藥品標示外使用刑事責任之探討

Abstract

對於藥品之管理，主管機關往往僅著重於新藥的核准，對於藥品上市後之監督即第四階段往往付之闕如，因此許多藥商利用上市後對於藥品之反應，往往變相做為另外新適應症的適用研究，對於主管機關而言，藥品標示外使用原則上是已核准藥品之運用，因此，若非有重大不良反應之回報，否則基本上是漠視。\n藥害救濟基金會在西元1999年至西元2015年2月第1～217次審議會之統計資料顯示，其中有1030件申請案，審議會審定結果是不予救濟，進一步分析其不予救濟之理由，名列第二名的原因為「未依藥品許可證所載之適應症或效能而為藥品之使用」，占整體不予救濟給付案件的23%，突顯現行的藥害救濟制度下藥害政策與實際臨床用藥的落差。\n本文認為醫療行為之目的，乃在救治病人生命及恢復病人之健康，其過程本就充滿不確定性與高度危險性，醫療行為之歸責，應以可合理期待之安全性為考量。然根據衛生署(民國102年7月改制成衛生福利部)於民國91年之函釋說明藥品標示外使用原則為「應據實告知病人」與「不得違反藥品使用當時，已知的、具公信力的醫學文獻」等。因此，雖藥品標示外使用為醫師治療方式之選項之一，但法令上對於藥品標示外使用，卻未有明確之規範，因此產生許多醫學倫理與法律責任之爭議。\n本文主題內容鎖定在藥品標示外使用與醫療過失之探討，且從刑法理論觀點，探討藥品標示外使用之法律性質，其在我國刑法規範體系中之定位，並加以闡釋注意義務，告知後同意，醫療過失，醫師說明義務等概念，並以實際發生的實際案例為例，進行說明。\n其中，藥品標示外使用是否成為醫師應說明義務之內容?又其說明義務之基礎如何架構，說明內容又為何?\n除此之外，文中將分析醫師注意義務與說明義務在藥品標示外使用時所應該達成的程度為何，結合國內的實務現狀與看法提供立法意見。

After marketing approval, the labels of on drug packages should outline the indications for use, dosage, administrative directions, and safety information. The use of drug could expand over time. Off-label use, which means prescribing an approved drug for a use that is not claimed in the product information, is common in medical practice, especially for some serious or rare diseases. Since there is no regulation for off-label use , a number of clinical , legal and ethical issues arise.\nAccording to Taiwan Drug Relief Foundation for Drug Hazards’ statistics regarding the rejected reasons by foundation from 1030 application cases 1999 to 2015. The 2nd reason for unapproved cases is off-label use which is around 23% of total unapproved cases. This shows current criteria for drug relief is quite not fit in real world practice.\nMedicine is intended to save patients’ lives and to help patients reach renewed health. During the process of treatment, the risk versus benefit profile beyond the original product approval should first be taken into consideration. In Taiwan, the department of health provides an guidance regarding off-label use, ex: The necessity of informed consent before prescribing off-label products. \nDo physicians need to follow the duty of informed consent whiling prescribing a drug which is off-label use? There should be a guidance to follow in this regard. \nThis study has established the principles and flow chart of off-label use. We suggest that some amendments to the laws are necessary, including setting up the scope of the duty of disclosure.