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April 25, 2014

行政の権限不行使

日本の官庁には制裁金の考え方がない。行政罰としては,金融庁,公正取引委員会の課徴金くらい。行政罰は刑事罰ではない。二重処罰には当たらない。(判例もある)
金商法はインサイダー取引を禁止している。証券取引等監視委員会は、家電量販店大手ノジマの顧問弁護士が同社株でインサイダー取引をしたとして、課徴金を科すよう金融庁に勧告した。課徴金は39万円。そうなるのを知っている弁護士が,インサイダー取引で金融商品取引法による課徴金勧告を受ける。
また,独占禁止法は不公正な取引の類型を定めて,違反行為に対して課徴金を課している。公正取引委員会は段ボールでカルテルを行った約60社に,総額60億円の課徴金を納付するよう命じる(4.24日経夕)。同法7条の2は,委員会にこの権限を与えている。
同委員会は,優越的地位の乱用により,ディスカウント店を展開する「ダイレックス」に,12億7千万円の課徴金納付命令と再発防止を求める排除措置命令を出す方針。

公害訴訟,薬害訴訟,ダム訴訟など,国を相手にした国賠訴訟は,数え切れないほどある。
しかし,行政が行使でき,行使すべき権限を行使しないために,被害・損害を与えた責任を認めた判決は少ない。権限不行使は,監督官庁の怠慢であるにもかかわらず,である。
その理由は,行政には一定の裁量権がある。権限を行使するもしないも行政の裁量に任されている。行使,不行使を含めて,権限を逸脱するものが行政事件訴訟となり,国家賠償訴訟となる。
ただし,制裁金はなくても適切な監督行政はできる。これを怠れば,行政の怠慢が裁判で指摘されて,国が損失補償する。さあ,これでいいのだろうか。賠償しても被害を受ける前の状況には戻れない。行政の規制は,不当な行為が行われている途中で行使されるからこそ効果を生じる。被害も未然に防止できる。
医薬品の販売が停止されるのも,行政の回収命令があればこそである。国賠訴訟では間に合わない。そもそも,医薬品販売を許可したのは,厚生労働大臣だ。
大臣は,医薬品輸入の承認に際しても,添付文書に安全性確保のための必要な記載が欠けているときは輸入承認してはならない。添付文書にそのような記載があると判断できれば,承認権限を行使できる。
はて,どこかおかしくないですか?
添付文書に副作用のおそれの記載があるかどうかではなく,安全な医薬品かを厚労省が判断すべきではないか。添付文書の記載があれば,厚労省の承認責任は果たせる,というような形式的な議論には納得できない。また,承認後は追跡調査しなくてよい,という理屈も納得できない。承認時に,「定期的に副作用情報を収集し報告すること」というような条件をつけることもできるからだ。行政が柔軟に対応する方法はいくらでもあるだろう。
 製薬会社の設計上の欠陥(製造物責任法2条2項)の有無はつぎの問題。
薬品は殆どが副作用を伴う。副作用のゆえに,重篤な症状に対する治療効果を期待しないのは,医療の放棄を意味するから,副作用を記載し警告した上で,目的とした治療効果を期待することも許される。
金が大事か命が大事か,という言葉がある。事故で骨折壊死し脚を切断しないと,敗血症で命を失う,と医者に宣告されたとする。誰でも,軽い症状と重い症状のどちらを選ぶか,と言われたら前者を選ぶだろう。副作用のある医薬品投与もそれに似ている。「多少の副作用なら我慢するから,重篤の病気を治してくれ。」と。そうなると,副作用の記載は,ますます重要な意味を持つことになる。AかBか,選択しなければならないからだ。
 記載は,「重大な副作用がある」「観察を十分に行い,異常が認められたときは,投与を中止し,適当な処置を行うこと」という内容になろう。どの程度記載するかは,投与する医薬品と症状との関係で決まるだろう。「死亡に至るおそれがある」とまで記載すれば,誰でも投与を控える。それでは,医薬品の適切な説明といえない。事実として,抗がん剤投与が肺炎を誘発して死ぬこともある。予後よくがんを征圧した,重篤な副作用(肺炎)に細心の注意を払ったが結局,死に至った。投与時にはこの転帰を予測できない。治療の本質に迫る選択をしなければならない。
 ほかにも,大臣の医薬品承認時に予測できなかった副作用が出ることもある。予測できない副作用の記載はできない。「重篤な症状がでるおそれがある」と何のことか分からない記載しかできない。それでも今の症状に有効な医薬品として投与するかは,医師の判断と説明,患者の承諾にゆだねられる。
 糖尿病治療薬アクトスが膀胱がんを併発したとすれば,武田がそれを予測できなかった臨床医学,薬学上の知見と予測可能性に帰着するだろう。そして,FDAも承認時にがん併発のリスクを確認すべきではなかったのか。
行政の義務が国によって差があってはならない。治療を受ける患者の権利を実現するため,医薬品承認するときは,リスク表示させて,これを承知の上で使うよう指示するべきだ。承認後の副作用の追跡調査も行政の責任である。もし,治療効果を帳消しにする副作用が生じれば,もはや医薬品と言えないからだ。判例をみてみよう。

 まず,医師の注意義務について。
①承認時までに得られた医学的,薬学的知見によれば,承認用量で副作用(肺炎)が発症する可能性は否定できない。症例によっては致死的となることもある。ただし,その副作用の発症頻度や重篤度は従来の抗がん剤を超える根拠はないというものであったから,「用量によっては致死的になる」と書くべきだ。肺炎は抗がん剤投与により生じる一般的副作用であることは専門医も知っている。
②行政の通達,製薬工業界の自主基準では,添付文書の「重大な副作用」とは,「患者の体質や発現時の状態によっては,死亡に至るおそれががあるもの」とされていた。①のような医薬品はこれに該るから,「重大な副作用(肺炎)」と書くべきだ。
③他方,がん治療効果は期待できたし,承認時の添付文書にもそう書かれていた。
予想される副作用は,従来の抗がん剤でも起こりえたし,症例によっては死に至ることも知られていた。医師もその結果を予見でき,職務上注意して投与すべきである。つまり,観察を十分に行い,異常が認められたときは投与を中止し,適切に処置するのである。
④投与は承認により認められているから,がん専門医でなくても使用してかまわない。

行政指導については,以下のように述べている。
①薬事法上,医療品添付文書は承認審査資料ではない。記載内容も承認審査の対象ではない。添付文書の記載事項は,法定されている通りだ(52~54条)。大臣はこれをみて行政指導する。ただし,行政指導する義務を定めたものではない。
②添付文書の記載内容に責任を持つのは,製造業者・販売業者である。これをみて,医師が判断して治療行為を行う。大臣は何をするべきか。記載内容につき広範に行政指導する。
 次が,東京地裁が新しく指摘する点である。
③営利を追求する企業が,添付文書に十分な情報提供するとは期待できない。大臣がしっかり,行政指導すべきだ。大臣は記載内容に踏み込んで指導しなければならない。
④行政指導には相手方の協力が必要になる。協力が得られなければ,強制できないから,行政の不作為が問われることはない。(つまり不作為も違法ではない)。
もっとも,これには議論があって,行政作用法の根拠がなくても行政指導すべき義務が認められた例もある(豊田商事,三菱自動車車輪脱落事故)。要件としては,国民の生命,身体,健康に差し迫った重大な危険がある,既存の法令が予想しなかった事態が生じ同様の危険が迫った,行政が被害回避のために指導できるのにしない,などである。例えば,原発事故は,法律がなくても,国が運転停止,住民避難命令等の緊急措置を講じなければならない。所管や法的根拠(原子力災害対策特別措置法,平成11年制定)を議論している場合ではない。冒頭の司法省の制裁金は,危険防止の対策というより,司法省軽視への制裁,巨額にするのは再発防止の警告,と思われる。

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