Library of Congress

Law Library of Congress

The Library of Congress > Law Library > News & Events > Global Legal Monitor

Japan: New Laws for Healthcare and Medical Strategy

(June 10, 2014) The Act to Promote Healthcare and Medical Strategy was promulgated in Japan on May 30, 2014. (See Kenko iryo senryaku suishin ho, Act No. 48 of 2014, House of Representatives website.) The Act is designed to create a system to support research and development in healthcare and the medical industry that will support world-class standards of medical services, so that the Japanese people can live long, in good health. (Id. art. 1.)

More specifically, the Act will implement measures to facilitate connections between basic research, applied research, clinical practice, and clinical trials and to improve the research environment at the clinical trial stage. (Id. arts. 10 & 11.) The process of approval for pharmaceutical and medical devices will be accelerated. (Id. art. 13.) The government will establish a national healthcare and medical strategy that includes a summary of measures taken for advanced research and development and the creation of new healthcare- and medicine-related business. (Id. art. 17.) The Headquarters for Healthcare and Medical Strategy Promotion that was established under the jurisdiction of the Cabinet in 2013 will draft strategies and establish implementation plans. (Id. arts. 17, 18, 20 & 21; Headquarters for Healthcare and Medical Strategy Promotion, THE PRIME MINISTER IN ACTION (Aug. 2013).)

Act on an Independent National Research Institution

At the same time, the Independent Administrative Institution Japan Medical Research Development Institution Act was adopted. (Dokuritsu gyosei hojin nihon iryo kenkyu kaihatsu kiko ho, Act No. 49 of 2014, House of Representatives website.) The government is planning to establish this Institution in 2015. The Headquarters, the Ministry of Education, Culture, Sports, Science, and Technology (MEXT), the Ministry of Health, Labor, and Welfare (MHLW) and the Ministry of Economy, Trade, and Industry (METI) jointly discuss and determine priority research and/or development areas and the budget for each area. Nine priority areas were chosen, including cancer treatment and regeneration medicine. A 140 billion yen (about US$1.4 billion) budget was set for the 2014 fiscal year. (“Nihonban NIH” no yakuwari wa? [What Is the Role of the “Japanese Version of NIH”?], YOMIURI NEWSPAPER (Apr. 27, 2014).)

At present, more Japanese scientists publish articles on basic research than in applied fields. The government has decided it can best support science and the industries that apply it if there is a comprehensive strategy. MEXT, MHLW, and METI will all be involved in planning for research in health care and medicine. (Id.)