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Type of Litigation: Challenge to Government Policies Relating to Tobacco Control/Public Health

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Search Results Results 1-10 of 310

B.A.T. v. Executive Branch [Uruguay] [October 11, 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 Administrative First Instance Court decided in favor of BAT because the plain packaging policy was approved through a decree instead of a law passed by Congress.

Here, the government appealed the decision by the Administrative First Instance Court, 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. This decision was final, and BAT cannot appeal the decision. 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.

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.

Australia - Tobacco Plain Packaging [Australia] [June 28, 2018]

In 2012 and 2013, Honduras, Indonesia, Cuba and Dominican Republic brought complaints in the World Trade Organization (WTO) claiming that Australia's tobacco plain packaging laws breached the WTO agreements. The complaining countries argued that Australia’s law breached the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) by failing to provide required protections to trademarks rights and because it is an unjustifiable encumbrance on the use of tobacco trademarks; and the Agreement on Technical Barriers to Trade (TBT Agreement) because it is more trade-restrictive than necessary to fulfill a legitimate objective.

This long anticipated ruling by the WTO rejected all grounds of complaint against Australia's plain packaging laws in a 900 page ruling. The panel's authoritative ruling should be powerful in persauding governments to move forward with tobacco plain packaging and can be used to resist many of the flawed arguments the tobacco industry puts forward to oppose the policy. The WTO considered extensive evidence from Australia and the complaining countries and found the evidence demonstrates tobacco plain packaging works to reduce tobacco use. The panel re-affirmed that states have the right to regulate for public health under WTO law and the policy does not interfere with international trademark rights. The panel made strong findings of fact which undermine many of the other arguments that the tobacco industry tries to use to oppose plain packaging laws. These are detailed in the briefing document that can be downloaded under the 'additional documents' tag. 

New Zealand MOH v. PMI [New Zealand] [March 12, 2018]

The Ministry of Health ("MOH") charged Phillip Morris Ltd. with selling tobacco product called “Heets,” a heated tobacco product, in violation of Sec. 29(2) of the Smoke-free Environment Act 1990 (‘the Act’). The Act prohibits the sale of tobacco "labelled, or otherwise described as suitable for chewing, or for any other oral use (other than smoking)." The Court held that the Act was originally intended to control the sales of chewing tobacco and other tobacco products consumed orally, and therefore "Heets" did not fall within Sec. 29(2).

National Confederation of Industry (Confederação Nacional da Indústria) v. ANVISA [Brazil] [February 01, 2018]

In 2012, Brazil banned tobacco additives and flavors. The National Confederation of Industry (Confederação Nacional da Indústria) challenged the ban. The Supreme Federal Tribunal, Brazil’s highest court, upheld the 2012 regulation and affirmed the Brazilian Health Regulatory Agency’s (ANVISA) right to regulate tobacco products. The court held that freedom of enterprise does not prevent Brazil from imposing conditions and limitations on private activities. The court found that while businesses have rights, they must be compatible with other fundamental and constitutional rights. In the case of tobacco control, these fundamental and constitutional rights include the right to health and the right to information. The court further held that the risks associated with tobacco consumption justify the tobacco market being subjected to intense health regulations.

Because the court failed to reach a majority (5-5 tie), the decision is not binding on other tribunals, and, by not reaching a majority, the court rejected the constitutionality claim against the ANVISA regulation (“Resolução da Diretoria Colegiada da ANVISA 14/2012”). Although the decision is not binding because of a lack of quorum, it is unlikely that subsequent challenges to the regulation would be decided differently.

Health for Millions Trust v. Union of India [India] [January 08, 2018]

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.  After months of hearings, a two judge bench of the Karnataka High Court struck down the 2014 rules, and the Government and public health groups appealed the matter to the Supreme Court. The Supreme Court stayed implementation of the Karnataka High Court order and set final disposal of the matter for March 12, 2018. The Court stated: "[W]e are inclined to think that health of a citizen has primacy and he or she should be aware of that which can affect or deteriorate the condition of health. We may hasten to add that deterioration may be a milder word and, therefore, in all possibility the expression ‘destruction of health’ is apposite." India’s 85% graphic health warning rules accordingly remain in effect for now.

Ghumman v. National Health Services, Regulation and Coordination [Pakistan] [December 18, 2017]

Public health organization, Pakistan National Heart Association, through its General Secretary, Sana Ullah Ghumman, filed a complaint in the office of the Federal Ombudsman alleging that the Federal Board of Revenue (FBR) and the Ministry of Health made inappropriate tax decisions which resulted in a reduction in price for certain tobacco products.  The Ombudsman ruled that the government's departure from established practice amounted to maladministration under Article 2(1)(a) of President Order No. 1 of 1983. The Ombudsman directed the government to either mandatorily comply with Articles 6 and 15 of the FCTC, or intimate reasons for non-compliance under Article 11(2) of the President Order No. 1 of 1983, both within thirty days.  The FBR appealed to the President's Secretariat. The Secretariat set aside the Federal Ombudsman's decision, finding that the Ombudsman did not possess jurisdiction to hear the matter as taxation strategy cannot be reviewed for maladministration and a tax bill passed by Parliament is not an act of an agency as required by the President's Order establishing Federal Ombudsman jurisdiction. The Secretariat further held that compliance with treaty obligations is a government policy issue and cannot be reviewed by judicial or quasi-judicial bodies like the Federal Ombudsman.

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.

Ghumman v. National Health Services, Regulation and Coordination [Pakistan] [September 23, 2017]

Public health organization, Pakistan National Heart Association, through its General Secretary, Sana Ullah Ghumman, filed a complaint in the office of the Federal Ombudsman alleging that the Federal Board of Revenue and the Ministry of Health made inappropriate tax decisions which resulted in a reduction in price for certain tobacco products.  The Ombudsman ruled that the government's departure from established practice amounted to maladministration under Article 2(1)(a) of President Order No. 1 of 1983. The Ombudsman directed the government to either mandatorily comply with Articles 6 and 15 of the FCTC, or intimate reasons for non-compliance under Article 11(2) of the President Order No. 1 of 1983, both within thirty days.

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.