行政院國家科學委員會補助專題研究計畫成果報告
後基因時代智慧財產法制應有之理性思維 -我國基因科技相關智財法制之決策與國際參與
計畫類別：▇ 個別型計畫 □ 整合型計畫 計畫編號：NSC94-3112-H-011-001-
執行期間：2005 年 5 月 1 日至 2006 年 10 月 30 日
計畫主持人：林瑞珠 共同主持人：陳李魁 計畫參與人員：
范建得、邱永和、顏上詠、林昀嫺、王存福、陳彥碩、陳冠維、胡明怡 成果報告類型(依經費核定清單規定繳交)：□精簡報告 ▇完整報告
本成果報告包括以下應繳交之附件：
□赴國外出差或研習心得報告一份
□赴大陸地區出差或研習心得報告一份
□出席國際學術會議心得報告及發表之論文各一份
□國際合作研究計畫國外研究報告書一份
處理方式：▇除產學合作研究計畫、提升產業技術及人才培育研究計畫、
列管計畫及下列情形者外，得立即公開查詢
□涉及專利或其他智慧財產權，□一年□二年後可公開查詢
執行單位：國立台灣科技大學
中 華 民 國 2006 年 12 月 12 日
行政院國家科學委員會專題研究計畫成果報告
計畫編號：NSC 94-3112-H-011-001
執行期限：2005 年 5 月 1 日至 2006 年 10 月 1 日 主持人：林瑞珠
計畫參與人員：范建得、邱永和、陳李魁、顏上詠、林昀嫺
執行機構及單位名稱：國立台灣科技大學 一、中文摘要
本計畫自 2003 年 6 月起開始執行以來，依第一年之計畫目標而言，主要在：研究能量 之養成（Capacity Building）；第二年之中期目標，主要在研究成果之自我定位與國際參與
（Self Evaluation & International Contribution）。至於，第三年之目標在於將研究成果轉換為 參與國際組織過程中之資源；基此，於 2006 年 8 月計畫總主持人與聯合國官員順利組織合 組一個 panel 於世界生命倫理大會發表相關論述。其主要重點如下：（1）生醫研究工具在醫
藥產業中資本化或資產化之法律與倫理問題研究；（2）醫療機構因應基因醫藥發展需求應
有之應用倫理及其法規範支援體制；（3）基因體醫學之法社會課題研究：以人工生殖之發
展為例；（4）基因體醫學相關產業應有之法律與倫理治理架構：以異體移植為例；（5）台
灣生技產業之發展績效。
關鍵詞：生物科技、產業政策、智財政策、國際參與
Abstract
This project had been executed since June, 2003. The established goal for the first year was mainly to build up the research capacity. The aim of medium term for the second year was
self-evaluation for the research results and international participation. As regard to the purpose of the third-year is transforming the results of research into the resources of process in participating in international organizations. Therefore, we has successfully cooperated with UN officials to hold a panel in the International Association of Bioethics, IAB.
So called “biomedicalindustry”isstillan evolutionary concepteitherin termsoflegal,social, medical and/or economical perspectives. Therefore, it becomes unavoidable that the ELSI research shall be designed in a parallel paradigm in terms of different disciplinary approaches, so
as to enhance the collaboration between the progress of genomic and/or biomedical research and the ELSI concerns by large.
In this symposium, from the ELSI perspective, three dimensions can be taken as the main themes to fulfill the objectives of the symposium; Firstly, it’sthebasicELSIresearch relating to pharmacogenomic and/or clinical research and some of the most visible/possible biomedical issues, i.e., gene therapy, tissue engineering, stem cell research, regenerative medicine, xenotransplantation, ART & etc.(dimension A) Secondly, it’s the study relating to the application and/or commercialization of genomic research into the anticipatory market exploitation, including the development of governmental and/or self-regulatory code of practices.
Thirdly, it’s the social implication derived from the process of biomedical industrial development, including the policy analysis and social risk management studies.
The ELSI research designed in this way might look more like a project driven by the market demand. However, we would like to quote a phrase from a report written by Erik Parens & Lorip KnowlesofHasting Center,titled as“REPROGENETICS AND PUBLIC POLICY”asa balance. It is said:“Thefuture ofreprogenetic practiceistoo importantto bedecided solely by themarket. We call for the creation of an oversight structure that will make possible a thorough and transparent policy discussion of reprogenetics and effective regulation of those facilities involved in reprogeneticresearch and services.”
Keywords: Biotechnology; Industrialization Policies; Intellectual Property Policies; International Participation.
二、緣由與目的
本次國際會議主要在於討論基因科技之應用及發展所引發的 ELSI 議題，特別是在該產 業商業化後所帶來的衝擊。除倫理、法律、社會之 ELSI 議題外，醫療、經濟或基因藥物之 商業化問題，亦應加以重視；於茲試舉其要者如下：
1. 商業化所帶來的政治/社會壓力：隨著基因工程之發展也牽動其他產業之發展，如健 康照護、農業、環境保護以及生技產業及生技能源等，此均對社會產生影響，而值得關注。
2. 族群中大量人口之研究所帶來的衝擊：此將探討基因藥物之開發對於從個人基因隱 私到群體的基因型議題所影響的法律及倫理層面問題。
3. 生物科技之發展與影響：生物科技的進步雖對於基因藥物、罕見疾病、遺傳疾病之 助益，然其所可能引發之負面問題，亦應一併加以重視。
4. 新興產業之政策方向：最後之討論重點，在於生物科技對於政策面的影響，例如建
立 NHII、國家型基因資料庫、臨床研究機構，及其所涉人權保障之相關議題。
本次會議之目的，在於針對上述議題，透過不同學門的角度及研究方法加以探討，以呈 現出：政治層面、技術層面、經濟層面、商業利益層面、法律層面、社會學層面以及倫理 層面等不同面向，藉以達到檢視生物科技產業對未來人類社會的衝擊及影響。
三、結果與討論
在基因科技的革命性發展過程中，整體社會似乎未能提供一個充分保障研究參與者與 科學研究之完整性的機制，故此，本研究以基因體醫學研究所衍生新興醫藥產業相關 ELSI 議題之研究為相關探討如下：
（一） 於 The Legal and Ethical Issues Concerning the Capitalization & Privatization for Biomedical Tools in Developing Biotech Industry 一文中【附件一】
1. 本文指出生醫工具的資本化及私人財產化所必需面對的法律及倫理相關議題，是台 灣發展生物醫藥產業即將面臨的重要挑戰。生醫工具及技術開創了新研究通道來發 覺健康人體如何運作，以及健康問題出狀況時到底可能是那裡出錯。
2. 進行科學研究時，必須使用相關基因體資訊於藥物基因體學及基因診斷試驗，故關 於該相關基因資訊的資本化及私人財產化衍生出所必需面對的法律及倫理議題；有 兩個重點問題必須被討論研究及解決：第一為如何建立一套組織完善且被大眾所接 受的告知同意系統機制；第二為研究討論誰擁有此基因資訊。
3. 文末最終希望能將這些研究成員及資訊普遍推廣應用到台灣其他醫療機構；同時透 過論文的發表、論述，並積極參與台灣生醫論壇或國際相關會議，來分享研究成果、
建議，更進一步交換彼此的經驗。
（二）於 Applied Ethics and Legal Support Systems Required by Medical Institutes for the Development of Gene Medicine 一文中【附件二】
1. 本文提出在基因圖譜解碼之解碼之後，生醫研究帶給人類對疾病治療與人類福祉企 求新的希望，然同時也引發諸多的安全性問題與倫理性爭議。
2. 文內探討銜接基因醫藥臨床研究與新興醫藥產業之關鍵作為核心，將臨床醫學密切 相關的告知同意問題、與研究倫理密切相關的監督機制問題，以及與應用階段相關 的損害填補（損害賠償與損失補償）問題一併討論。
3. 另外在應用產業發展的願景下，現階段值得重視者包括在中短期的發展中，將以醫 藥行為視之的組織工程、基因治療，以及長期來看的新興基因醫藥產業發展問題。
最後，本文將以當前生物相關資料庫保護制度之發展為例，嘗試銜接新舊倫理與法 律治理機制，研提新世代基因醫藥之治理措施及其機制，進而為促進基因醫藥產業 之發展奠基。
（三）於 The Social-Legal Perspectives of Genomic Medicine: Focusing on theDevelopment of
Assisted Reproductive Technologies 一文中【附件三】
1. 本文以為基因體科技的潛力一旦應用在人工生殖程序中，難免引發「科學的界限
何在」等道德上的顧慮。集中討論人工生殖科技之一、即備受爭議的胚胎植入前基 因診斷(以下簡稱 PGD)。對於 PGD 的倫理上顧慮，最重要的即是它可能被用來作 為非醫學上特徵的篩選，例如選擇外貌或智能較好的基因來製造下一代。多數人的 恐懼是，PGD 將會使社會陷入所謂「基因增強」、甚至「優生主義」的地步。
2. 唯 PGD 的技術是否適合用在篩選非醫學性質的胚胎特徵呢？本文認為應該將父母 的生育自主權與未來子女的權利、以及社會的公共利益做一個利益衡量。首先，在 民主的制度下，人民有生殖的自由。這包涵了生育與否的自由，同時也包涵以何種 方式生育的選擇自由。
3. 未來的子女是否在胚胎期就擁有被生下的權利？胚胎的地位一直是學界熱烈討論
的主題，唯早期胚胎不但尚未發展出知覺，亦未被植入母體，與一般對於胎兒之定 義有異。在社會方面，由於 PGD 程序的昂貴，將可預見造成更大的階級落差。故 林老師認為，以 PGD 篩選胚胎特徵時，宜謹慎訂立相關法則，使醫療機構得以遵 循。
（四）於 The Study on ELSI Issues Relating to the Applications of Xenotransplantation / 一文 中【附件四】
1. 首先定義異種移植，即涵蓋將非人類動物的活細胞、組織或器官移植到人類。近年 來免疫學及基因工程之快速發展，異種移植因而被認為具有極大的潛力作為人體器 官組織障礙時之替代修補來源。然而異種器官移植同時也帶來許多風險，特別是在 移植過程中已知或還未被確認的從動物到人類異種移植上的感染物原，並且受移植 者潛在可能性地將此種感染原擴散到其所接觸的社會大眾。
2. 除安全性議題，諸如告知同意、人權、公共資產、社區利益、使用新興生物科技
所產生之社會平等、人類器官移植之公平分配以及動物福利等等議題，亦受到許多 個人或團體之關心。為建構再生醫學之異種移植於台灣之健全環境，針對異種移植 進行全面性倫理、法律與社會衝擊之探討乃為必要。
（五）於 The Development and Performance of Biotechnology Industry in Taiwan /一文中【附 件五】
1. 本研究利用資料包絡法（DEA）與 Malmquist 生產力指數，來探討台灣生物技術 產業之效率與生產力表現，以瞭解台灣的生技產業發展與其在市場之地位。同時 本研究也利用財務比例法來評估政府政策對生技、資訊、化學與設備等四大產業 影響。
2. 本文研究資料來源為台灣行政院主計處，實證結果顯示： （1）台灣產業的效率 及生產力表現，生技產業比非生技產業好；（2）農業產業在生技產業中，效率與
生產力表現最佳；（3）就技術效率變動而言，生技產業及非生技產業皆有提昇；
但在技術進步及生產力則二者皆表現不佳。（4）製造業中，電子業的效率值高於 生技產業的平均效率值。（5）生技產業在政府政策之下，其生產力與專利成長最 好。在政府政策下，專利數目最多為電子設備業，而生技產業之專利成長最好。
四、計畫成果自評
（一）本次參加世界生命倫理大會，除增加本團隊與國際接觸的機會，並且能將台灣的 ELSI 及生物產業發展向國際介紹，其中與萊登大學 Margaret Sleeboom-Faulkner 教授 及 Social and Human Science in Asia and the Pacific 的 Regional advisor Macer, Darry 教 授之合作與接觸，更讓我們清楚目前國際潮流如何發展。
（二）由於主辦國為中國，與會者亦有相當多大陸的學者、研究人員等，對本團隊之報告 內容相當感興趣。文化上的近似，台灣遇到的問題在很快的將來或馬上也會在中國 發生。在報告結束後，與會者有北京協和醫院的人員，對我們討論的議題相當感興 趣，因此打算透過未來更多的合作，與我們建立兩岸合作平台；另外與會者亦有大 陸核心重點期刊雜誌社的工作人員，在聽完報告後意欲向我們邀稿，增加兩岸互相 瞭解合作的機會。
（三）綜上，經過三年的過程，能將具體的研究成果透過國際會議的形式發表，除了增加 國際能見度、符合國際發展現勢外，在透過合作與各個國家學者人員進行交流，無 論對知識交流或促進台灣對此國際議題之參與均有相當貢獻與幫助。
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附件一
The legal and ethical issues concerning the capitalization and privatization for biomedical tools in developing biotech industry
CHEN Lee-Kui, FAN Chien-Te, YI Ji-Ming
Abstract
The legal and ethical issues about the capitalization and privatization for biomedical tools could be an upcoming challenge for Taiwan to develop biotech industry. Knowing the molecular basis of health and disease leads to develop improved and novel methods for treating and preventing diseases. There are two main categories for the biomedical tools: one is applying the data of genetic information in gene chip for pharmacogenomics or genetic diagnostic tools and the other is those biomedical innovations in different medical institutes, including clinical therapeutics, regenerative medicine, stem cells, cell nuclear replacement, vaccines and proteomics. When we study the legal and ethical issues about the capitalization and privatization for using those genomic data in pharmacogenomics and genetic diagnostic tests, two key-point problems should be discussed and resolved. The first is how to set up a well-organized and publicly-accepted informed consent system to obtain the genetic information from those participating donors by considering their autonomy, confidentiality and the intention of
“altruism”.Thesecond iswho ownsthegeneticinformation,ifwerecognizethegeneticdataasa kind of property. When we study the legal and ethical issues about the capitalization and privatization for those biomedical innovations in different medical institutes, there could be another two key-point problems needing our effort to investigate. The first is still how to build a well-organized and publicly-accepted informed consent mechanism and use it in applying those biomedical innovations for clinical trial. The second is the ethical and social considerations for the“patentability”ofthosebiomedicalinventionsand how to properly apply the“intellectual property”legalsystem to protectand makethebestuseofthoseusefulinventionsforthe“public good.” In thelong run,wewould like to shareourconclusionsorexchange ourexperiencesby publishing papers and taking part in some Taiwan biotech forum or international conferences.
Those results and suggestions from our study might be helpful for Taiwan to synchronize with those international regulations for those legal and ethical issues about the capitalization and privatization for biomedical tools.
摘要
生醫工具的資本化及私人財產化所必需面對的法律及倫理相關議題，是台灣發展生物 醫藥產業即將面臨的重要挑戰。生醫工具及技術開創了新研究通道來發覺健康人體如何運 作，以及健康問題出狀況時到底可能是那裡出錯。逐漸明瞭健康和疾病的基本分子運作模 式，將有助於研發更進步及新穎的醫藥方法來治療或預防疾病。在現代醫療照護系統中，
生醫藥科技產品包括了更快、更準確的診斷測試工具；根據個人基因體質的差異與不同癒 合能力，提供較少副作用的治療方式；以及更新、更安全的疫苗。主要有兩個領域：一為 在很快的將來，可利用基因晶片上的基因資訊於藥物基因體學或基因診斷測試工具上的新 技術或方法；二為由各不同醫療機構體系所研發的生醫創新方法，包括臨床醫療方式、再 生醫學、幹細胞、細胞核替換、免疫疫苗以及蛋白質體學。當我們研究使用相關基因體資 訊於藥物基因體學及基因診斷試驗時，有關於該相關基因資訊的資本化及私人財產化所必 需面對的法律及倫理議題；有兩個重點問題必須被討論研究及解決：第一為如何建立一套 組織完善且被大眾所接受的告知同意系統機制，來合理、合法取得參加捐贈者的基因資訊；
同時並兼顧他們的自主權、隱私權以及利他行為的本義。第二為研究討論誰擁有此基因資 訊，如果前提是我們認定這些此基因資料具有某一種財產權的屬性。當我們研究由不同醫 療機構機構體系所研發的生醫創新方法時，有關於該生醫創新方法的資本化及私人財產化 所必需面對的法律及倫理議題；同樣有另外兩個重點問題必須被討論研究及解決：第一仍 是如何建立另一套組織完善且被大眾所接受的告知同意系統機制，並使之適用於將來如何 使那些生醫創新方法合理、合法地接受臨床測試。第二為探討那些生醫創新方法『可否專 利性』的倫理、社會面向；並研議如何適用合適的智慧財產法律機制來保護那些高利用性 的生醫創新方法，並充分地應用那些發明來促進公共利益。最終希望能將這些研究成員及 資訊普遍推廣應用到台灣其他醫療機構；同時透過論文的發表、論述，並積極參與台灣生 醫論壇或國際相關會議，來分享我們研究成果、建議，更進一步交換彼此的經驗。使台灣 在發展生醫科技產業時，對於生醫工具的資本化及私人財產化所必需面對的法律及倫理議 題，能與國際同步、接軌。
1. Introduction
To develop biotech industry and make“Taiwan”asagreen biomedicalisland mightbethekey-issue to create the second-time economic miracle in Taiwan. The first priority might be how to study the legal and ethical issues and resolve those problems about the capitalization and privatization for biomedical tools in different medical institutes. To obtain the informed consent for those bio-information (including genetic data and clinical record) and for applying biomedical innovations in clinical trial, we need to create a well-organized and publicly-recognized legal system and especially keep in accordance with the guidance followed by other countries in the world. Otherwise, those results or advantages from our bio-information and new bio-medical inventions could not be accepted or applied by the international society. To make the best use of those bio-information and biomedical inventions, a well-designed “intellectual property” mechanism should be proposed to take care of the self-interest and benefit-sharing among participating donors, inventors and the general public, in order to improve the public health. To study those issues and find out the solution for those problems, we suggest to establish a communicating platform in a national teaching hospital (like National Taiwan University Hospital), and create a face-to-face discussing channel among different experts in the fields of medical science, bioethics, social science and legalregulation.In themeantime,by studying those“real practical”cases,how to compiletheconclusionsand suggestthesolution waysforthoseproblemsabove should be the key point for Taiwan to deploy the biomedical research and industry and meanwhile, to strengthen the advantages and competition capability with the other developing countries in developing biotech industry.
2. Background
How to identify and dig out those useful biomedical innovations from different medical institutes and then successfully transferred those potential inventions into other private companies through capitalization and commercialization, might be the key-point stage to develop biotech industry. The broad definition of biomedical tools for the development of biotech industry post-HGP era included diagnostic tools, research tools and therapeutic tools (both traditional pharmacology treatment and new genetic manipulation). There could be two main categories of biomedical tools for developing biotech industry: one is applying the data of genetic information in gene chip for pharmacogenomics or genetic diagnostic tools and the other is those biomedical innovations in different medical institutes. In the past decade, there were debates and theories for the development of biomedical industry. Can patents deter innovation, especially the biomedical tools?1 Which system was proper for the development of biomedical research and industry, “Anti-commons” or
“Commons?2 , 3 The metaphor “tragedy of the commons” introduced by Garrett Hardin4 could explain overpopulation, air pollution and species extinction, because people often overuse resources without incentive
1 Heller M. A. & Eisenberg R. S., Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280(5364) SCIENCE, 698-701 (1998).
2 Benkler Y., Commons-Based Strategies and the Problems of Patents, 305(5687) SCIENCE, 1110-1115 (2004).
3 Doll, J. J., The Patenting of DNA, 280(5364) SCIENCE, 689-690 (1998).
4 Hardin, G., The Tragedy of the Commons, 162(1968) SCIENCE, 1243 (1968).
