生醫研究利益衝突之規範-兼論人體試驗及智財授權

Abstract

利益衝突會腐蝕、侵蝕人們對於生技（生醫）研究活動的信賴，破壞民眾對於科學家及其從事之生技研究活動之信賴，且會削弱科學家彼此間之信賴感。以往揭露利益衝突被視為是管理利益衝突之主要方法，但此種管理利益衝突之措施應該加以改進，且必須建立處理機構內利益衝突之新思維。為了健全生技產業之發展，政府有必要率先提出更新、更有效率之利益衝突管理方式。本文認為，政府可先透過管理政府資金資助之生技研究方式著手，政府應確保其資助之生技研究之客觀性，亦即確保政府資助之生技研究不會因利益衝突而喪失研究客觀性、損及民眾生命、健康，而美國國家衛生主管機關（即HHS及其下屬機構）基於上開理由，於2011年8月修正公布有關「公共衛生經費贊助之研究案申請人有義務促進科學研究之客觀性」（42 C.F.R. Part 50, Subpart F）及「應負責的潛在契約主體」（45 C.F.R. Part 94）此二部分之相關規定，上開規定要求那些接受國家衛生主管機關贊助款項或與國家衛生主管機關合作之機構必須符合上開二部分之監管規定。綜觀規定內容，本文認為此套規範乃將管理學（即專案管理：project management）中有關風險管理（risk management）概念加以法制化，將利益衝突可能造成之研究不客觀之負面效應當成「風險」，藉由系統化之控管措施，監控機構內利益衝突之狀況（風險），透過嚴密的事前、事中、事後風險管制方式，即制訂風險管理政策、辨識風險、制訂風險應對規劃、監督執行風險應對規劃直至風險狀況被控制或消除，以求達到全面監控、管理利益衝突之效果，達到消除或減少利益衝突對於研究客觀性造成負面效益之目的。本文認為這套法制化之風險管理措施兼具原則性以及彈性運用空間，用於處理生技領域中之利益衝突可有效達到預防、監督、控管之效果；藉由介紹上開新規定，並提出對於本國法制之建議以作為未來立法政策之參考。 在生技（生醫）研究整個運作環節中，每個階段及層面都可能會面臨利益衝突之議題，然本文擇其中較重要之領域即人體試驗階段以及生技（生醫）技術成果授權階段加以探討之，人體試驗階段是因為試驗結果影響層面除了受試者之生命、健康權益外，也會對廣大公眾健康權益產生影響，故而利益衝突之議題自然有深入探討之必要性；另若生技（生醫）研究涉及國家資源資助之情況，則讓研究成果公平、透明、妥適的運用，務求讓研發成果可以更全面推廣、造福公眾健康福祉，故而避免因利益衝突問題造成研發成果授權失去公平、公正、客觀亦十分重要。

Conflicts of interest have an erosive effect on people’s trust in biotechnology research activities, damaging not only the attitude and trusts of the public toward scientists and their research studies, but also weakening scientist’s mutual trust on each other. Disclosure is recognized as the major methods for dealing with conflicts, but the approaches to managing and resolving conflicts must be improved. Furthermore, new ways of thinking on institutional conflicts of interest must be built. For the complete development of the biotechnology industry, the government should take the lead in proposing the best and innovative solutions on conflict of interest management. The government can begin first from government-funded research at biotechnology. The government must ensure the objectivity of providing the funds for biotech research activities and also make certain that the conflict of interest will not affect and reduce the objectivity of the study, as well as affecting people’s lives and health. Thus, U.S. Department of Health and Human Services (HHS) has also issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).The relevant regulations of these two parts state that those accepting the sponsorship from HHS and its partner institutions must comply with the above two amended monitoring rules. To take a broad view of the overall rule set by HHS, the concept of the risk management included in the project management is likely to be legislated. That is to say, the risk under the rule is the negative effect of the subjective research caused by the conflict of the interest. Risk management is a structured approach to managing institutional conflict of interest, through a sequence of activities including: the risk evaluation in three stages-before, within and after the assessment, and strategies development to manage it. Risk management also involves identifying, analyzing, and taking steps to reduce or eliminate the conflict of interest leading to negative effect of the research. The legislation of risk management utilizes many principal and flexible techniques, especially to manage conflict of interest encountered by the bio industry. The content of this article is intended to provide a general reference to the subject matter. The overall operational aspects of biotechnology (biomedical) research, each stage and level may be faced with the issue of conflict of interest. However this thesis selects one of the most important areas and will explore further in the thesis on the human subject research and the result of Biotechnology (Biomedical) licensing stage , this is because the test results of human subject research not only affect the level of the patient’s life, healthy right, but also have an impact on the majority of public health interests. Therefore there is the need for in-depth investigation for the issue of conflict of interest. In addition if biotech (biomedical) research involving financial assistance from national resources, then the research results must be fair, transparent, appropriately used. R & D results must allow for a more comprehensive promotion and for the benefit of public health and welfare. Therefore it is very important to avoid the issue of conflicts of interest which caused the R&D result authorization lack of fairness, justice and objectivity.