Health Policy Players

Health policy in Japan, similar to other advanced countries, is a high-stakes arena involving a variety of actors each with their own interests in the health policy process. The following is an overview of the main health policy players in Japan.

Central Government

The central government supervises and regulates health care through control of the health insurance system. Specifically, the central government oversees health insurance contracts between the government and providers. This power is provided through the 1922 Health Insurance Law.1

The central government is 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 of the Ministry of Health, Labour and Welfare (MHLW). The evaluation of new drug and medical device applications is left to the Pharmaceutical and Medical Device Agency (PMDA).2

Ministry of Health, Labour and Welfare

The 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 2001.3 As of July 2015, the MHLW includes over 143 national hospitals, 8 national social welfare offices, 6 research institutes, and 16 councils. The 47 labor bureaus and 47 social insurance bureaus (one of each for each prefecture) are also within the MHLW organization.4 In addition, the MHLW has multiple bureaus, each with its own function. The bureaus that influence health policy include the following.5

  • Health Insurance Bureau (HIB) plays an active role in the bi-annual fee schedule revision and supports health care system improvements.6
  • Health Policy Bureau researches and proposes various policy options in relevant policy areas, including responsiveness, service provision, workforce, and health technology.7
  • Health Service Bureau focuses on regional health care, health promotion, measures to address infectious diseases, sanitation, and organ transplantation.8
  • Pharmaceutical and Food Safety Bureau establishes policies to ensure the safety and efficacy of pharmaceuticals, medical devices, and cosmetics. It also establishes safety regulations for hospitals and manages the blood supply. This bureau is also charged with addressing illicit substance use.9
  • Social Welfare and War Victims’ Relief Bureau addresses a myriad of social welfare issues including homelessness and poverty. This bureau also administers services for families affected by war.10
  • Health and Welfare Bureau for the Elderly proposes policies to support the growing ageing population with a focus on health insurance and support care services.11
  • Pension Bureau oversees the provision of pensions to pension recipients. This bureau also plans and implements the public pension system and corporate pension system.12
  • Labour Standards Bureau oversees the health and safety of workers, including working hours, workers’ compensation, and wages.13
  • Equal Employment, Children and Families Bureau plans policies that support working families and child well-being.14

Pharmaceutical and Medical Device Agency (PMDA)

The PMDA established in 2004, is a government regulatory agency responsible for evaluating 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; 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. Through various policies and organizational strategies, the PMDA has been successful at bringing average review time of standard review products down from 22 months in 2008 to 11.5 months in 2011. The average review time of priority review products went from 15.4 months in 2008 to 6.5 months in 2011.15

Central Social Insurance Medical Council

The Central Social Insurance Medical Council, or Chuikyou in Japanese, is run by staff of the MHLW’s HIB and convenes to advise the Health Minister on health insurance and health services. The council has representatives from the payer side, the provider side and the public interest who serve on the council. While there are various discussions that take place throughout the year, the main role of this council is to debate and set fee schedule revisions of medical services and pharmaceuticals.16

Ministry of Finance Budget Bureau

The Budget Bureau (BB) of the Ministry of Finance is included in the list of health policy players because it oversees the subsidy provided to national health insurance by the government. This subsidy, which is in essence government spending, is comprised of revenue from taxes as well as government borrowing. The BB has the most influence during the bi-annual fee-schedule revision process when it works with the MHLW’s HIB to establish the global rate of price revision, global revision rate of pharmaceuticals and global revision rate of medical services. As stakes are high in the process, these revisions involve lengthy negotiations that involve a variety of actors.17

Lining up from early morning to see Chuikyo

Some say that “Chu-i-kyo” is the one Japanese health policy term that non-Japanese people working with the Japanese health care industry should certainly remember because the Chuikyo, or the Central Social Insurance Medical Council (CSIMC), is one of the most important government-related groups. Regulations stipulate that meeting proceedings be open with attendance open to the general public. The bulk of CSIMC’s work takes place once every two years between fall and February before the fee schedule revision which takes place the following April. During this short time period, the council members engage in detailed discussions. In order to stay informed of discussions, members of the media, pharmaceutical industry, and health care sector line up from the very early morning to get a ticket to sit in the meeting room (tickets are handed out in order of arrival). It has become common to see the council’s meeting room, which comfortably seats 10 people, become filled with over 100 people up to 3 hours before the meeting is scheduled to begin.

Liberal Democratic Party

The Liberal Democratic Party (LDP) has been at the forefront of health policy since the end of the Occupation in the early 1950s. At that time, with political parties veering for power, health care emerged as a point of debate and LDP leaders took the lead by emphasizing increased access to health insurance, a concept that was highly favorable in Japan. In fact, it was the LDP that championed universal health coverage by pressing forward the 1958 amendment to the National Health Insurance Law that expanded NHI by requiring all municipalities to establish programs for their non-employed, retired, and independently or irregularly employed residents.18 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 health care system, the LDP has dominated politics and held the majority almost the entire time, with exception of an 11-month period between 1992 and 1994 and the 3 years between 2009 and 2011.

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. Within the JMA, private practice physicians are known to be the most vocal and active. The JMA works closely with bureaucrats, government agencies, and the majority party (which has overwhelmingly been the LDP) to protect physician autonomy, revenue, and professional interests.19 The JMA has seats on the Central Social Insurance Medical Council, which sets the fee schedule.20 In addition to official appointments, informal leadership and lobbying from the JMA is present and critical to a majority of health policy legislation. When the JMA is not on board a proposed change, it is not uncommon for concessions or compromises to be made to ensure smooth relations.21 For example during the Koizumi Administration (2001-2006), attempts to introduce market-based approaches into the health care field by lifting the ban on the mixed billing and approving management of hospitals by investment institutions were met with major push back from the JMA. As a result, this opportunity for major reform concluded with very minor changes to the existing system.22

Prefectural Governments

Through the 1948 Medical Care Act, prefectural level governments oversee medical facilities and providers within the prefecture. As opposed to the central government, which regulates using contractual and payment levers, prefectural governments regulate management issues including facilities, workforce, and suppliers. Prefectural governments’ role in hospital planning was introduced in the 1985 revision of the Medical Care Act

Prefectural governments also manage public health centers that lead sanitation, disease control, and environmental issues. Governments of over 70 major Japanese cities share in these public health responsibilities.23

Municipal Governments

Municipal governments set public health policy related to disease prevention and family health through community health centers. The 1982 Health Care for the Aged Law increased municipal involvement by asking municipal governments to increase health services for older persons, such as prevention education and health screenings. The 2002 Health Promotion Act called for municipal governments to actively participate in community health planning.24

3 Doctors’ Association

As is the case in other countries, physicians groups have a large amount of influence on health policy. In Japan, the Japan Medical Association, the Japan Dental Association, and the Japan Pharmaceutical Association are referred to collectively as the “3 Doctors’ Association” because of the unrivaled presence these groups have. There are nearly 50 other professional associations, including the Japanese Nursing Association, the All Japan Hospital Association and the Japan Pharmaceutical Manufacturers Association, that work to maintain favorable relationships with the government and the ruling party in order to affect the policy environment.

References

1 Tatara K, Okamoto E, Allin S. Health systems in transition. Copenhagen: World Health Organization, European Observatory on Health Systems and Policies, 2009 p.73

2 Tatara K, Okamoto E, Allin S. Health systems in transition. Copenhagen: World Health Organization, European Observatory on Health Systems and Policies, 2009 p.74

3 Tatara K, Okamoto E, Allin S. Health systems in transition. Copenhagen: World Health Organization, European Observatory on Health Systems and Policies, 2009 p.29

4 Ministry of Health, Labour and Welfare. Facilities and Agencies/Regional Offices.http://www.mhlw.go.jp/english/org/policy/p42.html (accessed on July 12, 2015)

5 Ministry of Health, Labour and Welfare. Organization Chart. http://www.mhlw.go.jp/english/org/detail/dl/organigram.pdf(accessed on July 12, 2015)

6 Ministry of Health, Labour and Welfare. Health Insurance Bureau. http://www.mhlw.go.jp/english/org/policy/p34-35.html(accessed on July 15, 2015)

7 Ministry of Health, Labour and Welfare. Health Policy Bureau. http://www.mhlw.go.jp/english/org/policy/p8-9.html(accessed on July 15, 2015)

8 Ministry of Health, Labour and Welfare. Health Service Bureau. http://www.mhlw.go.jp/english/org/policy/p10-11.html(accessed on July 15, 2015)

9 Ministry of Health, Labour and Welfare. Pharmaceutical and Medical Safety Bureau.http://www.mhlw.go.jp/english/org/policy/p13-14.html (accessed on July 15, 2015)

10 Ministry of Health, Labour and Welfare. Social Welfare and War Victims’ Relief Bureau. http://www.mhlw.go.jp/english/org/policy/p29-30.html (accessed on July 15, 2015)

11 Ministry of Health, Labour and Welfare. Health and Welfare Bureau for the Elderly.http://www.mhlw.go.jp/english/org/policy/p32-33.html (accessed on July 18, 2015)

12Ministry of Health, Labour and Welfare. Pension Bureau. http://www.mhlw.go.jp/english/org/policy/p36-37.html(accessed on 18 July,2015)

13 Ministry of Health, Labour and Welfare. Labour Standards Bureau. http://www.mhlw.go.jp/english/org/policy/p16-17.html (accessed on 18 July,2015)

14 Ministry of Health, Labour and Welfare. Equal Employment, Children and Families Bureau.http://www.mhlw.go.jp/english/org/policy/p26-28.html (accessed on 18 July,2015)

15 Y. Ando, T. Tominaga, and T. Kondo, “PMDA Update: the current situation and future directions,” Generics and Biosimilars Initiative Journal (2013) 1, p.41-44

16 Ikegami N. Universal Health Coverage for Inclusive and Sustainable Development. Washington, D.C.: World Bank Group, 2014 p.111 and p.112

17 Ikegami N. Universal Health Coverage for Inclusive and Sustainable Development. Washington, D.C.: World Bank Group, 2014 p.103

18 Ikegami N. Universal Health Coverage for Inclusive and Sustainable Development. Washington, D.C.: World Bank Group, 2014 p.19

19 Ikegami N. Universal Health Coverage for Inclusive and Sustainable Development. Washington, D.C.: World Bank Group, 2014 p.137

20 Ikegami N.Universal Health Coverage for Inclusive and Sustainable Development. Washington, D.C.: World Bank Group, 2014 p.3

21 Ikegami N. Universal Health Coverage for Inclusive and Sustainable Development. Washington, D.C.: World Bank Group, 2014 p.20

22 Ikegami N. Universal Health Coverage for Inclusive and Sustainable Development. Washington, D.C.: World Bank Group, 2014 p.24

23 Tatara K, Okamoto E, Allin S. Health systems in transition. Copenhagen: World Health Organization, European Observatory on Health Systems and Policies, 2009 p.74

24 Tatara K, Okamoto E, Allin S. Health systems in transition. Copenhagen: World Health Organization, European Observatory on Health Systems and Policies, 2009 p.77-78