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What are the key entities for health system governance?

  • Australia

    Intergovernmental collaboration and decision-making at the federal level occur through the Council of Australian Governments (COAG), with representation from the Prime Minister and first ministers of each state. The COAG focuses on the highest-priority issues, such as major funding discussions and the interchange of roles and responsibilities between governments. The COAG Health Council is responsible for more detailed policy issues and is supported by the Australian Health Ministers Advisory Council.

    The federal Department of Health (DH) oversees national policies and programs such as the Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS). Payments through these schemes are administered by the Department of Human Services. The Pharmaceutical Benefits Advisory Committee (PBAC) provides advice to the Minister for Health on the cost-effectiveness of new pharmaceuticals (but not routinely on delisting).

    Several national agencies and the state governments are responsible for quality and safety of care. The Australian Institute of Health and Welfare (AIHW) and the Australian Bureau of Statistics (ABS) are the major providers of health data.

    Regulatory oversight is provided by a number of agencies, such as the Therapeutic Goods Administration, which oversees supply, imports, exports, manufacturing, and advertisement; the Australian Health Practitioner Regulation Agency, which ensures registration and accreditation of the workforce in partnership with National Boards; and the Australian Prudential Regulation Authority, for private health insurance. The Australian Competition and Consumer Commission promotes competition among private health insurers. Beginning in July 2016, the Australian eHealth Commission will take over responsibility from the National eHealth Transition Authority for matters relating to electronic health data.

    State governments operate their own departments of health, and have devolved management of hospitals to the Local Hospital Networks (LHNs). The LHNs are responsible for working collaboratively with Primary Health Networks (PHNs). There are patient consumer organizations and groups operating at the national and state level.

  • Canada

    Because of the high level of decentralization, provinces have primary jurisdiction over administration and governance of their health systems. The federal ministry of health, Health Canada, plays a role in promoting overall health, disease surveillance and control, food and drug safety, and medical device and technology review. The Public Health Agency of Canada is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention.

    At the national level, several intergovernmental nonprofit organizations aim to improve governance by monitoring and reporting on health system performance; disseminating best practice in patient safety (the Canadian Patient Safety Institute); providing information to the public on health and health care and standardizing health data collection (the Canadian Institute for Health Information); and providing funding and support for provincial health information systems (Canada Health Infoway). The Canadian Agency for Drugs and Technologies in Health oversees the national health technology assessment process, which produces information about the clinical effectiveness, cost-effectiveness, and broader impact of drugs, medical technologies, and health systems. The Agency’s Common Drug Review reviews the clinical effectiveness and cost-effectiveness of drugs and provides common, nonbinding formulary recommendations to the publicly funded provincial drug plans (except in Quebec) to support greater consistency in access and evidence-based resource allocation.

    Nongovernmental organizations with important roles in system governance include professional organizations such as the Canadian Medical Association, provincial regulatory colleges, which are responsible for licensing professions and developing and enforcing standards of practice, and Accreditation Canada (see below). Most providers are self-governing under provincial and territorial law; they are registered with professional associations that ensure that education, training, and quality-of-care standards are met. The professional associations for physicians are also responsible for negotiating fee schedules with the provincial ministries of health. Most provinces have an ombudsperson providing patient advocacy.

  • China

    In 2013, the Ministry of Health and the National Population and Family Planning Commission were merged into the National Health and Family Planning Commission as the main agency for health controlled by the State Council (central government). The State Administration of Traditional Chinese Medicine is affiliated with the new Commission. The National People’s Congress is responsible for health legislation. However, major health policies and reforms may be initiated by the State Council and the Central Committee of the Communist Party as well, and these are also regarded as law.

    The National Development and Reform Commission, which has been heavily involved in the recent health care system reform, oversees health infrastructure plans and competition among health care providers. The Ministry of Finance provides funding to government health subsidies, health insurance contributions, and health system infrastructure. The Ministry of Human Resource and Social Security runs urban employment-based basic insurance and urban resident basic insurance. The China Food and Drug Administration is responsible for drug approvals and licenses, but health technology assessment or cost-effectiveness have not played a significant role yet. The China Center for Disease Control and Prevention is administrated by the National Health and Family Commission, though it is not a government agency. The Chinese Academy of Medical Science, under the National Health and Family Planning Commission, is the national center for health research.

    The National Health and Family Planning Commission directly owns some hospitals in Beijing, and national universities directly administrated by the Ministry of Education also own affiliated hospitals. Local government health agencies, usually the Bureau of Health or Health and Family Planning Commission in each province, may have a similar structure and often own provincial hospitals. Local governments (for prefectures, counties, and towns) may have departments of health and own hospitals directly. Centers for Disease Control and Prevention also exist in local areas and are administrated by the local bureaus or departments of health. At the national level, the China Center for Disease Control and Prevention only provides technical support to the local centers.

    Both national and local Health and Family Planning Commissions have comprehensive responsibilities for health quality and safety, cost control, provider fee schedules, health information technology, and clinical guidelines.

  • Denmark

    The general regulation, planning, and supervision of health services, including cost control mechanisms, take place at the national level through the Ministry of Health and the Danish Health Authority, Danish Medicines Agency, and Danish Patient Safety Authority. The national authorities are responsible for general supervision of health personnel and for development of quality management in line with national clinical guidelines and standards, usually in close collaboration with representatives from medical societies. These authorities also have important roles in planning the location of specialist services, approving regional hospital plans, and making mandatory “health agreements” between regions and municipalities to coordinate service delivery. Health technology assessments are developed at the regional level, while the national authorities do comparative effectiveness (productivity) studies that are published on a regular basis, allowing regions and hospital managers to benchmark performance of individual hospital departments.

    Regions are in charge of defining and running hospital services and supervising and paying general practitioners and specialists. Municipalities have important roles in prevention, health promotion, and long-term care. Rates for general practitioners and practicing specialists are set through national agreements. Doctors’ associations negotiate with a collective body of the regions, also including state representatives. Regions may enter into additional regional agreements for specific services.

    A national website ( supports patient choice. Organized patient groups engage in policymaking at the national, regional, and municipal levels. A patient ombudsman handles patient complaints and compensation claims, collects information about errors for systematic learning, and provides information about treatment abroad.

    Aspects of care that are affected by regional benchmarking results, which are published online, include expenditures for administration; expenditures for support functions (washing and cleaning); organization and handling of free choice (of private provider); and psychiatry, obesity operations, selected medical treatments, knee operations, shoulder operations, heat treatment, and back operations.

  • England

    The Department of Health and the Secretary of State for Health are ultimately responsible for the health system as a whole. The Health and Social Care Act 2012 transferred important functions to National Health Service (NHS) England, including overall budgetary control, supervision of Clinical Commissioning Groups (CCGs), and, along with Monitor, responsibility for setting diagnosis-related group (DRG) rates for provision of NHS services. NHS England also commissions some specialized low-volume services, national immunization and screening programs, and primary care. It is also responsible for setting the strategic direction of health information technology, including the development of online services to book appointments, the setting of quality standards for electronic medical record-keeping and prescribing, and the IT infrastructure of the NHS.

    The National Institute for Health and Clinical Excellence (NICE) sets guidelines for clinically effective treatments and appraises new health technologies for their efficacy and cost-effectiveness. The CQC ensures basic standards of safety and quality through provider registration and monitors care standards achieved. It can require closure of services if serious quality concerns are identified.

    The 2012 Act extended Monitor’s role to being the economic regulator of public and private providers, with powers to intervene if performance deteriorates significantly. Monitor licenses all providers of NHS-funded care and may investigate potential breaches of NHS cooperation and competition rules and mergers involving NHS foundation trusts. Where such mergers are found to be prima facie undesirable, they are referred to the Office of Fair Trading and the Competition Commission.

    Healthwatch England promotes patient interests nationally. In each community, local Healthwatches support people who make complaints about services; quality concerns may be reported to Healthwatch England, which can then recommend that the Care Quality Commission (CQC) take action. In addition, local NHS bodies, including general practices, hospital trusts, and CCGs, are expected to support their own patient engagement groups and initiatives. The Department of Health owns NHS Choices, the primary website for public information about health conditions, the location and quality of health services, and other information. The website, which also offers a platform for user feedback, received 27 million visits a month in 2012–13.

  • France

    The Ministry of Health sets and implements government policy in the areas of public health and the organization and financing of the health care system, within the framework of the Public Health Act. It regulates roughly 75 percent of health care expenditure on the basis of the overall framework established by parliament, which includes a shared responsibility with statutory health insurers for defining the benefit package, setting prices and provider fees (including diagnosis-related group fees and copayments), and pricing drugs. The parliamentary “Alert” Committee provides a midyear assessment of health care expenditures and proposes corrective measures in case expenditures exceed the target by more than 0.75 percent.

    The French Health Products Safety Agency oversees the safety of health products, from manufacturing to marketing. The agency also coordinates vigilance activities relating to all relevant products.

    The Agency for Information on Hospital Care manages the information systematically collected from all hospital admissions and used for hospital planning and financing. The remit of the National Agency for the Quality Assessment of Health and Social Care Organizations encompasses the promotion of patient rights and the development of preventive measures to avoid mistreatment, in particular in vulnerable populations such as the elderly and disabled, children, adolescents, and socially marginalized people. It produces practice guidelines for the health and social care sector and evaluates organizations and services.

    The National Health Authority (HAS) is the main health technology assessment body, with in-house expertise as well as the authority to commission assessments from external groups. The HAS remit is diverse, ranging from the assessment of drugs, medical devices, and procedures to publication of guidelines, accreditation of health care organizations, and certification of doctors.

    Competition is limited to voluntary health insurance (VHI), whose providers are supervised by the Mutual Insurance Funds Control Authority.

  • Germany

    The German health care system is notable for two essential characteristics: 1) the sharing of decision-making powers between states, federal government, and self-regulated organizations of payers and providers; and 2) the separation of statutory health insurance (SHI) (including the social long-term care insurance) and private health insurance (PHI) (including the private long-term care insurance). SHI and PHI (as well as the two long-term care insurance systems) use the same providers—that is, hospitals and physicians treat both statutorily and privately insured patients, unlike many other countries.

    Within the legal framework set by the Ministry of Health, the Federal Joint Committee has wide-ranging regulatory power to determine the services to be covered by sickness funds and to set quality measures for providers. To the extent possible, coverage decisions are based on evidence from health technology assessments and comparative-effectiveness reviews. The Federal Joint Committee is supported by the Institute for Quality and Efficiency (IQWiG), a foundation legally charged with evaluating the cost-effectiveness of drugs with added therapeutic benefits, and the newly formed Institute for Quality and Transparency (IQTiG). The Federal Joint Committee has had 13 voting members: five from the Federal Association of Sickness Funds, two each from the Federal Association of SHI Physicians and the German Hospital Federation, one from the Federal Association of SHI Dentists, and three who are unaffiliated. Five patient representatives have an advisory role but no vote in the committee. Representatives of patient organizations have the right to participate in different decision-making bodies, e.g., the subcommittees of the Federal Joint Committee.

    The Federal Association of Sickness Funds works with the Federal Association of SHI Physicians and the German Hospital Federation to develop the SHI ambulatory care fee schedule and the diagnosis-related groups (DRG) catalogue, which are then adopted by bilateral joint committees.

  • India

    Public actors in the Indian health care system include the Ministry of Health and Family Welfare, state governments, and municipal and local level bodies. The ministry consists of the Department of Health and Family Welfare and Department of Health Research. Despite the existence of the latter, there is very little evidence that comparative research and cost-effectiveness studies are used in policy formation.

    The Directorate General of Health Services, an attached office of the Department of Health and Family Welfare, provides technical advice and is involved in the implementation of health schemes. In 2014, the new Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy was formed. In addition, health care services are provided by other ministries and departments to their personnel (e.g., defense, railways, ports, mines, and employee state insurance schemes).

    Each state has its own State Directorate of Health Services and State Department of Health and Family Welfare, which is responsible for providing care to its population. District-level health services provide a link between each state and primary care services.

    Other agencies involved in health system governance include the Insurance Regulatory and Development Authority, which regulates the health insurance industry, and the National eHealth Authority, which is to become the nodal authority for development of an integrated health information system. There is confusion in India with respect to which entities are responsible for regulating the private sector and for ensuring quality of care, as there are multiple agencies under different ministries, with no single responsible agency. For example, the Bureau of Indian Standards and Consumer Protection Act are under the Ministry of Consumer Affairs, whereas the Quality Council of India is under the Ministry of Commerce and Industry. An attempt is being made to bring these agencies under one authority.

  • Israel

    Parliament (the Knesset) adopts and amends legislation related to the health system. The Cabinet, comprising a selection of Knesset members from the ruling parties, has executive responsibility for the government as a whole, including the Ministry of Health (MoH). The MoH has overall responsibility for population health and the effective functioning of the health care system. It includes:

    • The Minister, an elected member of the Knesset and typically also a member of the Cabinet. The Minister has full authority and responsibility for the functioning of the MoH.
    • The Director-General, the MoH’s top professional, who is appointed by the Minister to run the operations of the MoH.
    • A large number of departments, including those responsible for quality and safety, assessing cost-effectiveness, fee-setting, public information, and health IT.
    • Various advisory bodies, including the National Health Council, a public advisory; the benefits package committee, which advises on prioritization of new technologies for inclusion in the national health insurance (NHI) benefits package; and national councils in such areas as trauma care, mental health, and women’s health.

    The Ministry of Health has an ombudsman’s office to help citizens realize their rights under the NHI law. In addition, there are various nongovernmental patient advocacy organizations, many of which focus on particular diseases.

    The Budget Division of the Ministry of Finance prepares the budgets of all ministries, including the MoH, for consideration by the Cabinet and then the Knesset. It also plays a major role in promoting and shaping major structural reforms to the health system and partners with the MoH on interministerial committees, such as those that set maximum hospital prices and the capitation formula. The Ministry of Finance Insurance and Capital Markets Division regulates commercial health insurers. The government also has an antitrust unit responsible for promoting competition, but it is not very active in the health area.

    The Scientific Council of the Israel Medical Association is responsible for the specialty certification programs and examinations, in coordination with the MoH. The Council for Higher Education is responsible for the authorization, certification, and funding of all university degree programs, including those for training health care professionals.

  • Italy

    The Ministry of Health is currently structured into 12 directorates that oversee specific areas of health care (health care planning; essential levels of care and health system ethics; human resources and health professionals; information systems; pharmaceuticals and medical devices) or supervise the main institutions related to the Ministry of Health (e.g., National Health Council, National Institute of Health).

    Key nongovernmental entities supporting the Ministry of Health include the National Health Council (which provides support for national health planning, hygiene and public health, pharmacology and pharmaco-epidemiology, continuing medical education for health care professionals, and information systems) and the National Institute of Public Health (which provides recommendations and control in the area of public health).

    The National Committee for Medical Devices develops cost-benefit analyses and determines reference prices for medical devices. The Agency for Regional Health Services is the sole institution responsible for conducting comparative effectiveness analysis and is accountable to the regions and the Ministry of Health.

    The National Pharmaceutical Agency is responsible for all matters related to the pharmaceutical industry, including prescription drug pricing and reimbursement policies. It is accountable to the Ministry of Health and the Ministry of Economy and Finance (Lo Scalzo et al., 2009).

    Payment rates for hospital and outpatient specialist care are determined by each region, with national rates (determined by the Ministry of Health) as a reference.

    Some regional governments have established agencies to evaluate and monitor health care quality and to provide comparative effectiveness assessments and scientific support to regional health departments. Regional governments periodically sign with the national government “Pacts for Health” linking additional resources to the achievement of health care planning and expenditure goals.

    Safeguarding of patients’ rights has not been uniform and has depended on the level of effort of individual regions. Regions have implemented different models of empowerment: some through standing committees, which include members from citizens’ associations, as an institutional means of patient involvement, while others have emphasized systematic patient satisfaction surveys.

    Each public institution has an office for public relations (Ufficio Relazioni con il Pubblico) providing information to citizens and, in many cases, monitoring quality of services from the citizen’s point of view.

  • Japan

    The Social Security Council, a statutory body within the Ministry of Health, Labor and Welfare, is in charge of developing national strategies on quality, safety, and cost control, and sets guidelines for determining provider fees. Within the Ministry, the Central Social Insurance Medical Council defines the benefit package and fee schedule. National government and prefectures devise cost-control plans (described below).

    The Japan Council for Quality Health Care, a nonprofit organization, works to improve quality throughout the health system and develops clinical guidelines, although it does not have any regulatory power to penalize poorly performing providers. Specialist societies themselves also produce clinical guidelines.

    Technology assessment of pharmaceuticals and medical devices is conducted by the Pharmaceutical and Medical Devices Agency, a governmental regulatory agency. It also sets the Public Health Insurance Drug Price List, which is a list of pharmaceuticals and their prices covered by the public health insurance system (PHIS). The criteria for coverage include clinical effectiveness but not economic appraisal. Since 2012, the agency has been discussing the possible application of comparative cost-effectiveness studies in its decision-making (described below).

    Nonprofit organizations work toward public engagement and patient advocacy, and every prefecture establishes a health care council to discuss the local health care plan. Under the Medical Care Law, these councils must have members representing patients.

    The Japan Fair Trade Commission, an independent governmental administrative commission, promotes fair competition in health care as well as other sectors.

  • The Netherlands

    Since 2006, the Ministry of Health’s role has been to safeguard health care from a distance rather than managing it directly. It is responsible for the preconditions pertaining to access, quality, and cost of the health system, has overall responsibility for setting priorities, and may, when necessary, introduce legislation to set strategic priorities.

    A number of arm’s-length agencies are responsible for setting operational priorities. At the national level, the Health Council advises government on evidence-based medicine, health care, public health, and environmental protection. The National Health Care Institute advises government on the components of the statutory benefits package and has various tasks relating to quality of care, professions and training, and the insurance system (e.g., risk adjustment). The Medicines Evaluation Board oversees the efficacy, safety, and quality of medicines. Decisions about the benefits package rest with the health minister. The Dutch Health Care Authority (Nederlandse Zorgautoriteit) has primary responsibility for ensuring that the health insurance, health care purchasing, and care delivery markets all function appropriately (e.g., by setting the prices for 30 percent of diagnosis treatment combinations). Meanwhile, the Dutch Competition Authority (Autoriteit Consument en Markt) enforces antitrust laws among both insurers and providers. The Health Care Inspectorate (IGZ) supervises quality, safety, and accessibility of care. Self-regulation by medical doctors is also an important aspect of the Dutch system. Private insurers are tasked with increasing health system efficiency and cost control through prudent purchasing of health services.

    The patient movement consists of a wide range of organizations, some for specific diseases and some functioning as umbrella organizations. The patient umbrella organization Nederlandse Patiënten Consumenten Federatie conducts a range of activities to promote transparency. Health Information Technology is not centralized in one body. The Union of Providers for Health Care Communication (De Vereniging van Zorgaanbieders voor Zorgcommunicatie) is responsible for exchange of data via an IT infrastructure.

  • New Zealand

    As the health system is primarily public, government-funded and -appointed entities dominate governance structures. Some, like the health and disability commissioner (whose function is to champion consumers’ rights in the health sector), sit at arm’s length from the central government. Others are “crown entities,” with their own boards, and are required to follow government policy through letters of expectation. Key national arrangements, all of which have a role in providing information to, and engaging with, the public, are:

    • the Ministry of Health, which has overall responsibility for the health and disability system. The ministry acts as the Minister of Health’s principal advisor on health policy and maintains a role as funder, monitor, purchaser, and regulator of health and disability services. While it sets capitation rates paid to GPs, it has no role in regulating patient copayments.
    • the National Health Board (NHB), which aims to improve the quality, safety, and sustainability of health care by actively engaging with clinicians and the wider health sector. The NHB provides advice to the health minister and the director-general of health on all of the aforementioned matters. It has two subcommittees: the Capital Investment Committee, which provides advice on matters relating to capital investment and infrastructure in the public health sector, in line with the government's service planning direction; and the National Health IT Board, which provides advice on the implementation and use of IT systems across the sector.
    • NZ Health Partnerships, established in July 2015 to support district health boards (DHBs) in delivering shared services and reduce costs by identifying opportunities for savings in administrative, support, and procurement.
    • the Pharmaceutical Management Agency of New Zealand, which assesses the effectiveness of drugs, distributes prescribing guidelines, and determines inclusion of drugs on the national formulary (with relative cost-effectiveness being one of nine criteria for inclusion). In addition, certain medical devices have been added to its schedule. As of late 2015, a new set of “factors for consideration” will be used to underpin decisions: need; health benefit; costs and savings; and suitability.
    • the Health Quality and Safety Commission, which ensures that New Zealanders receive the best health and disability care possible given available resources. It is also working toward what is known as the New Zealand “triple aim”—improved quality, safety, and experience of care; improved health and equity for all populations; and better value for public health system resources.
    • the National Health Committee (NHC), which advises government on priorities for new and existing health technologies. All new diagnostic and nonpharmaceutical treatment services and significant expansions of existing services are referred to the NHC for evaluation and advice. The committee also provides advice on what technologies are obsolete or no longer provide value for money.
  • Norway

    The Ministry of Health and Care Services is politically led by the Minister of Health, who ensures that political decisions are translated into practice. This is done through legislation, economic measures, and documents instructing the regional health care authorities (RHAs) and the Directorate for Health and other underlying agencies regarding activities and priorities. The political values conveyed by the annual national budget and the instructions in the annual letter of allocation from the ministry are determinative, and specify provider fees, out-of-pocket payments, and ceilings.

    The Directorate for Health is an executive agency and authority subordinate to the ministry. It issues clinical guidelines, maintains the National System for the Introduction of New Health Technologies, coordinates 18 patient ombudsmen, and provides public information on health and health care through the website The Directorate for Health is not responsible for producing systematic reviews or health technology assessments (HTAs) but rather applies them to decision-making pertaining to the system for new technologies, to guidelines, and to policymaking. From 2014 to 2018, the directorate is also in charge of the secretariat for the National Patient Safety Program. It is responsible overall for setting standards and leading the development and application of health information technology in health care. The Directorate for Health is responsible for fee-setting in the DRG system, and also for the five-year project on quality-based financing. There is no single authority overseeing fee-setting for providers other than hospitals.

    The Medicines Agency determines which medications to reimburse. For new drugs, the agency determines whether a prescription drug should be covered (on the blue list) by evaluating its cost-effectiveness in comparison with that of existing treatments; a “green” scheme encourages providers to prescribe lifestyle and nutrition programs as a first alternative to more expensive preventive medicine. The agency also decides on the maximum price of specific drugs. The Norwegian Knowledge Center for Health Services, financed by government, produces comparative effectiveness studies (systematic reviews and HTAs) and works with quality and patient safety, quality indicators, and national patient experience surveys. Its HTAs are used by the Norwegian Council for Priority Setting in Health Care and the National System for the Introduction of New Health Technologies. The center also runs the national Reporting and Learning System for adverse events in hospitals.

    The Board of Health Supervision is a national public institution organized under the Ministry of Health. The board audits the different areas of the health care system, either systematically on a national basis or individually. An alert system ensures that hospitals alert the board to serious adverse events, and the board may then decide to investigate particular incidents. The board can issue fines to institutions and warnings to health personnel, and can revoke authorization for health care personnel who engage in misconduct.

    The Norwegian Institute of Public Health is a center for research on and surveillance of the health status of the population. It provides the Ministry of Health with advice on public health. It is the main authority regarding infection control and infectious disease surveillance. It provides community health profiles regarding prevalence of disease and holds several of the large health registers, including the prescription registry. The institute also assists the prosecuting authorities and the judiciary regarding forensic medicine.

  • Singapore

    Organization and planning: Singapore’s Ministry of Health has overall responsibility for health care, setting policy direction and managing the public health care system. Its responsibilities include needs assessment, services planning, manpower planning, system governance and financing, provider fee-setting, cost control, and health information technology, with an overall goal of ensuring quality of care and responsiveness to Singaporeans’ needs.

    Regulation: The Ministry of Health regulates the health system through legislation and enforcement. Among the its core regulatory functions are licensing health care institutions under the Private Hospitals and Medical Clinics Act and conducting regular inspections and audits. Advertising is subject to monitoring and analysis to identify potential problems, which can lead to compliance audits and prosecutions in some cases. Marketing by licensed facilities is also regulated in order to safeguard the public against false or unsubstantiated claims and to prevent inducements to using nonessential services, such as aesthetic medicine.

    Professional bodies, including the Singapore Medical Council, Singapore Dental Council, Singapore Nursing Board, and Singapore Pharmacy Board, regulate professionals through practice guidelines and codes of ethics and conduct. The Ministry of Health also engages these bodies to explain policy rationale and to garner support for various initiatives. The Health Sciences Authority regulates the manufacture, import, supply, presentation, and advertisement of health products, including conventional medicines, complementary medicines (traditional medicine and health supplements), cosmetic products, medical devices, tobacco products, and medicinal therapies for clinical trials. Its mission is to ensure that all these products meet internationally benchmarked standards of safety, quality, and efficacy. The insurance industry is regulated by the Monetary Authority of Singapore as part of its financial regulatory role.

    Public consultation: The government takes the views of patients and other stakeholders into account through various means, including the “Our Singapore Conversation” sessions and an online survey. Public consultation occurs before policies are enacted to ensure that public sentiment, concerns, and feedback are added to the discussion; that diverse views are heard and ideas are tested and refined; and that public understanding and support are cultivated to facilitate implementation. As an example, after public consultation, Medisave was expanded to include a variety of preventive and treatment services, such as mammograms and colonoscopies, treatment of some mental health disorders and chronic diseases, and palliative care.

  • Sweden

    The Health and Medical Services Act specifies that responsibility for ensuring that everyone living in Sweden has access to quality health care lies with the county councils and municipalities. The county councils are responsible for the funding and provision of health services, while the municipalities are responsible for meeting the care and housing needs of older adults and people with disabilities. In primary care, there is competition among providers (public and private) to register patients, although they cannot compete through pricing, since the county councils set fees.

    County councils control the establishment of new private practices by regulating conditions for accreditation and payment. Those conditions pertain primarily to opening hours and to the minimum number of clinical competencies at the practice. The right to establish a practice and be publicly reimbursed applies to all public and private providers fulfilling the conditions for accreditation.

    The central government, through the Ministry of Health and Social Affairs, is responsible for overall health care policies. There are eight government agencies directly involved in the areas of medical care and public health.

    The National Board of Health and Welfare supervises all health care personnel, disseminates information, develops norms and standards for medical care, and, through data collection and analysis, ensures that those norms and standards are met. The agency is the licensing authority for health care staff. (Health care personnel are not required to reapply for their license.) The National Board of Health and Welfare also maintains health data registries and official statistics.

    The Swedish eHealth Agency, established in 2014, focuses on promoting public involvement and providing support for professionals and decision-makers. The agency stores and transfers electronic prescriptions issued in Sweden and is responsible for transferring electronic prescriptions abroad. The agency is also responsible for Sweden’s national drug statistics and for statistics on pharmaceutical sales.

    The Health and Social Care Inspectorate is responsible for supervising health care, social services, and activities concerning support and services for persons with certain functional impairments. It is also responsible for issuing permits in those areas.

    The Swedish Agency for Health and Care Services Analysis analyzes and evaluates health policy, as well as the availability of health care information to citizens and patients. The results of such analyses are published.

    The Public Health Agency provides the national government, government agencies, municipalities, and county councils with new knowledge, based on scientific evidence, in the area of infectious disease control and public health, including health technology assessment. The Swedish Council on Technology Assessment in Health Care, which promotes use of cost-effective health care technologies, has a mandate to review and evaluate new treatments from medical, economic, ethical, and social points of view. Information from the council’s reviews is disseminated to central and local government officials and medical staff to provide basic data for decision-making purposes.

    The principal agency for assessing pharmaceuticals is the Dental and Pharmaceutical Benefits Agency. Since 2002, it has had a mandate to decide whether particular drugs should be included in the National Drug Benefit Scheme; prescription drugs are priced in part on the basis of their value. The agency’s mandate also includes dental care. The Medical Products Agency, meanwhile, is the Swedish national authority responsible for the regulation and surveillance of the development, manufacture, and sale of drugs and other medicinal products.

  • Switzerland

    Since health care is largely decentralized, the key entities for health system governance exist mainly at the cantonal level. Each of the 26 cantons has its own elected minister of public health. Supported by their respective cantonal offices of public health, ministers are responsible for licensing providers, coordinating hospital services, subsidizing institutions, and promoting health through disease prevention. Their common political body, the Swiss Conference of the Cantonal Ministers of Public Health, plays an important coordinating role. At the cantonal and the national level, market pressure, i.e., from competition, is felt most by hospitals and by health insurers.

    The main national player is the Federal Office of Public Health (FOPH), which, among other tasks, supervises the legal application of mandatory SHI, authorizes insurance premiums offered by statutory insurers, and governs statutory coverage (including health technology assessment) and the prices of pharmaceuticals. Other cost-control measures are shared with cantonal and communal governments. The Federal Department of Home Affairs (FDHA) legally defines the statutory health insurance (SHI) benefits basket. Professional self-regulation has been the traditional approach to quality improvement.

    Prices for outpatient services are set in the fee-for-service scale TARMED, which defines the relative cost weights of all services covered by SHI on the national level and is authorized by the Swiss Federal Council. TARMED values can vary among cantons and service groups (physicians, outpatient hospital services) as negotiated annually between the health insurers’ associations and cantonal provider associations, or are set by cantonal government if the parties cannot agree. For inpatient care, the Swiss national diagnosis-related group (DRG) system has been in use since 2012. The nonprofit corporation SwissDRG AG is responsible for defining, developing, and adapting the national system of relative cost weights per case.

    In addition to the responsibilities of the FOPH and cantonal governments, Health Promotion Switzerland, a nonprofit organization financed by SHI, is legally charged with disease prevention and health promotion programs and provides public information on health. A national ombudsman for health insurance and the Association of Swiss Patients engage in patient advocacy.

  • United States

    The Department of Health and Human Services (HHS) is the federal government’s principal agency involved with health care services. Organizations that fall within HHS include the:

    • Centers for Medicare and Medicaid Services;
    • Centers for Disease Control and Prevention, which conducts research and programs to protect public health and safety;
    • National Institutes of Health, which is responsible for biomedical and health-related research;
    • Health Resources and Services Administration, which supports efforts to improve health care access for people who are uninsured, isolated, or medically vulnerable;
    • Agency for Healthcare Research and Quality, which conducts evidence-based research on practices, outcomes, effectiveness, clinical guidelines, safety, patient experience, health information technology, and health disparities;
    • Food and Drug Administration, which is responsible for promoting public health through the regulation of food, tobacco products, pharmaceutical drugs, medical devices, and vaccines, among other products;
    • Center for Medicare and Medicaid Innovation, an agency within the Centers for Medicare and Medicaid Services (CMS) that was created by the Affordable Care Act to test and disseminate promising payment and service delivery models designed to reduce spending while preserving or improving quality; and
    • Patient-Centered Outcomes Research Institute, also created by the ACA, which is tasked with setting national clinical comparative-effectiveness research priorities and managing research on a broad array of topics related to illness and injury.

    The Institute of Medicine (IOM), an independent nonprofit organization that works outside of government, acts as an adviser to policymakers and the private sector on improving the nation’s health. Stakeholder associations (e.g., the American Medical Association) comment on and lobby for policies affecting the health system.

    The independent, nonprofit Joint Commission accredits more than 20,000 health care organizations across the country, primarily hospitals, long-term care facilities, and laboratories, using criteria that include patient treatment, governance, culture, performance, and quality improvement. The National Committee for Quality Assurance, the primary accreditor of private health plans, is responsible for accrediting the plans participating in the newly created health insurance marketplaces. The nonprofit National Quality Forum builds consensus on national performance priorities and on standards for performance measurement and public reporting. The American Board of Medical Specialties and the American Board of Internal Medicine provide certification to physicians who meet specified standards of quality.