The need to catalyze the Japanese medical research field has been evident for years. Japanese medical research sector is known around the world as being cutting-edge and productive, yet despite rapid healthcare market growth since the early 2000s, the Japanese health and medical sector faced a trade deficit of two trillion yen in 2011 and Japanese patients lack access to the benefits of advances in research because little discovery makes it to market.
These outcomes shed light on what has been lacking- a mechanism to support the application of discoveries and advances in technology.
In response to this, the Japan Agency for Medical Research and Development (AMED), an independent administrative agency, was created to facilitate the translation of basic research into practical application. Officially inaugurated in April 2015, this agency is essentially expected to serve as a bridge between the two complementary sectors. Through the pursuit and successful realization of new technology, there is a hope that economic growth and market expansion will follow.
In fact, legislation for AMED (Act No. 49 of 2014) was enacted in May 2014 alongside the Act on Promotion of Healthcare Policy, under which the current “Healthcare Policy.” Further context includes the implementation of Prime Minister Shinzo Abe’s economic revitalization strategy in June 2013, the Comprehensive Policy on Medical R&D in January 2014, and the establishment of the Headquarters for Healthcare Policy in June 2014. Medical R&D and the health care industry are identified as critical to economic growth initiatives as well as to the health of people in Japan. AMED, if properly executed, will aide in the pursuit of these goals.
AMED was designed to strategically foster R&D and support the processes that exist between research and application with a focus on research with practical applicability potential. In order to achieve this goal, AMED will:
- Centrally manage research funding of over 140 billion yen that was previously divided between three different government agencies: the Ministry of Health, Labour and Welfare (MHLW); the Ministry of Education, Culture, Sports, Science and Technology (MEXT); and the Ministry of Economy, Trade and Industry (METI).
- Be overseen by the Headquarters for Healthcare Policy, a Cabinet office led by the Prime Minister and enlisting all Cabinet ministers. This office will oversee the long-term strategy to growth of new health industries and advance R&D in the medical field, including AMED.
- Manage medical R&D by conducing thorough review of research plans, identifying potential areas of research potential, planning to translate research outcomes to clinical trials, providing support with licensing and commercialization.
- Oversee clinical trial and research data of the research promoted by AMED. This includes establishing research protocols and the managing research outcomes.
- Provide support for practical applications through collaboration and partnership with PMDA, industry, academia, and other relevant partners. The Drug Discovery Network, created by the government in 2013, has been incorporated into AMED and support this effort.
- Lay the groundwork for a stronger R&D infrastructure. Through AMED’s work, the seeds of a stronger R&D infrastructure will be laid through increased protocols, guidance, and inter-sector and ministerial collaboration.
- Have an advisory board that will include patients, doctors, and industry representatives chosen by AMED staff. The advisory board will assist in supporting the identification and planning of innovative projects, with a large focus on issues of aging and infectious disease.
While AMED has largely been characterized as the Japanese version of the US National Institutes of Health (NIH), the function and role of AMED is much closer to that of the UK’s system for connecting health research with development.
International Collaborative Research Program: Science and Technology Research Partnership for Sustainable Development (SATREPS)
In an effort to address global health issues, this project supports joint research between Japan and partners in developing countries by combining contracted AMED research with JICA operated official development assistance (ODA).
There are currently 44 projects in 26 countries between Japanese academia and research institutes and their counterparts in developing countries with a large focus on research infectious diseases such as H5N1, rabies, HIV/AIDS, Ebola, Dengue fever, TB.
Research Center Network for Realization of Regenerative Medicine
iPS Cells Stock Project for Regenerative Medicine
This project promotes the practical application of iPS cells and other aspects of regenerative medicine through research on safety and standardization, development of iPS cell stocks for use in regenerative medicine, and development of a research framework. The goal is to make regenerative medicine available for practical use for different diseases and tissues, which will then enable the clinical application of regenerative medicine and drug discovery utilizing techniques such as iPS cells in advance of the rest of the world. In August 2015, the Center for iPS Cell Research and Application at Kyoto University (CiRA), consigned by AMED, launched iPS cells stocks for regenerative medicine in an effort to increase the stock of iPS cells to be used for clinical application in Japan and abroad over the next 10 years. This will also support the creation of a new medical technology network.
Research project to accelerate an ICT-based, universal post-market clinical research network
The goal of this project is to make clear indicators for clinical research assessment using DPC/NBD data and develop a comprehensive platform for collaboration with other databases. This platform will enable the reassessment of existing drugs, the identification of rare side effects, and the identification of unmet medical needs.
Comprehensive research project to support women’s health
This project promotes research and implementation of comprehensive support for women’s health by combining disease-based research with support for each stage of the life course. It serves as a platform for global health policy information, surveillance in Japan, and research, prevention and treatment discovery for diseases specific to women.
Promoting Support for Drug Discovery – DISC
This project provides technical support to the Drug Discovery Support Network to enable the commercialization of potential new drugs owned by researchers at universities and other institutions with the aim of the early commercialization of these formulations. It also support the development of the platforms and other resources necessary for drug, including orphan drug, discovery in order to shorten R&D time and increase the likelihood of creating innovative new drugs.
AMED, along with the National Cancer Center, is facilitating a nationwide genomic screening program called “SCRUM-Japan” that will gather genetic information of 4,500 cancer patients in Japan between 2015 and 2017. This screening program is a private-public partnership between 14 pharmaceutical companies and 207 medical facilities in Japan (as of September 2015). The goal of this project is to collect cancer specimens from registered cancer patients. These cancer specimens will then be analyzed and tested for cancer related genetic defects. This data will be shared between all parties involved and support greater understanding of molecular epidemiology of cancer in Japan. It is hoped that this will lead to increased drug discovery and drug development for cancer.