Pan American Health Organization

Inequities and barriers in health systems

  • Equity in the context of Regional transformation processes in health
  • Inequities and barriers in health systems: defining the problem
  • Health systems–generated inequities and barriers
  • Barriers in access to services and inequities in coverage
  • The critical role of human resources for health
  • Access to medication and appropriate health technologies
  • Social determinants: barriers to equitable health and well-being
  • Measuring equity in health systems performance: the paucity of information
  • References
  • Full Article
Page 1 of 9

Equity in the context of Regional transformation processes in health

The quest for equity is a persistent challenge for health systems in the Region of the Americas. Significant advances have been achieved in health in part as a result of the economic and social development of countries, the consolidation and strengthening of health systems, and the ability to incorporate and apply emerging technologies to improve health and well-being. The political commitment of countries to respond to the health needs of their populations has been an essential contributing factor to these achievements ().

Despite the advances, poverty and inequities remain a challenge in the Region. Recent data suggest that Latin America and the Caribbean (LAC) remains the most inequitable region in the world, with 29% of the population below the poverty line and the poorest 40% of the population receiving less than 15% of total income. Such inequities are reflected in health outcomes: for example, the Region of the Americas did not achieve the Millennium Development Goal (MDG) target for the reduction of maternal mortality by 2015, and despite significant reductions in infant mortality, very sharp differences exist between countries. Without specific interventions to transform health systems, economic growth is not sufficient to reduce inequities ().

In October 2014, PAHO Member States approved the Strategy for Universal Access to Health and Universal Health Coverage (from here on, referred to as “universal health”) (). The strategy emphasizes the need to strengthen health systems to achieve universal access and coverage, namely by reducing health inequities; expanding access to comprehensive, quality care; and improving the health and well-being of the population. The strategy underscores the need for more and better investments in health, in particular to strengthen the first level of care, and for moving decisively toward integrated health services. In addition, it calls for strengthening intersectoral approaches to the social determinants of health in order to reduce social inequalities and inequities in access and health outcomes.

Achieving equitable, comprehensive, and integrated health services will require important transformations in the model of care and in the organization of health care delivery. The countries of the Region agree that models of care based on the values and principles of the primary health care strategy should govern health care organizations or networks to provide integrated, quality, people- and community-centered services (). Certain changes will be essential, including more equitable health financing, new or adjusted regulatory frameworks, innovative approaches to human resources education and allocation, and strong leadership by the national health authorities.

Most health systems in the Region of the Americas struggle with the dichotomy of a declared policy intention to move toward universal health and people- and community-centered models of care based on the values and principles of primary health care and the reality of maintaining structures and practices of the old biomedical model. In curative services–oriented systems, a preponderance of funds is allocated to inpatient care. Evidence of this can be found in the way in which most ministries of health in the Region allocate the larger portions of their budgets to hospital services that are inequitably distributed nationwide.

In light of the above, countries urgently need to accelerate the transformation of their health systems—with universal health as a deliberate goal. Comprehensive strategic actions implemented in a progressive and sustained manner are required to build health services that are responsive to the needs of all populations. As democratic processes in the Region are consolidated and greater decision-making power is transferred to people and their communities, the social demand for universal health can be expected to grow, supported by increasingly well organized advocacy efforts.

Inequities and barriers in health systems: defining the problem

It is important to differentiate inequality from inequity. Inequalities, as defined by WHO (), are differences in health status or in the distribution of health determinants between different population groups. Inequities are those inequalities that are considered avoidable, unnecessary, and unfair ().

This means that not all inequalities are avoidable or unfair. Differences in life expectancy between men and women are a good example. When variances are due to intrinsic biologic differences, they are not considered unfair; however, when they are caused by social policies or barriers to the exercise of essential rights, they become inequalities that are unfair, unnecessary, and avoidable—thus, inequitable ().

The current debate on inequities in health introduces new terms and definitions that are useful in characterizing important aspects of the problem. One such term, structural inequities, refers to “how policies and practices embedded in systems such as social welfare, economic, justice and health care operate to produce inequitable distribution of the determinants of health” (). As such, “inequities are structural because they are entrenched in the political and economic organizations and they are violent because they cause injury to people” ().

Health systems–generated inequities and barriers

The health system is an important cause of inequity in health. As stated by Barbara Starfield, “Inequity is built into health systems—especially western health systems that are based on a view of health needs disease-by-disease” ().

Due to certain conditions of their historical development, the traditional organizational structure of health systems in the Americas was in most countries characterized by uncoordinated subsystems providing care to different strata of the population. This led to a high level of segmentation and fragmentation, profoundly affecting the systems’ performance, efficiency, solidarity, and equity. Indeed, health systems with these characteristics do not adapt to the needs of populations with present-day epidemiological profiles, in which aging and noncommunicable chronic conditions are increasingly important challenges.

The segmentation and fragmentation observed in the majority of health systems in the Region result in inequity and inefficiency that compromise universal access, quality, and financing. Segmentation and fragmentation are perpetuated by poor governance and weak regulatory capacity of health systems (). Fragmentation, on its own or with other factors, generates difficulties in access to services, delivery of services of poor technical quality, irrational and inefficient use of available resources, unnecessary increases in production costs, and great user dissatisfaction. Moreover, the evidence indicates that in insufficient coverage schemes, the focus on disease rather than meeting the health needs of people and communities results in not only greater costs but also loss of income, creating a vicious cycle of disease and poverty in families.

Although health services in the majority of the Region’s countries are fragmented, the degree of fragmentation and the underlying causes vary from country to country. The literature reviewed and consultations in countries suggest multiple causal factors, including institutional segmentation, decentralization, suboptimal funding, predominance of vertical programs, separation of public health services from curative services, disease-centered models, weak steering capacity, and human resources in health that are numerically insufficient, inadequately trained, and poorly distributed ().

Fragmented health services, which are predominantly based on the model of inpatient hospital care, undermine the capacity to respond to the overall health needs of the population. In most health systems, the current delivery model centers on episodic care of acute conditions in hospital centers, with intensive use of technology and specialist physicians. Health system investments and reforms have not always been targeted to meet new challenges, and new technology and innovation have not been sufficiently incorporated into the management and delivery of services. In many of the Region’s countries, this creates an unbalanced investment in urban hospital-based services and new technologies, to the detriment of health promotion and preventive interventions at the first level of care. Meanwhile, services in rural communities or for populations in conditions of vulnerability are neglected or under-resourced.

Fragmentation is not simply a problem of referral mechanisms. More importantly, it affects comprehensiveness, coordination, and continuity of care between different health facilities, levels of care, and clinical specialist/teams throughout the life course. It therefore demands more complex approaches and solutions. Lack of coordinated care is further compounded by limited resolution capacity. This is particularly true at the first level of care, which affects the capacity to respond to emerging health needs, especially the growing needs of aging populations and the growing burden of chronic conditions throughout the Region.

On the other hand, in many countries of the Region, health care services do not respond appropriately to the differential health needs of people and communities. Populations in conditions of vulnerability (extremes of life, women and children, ethnic minorities, patients with chronic and/or incapacitating diseases, etc.) are the most affected by this problem. For example, women’s health issues are a combination of health risks and disorders that they have in common with men, and issues that exclusively affect women because they relate to biology. Both are strongly affected by gender, ideology, and politics.

The changing scope of the worldwide burden of disease shows important advances in some of women’s foremost health priorities (), but considerable challenges and inequalities exist. While the achievement of sexual and reproductive health rights is still an unmet goal, noncommunicable diseases such as cardiovascular disorders, stroke, cancer, diabetes, chronic obstructive pulmonary disease, and mental health disorders are now the leading causes of death and disability for women of almost all countries (). On the other hand, in the Americas, men die from external causes four times more often than women. The lack of appropriate coverage of these groups affects their right to health and well-being and has negative effects on the social and economic development of countries. The same is true for populations subject to structural racism (especially indigenous and Afro-descendant populations). Structural racism describes the confluence of institutions, culture, history, ideology, and codified practices that generate and perpetuate inequity among racial and ethnic groups. In the United States, “structural racism, the systems-level factors related to, yet distinct from, interpersonal racism, leads to increased rates of premature death and reduced levels of overall health and well-being” ().

Problems of exclusion and lack of access to quality services persist for large sectors of the population. The lack of appropriate coverage and access has a considerable social cost, with catastrophic effects on population groups in conditions of greatest vulnerability. In the Region, 30% of the population does not have access to health care for financial reasons and 21% does not seek care due to geographical barriers. Populations in conditions of vulnerability are among the groups most affected by this problem ().

Barriers in access to services and inequities in coverage

Classically, access to health has been defined in three dimensions. The first is physical access, understood as the availability of good health services in different parts of a country, of reasonable scope, with opening hours as well as other amenities that make it possible for users to obtain services when needed. The second dimension is financial access, which consists of monetary arrangements that affect the capacity to make use of services and that include not only fees but also indirect costs (e.g., transportation). The third is sociocultural acceptability, which represents the will to request services and is understood as the capacity of the services to adapt and respond to the realities and social and cultural requirements of the population. Acceptability is lowest when people perceive that services are ineffective or when, for reasons of language, age, sex, sexual orientation, ethnic origin, or religion, the service provider dissuades them from seeking care. Inequalities exist in girls’ and women’s access to health care for their comprehensive needs across the life course. The reproductive health services that are most unequally distributed among women by socioeconomic status, ethnicity, and age are prenatal care, skilled birth attendance for delivery, and family planning. These disparities have many complex sources, including poverty, poor education, disempowerment, weak health systems, and gender discrimination. The poor technical and interpersonal quality of care for all women has also been highlighted as a frequent problem. Improving health services coverage demands analyzing and selecting actions to modify and eliminate the barriers to access in each of these dimensions. For communities seeking to achieve universal health, services should be physically accessible, financially attainable, and socioculturally acceptable for individuals.

PAHO defines access as the availability of comprehensive, appropriate, timely, quality health services when they are needed. But more specifically, access takes into account cultural and ethnic preferences, is linguistically appropriate and gender-sensitive, and bases actions and interventions on the identified needs of the populations. Further, such services promote health, prevent diseases, and throughout the life course, provide quality care that includes diagnosis, treatment, rehabilitation, and palliative end-of-life care. Quality health service encompasses intersectoral approaches to the social determinants of health and encourages active participation of individuals and social and community organizations.

Analysis of health infrastructure distribution in the Region reveals significant inequities in the concentration of service facilities, particularly hospitals, in large urban centers. Likewise, the farther removed health facilities are from cities or urban areas, the greater the shortage of competent personnel and inputs. This affects access and aggravates inequities. At the first level of care, the lack of adequate infrastructure (in number, geographical distribution, and response capacity) generates, among other adverse phenomena, excessive use of emergency services. This drives up costs, hampers efficiency, negatively affects both the continuity and quality of care, and increases the level of dissatisfaction among users and health care workers.

Poor quality care, provided by models that are inappropriate for the needs and health priorities of the population, also negatively impact health equity. Poor quality and warmth in the delivery of services—such as, courteous indifference, crowded waiting rooms, poor or lack of information, long wait times for surgery or other procedures or treatments, opening days and hours that do not accommodate people’s preferences and needs, refusal to provide care or treat patients who cannot pay, and poor maintenance of ancillary facilities (e.g., restrooms that lack soap and water or that are unclean or out of order, and a general absence of commodities such as seating in the waiting area) are unfortunate characteristics of many health services in countries of the Region. These situations are further compounded by frequent cancellation of long-awaited appointments due to the absence or shortage of personnel, malfunctioning diagnostic and treatment equipment, or unavailability of essential supplies, particularly medications.

The critical role of human resources for health

Serious imbalances and gaps persist in the availability, distribution, composition, competency, and productivity of human resources for health, particularly at the first level of care. Worldwide, evidence indicates that a threshold of 25 health workers/10,000 population (physicians, nurses, and certified midwives) is a useful benchmark for achieving adequate coverage (i.e., 80% of the target population) for programs or basic health interventions such as immunization and deliveries attended by skilled personnel (). However, this threshold does not account for the broader offering of health services made necessary by changes in the burden of disease, particularly by the growing prevalence of chronic conditions. The regional variation ranges from 3.6 health workers per 10,000 people in Haiti to 135 per 10,000 people in Cuba. In total, 16 countries of the Region demonstrate a critical shortage of health workers. The situation is even more serious if one considers the availability of health workers at the first level of care ().

The shortage of human resources for health care constitutes one of the main challenges or stumbling blocks in achieving universal health. The first challenge is relevant to all countries of the Region regardless of income level: providing care to dispersed populations in rural or remote areas and to communities in conditions of vulnerability. The second challenge is the profound historical imbalances in many countries; there are significant differences in the availability, distribution, composition, competencies, and productivity of the health care work force, which to a great extent is determined by segmented and asymmetrical work markets. In turn, training institutions play a critical role in the quality of training for health workers but respond to an educational market that is mostly unregulated. Finally, depending on the leadership and managerial capacity of the health system and the strategies implemented, health care workers and their organizations may either contribute to creating more equitable health systems or may become an impediment.

The available data suggest that by 2030, the majority of the countries in the Region will have surpassed the minimum level of 25 health care workers per 10,000 population, although a small number will still have critical deficits. However, in light of present commitments in countries of the Region, changing epidemiological and demographic profiles, and the ongoing transformation of the model of care, the relevance of this indicator needs to be reassessed in relation to the challenge posed by universal health.

The availability of health workers nationally does not reflect the profound imbalances in how they are distributed relative to health needs. One indication is the high concentration of health care workers in large cities to the detriment of the most remote, rural areas. For example, a study conducted in Brazil documents a doctor shortage in 1,280 non-metropolitan municipalities, (primarily in the northern and northeastern regions of the country) that affects more than 28 million people ().

The composition of the health care work force is another critical element that affects access to skilled health workers, consistent with the health needs of the population and the transformation of the model of care. In many countries, medical professionals, particularly specialized physicians, often serve as patients’ first point of contact in the health care system. There are only five countries in which primary care physicians constitute more than 40% of the total medical work force. Regarding the ratio of nurses to physicians, with the exception of the English-speaking Caribbean (where a majority of countries have a ratio of 3–5 nurses per doctor), there are significant nurse-to-doctor imbalances; only five countries in Latin America register a ratio close to one nurse per physician ().

Another relevant challenge is the availability of personnel with the right competencies; this is related to cooperation among educational institutions and with health authorities. Important gaps persist in the ability of countries to institute undergraduate curricula oriented toward primary health care, and to ensure that students from underserved populations have access to educational opportunities in the health professions. Only two countries in the Region reported that at least 80% of the health science schools have reoriented their curricula toward primary health care and have incorporated strategies for interprofessional training. Thus, building a health care work force trained and aligned to the current objectives and goals of primary health care and universal health has emerged as the great pending challenge in the area of human resources for health education and training.

Access to medication and appropriate health technologies

Access to and rational use of safe, effective, quality medicines and other health technologies, as well as respect for traditional medicine, continue to present challenges for most countries of the Region and affect quality of care. Supply problems, the underuse of generic drugs, higher-than-expected drug prices, and inappropriate and ineffective use of medicine all constitute additional barriers to universal health coverage affecting equity in health (). The regulatory capacity for medicines and health technologies is improving Region-wide, but it remains a challenge, particularly for the newer and more complex health technologies required by health systems.

For significant sectors of society, expenditures on drugs remain the most important component of out-of-pocket expenditure due to absent or inadequate health care coverage. Per capita, the average out-of-pocket expenditure for drugs in LAC reached US$ 97; it ranged from US$ 7 in Bolivia to US$ 160 or more in Argentina and Brazil. Additionally, compared to men, women pay 16–40% more for health care, they live longer, provide more unpaid health care more, and have more unmet health needs.

In the majority of countries of LAC, expenditures on medications are among the most significant items in health budgets (along with human resources); the costs constitute 25% to 65% of a country’s health-related expenditures. In comparison, in developed countries, expenditures for pharmaceuticals range from 7% to 30% of their total health-related expenditures.

Accordingly, increases in the cost of medications (and the lack of financial protection to cover those costs) limit individuals’ access and impact the sustainability of health systems and the attainment of universal health.

A similar challenge is posed by the dizzying development of health technologies in diagnostic imaging and radiation therapy; often there is a gap in access to these services. Additionally, the often rapid incorporation and use of these technologies create important inefficiencies.

Social determinants: barriers to equitable health and well-being

In the Americas, efforts to achieve universal access to health and universal health coverage began as early as the 1970s. Over the past three decades, several countries in the Region have implemented health system reforms that fostered inclusion, citizen participation, and equitable access to health care. Despite this progress, however, most countries in the Region still experience great inequities in health status and coverage of health interventions, with the result that there are major differences in health outcomes based on people’s wealth, education, geographic location, gender, ethnicity, and/or age ().

In LAC, for example, affordability is one of the most important determinants of access to and coverage of health care, and populations from poor communities are less likely to seek or attain care due to the direct and/or indirect cost of treatment (). Although many countries throughout LAC have made substantial efforts to expand health services to poor populations, health inequities caused by economic factors remain widespread in the region, especially for women, infants, and children (). In the United States, health inequity is a persistent problem, despite attempts to address it. United States government reports show that since 2007, “inpatient care for people with heart failure has actually grown worse for Hispanics or Latinos, Native Americans, and Alaska Natives. These minorities…are younger than their white counterparts. They also encounter socioeconomic, language, and cultural barriers to care that lead to higher rates of re-admission to hospitals and to poorer outcomes” ().

On the other hand, in Haiti and Nicaragua, the gap between the poorest and wealthiest women who have had at least four prenatal visits is more than 30%. Also, women from the poorest quintile in El Salvador, Guatemala, Bolivia, and Panama have unmet needs for contraception that is four times higher than the women from the wealthiest quintile ().

For populations living in poor settings, a range of different interventions has proven effective in overcoming financial barriers to health care. For example, by redistributing tasks to trained community health workers at the health facility level, a “task shifting” intervention, which was originally piloted in Haiti and later validated by WHO, has improved access to health services at the facility level by decreasing indirect costs (such as for transportation and lodging) for populations living in these settings ().

Education is another factor that significantly impacts access to health care. According to a systematic review of health literacy and health outcomes, individuals with lower levels of health literacy consistently had poorer health-related knowledge and comprehension, were less able to demonstrate taking medications properly, and were less likely to understand medication labels and health messages. They also had more hospitalizations and emergency care, received less preventive care and, among the elderly, had poorer overall health status and higher mortality ().

Furthermore, a recent study showed that low education levels affect women’s abilities to access basic health commodities (). This is evident in Costa Rica, El Salvador, Guatemala, Panama, Peru, and Suriname, where women with no education have an unmet need for contraception that is at least twice as high as that of women with secondary education or higher ().

In order to respond to the low levels of literacy, countries must improve access to effective school education, including providing adult education for those who missed out. The WHO Commission Report concludes that “removing the numerous barriers to achievement of primary education will be a crucial part of action on the social determinants of health” (). Thus, achieving high literacy levels in the population is not only a vital development goal, but will also produce substantial public health benefits (). The education of girls, expansion of social protection, and protection of the environment can have substantial health benefits. Less well established but equally important is how these investments affect women’s roles as health care providers and producers. Gender-responsive policies that recognize health as more than a sectoral outcome, and multisectoral programs that involve women in an enabling environment can empower them to achieve their full potential at home, in their communities, and in the health care work force.

Geographic residency is a third factor that significantly impacts access to health care. In LAC, people who live in rural and/or geographically marginalized areas often encounter barriers that limit their ability to get the health services they need. For instance, in many countries there is often a shortage of health care professionals in certain areas; this limits the supply of available services and in turn reduces access to care. Further, people in rural and/or geographically marginalized areas are more likely to have to travel long distances for health services, which can impose significant burdens on health, money, and time. In addition, there is often a lack of reliable public transportation, making it even more difficult to access needed care (). Other barriers to health services in these remote areas include social stigma and privacy concerns, poor health literacy, facility overcrowding, inability to take time off work, and lack of alternate childcare (). Such barriers to services result in unmet health care needs, which ultimately threaten the well-being and optimal health of populations.

There are many different strategies that can improve access to health care among populations living in rural and/or geographically marginalized areas. Establishing equity-based interventions have proven effective in reaching remote populations. For example, casas maternas (maternity waiting houses) are community-run health facilities that host pregnant women for days or weeks before their scheduled delivery. The objective is to increase access to maternal health services, including births attended by skilled health staff, for populations living in rural and/or geographically marginalized areas (). Several studies indicate that this community-based strategy has been effective in increasing the number of assisted births in geographically remote areas, which consequently decreased the probability of complications during delivery ().

In spite of the vast progress made in the Americas, inequities in vaccine coverage within countries have often been masked by high estimates of vaccine coverage nationally. However, population groups that are unvaccinated or that are vaccinated at lower than the national level are among the most underserved and poorest municipalities or areas. In 2015, in 56% of 15,000 municipalities in Latin America and the Caribbean (8,456 in all), fewer than 95% of children received three doses of diphtheria, pertussis, and tetanus vaccine (DPT3), missing the target level (). The proportion of children under 1 year living in municipalities with suboptimal coverage for DPT3 is almost 20% higher in countries in the lowest income quartile compared with countries in the highest income quartile. The high risk of exposure for diseases that can be prevented with a vaccine is attributable to the prevailing economic inequality between countries in the Region ().

In order to ensure equitable access to vaccines, it is essential to maintain efforts and to further analyze, at both the Regional and national levels, the causes of inequity, including those related to the social determinants of health. Immunization coverage should be a key indicator for achieving universal health given that immunization has the potential to be directly integrated with other services, including prenatal care, adolescent sexual and reproductive health, elderly care, and prevention and control of chronic conditions.

Measuring equity in health systems performance: the paucity of information

Measuring inequalities and equity in health systems is a challenging task for many countries in the Region. As is often said, if it is not measured there is no way to know where we are, where are we going, and whether we are making progress. On the other hand, there is still much debate on some of the basic definitions—for example, what we mean by “unfair” inequalities.

Many measurement frameworks for inequity in health have been proposed and discussed, and there is no shortage of approaches in the specialized literature (). This continues to be a complex issue that “requires consideration of ethics (e.g., defining unfair inequalities), methods (e.g., quantifying health inequities), and policy (e.g., offering policy relevant information)” ().

Aside from methodological difficulties, countries often lack capacity for generating and sharing quality data to inform assessments of inequalities and inequities. PAHO Member States will require purposeful interventions and investments in health information and statistical systems to build competencies that will provide effective capacity to measure and report on health inequities on a regular basis.

In the interim, PAHO has proposed including proxy indicators for measuring equity in health care services in the assessment framework of PAHO’s Strategic Plan 2014–2019 (). Technical cooperation with Member States will be key to building capacity to achieve this goal and to further develop a Regional framework for measuring and monitoring inequalities and inequities in health.

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Reference/Note:

1. Resolution capacity in this context is defined as the ability of health services to provide health care responses adapted to people’s needs and demands, in line with current scientific and technical knowledge, resulting in an improvement in health status.

2. The PAHO Gender equality policy recognizes that there are differences between men and women with regard to health needs, and to the access and control of resources, and that these differences should be addressed in order to correct the imbalance between men and women ().

3. As of 2010, 36 million people in the Region did not have access to drinking water fit for human consumption. Some 120 million lacked improved services for the disposal of waste water and sewerage, and almost 25 million people in Latin America and the Caribbean defecate in the open ().

4. Behavior displayed by service personnel (not only in health services) who speak to clients or users using courteous language but whose demeanor, body language, and attitude displays lack of warmth, poor interest, or indifference and even aggressiveness.

Stewardship and governance toward universal health

  • Introduction
  • Conceptual dimensions of stewardship and governance
  • Stewardship and governance of health system transformation processes
  • Conclusions
  • References
  • Full Article
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Introduction and rationale

The objective of this topic is to analyze how the health authorities have led processes of change in the governance of health systems in the Region of the Americas, as they move toward universal access to health and universal health coverage. Stewardship describes the capacity of health authorities to lead and support joint action, which allows the creation, strengthening, or changes to governance structures in the health system. Governance is understood to be the institutional arrangements that regulate the actors and critical resources that influence conditions of coverage and access to health services ().

In order to make universal access to health and universal health coverage possible, health systems must overcome their institutional limitations, generally characterized by segmented coverage and fragmented services. The health authorities must exercise stewardship in order to strengthen governance of the financial model and of the health services, human resources, medicines, and technologies that constitute the sector ().

An analysis of the strategies of universal access to health and universal health coverage implemented in the countries in the Region of the Americas allows us to recognize different processes of change that address these issues. The differences lie both in the way health authorities practice stewardship and in the kinds of governance innovations proposed as engines to transform health systems.

This topic is divided into three sections. First, the various aspects of leadership capacity and governance in the health sector are discussed. Second, there is an analysis of health system transformations in the countries of the Americas, the role of stewardship by the health authorities, innovations in governance, and the main objectives and progress made. Finally, by way of conclusion, this document indicates the challenges that must be addressed in order to move toward universal health.

Conceptual dimensions of stewardship and governance

Stewardship for universal health

When the health authorities exercise stewardship, they lead the sector by formulating, organizing, and directing national health policy. This in turn allows them to improve the effectiveness, efficiency, and equity of the health system by strengthening or transforming the governance structures of the health sector. The process of transforming health systems is necessarily political, because the actors involved in this collective action are responsible for making the process both feasible and viable (). For this reason, there is a need for stewardship that is not exclusively associated solely with the influence of the health authorities, expressed by the role of the ministries of health. Rather, consideration must be given to the authorities’ role in leading collective action that also includes other actors within and outside State structures.

Agencies in other sectors or jurisdictions (housing, education, finance, trade, etc.) within the State also bear mention, as they are indispensable for sustaining intersectoral initiatives to address the social determinants of health by strengthening social protection systems (). We must also consider actors in subnational (provincial and municipal) jurisdictions that play a key role in adjusting or implementing initiatives in the local context, as well as non-State actors (organized and unorganized civil society, non-profit and for-profit private sector organizations with varying degrees of formality and visibility) that perform important roles of social oversight, advocacy, and influencing processes of change and service delivery ().

Governance for universal health

The concept of governance has been evolving from one centered on institutional attributes toward one which addresses changes to the institutional mechanisms that regulate actors and critical health sector resources (). This approach allows us to interpret those health system transformations that, in order to improve access to health and to health coverage, require related changes to health sector institutions ().

Governance of health services

The type of governance required to achieve comprehensive health service networks, with a people- and community-centered model of care, requires changes to how different relationships or processes are regulated ():

  1. value and understanding of the actors involved in the health services network;
  2. regulation of the interactions among actors involved in the organization, management, and care provided by the health services;
  3. regulation of the relationship between services and the population;
  4. intersectoral regulations for the services and other social sectors.

The values (right to health, equity, and solidarity) of the actors involved in producing health services constitute a foundation for social regulation that helps legitimize the transformation of health service delivery. Therefore, they are crosscutting for all actors involved.

Regulations within networks can be grouped into three categories: those related to organization of the health system; those related to management; and those related to care. The rules governing how the health system is organized determine where health services are delivered (outpatient care in hospitals, in specialized diagnostic centers, and primary care); how health services are coordinated among the different levels of care (referral and cross-referral systems); and how resources (financial, human, and material) are allocated and managed in the health services network. The rules governing management include service programming (centralized or decentralized programming); labor standards (record-keeping on production, working hours, extended schedules, care hours and non-care hours); the coordination of work teams at health care centers (collegial management decisions, unilateral decisions); and relationships between health centers and social organizations (mechanisms for coordination or community participation). The standards of care determine standards of production, quality of services, and models for organizing the work among both professionals (interdisciplinary) and within the health services or in different organizations or levels of care.

The regulatory mechanisms that govern the relationship between health services and the population encompass more than the standards of care that determine access and the responsibility that health teams have for the health of the population in specific territories. They also include the expectations, demands, and rights of individuals, communities, and civil society (spaces for participation and consultation) as a part of the management model.

Intersectoral regulation can be situated at different levels. At the macro- or mezzo-institutional level, there are mechanisms to connect health policies with other social policies for coordinated implementation within the territory. At a micro-institutional level, there are intersectoral initiatives that regulate the relationship between health service delivery and other sectors or services that influence the determinants of health of the population.

Human resources

Governance of human resources is a central part of the stewardship of health authorities (). Policies related to human resources range from educating future health workers to helping them enter the job market and perform well there. In order to make progress nationally toward universal health, a set of policies, regulations, and interventions must be established to organize and align the output, competencies, internal and external mobility of professionals, employment, working conditions, and needs-based distribution of personnel-just to mention some crucial aspects ().

Multiple actors intervene in these processes-with given responsibilities and objectives-from a variety of sectors, such as education and health, with dissimilar interests in the public, private, for-profit, or non-profit sectors. From the perspective of the health authorities, the goal of effective governance and leadership is to channel, organize, and motivate these various legitimate interests in order to achieve universal health. Four dimensions of governance related to human resources are recognized: (a) human resources education, (b) professionalization, (c) regulation of professional practice, and (d) regulation of the job market.

Human resources education includes undergraduate and graduate education, residencies, and the job market, as well as continuing education during professional practice. Authorities must ensure that all health workers have up-to-date and appropriate competencies to properly perform their duties and responsibilities. Ensuring competency ranges from undergraduate education with a renewed focus on primary health care (PHC), the acquisition of collaborative and interdisciplinary work skills, the establishment of competency profiles for future professionals, the establishment of single national exams, and postgraduate education with medical residencies and continuing education. It should also take into account the requirements of periodic recertification for certain professions.

Professionalization is the professional regulation of those involved in providing health services. It requires new definitions of the professions, including profiles, responsibilities, and specializations suitable for the challenges of building comprehensive and integrated models of care, centered on people and their communities ().

The regulation of professional practice entails defining standards of practice and the instruments and entities to evaluate the performance of health professionals.

Finally, regulation of the job market refers to both working conditions (work load) and hiring conditions (job security, collective bargaining, and methods of payment).

Governance of technology and medicines

The attainment of universal access to high-quality, safe, effective, and affordable medicines and health technologies is possible if policies and regulatory legal frameworks are adopted to ensure that health authorities strengthen governance at all stages of the lifecycle of these products. Such governance includes (i) supply issues, from innovation and development of new products through regulation of the quality of production and marketing; (ii) demand issues, including mechanisms to define the criteria for inclusion in health systems coverage, as well as rational prescribing; and (iii) other factors that impact effective access to these products, such as setting market prices and operation of the systems for dispensing these products ().

Regarding supply issues, the health authorities have a critical role to play in providing guidance to innovation and development in the industrial health sector, to ensure that it addresses the health needs of the population, rather than just satisfying commercial interests. If intellectual property rights are handled from a public health perspective, high-quality patents will be promoted and innovative drugs will be developed. This will also help avoid inappropriate extension of market exclusivity and facilitate the timely introduction of generic products from multiple sources. In order to achieve this objective, use can be made of the licensing flexibilities allowed under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and included in the 2001 Doha Declaration on TRIPS and Public Health ().

These policies should align with national health policies and social development policies in the areas of science, technology, and industrial development, given the importance of these products and sectors to economic growth. Once on the market, the production and marketing of medicines and other health technologies should be subject to strict regulation and oversight (). The work of regulatory agencies is needed to help develop markets for medicines and technologies that ensure the efficacy and quality of the products offered ().

Governance of demand conditions ranges from criteria for inclusion of these products in health systems coverage, to regulation and incentives for rational prescribing and use. Inappropriate prescribing, dispensing, and use of drugs and other health technologies cause poor health outcomes (). As of 2015, only 42.9% of countries in Latin America and the Caribbean had adopted standards and procedures to prepare clinical practice guidelines.

Finally, governance of these products includes dissimilar strategies to address economic aspects related to setting relative prices and the price structure. While some countries have price regulation mechanisms, others have encouraged negotiations to leverage the purchasing power of the public sector, such as joint national or regional procurement. This is complemented by comprehensive, transparent supply chain planning, which is crucial for ensuring access to health. The planning process should start by determining the need for these products and how they should be financed, with adjustments to the coverage, reimbursement, and procurement systems (or public production), and the corresponding distribution and supply.

The information sharing, cooperation, and networking that different sectors and countries have undertaken have significantly helped to strengthen regulatory systems and stewardship and governance in the health sector. The Pan American Network for Drug Regulatory Harmonization (PANDRH), created in 1999, includes 29 of the 35 countries of the Americas and supports drug regulatory harmonization in the Region.

Governance of financing

Governance of health systems financing entails regulation of its three central dimensions: the generation of financial resources for the health sector, determined by compulsory or voluntary contribution mechanisms; insurance, determined by the mechanisms that collect the resources, which either consolidate or segment the health system; and the transfer of financial resources to the health services, which determines the incentive structure for health service delivery ().

Governance through regulation of the mechanisms to collect, insure, and transfer resources influences the rest of the critical resources (human resources, medicines and other technologies, health service delivery) that make up the health system, as well as progress made in terms of access to health services and coverage for the population. A detailed analysis of the progress made and the governance challenges of the financing model will be discussed in topic 5 of this chapter, “Health financing in the Americas.”

Regulatory mechanisms for the production and consumption of goods that impact health

The growing leadership of the health authorities is also seen in the development and improvement of systems to regulate the production and consumption of mass-produced goods (e.g., in the food industry; use of pesticides; regulation of alcohol, drug, and tobacco consumption; and environmental stewardship). These seek to act on risk factors that affect the health of the population ().

These strategies consist of mechanisms to regulate activities not controlled by the health systems, which are national in scope and affect the health of the population. However, we should note the strong role played by global governance, as defined by international agreements.

The health authorities have also made progress with their regulatory functions due to the support of social movements and organized civil society. These partnerships have made it possible to include the health authorities in economic and commercial decision-making, traditionally outside their purview and reserved for the ministries of finance and trade. A detailed analysis of the progress made and challenges faced in intersectoral governance and its relationship to the Health in all Policies approach is presented in topic 3 of this chapter, “Social determinants of health.”

Stewardship and governance of health system transformation processes

Health system transformation processes in the countries of the Region of the Americas can be analyzed in terms of governance changes brought about by the stewardship of the health authorities. These processes are institutional-because changes in governance involve changing the “rules of the game” that regulate actors and critical health sector resources-and political-because the changes in governance are led by the health authority, together with a broad range of actors working to bring about these transformations (). In order to differentiate the various types of health system transformation processes, we will look at political aspects associated with stewardship and the institutional aspects related to governance.

Along these lines, two types of health system transformation approaches () are presented below: those based on changes in health insurance, which seek to increase financial coverage of the population, and transformations based on changes to the health services organizational model, which seek to improve access to health services.

Transformations based on changes in health insurance

These processes start by changing the mechanisms that regulate financing models-particularly for the coverage of health services-with the introduction of market incentives and competition (among resource managers, service providers, and pharmaceutical companies). The main objective of these reforms is to increase the covered population, thereby providing financial protection and determining the health services included in the coverage. For this reason, innovations in governance focus on changes to insurance mechanisms as the main engine of reform. Table 1 lists the cases of Bahamas, Colombia, Honduras, Turks and Caicos, United States of America, and Uruguay. These examples show how financial coverage expansion policies can follow different strategies, with uneven progress and limitations ().

Table 1. Changes in insurance mechanisms, by country

Country Date Policy Objectives Innovations in governance Achievements and progress
Bahamas 2016 to present National Health Insurance Law Increase coverage: ensure free-of-charge health services to all residents at point of care. Cost to be fully or partially covered by government The National Health Insurance Authority was created to oversee implementation of the National Health Insurance plan Designed in stages (); stage 1 is registration of users
Colombia 1993 Law 100 of 1993 Expand coverage; Create a system of regulated competition by introducing private administrators to handle social security resources; 100% population coverage
2012 Convergence of contributory and subsidized systems with the unification of covered benefits Standardize coverage under the two subsystems
2015 Overcome access barriers Eliminated service coverage criteria and moved to a system of an exclusions-based benefits system In the process of implementation
Honduras 2015 Framework Law of the Social Protection System Achieve universal health insurance Public or private administrators of health service networks may be included in the social security funds, and, progressively, in the public sector In the process of implementation, with complementary legislative initiatives regarding social security and national health system laws
Turks and Caicos Islands 2009 to present National Health Insurance Plan Increase insurance coverage (goal of 100%), eliminate direct payment, and provide access to a comprehensive benefits plan in the public and private sectors National Health Insurance Council is established to monitor the plan, define benefits, determine contributions, and advise the minister of health; it is comprised of representatives of ministries and political parties Implemented in 2009, but starting in 2016 amendments are approved to extend coverage to unemployed people and children of migrant workers, and to allow voluntary membership
United States of America 2010 to present Patient Protection and Affordable Care Act Increase the uninsured population’s coverage and access to health services Private insurance sector: compulsory universal insurance; no applications turned down regardless of health status; same premium for all plans; subsidized premiums and copayments for those who qualify; expansion of the public sector through Medicaid (state and federal) has been optional for each state Reduction of the population without health insurance from 16.4% in 2010 to 11.4% in 2015, and lower barriers to access; Expansion of Medicaid coverage in 25 states
Uruguay 2007 to present Law 18,211 of the Integrated National Health System Increase insurance coverage through social security Changed the financing model (more public financing and insurance equity) Increase in coverage from 20% of the national population to almost 70% in 2016

The logic of introducing economic incentives as a strategy to change health insurance requires powerful stewardship and governance mechanisms to regulate all the critical resources of the health system (financing, human resources, and medicines and health technologies). Stewardship of these reforms centers on the participation of regulatory and control agencies, whose obligations usually revolve around social security. These actors are housed in new management, regulation, and control structures associated with the new financing model (). In countries where relevant changes have occurred in social security, these new structures are seen in the operation of regulatory authorities governing the organizations in charge of health services finances (e.g., the superintendencies in Chile and Colombia). Other countries focus on greater involvement of the Ministry of Health in regulation and management of contribution-funded insurance (e.g., JUNASA of Uruguay) or the agencies responsible for public insurance (e.g., FONASA of Chile and SESAL of the Dominican Republic). However, countries still need to develop the political and technical authority needed to control the direction of these transformation processes. Some countries, with the support of international financing agencies, have also created new executing units with structures in charge of implementing these reform projects.

Joint activities can also be complemented by new or traditional private actors involved in managing health insurance and providing health services. The characteristics of these for-profit or not-for-profit private actors that complement collective efforts-their local history, corporate development, vertical integration between insurers and providers, and the type of local and international partnerships involved-are elements that determine their influence on transformation processes and the strategies used to achieve them.

Governance of medicines, health technologies, and human resources for health can be influenced by the key players involved in this type of transformation process. First, there are specific structures at the ministries of health and regulatory agencies on each of these topics, with varying levels of regulatory capacity. However, private insurers and providers also have potential influence on the governance of drugs, health technologies, and human resources through partnerships and trade agreements. Examples of this include virtual integration between private insurers and companies that supply medicines and technologies, and strategies to train new professionals and recruit them to work at these companies’ own health service delivery facilities. There is a complex web of tension between different private interests and the objectives of public policies to promote universal access to health and universal health coverage, requiring active strategies to strengthen the leadership and influence of the health authorities. For this reason, drug policies must be further developed. They must include regulatory mechanisms to strike a balance between the market and incentives to promote innovation (intellectual property) and competition (generic drugs), on the one hand, and the health needs of the population and social policy objectives of equity, solidarity, and the guaranteed right to health, on the other hand. To this end, it is essential to strengthen the government’s regulatory authority and give it the political and technical power to enforce compliance with regulations and encourage the pharmaceutical industry to take an innovative, competitive, and social approach. Examples of such actors are the Food and Drug Administration (FDA) of the United States, the National Health Surveillance Agency (ANVISA) of Brazil, and the National Drug, Food, and Medical Technology Administration (ANMAT) of Argentina. With its capacity to innovate and introduce health technologies, the medicines and technology market holds great economic and political power and must therefore be counter-balanced by State power representing the interests of society. This will ensure that the market will not have undue influence on how the health systems and health services are organized, how human resources are trained, how new devices and equipment are introduced, and the opening of new units, hospital services, and new professional specialties.

Finally, these reform processes result in pressure for changes in the training and performance of human resources, brought about by the insurance market, private services, and health technologies. Agencies that purchase services can introduce innovations in the standards and dimensions of professional practice, either through economic incentives or through standards of care specifically included in job contracts. For this reason, the health authorities must exercise stewardship to strengthen the governance of human resources education, ensuring that it is aligned with the objectives of universal health. Educational programs must be consistent with PHC and people- and community-centered models of care.

Transformations based on the model of care and organization of health services

A second type of reform revolves around transformations in the governance of health systems and services, in conjunction with changes in the regulation of human resources aimed at increasing access to health services. Table 2 shows certain countries (Bolivia, Brazil, Canada, El Salvador, and Guatemala) that have health system transformation policies in place, whose main objective has been to expand access. The models they have used to organize, manage, and deliver health care have been key factors in bringing about change ().

Table 2. Changes in the organization of health services, by country

Country Date Policy Objectives Innovations in governance Achievements and progress
Bolivia 2013 to present Mi salud model Ensure that the population not covered by social insurance has access to family doctors Human resources education and changes to the model of care, with the introduction of traditional medicine Has been implemented in 306 of Bolivia’s 339 municipalities with the addition of 2,389 physicians
Brazil 2011 National PHC Policy (), National Program to Improve Access and Quality (PMAQ) Ensure the quality of care Expand health teams by paying outcome-based incentives Between 2011 and 2015, increased from 71% to 96% of all municipalities, and from 53% to 94% of family health teams
Canada 2004 to present Development of Integrated Health and Social Service Centres (CISSS) in Quebec Transform the model of care at 90 CISSS that serve specific local populations, with a focus on accessibility and continuity of care, with preventive and curative care for the most vulnerable Integration of health and social welfare services through PHC in “autonomous” family practice clinics; this has encouraged multidisciplinary work by giving the nursing staff and public health workers a more important role, and by focusing on the participation of community groups, including citizens’ committees and community representation Progress was made toward achieving an integrated network with: expansion of the duties of nursing staff at the clinic and community levels; integration of other health professionals to support family doctors; monitoring of the quality of private medical care for older persons; low level of citizen collaboration in management, but greater user participation in planning, and better integration of the curative and preventive approaches in family medicine
El Salvador 2009 Construyendo la Esperanza (Building Hope) Ensure access to health services for the rural population Organization of the health services (community family health teams and specialized teams) 7.21% increase in institutional deliveries and 13.68% increase in deliveries at regional hospitals between 2009 and 2012
Guatemala 2016 Inclusive Health Model Increase equitable access to health services for the rural indigenous population facing problems in receiving care Strengthening of the primary care model through territory-based health teams, as a complement to traditional medicine Limited progress in 10 health districts and 5 departments with trained staff and a comprehensive information system on individuals, families, and communities

These kinds of transformations are based on new understandings of health and disease in the population and, as a result, in changes to the way the health services respond to the needs of the population. They generally require changes to the governance both of services and human resources. These innovations result from the collective efforts of new groups of professionals included in health teams (family doctors and general practitioners, social workers, psychologists, and nurses) who lead the introduction of new concepts, in partnership with decision-makers, health service managers, and social movements. Their guiding principles are the social values associated with equity, social inclusion, and health as a social right.

According to this approach, changes in the governance of services involve new regulatory frameworks and organizational structures, including new ways to coordinate the organization of health services into integrated networks. Health services management thus becomes proactive and encompasses logistics for medicines and other health technologies, and the development of instruments to register, measure, and evaluate the performance of the health services. Finally, changes to the governance of health services also imply changes to the model of care, leading to a new relationship between health teams and the population. These teams take responsibility for the health of a population within a given territory, with greater resolution capacity in primary care, within a context of comprehensive care and collective compliance with integrative standards at the different levels of care.

Changes are needed in the governance of human resources primarily due to innovations in the health services. New social values must be incorporated into professional training. Mechanisms must be established to coordinate organization and care through integrated health service networks. This requires new approaches to professional practice that incorporate interdisciplinary and crosscutting work into health care. Similarly, it is necessary to make changes in the regulation of the health professions as new specialties (within general medicine and family health) facilitate changes to the models of care. Thus, the new models of care also require regulatory changes in professional working conditions, including full- or part-time work, workload, wage scales, decent working conditions, and responsibilities.

These transformation processes have implications for governance of medicines and technology. In order to ensure access to quality health services and response capacity at the primary care level, medicines and health technologies must be available. This is possible if appropriate price negotiating mechanisms are used, generally including centralized (national or regional) procurement, and with the introduction of systems to ensure that supplies are sufficient to cover health needs.

Financing mechanisms also have a big impact, such as innovations in budget formulation and execution. In this case, the establishment of comprehensive health service networks requires resource allocation mechanisms that are aligned with integrated management of the production processes, assuming that primary health care, specialized services, and hospital services are all integrated. Similarly, the development of comprehensive health service networks also requires efforts to combat or minimize segmented health systems and, as a result, to coordinate or establish different systems to finance, insure, and deliver individual and collective health services. Finally, transformations in the supply of health services to achieve universal access to comprehensive, quality services have driven policy arguments in favor of increasing public financing for health.

Stewardship of transformation processes can be seen in the new institutional and organizational frameworks responsible for managing these health service networks. One example is the emergence of new municipal health secretariats, areas, and regions that act as decentralized entities or primary health care bureaus in charge of managing health services and promoting policies of change. These structures house strategic players in the reform processes. They include health authorities and health service managers (with a strong presence in the management structures governing the health service organizations), new actors (such as groups of health professionals involved in primary care), and social movements that give political support for the expansion of health services, while exercising public oversight to ensure that the supply of health services is aligned with the demands and expectations of the population (e.g. in Bolivia, Brazil, Ecuador, and El Salvador).

Conclusions

Developing health systems able to achieve universal access to health and universal coverage requires changes in governance affecting the critical resources of those health systems (financial and human resources, services, medicines, and technology) (). An analysis of health system transformation processes in the Region shows that the dynamics of such reforms have not been uniform. On the contrary, we see two types of transformations, each with its own underlying logic. According to the logic of each, stewardship and governance possess unique characteristics.

Supply-centered health system transformations have been led by health authorities whose main objective was to improve access to health services. These initiatives were based on organizational structures to manage the health services network, along with the collective action of different health professionals and social movements.

These governance transformations revolved around changes to the model of care, in conjunction with new regulations for human resources. This approach assumes that changes to the framework in which health services are produced helps facilitate and structure institutional innovations (financing, intersectoral regulations, and intersectoral governance of medicines and technology) in the rest of the health system. Countries that have promoted this type of reform have achieved substantial progress in terms of access to services through more integrated and less fragmented models of care. Such changes have generally been limited to the public sector and have shown a limited ability to reduce the segmentation of health systems.

Demand-centered health system transformations have focused on increasing the financial coverage of the population by introducing economic incentives in the institutional arrangements that regulate insurance. Stewardship is exercised by agencies and structures to regulate and oversee private actors that serve as either fund administrators or health service providers. According to this approach, introducing competition-through demand for both insurance packages and for health services-will encourage innovation in the rest of the health system (in service organization and human resources). These kinds of changes have managed to expand financial coverage for a larger segment of the population, in a context of reforms that include both the public sector and social security. However, the challenges lie in ensuring that the regulatory agencies work, and showing that coverage has expanded, yielding real improvements in access for the population ().

It is also important to realize that although these two approaches to change tend to yield different kinds of health system reform, both approaches are sometimes applied simultaneously in countries. This is true of federal countries (in which national and local jurisdictions promote different approaches) and of countries that have segmented systems (in which both social security and the public sector include private initiatives) where the dual approach is part and parcel of the transformation process ().

Finally, the stewardship of the health authorities and involvement of key actors in joint activities does not end with a formal delineation of responsibilities, but with the development of critical capacity to respond to the specific context of each country. This brings us back to the concept of essential public health functions, such as the critical capacities of the health authority and an agenda to develop the health authority’s stewardship, within the framework of processes aimed at transforming and strengthening health systems ().

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Reference/Note:

1. There are various initiatives in the Region promoted by institutions that regulate service quality. Ecuador has an initiative promoted by a specialized, autonomous entity for managing the quality of health services. It is called the Agencia de Aseguramiento de la Calidad de los Servicios de Salud y Medicina Prepaga (Agency to Ensure the Quality of Health Services and Prepaid Medicine) (Access). The purpose of the agency is to ensure stewardship of the public network and comprehensive health care, and to regulate the quality of service delivery in both the public and private sectors. This process starts by qualifying, certifying, and accrediting institutions, and strives for continuous improvements in quality. Out of 44 hospitals in 2016, 28 received a Gold rating, 2 Platinum, 11 were awaiting accreditation, and 3 had not been accredited. In Mexico, the quality management model takes a people-centered approach. It measures results through indicators on the health of the population, real access, reliable and safe organizations, customer satisfaction, and reasonable costs. Finally, Peru has implemented the Dirección de Calidad en Salud (Bureau of Health Quality) based on the National Health Quality Policy adopted in 2009. It seeks to improve the quality of service at institutions delivering health care by following guidelines handed down by the national health authority. One policy is aimed at accrediting health establishments and medical support services. Between 2008 and 2012, hospitals began to conduct self-assessments. In 2013 and 2014, the accreditation process began to be transferred, in accordance with the Health System Reform Framework ().

2. The health authorities of some countries of the Region (e.g., Brazil and Cuba) play an important role in governing innovation for health. However, a lack of technological innovations that make a significant difference, along with prices that significantly exceed the marginal contributions, is still a persistent problem in many cases.

3. Some countries of the Region have used such licenses: Canada granted a compulsory license for export purposes only which authorized a generic drug manufacturer to export HIV/AIDS drugs to Rwanda in two shipments in 2008 and 2009; in 2007, Brazil granted a compulsory license for efavirenz for the treatment of HIV-1; and between 2010 and 2014, Ecuador granted compulsory licenses for ritonavir, abacavir+lamivudine, etoricoxib, mycophenolate, sunitinib, and certolizumab.

4. In 2016, 13 countries of the Region had structures to evaluate health technology and 7 had adopted legislation requiring that health technologies be evaluated before decisions are made. Furthermore, 92.9% of countries already have national selection committees and drug and treatment committees, and have prepared national lists of essential medicines. Establishment of the Caribbean Regulatory System (CRS) is an innovative subregional integration model for small states and territories. It is based on common policies that allow states to preserve sovereignty in health decision-making, while maximizing multinational cooperation to strengthen health stewardship and governance ().

5. Atlases of health care variations in different countries highlight the need to also consider the high degree of noncompliance with therapeutic positioning and clinical practice guidelines, as well numerous unjustified variations in medical practice.

6. The MERCOSUR countries (Argentina, Brazil, Paraguay, Uruguay, and Venezuela) have systematically used this mechanism to share inspection reports and report adverse events. The National Regulatory Authorities of Regional Reference and the five countries (Australia, Brazil, Canada, Japan, and United States) involved in establishing the Medical Device Single Audit Program (MDSAP) (http:/www.fda.gov/Medicaldevices/InternationalPrograms/MDSAPPilot/default.htm) also consider information exchange to be an essential part of their work. In order to support the secure exchange of non-public information, an IT portal was developed called the Regulatory Exchange Platform – secure (REP), which in its initial phase will include the countries participating in the MDSAP initiative. It affords a safe and dynamic environment for the exchange of regulatory documents for the authorization and control of health technologies.

7. These functions were traditionally distributed in different dimensions of stewardship, such as regulation of insurance plans (as part of regulation by the health authorities), the monitoring of insurance, and financial oversight ().

8. One example is the WHO Framework Convention on Tobacco Control (WHO FCTC), which reaffirms the right of all the people to the highest standard of health and was negotiated under the auspices of the World Health Organization ().

9. Insurance is understood to consist of mechanisms that pool financial resources to ensure that the population has access to health services when it needs them.

10. The introduction of commercial or management contracts with service delivery institutions and with professionals is an important regulatory tool. It should be designed to align incentives by determining specific prices and products with new forms of payment, and should promote standards of care and performance indicators for the services. These are the general conditions necessary for changing the way in which health services are produced.

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