管制藥品仿單外使用爭議案：管制藥品仿單外使用與過失致死罪及販毒罪之關係【學習式判解評析】 試閱
An Issues about Off-Label-Use of Controlled Medicines: The Off-Label-Use of Controlled Drugs and Its Outsourcing in Hospitals: Medicine's Duty to Disclosure Negligence and Unlawful Sale of Controlled Drugs
本文評析普洛福案之最高法院112年度台上字第3373號刑事判決維持該案第二審更審判決，在管制藥品仿單適應症外使用相關問題上闡述之觀點與本文意見，可歸納如下：首先，管制藥品管理條例第5條第1項、第6條第1項所規定管制藥品之正當醫療目的使用必須限於仿單核准之適應症。又，衛生福利部（下稱衛福部）函釋曾對於藥品非仿單適應症使用提出合法化要件，其立場似乎不同於上開法院見解。本文贊同最高法院主張之管制藥品限於仿單核准適應症使用始為正當之見解。其次，醫師非正當醫療目的使用管制藥品行為與販賣毒品罪之基礎事實不同，其是否成立販賣第四級毒品罪，應就具體案例事實檢驗犯罪構成要件。再者，醫師開立普洛福治療毒品戒斷、失眠之病患，為管制藥品使用於非仿單核准適應症，雖已是非正當醫療目的之醫療行為，仍須依醫療法第82條各項規定檢驗注意義務與刑法上相當因果關係，始能確認是否成立過失致死罪。本文著重於管制藥品之正當醫療目的例外允許使用規定與販賣第四級毒品罪之討論，並於最後建議參考德國麻醉藥品交易法，修正我國管制藥品管理之正當醫療目的規定，以使例外允許規定之內涵更為明確。
The High Court decisions upheld by the Supreme Court around the issues of the off-label use of controlled drugs can be summarized as follows: firstly, the legitimate medical purpose use of controlled drugs under Article 5(1) and Article 6 (1) of the Controlled Drugs Act must be limited to the label-use. The court decisions seem to conflict with the opinions issued by the Ministry of Health and Welfare. The argument of court decisions taking into account of the nature of controlled drugs may be more persuasive. Secondly, clinical physicians’ prescription of controlled drugs for no legitimate medical purpose does not necessarily constitute the offense of unlawful sale of Schedule 4 (IV) drugs. It will depend on whether they meet the elements of the offense. Thirdly, the question of whether the off-label use of controlled drugs to addicted patients constitute the offense of causing death by negligence must be determined in light of circumstance according to Article 82 of the Medical Care Act. This comment focuses on the issues of legitimate medical purpose use of controlled drugs and proposes future amendment to the Controlled Drugs Act with reference to German Narcotic Substance Act.
062-081
