Stewardship and governance toward universal health
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 ():
- value and understanding of the actors involved in the health services network;
- regulation of the interactions among actors involved in the organization, management, and care provided by the health services;
- regulation of the relationship between services and the population;
- 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.
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).
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 ().
1. Hufty M, Báscolo E, Bazzani R. Gobernanza en salud: un aporte conceptual y analítico para la investigación [Governance in health: a conceptual and analytical approach to research]. Cadernos de Saúde Pública 2006;22(supplement):S35–S45.
2. Pan American Health Organization. Strategy for universal access to health and universal health coverage. 53rd Directing Council, 66th Session of the Regional Committee of the WHO for the Americas, Washington, D.C., 2014 Sept. 29–Oct. 3 (CD53/5.R2). Available from: https://www.paho.org/uhexchange/index.php/en/uhexchange-documents/technical-information/26-strategy-for-universal-access-to-health-and-universal-health-coverage/file.
3. Pan American Health Organization. The steering role in health and institutional strengthening of the national and subnational health authorities. In: Public Health in the Americas. Washington, D.C.: PAHO; 2002:7–14. Available from: https://www.paho.org/hq/dmdocuments/2010/EPHF_Public_Health_in_the_Americas-Book.pdf.
4. Travis PD, Egger D, Davies P, Mechbal A. Towards better stewardship: concepts and critical issues. Geneva: World Health Organization; 2002. Available from: http://www.who.int/entity/healthinfo/paper48.pdf?ua=1.
5. Saltman RB, Ferroussier-Davis O. The concept of stewardship in health policy. Bulletin of the World Health Organization 2000;78(6):732–739.
6. Báscolo EP, Yavich N, Denis JL. Analysis of the enablers of capacities to produce primary health care-based reforms in Latin America: a multiple case study. Family Practice 2016:33(3):207–218.
7. Pan American Health Organization. Guía para el mapeo de la Autoridad Sanitaria Nacional [unpublished report]. Washington, D.C.: PAHO; 2005.
8. Pan American Health Organization. Función rectora de la Autoridad Sanitaria Nacional. Desempeño y fortalecimiento. Special Issue No. 17. Washington, D.C.: PAHO; 2007. Available from: https://www.paho.org/hq/dmdocuments/2010/Funcion_Rectora_ASN.pdf.
9. Bolis M. La dimensión regulatoria en el contexto de la rectoría de la Autoridad Sanitaria Nacional. Steering Role in Health Sector Reform Processes Meeting; Washington, D.C.; 2004 June 14–15. Washington, D.C.: PAHO; 2004.
10. Bolis M. La dimensión regulatoria en el contexto de la función rectora de la Autoridad Sanitaria. Taller sub-regional para América Central, República Dominicana y Puerto Rico sobre evaluación del desempeño y fortalecimiento de la Función de conducción de la Autoridad Nacional de Salud, San Salvador, 2005 March 2–4, Pan American Health Organization.
11. Pan American Health Organization. El nuevo papel de las regulaciones gubernamentales en salud a cargo de los Ministerios de Salud. Organization and Management of Health Systems and Services Series, No. 7. Washington, D.C.: PAHO, Division of Health Systems and Services Development; 1998.
12. Pan American Health Organization. Desarrollo de la capacidad de conducción sectorial en salud (una propuesta operacional). Organization and Management of Health Systems and Services Series, No. 6. Washington, D.C.: PAHO, Division of Health Systems and Services Development; 1998.
13. Pan American Health Organization. Regional Forum Report. Universal health: healthcare systems and quality of care [unpublished report]. Washington, D.C.: PAHO; 2015.
14. Báscolo EP. Gobernanza de las organizaciones de salud basados en atención primaria de salud. Revista de Salud Pública 2010;12(1):8–27.
15. Pan American Health Organization. Human resources for health: increasing access to qualified health workers in primary health care-based health systems. 52nd Directing Council, 65th Session of the Regional Committee of WHO for the Americas, Washington, D.C., 2013 Sept. 30–Oct. 4 (CD52.R13). Available from: http://iris.paho.org/xmlui/bitstream/handle/123456789/4441/CD52-R13-eng.pdf?sequence=1&isAllowed=y.
16. World Health Organization. Global strategy and plan of action on public health, innovation and intellectual property. 61st World Health Assembly, Geneva, 2008 May 24 (WHA61.21). Available from: http://apps.who.int/medicinedocs/documents/s21429en/s21429en.pdf.
17. World Trade Organization. Declaration on the TRIPS Agreement and Public Health. WTO Fourth Ministerial Conference, Doha, 2001 Nov. 9&needs-basedsh;14 [Internet]. Geneva: WTO; 2001. Available from: https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
18. Amin T. Voluntary licensing practices in the pharmaceutical sector: an acceptable solution to improving access to affordable medicines? Geneva: WHO; 2007. Available from: http://apps.who.int/medicinedocs/documents/s19793en/s19793en.pdf.
19. Pan American Health Organization. Access to high cost medicines in the Americas; situation, challenges and perspecives. Technical Series No. 1: Essential Medicines, Access, and Innovation. Washington, D.C.: PAHO; 2010. Available from: https://www.paho.org/hq/dmdocuments/2010/High%20cost%20Med%20%20Tech_Series_No%201_Sep_15_10.pdf.
20. Frank RG. The ongoing regulation of generic drugs. New England Journal of Medicine 2007;357:1598–1607.
21. Pan American Health Organization. Strengthening national regulatory authorities for medicines and biologicals. 50th Directing Council, 62nd Session of the Regional Committee of WHO for the Americas, Washington, D.C., 2010 Sept. 27–Oct. 1 (CD50.R9). Available from: https://www.paho.org/hq/dmdocuments/2010/CD50.R9-e.pdf.
22. Pan American Health Organization. Health technology assessment and incorporation into health systems. 28th Pan American Sanitary Conference, 64th Session of the Regional Committee, Washington, D.C., 2012 Sept. 17–21 (CSP28.R9). Available from: https://www.paho.org/hq/index.php?option=com_docman&task=doc_view&Itemid=270&gid=26539&lang=en.
23. World Health Organization. Equitable access to essential medicines: a framework for collective action. WHO Policy Perspectives on Medicines, No. 8. Geneva: WHO; March 2004. Available from: http://apps.who.int/medicinedocs/en/d/Js4962e/.
24. Pan American Health Organization. PAHO Sub-Regional Regulatory Framework for Medicines and Health Technologies: concept paper and roadmap [unpublished report]. Washington, D.C.: PAHO; 2013.
25. Mercado Común del Sur. Resolución 34/12. Procedimientos comunes para las inspecciones en los establecimientos farmacéuticos en los Estados Partes y contenido mínimo de actas/informes de inspección en los establecimientos farmacéuticos en los Estados Partes (repeal of RES.GMC n.o 16/09. Foreign Trade Information System) [Internet]; 2012. Available from: http://www.sice.oas.org/trade/mrcsrs/resolutions/RES_034-2012_PT.pdf.
26. Hurtado M. La cuestión del aseguramiento y el nuevo papel de los ministerios de salud en el contexto de la reforma. Organization and Management of Health Systems and Services Series, No. 8. Washington, D.C.: PAHO; 1998.
27. Pan American Health Organization. Report on tobacco control for the Region of the Americas. WHO Framework Convention on Tobacco Control: 10 years later. Washington, D.C.: PAHO; 2016. Available from: http://iris.paho.org/xmlui/bitstream/handle/123456789/28393/9789275118863_eng.pdf?sequence=1&isAllowed=y.
28. Dmytraczenko T, Almeida G, eds.Toward universal health coverage and equity in Latin America and the Caribbean: evidence from selected countries. Washington, D.C.: World Bank; 2015.
29. Pan American Health Organization. Report of the Regional Forum on Universal Health: an indispensable investment for sustainable human development [unpublished report]. Washington, D.C.: PAHO; 2015.
30. Ferreiro Yazigi A, Sierra LA. El papel de las superintendencias en la regulación de seguros de salud: los casos de Chile, Argentina, Perú y Colombia. Washington, D.C.: PAHO; 2000.
31. Reveiz L, Chapman E, Torres R, Fitzgerald J, Mendoza A, Bolis M, et al. Litigios por derecho a la salud en tres países de América Latina: revisión sistemática de la literatura. [Right-to-health litigation in three Latin American countries; a systematic literature review]. Pan American Journal of Public Health 2013;34(1):213–222.
32. Gotlieb V, Yavich N, Báscolo E. Litigation and the right to health in Argentina. Cadernos de Saúde Pública 2016;32(1):e00121114.
33. Yavich N, Báscolo EP, Haggerty J. Comparing the performance of the public, social security and private health subsystems in Argentina by core dimensions of primary health care. Family Practice 2016;33(3):249–260.
34. Pan American Health Organization. Essential public health functions. 42nd Directing Council of PAHO, 52nd Session of the Regional Committee of WHO for the Americas, Washington, D.C., 2000 Sept. 25–29 (CD42.R14). Available from: http://iris.paho.org/xmlui/bitstream/handle/123456789/1423/CD42.R14en.pdf?sequence=1&isAllowed=y.
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.