行政院國家科學委員會補助專題研究計畫成果報告

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1 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 :NSC H 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 1

2 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 H 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, 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 caled biomedical industry is stil an evolutionary concept either in terms of legal, 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 2

3 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 s the basic ELSI research 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 proces 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 Knowles of Hasting Center, titled as REPROGENETICS AND PUBLIC POLICY as a balance. It is said: The future of reprogenetic practice is too important to be decided solely by the market. 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 reprogenetic research 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 3

4 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 4

5 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 5

6 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 五 參考文獻 1. Anne Underwood & Karen Springen, Medicine Tailored Just for You, NEWSLETTER Special Issue on Your Health in the 21 st Century 83 (Summer, 2005) 2. Heller M. A. & Eisenberg R. S., Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280(5364) SCIENCE, (1998). 3. Benkler Y., Commons-Based Strategies and the Problems of Patents, 305(5687) SCIENCE, (2004). 4. Doll, J. J., The Patenting of DNA, 280(5364) SCIENCE, (1998). 5. Hardin, G., The Tragedy of the Commons, 162(1968) SCIENCE, 1243 (1968). 6. Demsetz, H., AM. ECON. REV. 57, 347 (1967). 7. Heller, M., HARV. L. REV. 111, 621 (1998). 8. Barton, J. H., Research-tool patents: issues for health in the developing world, 80(2) BULL WORLD HEALTH ORGAN, Genebra (2002). 9. Shaffer, E. R., et al., Ethics in public health research, 95(1) AMERICAN J OF PUBLIC 6

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9 and the Ethical Issues, Journal of China Psychological Health. Vol.18, No. 1, at (2005). 40. See George W. Bush, Address to the Nation, August 9,2001, in The Future Is Now: America Confronts the New Genetics306, 309, William Kristol & Eric Cohen eds., Stephan Viville et al., Ethical Perspectives and Regulation of Preimplantation Genetic Diagnosis Practice, in Preimplantation Genetic Diagnosis, Ethics Comm., Am. Soc y for Repro. Med., Sex Selection and Preimplantation Genetic Diagnosis, 72 Fertility & Sterility 595,598 (1999). 43. Ethics Comm., Am. Soc y for Repro. Med, Preconception Gender Selection for Non-medical Reasons, 75 Fertility & Sterility 861,863 (2001). 44. Vicky G. Norton, Comment, Unnatural Selection: Non-therapeutic preimplantation Genetic Screening and Proposed Regulation, 41 UCLA L. Rev. 1581, at 1608 (1994). 45. Ho, Jian-Ji, Ethical and Legal Problems of Preimplantation Genetic Diagnosis (in Chinese), Research of Biotechnology and Law Newsletter, Vol. 3, at 29 (1999). 46. Florencio, Patrik S. and Ramanathan, Ramanathan, Legal Enforcement of Xenotransplantation: Public Health Safeguards, Journal of Law, Medicine & Ethics, Allen, Jonathan S The Risk of Using Baboons as Transplant Dornors. Xenotransplantation: Scientific Frontiers and Public Policy (eds. by Fishman, Jay etc) pp Thomas Traian Moga, Transgenic Animals as Intelectual Property JPTOS. 7: Patience C, Takeuchi Y, Weiss RA. Infection of human cells by an endogenous retrovirus of pigs. Nat Med 1997; 3: Megan Sykes, Anthony d'apice and Mauro Sandrin (IXA Ethics Committee), Position Paper of the Ethics Committee of the International Xenotransplantation Association, Xenotransplantation 2003; 10: Abergel, Elisabeth and Katherine Baret (2002), Puting the Cart Before the Horse: A Review of Biotechnology Policy in Canada. Journal of Canadian Studies, 37, Banker, R.D., A. Charnes and W.W. Cooper, (1984), Some Models for Estimation of Technical and Scale Ineficiencies in Data Envelopment Analysis, Management Science, Vol.30, No.9, Bowonder, S., Yadav and B. Sunil Kumar (2000), R&D Spending Paterns of Global Firms. Research, Technology Management, Byerlee, Derek and Ken Fischer (2002) Accesing Modern Science: Policy and Institutional Options for Agricultural Biotechnology in Developing Countries. World Development, 9

10 Volume: 30, Issue: 6, Charnes, A., W.W. Cooper and E. Rhodels, (1978), Measuring the Eficiency of Decision Making Units, European Journal of Operational Research, Vol. 2, No.6, Diaz,V. E. Munoz, J. Espinosa de los Monteros and Jacqueline Senker (2002), The Socio-Economic Landscape of Biotechnology in Spain. A Comparative Study Using the Innovation System Concept, Journal of Biotechnology, 98, Doeksen, Gerald A. and Tom Johnson (1997), Health Sector is Crucial for Community Economic Development, Paper given at WRSA in Kona, HI. 58. Fare, R., S. Groskopf, B. Lindgren and P. Roos (1992), Productivity Changes in Swedish Pharmacies : A Non-Parametric Malmquist Approach, The Journal of Productivity Analysis, Vol. 3, No.1, pp Frost and Sulivan (2003) Asia Pacific Biotechnology Markets: A Strategic Analysis of Equity New York. U.S.A. 60. Juma, Calestous (2005), Science and Technology - The New Age of Biodiplomacy, Georgetown Journal of International Affairs, 6, 1, Kaiser, Robert and Heiko Prange (2004), The Reconfiguration of National Innovation Systems - The Example of German Biotechnology. Research Policy, 33, Lele, Uma(2003) Biotechnology: Opportunities and Chalenges for Developing Countries, American Journal of Agricultural Economics, Volume 85, Number 5, Marsh, D. (2003), Does New Zealand have an Innovation System for Biotechnology? Techovation, 23, Miler, Wayne P. (1995) Economic impact of closing rural hospitals: The Case of Huntsville Memorial Hospital, International Journal of Public Administration: 18(1), Onishi, Akira (2001), The World Economy to 2015 Policy Simulations on Sustainable Development. Journal of Policy Modeling, 23, Schimmelpfenning, David E., Carl E. Pray and Margaret F. Brennan (2004), The Impact of Seed Industry Concentration on Innovation: A Study of US Biotech Market Leaders, Agricultural Economics, 30, Taylor, Nigel J. and Claude M. Fruquet (2000), Biotechnology s Greatest Chalenge, Forum for Applied Research and Public Policy, 15, Zechendorf (2004), Biotechnology Policy in European Countries: An Assesment. Journal of Commercial Biotechnology, 10, 4,

11 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. The second is who owns the genetic information, if we recognize the genetic data as a 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 of those biomedical inventions and how to properly apply the intelectual property legal system to protect and make the best use of those useful inventions for the public good. In the long run, we would like to share our conclusions or exchange our experiences by 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. 11

12 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 12

13 1. Introduction To develop biotech industry and make Taiwan as a green biomedical island might be the key-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 intelectual 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 legal regulation. In the meantime, by studying those real practical cases, how to compile the conclusions and suggest the solution ways for those problems above 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 Garet Hardin 4 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, (1998). 2 Benkler Y., Commons-Based Strategies and the Problems of Patents, 305(5687) SCIENCE, (2004). 3 Doll, J. J., The Patenting of DNA, 280(5364) SCIENCE, (1998). 4 Hardin, G., The Tragedy of the Commons, 162(1968) SCIENCE, 1243 (1968). 13

14 to conserve. For privatizing commons property in economics, law and science, Hardin s metaphor provides a powerful justification. 5 However, the recent proliferation of intellectual property rights in biomedical research and industry might induce another tragedy, an anti-commons in which people under-use scarce resources because too many owners can block each other. 6 Privatization of biomedical research and for biomedical industry must be more carefully deployed and kept balance to sustain both upstream research and downstream product development. 7,8 In this article, we have foresight to suggest that the government organization in Taiwan should constructively plan to contact the research staffs in the hospitals or in the public institutes, and furthermore make the dialogue with them face to face. Through this mobile, two-way communicating platform, much more useful and valuable IP rights could be discovered and created. 9,10 In the future, through this communicating platform mechanism, there could be a great deal of opportunities to transfer these biomedical techniques, informatics and tools to other private companies. 11,12 To make the balance among capitalization & privatization system, public good, benefit sharing and social justice, 13,14 the ethical issues for the patenting system in public health research and industry should also be discussed through the viewpoints of jurisprudence demonstration and legal economic analysis. We believe that this kind of well-organized with full functioning, two-way communicating platform system or mechanism in the big hospital will be the great and important step and milestone for Taiwan to develop biotech industry. In this article, for the ethical issue of capitalization and privatization for biomedical tools, we are going to discus the informed consent system to obtain genetic information and the informed consent mechanism for clinical trial in biomedicalfield. For the legal isue of capitalization and privatization for biomedical tools, we are going to elucidate the patent system in developing biomedical industry (including patent issues of genetic information and the patent protection for biomedical innovation). At last, we wil take International patenting of human DNA sequences as an example to study and find out the advantages or strong points of developing countries, like Taiwan to strengthen the competition capability in developing biotech industry in this technology. (1) The informed consent system to obtain genetic information and the informed consent mechanism for clinical trial in biomedical field (A) The current informed consent system or mechanism in obtaining human specimens for academic research in Taiwan 5 Demsetz, H., AM. ECON. REV. 57, 347 (1967). 6 Heller, M., HARV. L. REV. 111, 621 (1998). 7 Barton, J. H., Research-tool patents: issues for health in the developing world, 80(2) BULL WORLD HEALTH ORGAN, Genebra (2002). 8 Shaffer, E. R., et al., Ethics in public health research, 95(1) AMERICAN J OF PUBLIC HEALTH, (2005). 9 Gold, R. et al., Gene patents and the standard of care, 67(3) CMAJ/JAMC, (2002). 10 Barton, J. H, Reforming the patent system, 287(5460) SCIENCE, (2000). 11 David, M., Patent protection for medical technologies: why some and not others?, 351(9101) LANCET, (1998). 12 Walsh, J. P. et al., Working Through the Patent Problem, 299(5609) Science, (2003). 13 Bostyn, S. J. R., The Prodigal Son: The Relationship between Patent Law and Health Care, 11(1) MEDICAL LAW REVIEW, , (2003). 14 Mitnovetski, O1 & Nicol, D2, Are patents for methods of medical treatment contrary to the ordre public and morality or generally inconvenient?, 30(5) JOURNAL OF MEDICAL ETHICS, (2004). 14

15 The notion of informed consent: There were several areas of apparent agreement in community comments. Firstly, the notion of informed consent was generally supported, again according with the findings of DeCosta et al. 15 in rural India. Decision-making surrounding informed consent: Informed consent is often taken as the paramount principle of research ethics, with its application considered synonymous with conducting ethically sound research. In the traditional model of informed consent the patient is given the facts concerning the diagnosis, prognosis and treatment options options that may include enrolment in a research protocol. The patient's choice is thought to follow from values such as risk taking or risk aversion, or qualities that allow the patient to make trade-offs between pain and suffering, and opportunities to potentially extend their quality of life and meet certain goals 16. However, a model based on subjects or their proxies making sound, competent, thoughtful and rational choices on the basis of the information given may not adequately take into consideration the complex social contexts and relations that influence the amount and type of information disclosed, and when and what decisions are made 17,18.Trust is fundamental, in that potential participants have to trust that correct information is being given, and that assurances (such as regarding systems to protect confidentiality, ability to withdraw, and alternative options for those who refuse) will be adhered to. Deep interpersonal trust in individual clinician researchers, and institutional trust in hospitals, in research institutions and in the research enterprise can have a profound impact on the communication and understanding of health and research information, on ability to distinguish between medical care and research, and on perceptions of study benefits and risks 19,20,21,22. The rational model of informed consent fits particularly poorly in situations where perceived risks associated with the illness and research investigations are highest, where there are relatively few alternative treatment options, and where patients or their proxies and clinicians have major differences in socio-economic status, in cultural background, or in understanding of illness causation 23,24,25,26. In such situations where potential research participants are most likely to put their trust in researchers/clinicians rather than make rational choices based 15 DeCosta, A.,D SouzaN., Krishnan, S., Chhabra M.S., Shihaam, I. and Goswami, K., Community based trials and informed consent in rural north India, 30 JOURNAL OF MEDICAL ETHICS, , (2004). 16 Kuczewski, M.G. & Marshall, P., The decision dynamics of clinical research the context and process of informed consent, 40 MEDICAL CARE (Suppl. 9), V45 V54 (2002). 17 Elbourne, D., Snowdon C., and Garcia, J., Informed consent. Subjects may not understand concept of clinical trials, 315(7102) BRITISH MEDICAL JOURNAL, (1997) 18 Silverman, A.W., The myth of informed consent in daily practice and in clinical trials, 15 JOURNAL OF MEDICAL ETHICS, 6 11 (1989). 19 Appelbaum, P. S., Roth, L.H., Lidz, C.W., Benson, P. and Winslade, W., False hopes and best data consent to research and the therapeutic misconception, 17(2) HASTINGS CENTRE REPORT, (1987). 20 Bosk, C.L., Obtaining voluntary consent for research in desperately ill patients, 40 MEDICAL CARE 40 (Suppl. 9), V64 V68 (2002). 21 Joffe, S., Cook, E.F., Cleary, P.D., Clark, J.W. and Weeks, J.C., Quality of informed consent in cancer clinical trials a cross-sectional survey, 358(9295) LANCET, (2001). 22 Lidz, C.W., & Appelbaum, P. S., The therapeutic misconception problems and solutions, 40 MEDICAL CARE (Suppl. 9), V55 V63 (2002). 23 Allmark, P., Mason, S., Gill, A.B. and Megone, C., Obtaining consent for neonatal research, 88(3) ARCHCHIVES OF DISEASE IN CHILDHOOD FETAL NEONATAL EDITION, F166 F167 (2003). 24 Kass, N. E., Sugarman, J., Faden, R. and Schoch-Spana, M., Trust, the fragile foundation of contemporary biomedical research, 26(5) HASTINGS CENTRE REPORT, (1996). 25 Smyth, R.L. & Weindling, A.M., Research in children ethical and scientific aspects, 354 LANCET (Suppl. 2), SII21 SII24 (1999). 26 Resnik, D., Ethical dilemmas in communicating medical information to the public, 55 HEALTH POLICY, (2001). 15

16 on the information given regulatory institutions play an especially critical role in protecting that trust. Trust, mistrust and community views about the relevance of informed consent: The notion of informed consent was generally supported by community members, but there were enormous debates and almost always exceptions, particularly regarding the gender dynamics of decision-making and the appropriateness of informed consent in in-patient studies. These debates are described in greater detail in Molyneux et al. (2005) 27. Discussions centred on the practical impediments of meeting the requirements for informed consent; most often whether those involved would be able to fully understand and accept information. For such reasons there were suggestions from some community leaders that research Unit staff themselves be entrusted with looking at someone first and seeing if they seem capable of understanding. There was apparent agreement among most leaders that to openly talk of storing some blood for future research would raise concerns about what was being done with that blood. HIV testing was considered the key sensitivity, regardless of what is actually said by FWs. The latter emphasizes the importance of trust and mistrust in concerns surrounding informed consent procedures, independent of what information is disclosed. (B) The current system or mechanism for informed consent in biomedical filed and its implication status in Taiwan The informed consent system or mechanism in Taiwan have been adopted and executed in the fields of both clinical practices and basic biomedical researches for many years. Except the bioethical consideration, some compulsive legal regulations, including civil law, criminal law, IRB or EC supervision system and the methods to colect human tisue specimens for medical researches (like the executive code ) have been applied in some special medical fields. For all the procedures and treatments in clinical practice, the informed consent system or mechanism in Taiwan nowadays could be thoroughly designed and well organized. There were still some tiny problems, like the definition for the obligation and responsibility of complete informed or explanation needed to be resolved. For most of the procedures and treatments in clinical test or trial, the informed consent system or mechanism in Taiwan nowadays might be approve and supervised by institute review board (IRB) or ethical commitee (EC) in diferent institutes. For IRB or EC to examine the informed consent by the participants must folow the guidance of the examining key points for human body clinical trial. The legal level of the examining key points for human body clinical trial is as high as the executive order. For colecting al human specimens (including blood, tisue, organ ) only for academic researches, there might be three types of system or mechanism to get the informed consent from the volunteers. The first is through the approval and supervision mechanism by IRB or EC. The second method is not to inform patients in advance and collect their specimens secretly, without signing any informed consent by the patients. The third way is packaged informed. That means the informed consent for colecting al human specimens only for academic researches could be packaged together with the informed consent for the procedures and treatments in clinical practice. Then, patients might sign these two types of informed consent at the same time. Under the system or mechanism of packaged informed, patients might not be informed completely with easy confusion 27 Molyneux, C.S., Peshu, N. and Marsh, K., Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast, 59(12) SOCIAL SCIENCE & MEDICINE, (2004). 16

17 and misunderstanding. Nowadays, in Taiwan, for collecting all human specimens only for academic researches, we have the regulation by the guidance for colecting human specimens only for academic research usage. The legal level of this guidance is often regarded below executive construction, thus its enforcement is usualy queried. As we know the actual overlap between clinical care and research practice in much clinical research does exist and it might be much more difficult to distinguish clinical research and practice in the future. Especially this kind of situation could become much more complicated and involve more extensive commercial benefit in the post human genome project era. For the academic research practice is usually related to a requirement by ethical review committees that research benefits outweigh the risks, and to clinician researchers own moral and practical concerns (Richardson & Belsky, 2004). The question is only regulated by researchers own self moral or ethical consideration could be enough or well organized. But for collecting all human specimens only for academic researches, if we request any researcher has to inform all participants face to face and explain everything (like the guidelines in UK biobank) thoroughly and completely, then that might lead to high refusal rates, not out of a lack of altruism butthrough mistaken ( heightened ) perceptions of risk or infringe of unpredictable benefit. How to make the balance between these advantages and disadvantages might be a key stone and hot issue for Taiwan to establish population-base biobank when facing the specimen collection issues. (C)Population-based pharmacogenomics databases and informed consent from the participants The FDA's recent statements encouraging a greater focus on obtaining informed consent before using banked specimens in research underscores the importance of state law. (Whether FDA's position is correct is a separate issue.) To the extent that the informed-consent requirements apply to such specimens, the criteria for determining whether valid consent has been obtained come from the states. There are still a lot of problems and questions about how to get informed consent from participants who provide samples in different drug research phases. What kinds of consent should be required for the collection of samples for research in pharmacogenomics? Should pharmaceutical companies who collect samples in the course of research be able to use such samples for any purpose, or should consent of the donor be restricted to allow usage only for specific kinds of research? The general rule to get informed consent for pharmacogenomic data should be as follows: Collection of samples for future nonspecific purposes would need specific safeguards. Prior consent for further nonspecific purposes should be obtained at the time of collecting the sample. Consent for such purposes must be valid, i.e. explicit and properly informed. Samples should be kept anonymously if they are purely for research purposes, i.e. if there is no intention to use the information in the future treatment of the donors. But because the clinical trial for a new drug approval process uses healthy volunteers in the initial stages and affected individuals in the later stages, it is important that FDA require drug sponsors to clearly define which subgroups of individuals, based on their genetic profiles, fall into which category. The goal of the new drug approval process is to approve safe and effective medicines; along the way, both the industry and FDA must not forget that the humans enrolled in the trials need to have their safety protected as well. If a sponsor chooses to use healthy individuals in Phase I trials, FDA needs to make sure that only those patients who are both genotypically and phenotypically healthy enroll. The agency also must make sure that the correct 17

18 subpopulations of people are included in Phases II and III--those who stand to benefit from the drug. To accomplish these ends, there are several steps in the new drug approval process that are ripe for change. It is clear that one for al type of informed consent wil not fit for getting the permission from the participants in the different phases of the new drug approval process, since the scenarios for each phase will be fundamentally different. To consider the feasibility, cost/benefit effect and also the autonomy and individual choice of the participants, I therefore try to design an informed consent model for obtaining individual genetic information in order to build up pharmacogenomic data banks. (D) Conclusion In applying the informed system for different kinds of biomedical tools, the one size fits al concept and policy could not work well definitely, because of the complexity and different consideration of different kinds of biomedical tools. Not only for the social justice or fairness, but for the future commercial and general implication, we should design and apply different levels of informed consent to meet the requirement under different situation. (2) The patent system in developing biomedical industry (including patent issues of genetic information and the patent protection for biomedical innovation) The patent system: U. S. patent law is rooted in Article I, Section 8, of the Constitution, which gives Congress the power to promote the progres of science and useful arts by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries. The patent system has been driven by various motives, but its current public-policy objective is to stimulate innovation and encourage investment in research and development. A patent is a government authority stopping others from manufacture, use, or sale of an invention, except under license from the patent holder. The right may be granted if an invention is new, involves an inventive step (not obvious) and is capable of industrial application. Patents are limited in duration (usually to 20 years) and are issued in exchanged for public disclosure of the innovation in sufficient detail to allow a person skilled in the area to reproduce the invention and procedure. The patenting process itself involves a tradeoff, that is in turn for a time-delimited period of exclusive right to benefit from the commercial exploitation of an invention, the inventor mush publish (in the patent claim) a full description of the invention and at least one reduction of the invention to practical use. (A) Introduction for patent policy and liability standards in biomedical filed The existing patent protecting policy might be not fit for all kinds of biomedical tools. How to make the balance between the common property and anti-common property or the bioethical consideration and public good could be a tough work to make the judgment. The fundamental premise of the patent system is that society benefits when people conceive of new invention; develop and commercialize new products incorporating those inventions (a process referred to as innovation, as distinct from invention); and publicly disclose information about their inventions, so that others may learn from and improve upon those inventions. Most people probably agree with this premise, and we will not bother to defend it. The difficult question is how to maximize these social benefits or, more precisely, the surplus of social benefits over social costs. The patent system can be thought of as one way of attempting to achieve this goal. 18

19 Studying the liability for intellectual property rights (IPRs) in biomedical field could be another difficult issue. To define the standards and scope of patent liability, especially for developing biotech industry, we should consider the economic cost, the incentive for invention, the possibility of commercial implication and the benefit sharing. Patent infringement is a strict liability tort in the sense that a defendant may be liable without having had any notice, prior to the filing of an infringement action that her conduct was infringing. In other words, innocent (unintentional or inadvertent) infringement is not a defense to a patent infringement claim and a court will prospectively enjoy the defendant from infringing even though the defendant was put on notice only by the filing of the lawsuit. Patent law nevertheles departs from the pure strict liability model in two important respects. First, the defendant s state of mind can be relevant to a variety of substantive and procedural maters. Under U.S. law, for example, a defendant who wilfuly infringes may be liable for up to three times the amount of the plaintif s damages and the most important factor in determining wilfulnes is whether the defendant knew of the plaintif s patent before she started infringing. 28 Because patent plaintiffs frequently plead wilful infringement, the defendant s state of mind is a common isue in patent litigation, notwithstanding the frequent characterization of patent infringement as a strict liability tort. Thus, a patentee who markets products embodying his patent can recover damages only for infringing conduct that occurs after he has provided the requisite notice in one of the three ways described in 287(a). First, the patent owner may put the defendant on notice by commencing an infringement action against the defendant. 29 Second, the patent owner may provide actual, specific notice of the infringement, prior to the filing of the lawsuit. 30 Third, the patent owner might conclude that the Patent Act makes the recovery of damages contingent upon the defendant s intentional decision to infringe after having received notice and that this outcome is considerably different from the common meaning of strict liability. (B)In Lancet (1998) the topic of Patent protection for medical technologies: why some and not others? was discussed. The following issues were proposed in this paper: 1) Patent law does not reward discovery, but protects useful innovations capable of application; scientific theories, mathematical formulae, and in Europe, all inventions: of methods of treatment of the human or animal body by surgery or diagnosis practiced on the human or animal body are excluded, Similar exclusions apply worldwide, apart from in the USA and Australia, there have been moves to limit medical-procedure 28 See 35 U.S.C. 284, which states that courts may award treble damages; see Corp. v. Portec, Inc., 970 F.2d 816, 826 (Fed. Cir. 1992), which sets forth factors relevant to willful infringement. 29 There are two other circumstances in which the Patent Act departs from the strict liability model. See 35 U.S.C. 287(b) that sets forth the conditions under which one may obtain a remedy for the unauthorized manufacture, sale, use, or importation of an unpatented product made by a patented process; id. 154(d)(A), which sets forth the conditions under which one may obtain a remedy of the unauthorized manufacture, sale, use, or importation of an invention described in a published patent application that later results in the issuance of a patent. These provisions are of only limited importance, and we omit them from our earlier discussion. 30 The case law provides some detail concerning what constitutes actual notice. See Lans v. Digital Equip. Corp., 252 F.3d 1320, (Fed. Cir. 2001), where it was held that notification must come from and identify the patentee and that notice even from one closely associated with the patentee is therefore insufficient; SRI Int l, Inc v. Advanced Tech. Lab., Inc., 127 F.3d 1426, 1470 (Fed. Cir. 1997), which states that 287(a) is satisfied when the recipient is informed of the identity of the patent and the activity that is believed to be an infringement, accompanied by a proposal to abate the infringement, whether by license or otherwise ; Amsted Indus. v. Buckeye Steel Castings Co., 24 F.3d 178, 187 (Fed. Cir. 1994), which holds that actual notice requires the affirmative communication of a specific charge of infringement by a specific accused product, and that the defendant s actual knowledge of the patent or its own infringement is irrelevant. 19

20 patents in the USA. 2) Total pre-market development costs relate to clinical trials to establish efficacy and safety and meet regulations on drug licensing. Non patentable therapies face obstacles since the trials necessary for marketing approval are beyond the financial capacity of non-commercial interests. 3) The pharmaceutical industry has called for the expansion of protection. Patents have always covered new compounds and their synthesis, irrespective of any medical use. However, protection has been extended to known substances not previously used as drugs, known drugs used for a new medical purpose, biotechnology products, and genetically altered animals. 4) For public good, health, Patent-style production could be easily modified by forcing patent licensing, with the costs of research and development being recovered through royalties paid to the patent holder. (C)Conclusion The strategy and policy for applying patent protection mechanism in inventing biomedical tools could be one of the key issues in developing biomedical industry. A well organized platform or channel to resolve all the problems related to patent liability and implication, including the patent management, patent litigation and ventral capital for those biomedical patents with developing potential, should be very important and urgent for developing biotech industry in Taiwan. (3)Taking International Patenting of Human DNA Sequences as an example With a patent, the inventor has the legal right to license others to make, use, or sell that invention. When inventions result in new or improved products or processes, patent owners can reap economic benefits that typically spill over to associated users and consumers. At the meantime, inventions that lead to the creation of entire new industries have more profound impact on national economies and on international relations. Patents of human DNA (deoxyribonucleic acid) sequences are a recent example of industry-creating inventions. There is a great deal of controversy in shadowing the widely anticipated economic and medical benefits associated with this technology. Proponents argue that patents on human DNA sequences are necessary to make diagnostic and therapeutic products commercially available. Others voice concerns about the patenting of naturally occuring elements and more general concerns that giving company s monopoly rights over specific DNA sequences will hinder scientific progress. Ethical issues surrounding cloning for reproductive and therapeutic purposes also cloud the debate. Despite the ongoing controversies, patent offices in many countries have issued thousands of patents on human DNA sequences. As researchers move from mapping sequences to decoding their functions and manipulating them for diagnostic and therapeutic purposes, their work will likely transform the way many diseases are treated. And the companies and countries that own key patents in this technology area will benefit most from these developments. (A) Are DNA sequences eligible for patenting? A "DNA sequence" may be informational or it may be a composition of matter. It may thus convey information about the precise order of nucleotide bases or it may be a composition of matter that has that sequence. In principle, there is no difference between a DNA sequence and a chemical compound. The difference between the two types of compositions of matter is simply that some (but not all) DNA sequences are naturally occurring and the majority of chemical compounds are not. Naturally occurring molecules give rise to issues 20