國際間科學專家利益衝突管理規範趨向－以美、歐藥品審查機構科學諮詢委員會專家利益衝突解決政策與機制為例

To Introduce the Current International Regulatory Trend of Conflict of Interest of Scientific Committee Members and Experts-Take FDA and EMA Policy and Mechanism as an Example

孫世昌

《科技法律透析》 23卷9期 (2011/09) Pp. 40-61

https://doi.org/10.7062/STLR.201109.0040

摘要

為確保政府所投入之龐大資金能確實發揮預期成效、導引該國生技醫藥產業朝既定產業政策方向發展、與促進具重要性之生技醫藥研發計畫不致受到非預期性阻礙，美、歐等先進國家於近年間，已相繼公布新政策及相關規定來架構其防免與管理之原則及措施，以解決醫藥品查驗機構專家諮詢委員利益衝突問題。故於上述前提下，為充分理解目前美、歐等先進國家政府對此類問題究係採何種態度及相關措施？以下本文將先就生技醫藥領域之利益衝突所可能涉及之相關基本概念加以說明，並嘗試釐清其概念涵攝範圍及可能之態樣；其次，則要針對美國FDA與歐盟EMA等機構所設置之科學專家委員利益衝突管理機制，其規範上特點與共通處等部分，簡要加以整理及觀察介紹；最後，再回頭檢視我國目前規範現狀，並提出可能建議，以供我相關政府主管機關日後解決科學諮詢委員會專家利益衝突問題時之參考。

關鍵字

利益衝突 ； 潛在利益衝突 ； 個人利益衝突 ； 利益衝突管理 ； 生醫專家利益衝突

並列摘要

To ensure the government founding will achieve the expected success, conduct the domestic biomedical industry to step forward with the decided industrial policy and orientation, and the promoted important biopharmaceutical research project will not be affected by unexpected obstacle. Therefore, the advanced countries (ex: EU and US) has already published new policy and related regulation to construct the prevention, management principle, and measurement for solving the biomedical expert's conflict of interest in recent years. In context, for fully understanding the advanced country's conflict of interest in regulatory position and measurement, this article will firstly give an illustration about the general conception for possible conflicts of interest in biomedical field, and try to clarify its scope and type. Secondly, it will simply generalize and identify the characteristic and common part of FDA and EMA scientific committee members' conflicts of interest under regulatory mechanism. Finally, it will check the current domestic related regulation, and try to make some possible suggestion for the authority to refer to deal with the scientific committee expert's conflict of interest.

並列關鍵字

Conflict of Interest ； Potential Conflict of Interest ； Personal Conflict of Interest ； Conflict of Interest Management ； Biomedical Expert's Conflict of Interest

參考文獻

(5 CFR 2640.201(a).).

(5 CFR 2640.201(b).).

(5 CFR 2640.201(c).).

(5 CFR 2640.201(d).).

(5 CFR 2640.202.).