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This dissertation investigates the rising authority of non-state actors vis-à-vis the state by examining how tobacco companies are using trade agreements to constrain governments from implementing progressive public health policies that require placing pictorial health warning labels (HWLs) on cigarette packages. In particular, the dissertation seeks to address two different but related puzzles. First, despite being developed countries and global health leaders, it is unclear why Australia has implemented strong HWLs on cigarette packages while New Zealand has delayed its HWL proposal. Second, it is unknown why Uruguay, a developing country, has implemented strong HWLs while New Zealand, a developed country, has delayed its proposal. Informed by archival research of previously secret tobacco industry documents, interviews conducted with policymakers and health advocates closely involved in the policymaking process, and applying a most-similar and most-different systems design, this research demonstrates that tobacco industry trade threats are causing a chilling effect by delaying strong HWLs in New Zealand, but not in Australia and Uruguay and that the key factor in determining the implementation of strong HWLs lies in the governments' reception to these trade threats. The findings suggest that leftist governments, continued bureaucratic leadership and capacity in the Health Ministry, and independent and confident tobacco control and trade advocacy are necessary conditions in explaining how governments can shape the reception of tobacco industry trade threats and properly implement progressive HWL policies without being weakened or delayed. Given the limitations of using existing trade agreements to globally preempt strong HWLs in Australia and Uruguay, this analysis also examines the evolving nature of global trade and health governance to demonstrate how tobacco companies are aggressively attempting to shape the pending Trans-Pacific Partnership Agreement (TPP) to further distance decision-making authority away from governments. These efforts have succeeded in securing trade mechanisms, including trade promotion authority, aimed at eliminating the policy space for health advocates to lobby for public health exemptions in trade agreements, but have failed to secure the investor-state dispute settlement (ISDS) mechanism in the TPP to directly challenge tobacco control policies in TPP member states. The results of this research will assist governments to properly implement strong HWLs without being weakened or delayed, which will dramatically help reduce smoking initiation and cessation rates, lower government health expenditures and tobacco industry profits, and help accelerate the global diffusion of strong HWLs. These results also have important implications for future regulations of alcohol, food, and medicine, which are increasingly being targeted through trade agreements.

Following publication of the original article [1], the authors flagged an error concerning two missing article references, which were unfortunately not provided prior to publication of the article.

Preemption-when a higher level of government limits the authority of a lower level to enact new policies-has been devastating to tobacco control. We developed a preemption framework based on this experience for anticipating and responding to the possibility of preemption in other public health areas. We analyzed peer-reviewed literature, reports, and government documents pertaining to tobacco control preemption. We triangulated data and thematically analyzed them.Since the 1980s, tobacco companies have attempted to secure state preemption through front groups, lobbying key policymakers, inserting preemption into other legislation, and issuing legal threats and challenges. The tobacco control community responded by creating awareness of preemption through media advocacy, educating policymakers, mobilizing national collaborations, and expanding networks with the legal community. Ten of the 25 state smoke-free preemption laws have been fully repealed. Repeal, however, took an average of 11 years.State preemption has been detrimental to tobacco control by dividing the health community, weakening local authority, chilling public education and debate, and slowing local policy diffusion. Health scholars, advocates, and policymakers should use the framework to anticipate and prevent industry use of preemption in other public health areas.

Preemption—when a higher level of government limits the authority of a lower level to enact new policies—has been devastating to tobacco control. We developed a preemption framework based on this experience for anticipating and responding to the possibility of preemption in other public health areas. We analyzed peer-reviewed literature, reports, and government documents pertaining to tobacco control preemption. We triangulated data and thematically analyzed them. Since the 1980s, tobacco companies have attempted to secure state preemption through front groups, lobbying key policymakers, inserting preemption into other legislation, and issuing legal threats and challenges. The tobacco control community responded by creating awareness of preemption through media advocacy, educating policymakers, mobilizing national collaborations, and expanding networks with the legal community. Ten of the 25 state smoke-free preemption laws have been fully repealed. Repeal, however, took an average of 11 years. State preemption has been detrimental to tobacco control by dividing the health community, weakening local authority, chilling public education and debate, and slowing local policy diffusion. Health scholars, advocates, and policymakers should use the framework to anticipate and prevent industry use of preemption in other public health areas.

AIMS: To describe the process of enacting tobacco standardised packaging (SP) amidst tobacco industry legal threats in New Zealand. METHODS: Relevant government and NGO documents, and media items were reviewed. Policymakers and health advocates in New Zealand were interviewed. The data were triangulated and thematically analysed. RESULTS: In 2011, the New Zealand Government announced the goal of becoming a smokefree country (reducing smoking prevalence to 5%) by the year 2025, and considered adopting SP. In April 2012, the Government announced it would introduce SP, but tobacco companies threatened the Government with litigation in international courts for violating investment and intellectual property rights. In response, the Government adopted a 'wait and see' approach, waiting until two legal challenges against Australia's SP law were resolved before it enacted its legislation in September 2016. Health advocates, limited due to funding constraints, attempted to alter the Government's approach to the legal threats without success. Interviews with policymakers and health advocates confirmed these threats helped produce a regulatory chill, delaying the policymaking process by three years. CONCLUSION: The New Zealand case illustrates how the threat of a potential international lawsuit can create a chilling effect by helping delay the implementation of public health policies.

In October 2019, the Mexican government reformed its General Health Law thus establishing the warning approach to front-of-pack nutrition labeling (FOPNL), and in March 2020, modified its national standard, revamping its ineffective FOPNL, one preemptively developed by industry actors. Implementation is scheduled for later in 2020. However, the new regulation faces fierce opposition from transnational food and beverage companies (TFBCs), including Nestlé, Kellogg, Grupo Bimbo, Coca-Cola, PepsiCo through their trade associations, the National Manufacturers, American Bakers Associations, the Confederation of Industrial Chambers of Mexico and ConMéxico. Mexico, as a regional leader, could tip momentum in favor of FOPNL diffusion across Latin America. But the fate of the Mexican FOPNL and the region currently lies in this government's response to three threats of legal challenges by TFBCs, citing international laws and guidelines including the World Trade Organization (WTO), Codex Alimentarius, and the North American Free Trade Agreement (NAFTA)/US-Mexico-Canada Agreement (USMCA). In this perspective, we argue that these threats should not prevent Mexico or other countries from implementing evidence-informed policies, such as FOPNLs, that pursue legitimate public health objectives.

In October 2019, the Mexican government reformed its General Health Law thus establishing the warning approach to front-of-pack nutrition labeling (FOPNL), and in March 2020, modified its national standard, revamping its ineffective FOPNL, one preemptively developed by industry actors. Implementation is scheduled for later in 2020. However, the new regulation faces fierce opposition from transnational food and beverage companies (TFBCs), including Nestlé, Kellogg, Grupo Bimbo, Coca-Cola, PepsiCo through their trade associations, the National Manufacturers, American Bakers Associations, the Confederation of Industrial Chambers of Mexico and ConMéxico. Mexico, as a regional leader, could tip momentum in favor of FOPNL diffusion across Latin America. But the fate of the Mexican FOPNL and the region currently lies in this government's response to three threats of legal challenges by TFBCs, citing international laws and guidelines including the World Trade Organization (WTO), Codex Alimentarius, and the North American Free Trade Agreement (NAFTA)/US-Mexico-Canada Agreement (USMCA). In this perspective, we argue that these threats should not prevent Mexico or other countries from implementing evidence-informed policies, such as FOPNLs, that pursue legitimate public health objectives.

OBJECTIVE: Analyse the transnational tobacco companies' (TTCs) memoranda of understanding (MoUs) on illicit trade and how they could undermine the WHO Framework Convention on Tobacco Control (FCTC) and the Protocol to Eliminate Illicit Trade in Tobacco Products (Protocol). METHODS: Review of tobacco industry documents and websites, reports, news and media items using standard snowball search methods. RESULTS: Facing increasing pressure from governments and the FCTC to address illicit tobacco trade during the late 1990s, TTCs entered into voluntary partnerships embodied in MoUs with governments' law enforcement and customs agencies. One of the earliest known MoUs was between Philip Morris International and Italy in 1999. TTCs agreed among themselves to establish MoUs individually but use the Italian MoU as a basis to establish similar connections with other governments to pre-empt more stringent regulation of illicit trade. TTCs report to have signed over 100 MoUs since 1999, and promote them on their websites, in Corporate Social Responsibility reports and in the media as important partnerships to combat illicit tobacco trade. There is no evidence to support TTCs' claims that these MoUs reduce illicit trade. The terms of these MoUs are rarely made public. MoUs are non-transparent partnerships between government agencies and TTCs, violating FCTC Article 5.3 and the Protocol. MoUs are not legally binding sodo not create an accountability system or penalties for non-compliance, rendering them ineffective at controlling illicit trade. CONCLUSION: Governments should reject TTC partnerships through MoUs and instead ratify and implement the FCTC and the Protocol to effectively address illicit trade in tobacco products.

Objective. To analyze successful national smokefree policy implementation in Colombia, a middle income country. Materials and methods. Key informants at the national and local levels were interviewed and news sources and government ministry resolutions were reviewed. Results.Colombia's Ministry of Health coordinated local implementation practices, which were strongest in larger cities with supportive leadership. Nongovernmental organizations provided technical assistance and highlighted noncompliance. Organizations outside Colombia funded some of these efforts. The bar owners' association provided concerted education campaigns. Tobacco interests did not openly challenge implementation. Conclusions. Health organization monitoring, external funding, and hospitality industry support contributed to effective implementation, and could be cultivated in other low and middle income countries.

OBJECTIVE: Describe the process of enacting and defending strong tobacco packaging and labelling regulations in Uruguay amid Philip Morris International's (PMI) legal threats and challenges. METHODS: Triangulated government legislation, news sources and interviews with policy-makers and health advocates in Uruguay. RESULTS: In 2008 and 2009, the Uruguayan government enacted at the time the world's largest pictorial health warning labels (80% of front and back of package) and prohibited different packaging or presentations for cigarettes sold under a given brand. PMI threatened to sue Uruguay in international courts if these policies were implemented. The Vazquez administration maintained the regulations, but a week prior to President Vazquez's successor, President Mujica, took office on 1 March 2010 PMI announced its intention to file an investment arbitration dispute against Uruguay in the International Centre for the Settlement of Investment Disputes. Initially, the Mujica administration announced it would weaken the regulations to avoid litigation. In response, local public health groups in Uruguay enlisted former President Vazquez and international health groups and served as brokers to develop a collaboration with the Mujica administration to defend the regulations. This united front between the Uruguayan government and the transnational tobacco control network paid off when Uruguay defeated PMI's investment dispute in July 2016. CONCLUSION: To replicate Uruguay's success, other countries need to recognise that strong political support, an actively engaged local civil society and financial and technical support are important factors in overcoming tobacco industry's legal threats to defend strong public health regulations.

The objective of this paper is to examine the implementation of Colombia's tobacco control law. Methods involved are triangulated government legislation, news sources, and interviews with policy-makers and health advocates in Colombia. Colombia, a middle-income country, passed a tobacco control law in 2009 that included a prohibition on tobacco advertising, promotion, and sponsorship; and required pictorial health warning labels, ingredients disclosure, and a prohibition on individual cigarette sales. Tobacco companies challenged the implementation through litigation, tested government enforcement of advertising provisions and regulations on ingredients disclosure, and lobbied local governments to deprioritise policy responses to single cigarette sales. A transnational network including international health groups and funders helped strengthen domestic capacity to implement the law by; promoting public awareness of Ley [Law] 1335; training local health department staff on enforcement; facilitating health agencies' sharing of educational strategies; and providing legal defence assistance. This network included vigilant efforts by local health groups, which continuously monitored and alerted the media to noncompliance, engaged government officials and policy-makers on implementation, and raised public awareness. Support from international health NGOs and funders and continuous engagement by local health groups enhanced implementation capacities to counter continued tobacco industry interference and ensure effective tobacco control implementation.

Objective. To analyze the passage of Costa Rica's 2012 tobacco control law. Materials and methods. Review of legislation, newspaper articles, and key informant interviews. Results. Tobacco control advocates, in close collaboration with international health groups, recruited national, regional and international experts to testify in the Legislative Assembly, implemented grassroots advocacy campaigns, and generated media coverage to enact strong legislation in March 2012 consistent with the World Health Organization Framework Convention on Tobacco Control, despite tobacco industry lobbying efforts that for decades blocked effective tobacco control legislation. Conclusion. Costa Rica's experience illustrates how with resources, good strategic planning, ag- gressive tactics and perseverance tobacco control advocates can overcome tobacco industry opposition in the Legislative Assembly and Executive Branch. This determined approach has positioned Costa Rica to become a regional leader in tobacco control. ; Objective. To analyze the passage of Costa Rica's 2012 tobacco control law. Materials and methods. Review of legislation, newspaper articles, and key informant interviews. Results. Tobacco control advocates, in close collaboration with international health groups, recruited national, regional and international experts to testify in the Legislative Assembly, implemented grassroots advocacy campaigns, and generated media coverage to enact strong legislation in March 2012 consistent with the World Health Organization Framework Convention on Tobacco Control, despite tobacco industry lobbying efforts that for decades blocked effective tobacco control legislation. Conclusion. Costa Rica's experience illustrates how with resources, good strategic planning, aggressive tactics and perseverance tobacco control advocates can overcome tobacco industry opposition in the Legislative Assembly and Executive Branch. This determined approach has positioned Costa Rica to become a regional leader in tobacco control. DOI: ...

Objective. To analyze the passage of Costa Rica's 2012 tobacco control law. Materials and methods. Review of legislation, newspaper articles, and key informant interviews. Results. Tobacco control advocates, in close collaboration with international health groups, recruited national, regional and international experts to testify in the Legislative Assembly, implemented grassroots advocacy campaigns, and generated media coverage to enact strong legislation in March 2012 consistent with the World Health Organization Framework Convention on Tobacco Control, despite tobacco industry lobbying efforts that for decades blocked effective tobacco control legislation. Conclusion. Costa Rica's experience illustrates how with resources, good strategic planning, aggressive tactics and perseverance tobacco control advocates can overcome tobacco industry opposition in the Legislative Assembly and Executive Branch. This determined approach has positioned Costa Rica to become a regional leader in tobacco control. ; Objetivo. Analizar la adopción de la ley de control del tabaco de 2012 en Costa Rica. Material y métodos. Revisión de la legislación, artículos de periódicos y entrevistas con informantes clave. Resultados. Los defensores del control del tabaco, en estrecha colaboración con grupos internacionales de salud pública y expertos nacionales, regionales e internacionales, reclutados para testificar en la Asamblea Legislativa, implementaron campañas de comunicación e incidencia política que resultaron en la aprobación en marzo de 2012 de una legislación fuerte y en consonancia con el Convenio Marco para el Control del Tabaco de la Organización Mundial de la Salud. Todo esto a pesar de los esfuerzos de la industria tabacalera que, por décadas, había logrado bloquear la aprobación de una legislación eficaz de control del tabaco en Costa Rica. Conclusión. La experiencia de Costa Rica ilustra cómo con recursos, una buena planificación estratégica, tácticas agresivas y perseverancia, los defensores del control del tabaco pudieron ...

Objetivo. Analizar cómo la industria tabacalera influyó en la formulación de las políticas de control del tabaco en Costa Rica. Materiales y métodos. Revision de documentos de la industria tabacalera, de la legislación costarricense de control del tabaco y de periódicos y entrevistas con informates clave. Resultados. Durante los años ochenta, el Ministerio de Salud aprobó varios decretos para restringir el consumo de tabaco, lo que causó que British American Tobacco y Philip Morris International fortalecieran su presencia politica, cuyo resultado fue la promulgación de una ley débil en 1995 todavia vigente. Desde 1995 la industria tabacalera ha ultizado a Costa Rica como piloto para los programas latinoamericanos y ha dominado la formulación de politicas influenciando al Ministerio de Salud, incluyendo negociaciones privadas con la industria tabacalera en violación de las directrices del Articulo 5.3 del Convenio Marco para el Control de Tabaco (CMCT) de la Organización Mundial de la Salud. Conclusión. La experiencia de Costa Rica demustra la gran importancia que tiene la implementación del Articulo 5.3 del CMCT para proteger las políticas de la salud pública de la interferencia de la industria tabacalera. Objective. To analyze how the tobacco industry influenced tobacco control policymaking in Costa Rica. Materials and Methods. Review of tobacco industry documents, tobacco control legislation, newspaper articles, and interviewing of key informants. Results. During the mid-to-late 1980s, Health Ministry issued several advanced (for their time) smoking restriction decrees causing British American Tobacco (BAT) and Philip Morris International (PMI) to strengthen their political presence there, resulting in passage of a weak 1995 law, which as of August 2011, remained in effect. Since 1995 the industry has used Costa Rica as a pilot site for Latin American programs and has dominated policymaking by influencing the Health Ministry, including direct private negotiations with the tobacco industry which violate Article 5.3's implementing guidelines of the World Health Organization Frameowrk Convention on Tobacco Control (WHO FCTC).Conclusions. The Costa Rica experience demonstrates the importance of vigirous implmentation of FCTC Article 5.3 which insulates public health policymaking from industry interference.

Objective. To analyze how the tobacco industry influenced tobacco control policymaking in Costa Rica. Materials and Methods. Review of tobacco industry documents, tobacco control legislation, newspaper articles, and interviewing of key informants. Results. During the mid-to-late 1980s, Health Ministry issued several advanced (for their time) smoking restriction decrees causing British American Tobacco (BAT) and Philip Morris International (PMI) to strengthen their political presence there, resulting in passage of a weak 1995 law, which, as of August 2011, remained in effect. Since 1995 the industry has used Costa Rica as a pilot site for Latin American programs and has dominated policymaking by influencing the Health Ministry, including direct private negotiations with the tobacco industry which violate Article 5.3's implementing guidelines of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC). Conclusions. The Costa Rica experience demonstrates the importance of vigorous implementation of FCTC Article 5.3 which insulates public health policymaking from industry interference. ; Objetivo. Analizar cómo la industria tabacalera influyó en la formulación de las políticas de control del tabaco en Costa Rica. Materiales y métodos. Revisión de documentos de la industria tabacalera, de la legislación costarricense de control del tabaco y de periódicos y entrevistas con informantes clave. Resultados. Durante los años ochenta, el Ministerio de Salud aprobó varios decretos para restringir el consumo de tabaco, lo que causó que British American Tobacco y Philip Morris International fortalecieran su presencia política, cuyo resultado fue la promulgación de una ley débil en 1995 todavía vigente. Desde 1995 la industria tabacalera ha utilizado a Costa Rica como piloto para los programas latinoamericanos y ha dominado la formulación de políticas influenciando al Ministerio de Salud, incluyendo negociaciones privadas con la industria tabacalera en violación de las directrices del Artículo 5.3 del ...