of safer products.

Agenda point 4.5 also refers to FCTC Article 5.3, which states that Parties must “protect … policies from commercial and other vested interests of the tobacco industry in accordance with national law.” The inclusion of this reference is again suggestive that harm reduction is being framed as a tactic of the tobacco industry.

A request for the formation of a working group to discuss harm reduction, submitted by Saint Kitts and Nevis, has been ignored and will not feature at COP11.

Papers from a new Expert Group on ‘Forward-looking tobacco control measures (in relation to Article 2.1 of the WHO FCTC)’ were added in late September to the suite of documents published ahead of COP11. In this context, ‘forward-looking tobacco control measures’ are those that go further than the measures outlined in the FCTC, “in order to better protect human health” (Article 2.1). The report of the Expert Group contains several recommendations that could reduce consumer access to SNPs, particularly oral tobacco and heated tobacco products.[32] Tobacco harm reduction advocates were also concerned by the composition of the Expert Group, with representation from numerous NGOs with an expressly anti-harm reduction position.[33]

As at COP10, potential areas affecting SNP at COP11 may include calls for tighter regulation or bans on open and customisable systems for vapes, bans or restrictions on flavours that are said to appeal to minors, a restriction on nicotine salts, and a redefinition of ‘smoke’ which might classify the aerosols from heated tobacco products as smoke.

It is also possible that COP11 may see other discussions relevant to SNP, including about an expansion to the definition of tobacco products, extending controls on tobacco advertising and promotion to ban or restrict online sales of SNP, encouraging ‘tobacco endgame strategies’ such as nicotine reduction, reduction of points of sale, or generational bans on purchase of tobacco products, human rights, and discussion on the civil and criminal liability of manufacturers.

How can I/my organisation engage with the COP?

As noted, there are very few opportunities for individuals or organisations outside of the COP structure to follow and contribute to the proceedings.

The COP business and decisions are the responsibility of the Parties. Nationally, the lead for COP business will usually be the Ministry of Health and sometimes other Ministries with competence to deal with related topics. A list of the delegates from the previous COP meeting, COP 10, can be found here.[34] It is likely many of the same people will be attending COP 11.

Organisations can make direct approaches to ministry officials responsible for tobacco control, or via parliamentarians. Parliamentarians are often unfamiliar with the significance of the COP meetings and of their government’s position on FCTC issues, and organisations can brief them on key issues.

Organisations can also make their views known to those IGOs and NGOs with observer status. The mainstream media are not well-informed about the FCTC and the COP and can be alerted to the significance of issues discussed at the meeting.

Organisations can also engage the FCTC Secretariat on social media via @FCTCofficial, and during the event, via #COP11 and #FCTCCOP11.

The COPWATCH website https://copwatch.info/ provides updates on issues before and during the COP.

Conclusion

It has been evident for some time that the FCTC has been ineffective in reducing the global toll of death and disease caused by tobacco use. There remain over a billion people who smoke and an estimated eight million tobacco-related deaths each year.

The only realistic vehicle for reform of the FCTC is through the Parties to the Convention. Parties that have adopted, enabled and supported access to SNP in order to enable adults who smoke to quit are seeing the benefit in falling smoking rates. These countries need to take steps to ensure their progress is not impeded by COP decisions. And these Parties also have a broader responsibility to global public health: to ensure that the capacity of tobacco harm reduction to catalyse reductions in tobacco use is given due consideration at COP11 and beyond.

For further information about the Global State of Tobacco Harm Reduction’s work, or the points raised in this GSTHR Briefing Paper, please contact [email protected]

About us: Knowledge·Action·Change (K·A·C) promotes harm reduction as a key public health strategy grounded in human rights. The team has over forty years of experience of harm reduction work in drug use, HIV, smoking, sexual health, and prisons. K·A·C runs the Global State of Tobacco Harm Reduction (GSTHR) which maps the development of tobacco harm reduction and the use, availability and regulatory responses to safer nicotine products, as well as smoking prevalence and related mortality, in over 200 countries and regions around the world. For all publications and live data, visit https://gsthr.org

Our funding: The GSTHR project is produced with the help of a grant from Global Action to End Smoking (formerly known as Foundation for a Smoke-Free World), an independent, US non-profit 501(c)(3) grant-making organisation, accelerating science-based efforts worldwide to end the smoking epidemic. Global Action played no role in designing, implementing, data analysis, or interpretation of this Briefing Paper. The contents, selection, and presentation of facts, as well as any opinions expressed, are the sole responsibility of the authors and should not be regarded as reflecting the positions of Global Action to End Smoking.

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[10] Shapiro, H., Jerzyński, T., Mzhavanadze, G., Porritt, O., & Stimson, J. (2024a). The Global State of Tobacco Harm Reduction 2024: A Situation Report (No. 4; GSTHR Major Reports). Knowledge-Action-Change. https://gsthr.org/resources/thr-reports/the-global-state-of-tobacco-harm-reduction-2024-a-situation-report/.

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[13] FCTC/COP10(25) Workplan and Budget for the financial period 2024–2025. (2023, May 19). WHO Framework Convention on Tobacco Control. https://fctc.who.int/resources/publications/i/item/fctc-cop10(25)-workplan-and-budget-for-the-financial-period-2024-2025.

[14] WHO Framework Convention on Tobacco Control Convention Secretariat. (2025). Proposed Workplan and Budget for the Financial Period 2026–2027 (FCTC/COP11/INF.DOC./2). Eleventh Session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control (COP11), Geneva. https://storage.googleapis.com/who-fctc-cop11-source/Additional%20documents%20-%20Information/fctc-cop11- inf-doc2-en.pdf.

[15] Status of payments of assessed contributions (VAC) as of 31 March 2025. (2024, October 14). WHO Framework Convention on Tobacco Control. https://fctc.who.int/resources/publications/m/item/status-of-payments-of-assessed-contributions-(vac)-as-of-31- october-2024.

[16] WHO Framework Convention on Tobacco Control Convention Secretariat, 2025.

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[22] Gunther, M. (2021, March 23). Bloomberg’s Millions Funded an Effective Campaign Against Vaping. Could It Do More Harm Than Good? The Chronicle of Philanthropy. https://www.philanthropy.com/article/bloombergs-millions-funded-an-effective-campaign-against-vaping-could-it-do-more-harm-than-good.

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[25] Minton, M. (2021, June 15). Exposed: Bloomberg’s Anti-Tobacco Meddling in Developing Countries. Competitive Enterprise Institute. https://cei.org/blog/exposed-bloombergs-anti-tobacco-meddling-in-developing-countries/.

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[27] Bates, C. (2021, November 8). The WHO tobacco control treaty meetings are closed bubbles of cultivated groupthink – a comparison with the UN climate change treaty. The Counterfactual. https://clivebates.com/the-who-tobacco-control-treaty-meetings-are-closed-bubbles-of-cultivated-groupthink-acomparison- with-the-un-climate-change-treaty/.

[28] Observer organizations. (2024). UN Framework Convention on Climate Change (UNFCCC). https://unfccc.int/process-and-meetings/parties-non-party-stakeholders/non-party-stakeholders/overview/ observer-organizations.

[29] International intergovernmental organizations accredited as observers to the COP. (2025). WHO Framework Convention on Tobacco Control. https://fctc.who.int/convention/conference-of-the-parties/observers/international-intergovernmental-organizations; Nongovernmental organizations accredited as observers to the COP. (2025). WHO Framework Convention on Tobacco Control. https://fctc.who.int/convention/conference-of-the-parties/observers/nongovernmental-organizations.

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[33] World Health Organization. (2024, June 20). First Meeting of the Expert Group on Forward-Looking Tobacco Control Measures (in relation to Article 2.1 of the WHO FCTC). Eleventh Session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control (COP11), Geneva. https://storage.googleapis.com/who-fctc-cop11-source/Supplementary%20documents/fctc-cop11-supp-inf-5-firstmeeting- of-the-expert-group-on-forward-looking-tobacco-control-measures-(in-relation-to-article-2.1-of-the-whofctc)- en.pdf.

[34] WHO Framework Convention on Tobacco Control. (2023, May 19). List of participants. Tenth session of the Conference of the Parties to the WHO FCTC, Geneva, Switzerland. https://fctc.who.int/resources/publications/i/item/fctc-cop-10-div-1-list-of-participants.