医療機器入超 承認の遅れは競争力を殺ぐ

The Yomiuri Shimbun (Feb. 6, 2013)
Slow medical device approval hinders intl competitiveness
医療機器入超　承認の遅れは競争力を殺ぐ（2月5日付・読売社説）

We want Japanese makers of medical devices to strengthen their international competitiveness. The government should remove any obstacles that prevent excellent products from being more widely used.
　日本の医療機器メーカーの国際競争力を強化させたい。優れた機器の普及へ、障壁を取り除く政府の役割は重要だ。

The health ministry has decided to shorten the time required for approval and certification of medical devices. To expand the range of products allowed for screening by private certification bodies, the ministry plans to submit a bill to revise the Pharmaceutical Affairs Law to the current Diet session.
　厚生労働省は、医療機器の承認や認証にかかる期間を短縮する方針を決めた。民間の認証機関に審査を任せる対象製品を拡大するため、今国会に薬事法改正案を提出する考えだ。

This decision was made after the government's Industrial Competitiveness Council, which is holding discussions on growth strategy, called for deregulation in this field. The Regulatory Reform Council also will take up medical issues. We believe the ministry has taken a proper course of action.
　成長戦略を議論している政府の産業競争力会議が、規制緩和を求めたことを受けたものだ。規制改革会議でも医療はテーマになる。妥当な判断と言えよう。

In Japan, an average of about three years is needed from the development of medical devices to approval by the health ministry. As this is about two years longer than in the United States, the time lag is significant.
　日本では現在、医療機器の開発から厚労省による承認まで平均３年程度かかり、米国と比べて約２年も長い。大幅な承認遅れだ。

This has deprived domestic makers of their competitiveness. Although their technological strength is extremely high, commercialization of their products takes far too long, making them reluctant to develop new products or enter the market.
　これが、国内メーカーの競争力を殺(そ)ぐ要因となっている。高い技術力がありながら、製品化に時間がかかり、新商品開発や市場参入に二の足を踏むからだ。

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Domination by foreign rivals

Cardiac pacemakers and heart valves, for example, are dominated by foreign companies, with most of them being imported. Imports of medical devices exceed exports by about 600 billion yen annually, indicating how serious the situation is.
　例えば、心臓ペースメーカーや人工心臓弁は海外企業に押され、ほぼすべてを輸入に頼っている。医療機器は年間約６０００億円の輸入超過という深刻な状況だ。

Medical devices are a promising growth market. The current situation in which Japanese makers lag far behind foreign rivals must be rectified.
　医療機器は成長が見込まれる有望市場である。日本メーカーの劣勢を挽回しなければならない。

It is crucial to revitalize the domestic industry, strengthen strategies to compete in markets abroad and boost Japan's economic growth.
　国内業界を活性化させ、世界の市場を攻略する戦略を強化し、日本の経済成長に弾みをつけることが急務である。

If cutting-edge products become available for immediate use by shortening the time it takes to approve products, it also will help patients.
　承認期間の短縮によって、効果が高い最先端の機器が国内ですぐに使えるようになれば、患者にとっても有益だろう。

The latest decision by the Health, Labor and Welfare Ministry is aimed at expanding the range of products allowed for certification by private entities to those that involve relatively higher risks.
　厚労省の今回の決定は、民間機関の認証対象を比較的リスクの高い製品にも拡大する内容だ。

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Simplify regulatory process

The range of products--now limited to magnetic resonance imaging and a few other devices--is expected to be expanded to generic versions of contact lenses, dental implants and other products.
　ＭＲＩ（磁気共鳴画像装置）などに限られている対象をコンタクトレンズ、歯のインプラントなどの後発品に広げる。

In Europe, private entities generally certify medical devices, allowing them to be commercialized quickly. In Japan, we want to accelerate the commercialization and sales of products. Further expansion of the range of products permitted to be certified by private entities is an issue that must be addressed.
　欧州では原則として民間機関が医療機器を認証し、迅速に製品化している。日本も速やかな製品化で販売を加速してもらいたい。対象の一層の拡大も課題だ。

Naturally, the safety of medical devices must not be neglected. The government should oversee certification bodies and consider measures to enhance the quality of screening processes.
　無論、医療機器の安全性の確保を忘れてはならない。国が認証機関を監督して、審査の質を高める方策を検討する必要がある。

Regarding subcontractors producing devices for major makers, the health ministry plans to simplify the regulatory process by shifting to a notification system from one in which permission is necessary. This is expected to allow companies to develop products and enter the market more easily.
　厚労省はまた、大手メーカーの下請けの製造事業者について、許可制から届け出制に簡素化する。製品開発に取り組みやすい環境が整い、企業の新規参入を促す効果が期待できよう。

Slow market penetration is also attributable to the difficulty in carrying out clinical trials for medical devices, in which the effectiveness and safety of products are tested on patients. It is essential to review the current system through such measures as expanding joint clinical trials with overseas institutions.
　医療機器普及の遅れの背景には、患者に使って機器の効果や安全性を調べる治験が進まないこともある。海外との共同治験の拡大など体制の見直しが肝要だ。

(From The Yomiuri Shimbun, Feb. 5, 2013)
（2013年2月5日01時40分  読売新聞）