主张基于知情同意的人格保护和无偿捐赠并不排斥人体组织提供者就商业后续开发主张利益分享。在此领域,单独开辟一个利益分享机制是必要的,以平衡研究材料提供者和科研人员之利益。
【作者简介】
赵西巨,山东中医药大学人文社科学院。
【注释】 人体组织包括器官和器官组成部分(Organs and parts of organs)、细胞和组织(Cells and tissue)、亚细胞结构和细胞产品(Sub-cellular structures and cell products)、血液(Blood)、精子和卵子(sperm and ova)、胚胎和胎儿组织(Embryos and fetal tissue)。参见 Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues, April 1995, page 19. 也有更简捷的表达,即将人体组织定义为“细胞的功能组(a functional group of cells)”,参见Opinion of the European Group on Ethics in Science and New Technologies to the European Commission, 21 July 1998.
Opinion of the European Group on Ethics in Science and New Technologies to the European Commission, 21 July 1998.
参见 崔国斌: 基因技术的专利保护与利益分享, 郑成思主编 《知识产权文丛》第5卷 中国政法大学出版社 2000年第1版 页240-344。
Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990).
这种疾病的特征在于患者血液与骨髓中的网状细胞(reticulum cell)的表层有许多像头发般的突起物(projection),并且患者脾脏会大幅胀大。
由哺乳动物生体(living body)或组织(tissue)中分离出单细胞,并且使此单细胞在试管中继续不断的分裂增殖,而成为相同的细胞群。此一细胞群由同一个母细胞所分裂增殖而来,称之为细胞株或细胞系(cell line)。
Del E. Webb Corp. v. Structural Materials Co. (1981) 123 Cal. App. 3d 593, 610-611 .
Lugosi v. Universal Pictures (1979) 25 Cal. 3d 813 ; Motschenbacher v. R. J. Reynolds Tobacco Company (9th Cir. 1974) 498 F.2d 821.
Bouvia v. Superior Court (1986) 179 Cal. App. 3d 1127 .
Schloendorff v. New York Hospital, 211 N.Y. 125 .
Health and Safety Code section 7054.4.
Cobbs v. Grant (1972) 8 Cal. 3d 229, 242 ; cf. Schloendorff v. New York Hospital (1914) 211 N.Y. 125 .
Cobbs v. Grant, 8 Cal. 3d at p. 242.
Stafford v. Schultz (1954) 42 Cal. 2d 767, 777 ; Nelson v. Gaunt (1981) 125 Cal. App. 3d 623, 635 ; Berkey v. Anderson (1969) 1 Cal. App. 3d 790, 805 ; Bowman v. McPheeters (1947) 77 Cal. App. 2d 795, 800 .
本案多数意见的持有者是Panelli法官、Lucas法官、Eagleson法官、Kennard法官和Arabian法官。Broussard法官出具了部分协同部分反对意见。Mosk法官针对“conversion”诉因的可用性出具了与多数派意见针锋相对、措辞激烈的反对意见。
Cobbs v. Grant (1972) 8 Cal. 3d 229, 245 .
See Danforth, Cells, Sales, & Royalties: The Patient''s Right to a Portion of the Profits (1988) 6 Yale L. & Pol''y Rev. 179, 195; Note, Source Compensation for Tissues and Cells Used in Biotechnical Research: Why a Source Shouldn''t Share in the Profits (1989) 64 Notre Dame L. Rev. 628, 634.
Greenberg v Miami Children’s Hospital, 264 F.Supp.2d 1064, 16 Fla. L. Weekly Fed. D 417, 121 A.L.R.5th 687.
Nat''l Union Fire Ins. Co. of Penn. v. Carob. Aviation, Inc., 759 F.2d 873, 878 (11th Cir.1985) (citing Senfeld v. Bank of Nova Scotia Trust Co. (Cayman), 450 So.2d 1157, 1160-61 (Fla. 3d DCA 1984).
State v. Powell, 497 So.2d 1188, 1192 (Fla.1986).
Fla. Stat. § 766.103.
Cedars Med. Ctr., Inc. v. Jose R. Gomez, 738 So.2d 362, 366 (Fla. 3d DCA 1999).
Dale v. Jennings, 90 Fla. 234, 107 So. 175 (1926).
Neade v. Portes, 193 Ill.2d 433, 250 Ill.Dec. 733, 739 N.E.2d 496 (2000).
Abele v. Sawyer, 747 So.2d 415, 417 (Fla. 4th DCA 1999).
Tooltrend, Inc., v. CMT Utensili SRL, 198 F.3d 802, 805 (11th Cir.1999) ; Duncan v. Kasim, Inc., 810 So.2d 968, 971 (2002).
4 All ER 474, 1 FLR 598, 1 WLR 596, 2 FCR 651, BMLR 146.
Williams v Williams (1882) 20 Ch D 659 at 662-663 and Clerk and Lindsell on Torts (17th edn, 1995) p 653, para 13-50; Erle J, delivering the judgment of a powerful Court of Crown Cases Reserved in R v Sharpe (1857) Dears & B 160 at 163, 169 ER 959 at 960.
Doodeward v Spence (1908) 6 CLR 406.
QB 621, 3 All ER 741, 2 WLR 384.
Margaret Jane Radin, Market-Inalienability, 100 Harv. L. Rev.( Harvard Law Review) 1849 (June, 1987).
Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues, April 1995, page 50.
Charlotte H. Harrison, “Neither Moore Nor the Market: Alternative Models for Compensating Contributors of Human Tissue”, 28 Am. J.L. & Med.( American Journal of Law and Medicine) 77.
Christine Grady, Money for Research Participation: Does It Jeopardize Informed Consent? The American Journal of Bioethics, Spring 2001, Volume 1, Number 2.
Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues, April 1995, pages 50, 51.
参见 张良:浅谈对尸体的法律保护,《中外法学》1994年第3期,页35-37;杨芳等:论人体器官权及其对
物权法的新发展,法治论丛,2006年第6期,页44-47.
杨立新、曹艳春:论脱离人体的器官及组织的法律属性及其规则,《中国法学》,2006年第1期,页47- 。
史蒂文 L 伊曼纽尔 著,财产法(影印本),北京:中信出版社,2003.6,页8.
参见 王利明、尹飞、程啸著:中国
物权法教程,北京:人民法院出版社,2007年5月第1版,页62.
参见 赵西巨:医学法上的知情同意原则研究,《私法研究》(第5卷),中国政法大学出版社,2006年。
如我国《
执业医师法》(1998)第
26条,《
医疗事故处理条例》(2002)第
11条,《
医疗机构管理条例》(1994)第
33条,《
医疗机构管理条例实施细则》(1994)第
62条。
参见 赵西巨:知情同意原则下医疗过失损害赔偿责任的几个问题,《法律与医学》(北京),2004年第4期,第264-267页。
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, Strasbourg, 25.I.2005. 该议定书适用于在健康领域涉及“人体干预(interventions on human beings)”的研究活动,此处的“干预”包括“身体的干预(a physical intervention)”和其它涉及“心理健康风险(a risk to the psychological health)”的干预。
Council of Europe, Committee of Ministers, Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin (Adopted by the Committee of Ministers on 15 March 2006 at the 958th meeting of the Ministers'' Deputies). 该建议书适用于涉及移取人源性生物材料储存以研究之用的研究活动。它包括以其它目的而移取的生物材料的使用。
Right 7 (9), The Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations, New Zealand.
Health Research Council, Guidelines on Ethics in Health Research, May 2002 (Revised 2005).
如我国《
人体器官移植条例》第
三条规定,任何组织或者个人不得以任何形式买卖人体器官,不得从事与买卖人体器官有关的活动。还比如,Article 21, Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, Strasbourg, 24.I.2002.
参见赵西巨译:欧洲人权与生物医学公约(节译),法律与医学杂志,2005年第2期,页155-157. 欧洲理事会关于生物医学研究(Biomedical Research)的附加议定书第3条也有同样规定。
参见澳大利亚案件Chappell v Hart (1998) 72 ALJR 1344 (HC of A)和英国案件Chester v Afshar 4 All ER 587.
参见 王利明、尹飞、程啸著:中国
物权法教程,北京:人民法院出版社,2007年5月第1版,页58,59.
Article 21, Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, Strasbourg, 24.I.2002.
Julia D. Mahoney, The Market for Human Tissue, 86 Va. L. Rev. (Virginia Law Review) 163 (March, 2000).
Charlotte H. Harrison, “Neither Moore Nor the Market: Alternative Models for Compensating Contributors of Human Tiisue, 28 Am. J.L. & Med. ( American Journal of Law and Medicine) 77.
参见 崔国斌: 基因技术的专利保护与利益分享, 郑成思主编 《知识产权文丛》第5卷 中国政法大学出版社 2000年第1版 页240-344。
王泽鉴:《侵权行为法 第一册》,北京:中国政法大学出版社,2001年,页111.