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2013年4月29日 (月)

再生医療推進法 産学官の連携強化を図りたい

The Yomiuri Shimbun April 29, 2013
Closer govt-industry-academia ties needed on regenerative medicine
再生医療推進法 産学官の連携強化を図りたい(4月28日付・読売社説)

The fruits of research and development into regenerative medicine that can repair organs damaged by disease or injury should be swiftly utilized for therapeutic purposes. A new law is the first step toward establishing a system for this end.

A bill promoting regenerative medicine unanimously passed the House of Councillors in a plenary session Friday to become law. With the aim of helping regenerative treatments including those using induced pluripotent stem (iPS) cells come into practical use, the law sets the goal of enabling this country to "provide the public with opportunities to benefit from regenerative medicine ahead of the rest of the world."

Pillar of growth strategy

Under the law, the government is responsible for mapping out basic policies regarding regenerative medicine R&D projects and extending support to cutting-edge, promising research programs at universities and other institutions.

The government has made regenerative medicine development a major pillar of its economic growth strategy. We welcome the fact that the legal foundation for facilitating this has been put in place through legislation sponsored by a bipartisan group of lawmakers.

Regenerative medicine basically works by using the cells or tissues of patients themselves. There is no danger of rejection by the patient, unlike organ transplants.

Riken, one of Japan's largest research institutions, has already applied to the Health, Welfare and Labor Ministry for permission to conduct clinical studies using iPS cells for treating age-related macular degeneration, a currently intractable eye disease.

Applications involving iPS cells have also been envisioned for a wide spectrum of therapies, such as treatment of heart disease and spiral cord injuries resulting from traffic accidents.

Kyoto University Prof. Shinya Yamanaka, the creator of iPS cells, won the Nobel Prize in Physiology or Medicine. This illustrates how Japan is a leading nation in basic research of regenerative medicine.

However, the problem is that many impediments still block research results from being used for actual clinical treatments.

Clinical trials that examine the effectiveness of these therapies are extremely expensive and time-consuming. Under the circumstances, enthusiasm could flag among startups and other businesses trying to enter regenerative medicine fields.

Taking this into account, the new law calls for speedy government authorization of regenerative medicine products and prompt screening of such products. The law stipulates the government should "take preferential taxation steps when necessary" to encourage businesses to enter the sector.

Currently, this screening primarily covers pharmaceutical products that are foreign substances to the human body. New screening standards will need to be set for regenerative medicine products, which are produced from human cells.

Safety, bioethics imperative

Competition between Japanese researchers and research organizations and businesses overseas is intense. The government must urgently study detailed measures that will prevent Japan from lagging in terms of yielding practical applications of regenerative medicine technologies.

We hope the new law's enactment will spur greater cooperation between the government, industry and academia.

By the same token, the new law rightly notes the need for due consideration of bioethics and ensuring regenerative medicine is safe to use. Arrangements must be taken to enable the public to receive regenerative medicine treatment with peace of mind.

During the current Diet session, the health ministry plans to submit a bill on regulations for regenerative medicine. A proper balance between the accelerator of the regenerative medicine promotion law and the brake of the ministry-envisioned regulatory law will be crucial.

(From The Yomiuri Shimbun, April 28, 2013)
(2013年4月28日01時31分  読売新聞)


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