Drug Injury Relief Act Article 13
Drug injury relief shall not be granted under any of the following circumstances:1. The drug injury is proved to be the responsibility of the drug injury victim, drug manufacturer or importer, physician, or other parties.2. The drug injury occurred prior to the implementation of this Act.3. The injury resulted from vaccination and is eligible for relief under other laws and regulations.4. Compensation or indemnification has already been received for the same basis and facts, excluding benefits received from personal insurance.5. The adverse reactions caused by drug use do not meet the severity criteria of death, disability or severe illness.6. The injury resulted from a drug overdose during emergency medical care.7. The injury resulted from the use of investigational drugs.8. The injury resulted from off-label use of a drug, defined as usage not aligned with the indications or purposes stated on the drug permit, unless such use aligns with current medical practice and is deemed appropriate.9. The injury resulted from common and foreseeable adverse reactions to the drug.10. Other conditions as promulgated by the competent authority.
中文原文 藥害救濟法第13條
有下列各款情事之一者，不得申請藥害救濟：
一、有事實足以認定藥害之產生應由藥害受害人、藥物製造業者或輸入業者、醫師或其他之人負其責任。
二、本法施行前已發見之藥害。
三、因接受預防接種而受害，而得依其他法令獲得救濟。
四、同一原因事實已獲賠償或補償。
但不含人身保險給付在內。
五、藥物不良反應未達死亡、障礙或嚴重疾病之程度。
六、因急救使用超量藥物致生損害。
七、因使用試驗用藥物而受害。
八、未依藥物許可證所載之適應症或效能而為藥物之使用。
但符合當時醫學原理及用藥適當性者，不在此限。
九、常見且可預期之藥物不良反應。
十、其他經主管機關公告之情形。
一、有事實足以認定藥害之產生應由藥害受害人、藥物製造業者或輸入業者、醫師或其他之人負其責任。
二、本法施行前已發見之藥害。
三、因接受預防接種而受害，而得依其他法令獲得救濟。
四、同一原因事實已獲賠償或補償。
但不含人身保險給付在內。
五、藥物不良反應未達死亡、障礙或嚴重疾病之程度。
六、因急救使用超量藥物致生損害。
七、因使用試驗用藥物而受害。
八、未依藥物許可證所載之適應症或效能而為藥物之使用。
但符合當時醫學原理及用藥適當性者，不在此限。
九、常見且可預期之藥物不良反應。
十、其他經主管機關公告之情形。