Website Article Assignment

CHAPTER

375

HEALTH POLICY DESIGN

Suzanne Babich, DrPH, Irene Agyepong, DrPH, Egil Marstein, PhD, and Francisco Yepes, MD, DrPH

Chapter Focus

This chapter is designed to help health managers develop the knowledge and skills needed to understand, effectively influence, and adapt to global health policies. It focuses on key concepts in the design of health policies around the world that are of particular importance for health managers and organizational leaders.

Learning Objectives

Upon completion of this chapter, you should be able to

• discuss the relevance of global health policy design and analysis for health managers,

• describe key concepts in global health policy design and analysis, • explore the implications of sociocultural factors on global health policy

and management practice, and • apply knowledge of these issues to managerial decision making and

actions.

Competencies

• Advocate for and participate in healthcare policy initiatives. • Interpret public policy, legislative, and advocacy processes within an

organization. • Describe the roles and relationships among the entities influencing

global health. • Analyze context-specific policymaking processes that influence health.

11

C o p y r i g h t 2 0 1 9 . H e a l t h A d m i n i s t r a t i o n P r e s s .

A l l r i g h t s r e s e r v e d . M a y n o t b e r e p r o d u c e d i n a n y f o r m w i t h o u t p e r m i s s i o n f r o m t h e p u b l i s h e r , e x c e p t f a i r u s e s p e r m i t t e d u n d e r U . S . o r a p p l i c a b l e c o p y r i g h t l a w .

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Key Terms

• Allocative or redistributive policies

• Global health policy • Policy

• Policy analysis • Policymaking • Regulatory policies • White paper

Key Concepts

• Global health policy • Government policy • Health policy analysis • Health policy circuit

• Health policy design • Sociocultural context • Step method for policy analysis • Transnational health policy

Introduction

Global health policy can be described as a complex web of rules, both formal and informal, that police vested interests in the attainment of the highest level of health possible for all people (World Health Organization [WHO] Regional Office for South-East Asia 2016). This description acknowledges the role of various stakeholders as key players in these systems that determine who gets what health services and with what level quality, length of wait, and cost. The description also goes beyond personal health services to include policies that directly or indirectly affect health—whether those policies are rules that allocate or reallocate important resources (e.g., food, medicines) or regulations that control the behaviors of individuals and organizations (e.g., food companies, drug and device manufacturers, coal-burning power plants).

The health policy landscape includes macro-level, transnational policies; country-level government policies; and micro-level policies in smaller units of governance or in individual organizations. Examples of macro-level, transna- tional policies include the doctors’ directive in the European Union (EU), which aims to promote the free movement of healthcare professionals, as well as EU laws targeting issues that directly or indirectly affect health or health services delivery (e.g., bovine spongiform encephalopathy, genetically modi- fied foods). Often, different levels of health policy overlap. Some country- or local-level policies, for instance, have a global reach and should therefore be of vital interest to health managers globally. Examples might include policies to limit the spread of Zika virus, H1N1/avian influenza, chikungunya, or Ebola. Although national health policies often focus on domestic health services allocation, they may also call for specific actions in response to global health

global health policy The complex web of rules, both formal and informal, that police vested interests in the attainment of the highest level of health possible for all people.

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issues, including transnational initiatives on such topics as climate change or the treatment of refugees and migrants. Policies also exist at the organizational level, of course, with organizations located all over the world. An organiza- tion might prescribe health services for employee groups in conjunction with country-specific national health services.

The professional arena for many health managers today includes opportu- nities in global organizations, where significant cultural differences require new knowledge, skills, and abilities. Competent managers need to be knowledge- able and flexible enough to adapt to these organizational differences. Chapter 6 focused on the leadership principles necessary for managers undertaking that challenge; this chapter, meanwhile, focuses specifically on the health policies that are relevant in today’s global context. This chapter focuses not on the policies that exist at the organization level but rather on the politically structured, insti- tutionalized frameworks that govern the allocation of health resources for popu- lation groups. Such policy frameworks are largely shaped by national, regional, and transnational interest groups, and they come about through a process of stakeholder intervention, with each group representing a stake in the outcome, to determine health services procurement practices and distribution. Stakeholder interest groups include powerful corporations, nongovernmental organizations, charitable foundations, and competing political institutions seeking to safeguard their capacities to influence the impact and outcomes of health policies.

Making sense of any health policy issue requires an understanding of the social and political factors that dictate a policy’s shape, pace, and direc- tion. Many health managers possess extensive knowledge and experience in the country in which they work, and a high level of insight into many of the factors that influence health policies close to their locus of control and practice. They often have great familiarity with environmental conditions, including the social, political, economic, and organizational factors that provide the backdrop for the development and implementation of local policies. However, given the increasing interdependence of health systems and policies around the world, today’s health managers—regardless of where they practice—must be proficient in analyzing and understanding health policies that span geographic boundaries and cultures.

Key Concepts in Health Policy Design and Analysis

Policies are rules that can be either formal or informal, written or unwritten. Policymaking is the process of creating those rules. Policy analysis involves examining those rules, the problems the rules are meant to address, the goals of the rules, and the criteria used to evaluate the efficacy of the rules. Typically, policy analysis also assesses alternatives to current policy and, based on results of the comparisons, makes recommendations from among the alternatives.

policy A rule, whether formal or informal, written or unwritten.

policymaking The process of creating the rules of policy.

policy analysis The act of examining rules, the problems the rules are meant to address, the goals of the rules, and the criteria used to evaluate the efficacy of the rules.

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Health policies have many sources, with governance structures that vary depending on where in the world the policies originate. Policies may be made at the federal, state, provincial, or local levels via legislative or elected bodies, administrative agencies, boards, commissions, courts, and so on. Health poli- cymakers may include legislators, elected officials, agency members, board or commission officials, judges, and the like.

The forms that health policies take also vary. They may be set out in national, state, or provincial constitutions, or they may be put forth in doctrines, statutes, ordinances, rules and regulations, operational or judicial decisions, and other forms specific to the governance structure of the country in which they were created. As a general rule, federal or country-level policies tend to wield the most power, state or provincial policies have somewhat less power, and local-level policies have the least amount of strength or authority. As a result, top-level policies tend to be the slowest and most difficult to change, whereas local-level policies tend to be the easiest to influence.

Health policies can serve any number of purposes, but most fall into one of two broad categories:

1. Allocative or redistributive policies are policies that determine the way public goods or resources are shared. Such policies typically give more resources to some groups and less to others. Examples include policies that provide free or reduced-cost services only to people who fall under a specified income level.

2. Regulatory policies are policies that are designed to affect the behavior or actions of others through rules that dictate what can and cannot be done.

The Global Health Policy Circuit

The model in exhibit 11.1 provides a visualization of the complexity of global health policy processes. The model highlights the following:

• The interconnectedness of public health policy, starting from the point of policy inception (political initiative)

• The shaping of rules and regulations (governance policies), perhaps establishing a new policy/reform paradigm

• The introduction of policy premises subsequent to implementation and sector administration

• Renewed stakeholder initiatives, perhaps engaging in strategic ploys, drawing attention to a preferred revision, potentially with the result of new political initiatives—completing the policy circuit

allocative or redistributive policies Policies that determine the way public goods or resources are shared.

regulatory policies Policies that are designed to affect the behavior or actions of others through rules that dictate what can and cannot be done.

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Governing structures vary among countries. In a social democracy, like those common in Western nations, policy initiation and implementation emerge following some level of national debate. Emerging policies commonly reflect the paradigm that governs knowledge development at a given time. Policies that break with established epistemology or generally accepted philosophy about a given topic may be seen as radical proposals, setting the stage for intensified policy debates.

In a top-down approach to policymaking, policies are formalized at the more central health system levels and then passed down to peripheral gover- nance structures responsible for implementation. The ultimate performance or output of any policy will be shaped by how these peripheral governance structures actually translate the policy into programs. Their actions and inac- tions—decisions and nondecisions—can effectively shape the public face of the policy. Whatever public service or good a policy is intended to govern, the relevant sector stewards promote that policy.

Ministries of health in many countries may have a hierarchical structure, with a central or national-level ministry responsible for agenda setting, policy formulation, and health sector coordination and more peripheral levels, espe- cially district level and below, responsible for policy implementation. Plans, budgets, and programs for health services, education, and other areas may or may not completely reflect the established policy premises, depending on the extent to which centrally designed policies are modified peripherally in implementation.

Political initiative

Governance policies

Sector administration

Stakeholder initiatives

Policy circuit

Paradigm I

Premises II

Ploy IV

Promotion III

EXHIBIT 11.1 The Global Health Policy Circuit

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Regardless of how complete and well-intended policies may be, they may, over time, be contested. A policy might not work as well as hoped, stakeholders might become unhappy, or public opinion might shift. Changing conditions in the policy environment might favor a new paradigm that prompts review of the policy. The discourse that subsequently takes place includes the ploy sec- tion of the exhibit—when actor agents might mask their actions for whatever gains may be sought. The potential for new political initiatives at this point illustrates the circular nature of the policy circuit.

In societies that lack well-functioning governance and legal structures, policy development and execution practices might be significantly different from what the model describes. In general, the practices of corrupt or incomplete policy development are beyond the scope of this chapter. However, in seeking to understand the policymaking contexts of those situations, the identification of key stakeholders and their policy goals and practices is critical.

Analyzing Health Policy

Health policy design and analysis are inherently social and political exercises. The environmental context in which policies play out may be shaped by a variety of changing conditions, including such factors as the economy, public opinion, election and budget cycles, and organizational interests. All of these factors can influence the shape, pace, or direction of a particular policy at a given time. Throughout the world, the conditions shaping policy environments, including governance structures and the power of stakeholder influences, vary widely.

At the top levels—the national, state, or transnational levels, such as within the EU—policy initiatives are approached systematically, often calling for complex structures and decision-making processes. At these levels, groups seeking to promote trade and regional development—such as the Association of Southeast Asian Nations (ASEAN), the European Free Trade Association (EFTA), the Latin American Free Trade Association (LAFTA), and the South- ern African Development Community (SADC)—play an important role in determining how health policies are shaped and how they work once approved.

In Western countries, policy papers known as “white papers” are often drafted by governments as a first stage in a parliamentary process for establish- ing a future policy. White papers provide policy analysis as depicted in exhibit 11.2, with an emphasis on the following:

1. Formulating a problem statement and underscoring its relevance 2. Recognizing budgetary implications; identifying financial options 3. Identifying all resources considered necessary to determine a capacity to

enact, following an assessment of critical prerequisites

white paper A comprehensive yet concise report that summarizes a position on a complex and often controversial or difficult issue; it aims to increase stakeholders’ understanding of the issue to support the development of policy.

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4. Reflecting on the policy’s presumed credibility with regard to key stakeholders (constituency acceptance)

5. Concluding its analysis of the policy initiative as summarized in a model acceptance

Despite this complexity—or, indeed, in recognition of it—health manag- ers should put forth the effort to understand the basic concepts and steps of policy analysis, because such knowledge can foster better organizational decision making and strategic planning. Performing a thorough analysis of a complex health policy can be extremely time consuming, however, and organizations will often be limited by time and other resources. Therefore, in organizational settings, analyses of health policies may be limited to relatively quick reviews or abbreviated studies, with certain steps in the process skipped or addressed in only a cursory way.

Given the time-consuming nature of policy analysis, it may be practical for analysis to be conducted by individuals who have prior knowledge of the policy in question. Even though such individuals might not be as objective as an analyst who has no prior knowledge of the case, the amount of time and energy needed for a newcomer to get familiarized with the necessary back- ground may be too great (Patton, Sawicki, and Clark 2012).

No single, correct approach exists for conducting a policy analysis; in fact, the activity is as much an art as a science. Nevertheless, a number of approaches have been described in the literature, each attempting to apply a

Budgetary implications

Relevance

Capacity to enact

Constituency acceptance

Policy circuit

Financial options

(I)

Critical prerequisites

(II)

Model acceptance

(IV)

Credibility (III)

EXHIBIT 11.2 Analysis of Health Policies

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structure to a complex, multidimensional situation that typically evolves even as it is being studied. One of the most popular approaches—the step method—is widely taught in university courses, in part because it is easy to explain and intuitive to grasp.

The Step Method for Health Policy Analysis

The step method for the analysis of health policies follows a systematic sequence of logical activities that comprehensively examine a problem, the policy designed to address it, the intended consequences of the policy, the policy’s outcomes, and the variants of the policy that could potentially improve the results. The analysis may include a recommendation for a “best choice” from among the suggested alternatives, plans for advocating for the preferred variant, and plans for evaluating the outcomes of the policy alternative.

The number of steps included in the model can vary depending on the source, but it typically includes five to eight steps. The core of the analy- sis—without including advocacy or evaluation plans—generally includes the following five activities:

1. Defining the problem and its corresponding policy. Think of the old adage, “There ought to be a law.” This step consists of several linked components: A problem has to be identified; it has to be deemed sufficiently significant in magnitude, scope, cost, or some other criteria; and it has to draw the attention of policymakers. Once the problem has met these requirements, a policy may be created to address it.

2. Collecting evidence. In this step, a policy analyst becomes educated— often quickly—on as many facets of the problem as possible within time and other resource constraints. Evidence includes information from diverse sources, potentially including reports, news articles, governmental proceedings, published papers, financial records, scientific data, and input from stakeholders, including opinions and anecdotes. The evidence may be objective or subjective.

3. Determining the policy goals and evaluation criteria. The goals and evaluation criteria are often one and the same. In other words, once an analyst determines what the policy is meant to accomplish, assessment of how well the policy is working can be done by comparing the actual and intended outcomes.

4. Laying out the alternatives. The next step includes brainstorming several evidence-based variations of the current policy that might reasonably be expected to yield improved results. A “do nothing” option should be one of the alternatives, with the status quo serving as the standard

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against which other alternatives are compared. The alternatives should be sufficiently diverse that meaningful differences can be discerned among them. Once several alternatives have been identified, the list should be culled to the three or four strongest options.

5. Playing out the options and picking one. For each potential policy alternative, the analyst extrapolates the likely results, assigning scores for each of the evaluation criteria. Matrixes, spreadsheets, grids, and charts can help illustrate the comparisons among the alternatives. This step should lead to the selection of the best option.

After the best option has been selected and the recommendation com- pleted, the analysis may end, or it may continue with development of an advocacy plan or a plan for evaluating the new policy, should it be adopted.

Policy analyses are iterative. At any point in the analysis, if the results are unclear, the analyst can and should return to earlier steps and repeat the processes until the results enable a move to the next step.

Given the complex and time-consuming nature of policy analysis, most analyses, in reality, are incomplete or at some point deemed to be “good enough for now.” Analysts may be forced to cut short or skip entire steps in the process if faced with time or resource constraints, meaning that a decision has to be made based on information that is less than ideal.

Exhibit 11.3, using an example from a major capital city in Western Europe, illustrates one way in which a policy analysis might be set up. In this example, the problem is that the city’s hospitals are receiving large numbers of pregnant migrant women who present for delivery without having received adequate prenatal care, resulting in costly complications and adverse outcomes for infants and mothers. The policy alternatives represent ways in which the hospitals might provide prenatal care free of charge for pregnant migrant women who come to on-site outpatient clinics. Based on the comparison presented in the exhibit, the fourth policy alternative appears to be the best choice among those presented.

As noted in chapter 6, cultural competence is a crucial aspect of effective leadership, but the concept is equally important in the context of global health policy. Policies that do not take into consideration the community’s unique social and cultural needs and characteristics risk underperforming or failing to meet their goals. Policies that are culturally incompetent might, for example, result in intended beneficiaries losing interest in a program or failing to use services intended to help them.

Background about the sociocultural factors pertinent to a particular policy context can be collected during the evidence-gathering phase of policy analysis. In many cases, it can be acquired through document reviews or discus- sions with stakeholders. Ideally, though, health policies should be conceived

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and constructed with the active involvement and leadership of representatives of the community at which the policy is aimed. Participatory approaches to community engagement that are considered standard for health services research are equally relevant to the design and analysis of health policies. Policies are most valuable when they respect and respond to the health beliefs, practices, and cultural needs of the diverse populations being served.

Summary

Global health policy is a complex web of rules that police vested interests to promote the attainment of the highest level of health possible for all people. Health policies can be either formal or informal, and either written or unwrit- ten. The health policy landscape includes macro-level, transnational policies; country-level government policies; and micro-level policies in smaller units of governance or in individual organizations. Health policies come from a variety of sources and take a variety of forms, but they typically can be divided into two broad categories: (1) allocative or redistributive policies, dealing with the way goods or resources are shared, and (2) regulatory policies that dictate what can and cannot be done. Health policy analysis involves examining the various rules, the problems the rules are meant to address, the goals of the rules, and the criteria used to evaluate the efficacy of the rules. One of the most popu- lar approaches for health policy analysis is the step method, which follows a systematic sequence of activities to comprehensively examine a problem, the

Criterion 1: Cost

Criterion 2: Time to

Implement Criterion 3:

Effectiveness

Alternative 1: Maintain status quo

Poor Good Poor

Alternative 2: Increase the number of hospital- based outpatient prenatal clinics

Poor Good Fair

Alternative 3: Provide free transportation to hos- pital outpatient prenatal clinics

Fair Good Fair

Alternative 4: Move clinics to community-based sites in migrant neighborhoods

Good Good Good

EXHIBIT 11.3 Comparing

Projected Effectiveness

of Policy Alternatives

Based on Evaluation

Criteria

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policy designed to address it, the policy’s intended consequences, the policy’s outcomes, and the variants of the policy that could potentially improve the results.

Discussion Questions

1. Define global health policy. 2. Identify the steps in the policymaking process. How does the process

differ from one country to another? How is it similar? 3. Analyze the impact of sociocultural and political factors on the

establishment and implementation of health policy. How does national health policy affect organizational management practice?

4. Describe the health policy process in your country. Analyze the impact that redistributive policy and regulatory policy have on your organization. How does this affect your approach to strategic planning?

5. As a healthcare leader or manager, what steps could you take to influence national health policy? How open is your ministry of health, or similar organization, to policy analysis emanating from the grassroots level? How can you work through the national political process to influence policy?

Case Study: The Global Policy to Immunize Against Human Papillomavirus

Human papillomavirus (HPV) is a necessary cause, though not the only cause, of several sex-related cancers, capable of leading to cancers of the uterine cervix, anus, penis, and pharynx. Of the more than 150 types of HPV, 15 are carcinogenic, and two are responsible for 70 percent of cases (Tomljenovic, Spinosa, and Shaw 2013).

After completing phase I, II, and III studies, three HPV vaccines have been approved by the US Food and Drug Administration (FDA), with the first—Gardasil—having been approved in 2006. The HPV vaccine has been endorsed by several major health authorities worldwide, including the World Health Organization (WHO), the European Medicines Agency (EMA), the US Centers for Disease Control and Prevention (CDC), and the ministries of health of more than 100 countries. However, despite its effectiveness and safety assurances, growing scientific controversy surrounds the use of the

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HPV vaccine, with a number of case reports suggesting serious adverse effects (Nicol et al. 2016; Brinth et al. 2015). The global health policy support- ing HPV vaccination meets the generally accepted criterion of having a basis in a preponderance of scientific evidence. However, debate focuses on the potential for overestimation of vaccine effectiveness and the underestimation of vaccine safety risks. In addition, some have raised ethical concerns related to possible conflicts of interest on the part of scientists who have vested economic interest in the pharmaceutical industry (Cochrane Nordic 2016).

Health organization acceptance and advocacy of the HPV vaccine policy varies from country to country. Although the WHO, FDA, EMA, CDC, and most ministries of health continue to support widespread HPV vac- cination for girls, some countries have changed course. Japan suspended public financing for the vaccine after adverse effects were reported (Wilson et al. 2015). The Danish Health and Medicines Authority (2015) submitted a report to EMA based on the Japanese findings and similar observations in Denmark. Similarly, the American College of Pediatricians (2016) sent a notice of alarm to its associates, and an important Canadian physician asked the government for a moratorium on the vaccination (Dyer 2015). Finally, Cochrane Nordic (2016), a center in Denmark, denounced EMA for ethical breaches.

Clearly, the HPV vaccine represents a complex and challenging area of global health policy. The vaccine policy is purportedly based on evidence, with application through ministries of health, health insurers, and health providers, with the intention of preventing cancers but with the possibility of causing adverse, unintended health consequences for the population it was meant to protect. Health administrators must be aware of the implications and ethical dilemmas associated with compliance or noncompliance with the global policy, and they must encourage serious and balanced discus- sions within their organizations.

Case Study Discussion Questions 1. What problem does the policy aim to address? State the problem in

a sentence or two. 2. Describe the pros and cons of the current global policy. 3. Who has a stake in HPV vaccine policy? What are the interests of

the primary stakeholders in the case, and how might these interests place practical limits on evidence-based standards for global health policy?

4. What are the ethical considerations associated with compliance or noncompliance with the policy?

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5. What is the role of health managers in implementing HPV vaccination policy?

6. Should informed consent be required for application of the HPV vaccine?

7. Does the principle of primum non nocere (first do no harm) have any practical consequences in the application of this policy?

Case Study: The Ghana Arm of the 2015 Global Phase II Ebola Vaccine Clinical Trial

by Irene Akua Agyepong

Learning outcomes addressed by this case study include the following:

• Identification of contextual factors that affect policy implementation • Analysis of how and why contextual factors affect given situations • Analysis of the effect of health system complexity on intended and

unintended policy outcomes • Synthesis of the information to guide and justify possible response

alternatives

Introduction This case involves the contentious policymaking process used to address vaccine development in response to the Ebola virus disease (EVD) epidemic in West Africa in 2014 and 2015. Vaccines are effective public health tools that can bring about dramatic declines in the incidence and attributable mortality of various communicable diseases. Vaccines have been successful for such diseases as measles, whooping cough, diphtheria, and tetanus; in the case of smallpox, vaccines were key to the global eradication of the disease.

New vaccine development is a long and expensive process that involves science and epidemiological research in the form of clinical trials. Because clinical trials involve human subjects, strict national and interna- tional standards and best practices are in place to ensure that the trials are conducted in an ethical manner. Given the lengthy and expensive nature of the vaccine development process, priority in the use of public funding is given to diseases that affect large numbers of people. In instances where private organizations finance clinical trials, profitability of the new product is also an important concern.

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The Ebola Virus Disease Emergency EVD became a global public health emergency in 2014 and 2015. Following a case that occurred in December 2013 in a remote rural area of the West African country of Guinea, the disease spread across borders into Sierra Leone and Liberia. The three countries soon faced an epidemic, affecting more than 22,000 people, with case fatality rates of at least 50 percent (Ohimain 2015). Panic spread globally with media reports and images of overflowing hospitals, dead bodies on the streets, health workers in protec- tive suits, and the already-stressed health systems of Guinea, Liberia, and Sierra Leone seemingly caving in.

All the countries of the Economic Community of West African States (ECOWAS) recognized that they were at high risk. The disease was carried into Nigeria by an air traveler and into Mali and Senegal by people crossing the border by road. Imported cases were also found in Europe and the United States. The cases in Nigeria, Mali, Senegal, Europe, and the United States were quickly contained, and the disease did not spread in any of those areas. In Ghana, as in the rest of the West African subregion, the health institutions and the general public were on high alert. People were doubly concerned because of the country’s relatively under-resourced health system.

The only tools available to fight Ebola were isolation, quarantine, and supportive treatment. No vaccine or medicines were available for use, although candidate vaccine products were at various stages of development. The epidemic and the declaration of a public health emergency of interna- tional concern led to a global acceleration of Ebola vaccine development and massive international funding to support the process. Phase I clinical trials were conducted, mainly in Europe and the United States, and some promising candidate vaccines were identified. Phase II clinical trials were planned, with coordination by the WHO, to be carried out in several countries in Europe, North America, and sub-Saharan Africa.

Clinical Trials in Ghana Ghana has an extensive research infrastructure at the health and demo- graphic sites of the Ghana Health Service, as well as at universities. The country has laboratories, clinical trials expertise, and well-established ethi- cal review processes. Successful clinical trials in Ghana had informed the development of meningitis vaccines, and clinical trials for malaria vaccine development had been ongoing in the towns of Navrongo and Kintampo. Therefore, Ghana was one of the countries in sub-Saharan Africa that had been identified for the Ebola vaccine trials. Two Ebola candidate vaccines were to be tested in Ghana. The vaccines to be tested did not have Ebola

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virus (dead or alive) but rather had components of the identifying protein of Ebola attached to the common cold virus, to stimulate the body to produce antibodies against Ebola.

Part 8 of Act 851 of the Parliament of the Republic of Ghana, known as the Ghana Public Health Act, provides for clinical trials to be conducted in Ghana. The act also provides for the legal backing of the Clinical Trials Advi- sory Committee, which operates under the Ghana Food and Drugs Authority (FDA). Under section 151 of the law, the committee is tasked with providing the Ghana FDA with “ongoing and timely medical and scientific advice on current and emerging issues related to clinical trials” (FAOLEX Database 2012). The advisory committee is an independent, multidisciplinary panel of experts from various relevant specialties. The law specifies that it should include a clinical pharmacologist, a social scientist, an internal medicine practitioner, a clinical pharmacist, an epidemiologist, a pharmacologist, and a biostatistician, among other specialists. Before any clinical trial can be conducted in Ghana, it must undergo a review not only by the ethical review committee of the Ghana Health Service but also by the Clinical Trials Advisory Committee.

The Ghana Public Health Act, in section 156, maintains that “an appli- cant who is aggrieved by a decision of the Authority as regards the grant of an authorisation for the conduct of a clinical trial may make a representation to the Minister within sixty days” (FAOLEX Database 2012). Under Ghana’s law, the FDA is the body with the authority to stop or suspend clinical tri- als. Section 160 (subsection 1) of the law states: “If at any stage during the authorised clinical trial of a medicine, herbal medicinal product, cosmetic or medical device the Authority is satisfied that considering the initial risks, discomforts or any other adverse event caused to a person or an animal taking part in the trials, it is in the public interest to stop or suspend the trial, the Authority shall order the person conducting the clinical trial to stop or suspend the trial immediately.” Section 160 (subsections 2 and 3) adds: “Without limiting subsection (1), the Authority may for any other reasonable cause suspend, vary or stop a clinical trial . . . The Authority shall notify the person conducting the trial of its decision immediately and the reasons for the decision.”

The principal investigators and collaborators on the Ghana clinical trials of the Ebola vaccine developed their protocol and subjected it to all the review mechanisms required by law. Given the global nature of the col- laboration for Ebola vaccine development, the protocols were also subject to international review within the WHO. The investigators and collaborators,

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however, did not organize any national media education or discussions about the proposed clinical trials. In their experiences with previous clinical trials, they had found that following the law and educating the trial participants had always been enough. Ebola turned out to be a special case.

Controversy and Delay Just as the clinical trials were set to begin, newspapers and radio stations broke the news that an Ebola vaccine trial was taking place in Ghana. The news reports suggested that participants were being bribed to take part in a dangerous undertaking that could potentially introduce the Ebola virus into the country. The stories prompted heated discussions on social media, in the press, and among the public and led to debates in Parliament and within the medical and academic communities. Clinical trials are a special- ized area of research, and general understanding of what they entail is often low, even within parts of the medical community.

A section of the Ghana Academy of Arts and Sciences (GAAS) revealed that it had presented a position statement to the government advising caution in deciding to conduct Ebola vaccine trials in Ghana, and it made available a series of sophisticated questions to which it felt the government had not provided adequate answers. The group also stressed the need of the communities and individuals taking part in the trials to be adequately informed of the relevant benefits and risks. Ultimately, it advised that, “con- sidering the gaps in our knowledge and state of preparedness, it would be unsafe to undertake the proposed EVD vaccine clinical trials in Ghana” (Osam 2015).

Whereas the researchers had focused on science and adherence to law, the GAAS proved adept at engaging national politics and the general public, making their concerns widely known through a press statement. The concerns voiced by the GAAS carried significant weight, because the GAAS is a prestigious body of eminent academics highly respected by the government and the public. The researchers involved in the clinical trials, on the other hand, did not engage the public or become involved in politics beyond the study sites because the rules for clinical trials did not allow them to “advertise” before receiving ethical approval. For the public, much of the medical community, and politicians, the perception that experts in the sciences were divided over the clinical trials further raised anxiety and doubt about the trials’ wisdom and safety.

The Minister for Health and Parliament called a halt to the trials until the concerns about safety could be adequately addressed. If the concerns were not adequately answered, the trials were to be totally cancelled. The

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Additional Resources

Hamowy, R. 2007. Government and Public Health in America. Northampton, MA: Edward Elgar Publishing.

Holland, W., E. Mossialos, P. Belcher, and B. Merkel (eds.). 1999. Public Health Policies in the European Union. Farmham, UK: Ashgate.

Kay, A., and O. D. Williams (eds.). 2009. Global Health Governance: Crisis, Institutions and Political Economy. London: Palgrave MacMillan.

Nichter, M. 2008. Global Health: Why Cultural Perceptions, Social Representations, and Biopolitics Matter. Tucson, AZ: University of Arizona Press.

People’s Health Movement, Medact, Medico International, Third World Network, Health Action International, and Asociación Latinoamericana de Medicina Social. 2014. Global Health Watch 4: An Alternative World Health Report. London: Zed Books.

Rosanvallon, P. 2011. The Society of Equals. Cambridge, MA: Harvard University Press.

researchers put out rebuttals challenging the perception that the trials were dangerous, and they tried to address the key concerns through press conferences (Graphic Online 2015a; Daily Guide 2015). The Ghana Medical Association also organized a seminar on clinical trials and the Ebola vaccine trials, specifically.

Several months later, the concerns had been laid to rest, and Parlia- ment gave permission for Ghana’s Ebola vaccine trials to go ahead (Graphic Online 2015b). The horse, however, had already left the stable. Because the phase II trials were an international process involving several countries with agreed-upon time lines, the process had moved on without Ghana’s participation. A phase II Ebola vaccine trial in Ghana was no longer relevant.

Case Study Discussion Questions 1. What is the global policy issue of concern in this case study? 2. What contextual issues affected the decision-making and

implementation processes? Why do you think that previous clinical trials in Ghana, such as those for the meningitis and malaria vaccines, did not have such a stormy experience?

3. What do you think could have been done differently by the national investigators and by the global team of which they were a part?

4. What lessons or insights do you take away with regard to context- specific policymaking, the complexity of health systems, the intended and unintended effects on outcomes, and the roles and relationships of entities influencing global health?

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References

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Brinth, L., A. C. Theibel, K. Pors, and J. Mehlsen. 2015. “Suspected Side Effects to the Quadrivalent Human Papilloma Vaccine.” Danish Medical Journal 62 (4): A5064.

Cochrane Nordic. 2016. “Complaint to the European Medicines Agency (EMA) over Maladministration at the EMA.” Published May 26. http://nordic.cochrane. org/sites/nordic.cochrane.org/files/public/uploads/ResearchHighlights/ Complaint-to-EMA-over-EMA.pdf.

Daily Guide. 2015. “Ebola Vaccine Trials Not Harmful—Experts.” Published July 9. www.ghanaweb.com/GhanaHomePage/health/Ebola-vaccine-trials- not-harmful-Experts-367470.

Danish Health and Medicines Authority. 2015. “Report from the Danish Health and Medicines Authority for Consideration by EMA and Rapporteurs in Relation to the Assessment of the Safety Profile of HPV-Vaccines.” Published September 4. http://sundhedsstyrelsen.dk/~/media/0A404AD71555435BB311CD59 CB63071A.ashx.

Dyer, O. 2015. “Canadian Academic’s Call for Moratorium on HPV Vaccine Sparks Controversy.” BMJ 351: h5692.

FAOLEX Database. 2012. “Public Health Act, 2012.” Food and Agriculture Organi- zation of the United Nations. Accessed July 6, 2018. http://extwprlegs1.fao. org/docs/pdf/gha136559.pdf.

Graphic Online. 2015a. “Noguchi Boss Criticises Suspension of Ebola Vaccine Trials.” Published June 14. www.graphic.com.gh/news/politics/noguchi-boss-criticises- suspension-of-ebola-vaccine-trials.html.

———. 2015b. “Parliament Approves Ebola Vaccine Trials in the Country.” Published November 14. www.graphic.com.gh/news/general-news/parliament-approves- ebola-vaccine-trials-in-the-country.html.

Nicol, A. F., C. V. Andrade, F. B. Russomano, L. L. S. Rodrigues, N. S. Oliveira, and D. W. Provance Jr. 2016. “HPV Vaccines: A Controversial Issue?” Brazilian Journal of Medical and Biological Research 49 (5): e5060.

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Osam, E. I. 2015. “Gov’t Was Warned Against Ebola Vaccine Trial—Academy of Arts and Sciences.” CitiFMOnline. Published June 12. http://citifmonline. com/2015/06/12/govt-was-warned-against-ebola-vaccine-trial-academy-of- arts-and-sciences/.

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