Health policy in Japan, similar to other advanced countries, is a high-stakes arena involving a variety of stakeholders. The following is an overview of the main health policy players in Japan.
2.3 Health Policy Players
Central government and administrative agencies
Public administrative agencies supervise and regulate healthcare through control of the health insurance system. Specifically, government organizations oversee health insurance contracts between the government and healthcare agencies. This power is provided through the 1922 Health Insurance Act. These organizations are also responsible for regulating pharmaceutical industry practices, including clinical trials, post-market research, and manufacturing. These regulations are created and carried out by various bureaus in the Ministry of Health, Labour and Welfare (MHLW). For example, the evaluation of new drug and medical device applications is the responsibility of the Pharmaceutical and Medical Device Agency (PMDA).
Ministry of Health, Labour and Welfare
MHLW, a Ministry of the central government, was originally established in 1938 as the Ministry of Health and Welfare, and came into its current form after it merged with the Ministry of Labour in 2001. As of July 2015, MHLW includes 16 councils, 8 regional bureaus of health and welfare, a labor department in every prefecture, incorporated administrative agencies (including PMDA and the National Hospital Organization, which operates 143 national hospitals as external departments), and government-affiliated corporations such as the Japan Pension Service. In addition, MHLW’s head office houses multiple internal bureaus with various functions. The main bureaus that influence health policy include the following:
Health Insurance Bureau: Plays an active role in bi-annual fee schedule revision and supports healthcare system improvements
Health Policy Bureau: Researches and proposes various policy options in relevant policy areas to respond to the changing demographic and morbidity profile in Japanese society, including healthcare delivery, staff assignment, and health technology
Health Service Bureau: Focuses on regional healthcare, health promotion, measures to address infectious diseases, sanitation, and organ transplantation.
Pharmaceutical and Food Safety Bureau: Establishes policies to ensure the safety and efficacy of pharmaceuticals, medical devices, and cosmetics. It also establishes regulations for hospitals and supervises blood derivatives. This bureau is also charged with addressing the mislabeling of drugs, illicit drug use and stimulants.
Social Welfare and War Victims’ Relief Bureau: Addresses a myriad of social welfare issues including homelessness and social relief. This bureau also administers services for families affected by World War II.
Health and Welfare Bureau for the Elderly: Promotes policies related to the Long-term Care Insurance System and welfare services for the elderly in order to support the aging society.
Pension Bureau: Plans and implements the public pension system and corporate pension system.
Labour Standards Bureau: Oversees the health and safety of workers, including working hours, workers’ accident compensation, and wages.
Equal Employment, Children and Families Bureau: Plans policies that support working families and the well-being of children.
Pharmaceuticals and Medical Devices Agency (PMDA)
PMDA, established in 2004, is an independent administrative agency, responsible for evaluating the quality and effectiveness of new drug and medical device applications, post-market safety, and addressing damages related to adverse health effects. The agency is comprised of multiple offices, including the Office of International Programs, which liaises with non-Japanese applicants and inquiries; the Office of Regulatory Science, which works to build Japan’s regulatory science capacity, and the Office of Cellular and Tissue-based Products, which focuses on biologics and tissue-engineered medical products. Through various policies and organizational strategies, PMDA has been successful at bringing the average review time of standard review products down from 22 months in 2008 to 11.3 months as of the end of August 2015. The average review time of priority review products went from 15.4 months in 2008 to 6.1 months in 2012, and as low as 8.7 months as of the end of August of 2015.
Central Social Insurance Medical Council
The Central Social Insurance Medical Council, or Chu-i-kyo in Japanese, is run by staff of MHLW’s Health Insurance Bureau (HIB) and convenes to advise the Minister of Health, Labour and Welfare on health insurance and health services. The Council includes representatives from the payer side, the provider side and academics representing the public interest. While it conducts various discussions throughout the year, its main role is to debate and set fee schedule revisions for medical services and pharmaceuticals and National Health Insurance (NHI) drug prices.
Ministry of Finance Budget Bureau
The Budget Bureau (BB) of the Ministry of Finance overseas subsidies to NHI through its jurisdiction over the national budget. It is one of the foremost players in healthcare policy. The subsidies, which are in essence government spending, are comprised of revenue from taxes as well as funds borrowed by the government. The BB has the most influence during the bi-annual fee-schedule and drug-price revision, when it works with MHLW’s HIB to establish the global rate of price revision. As stakes are high in this process, revisions involve lengthy negotiations with a variety of actors.
The Liberal Democratic Party
The Liberal Democratic Party (LDP) has been at the forefront of health policy since the end of the occupation by U.S. Forces in the early 1950s. During that time of political transition, healthcare emerged as a focal point of debate and the LDP, the ruling party then, took the lead by pushing for universal health coverage, thus garnering a wide support base. Through amendments to the National Health Insurance Act in 1958, which aimed to expand health insurance coverage, the LDP established systems of insurance for the unemployed, retired, self-employed and irregularly employed in every municipality throughout Japan, achieving universal health coverage in the process. Since then, the LDP has continued to play an active role in health policy through legislative action and political leadership built atop relationships with bureaucratic circles and interest groups. Since the start of Japan’s current healthcare system, the LDP has dominated politics and held the majority in the Diet almost the entire time, with the exception of an 11-month period between 1993 and 1994 and the 3 years between 2009 and 2011.
The Japan Medical Association
Approximately 55% of physicians in Japan are members of the Japan Medical Association (JMA), by far the most prominent health policy interest group. The JMA works closely with bureaucrats, government agencies, and the majority party (which, throughout modern history, has overwhelmingly been the LDP) to protect physician autonomy and professional interests.
The JMA has seats on the Central Social Insurance Medical Council, which sets the NHI fee schedule. In addition to official appointments, the JMA regularly issues informal recommendations and engages in active lobbying, which exerts a strong influence on health policy-related legislation. However, even when opposed to certain proposed revisions, it is not uncommon for it to make concessions or compromises to ensure smooth relations with the government. For example, during the Koizumi Administration (2001-2006), attempts to introduce market-based approaches into the healthcare field by lifting the ban on the mixed billing and approving management of hospitals by investment institutions were met with major pushback from the JMA. Although no major reforms materialized, this opportunity for reform did conclude with some minor changes to the existing system.
The Medical Service Act stipulates that prefectural governments oversee medical facilities and providers within the prefecture. In contrast with the administrative agencies of the government, which supervise the contracts and payment systems, prefectural governments monitor adherence to regulations related to the establishment of medical facilities, staffing, and the management of pharmaceuticals and other products. This role for prefectural governments was introduced in the 1985 revision of the Medical Service Act. Prefectural governments also have jurisdiction over the establishment of healthcare centers, and measures addressing diseases and sanitation. Health centers are also established by government-designated cities and special wards.
Currently, local governments such as municipal town halls set public health policy related to disease prevention and family health through community health centers. The 1982 Healthcare for the Aged Act increased municipal involvement by asking municipal governments to increase health services for the elderly, including health instruction and health screenings. The 2002 Health Promotion Act called for municipal governments to actively participate in community health planning.
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 Ministry of Health, Labour and Welfare. The beginnings of the Ministry of Health, Labour and Welfare
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 Pharmaceuticals and Medical Devices Agency. Our achievements up until now (2016) and challenges for the future. (accessed 11 October 2017) Retrieved from https://www.pmda.go.jp/files/000215764.pdf
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