Argument: Ultra Vires Regulation

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Dep't of Health v. Philippine Tobacco Institute [Philippines] [July 13, 2021]

In 2011, the Philippine Tobacco Institute (PTI) sued for declaratory relief, seeking to set aside the "Implementing Rules and Regulations of the Republic Act No. 9711" (otherwise known as the "Food and Drug Administration Act of 2009" or "IRR").  PTI sought to prohibit the Department of Health and the Food and Drug Administration of the Philippines from implementing the IRR "insofar as it relates to the regulation of Tobacco Products." The Court held the law constitutional and explained that the PTI "failed to establish an existing right that was violated" and that any "alleged damage or injury the subject IRR would cause is merely speculative and prospective in nature." 

On January 27, 2012, the Regional Trial Court ruled on the merits and granted PTI's petition, voiding the IRR insofar as it regulated tobacco products and the tobacco industry.  PTI argued that they should be principally regulated by the Inter-Agency Committee on Tobacco as provided for by the Tobacco Regulation Act of 2003 (IAC-Tobacco) and the court agreed that it was improper for the DOH or FDA to regulate tobacco products outside of IAC-Tobacco.

On March 29, 2012, the DOH and FDA filed a Petition for Review to the Supreme Court. On July 13, 2021, the Supreme Court granted the Petition, reversing and setting aside the 2012 decision which nullified certain provisions of the IRR insofar as it regulated tobacco products and the tobacco industry. The Supreme Court held that (1) Section 25 of the IRR does not exclude the regulation of the health aspects of tobacco products from the FDA's authority and (2) tobacco products are "health products" under the definition provided under Section 10(ff) of Republic Act No. 3720, as amended by Section 9 of the IRR. The Supreme Court stated that principal regulation by IAC-Tobacco would be contrary to law and the international obligations of the Philippines. The Supreme Court held the given IRR, the Constitution, and the WHO Framework Convention on Tobacco Control, petitioners have technical authority of matters of public health and therefore, regulation of the health aspects of tobacco products fall under the FDA's authority.

Confederação Nacional do Turismo et. Confederacao Nacional do Comercio de Bens, Servicos e Turismo v. Paraná [Brazil] [August 24, 2020]

The National Confederation of Tourism, together with the National Confederation of Commerce of Goods, Services, and Tourism, filed a lawsuit against the Paraná (state-level) tobacco control law, which prohibits smoking in public or private collective environments in the state of Paraná. The Court unanimously held that state legislative assembly did not exceed its competence to legislate public health. The Court concluded that the state law did not offend fundamental freedoms since it did not prohibit the exercise of the individual's right to consume tobacco products. Furthermore, the Court affirmed that the restriction of using tobacco products in collective enclosed environments respected the rights of non-smokers and the adequate protection of health.

Confederacao Nacional do Comercio de Bens, Servicos e Turismo v. Paraná [Brazil] [August 24, 2020]

The National Confederation of Commerce of Goods, Services, and Tourism filed a lawsuit against the Paraná (state-level) tobacco control law, which prohibits smoking in public or private collective environments in the state of Paraná. The Court unanimously held that the state legislative assembly did not exceed its competence to legislate public health. The Court also concluded that the state law did not offend fundamental freedoms since it did not prohibit the exercise of the individual's right to consume tobacco products. Furthermore, the Court affirmed that the restriction of using tobacco products in collective enclosed environments respected the rights of non-smokers and the adequate protection of health.

Confederacao Nacional do Comercio de Bens, Servicos e Turismo v. Rio de Janeiro [Brazil] [December 20, 2019]

The National Confederation of Commerce of Goods, Services, and Tourism filed a lawsuit against Rio de Janeiro's tobacco control law on smoke-free environments, which banned smoking in public or private collective environments. The Court unanimously held that the state legislative assembly did not exceed its competence to legislate public health. The Court noted that local regulations could be more restrictive than the federal regulation. Further, the judges established that (i) freedom of commerce must be interpreted together with the principle of consumer protection and (ii) restrictions on products that are potentially dangerous are legitimate.

Confederação Nacional do Turismo v. São Paulo [Brazil] [December 03, 2019]

The National Confederation of Tourism filed a lawsuit against a São Paulo (state-level) tobacco control law regulating smoke-free places. The judge considered that the action was impaired because, after the claim was filed, a federal law was enacted which regulated smoke-free places in a more comprehensive manner. The newly enacted federal law banned smoking lounges, which the challenged state law had already done.

British American Tobacco Kenya, PLC v. Ministry of Health [Kenya] [November 26, 2019]

British American Tobacco Kenya filed a petition to the Kenya Supreme Court appealing a 2017 Court of Appeal decision upholding nearly all elements of Kenya’s Tobacco Control Regulations. The Supreme Court ruled that the tobacco company’s appeal had no merit, dismissed the petition in its entirety and affirmed the decision of the lower court.

Both lower courts 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;
- picture health warnings;
- ingredient disclosure;
- smoke-free environments in streets, walkways, 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.

Philippine Tobacco Institute v. City of Balanga, et al. [Philippines] [July 22, 2019]

The Philippine Tobacco Institute (PTI), whose members include Philip Morris Philippines Manufacturing, Inc. and JTI Philippines, Inc., challenged a City of Balanga ordinance making the City's 80-hectare University Town and its three kilometer radius "tobacco free," meaning the sale, use and marketing of tobacco products and e-cigarettes are banned. In July 2018, the Regional Trial Court declared the ordinance unconstitutional and invalid. The City appealed the decision to the Court of Appeals, which upheld the lower court's decision. The Court of Appeals concluded that the ordinance was invalid because it went beyond the provisions of Republic Act No. 9211, a federal law. (The federal law prohibits smoking in specified places and the sale of tobacco products within 100 meters of schools, playgrounds, and other facilities frequented by minors. The City ordinance, on the other hand, prohibits selling, distributing, using, advertising, and promoting tobacco products within University Town and within a three-kilometer radius.) The City's Motion for Reconsideration was also denied.

Philippine Tobacco Institute v. City of Balanga et al. [Philippines] [May 21, 2019]

The Philippine Tobacco Institute ("PTI"), whose members include JTI and PMI, challenged a City of Balanga ordinance creating a tobacco-free generation, which prohibits the sale of tobacco products and e-cigarettes to any person born on or after January 1, 2000. The Regional Trial Court ruled in favor of PTI in July 2018, concluding that "any ordinance prohibiting PTI from selling to any person regardless of age is an unreasonable and oppressive interference of business." The court reasoned that the ordinance now covers individuals who have reached the age of majority and is not limited to minors. In addition, the court held that the ordinance violates substantive due process of those exercising parental authority since the ordinance attempted to extend criminal liability to parents.

The City’s appeal to the Court of Appeals was denied, as was a motion for reconsideration.

B.A.T. v. State - Executive Branch [Uruguay] [September 18, 2018]

British American Tobacco (BAT) challenged an executive decree requiring plain packaging of tobacco products. While an administrative tribunal (Tribunal de lo Contencioso Administrativo) is considering the initial challenge, BAT also filed a rapid constitutional challenge, called an “amparo,” requesting suspension of the decree until the administrative challenge is decided (which may take up to one year). With regard to the amparo, the court decided in favor of BAT because the plain packaging policy was approved through a decree instead of a law passed by Congress. The decision does not address the merits as to whether the policy is constitutional, only that the President did not have the power to enact the policy by way of executive order.

Note: The government appealed this decision, and the Court of Appeals ruled in favor of the government. The Court of Appeals found that the amparo was not the proper mechanism for the challenge, because there is a pending administrative claim. That decision was final and the case cannot be appealed by BAT.

Godfrey Phillips India Limited vs. Union of India [India] [August 31, 2018]

ITC and Godfrey Phillips India filed petitions in the Karnataka High Court challenging new 85% health warnings (dated April 3, 2018) that prescribed new images along with a quit line number. The tobacco companies asserted that the Government was not free to amend the Rules as the legality of related Rules (establishing 85% pack warnings) currently is pending in the Supreme Court. The Government maintains that the legality of the April 3rd pack warnings also was challenged in the Supreme Court, where the court refused to stay implementation, choosing instead to condense this matter with the review of the related 85% pack warnings. The Karnataka court refused to stay the April 3rd warnings, noting that using these new images would not constitute hardship to the tobacco companies as already 85% pack warnings are placed on packs.