ゼロリスク神話

日本における薬事法では、承認権者の責任が問われる。
そのため、リスクの高い医療機器は日本では承認されにくいとされる。
万が一、承認した医薬品・医療機器で重大な事故が発生した場合、承認した厚労省の課長が刑事訴追を受けることになってしまう。
つまりすべての過ちは政府が担う。欧米では、その時点の基準をもって判断したならば審査責任は問われない

日本のマスコミは、事故を起こした企業を糾弾することが社会正義と思っている。
また我々国民も、その論調に同調しがちである。
つまりゼロリスクを要求する。いわゆる「ゼロリスク神話」である。

日本では、このように苦情リスクが非常に高いため、風評悪化を懸念し、医療機器産業への参入が阻害され輸入に依存することになる。
医療機器は、年間6,000億円もの輸入超過状態である。

では、飛行機は何度も墜落事故を起こしたが、飛行を禁止したであろうか。
また、毎年交通事故で1万人もの死亡者が出るが、自動車の運転を禁止したであろうか。
もちろん、事故はできる限り起こしてはならない。
しかしながら、事故を起こしたからといって、開発を中止したり、製造を中止すると科学や技術の発展は望めない。
医療技術が進歩することを阻害してしまう。
事故を起こしてしまったら、根本的原因を追究し、二度と同じ事故を起こさないように是正を図るべきである。
医療機器業界でCAPAが重要視される所以である。

欧米では、インフォームドコンセント（十分な説明）のもと、Take your own risk.とされる。
リスクをとるかとらないかは、患者の判断による。

医薬品や医療機器における臨床試験においては、科学性、倫理性に関する基本原則を定めた「ヘルシンキ宣言」が有名である。
もう一つ、著名なものに「ベルモントレポート」がある。
ベルモントレポートは、1979年4月に米国で「研究対象者保護のための倫理原則および指針」として発行された。
臨床研究における倫理的な問題を考える際の枠組みを端的にあらわしており、その三原則は、
１．人格の尊重
２．善行
３．正義
である。
2番目の「善行」では、科学性、利益とリスクの評価を論じている。
すべての非科学的な行いは、倫理的ではない。
つまり科学を論じずに倫理面だけを論じることは全く意味をなさない。
また、我々の生命・健康は、過去の病気になった方々、被験者の方々、過去に医療事故に見舞われた方々の献身の上に成り立っている。
犠牲があったからこそ、我々が高度かつ高品質な医療を受けることができる。
我々も子々孫々のため、ある意味の犠牲を払わなければならない。

ベルモントレポートは、あくまでも米国内倫理綱領だが、研究倫理の歴史に大きなインパクトを与えた。

これまで医療機器は、医薬品を対象として制定された「薬事法」により規制されてきた。
2014年11月25日から、薬事法が一部改正される。
これにより、現在の「薬事法」という名称から、「医薬品、医療機器等の品質、有効性および安全性の確保等に関する法律」（医薬品医療機器等法）という名称に変更される。
しかしながら、承認権者の責任は従前のとおりである。

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/O067.html” title=”【VOD】【180分で要点を学ぶ】改正GMPセミナーシリーズ　品質リスクマネジメント編” content=”2021年8月1日からGMP省令が改正されます。
改正GMP省令は、ICHやPIC/S等の国際標準のGMP基準に整合されました。
特にICH-Q9（品質リスクマネジメント）やICH-Q10（医薬品品質システム）の遵守が求められます。
医薬品等の製造・品質管理において、あらゆるリスクを低減し、患者の安全性を担保することは極めて重要です。
これまでICH-Q9 「品質リスクマネジメントに関するガイドライン」は課長通知として発出されていました。
品質管理・品質保証と品質リスクマネジメントは表裏一体です。どちらもPDCAサイクルを持ち、常に実践することが求められます。
しかしながら、ICH-Q9 「品質リスクマネジメントに関するガイドライン」は難解です。
改正GMP省令においては、適切に品質リスクマネジメントが活用されるよう、ICHQ9の原則に則して手順書の作成と実施が求められます。
しかしながら、品質リスクマネジメントでは、特定の部門を設置したり、新たな手順書を1冊作成すれば良いというものではありません。
すべての既存の組織におけるすべての手順書に品質リスクマネジメントに関する要素を盛り込んでいく必要があります。

本セミナーでは、難解なICH Q9を分かりやすく解説し、品質リスクマネジメントの要点をまとめます。
また、品質リスクマネジメント手順書のサンプルも配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-084.html” title=”【セミナービデオ】【180分で要点を学ぶ】改正GMPセミナーシリーズ　品質リスクマネジメント編” content=”2021年8月1日からGMP省令が改正されます。
改正GMP省令は、ICHやPIC/S等の国際標準のGMP基準に整合されました。
特にICH-Q9（品質リスクマネジメント）やICH-Q10（医薬品品質システム）の遵守が求められます。
医薬品等の製造・品質管理において、あらゆるリスクを低減し、患者の安全性を担保することは極めて重要です。
これまでICH-Q9 「品質リスクマネジメントに関するガイドライン」は課長通知として発出されていました。
品質管理・品質保証と品質リスクマネジメントは表裏一体です。どちらもPDCAサイクルを持ち、常に実践することが求められます。
しかしながら、ICH-Q9 「品質リスクマネジメントに関するガイドライン」は難解です。
改正GMP省令においては、適切に品質リスクマネジメントが活用されるよう、ICHQ9の原則に則して手順書の作成と実施が求められます。
しかしながら、品質リスクマネジメントでは、特定の部門を設置したり、新たな手順書を1冊作成すれば良いというものではありません。
すべての既存の組織におけるすべての手順書に品質リスクマネジメントに関する要素を盛り込んでいく必要があります。

本セミナーでは、難解なICH Q9を分かりやすく解説し、品質リスクマネジメントの要点をまとめます。
また、品質リスクマネジメント手順書のサンプルも配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/O071.html” title=”【VOD】（全5コース）【180分で要点を学ぶ】改正GMPセミナーシリーズ【一括受講コース】” content=””]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-088.html” title=”【セミナービデオ】（全5コース）【180分で要点を学ぶ】改正GMPセミナーシリーズ【一括受講コース】” content=””]

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