Tobacco companies may also launch challenges to tobacco legislation or regulations as a whole, particularly if a party has implemented a suite of complementary measures at once. These may raise arguments in relation to each individual measure, and may also raise arguments against legislation or regulations as a whole, often on procedural grounds. Parties may find the following cases useful as an illustration of the kinds of arguments that may be raised against tobacco regulations or legislation as a whole. This list is not exhaustive; the cases have been chosen because they involve challenges to a large number of measures at once and cover a variety of regions, legal systems, and ways to frame the relevant legal issues.

1. Illustrative case examples

British American Tobacco v. Cabinet Secretary for the Ministry of Health and Others (Court of Appeal of Kenya, 2017 and Supreme Court, Kenya, 2019)

This case illustrates a range of procedural arguments that relate to regulations, as well as arguments in relation to measures implementing WHO FCTC articles 5.3, 8, 10, and 19.

British American Tobacco (BAT) challenged the Tobacco Control Regulations (2014), which include requirements for large graphic and text health warnings; mandatory disclosures of tobacco product ingredients and revenues; smoke-free environments in public places and adjacent streets, walkways and verandahs; limitation of interactions between the tobacco industry and public officials; and requirements that tobacco companies pay a solatium compensation contribution (i.e. compensation for harm suffered) of 2% of the value of tobacco products manufactured or imported to fund tobacco control research, cessation, and rehabilitation programs. The regulations were made under the Tobacco Control Act.

BAT argued that:

  • the government had not provided for adequate public participation in the passing of the regulations
  • the government had not prepared a regulatory impact statement in developing the regulations
  • provisions limiting interactions between public officials and the tobacco industry were discriminatory and violated its constitutional rights to peaceful assembly and fair administrative action
  • the solatium compensatory contribution was an unconstitutional tax 
  • there was inadequate basis in the legislation for extending the smoke-free ban to outdoor areas adjacent to public places
  • the product and revenue disclosure requirements violated its constitutional rights to privacy and its intellectual property rights.

The Court of Appeal rejected all of these arguments. It found that:

  • The petitioner had had the opportunity to attend, and had in fact attended, public consultations on the regulations, and had made submissions to the government on the regulations. The right to public participation did not mean the petitioner had a right for its views to ‘carry the day’.
  • There was no need to prepare a regulatory impact statement because the regulations fell within an exception in the Statutory Instruments Act for regulations that are substantially uniform or complementary to an Act. The regulations were complementary to the Tobacco Act because they helped to achieve its object of regulating tobacco manufacture and use to protect tobacco users and the general public.
  • Limiting interactions between the tobacco industry and public authorities was not discriminatory, nor did it violate the right to peaceful assembly or fair administrative action.
    • The constitution only prevented arbitrary discrimination, and did not prevent distinctions based on legitimate public policy grounds. The concept of discrimination needed to take into account that the tobacco industry ‘cannot be compared to manufacturers of other products’; the ‘tobacco industry cannot expect equal treatment with other industries as due to the harmful effect of tobacco products [and] the State … obligation to protect the health of its citizens’. As the singling out of the tobacco industry was justified, and the regulation applied equally within the tobacco industry, it was not discriminatory.
    • There was no infringement of the right to peaceful assembly: the regulation did not bar all interactions between the tobacco industry and public officers but merely limited them in a way to ensure accountability and transparency, informed by the need to control and regulate the tobacco industry for public health reasons.
    • There was no infringement of the right to fair administrative action because the government had acted consistently with procedural requirements set out in the Statutory Instrument Act and the Constitution.
  • The solatium compensatory contribution was not a tax, because its proceeds did not go toward public revenue but to compensating the negative effects of tobacco product use. It was consistent with the law and with the state’s obligations to ensure the enjoyment of the highest attainable standard of health. It was also not an attempt to ‘irregularly apply the [WHO FCTC]’. The Court of Appeal emphasised, in a passage cited by the Supreme Court, that Kenya had ratified the WHO FCTC and therefore committed to ‘protect its present and future generations from the devastating social and environmental consequences of tobacco consumption and exposure to tobacco smoke’, and that under Article 2.6 of the Constitution treaties ratified by the state were part of the law of Kenya.
  • The ban on smoking in indoor public places and on streets, walkways, and verandas adjacent to public places was supported by the Tobacco Control Act – the provisions providing for smoke-free areas in indoor public places needed to be read together with provisions providing for a right to a clean and healthy environment and protection from exposure to tobacco smoke, and with provisions providing for obligations to effectively protect other individuals, including children, from second-hand smoke.
  • Any limitation on intellectual property rights caused by the product disclosure requirements was justified on public health grounds. The court cited a passage from the judgment of the High Court of England and Wales in the challenge to the UK’s standardized packaging regulations that recognised that intellectual property rights were not absolute and could be derogated from on public health grounds.

The Court of Appeal's decision was upheld by the Supreme Court of Kenya.

See also British American Tobacco v. Cabinet Secretary for the Ministry of Health and Others (High Court of Kenya, 2016).


Legislative Consultation with Constitutional Division of the Supreme Court No. 2012-003918 (Costa Rica, 2012)

This case involves a challenge to a tobacco control law on the basis of legislative procedure, as well as substantive challenges to measures implementing WHO FCTC articles 6, 8, 13, and 16

The Constitutional Division of the Supreme Court of Justice of Costa Rica upheld legislation that introduced a specific tax on cigarettes, created a comprehensive ban on advertising, promotion and sponsorship of tobacco products, prohibited smoking in enclosed public places and certain private places, and raised the minimum number of cigarette sticks per pack from 10 to 20. Certain legislators challenged the law on the basis that there were procedural flaws in its adoption, as well as objecting to individual provisions of the law.

The Court examined how the law had been drafted and adopted, and found that there were no relevant procedural flaws in the adoption of the law. It also rejected each of the individual objections to the law.

In relation to the tax, the Court rejected an argument that the tax would lead to illicit trade, finding that there was no evidence that such consequences would occur. In any case, the argument was not relevant to the determination of a constitutional issue – it was up to the legislature to decide how to address any potential consequences of the tax. The Court also found that the tax implemented article 6 of the WHO FCTC and therefore had an adequate legal basis.

In relation to the prohibition on advertising, promotion and sponsorship, the Court rejected the argument that the legislature could not institute a comprehensive ban. The court noted that the prohibition implemented article 13 of the WHO FCTC, which, as an international convention with the goal of protecting public health, was an instrument which had the purpose of protecting fundamental rights. The Court noted previous jurisprudence stating that international human rights instruments could take precedence over the constitution to the extent that they provided for greater rights to individuals. As such, the ban on sponsorship was not only allowed, but was fully in accordance with the constitutional law on human rights. The prohibition also did not unlawfully delegate the regulation of one-to-one communications to the executive.

In relation to protection from exposure to tobacco smoke, the court found that the prohibition was supported by the WHO FCTC’s general obligation to provide ‘effective’ protection against exposure to tobacco smoke. The prohibition also protected non-smokers’ right to health.

In relation to the increase in minimum pack sizes, the court found that the provision was not arbitrary but rather implemented obligations under WHO FCTC article 16 to protect minors. There were therefore clearly identifiable and legitimate grounds for implementing the legislation.

The court further added that the legislation implemented the WHO FCTC, and therefore was in line with the objective of ensuring public health in line with its international obligations on human rights matters. It extensively quoted from the WHO FCTC’s preamble and objective and from a previous opinion of the Court finding that the WHO FCTC protected the right to life and health of every citizen.

C-547/14 – R (on the Application of) Philip Morris Brands SARL et al. v Secretary of State for Health (European Union, 2016)

This case involves a challenge to the basis for adopting regional tobacco product regulations, as well as challenges to measures implementing articles 9, 10, 11, and 13.

The Court of Justice of the European Union upheld the validity of the Tobacco Products Directive (Directive 2014/40), which creates a regime regulating, among other things, the packaging, labelling, and product contents and disclosure rules for tobacco products. The Directive requires large graphic health warnings covering 65% of both the front and back of the external pack surface, bans cross-border distance sales, bans misleading descriptors, and mandates standard pack sizes and shapes. The Directive also includes a ban on the use of all characterising flavours including menthol, enhanced reporting and disclosure requirements, and standards for product contents, including in relation to certain novel tobacco products.

The Court found that the Directive had been validly adopted, and that all the challenged aspects of the Directive were proportionate to the aim of ensuring a functioning internal market while ensuring a high level of health protection. (The relevant EU bodies have the power to adopt rules to ensure the functioning of the internal market, but not for health protection as an independent basis).

The aim of improving the functioning of the internal market was served by partially harmonising product requirements so as to ensure consistent rules across the internal market and remove an obstacle to trade, while still ensuring a high level of health protection by imposing high standards. The Directive therefore had an adequate legal basis.

The flavouring ban was proportionate to its aims. The Court noted that the characterizing flavour ban took into account recommendations in the Guidelines to Articles 9 and 10 of the WHO FCTC, which are intended to assist the parties in the implementation of binding obligations under the Convention and are based on the best available scientific evidence, and should therefore be considered ‘of particularly high evidential value’. Less restrictive measures such as education campaigns or age limits were not likely to achieve the dual aims of improving the functioning of the internal market while ensuring a high level of health protection for all consumers, and the EU was entitled to consider the health of all consumers (rather than being restricted to considering youth smokers) in making its decision on which flavours to ban.

The Court found that the packaging and labelling requirements were proportionate to the aim of the regulation and to any interference with freedom of expression. The Court found that:

  • The large graphic health warnings were proportionate to their aims of ensuring a high level of health protection. The Court stated that ‘human health protection – in an area characterised by the proven harmfulness of tobacco consumption, by the addictive effects of tobacco, and by the incidence of serious diseases caused by the compounds those products contain that are pharmacologically active, toxic, mutagenic and carcinogenic – outweighs the interests put forward by the [tobacco companies].’ It noted that the Guidelines to Article 11 of the WHO FCTC recommended that Parties adopt warnings that cover ‘more than 50%’ of the pack, and that the choice of warning size in the Directive had been based on criteria derived from those recommendations. The Court considered that the WHO FCTC guidelines were based on the ‘best available scientific evidence’, and were ‘intended to have a decisive influence on the content of the rules adopted in the area under consideration’.
  • The ban on misleading descriptors was proportionate to any interference with freedom of expression: the tobacco companies had argued that banning ‘true’ descriptors was disproportionate. However, the Court found that the descriptors, which included terms such as ‘organic tobacco’ and ‘biodegradable filter’, could mislead consumers as to their health or environmental impact even if technically true – an organic cigarette was no safer than a regular one.
  • The standard pack sizes, shapes, and cigarette numbers per pack were proportionate to the aim of harmonising product regulations within the internal market while ensuring a high level of health protection.

The Court ruled that EU member states were free to adopt stricter regulations regarding those areas of the pack that were not harmonised by the Directive, including standardized packaging and colour restrictions on the remainder of the pack surface. The provision required member states to adopt the same requirements for 2/3rds of the pack, but allowed the remaining 1/3rd of the pack to be subject to further requirements at the discretion of the member states. The ability to adopt stricter regulations did not mean that the Directive lost its legal basis, as partially harmonising 2/3rds of the pack still removed an obstacle to trade and could therefore validly be the subject of a Directive to improve the functioning of the internal market.

The Court found that banning cross-border distance sales was proportionate and had an adequate legal basis, because such sales were required to ensure effective enforcement of the Directive.

The Court also found that the adoption of the Directive did not breach the principle of subsidiarity (which requires the EU to act only when the objective of an action cannot be achieved by national legislatures alone). Ensuring consistent standards for tobacco products across member states was an action which could only be effectively achieved through action at the regional level.