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Plan to make Japan world leader in drug development

  • December 31, 2017
  • , Sankei , Lead story
  • JMH Translation

The overall outline of the Ministry of Health, Labor and Welfare’s “Plan to Enhance Drug Development in Japan” was disclosed on Dec. 30. With an eye to making Japan a “world leader in drug development,” the plan aims to strengthen Japan’s international competitiveness by creating an environment for the creation of new innovative pharmaceuticals. To promote “genomic medicine” for types of cancer contracted by about one in every two people, the MHLW will designate medical institutions that provide genomic treatment as “core facilities for cancer genomic medicine.” Moreover, with an eye to developing new therapeutic medicines, the MHLW will create the “Cancer Genomic Information Management Center” to collect and manage the genomic information analyzed at the core facilities.

 

Plan to start from this fiscal year

 

The main components of the plan are as follows: improve the R&D environment, reduce costs and raise efficiency [of new drug development], promote the international spread of pharmaceuticals that originated in Japan, and create venture companies. The MHLW and the Cabinet Office secured a total of about 83 billion yen in the supplementary draft budget for FY2017 and the initial draft budget for FY2018, and the plan will gradually be put into effect from FY2017.

 

The promotion of genomic medicine will be the key focus in improving the R&D environment. Cancer has been the leading cause of death in Japan since 1981, and there were about 1 million new cases of cancer in 2016.

 

Japan lags behind the West in taking initiatives to bring genomic treatment into practical application. Treating patients based on their gene mutations ensures more optimal treatment than that based on the organ diseased.

 

The plan includes bringing new treatments into practical application earlier than other countries by promptly approving innovative pharmaceuticals. In this way, the plan aims to make Japan a leader in clinical testing.

 

In addition, the plan provides for the improvement of the financing environment for medical venture companies. It is said that venture companies are what enable the United States to be the world’s largest developer of new drugs. To create a new drug requires huge sums of money over a long period, and securing funds has been a serious challenge for venture companies.

 

As part of drug-pricing reform, only the top 25% of drug makers in rankings of the companies’ contribution to innovative drug development will be eligible for the “surcharge for new drug development,” which keeps the prices of revolutionary new drugs at high levels.

 

Because almost all new-drug manufacturers have been eligible for the surcharge to date, the Pharmaceutical Research and Manufacturers of America (PhRMA) and others have expressed concern: “This [new stipulation] will reduce the incentive to create new pharmaceuticals in Japan and make it hard for Japanese patients to use new drugs at an early date.”

 

In response, an MHLW official said that providing support to medical ventures “will make it easier for companies to accept the pain they are asked to bear in the pharmaceutical pricing system reform.”

 

Key points in the Plan to Enhance Drug Development in Japan

  1. Improve the R&D environment
    • Create cancer genomic medicine and use artificial intelligence (AI)
  • Lower costs and raise efficiency by reforming pharmaceutical regulation
    • Develop a system for prompt approval of innovative pharmaceuticals and use electronic medical information that incorporates clinical data
  1. Raise productivity in pharmaceuticals and develop manufacturing infrastructure
    • Develop quality control rules and develop biotech human resources
  2. Promote the global spread of pharmaceuticals that originated in Japan
    • Develop international consistency in pharmaceutical regulations and develop human resources that can spearhead international deployment
  1. Create global venture businesses
    • Support medical venture businesses and develop human resources
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