恩慈使用倫理議題與法規分析

Analysis of the Ethical Issues and Regulations of Compassionate Use

恩慈使用（compassionate use）是指患有嚴重、危及生命疾病的病人，在用盡所有可行治療後，破例被容許使用「未核准之試驗中藥物」。這項制度考量到新藥核准過程費時，且末期病人通常已無法等待。目前包括美國、歐盟多數國家、英國、日本等地區，已確立「恩慈使用」制度。儘管如此，恩慈使用牽涉的倫理議題非常廣泛，包括使用高風險藥物、病人自主與知情同意、末期病人之易受傷害性等。此外恩慈使用涉及病人以外的多方利益相關者，如藥廠、監管機構、醫師甚至整個社會。本文分析恩慈使用所涉及之倫理問題，介紹先進國家「恩慈使用」管理法規，提出我國恩慈使用相關法規可參考改進之處。

Compassionate use refers to the exceptional authorization granted to patients suffering from severe, life-threatening illnesses to access 'unapproved investigational drugs' after all viable treatments have been exhausted. This provision considers the time-consuming process of new drug approval and the fact that terminally ill patients often cannot afford to wait. Many countries, including the United States, most European Union countries, the United Kingdom, and Japan, have established compassionate use regulations and practices. However, the ethical issues associated with compassionate use are extensive, encompassing the utilization of high-risk drugs, patient autonomy and informed consent, and the vulnerability of terminally ill patients. Moreover, compassionate use involves multiple stakeholders beyond the patients, such as pharmaceutical companies, regulatory agencies, physicians, and society. This article analyzes the ethical issues involved in compassionate use, introduces the management regulations of compassionate use in advanced countries, and proposes areas for improvement in our country's related regulations.