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Can Japan Become a Leader in Genomic Medicine? Government Efforts Begin in Organizing Agendas

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A working group of the central government’s Headquarters for Healthcare Policy has announced that it will organize necessary agendas that need to be met when applying genomes (i.e. entire set of genetic information) to medical care by this summer. In addition to the handling of genomic information according to the Amendment of the Personal Information Protection Act, the working group aims to include qualifications and measures in the report to ensure quality in genomic medicine. They will organize these qualifications and support the promotion of genomic medicine as well as the development of health-related industries.

Specifically, the working group will discuss how the “personally identifiable information,” which is part of personal information, should be treated with respect to the handling of genomic information according to the Amendment of the Personal Information Protection Act. Statements by experts within the working group will be reflected into policies to ensure the quality and precision of genetic testing. Furthermore, the working group will compile a report after exchanging opinions on the prevention of discrimination based on genomic information as well as on data management and secondary use.

The working group was established in November 2015 with a goal to confront the particularly important issues in promoting genomic medicine. Discussions are being carried out in collaboration with the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Economy, Trade and Industry (METI), while The Ministry of Health, Labour and Welfare is functioning as its secretariat.

Practical implementation of genomic medicine has already begun in some fields including cancer treatment. However, new tasks are becoming apparent with the appearance of genetic testing business, which collects genetic specimen without the intervention of a physician, and countermeasures are now required.

National Cancer Center Japan, a research organization of genomic medicine

National Cancer Center Japan (NCC)”, announced on May 10th that they have established Genomic Medicine Promotion Headquarters, an organization to promote genomic medicine based on analytical results of genomes. The Promotion Headquarters will consist of existing research projects, such as research of selecting treatment methods that match patients by diagnosing genetic abnormalities and research of utilizing genomic analysis results in drug development, and it will foster collaboration between these projects. The center will work together to reinforce its efforts in genomic medicine.

At an interview held in Tokyo on the day the Promotion Headquarters was established, Hitoshi Nakagama, Director of NCC, stated, "I would like this Promotion Headquarters to take the lead in creating network between medical institutions towards the realization of genomic medicine."

Nakagama was appointed as director of NCC on April 1. At the interview, he explained, "I would like to strengthen efforts in developing talent and collaborating internationally by leveraging NCC's strength as both a hospital and a research center specializing in cancer."" In particular, he stressed, ""Creating a medical provision system optimized for each patient based on genomic information is one of our priority issues."

METI’s "smart-cell industry" strategy

METI plans to formulate a promotion strategy for the new bioindustry that produces high-performance substances such as fibers and medical materials from microorganisms, plants, and animals. They have coined the term ""smart-cell industry"" to describe the efforts to design the functions of organisms and extract large volumes of beneficial substances from their cells by making the functions appear accurately, and they will discuss whether it will be a viable and developing industry. Discussions will be started on May 30 by the Subcommittee on Biotechnology under the Industrial Structure Council (advisory body to METI). They plan on compiling an intermediate report by July or August and will include part of the promotion strategy in the budget request for the fiscal 2017 budget.

For the past 10 years or so, METI had not formulated a full-scale industrial strategy that was based on the conceptual definition of the biotechnology industry. Within the span of the next 10 to 15 years, it aims to establish the overall concept of the industry and to make that the underlying understanding in deploying government policies in the future. First of all, in terms of technology, the smart-cell industry will utilize IT and artificial intelligence (AI) with respect to genes, etc. to design specific functions of organisms. Furthermore, by genome-editing and metabolic control, the organisms will be controlled to ensure that those functions appear. METI has defined smart-cell industry as enabling the large-volume production of high-performance substances from organisms that cannot be produced by chemical synthesis.

The antibody drugs (biopharmaceuticals) produced by pharmaceutical companies and the artificial synthetic spider silk commercialized by Spiber Inc. headquartered in Tsuruoka city, Yamagata Prefecture are already utilizing biological cells.

In the strategy, METI predicts the strengths and weaknesses of biological production compared to existing methods, as well as the industries and product areas of use, once biological production is established as a new production method. On top of that, they will delineate the points that the Japanese industrial circle will need to focus on as well as the measures necessary for gaining a competitive edge.

The world market for high-performance products made by using organisms reached 2.5 trillion yen in 2013, mainly through the production of amino acids, antibiotics and enzymes.

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