Life Science Government Initiatives

Supporting the healthcare industry nationwide while promoting data utilization

The medical needs for diseases, particularly for rare diseases, for which no effective treatment is yet available (“unmet medical needs”) have been difficult to address due to the small number of patients and the difficulty of recovering R&D investment. However, with the 2013 amendment of the Pharmaceutical Affairs Law, if the MHLW designates the drug as therapeutic against a rare disease (orphan drug), the R&D costs are subsidized and tax deductions are granted, leading to increased development within the pharmaceutical industry.

In fact, a number of foreign companies, including Novartis Pharma (Switzerland), Janssen Pharma (Belgium), MSD (U.S.), Sanofi (France), GlaxoSmithKline (U.K.), and Pfizer (U.S.), have benefited from this orphan drug designation system. In addition, after the introduction of this system, a number of bio-ventures have entered the market in recent years, whereas until now, orphan drug development was mainly undertaken by large companies due to the high development hurdles. Another advantage is that by narrowing down the target patients, it is possible to avoid development competition with large companies that have not set their sights on this field yet.

On the other hand, for rare cancers, which represent a major unmet medical need, the government is focusing on research into genomic medicine and immunotherapy, which have the potential to develop new treatment methods. The National Cancer Center (NCC) established the “Center for Cancer Genomics and Advanced Therapeutics (C-CAT)” in June 2018 to collect and store genomic information of Japanese cancer patients and utilize this information appropriately. The MHLW is also working to increase the number of core hospitals for cancer genome and strengthen their functions.

In addition, in March 2019, the MHLW compiled guidelines to promote the development and efficiency of immunotherapy. Known as the “fourth pillar of cancer treatment”, following surgery, chemotherapy, and radiation therapy, immunotherapy includes immune checkpoint (CP) inhibitors, CAR-T cellular therapies, and cancer vaccines. Further, in September 2020, the MHLW approved the manufacture and sale of a drug developed by the pharmaceutical venture company Rakuten Medical Japan. This drug is used in “photoimmunotherapy” to kill cancer cells by irradiating laser light from outside the body, as a treatment for head and neck cancers. This will be the world’s first application of this therapy, indicating that efforts to eradicate rare cancers are gaining momentum.

The Japanese government holds regular meetings to promote foreign direct investment in Japan. Amid the challenges of the concentration of industries and population in Tokyo, the government is trying to attract competitive foreign capital nationwide to revitalize regional areas. The life science industry is also witnessing an increase in such activities. For instance, Italian medical equipment company AT-OS Japan and Taiwanese medical equipment company Japan Microware Precision have established their operations in Fukushima Prefecture. Fukushima Prefecture aims to become a cluster for the medical equipment industry and to expand the business of local companies, and has been successful in attracting foreign companies through its investment support subsidy program.

Furthermore, Kanagawa Prefecture has established “King Skyfront”, an international strategic zone for life science and environment industries, in the Tonomachi area of Kawasaki City. It has been attracting companies and R&D centers to the area since 2008. It was designated as a National Strategic Special Zone in 2014, and offers tax deductions and exemptions, financial and other incentives, and eases various regulations. In addition to domestic public research institutions and private companies, Johnson & Johnson (U.S.) has established a training facility for medical professionals to learn to operate its medical equipment, and it is expected to be visited by about 10,000 people annually from Japan and abroad.

In this way, each local government is actively working to attract foreign companies by providing subsidies and other incentives as well as business infrastructure.