Life Science Government Initiatives

Life Science Government Initiatives

Supporting the healthcare industry nationwide while promoting data utilization

(1)Data Health Reform Promotion Project

With the aim of further extending the healthy life expectancy and providing effective and efficient medical and nursing care services, as stated in the Japanese Government’s Future Investment Strategy, "Data Health Reforms" are underway to reform the ICT infrastructure to link health, medical, and nursing care data, and to introduce cutting-edge technologies such as genome analysis and AI into healthcare. In January 2017, the Data Health Reform Promotion Division was established within the MHLW to study the specifics of the reforms, and a list of eight services, which will be realized through the reforms in FY 2020-21, was developed. In addition, it has announced four promotional businesses to be pursued post FY 2021-22 (See Figure 4).

(Figure4)Aim for FY 2021-22 and beyond

(Figure4)Aim for FY 2021-22 and beyond
Project name Contents and Objective
Promotion of genomic medicine and AI utilization
  • Use of whole genome information to determine the causes of cancer and other intractable diseases, develop new diagnosis and treatment methods, and provide patient-centered medical care optimized for each individual
  • Use of AI to advance healthcare services and reduce onsite workload
Promotion of "Personal Health Record (PHR)" for linking personal data to improvement of daily life
  • To enable people to see health and medical information on their smartphones, etc.
  • To enable people to easily use this information for their health management and prevention purposes
Promotion of information utilization in medical and nursing care settings
  • To enable appropriate confirmation of past medical and other information of patients in medical and nursing care settings
  • To enable provision of higher-quality services
Promotion of effective use of databases
  • Utilization of big data related to healthcare
  • A wide range of entities will benefit from this, for it includes revitalization of research by private companies and researchers, and provision of treatments tailored to patients' conditions

Moreover, in light of the fact that analog management of patients’ underlying illnesses and medical history is laborious and time-consuming in dealing with coronavirus and the digitalization of patient information is emerging as a major issue, the MHLW has announced the Intensive Data Health Reform Plan. The Plan will make maximum use of the existing infrastructure such as online qualification verification system and social security and tax number system (known as “My Number” system), and promote the following three operations by the summer of FY 2022-23: 1) a system in which patients and medical institutions can check medical information; 2) an electronic prescription system; and 3) a system for using their own health and medical information.

(2) Utilization of medical big data based on the Next-Generation Medical Infrastructure Act

In Japan, the use of medical information has tremendous potential. Having access to medical big data with aggregated information on clinical outcomes related to advanced Japanese healthcare will lead to many advantages such as the further development of personalized medicine, and patients’ earlier access to medicines. Accordingly, the Next-Generation Medical Infrastructure Act was enacted in May 2018 with the aim of enabling government-authorized entities to collect medical information on each patient, which is the cornerstone of medical big data, from individual medical institutions and utilize it for research and development in the medical field.

As a result, it was announced in December 2020 that Pfizer, a U.S. pharmaceutical company, will receive medical information, the first such case since the enactment of the Next-Generation Medical Infrastructure Act. The company is expected to use data from Japanese cancer patients to evaluate the safety and efficacy of drugs and accelerate the development and commercialization of new drugs. As the domestic life science market expands, it is expected that an increasing number of companies will use medical information based on this Act.

(3)Efforts for unmet medical needs

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.

(4) Premium for new drug development

The "premium to promote the development of new drugs and eliminate off-label use" was introduced on a trial basis in FY 2010-11 for the promotion of generic drugs, the creation of innovative new drugs, and solving the "drug lag" problem where medicines available overseas are not available in Japan, and is still in effect. Under this system, pharmaceutical companies engaging in new drug development at the request of the MHLW can defer the reduction of drug prices based on prevailing market prices for the new drugs (for which no generic drugs have been launched) that they manufacture and sell.

The system is not only an incentive for foreign companies, but also an important decision-making tool to boost R&D investment in Japan. Even after the FY 2020-21 revision, foreign companies continue to dominate in terms of the number of components and products for which they receive the new drug development premium (See Figure 5).

Table of the top 10 companies in terms of the number of components eligible for new drug development premium to promote new drug development. In the ranking for FY 2020, 1st: Novartis Pharma (Switzerland) 2nd: Sanofi (France) 3rd: Pfizer (US) 4th: Janssen Pharma (Belgium) 5th: MSD (U.S.) 6th: Takeda Pharmaceutical Company (Japan) 7th: Nobelpharma (Japan) 8th: Daiichi Sankyo (Japan) 9th: GlaxoSmithKline (UK) 10th: Chugai Pharmaceutical (Japan) Created based on data published by MHLW

(5)Support to foreign companies investing in regional areas

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.

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