影/疫苗試驗招募違法?食藥署挨轟嗆立委「時間到了」 | Tensions run high as legislators press officials on vaccine trials legitimacy

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為了加速國產疫苗的生成,日前中央流行疫情指揮中心在記者會上宣布,啟用「COVID-19疫苗臨床試驗意向登記平台」,遭立委蔣萬安、林淑芬等立委質疑。

The Central Epidemic Command Center (CECC) recently launched a website to recruit volunteers to participate in the clinical trials of the locally developed vaccines in order to speed up the production of domestic vaccines.

However, the government’s decision has attracted criticism from legislators, including Lin Shu-fen (林淑芬) and Chiang Wan-an (蔣萬安), who expressed concerns of eventual health complications. 

由於新冠疫苗第二期臨床試驗未經人體試驗委員會(IRB)核准,綠營立委林淑芬今天上午在立院質詢時提到,根據藥害救濟法規定,如因使用試驗藥物而受害,不得申請藥害救濟。

Legislator Lin from the democratic progressive party questioned the director of the Food and Drug Administration, MOHW (食藥署) on the topic Tuesday at the Legislative Yuan. 

The Phase II clinical trial of the vaccine has not yet been approved by the “Institutional Review Board” (IRB, 人體試驗委員會), and according to the “Drug Injury Relief Act” (藥害救濟法), those injured using experimental drugs cannot apply for drug relief.

他質疑,政府建制登記平台招募受試者,未來如果出事、發生不良反應該由誰負責?

In this regard, she criticized the government for launching a registration platform recruiting volunteers despite the risks. 

She queried Wu Shou-Mei (吳秀梅), the director of MOHW, on who should be held responsible for any future incidents and adverse reactions that happened to the test subjects recruited by the government’s platform?

對此食藥署署長吳秀梅表示,只是「意向登記」,對於疫苗安全「沒有做保證」,未來如果發生事情還是要廠商自己負責。

In response, Wu Shou-Mei said that the website is only for a “registration of intent” and there is “no guarantee regarding vaccine safety” for which the manufacturers will be held responsible for any future incidents.

質詢過程中,林淑芬一度向委員會主席要求時間暫停、到桌上拿資料,卻遭吳秀梅回嗆:「十分鐘早就到了」,此舉讓林大怒,痛批官員傲慢,「竟然叫立委時間到了可以下台」。

Tensions ran high when Lin eventually asked the committee to pause the timing in order to grab some documents she prepared to which Director Wu Shou-mei retorted “ten minutes is already up,” which infuriated the ruling party’s legislator.

She lashed out at the arrogance of the officials saying: “How dare you ask legislators to get off stage just because their time is up?”

這篇文章 影/疫苗試驗招募違法?食藥署挨轟嗆立委「時間到了」 | Tensions run high as legislators press officials on vaccine trials legitimacy 最早出現於 The China Post, Taiwan

 

 

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