2013年02月17日
ｉＰＳ研究 実用化を進める法制度が要る
The Yomiuri Shimbun (Feb. 16, 2013)
Legal system needed to spur treatment with iPS cells
ｉＰＳ研究 実用化を進める法制度が要る（2月15日付・読売社説）
What could be a significant first step has been made toward practical medical treatment using induced pluripotent stem cells.
ｉＰＳ細胞（人工多能性幹細胞）を使った治療の実用化へ、意義ある第一歩となるだろう。
Clinical research by the Riken Kobe Institute on the treatment of age-related macular degeneration (AMD), an intractable eye disease, has been approved by the Institute of Biomedical Research and Innovation Hospital, where the research will be conducted.
目の難病「加齢黄斑変性」をｉＰＳ細胞で治療する理化学研究所（神戸市）の臨床研究が、実施先の先端医療センター病院で承認された。
A Riken team will file an application with the Health, Labor and Welfare Ministry for the implementation of its clinical research. If approved, clinical research will start in fiscal 2013 at the earliest to confirm the efficacy and safety by conducting iPS cell treatment on patients.
理研チームは厚生労働省に審査を申請する。承認されれば、患者で効果や安全性を確かめる臨床研究が２０１３年度にも始まる。
AMD is a disease that advances with age and leads to reduced vision or blindness due to a disorder in some retinal cells. No fundamental clinical treatment has been established. There are reportedly about 700,000 patients in Japan.
この病気は加齢に伴い、網膜細胞の一部に障害が出て視力が低下するものだ。失明の恐れもある。根本的な治療法はない。国内の患者は約７０万人とされる。
The planned treatment calls for applying a cell sheet generated from a patient's stem cells to the damaged retina, thereby restoring the patient's vision.
今回は、傷んだ網膜に患者のｉＰＳ細胞から作った細胞シートを貼り付けて視力の回復を図る。
As for iPS cells, the risk of them becoming cancerous has been pointed out. But eye tissue, including the retina, has little possibility of doing so. It also shows almost no cellular rejection. For these reasons, the treatment of AMD was chosen for the first clinical application of iPS cell treatment.
ｉＰＳ細胞は、がん化の危険性が指摘されるが、網膜を含む目の組織はがんになりにくい。拒絶反応もほとんどない。それだけに、この病気の治療が臨床研究の先陣を切ったのだろう。
===
Approval system defective
A matter of concern is that even if sufficient results are obtained through clinical research, it may take some time before approval is obtained from the health ministry for practical application.
問題は、この研究で十分な成果が得られても、実用化の段階では厚労省の承認までに時間がかかりかねないことである。
First of all, there is no legal system in place for that type of procedure.
まず法制度が整っていない。
In order for drugs to be approved for use, procedures must be taken in line with the Pharmaceutical Affairs Law. Clinical treatment using iPS cells--generated from patients' own cells--will require screening criteria different from that applied to manufactured drugs, which are foreign to humans.
医薬品が承認を得るには、薬事法で規定された手続きを取らねばならない。だが、自己の細胞を使うｉＰＳ細胞による治療には、人体にとって異物である薬とは異なる審査の基準が必要である。
So the approval system must be revised.
承認の仕組みも見直すべきだ。
Even in cases of regenerative medicine not using iPS cells, it takes time to obtain approval. Regenerative medicines, such as those using skin and cartilage, have been put into commercial use one after another in South Korea and the United States. In Japan, there are only two such products.
ｉＰＳ細胞を使用していない再生医療でも、承認までに手間取っている。皮膚、軟骨などが韓国、米国で次々に製品化されているのに、日本はわずか２製品だ。
In South Korea, provisional approval is given on regenerative medicines after their safety is confirmed to a certain degree, thereby encouraging the development of such products.
韓国では、一定の安全性が確認された再生医療製品に「仮承認」を与え、開発を促進している。
Japan must study a plan to establish a system under which regenerative medical products can be swiftly put into practical use by adopting a temporary approval system similar to South Korea's and giving full endorsement by accumulating safety data after sales begin.
日本でも仮承認し、販売後に安全性データを蓄積して本承認とするなど、迅速に実用化する仕組みを検討すべきだ。
===
Fiscal assistance vital
It is essential to provide funds to help expand this planned clinical research to the treatment of other diseases, such as heart disease and diseases of the blood. The government will provide 110 billion yen over 10 years to help finance regenerative medicine using iPS cells and the development of new drugs. Research centers must be continuously expanded.
今回のような臨床研究を、心臓や血液など他の病気に広げる支援も重要である。政府はｉＰＳ細胞による再生医療や薬の開発に１０年で１１００億円を支援する。継続的に研究拠点を整備すべきだ。
It must be noted, however, that hopes regarding regenerative medicine have led to the emergence of treatment methods whose safety is questionable. The health ministry plans to regulate such practices with a new law. Safety is important but legitimate research should not be constrained.
ただ、「再生医療」への期待に便乗し、安全性に疑問のある治療まで出現している。厚労省は、これを新法で規制する方針だ。安全は大切だが、正当な研究に支障が出ないようにしてもらいたい。
As symbolized by the fact that Prof. Shinya Yamanaka of Kyoto University received a Nobel Prize for production of iPS cells, Japan's basic research on regenerative medicine is among the world's best. The country should not fall behind in practical applications, either.
ｉＰＳ細胞を作製した山中伸弥・京都大教授のノーベル賞受賞に象徴されるように、日本は基礎研究でトップレベルにある。実用化でも後れを取ってはならない。
(From The Yomiuri Shimbun, Feb. 15, 2013)
（2013年2月15日01時20分 読売新聞）
Legal system needed to spur treatment with iPS cells
ｉＰＳ研究 実用化を進める法制度が要る（2月15日付・読売社説）
What could be a significant first step has been made toward practical medical treatment using induced pluripotent stem cells.
ｉＰＳ細胞（人工多能性幹細胞）を使った治療の実用化へ、意義ある第一歩となるだろう。
Clinical research by the Riken Kobe Institute on the treatment of age-related macular degeneration (AMD), an intractable eye disease, has been approved by the Institute of Biomedical Research and Innovation Hospital, where the research will be conducted.
目の難病「加齢黄斑変性」をｉＰＳ細胞で治療する理化学研究所（神戸市）の臨床研究が、実施先の先端医療センター病院で承認された。
A Riken team will file an application with the Health, Labor and Welfare Ministry for the implementation of its clinical research. If approved, clinical research will start in fiscal 2013 at the earliest to confirm the efficacy and safety by conducting iPS cell treatment on patients.
理研チームは厚生労働省に審査を申請する。承認されれば、患者で効果や安全性を確かめる臨床研究が２０１３年度にも始まる。
AMD is a disease that advances with age and leads to reduced vision or blindness due to a disorder in some retinal cells. No fundamental clinical treatment has been established. There are reportedly about 700,000 patients in Japan.
この病気は加齢に伴い、網膜細胞の一部に障害が出て視力が低下するものだ。失明の恐れもある。根本的な治療法はない。国内の患者は約７０万人とされる。
The planned treatment calls for applying a cell sheet generated from a patient's stem cells to the damaged retina, thereby restoring the patient's vision.
今回は、傷んだ網膜に患者のｉＰＳ細胞から作った細胞シートを貼り付けて視力の回復を図る。
As for iPS cells, the risk of them becoming cancerous has been pointed out. But eye tissue, including the retina, has little possibility of doing so. It also shows almost no cellular rejection. For these reasons, the treatment of AMD was chosen for the first clinical application of iPS cell treatment.
ｉＰＳ細胞は、がん化の危険性が指摘されるが、網膜を含む目の組織はがんになりにくい。拒絶反応もほとんどない。それだけに、この病気の治療が臨床研究の先陣を切ったのだろう。
===
Approval system defective
A matter of concern is that even if sufficient results are obtained through clinical research, it may take some time before approval is obtained from the health ministry for practical application.
問題は、この研究で十分な成果が得られても、実用化の段階では厚労省の承認までに時間がかかりかねないことである。
First of all, there is no legal system in place for that type of procedure.
まず法制度が整っていない。
In order for drugs to be approved for use, procedures must be taken in line with the Pharmaceutical Affairs Law. Clinical treatment using iPS cells--generated from patients' own cells--will require screening criteria different from that applied to manufactured drugs, which are foreign to humans.
医薬品が承認を得るには、薬事法で規定された手続きを取らねばならない。だが、自己の細胞を使うｉＰＳ細胞による治療には、人体にとって異物である薬とは異なる審査の基準が必要である。
So the approval system must be revised.
承認の仕組みも見直すべきだ。
Even in cases of regenerative medicine not using iPS cells, it takes time to obtain approval. Regenerative medicines, such as those using skin and cartilage, have been put into commercial use one after another in South Korea and the United States. In Japan, there are only two such products.
ｉＰＳ細胞を使用していない再生医療でも、承認までに手間取っている。皮膚、軟骨などが韓国、米国で次々に製品化されているのに、日本はわずか２製品だ。
In South Korea, provisional approval is given on regenerative medicines after their safety is confirmed to a certain degree, thereby encouraging the development of such products.
韓国では、一定の安全性が確認された再生医療製品に「仮承認」を与え、開発を促進している。
Japan must study a plan to establish a system under which regenerative medical products can be swiftly put into practical use by adopting a temporary approval system similar to South Korea's and giving full endorsement by accumulating safety data after sales begin.
日本でも仮承認し、販売後に安全性データを蓄積して本承認とするなど、迅速に実用化する仕組みを検討すべきだ。
===
Fiscal assistance vital
It is essential to provide funds to help expand this planned clinical research to the treatment of other diseases, such as heart disease and diseases of the blood. The government will provide 110 billion yen over 10 years to help finance regenerative medicine using iPS cells and the development of new drugs. Research centers must be continuously expanded.
今回のような臨床研究を、心臓や血液など他の病気に広げる支援も重要である。政府はｉＰＳ細胞による再生医療や薬の開発に１０年で１１００億円を支援する。継続的に研究拠点を整備すべきだ。
It must be noted, however, that hopes regarding regenerative medicine have led to the emergence of treatment methods whose safety is questionable. The health ministry plans to regulate such practices with a new law. Safety is important but legitimate research should not be constrained.
ただ、「再生医療」への期待に便乗し、安全性に疑問のある治療まで出現している。厚労省は、これを新法で規制する方針だ。安全は大切だが、正当な研究に支障が出ないようにしてもらいたい。
As symbolized by the fact that Prof. Shinya Yamanaka of Kyoto University received a Nobel Prize for production of iPS cells, Japan's basic research on regenerative medicine is among the world's best. The country should not fall behind in practical applications, either.
ｉＰＳ細胞を作製した山中伸弥・京都大教授のノーベル賞受賞に象徴されるように、日本は基礎研究でトップレベルにある。実用化でも後れを取ってはならない。
(From The Yomiuri Shimbun, Feb. 15, 2013)
（2013年2月15日01時20分 読売新聞）
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