Copyright GLOBIS

Prof. Shinya Yamanaka, a G1 Board member, received the Nobel Prize in Physiology or Medicine for his work in creating iPS cells, an event that is still fresh in our memory. iPS cells are a true homegrown medical technology for Japan. By its nature, Japan’s strength should lie in the area of advanced medicine. At present, however, with regard to medicines and medical devices, imports exceed exports by 2.4 trillion yen. It is necessary to establish a system that facilitates the development of advanced medical technology ahead of other countries and implement measures to take advantage of Japan’s inherent strength.

1. Create a “Japanese NIH” as a Command Center for Medical Research and Development!

One of the major reasons for Japan’s lagging far behind countries in Europe and the United States in the field of medicine is the government systems for drug development in those countries. In Europe and the United States, health ministries are basically responsible for research and development of advanced medicine. The National Institutes of Health (NIH) in the U.S. and the Laboratory of Molecular Biology at the U.K.’s Medical Research Council (MRC) are both under the administrative control of the health ministry in each country. This system facilitates research and development and enables a smooth approval process for medical technology.

In Japan, on the other hand, the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and the Ministry of Economy, Trade and Industry (METI) both play a leading role in research and development while, unlike in the U.S. and U.K., the Ministry of Health, Labour and Welfare (MHLW), which is in charge of review and approval, puts on the brake to slow down the practical application of basic research. For this reason, while there have been successful outcomes in basic research, such as the development of iPS cells, Japan has been lagging behind the rest of the world in terms of innovation in medical technology, in particular, medicines and medical devices, at the practical stage. This situation has resulted in the 2.4 trillion yen excess of imports over exports of medicines.

To address this situation, it will be effective to create a Japanese version of National Institutes of Health as a command center tasked with promoting research and development by taking into account basic research in the medical area as well as review and approval of products. In creating such an institute, what is important is to eliminate the vertically segmented administrative system. We must remove the vertically segmented bureaucracy between MEXT, which has a large budget for basic research, and the MHLW, which has the authority to approve practical applications, to create a system that can strategically allocate budgets in accordance with policy and using a cross-ministerial/cross-agency approach. It is earnestly hoped that the Japan Agency for Medical Research and Development (AMED), newly established in April 2015, will serve as the command center for this purpose.

2. Develop Research Guidelines for Regenerative Medicine!

Through discussion of ethical issues concerning human cloning, regulations to prohibit the growth of human organs in animal bodies were established in 2001. However, as a result of the progress in iPS cell research, researchers have already been successful in regenerating animal organs in animal bodies, paving the way for the regeneration of human organs. The MHLW is now developing guidelines, in which it is necessary to give due consideration to ethical and safety issues and to delineate the appropriate scope of research that should be approved and rules for such research.

3. Eliminate Drug Lag and Device Lag!

To achieve the practical application of cutting-edge medicines and medical devices, as well as regenerative medical products, it is necessary to accelerate the timeframe from research and development to commercialization of products. The “review lag” between the application filing and approval of new drugs between the United States and Japan has been shortened. However, with regard to the “development lag” – the difference in time between companies filing an application with the Japanese review authority and with the U.S. review authority – there is still a gap of more than one year. It is effective to implement policy measures, such as enhancing the organization of the review authority in order to accelerate the review process and expanding ongoing consultation services on pharmaceutical affairs-related strategies provided by the review authority to companies to help them draw a roadmap from the initial stage of development.

4. Export Medical Services through Government-led Trade Promotion!

Manufacturing technology for products, such as medical devices, is one of Japan’s inherent strengths. The government should establish a command center focusing on the appropriate practical application of basic research and the acceleration of the review process to promote the release of approved products on the domestic market as well as on international markets.

Medical institutions in Europe and the United States have been active in exporting entire hospitals to developing countries, meaning that they export medical services to establish medical centers. Samsung of South Korea has recently established a medical center in Dubai and started to engage in selling their products along with medical services. The Japanese government should also promote sales of cutting-edge medical technology and services to emerging markets.

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