論生物醫學產學合作中利益衝突之規範

Regulations of Academia-Industry collaboration In biomedicine to conflict of interest

陳志剛(Chih-Kang Chen)

指導教授 ： 陳櫻琴 ； 錢世傑

中原大學/商學院/財經法律研究所/碩士(2014年)

https://doi.org/10.6840/cycu201400047

摘要

生物醫學產業一直以來是政府經濟政策發展策略重點，1999年「科學技術基本法」立法通過後，生物醫學運用在生技醫藥領域，積極進行產學合作研發技術創新。2007年「生技新藥產業發展條例」施行後，開放生技產業的技術提供者如果是政府研究機構研究人員，得持有公司創立時百分之十以上之股權，並得擔任創辦人、董事，不受公務員服務法第十三條限制，更對生物醫學運用在生技產業的產學合作提供法制誘因。依此二法律，國家資助所生之科學研發成果可以有效轉化成為生技新藥，有助於生技產業成為重要經濟發展政策的發展。由於生醫科技領域的產學合作，研究經費大都是由藥廠或生技公司提供、或者透由學術機構與藥廠或生技公司合作進行，產學合作的效益是讓學術研究貼近產業界的需求，促進科技相關產業及經濟發展。然而亦須強調其利益衝突迴避，否則，恐影響學術研究，進而損及研究的客觀正確性；或因收受資助者委託而偏向符合資助者所要之研究成果，提出未具客觀正確性之研究成果，或者未盡揭露義務，可能隱含利益衝突問題，引發社會大眾對於研究成果產生疑慮與不信任，誤將研究成果認為應是有效或有益的治療之預期。
本文就生物醫學產學合作利益衝突可能涉及之相關基本概念加以說明，並嘗試釐清概念及可能之態樣予以說明；其次，就目前美國、歐盟等國家對產學合作「利益衝突」問題所採規制及相關措施之作法，以為台灣對於「產學合作與技術移轉利益衝突迴避」的法規範架構作為參考，以解決參與研究人員利益衝突問題。近來有關產學合作授權爭議的事件頻傳，2011年「科學技術基本法」修正放寛法令限制，然未予正視產學合作利益衝突問題，究應如何修正利益衝突禁止規範之訂定，是生醫產學合作關係當前首要思考之重點。

關鍵字

拜杜法案 ； 利益衝突 ； 技術移轉 ； 生物醫學 ； 科學技術基本法 ； 產學合作

並列摘要

The biomedicine Industries have always been development strategies for the government’s economic policy. The Science and Technology Basic Law was been legislated in 1999, the biomedicine apply to the biotech and pharmaceutical territory and proactive proceed the Academia-Industry collaboration in research and development of the technological innovation. The biotech and new pharmaceutical development act was effective in 2007, if the technology providers of biotech Industries are researchers of government research institution, the providers can hold more than 10% of the equity in the company was founded and have served as a founder, director to technology, without the article 13 of the Civil service Act restrictions. The article used in biomedical biotechnology industries to provide legal incentives for Academia-industry collaboration. According to the laws, the state-funded scientific research and development results were simultaneously enabled to transform into new biotech pharmaceutical. That will help Biotech Industries to become important economic development policy. Due to academia-Industries collaboration in the biomedical technology territory, the study funds are mostly provided by pharmaceutical factory and biotech companies or cooperated and have proceed with the Academic Institution, pharmaceutical factory and biotech companies. The benefit of Academia-Industry collaboration allowed university study closer to the requirements of the industries and advance the technical-related industries and economic development. However also must to emphasized the recusal to conflicts of interest or else that probably will affect the study of academic researchers, and then would harm the research objective correctness. Because accept the patron's entrust so the result has partial to the patron and bring up subjective incorrectness results, or the research have not completely disclosed and conceal some problems to conflict of interest. These will cause general public’s misgivings and distrust for the result of research, and then the general public will mistakenly the research result is effective and useful treatment. If the research results are not as good as expected, thus cause to effect popular participate intention, even obstruct the biomedical science and technology development. If the research results are not as good as expected, thus cause to effect popular participate intention, even obstruct the biomedical science and technology development.
In this article, further explanation for basic concepts to conflict of interest, and attempts to clarify the concept and further explain. Next, to adopt the regulation and related measures to conflict of interest in academia-Industry collaboration in the United States, the European Union and other advanced countries for the Taiwan’s “academia-industry collaboration and technology transference to the conflict of interest avoidances” for reference, thus resolve the problem issues on researchers or project manager to conflict of interest. For authorization disputed in academia-industry collaboration is increase and Science and Technology Basic Law is revised in 2011. In the article, that analyzes the modified law influence about research institutes and researchers, etc. in the article.

並列關鍵字

The science and technology basic law ； Producing study cooperation research ； Bayh-dole act ； Technology transfer ； Biomedicine ； Conflict of Interest

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