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date: 05 August 2020

Incorporating Ethics in Policy Change and Health Reform

Abstract and Keywords

This chapter examines ethical considerations related to policy change and health reform, and contrasts ethical reasoning with the policy process. The chapter begins by defining two broad ethical approaches for health policy: a teleological approach and a deontological approach. These are then discussed with reference to specific key ethical considerations for health policy. The next section shows how ethical concerns can motivate policy change and health reform. Examples include health policies from the United States, Mexico, and India. The chapter ends with a discussion of a common model of the policy process and compares it to ethical reasoning.

Keywords: health policy, health reform, ethical reasoning, United States, India, Mexico, teleological, deontological, public health ethics

(p. 857) Introduction

According to the World Health Organization, “[h]ealth policy refers to decisions, plans, and actions that are undertaken to achieve specific health care goals within a society” (WHO, 2019). Policy change and health reform are directed by public and private officials and promulgated in the form of laws, regulations, or organizational procedures and structures. Policymakers do not simply dictate health policy—they rely on ethical, scientific, economic, social, and political forces to guide their health policy deliberations (Brownson, Chriqui, and Stamatakis, 2009). These deliberations typically follow a policymaking process that is dictated by laws and regulations governing the policymakers.

Ethics plays a key role in health policy reform, both by influencing the policymaking process and highlighting specific health policy outcomes. In this chapter, we begin by discussing the theoretical relevance and practical impact of ethical reasoning in the policymaking process. We then provide examples of how ethical considerations are fundamental to health policy by using examples of major laws enacted in the United States, India, and Mexico. These examples are followed by a discussion of how the policymaking process operates and the similarities between ethical reasoning and the policymaking process. We illustrate the similarities using one model of the policy process and show its overlap with ethical reasoning.

(p. 858) Approaches in Ethical Reasoning and Their Impact on Health Policy

The deontological and teleological tenets of ethical reasoning often guide policymaking and acknowledge the implicit conflict between individual liberties and the role of the state. The teleological approach, focused on outcomes, incorporates the utilitarian tradition of moral conduct, which seeks to minimize harms and maximize benefits (Cooper, 2012). Impartiality, a tenet promoted by utilitarianism, suggests that it is important to include the preferences of all individuals when determining outcomes (Shapcott, 2010). A policymaker adopting the teleological approach is focused on the health outcomes for the entire population and is grounded by utilitarian calculations of which action will result in the best outcome for the most people. An example of applying the teleological approach to health policy is the promotion of immunizations. While there may be other reasons for promoting immunizations, emphasizing the health benefits for a population as the policy justification is an example of a teleological approach.

In contrast, a deontological approach, encompassing Kantian ethics, is grounded in moral duty and choosing the right thing to do. It is based on good will—motivation and intention to act morally for what is right—and respect for moral laws to determine the appropriate course of action (Cooper, 2012). A health policymaker following the deontological approach is concerned with a duty to align policies with specific ethical principles, such as justice or beneficence, in a way that could be independent of the population health outcomes. In practice, policymaking using a deontological approach could place extra consideration on the rights or health of minorities, persons with disabilities, and other disadvantaged populations. For example, a sense of duty might translate into crafting a policy promoting care for transgender individuals because these individuals may require specific health policies.

Deontological and teleological tenets can both be justifications for health policy. The Sustainable Development Goal (SDG) for health includes the subgoal of achieving universal health coverage in all countries. Universal health coverage may be advocated in teleological terms to expand access to care for more people, and in deontological terms to reduce health inequities (UN, 2015). Another subgoal of the SDG focuses on a subset of the population by aiming to eliminate preventable deaths of newborns and young children. This goal targets vulnerable populations, aligning with a deontological approach. Alternatively, eliminating preventable deaths of newborns and children can be viewed with teleological intent, since these health benefits can result in future economic growth benefiting the entire population.

Ethical reasoning is used as procedural guidance for various health policy reforms. A World Health Organization report, Making Fair Choices on the Path to Universal Health Coverage, is an example of a systematic effort to introduce ethical reasoning into policymaking. For example, the document provides three ethical rationales for achieving universal health insurance coverage—fair distribution, cost-effectiveness, and fair (p. 859) contribution (WHO, 2014). Fair distribution suggests health coverage policy should prioritize worse-off individuals. Cost-effectiveness suggests a promotion of fairness in the allocation of public resources. Fair contribution seeks to ensure that access cannot be limited based on an ability to pay. The report then examines critical choices concerning which services to expand first, which beneficiaries to include first, and how to structure the finances to achieve universal health coverage.

An example of ethical reasoning having a role in the policymaking process is the United States’ “notice of proposed rulemaking.” This mechanism is an example of the government attempting to include all perspectives and stakeholders in the policymaking process (Center for Effective Government, 2017). The notice of proposed rulemaking requires the government to notify the public of an impending regulatory change and provides the public an opportunity to comment on the regulations before the rule is finalized. While the government does not have to agree with the public comment, the government must justify its position and address the concerns of the person or entity providing the comment. This process ensures changes to regulations will consider the impact on stakeholders and weigh these against the impact on the overall population.

A Common Ethical and Policy Choice: Individual Autonomy versus the State

Ethicists and policymakers have struggled with two fundamental conflicting ideas in public health: the autonomy of the individual versus the interests of the state. Although the general aim of health policy is to simultaneously improve individual and population health, there are often conflicts. In achieving this aim, it may be necessary to impinge on the autonomy of the individual or restrict the actions of the state. Lawrence Gostin (2000, 11) characterizes the ongoing state-individual debate in public health policy by noting that the state “is compelled . . . to act affirmatively to promote the health of the people,” but “cannot unduly invade individuals’ rights in the name of the communal good.” This conflict is at the center of many health policy debates and ethical concerns.

For example, consider the issue of mandatory vaccinations, whose objective is to improve population health against infectious diseases. The public health benefits of vaccination have been well documented (Andre et al., 2008; Ehreth, 2003). However, when the government mandates that an individual should be vaccinated, the government is impinging on that individual’s autonomy. In this case, the argument for mandatory vaccination often prevails. However, in some circumstances the preference of the individual prevails. Policymakers need to make that trade-off in very specific circumstances.

Tobacco policy is an example of where policymakers tend to side with individual autonomy in lieu of state policies to maximize public health. Despite the enormous volume of clinical research suggesting the negative health effects of tobacco (WHO, 2011; (p. 860) Frieden and Bloomberg, 2007), many governments do not ban tobacco use by adults. Rather, the government attempts to influence an individual’s decision to use tobacco through public awareness campaigns, label warnings, and taxation. Banning the use of tobacco is perceived by many policymakers to impinge too much on individual autonomy, in spite of the dangers of secondhand smoke and other adverse impacts of smoking on the public.

The predominant principle that underpins the role of government in health care is the concept of the social contract. The idea of the social contract is that individuals within a community establish an understanding that certain freedoms and commitments to obey a government authority are exchanged for protections through the enforcement of laws to meet the “general will” and interest of society (Rousseau, 1762). Throughout history, health policy change has occurred when there was a sense that the government, through public health policy, could improve the welfare of the population after taking into account the rights of individuals.

Ethics and US Health Policy: Two Case Studies Involving Ethical Reasoning

While some policymakers view individual autonomy as paramount, for others there are strong ethical arguments for a substantial role of government in health care. Below we discuss key ethical arguments in the context of two significant US health policies over the last seventy years.

US Social Security Amendments of 1965

The 1950s was a decade of significant prosperity in the United States; however, not everyone participated in rising incomes and wealth, and by the late 1950s, a fifth of the nation was considered to be poor (Poverty in America Project, 2016). In response to these concerns over inequality, President John F. Kennedy launched the New Frontier policies in 1961. While the New Frontier platform addressed a variety of topics, ranging from science advancement to civil rights, one key concern involved “unanswered questions of poverty and surplus” (Kennedy, 1960).

One approach to address this concern was to provide adequate health insurance. At the time, the US health insurance system was based almost solely on employment, which meant few retired older Americans could afford health insurance. While President Kennedy pushed for universal coverage to address this problem, his push faced opposition from groups like the American Medical Association (AMA), which claimed the proposals would lead to socialized medicine (Dickerson, 2013). For groups like the AMA, this (p. 861) violated the ethical principle of individual autonomy and personal choice. It was also argued that a lack of government capability to provide health care for all would limit individual health capabilities (Sen, 1980; Nussbaum and Sen, 1993). This ethical argument over capability divides individual freedom into two aspects: one that pertains to the opportunity of the individual’s “ability to achieve,” and another that pertains to the “process of choice itself” (Sen, 2009, 228). Health capabilities relate to the conditions that impact health, the pursuit of good health (i.e., access to health care), and an individual’s ability to make choices that can improve his or her health (Ruger, 2010). While in many countries the idea that health care is a right is a fundamental tenet, in the United States this issue is continually debated, with ethical arguments being offered to justify both positions.

While President Kennedy was unable to pass any major health reforms before his assassination, his successor, President Lyndon Johnson, was able to enact health reforms through his “Great Society” platform. In 1965 there was a recognition that health care spending was hurting many older Americans—47 percent of elderly families were impoverished and could not afford to purchase health insurance (Moon, 2006). The plight of elderly families motivated the ethical justification for the “Great Society”—a belief that a great nation did not leave elderly people behind. President Johnson’s goal was to bring “equal justice to all,” including eliminating poverty, eradicating disease, eliminating illiteracy, and ending bigotry.

The “Great Society,” however, adopted two different approaches to health coverage policy—one approach for Medicare and a different one for Medicaid. They are based on different ethical principles, and these differences have been at the center of many ethical and policy debates over the decades. The Medicare program is government-issued insurance that provides coverage to the elderly, the disabled, and people with end-stage renal disease. People contribute to their future Medicare coverage while they are employed. The Medicaid program is government-issued insurance that covers the poor under certain conditions, but the poor are not expected to contribute to their coverage. The key ethical and financing difference between the two programs is whether the person directly contributes to funding his or her own coverage. The difference between Medicare and Medicaid has influenced much of the subsequent policy debate and reform. Internationally, some countries have adopted an entitlement approach for health insurance, while others have adopted the categorical approach.

Patient Protection and Affordable Care Act of 2010

A major US health policy change came with the Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111–148, 124 Stat. 119 [2010]), also known as the Affordable Care Act, in the United States. The law restructured the US health insurance market by mandating nearly all people purchase health insurance, prohibiting the use of preexisting conditions exclusions by health insurers, providing subsidies for poor individuals to purchase health insurance, and other health insurance reforms. It changed the (p. 862) economics of health care by providing income-determined financial subsidies for insurance, and these subsidies would be paid for by taxes primarily targeting the affluent. In spite of its name, the policies within the Affordable Care Act had one overarching mission—to ensure that people have access to health care and insurance. To accomplish this mission, it drew on ethical justifications in both the Medicare and Medicaid program (Cutright, 1965). It follows the Medicare principles of having people financially contribute to their own coverage. It also follows the Medicaid principles of having the more affluent population help contribute to funding for the poor. The ongoing policy debate is partially about who should be subsidized and the balance between subsidization and personal responsibility for an individual’s health coverage.

While access was the overarching mission of the Affordable Care Act, policymakers recognized that affordability was impeding access, and that this was being driven by health care market failures. For policymakers, addressing the adverse selection problem in health insurance was most crucial (Handel, 2013). Adverse selection occurs when individuals purchase health insurance only when they actually need it. The people most likely to defer the purchase of health insurance are the young and healthy. Without having the young and healthy in the pool of people purchasing health insurance, insurers are unable to spread the risk, resulting in high premiums for health insurance. To counter adverse selection, the Affordable Care Act provides incentives and penalties to persuade the young and healthy to purchase health insurance. The main policy and ethical issue is whether the government should compel young and healthy people to purchase health insurance if they do not believe they need to purchase insurance. By providing incentives and penalties, the Affordable Care Act interfered with individual autonomy, but this intrusion was ethically justified by principles of beneficence and equity, since socioeconomic status should not prevent an individual from having health insurance.

While the Affordable Care Act adopted the objectives of achieving beneficence and promoting justice through equity and fairness, repeal efforts to replace the act are dominated by a desire to preserve autonomy, personal freedom, and personal responsibility. Efforts to repeal are grounded on the desire to limit government control of the health care market, because intervention is viewed as an infringement of civil liberties. This shows the ongoing tension in the United States between beneficence and justice, on the one hand, and autonomy, on the other.

Dignity in Life and Death—Amending the Narcotics and Psychotropic Substances Act of 1985

India confronted the individual autonomy versus the state debate in a very different context. In 2015, India amended its long-standing Narcotics and Psychotropic Substances Act that controlled access to opioids, including morphine for medical purposes. This act (p. 863) limited the availability and access to treatments commonly used in palliative care and pain control. The original 1985 act imposed major restrictions on health facilities in acquiring, storing, and dispensing opioids. The restrictions impacted licensure and policy development and limited the manufacture of opioids. This led to extended delays and, in some cases, the inability of health facilities to procure opioids. This regulatory barrier meant millions of Indians were without access to pain relief (Rajagopal and Joranson, 2007; Rajagopal and Palat, 2002).

The policy objective of the 1985 act was to advance the principle of beneficence and protect the population from illicit drug use and addiction. However, it had an unintended effect of causing immense harm to many sick people needing pain relief, directly violating a principal tenet of beneficence to do no harm. Through years of advocacy from civil society and policy champions, the 1985 act was amended. The 2015 amendment standardized regulations across India, streamlined the process of acquiring licensure by reducing bureaucratic obstacles, and changed the culture of opiophobia (Rajagopal, 2015). Policymakers in many countries have tried to balance between protecting the population from harm while allowing personal freedoms. These trade-offs require ethical considerations of beneficence, dignity, and justice.

Seguro Popular and the Right to Health: Understanding Health Reform in Mexico

Countries have adopted a number of different approaches to universal health insurance coverage. Seguro Popular is the national insurance scheme of Mexico that was established in 2003 (Knaul et al., 2012). The system was designed to respond to growing poverty and the lack of health protection among poor Mexicans, many of whom had been excluded from other social protection schemes (Frenk et al., 2006). Seguro Popular targeted vulnerable groups and sought to expand coverage over time. The system requires people receiving government assistance to undertake certain preventive health behaviors in order to continue receiving government assistance, thereby impinging on their individual autonomy.

The reform was guided by both “ideas and ideals,” with the generation of evidence guiding the policy process and the choice of which preventive actions to require. The debate involved ethical deliberation over individual liberty versus a choice of additional public spending if a recipient of the financial aid got sick because he or she did not take appropriate preventive actions. (Frenk and Gómez-Dantés, 2009). The policy objective of uplifting the Mexican population from poverty and improving human development was enhanced by the adoption of health as a social right (Frenk and Gómez-Dantés, 2009). Segura Popular insures over 52 million Mexicans, providing health care with financial protection (Knaul et al., 2015).

(p. 864) The Relationship between the Policy Process and Ethical Reasoning

Many different models of the policy process exist (Birkland, 2014). Each model emphasizes different aspects of the policymaking process, but they all share similarities. The models are designed to help the person or the stakeholder group who is advocating a particular issue to identify the most effective policy option to present. In this way, the process is similar to what the ethicist does when conducting ethical reasoning.

Global health efforts acknowledge the need for aligning priorities based on technical, ethical, and political criteria (Roberts et al., 2004; WHO, 2010). As noted previously, the WHO published a specific report in 2014 on establishing guidelines, grounded by ethical reasoning, to aid countries as they make policy considerations on the path to achieving universal health care. The human rights framework has been championed to advance priority-setting processes to meet the SDGs, including the subgoal of achieving universal health care (Rumbold et al., 2017).

Eugene Bardach, a political scientist at the University of California-Berkeley, developed one of the most widely taught models of the policymaking process (Bardach and Patashnik, 2015). His model, known as the “eightfold path,” is in the family of models that assumes that the policymaking process is rational and based on data and reasoning. It is intended to assist the person advocating for a policy change to understand what is necessary to promote change. The eight steps and respective similarities with ethical reasoning are summarized in Table 73.1 and discussed further below.

Table 73.1 Comparing the Policy Process with Ethical Reasoning

Policy process (Bardach model)

Ethical reasoning

1. Define the problem

Moral appraisal and identification of ethical imperatives associated with the problem

2. Assemble some evidence

Consideration of ethical implications

3. Construct the alternatives

Identification of alternatives that uphold ethical principles

4. Select the criteria

Identification of theoretical basis for evaluation

5. Project the outcomes

Determine outcomes that fulfill moral obligation on basis of theoretical basis being applied

6. Confront the trade-offs

Review trade-offs in relation to upholding of ethical principles

7. Decide

Determine actionable ethical imperative

8. Tell your story

Describe the ethical imperative and how problem violates core societal values

Defining the problem is perhaps the most critical step for those advocating policy change. It is essential to clearly define what is wrong with the status quo and identify opportunities for change. The policy issue has to be sufficiently important to concern the policymaker. Similarly, ethical reasoning entails a moral appraisal of the status quo and a discussion of why it violates particular ethical principles. In addition, the ethical imperative associated with the specific problem must be evident; for example, why should universal coverage in all countries be an ethical concern? Both the Bardach model and ethical reasoning recognize the importance of context in decision-making and how economic, political, and historical context can shape policy.

Assembling the evidence requires addressing why the defined problem is an important public health problem and why the status quo is unacceptable. In assembling the evidence, it is important to select evidence that appears most compelling to policymakers. There are many sources of evidence, including personal stories, analogies, surveys of best practice, and collection and analysis of primary and secondary data. It is often necessary to show why the policy change is feasible at this time, what has been tried previously, and why it has failed in the past. There also needs to be a discussion of unintended consequences with the policy recommendation. In ethical reasoning, these same principles apply, and the evidence should be ethically gathered. For example, a clinical study may provide evidence for a new medical treatment, which may have health (p. 865) policy implications. However, researchers also have an obligation to conduct the study using ethical principles.

Constructing the alternatives requires the presentation of a range of policy options that could effectively address the problem. This is often very specific to the policymaker and the history of the issue. In practice, policymakers are accustomed to evaluating three or four options, including the status quo, although there are no restrictions on the number of options. In order to effect change, the advocate must select options that policymakers will actually consider, not ones that are aspirational and unlikely to be adopted. For ethicists, it is important to present alternatives that uphold a range of ethical principles. For example, one alternative may uphold individual autonomy in choice of health care, while another upholds beneficence by promoting subsidized health care.

Selecting the criteria requires the identification of criteria with which to evaluate the policy in domains of interest to the policymaker. The two most commonly used health policy criteria are cost and health impact. Policymakers focus on the cost of the various alternatives and how many people will benefit. Other criteria, such as respect, beneficence, justice, or autonomy, are potential factors. A more detailed discussion of policy criteria from an ethical perspective is included in the “benchmarks of fairness” developed by Norman Daniels (Daniels, 1996).

Projecting the outcomes requires an assessment of how each policy alternative scores with each criterion. Sometimes this is subjective, and sometimes there are models that project the outcomes. For example, the US Congressional Budget Office is required to project outcomes for each legislative proposal in the US Congress. From an ethical standpoint, an accounting of the impact of policy meets the moral duty of doing the right thing or enables a utilitarian calculation of which outcome produces the greatest good.

Confronting the trade-offs requires recognition that no policy option is likely to score highest on all criteria. For example, a policy that has the best outcomes may also be the (p. 866) most expensive. Ethical consideration of trade-offs will be grounded by the principle of beneficence and determining which trade-offs do no harm, or benefit-risk trade-offs. Sometimes, all policy options incur some harm to individuals.

Deciding which policy to propose can be difficult, since there is seldom universal agreement on a particular policy option and each option has strengths and weaknesses. This requires policymakers to make trade-offs (Peacock et al., 2006; Daniels and Sabin, 1998). From an ethics perspective, one perspective is to judge a priority-setting decision-making process to be fair is when the “process, decisions and rationales are accessible and relevant; and an appeals and enforcement mechanism are established” (Baltussen and Niessen, 2006).

The final step, telling the story, is to present the option as succinctly as possible so the policymaker can quickly recognize the importance of the problem and the proposed solution. The story is also important for ethicists, since the most compelling stories draw upon key values, and while all values may not be universally shared, certain principles, such as constitutional rights, resonate with most of society.

Conclusion

Ethical concerns have been part of the policy process for years. They also underpin most health policy change and reform, even when there is a debate on topics such as (1) the role of the state versus the role of the individual; (2) the responsibility of society for the poor and older persons; and (3) the balancing of benefits with risks to avoid doing any harm. The policy process and ethical reasoning share many of the same attributes, although the language describing them is often quite different. As noted by the World Health Organization, health policy seeks to “achieve specific health care goals within a society” (WHO, 2019), and policymakers have a responsibility to embrace ethical reasoning in the process and justification of policies to advance better health outcomes. This is the process of policy change and health reform.

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