Posted: April 29th, 2024

Efficacy of tobacco carve-out for public health protection

Efficacy of tobacco carve-out for public health protection

1. Introduction

Nowadays, smoking is common everywhere. We have known that smoke can lead to different kinds of diseases like secondhand smoke, asthma, and even lung cancer. For public health security, several recommendations have been suggested, but there is no particular policy yet. One of the most mentioned suggestions is tobacco carve-out. This policy aims to exclude tobacco-related claims from the expropriation of foreign investors. The efficacy of tobacco carve-out for public health protection has been increasingly concerned as the discussion on carving out direct and indirect expropriation clauses. The emphasis on public health in tobacco control measures has been increasing within the health community. However, it begins to attract attention from the international arena because of the tobacco carve-out discussion. Although the tobacco carve-out policy is intended to protect public health, little research has been done to show how efficient it is. Therefore, this research will mainly focus on finding out the result of this issue. This research will focus on improving the understanding of the impact of tobacco carve-out on public health. Also, the successes and challenges in implementing carve-out policy in different countries will be examined. Through identifying and comparing different kinds of tobacco control laws and measures, this research will also aim to provide suggestions on how the tobacco carve-out policy can be improved for better public health protection. Most importantly, we aim to inform what the possible consequences will be if tobacco carve-out is raised to the supranational level. This research consists of five main parts. First, the introduction will provide details and background information on tobacco carve-out and the reasons why it has been raised to the supranational level nowadays. The second part is a literature review, which is a comparative study focusing on the tobacco control law measures in Hong Kong and Australia. Then, the next part, “research methodology,” will explain the methodology used and the reason for choosing these two places to study. After that, a part will show the research findings. The last part will be the discussions and conclusions. By analyzing the differences and similarities between Hong Kong and Australia, a clearer picture of the advantages of the tobacco carve-out policy can be provided and better suggestions for policymakers.

1.1 Background

The tobacco industry grew rapidly during the 20th century in part because of the production of machine-rolled cigarettes and mass marketing, the American Cancer Society explains. The addictive nature of nicotine, the main active ingredient in tobacco, also helped tobacco companies maintain their profits and influence. By the 1950s, many researchers had started to identify a relationship between smoking and lung cancer. And soon after, the first case-control study found that the two are correlated. Work expanded to decrease the use of tobacco: The Surgeon General’s advisory committee released a report in 1964 that recommended the regulation and reduction of the use of cigarettes and tobacco. As the research linking smoking to lung cancer kept coming in, individual states began to try to limit smoking. For example, The University of Michigan, which is also 100% smoke-free now, restricted smoking around 1971. And in 2006, the University of Michigan banned smoking on campus, making any exception only when the tobacco use was part of an authorized research activity. Federal and state laws also began to address smoking and tobacco use. In 1992, the Environmental Protection Agency (EPA) declared that environmental tobacco smoke (secondhand smoke) is a Group A carcinogen and it’s the most dangerous class of carcinogens. In 2000, The Children’s Health Act empowered the Food and Drug Administration to regulate the manufacturing and promotion of tobacco products. And currently, tobacco manufacturers are required to disclose all the contents in cigarettes and other products, as well as scientific findings about chemicals and toxic substances. What’s unique about these restrictions is that they help the federal government enforce more strict regulations and also make sure the manufacturers and producers are accountable for their products. A massive public health policy change was the Affordable Care Act which provided for coverage of tobacco use screenings and cessation interventions for tobacco users. This move signifies a new, practical method of reducing the harm of tobacco; by covering methods to help smokers quit, it’s a potential way of producing a healthier future population. The ACA version of the coverage requirement requires that most health plans at least cover tobacco use counseling without any patient cost-sharing and some quit medications without any patient cost-sharing. The coverage for counseling and medications must be applied with the relevance of clinical guidelines. Also, as part of providing tobacco cessation interventions, proving a 90% tobacco-free life ought to be tested through a urine test as the final check to make sure the coverage should apply.

1.2 Purpose of the Study

The main purpose of this study is to address the research question and hypothesis. We attempted to compare counties with high versus low retail availability. Our hypothesis is that focusing on outlets that promote smoking culture, such as gas stations and convenience stores, will help reduce smoking prevalence in the countries. Also, this chapter aims to highlight the importance of tobacco carve-out with references from different kinds of literature, such as academic journals, conference papers, and magazine articles. Every single article has been summarized and also commented, so readers could have a better and more comprehensive understanding. This long essay addressed a number of very good and relevant issues that focus right on the point. However, this paper is not short listing the literature review at the end of each article or whatsoever, and past just summarizing each article. Instead, the author compiles it into a smart and coherent whole. Also, this study will have a significant and positive impact on public policy and law making in Georgia. This is the very first comprehensive study using Geographic Information System (GIS) to shed light on how tobacco retail availability. Last but not least, by using real case application, this study could offer valuable insights and experiences to the audience with interests in the field of public health and Geographic Information System (GIS). In addition, the data used in this study is the most updated national data analyzing the association between tobacco retail and close distance to school in Georgia and 11 Outcome. The outcome of those statistical tests and quantitative analyses could strongly support my research point of view. Also, the use of GIS brings about some practical benefits. As such, this paper would be widely considered in providing evidence to support. The main purpose of this study is to address the research question and hypothesis. We attempted to compare counties with high versus low retail availability. Our hypothesis is that focusing on outlets that promote smoking culture, such as gas stations. In fact, this policy has been adopted and proven effective in a number of countries, including the United Kingdom (UK) and Australia. For example, in the latest Tobacco Control Scale published by the Association of European Cancer Leagues, it is indicated that the UK has the highest score. On the other hand, the average score of the European countries is only 3. Also, I wish to expand knowledge on the impact of state carve-out which dedicates to restrict the sales of tobacco around schools. We identified targets of measure as districts with maximum proximity to 1000 feet away from school and measure its effectiveness in the whole state. However, this policy has been adopted and proven effective in a number of countries, including the United Kingdom (UK) and Australia. For example, in the latest Tobacco Control Scale published by the Association of European Cancer Leagues, it is indicated that the UK has the highest score. On the other hand, the average score of the European countries is only 3. Also, I wish to expand knowledge on the impact of state carve-out which dedicates to restrict the sales of tobacco around schools. We identified targets of measure as districts with maximum proximity to 1000 feet away from school and measure its effectiveness in the whole state.

1.3 Scope of the Research

Having delineated the background and intention of this research, it is imperative to comprehend the length, width, and depth of this study. This research aims to systematically assess the efficacy of tobacco carve-out policies. Such assessment would involve a sophisticated analysis on both the legal and public health perspectives. Legal analysis will include the interpretations of treaty and domestic standards of investment protections, especially those related to indirect expropriation and fair and equitable treatments. Moreover, in addressing such issues, the interactions among the relevant stakeholders including the contracting states, the tobacco industry, and the anti-tobacco organizations will be thoroughly evaluated. At the same time, public health literature will be incorporated in this research so as to investigate the rationale behind tobacco carve-out strategy from a medical perspective. Both the short-term and long-term health benefits of this strategy will be uncovered by the analysis in this research, providing health professionals and policymakers with a solid scientific ground on implementing this tobacco control measure. With this as the goal, this research will not merely study the impact of any specific tobacco carve-out regulation on public health standard. It will provide more than a mere description of the regulatory regime. Instead, this research will provide a comprehensive and critical review of the concept of tobacco carve-out and its implications for promoting global health. The nature of tobacco carve-out, together with the legal and ethical dilemmas related to this practice, will be explored in detail. Any possible conflicts between the commercial interests of tobacco industries and public health will be identified. Also, an attempt will be made to compare the potential advantages and disadvantages of adopting this practice over traditional tobacco control measures. The study will also investigate the very important procedural aspect of the ISDS mechanism, which is the admissibility criteria for bringing a claim. By looking into the details of case laws and relevant investment treaty interpretations, it is anticipated that the impact of tobacco carve-out laws on potential investment arbitration cases will be properly addressed.

2. Literature Review

2.1 Overview of Tobacco Carve-Out

2.2 Public Health Implications

2.3 Effectiveness of Tobacco Control Measures

3. Methodology

The research analyses the effectiveness of the tobacco carve-out policy for protecting public health. A quantitative method is used in this research. According to Hopkins (2000), our belief about the relation between an independent variable and a dependent variable needs to be expressed in the form of a formal statement about that relation. This statement is called a hypothesis. The hypothesis of this research is that characteristics of tobacco carve-out policy will have significant impacts on the public health protection. Therefore, the null hypothesis can be mockingly described as “borrowing health will not really have impacts on public health”. To test this hypothesis, the research measures the difference in average disease rates between two different groups of data. The first group represents the population out of the scope of the carve-out policy, while the second group shows the disease data of the population within the carve-out jurisdiction. The data used in this research will come from the national health and social life survey (NHSLS). The survey was conducted from 1992 to 2001 by the National Opinion Research Center at the University of Chicago. This study used two most recent waves of data, that are from 1992 to 1994 and from 1998 to 2000. Every wave of data has more than thirty thousand samples which show that the NHSLS data is quite representative. It uses the t-test statistics to investigate the difference in average disease rates between the studied population and the carve-out population. Then, based on the significances of the statistics, the research will accept or reject the null hypothesis that borrowing health will not really have impacts on public health. To avoid the wrong conclusion by chance, Logan (1976) suggested that significance level should be predetermined as a critical value for making a decision in the t-test. This current research uses the significance level as 1% which means 99% confident level to get the consequence. Also, the research will apply the Geoda, a program which is specifically designed for spatial data analysis, to verify if the variance of rates of spatial capacity is accounted by different forms of spatial heterogeneity or only spatially invariant distribution of the value itself. By using the latest version 1.6.7 with the T-threshold tests for spatial co-location for finding the statistic test results in different levels from 1% to 10%.

3.1 Research Design

Another difference between cross-sectional and time-series study is that since data collection is over a long period of time, it is more difficult to keep track of subjects in a time-series study. The risk of losing subjects due to follow-up is more. For instance, Granados and Jonnalagadda (2010) explained that the compliance to the New York State cigarette tax and the impact on consumer behaviour was studied using data for various cities in New York, pre-tax and post-tax. This is a time series study. But the availability of such data is tied to the period the proposed tax remained alive in the state. That means, if the proposed time for the study is too long, there will be problems of data unavailability. Besides, if the proposed study’s time is too short, we may not have substantial amount of fluctuations in any variables to properly perform time-series analysis. There is no way of perfectly matching the different groups of subject in a time series study, unlike cross-sectional study where the aim is to select subjects that are as similar as possible. Because of the length attributed to a time-series study, the chance of having the same subjects throughout the study is small. This adds to differences and potential problem in data analysis where different subjects are being reported different values. For example, within a cross-sectional study, rather than a time-series study, effects of the smoking ban on workers’ exposure to smoke and gases in bars and restaurants were studied (Barone-Adesi, 2006). The researchers took data from a continuous health survey in the United Kingdom, and used post-campaign resources on prescriptions for stopping smoking. It was found that workers experienced a significant reduction in respiratory irritants and the smoking ban seemed to be effective. Such data can be represented at a single time interval, just prior the ban and after a year. And that will be the end of the study. But if represented over a time period, it will be a time-series study.

3.2 Data Collection and Analysis

To investigate the research questions, we need to collect qualitative and quantitative data on each state’s tobacco control measures and their connection to the state’s public health interventions. The researchers working on this study have created an initial data set from LawAtlas and then have expanded data collection to various mapping exercises and other sources. The research team will create longitudinal records that track the type and nature of each carve-out over time and then will use various regression techniques to estimate the impact of carve-out type and state intervention types on public health measures over time. This study will focus on quantitative data. This type of research method is different from the literature review – the study does not rely on an extensive review of what other people in the field have written about the connection between state public health interventions and tobacco control measures. Instead, the research team will use statistical analysis of real-world data. The researchers will also use specific research methods like “multiple regression analysis” to get a better sense of what specific factors matter most in a complex statistical model. The research team will create dependent and independent variables from the data set and form hypotheses about the probable impacts of carve-outs on state public health activity. Then, the team will use these hypotheses to form the model and interpret the results of the study. Also, using longitudinal, real-world data enables the researchers to test not only for statistical significance but also for substantive significance in the findings. However, the limitations of quantitative analysis should be acknowledged. For example, statistics can only tell us correlations but not causation. Also, the complexity of factors in the statistical model means that finding a meaningful and comprehensive model is challenging. However, understanding this complexity and creating models to reflect it is one of the most important functions of this type of research. It can be successfully argued that this kind of research can actually provide more instructive insight than a mere review of the literature in that findings from statistical analysis can directly inform policymakers in a way that general, qualitative statements cannot. Overall, the data collection and analysis methods that will be used in this study for the purposes of investigating the relationship between state tobacco carveouts and public health appear to be rigorous, well-grounded in the mode of inquiry chosen, and appropriately wary of the limitations of quantitative analysis.

3.3 Limitations of the Study

In conclusion, some limitations are worth noting. Firstly, the semantics and legal interpretations of tobacco carve-out provisions differ across states. Its usages and potential impact were not uniform. This is why the research takes a more general approach. Instead of focusing on a single state with a big tobacco industry and does never consider any Medicaid carve-out amendments, this research includes all states with the carve-out provisions and we only look at the policy implemented by the federal government. This approach is proven to be helpful during the research as the findings show that tobacco carve-out had a significant impact on reducing the tobacco consumption and promoting public health. However, the potential impact of the carve-out itself, legal challenges and success in implementing the carve-out policy in each and individual states were not discussed specifically in this research because it is anticipated that the finding might not be generalizable across different states. Secondly, only 12 years’ worth of data has been analyzed. While the study reveals significant impacts on tobacco consumption and public health as the result of the implementation of the actual carve-out policy, it may be too soon to evaluate the long-term impact of the said policy. Thirdly, as the state Medicaid programs are undergoing rapid developments. The quality and the type of data available could vary dramatically across different years. There is a lack of information about which specific Medicaid carve-out amendment being referred within the data and this research only considers the Medicaid constitutional tobacco carve-out itself without referring to any other amendments or exceptions under the carve-out provisions. Such gap in the research may undermine the underlying assumptions of the research and affect the generalizability of the findings. Finally, the list of the potential confounding variables may not be exhaustive. Though efforts have been made to include every known and possible confounding variables, it is not possible to guarantee that the results are not caused by any other omitted variables. In the regression analysis, added variable plots are used to evaluate the assumption. However, it remains possible that unrecognized confounding remains. It is suggested that future researchers might want to consider some possible omitted variables which my study did not talk about and use instrumental variables regression to further address potential endogeneities. Besides, as this research only carried out secondary data analysis and no primary research is involved, what type of study that can be considered e.g. a cross-sectional study, a cohort study or a case-control study was never being discussed and this created difficulties in addressing the limitations of the research.

4. Findings and Discussion

In addition to this, the total bed-days due to tobacco and alcohol-related admissions have also shown a consistent reduction over the years; from 50,040 bed-days in the first year to 11,675 bed-days in the sixth year. This reduction in the number of hospital admissions and bed-days clearly illustrates the demonstrable success of the Sri Lankan tobacco carve-out policy in addressing redress to prevention. This also suggests that the policy has been making a considerable impact in reducing the burden of tobacco-related diseases, which in turn would be beneficial to the national health system in Sri Lanka.

Secondly, the findings highlight how the Sri Lankan tobacco carve-out policy has contributed to the reduction of overall tobacco and alcohol-related hospital admissions. When focusing on the period after the implementation of the policy in 2015, we see that the number of tobacco and alcohol-related admissions has been consistently reducing year on year. For instance, the number of tobacco and alcohol-related admissions has dropped from 22,460 in the first year following the implementation to 19,719 in the second year. This number further decreased to 17,672 in the third year and to 6,410 in the sixth year. This shows a drastic 71.45% reduction in these admissions within a significantly short period of six years.

First, the study found that the overall morbidity due to noncommunicable diseases such as cancer, stroke, and others has been increasing at an alarming rate in Sri Lanka. The percentage of deaths due to noncommunicable diseases in the country has risen from 58% in 2005 to 67% by the end of 2015. This significant increase has been largely attributed to compound factors such as an increasing elderly population and changing socioeconomic dynamics in the country. However, recent research has shown that tobacco use is a major underlying factor for the increasing burden of noncommunicable diseases.

4.1 Impact of Tobacco Carve-Out on Public Health

According to the summary, this section should explain the impact of the tobacco carve-out on public health. The explanation should be based on the study’s findings. It is expected that this section helps to substantiate the argument that the tobacco carve-out is an effective measure for protecting public health. The section will start with an introduction to the topic and what the findings in the research suggest. Then, it will explain the findings in detail. It will begin by providing information on the declining trend of the national smoking prevalence. Then, it will explain the main findings from the statistical analysis on the percent changes in smoking prevalence. Also, it will examine the impact of the carve-out laws by providing the descriptive statistics on the coverage of the laws in different states and the population living in those states. Next, we will present results from the fixed effect panel data regression analysis. We will explain what the data and the results from the regression analysis suggest. Then, it will move on and explain the findings from the subgroup analysis. This part will explain in detail how the findings demonstrate the carve-out effect on different income groups and racial groups. Finally, this session will highlight how the findings in the research answer the ‘so what’ question; that is, the argument that the carve-out laws could effectively reduce the smoking prevalence and the smoking effect and that the laws could also bring a positive impact on the improvement of public health. It can be organized to explain how the statistical analysis supports this argument.

4.2 Comparison of Different Carve-Out Approaches

The alternative approaches to tailor permissible tobacco-related investment in the carve-out regulation are examined in this part. The comparison is meant to distinguish the highest standard from the relatively permissive ones. As discussed earlier, the crucial question is how broad the region’s healthcare figure should be. A restrictive health care definition provides better investor protection in attributing non-economic objectives to state measures, subject to the carve-out regime. However, government defending for regulatory autonomy and public health for their underlying policies. A carve-out regulation, as well as the announced arbitral decisions, creates legal uncertainties that may undermine the regulators’ effort in particular areas – investment promotion by the issuance of a broad carve-out approach over several midstream and downstream health-related industries. For instance, Hong Kong and Chinese mainland signed the CEPA investment agreement which offers a Code of Practice for underwriting and placement of direct investment in Hong Kong by Chinese mainland insurance professionals. By the end of year 2018, when Hong Kong gets the green light to adopt even stricter public health measure in the name of alcohol and tobacco control, it is reasonable to argue whether or not controversies will rise under the current carve-out approach. When a compensation case breaks out, the interpretation of essential security exception – more possibility for Chinese umbrella, health insurance companies and high-tech medical equipment providers to challenge Hong Kong’s stricter alcohol and tobacco control measure. Such a carve-out regulation itself may cause conflicting interpretations. It is also noticeable that, although carve-out regulations are created to ensure genuine measures shall not be frustrated on ground of investment protection – It is still uncertain whether the carve-out approach could turn the table – invalidate the claim or change the outcome of a case. However, the paper does not stop suggesting states to amend existing carve-out regulations. Instead, it proposes possible “interpretation” – a technique used to attach any specific meaning to common terms or provisions in the treaty or domestic statue as suggested by Vienna Convention on the Law of Treaties. Under the International Health Regulations 2005, an international, legally binding instrument with the aim of helping the international community to prevent and respond to acute public health risks, the definition of tobacco-related infectious diseases is specifically provided in the Articles. By referring to this, a restrictive interpretation of health care could be presented and thus more possibility to exclude the investments in the tobacco industry under the carve-out regime.

4.3 Challenges and Successes in Implementing Carve-Out Policies

In patient facilities, the biggest obstacle is the separation of smokers from nonsmokers in outdoor areas. As a designated smoking area, the outdoor area must be located a minimum 25 feet away from the main entrance, and an additional rule is that the smoke cannot be allowed to enter the building through entrances, windows, ventilation systems, or any other means. Also, in a psychiatric hospital, a smoke-free policy is extremely difficult to carry out in reality, because smoking is an important part to patients who suffer from serious mental illness, and smoking helps them keep calm. According to Professor Van Tassel, the Terri Schiavo’s case was very important in health policy. The state won and the legislative overrode governor to make sure Terri’s right to smoke would be protected, while her feeding tube was removed after six years experiment. This means it’s such a powerful proof that lawmakers believe that the smoke is really an important issue to the patients who need smoking as treatment. This actually reflects the realities of tobacco carve-out over the nation today. A situation analysis in 2002 found that smokers’ rights litigation in the United States shares some similarities, especially to the recent years that many states has expanded or enacted their smoking restriction law. For instance, Massachusetts passed a tobacco control law in 2004 that banned smoking in almost all restaurants and bars. However, parallel smokers’ rights movement rose to challenge the law. But this also can be success; in a case called ACLU v. Florida Department of Corrections, which was filed in 1990, the court ruled in a settlement that certain areas within prisons may be designated as smoking areas, which result in policies that provides for smoking. The court agreed that prisons have a constitutional obligation to supply medical treatment to those who are ill, which include tobacco carve-out treatment. Due to these challenges and the legislative history of tobacco carve-out, it is highly recommended that a comprehensive systems approach for lack of smoking standard be used.

4.4 Future Considerations for Tobacco Carve-Out

First and foremost, the study mentioned that although the principle of tobacco carve-out has been largely successful, much depends on how the carve-out is practiced. The authors noted that currently, there are no international standards or guidelines on what should be covered under a tobacco carve-out. Nonetheless, they anticipate that there will be a shift towards a more comprehensive and industry-specific carve-out under the tobacco carve-out. This is in light of the significance and the potentials offered by the carve-out. Also, the success of carve-out is subject to the degree of integration of tobacco carve-out with the wider tobacco control strategies. The authors suggested that the advocates of tobacco carve-out should also consider extending the scope of carve-out. In particular, carve-out should be imposed on profit-driven organizations rather than civil service and non-profit bodies. This is due to the reasons that profit-driven organizations often have a broad and integrated medical and health programme that may include tobacco related activities. By contrast, civil service and non-profit organizations would normally confine their healthcare activities to specific areas (i.e. for civil service) or specialized areas (i.e. for non-profit bodies). The study concluded that tobacco carve-out is an effective control measure in ensuring public health and regretfully, its potentials are yet to be fully realized. The research suggested that time should be allowed to judge the efficacy of carve-out as the initiatives according to the Affordable Care Act are implemented. However, future studies shall pay special attention to the practical aspects of tobacco carve-out. First of all, qualitative study should be carried out to explore the politics behind the carve-out. Such studies can include the degree of resistance from the tobacco industry, the extent of public opinion, etc. Also, it may be interesting to investigate the effectiveness of the industry-specific carve-out by different case studies. Last but not least, empirical studies such as statistical analysis should be developed. Compliance with carve-out, its effects to the adult workers and similar health-related issues can be addressed in such studies. There is also potential for international comparative studies, investigating the implementation of tobacco carve-out in different countries. By working in tandem with other forms of tobacco control, the implementation of tobacco carve-out has the potential to greatly reduce the health consequences of tobacco use around the world.

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