藥害救濟法第13條第9款修法方向之探討【實務講座】 試閱
Proposals about the Amendment of Article 13(9) of the Drug Injury Relief Act
大法官在釋字第767號解釋中雖就藥害救濟法第13條第9款作成合憲性解釋,然而社會輿論對於所謂「常見且可預期之藥物不良反應」之定義仍有所爭論。本文認為貿然將常見且可預期之藥物不良反應納入藥害救濟,將巨幅提高救濟支出,恐影響臺灣藥害救濟制度的運行。本文建議未來修法時可作條文用字修正或強化法律授權規定,讓主管機關得以盱衡醫藥產業發展、制度健全永續,以及社會衡平等情事後,再就該款定義予以適當調整為宜。
Even though the Constitutional Court under the Judicial Yuan (J.Y.) issued J.Y. Interpretation No. 767 and declared that Article 13(9) of the Drug Injury Relief Act is in accordance with the Constitution, there was an ongoing debate about the definition of “common and foreseeable adverse drug reactions.” To ensure the long-term sustainability of Taiwan drug injury relief system, it is a reasonable approach to exclude “common and foreseeable adverse drug reactions” from the scope of drug injury relief. Nevertheless, the phrasing of Article 13(9) of the Drug Injury Relief Act should be revised to avoid abovementioned debate.
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