The authors have no conflicts of interest with tobacco, vaping or pharmaceutical industries. The views of this paper represent the personal opinions of the authors as independent experts and are not representative of their respective institution or organization.

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Purpose of this paper: The high smoking prevalence in the Asia-Pacific region, especially so in developing countries, imposes a significant burden on health systems as a result of premature death and morbidity related to smoking (i.e. 4.7 million deaths in the Asia Pacific Region in 2019 [1]). This paper shows how adopting tobacco harm reduction principles and the use of reduced harm products (RHPs) to complement existing smoking cessation policies can reduce smoking prevalence and reduce the health and economic burdens caused by smoking-related diseases in the region.

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Introduction

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Science and technology are drivers of positive development for societies globally; multiple innovations abound in various spheres of life. Innovation is particularly salient in the field of tobacco control.

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A central debate in tobacco control is the role harm reduction can play for smokers who opt to continue cigarette smoking. Tobacco harm reduction is defined as reducing harm to the health of cigarette smokers who are unable or unwilling to stop using nicotine through traditional combustible methods (primarily cigarette smoking) by encouraging the substitution of other nicotine yielding products that may pose fewer health risks to such individuals [2]. Apart from traditional Nicotine Replacement Therapies (NRT) such as nicotine lozenges, gums, sprays and trans-dermal nicotine patches and pharmacological treatment, there is significant potential to transition smokers away from combustible tobacco products with the use of Reduced Harm Products (RHPs). Like NRTs, scientific studies and population health evidence indicate that RHPs, as a category, are significantly less hazardous than continued cigarette smoking.  Furthermore, there is population health evidence indicating that the use of RHPs has begun to displace cigarettes and have had a material effect in reducing smoking prevalence [3],[4].  RHPs can play a meaningful role in reducing the harm caused by cigarette smoking, one of the leading preventable causes of non-communicable diseases (NCDs) in the world.

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The World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC) defines tobacco control policies as a range of supply, demand and harm reduction strategies that aim to improve the health of a population by eliminating or reducing the consumption of tobacco products and exposure to smoke from combustible tobacco products. Yet, harm reduction policies have been the least commonly applied and agreed upon. There is a need to complement existing tobacco control policies by creating access to a range of RHPs to assist smokers in transitioning away from combustible tobacco products and towards achieving tobacco harm reduction objectives.

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While the WHO recognizes the difference in national views and policies, it has advocated a precautionary approach to RHPs, encouraging countries to ban them; allow them to be introduced only if they are approved as safe and effective medicines; and/or to regulate them the same as cigarettes. That has provided many jurisdictions, particularly in low and middle-income countries, with justification to ban or heavily restrict RHPs.  This raises the prospect of widening health inequalities as those jurisdictions with the capacity and will to embrace tobacco harm reduction (THR) witness an acceleration in the reduction of combustible tobacco product consumption.

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It is therefore important to recognize the facts and establish the principles that leverage on scientific progress and technological advances that have the potential to bring harm reduction benefits to smokers who otherwise continue to smoke. The statements are as follows:

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Fact: As a class, RHPs are significantly less harmful than combustible tobacco products, and replacing use of combustible tobacco products with RHPs can significantly improve health outcomes.

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Unlike the combustion of cigarettes that produces approximately 7,000 Harmful and Potentially Harmful Constituents (HPHCs), and of which at least 70 are proven or suspected carcinogens[5], RHPs do not combust tobacco or other substrate and hence, the absence of smoke production leads to a 90-95% reduction in emission of HPHCs on average[6],[7]. As such, RHP users’ consequent exposure to carcinogens and toxicants is substantially reduced (as is bystanders’ exposure). Clinical studies have indicated that this reduction in exposure can lead to improvements in clinical risk markers such as oxidative stress, endothelial dysfunction, lipid metabolism, inflammation and lung function[8],[9].

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While RHPs are not risk-free, as is also the case with NRTs and smoking cessation drugs, the substitution of combustible tobacco products with scientifically substantiated RHPs reduce exposure to harmful toxicants[10]. This can reduce the risk of premature morbidity and mortality caused by smoking[11], which can translate to a beneficial impact on population health[12],[13] and ultimately, cost savings for the healthcare delivery system.

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Principle 1: Tobacco harm reduction is a viable and complementary component to strengthen national tobacco control strategies.

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Tobacco control efforts have primarily focused on (i) prevention of initiation, (ii) cessation for smokers, and (iii) protection from environmental tobacco smoke [14].

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Policies supporting abstinence to tobacco and nicotine products should be the preferred approach to create health and economic benefits. However, policies facilitating the switch to RHPs that can reduce a smoker’s exposure to toxicants can reduce the negative impact that combustible tobacco products has on the health of smokers and those around them[15]. As such, tobacco harm reduction is a viable strategy to support individual autonomy in controlling one’s health outcome. Countries have a responsibility under the right to health to not deny access to RHPs to smokers who want to quit using combustible tobacco products given the potential to improve their health outcomes[16].

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Principle 2: Policies must be in place to ensure the safety and quality of RHPs.

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Appropriate product safety standards should be put in place to protect RHP users. This may require the submission of product safety assessments, limitations on the amount of additives that may be carcinogenic, mutagenic, and/or are toxic additives, and the inclusion of a reporting structure for adverse events and product performance[17].

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Principle 3: A risk-proportionate regulatory regime should be applied to RHPs to enable complementarity with existing interventions designed to reduce the prevalence of combustible tobacco use.

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RHPs should not be over-regulated such as by requiring them to establish “safety” or “efficacy” as with pharmaceutical products. The restriction of access to RHPs could have the unintended effect of entrenching the use of cigarettes and other harmful combusted forms of tobacco use and perpetuating the health burdens such products cause.

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In addition, RHPs can play an effective role in tobacco harm reduction if governments avoid over-medicalizing RHPs, such as by classifying these products as prescription-only medicine, so as to avoid stigmatizing smokers who would like to consider switching to RHPs.

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A risk-proportionate taxation regime should be applied to RHPs to encourage smokers who otherwise continue to smoke to switch from combustible tobacco products to scientifically substantiated RHPs[18],[19],[20], and attract investments that promote research and innovation into RHPs. In doing so, potential population health, economic and social gains and benefits such as a reduction in national health expenditure and overall improvement in national productivity[21] can be achieved.

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Differential regulations should be imposed on the marketing and advertising of RHPs vis-à-vis combustible tobacco products[22],[23], to create greater consumer awareness on pragmatic, evidence-based and user-centric advice for RHPs. This can encourage a smoker to replace combustible tobacco products with RHPs to support the objectives of broader tobacco control policies to reduce the prevalence of combustible tobacco products use.

 

Principle 4: Policies must be in place to ensure equitable & affordable access to adult smokers, whilst limiting access to youth.

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RHPs should be made at least as accessible and affordable as combustible tobacco products to adult smokers to facilitate the replacement of combustible tobacco products with RHPs.

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RHPs should be prohibited from sale to minors who are not of legal age to smoke. Additional controls to further curb initiation by and minimize appeal to vulnerable youths[24][25][26] should be imposed on RHPs. This includes  implementing labelling and warning requirements, restrictions on ingredients, flavors and product descriptors, as well as appropriate advertising, marketing and sale restrictions. For example, the current regulatory and health measures applied to alcohol and tobacco can similarly be applied to RHPs[27],[28] in a risk-proportionate manner.

There must be a fine balance struck between implementing restrictions and regulatory controls to minimize access by youth whilst enabling access to smokers who want to move away from combustible tobacco products to RHPs.

 

Countries such as Italy, New Zealand and the United Kingdom have recognized and regulated the role of RHPs as a tool for overall tobacco harm reduction[29][30][31]. Moreover, there is evidence that the introduction of RHPs, in countries such as Italy, Korea and Japan, coincided with the accelerated decline of combustible tobacco product sales volume, in particular cigarettes [32][33][34]. In addition, the Japan National Health and Nutrition Survey revealed that overall tobacco use prevalence in Japan had not increased since the introduction of RHPs and was reported to be at an all-time low of 16.7% in 2019[35].

 

Recommendations

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As a matter of urgent public health policy, the Asia-Pacific Tobacco Harm Reduction Caucus recommends that regulators, policymakers and leaders of international health organisations draw lessons from scientific research, data and existing regulatory practices on RHPs all countries in the region. In doing so, regulators and policymakers can adopt a balanced, pragmatic and evidence-informed approach towards incorporating harm reduction to complement their local tobacco control policies to allow smokers to lead healthier lives and avoid premature death.

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Conclusion

 

Regulators, policymakers, international health organisations and the healthcare professionals community at large need to recognize that the high prevalence of NCDs such as heart disease, stroke, hypertension and diabetes, is in part caused by the high prevalence of smoking. In addition, the costs of externalities (e.g. healthcare, fires, other disamenities) is estimated to be reduced if the smoking population switches from cigarettes to RHPs[36].

The Asia-Pacific Tobacco Harm Reduction Caucus believes that the currently available published, peer-reviewed, scientific and population evidence now affords an opportunity for countries to implement policies to facilitate and encourage those who otherwise continue to smoke to switch to regulated RHPs as a complementary approach to contribute more effectively to existing smoking cessation programmes. This will significantly increase smokers’ chances of successfully quitting smoking and hence reduce the country’s burden of disease and mortality contributed by the use of combustible tobacco products.

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References:

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