The WHO Framework Convention on Tobacco Control and the Protocol to Eliminate Illicit Trade in Tobacco Products
The WHO Framework Convention on Tobacco Control
The WHO Framework Convention on Tobacco Control (WHO FCTC) was adopted by WHO Member States in 2003 and came into force in 2005. It was developed in response to the globalisation of the tobacco epidemic and its large negative socioeconomic impacts — as demonstrated by the World Bank and others in the 1990s — and in response to significant civil society advocacy. It is the first public-health treaty negotiated under the auspices of WHO, and has become one of the most rapidly and widely embraced treaties in UN history, with more than 180 Parties.
The WHO FCTC seeks “to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke” by obliging countries to enact a set of universal and comprehensive provisions limiting tobacco use. The treaty is a powerful, evidence-based, politically endorsed, multilateral and comprehensive tool to spearhead national action for tobacco control in the context of the powerful transnational nature of the tobacco industry — for example, in addressing cross-border issues such as smuggling or the leakage of tobacco advertising between countries. A treaty is a legal instrument that requires much stronger action than nonbinding “declarations” or “codes of conduct”: Parties are bound to implement the WHO FCTC’s provisions.
The treaty’s provisions include rules that govern the production, sale, distribution, advertising and taxation of tobacco, among others. Parties are encouraged to implement more stringent measures than the treaty requires. A Party shall implement all the treaty’s measures: no cherry-picking is allowed.
The WHO FCTC is governed by the Conference of the Parties (COP), which meets every two years to review implementation and make decisions to promote effective implementation — including adopting protocols, guidelines, annexes and amendments to the Convention. The COP is open to Parties and Observers.
To support implementation, a number of guidelines and policy options have been adopted by the COP. These are agreed to by Parties on specific, established, evidence-based measures for the implementation of key provisions; they represent best-practice statements of immense practical value. Because they are adopted by Parties to the treaty, these guidelines also have legal significance, and have been successfully relied on to justify State interpretations of the WHO FCTC and to defend related tobacco control measures when challenged. The COP’s eighth session also adopted a strategy setting priorities for implementation of the WHO FCTC from 2019 to 2025, including the work of the Parties and the Geneva-based Convention Secretariat.
Measures to reduce the demand for and supply of tobacco
Measures to reduce demand:
- Article 6 — Implementing tax and price policies and prohibiting or restricting sales to and/or importations by international travellers of tax- and duty-free tobacco products.
- Article 8 — Protection from exposure to tobacco smoke in indoor workplaces, public transport, indoor public places and, as appropriate, other public places.
- Article 9 — Testing and measuring the contents and emissions of tobacco products, and regulating them.
- Article 10 — Ensuring manufacturers and importers disclose information about contents and emissions, and making information on toxic constituents public.
- Article 11 — Health warnings on packaging and labelling in the country’s language, covering 50% or more of the display area (no less than 30%), ideally with pictures; labelling must be approved and must not mislead.
- Article 12 — Promoting education, communication, training and public awareness.
- Article 13 — A comprehensive ban on all forms of tobacco advertising, promotion and sponsorship (TAPS).
- Article 14 — Implementing cessation programmes for people with tobacco dependence.
Measures to reduce supply:
- Article 15 — Action to eliminate illicit trade in tobacco products, including smuggling, illicit manufacturing and counterfeiting — further articulated in the Protocol to Eliminate Illicit Trade in Tobacco Products.
- Article 16 — Prohibiting sales of tobacco products (or provision of free products) to minors; requiring evidence of age; making products inaccessible without proof of age; and prohibiting sales in small packets or as individual sticks.
- Article 17 — Supporting economically viable alternative activities for tobacco workers, growers and, if required, individual sellers.
Article 5.3 and other measures
Article 5.3 obliges Parties to protect tobacco control policies from commercial and other vested tobacco industry interests — insulating all policymakers and regulators from tobacco industry influence and making all interactions with the industry transparent. While tobacco industry interference remains among the most significant obstacles to the WHO FCTC’s implementation, evidence suggests that national initiatives enshrining the independence and transparency of tobacco control policymaking have often preceded and accompanied effective tobacco control. Other measures include the protection of the environment and the health of persons in relation to the environment in respect of tobacco cultivation and manufacture (Article 18), and research, surveillance, reporting and exchange of information (Articles 20–22).
The Convention Secretariat provides technical support to countries in implementing the treaty’s obligations, including through the FCTC 2030 project. WHO and other development partners also provide technical support, including through the WHO MPOWER package — a set of six cost-effective, high-impact measures that help countries reduce demand for tobacco.
The Protocol to Eliminate Illicit Trade in Tobacco Products
Illicit trade poses a serious threat to public health because it increases access to — often cheaper — tobacco products, fuelling the tobacco epidemic and undermining tobacco control policies such as graphic health warnings or plain packaging. It also causes substantial losses in government revenues, and contributes to the funding of international criminal activities.
The Protocol to Eliminate Illicit Trade in Tobacco Products (the Protocol), which entered into force in 2018, is intended to eliminate all forms of illicit trade in tobacco products. As of 2021 it had been ratified by more than 60 countries. Among the Protocol’s sections — which include supply-chain control, offences and international cooperation — Parties are expected to take forward a set of obligations including establishing a tracking-and-tracing system for tobacco products and implementing effective controls on all tobacco product manufacturing and transactions in tax-free zones. The Protocol is governed through biennial Meetings of the Parties (MOP) that occur immediately following COP sessions. The Convention Secretariat also serves as the Secretariat to the Protocol.
Novel and emerging tobacco and nicotine products
With the growing success of tobacco control efforts and declining cigarette sales in high-income countries, the tobacco and other industries have devised new products that can be positioned as “less harmful” — with consequences for the applicability of existing regulations and appeal to both current and non-users.
Heated tobacco products (HTPs) first appeared in the 1980s but achieved substantial use only in the mid-2010s. HTPs are specially engineered tobacco product inserts that, when placed inside custom-designed heating units, produce inhalable aerosols containing nicotine and other chemicals. As tobacco products, they are subject to the provisions of the WHO FCTC despite industry arguments that they should receive different treatment.
Electronic nicotine delivery systems (ENDS) do not contain tobacco. Instead, they vaporise a solution composed of numerous substances — including nicotine and flavouring chemicals. Although the long-term health effects of inhaling these substances are still unknown, there is evidence of potential adverse health effects as well as concerning population-health impacts in the form of nicotine uptake among youth.
Although minor as a share of the overall global market for tobacco and nicotine products, these novel products have threatened to hijack discussions of tobacco control policy, and the tobacco industry has sought to create and exploit an appearance of discord in order to undermine the impetus toward implementing evidence-based tobacco control measures. This can be seen in particular in the industry’s contention that ENDS and HTPs can form part of a harm-reduction strategy (akin to those used to reduce harm from injectable drug use), with mass advertising and widespread commercial availability claimed as necessary. In reality, HTPs are tobacco products that need to be regulated as such, and science-based evidence — rather than industry-driven marketing strategies — needs to guide the regulation of ENDS. Any public-health approach to tobacco harm reduction must be led by this evidence and organised around the fundamental principle of opposition to industry involvement in line with Article 5.3.
The problems associated with ENDS are regularly discussed at the COP. Its current position is that:
- allowing such products to penetrate national markets without regulating them could threaten the implementation of tobacco control strategies and undermine the denormalisation of tobacco use upheld by the Convention;
- ENDS’ health claims should be prohibited until they are scientifically proven;
- Parties should consider prohibiting or otherwise regulating ENDS (including as tobacco products, medicinal products, consumer products or other categories);
- Parties should apply regulatory measures to prohibit or restrict the manufacture, importation, distribution, presentation, sale and use of ENDS; and
- HTPs are recognised as tobacco products, subject to all relevant provisions of the WHO FCTC and the relevant domestic legislation and controls.
UN Interagency Task Force on NCDs
The Convention Secretariat and WHO have together worked to ensure support for and adherence to the WHO FCTC across the international system, with marked success in the treaty’s explicit incorporation in both target 3.a of the UN Sustainable Development Goals and the outcomes of the UN General Assembly’s three high-level meetings on NCDs.
To give substance to this high-level recognition, cooperation for tobacco control has been institutionalised in the UN Inter-Agency Task Force on the Prevention and Control of NCDs. Led by WHO and comprising over 40 intergovernmental organisations, the Task Force has paid particular attention to the WHO FCTC — for example, in its creation and monitoring of a policy on preventing tobacco industry interference within the UN system, adopted by the UN Economic and Social Council. The Task Force’s thematic group on tobacco control, chaired by the Convention Secretariat, ensures a concerted focus on all aspects of WHO FCTC implementation within the UN system and prevents UN agencies from working at cross-purposes.
Implications for policymakers and practitioners
These institutions and organisations together constitute a powerful set of tools for accelerating tobacco control, promoting health and saving lives. Although there has been substantial progress — the proportion of the global population benefiting from at least one cost-effective, high-impact WHO tobacco control policy quadrupled between 2007 and 2021 — there are still over eight million tobacco-use-related deaths each year. An estimated 100 million deaths could have been averted between 2009 and 2017 if just three main WHO FCTC obligations (increased tax, a ban on TAPS and a smoking ban in enclosed premises) had been implemented strictly since 2009. In the absence of further effort, the evidence-based and highly cost-effective WHO FCTC will fail to prevent an estimated one billion deaths over the course of the twenty-first century — with the great majority of this tragic loss of life occurring in low- and middle-income countries.
Because of the global tobacco epidemic’s devastating impact on social and economic well-being, and on the sustainability of universal health coverage, implementing the WHO FCTC is key to sustainable development; it is included as a specific component of the broader 2030 Agenda for Sustainable Development. The annual economic cost of the global burden of smoking-related disease, including lost productivity and health care, exceeds US$ 1.4 trillion — a third of this appearing as over US$ 400 billion in additional healthcare costs. At the same time, cigarettes are the single greatest source of litter worldwide, and tobacco farming is responsible for various forms of severe environmental degradation through soil depletion and deforestation.
The ongoing COVID-19 pandemic’s human, social and economic toll has also been exacerbated by the tobacco epidemic, with current tobacco users exposed to a higher risk of infection and severe disease progression — while people living with NCDs (a significant proportion of which are tobacco-related) have been more vulnerable to severe COVID-19 and suffered disruptions to treatment caused by the public-health response to this infectious disease. This deadly interplay reveals how the tobacco industry’s globalisation of this directly harmful product has rendered our health systems more vulnerable to communicable diseases, with consequences that are evident today and will be faced again unless action is taken.
To preserve human and planetary health, improve social and economic well-being and prepare for the next pandemic, countries need to urgently accelerate their implementation and enforcement of the WHO FCTC provisions with reference to both COP guidance and WHO’s MPOWER technical package. Policymakers, health and finance sector officials, public-health professionals and civil society organisations all have an active part to play in ensuring their countries are Parties to both the WHO FCTC and the Protocol and, where they are, adhering to the legal obligations assumed through ambitious adoption and implementation. Beyond this core set of obligations, it is incumbent on these actors to militate in favour of countries fulfilling supportive responsibilities such as sharing lessons, reporting on progress, and promoting global implementation with technical assistance and critically needed financing.