篇名

疫苗緊急使用授權與預防接種受害救濟之問題【月旦時論】   免費試閱

並列篇名

The Issues of the Authorization for Emergency Use of Vaccines and Relief for Victims of Vaccination

作者
中文摘要

COVID-19肆虐全球,因緊急防疫需求之特殊情況下,以緊急使用授權(emergency use authorization, EUA)方式核准尚未完成完整臨床試驗之疫苗取得上市許可,接種者所承擔之未知及潛在風險更高,對於接種疫苗之傷害則以救濟制度加以補償。而對於專案核准製造或輸入疫苗,中央主管機關本可自行審查決定准駁,但卻將實質決定權賦予「諮詢」性質之專家審查會議。預防接種受害救濟審議亦有類似問題,使主管機關有藉由專家委員之遴選來控制審定結果,並脫免責任之嫌。若主管機關公務員或其選任之外部專家於疫苗核准供國人使用的審查過程中,有違法失職或違背專業之情形,造成接種者之傷害,應可同時提出國家賠償請求。但可考慮對所有請求補償救濟者,限制其就同一受害事實,提起民事訴訟向第三人求償。此外,無論是國內製造或專案核准進口之疫苗,皆應納入疫苗受害救濟之範圍,且對於EUA專案核准之疫苗受害救濟應從寬認定,不應將此醫學實證不足之未知及潛在風險由接種者承擔。

英文摘要

COVID-19 ravaged the world, and due to the special circumstances of emergency preventive needs, the vaccine was approved to be marketed under the emergency use authorization without completing clinical trials. Since the unknown and potential risks borne by the vaccinees are higher, the injuries caused by the vaccination are compensated by the relief system. As to the manufacture or importation of the vaccination under special approval, the central authority could have made its own review and decision to approve it or reject. However, the actual decision is given to the expert review meeting giving advisories. And the situation in respect of the review of injury compensation of the preventive vaccination is similar with it. The competent authority is suspected of controlling the results of the evaluation by the selection of expert members and relieving itself of responsibility. If a civil servant of the competent authority or an outside expert selected by it during the examination process of the vaccine approved for the national use commits any illegal misconduct of breaches of professionalism and causes injury to the vaccine recipient, a national compensation to the both sides could be filed at the same time. Nevertheless, all of the accused should be restricted that he couldn’t claim a right for compensation to a third party in respect of the same issue of injury. Additionally, all vaccines, no matter they are manufactured domestically or imported under special approval, should be included in the scope of the vaccine victimization remedies, and the EUA program should be considered leniently, and the unknown and potential risks of the insufficient medical evidence shouldn’t be borne by the vaccine recipients.

起訖頁

109-135

出版單位
DOI

10.53106/241553062022050067009  複製DOI  DOI查詢

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