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Karnataka Beedi Industry Association v. Union of India [India] [December 15, 2017]
Using the powers conferred by India’s omnibus tobacco control law, the government introduced new graphic health warnings in October 2014 that, among other things, increased the graphic health warning size from 40 percent of one side to 85 percent of both sides of tobacco product packaging and amended the rotation scheme of the warnings. The Karnataka Beedi Industry Association, the Tobacco Institute of India, and other pro-tobacco entities challenged the validity of the 2014 pack warning rules in five cases in the Karnataka High Court – Bengaluru, and the court initially stayed the implementation of the warnings via interim orders. Following a petition by tobacco control advocates, the court lifted the stays, and a division bench of the court affirmed the decision on appeal. The association and others challenged this ruling in the Supreme Court. Paving the way for immediate implementation of the warnings, the Supreme Court, on May 4, 2016, directed that the matter be decided within six weeks in the Karnataka High Court by a bench constituted by the Karnataka Chief Justice and that any stays of the warnings in other high courts not be given effect until the conclusion of the matter. The Supreme Court identified pending pack warning challenges in courts throughout India (more than 27 in number) and transferred these cases to Karnataka. After months of hearings, a two judge bench of the Karnataka High Court struck down the 2014 rules. One judge found the rules illegal, holding that the Ministry of Health did not possess authority to act unilaterally. Both judges found the rules to be arbitrary and unreasonable.
Nicopure Labs, LLC v. Food and Drug Administration [United States] [July 21, 2017]
A manufacturer of e-cigarette devices and liquids challenged a federal regulation that deemed e-cigarettes to be “tobacco products.” This rule subjects e-cigarettes to the same federal laws as traditional cigarettes under the Tobacco Control Act (TCA). The manufacturer argued that the Food and Drug Administration (FDA), which issued the regulations, did not have the authority to regulate empty e-cigarettes or nicotine free e-liquids, because they were not made or derived from tobacco. The company also argued that the TCA’s ban on distributing free samples and pre-approval for modified risk statements was arbitrary and violated their First Amendment rights.
In this decision, the District Court upheld the FDA’s rule. The TCA gives the FDA the power to regulate “components” of tobacco products. The court found empty e-cigarettes and nicotine-free e-liquids are “components” of a tobacco product because together they make up an electronic nicotine delivery system. Further, the court found that the rule did not violate the manufacturers’ First Amendment rights because the ban on free samples was regulating conduct, not speech. The court also held that pre-approval for modified risk statements did not violate the First Amendment because it does not ban modified risk statements, it only requires the claims be substantiated. Finally, the court found because of the public health risks associated with nicotine and increasing rates of e-cigarette use in adolescents and adults, the decision to subject e-cigarettes to the TCA was not arbitrary.
British American Tobacco Ltd v. Ministry of Health [Kenya] [February 17, 2017]
British American Tobacco appealed a 2016 court decision, which upheld nearly all elements of Kenya’s Tobacco Control Regulations. The appeals court ruled that the tobacco company’s appeal had no merit and affirmed the decision of the lower court. The earlier ruling upheld nearly all elements of the Regulations, which are designed to implement the Tobacco Control Act, including:
- a 2% annual contribution by the tobacco industry to help fund tobacco control education, research, and cessation;
- graphic health warnings;
- ingredient disclosure;
- smoke-free environments in streets, walkways, and verandas adjacent to public places and in private vehicles where children are present;
- disclosure of annual tobacco sales and other industry disclosures; and
- regulations limiting interaction between the tobacco industry and public health officials.
The appeals court agreed with the lower court that the tobacco company had been given adequate opportunities for participation in the development of the regulations and that the regulations do not violate the tobacco company’s constitutional rights.
BAT v. UK Department of Health (Appeal) [United Kingdom] [November 30, 2016]
An appeal against the earlier High Court judgment which upheld the UK's Standardised Packaging of Tobacco Products Regulations 2015.
British American Tobacco, Japan Tobacco International and Imperial Tobacco, together with the tipping paper company Tannpapier, appealed the High Court judgment of May 2016. The Appeal Court rejected all grounds of appeal.
The appeal concerned the nature of the claimants' trade mark rights, the extent to which the Regulations interfere with those rights and the lawfulness of any interference. The Claimants also appealed the High Court judgment on the proportionality of the Regulations. The case concerned issues of European Union law and the European Convention on Human Rights (the right to property in Article 1 of Protocol 1), as well as domestic common law.
The Appeal Court confirmed that a positive 'right to use' a registered trade mark did not exist in either domestic law, European Union law or international law. The Court also confirmed that the Regulations amounted to a control on the use of the tobacco trade marks and did not amount to a deprivation of those marks. The Regulations were a proportionate response to the public health objectives and struck a fair balance between the objectives and the interference with the claimant's rights.
British American Tobacco Panama v. Panama [Panama] [August 03, 2016]
Decree 611 establishes that Panama's ban on the advertising, promotion and sponsorship of tobacco products includes a ban on tobacco product display at the point of sale. BAT Panama SA and other tobacco companies filed suit requesting an order declaring Decree 611 illegal, arguing that it violated the right to property including intellectual property and consumers’ right to access information. The Administrative Chamber of the Supreme Court of Panama upheld the decree finding that there was no violation of trademark rights as trademark registration and use still were allowed. The court also found that consumers’ right to access information was assured through the use of the textual listing of products and their prices and through health warnings on packages. Notably, the court used FCTC guidelines to interpret FCTC obligations with regard to tobacco advertisement, promotion and sponsorship.
BAT v. UK Department of Health [United Kingdom] [May 19, 2016]
The judgment dismissed all grounds of challenge against the UK's standardised (or "plain") packaging regulations. The judgment has significant wider implications because Mr Justice Green carefully considered all the evidence as part of the proportionality analysis, which will be similar to the justification analysis for plain packaging in most other jurisdictions. He was highly critical of the evidence put forward by the tobacco industry and provided a damning critique of individual studies and experts as well as making wider criticisms of the tobacco companies including that they failed to disclose any internal documents about their research or consideration of the impact of plain packaging on their business or smoking rates. He also linked his conclusions to the 2006 judgment of Judge Kessler in USA v Philip Morris Inc et al when she found, upon the basis of comprehensive evidence which included internal documents, that the tobacco companies were well aware of the strong causal nexus between advertising and consumer reaction.
The judge's conclusions on whether plain packaging amounts to an expropriation of the tobacco trade marks; on their claim for compensation; on the relevance of the FCTC and its guidelines; and on the compatibility with the WTO TRIPS agreement all have wider international relevance.
A summary of the key findings that have wider application is in the additional documents.
The McCabe Centre has produced an analysis of the key points for other jurisdictions which can be found here: http://www.mccabecentre.org/downloads/McCabe_Centre_-_Key_Points_on_UK_plain_packaging.pdf
Karnataka Beedi Industry Association v. Union of India [India] [May 04, 2016]
Using the powers conferred by India’s omnibus tobacco control law, the government introduced new graphic health warnings in October 2014 that, among other things, increased the graphic health warning size from 40 percent of one side to 85 percent of both sides of tobacco product packaging and amended the rotation scheme of the warnings. The Karnataka Beedi Industry Association, the Tobacco Institute of India, and other pro-tobacco entities challenged the validity of the 2014 pack warning rules in five cases in the Karnataka High Court – Bengaluru, and the court initially stayed the implementation of the warnings via interim orders. Following a petition by tobacco control advocates, the court lifted the stays, and a division bench of the court affirmed the decision on appeal. The association and others challenged this ruling in the Supreme Court. Paving the way for immediate implementation of the warnings, the Supreme Court, on May 4, 2016, directed that the matter be decided within six weeks in the Karnataka High Court by a bench constituted by the Karnataka Chief Justice and that any stays of the warnings in other high courts not be given effect until the conclusion of the matter. The Supreme Court identified pending pack warning challenges in courts throughout India (more than 27 in number) and transferred these cases to Karnataka.
Republic of Poland v. European Parliament & Council of the European Union [European Union] [May 04, 2016]
Poland challenged the provisions of a European Union (EU) Tobacco Products Directive (TPD) that prohibit the sale of menthol and other flavored cigarettes by member states as of May 2020. The Court of Justice of the European Union (CJEU) dismissed the claim, finding that it was appropriate for the EU to adopt a directive in order to prevent barriers to the trade of such products if different member states have different laws. The court noted that the TPD is also designed to protect public health. The Court rejected Poland’s argument that the EU should have adopted less restrictive measures, such as an age-related restriction on the use of menthol products, or that the regulation of such products should have been left to individual member states to regulate, as such alternative measures did not appear to be equally suitable for achieving the objective pursued. The Court also rejected the argument that the measure breached the principle of subsidiarity (which requires that the EU should not regulate on matters that are within the competence of individual Member States).
R (on the Application of) Philip Morris Brands SARL et al. v. Secretary of State for Health [European Union] [May 04, 2016]
A challenge to the validity of the European Union’s (EU) Tobacco Products Directive (TPD) 2014 brought by Philip Morris and British American Tobacco was dismissed on all grounds by the Court of Justice of the European Union (CJEU). The amended TPD was adopted in April 2014 and provides a wide range of requirements relating to emissions, reporting, 65% pictorial health warnings, packaging and labeling, a ban on characterising flavors and other additives, and regulates e-cigarettes. Article 24(4) permits member states to adopt further requirements to standardise packaging. The TPD applies to all countries within the EU.
In this case, Philip Morris and BAT brought a judicial review against the United Kingdom based on the government’s intention to implement the TPD requirements in UK legislation. The tobacco companies claimed that parts of the TPD and the Directive as a whole, were invalid because it was incompatible with the EU Treaties; was not proportionate or supported by evidence; was not sufficiently harmonising in nature; and contravened the principle of subsidiarity. The UK court hearing the case referred questions on the interpretation of EU law to the CJEU. The CJEU upheld all aspects of the TPD, including provisions to require pictorial warning labels, to prohibit menthol cigarettes, and to allow countries to prohibit cross-border sales and to adopt additional packaging restrictions, such as plain packaging. The court noted that the EU may act to prevent obstacles to the trade of tobacco products while also ensuring a high level of public health protection. The court found that the packaging and labeling requirements were proportionate and did not go beyond what were necessary and appropriate.
In addition the court highlighted the importance of the FCTC as a tool for interpretation and stated that it could have a 'decisive influence' on the interpretation of both EU law and Member States' tobacco control legislation.
EU Member States are obliged, under the TPD, to implement most provisions of the TPD into domestic law by May 20, 2016 (although a number of states have been late in their implementation).
Pillbox 38 (UK) Ltd. v. Secretary of State for Health [European Union] [May 04, 2016]
A challenge to the validity of the e-cigarette regulations in the European Union’s (EU) Tobacco Products Directive (TPD) 2014 was dismissed on all grounds by the Court of Justice of the European Union (CJEU). Pillbox 38 (UK) Ltd. (trading under the name "Totally Wicked"), an e-cigarette manufacturer, brought a judicial review against the UK government challenging its intention to implement the TPD into domestic law on the basis that it claimed the TPD was not valid. The TPD Article 20 sets out requirements for e-cigarettes for all EU Member States. The UK court hearing the case asked the CJEU for a reasoned opinion on the validity of Article 20.
The CJEU found the TPD to be valid and upheld all of the e-cigarette requirements, including health warnings; a ban on most e-cigarette advertising; a limit on nicotine levels and amounts and e-liquid container sizes; a requirement to notify the government before introducing a new product; and the requirement to include a leaflet with the product containing information such as a list of ingredients. Firstly, because the purpose of the Directive is to harmonise regulations across the EU, the court found that there were significant divergences between the regulations in different Member States which justified the EU regulating the market. The court found that it was permissible to regulate e-cigarettes differently than other tobacco products in part because e-cigarettes are novel products and there is insufficient information on their health effects. The identified and potential risks linked to the use of e-cigarettes means the EU may act according to the precautionary principle.