1 Andrew Pollack, Company Seeking Donors of DNA for a “Gene Trust, “ N. Y. Times. Aug. 1, 2000, at Al.

2 Tissue collected for biomedical research, which is the subject of this paper, is to be distinguished from tissue used for therapeutic purposes, including blood provided for transfusion and skin, heart valves or solid organs provided for transplantation, or for non-medical purposes.

3 For a survey of the importance of human biological materials to medical research, see Nat’l Bioethics Advisory Comm’n, 1 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance 19-24 (1999) [hereinafter NBAC Rep.].

4 793 P.2d 479 (Cal. 1990).

5 Id. at 480. The Court did recognize the physician’s obligation of informed consent. For discussion of the case, see infra notes 8-11, 15-20 and accompanying text.

6 Another reason may be that the parties most familiar with practice in this area generally have a professional or financial stake in maintaining the status quo. See Jesse A. Goldner, Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach, 28 J.L. Med. & Ethics 379, 385, 394 (2000).

7 NBAC Rep. 1, supra note 3, at 51.

8 793 P.2d 479 (Cal. 1990).

9 Id. at 482.

10 Id. at 481.

11 Moore v. Regents of Univ. of Cal., No. B021195, 1988 Cal. App. LEXIS 666, *11 (Cal. Ct. App. July 21, 1988).

12 NBAC REP. 1, supra note 3, at 7 (citing Jon F. Merz et al., Hospital Consent for Disclosure of Medical Records, 26 J.L. Med. & Ethics 241 (1998)).

13 Gina Kolata, Sharing of Profits is Debated as the Value of Tissue Rises, N.Y. Times, May 15, 2000, at Al.

14 Goldner, supra note 6, at 397-98; Jay R. Horton & Robert F. Weir, DNA Banking and Informed Consent - Part 2, IRB, Sept.-Dee., 1995, at 1.

15 Moore v. Board of Regents of Cal., 793 P.2d 479,484-85 (Cal. 1990).

16 Id.

17 Id. at 497.

18 Id. at 487.

19 Id. at 488, 494.

20 Id. at 496.

21 National Organ Transplant Act, 42 U.S.C. § 274e (1994).

22 For examples of state laws banning commerce in human tissue for various purposes, see Radhika Rao, Property, Privacy, and the Human Body, 80 B.U. L. Rev. 359, 376 n.58 (2000).

23 See, e.g., Council for Int’l Orgs. of Med. Sciences, Ethics and Research on Human Subjects: International Guidelines 43-46 (Zbigniew Bankowski & Robert J. Levine eds.,1993); Leonard H. Glantz et al., Research in Developing Countries: Taking “Benefit” Seriously, HASTINGS CTR. REP. Nov.-Dee., 1998, at 38; Human Genome Org. Ethics Comm., Statement on Benefit Sharing, 10 Eubios J. Asian & Int’l Bioethics 70 (2000).

24 See Christakis, Nicholas A. & Panner, Morris J., Existing International Ethical Guidelines for Human Subjects Research: Some Open Questions, 19 L., Med. & Health Care 214, 214 (1991)CrossRefGoogle ScholarPubMed; Ezekiel J. Emanuel, A World of Research Subjects, Hastings Ctr. Rep., Nov.-Dee., 1998, at 25; Bartha M. Knoppers, Status, Sale and Patenting of Human Genetic Material: An International Survey, Nature Genetics, May 1999, at 23.

25 Gen. Office of the State Council, People’s Republic of China, Interim Measures for the Administration of Human Genetic Resources (June 10, 1998) [hereinafter Interim Measures].

26 Matt Fleischer, Patent Thyself, Am. Lawyer, June 2001, at 84; see also Kolata, supra note 13.

27 Kolata, supra note 13.

28 Geraldine L. Collier, Families, Researchers Fear “Ownership” of Biological Codes Could Limit Genetic Testing, Worcester Telegram & Gazette, Dec. 11,2000, available at WL 10227785; Fleischer, supra note 26, at 97.

29 One much-discussed response to the commercialization of human biological materials, reflecting both dignitary and justice concerns, is to limit the patentability of inventions based on the human body or the human genome. See, e.g., Knoppers, supra note 24; Richard Saltus, Critics Claim Patents Stifle Gene Testing, BOSTON GLOBE, Dec. 20, 1999, at Cl. See also Mark M. Hanson, Religious Voices in Biotechnology: The Case of Gene Patenting, Hastings Ctr. Rep., Nov.-Dec., 1997, at 1; Glenn McGee, Gene Patents Can be Ethical, 1 Cambridge Q. Healthcare Ethics 417 (1998). This article will leave aside the important and complex questions associated with patentability. The discussion here will presume that with or without patenting, the use of certain human materials can provide a significant economic contribution to biomedical research that should be compensated, if compensation can be structured so as not to unduly offend other important values. In parts of this article concerned with institutional structure, the existence of some patents based on studies with human tissue will be assumed.

30 Moore v. Board of Regents of Cal., 793 P.2d 479, 510 (1990).

31 Michael Dodson & Robert Williamson, Indigenous Peoples and the Morality of the Human Genome Project, 25 J. Med. Ethics 204, 207-08 (1999).

32 See Thomas H. Murray, Who Owns the Body? On the Ethics of Using Human Tissue for Commercial Purposes, IRB, Jan.-Feb., 1986, at 1; see also Editorial, Gene Donors’ Rights at Risk, 381 Nature l (1996).

33 See Eric Rakowski, Equal Justice 138, 173-74 n.13 (1991).

34 See K. Berg, The Ethics of Benefit Sharing, 59 Clinical Genetics 240, 242 (2001). But see James Boyle, Shamans, Software and Spleens: Law and the Construction of the Information Society 97-107 (1996) (arguing that popular legal concepts of intellectual property, including those expressed by the Moore majority, reflect the mistaken worship of a “romantic” notion of authorship and a labor theory of value that overstates the contributions of inventors in relation to those of sources).

35 For a more generic understanding of procedural justice as “impartial and inclusive,” a standard similarly violated here, see Hugo Ethics Comm., supra note 23, at 70.

36 See Krier, James E. & Schwab, Stewart J., Property Rules and Liability Rules: The Cathedral in Another Light, 70 N.Y.U. L Rev. 440, 477 (1995)Google Scholar (noting both the legislature’s theoretical advantage and its practical susceptibility to abuse).

37 Moore v. Board of Regents of Cal., 793 P.2d 479, 496 (1990) (quoting Foley v. Interactive Data Corp, 765 P.2d 373, 397 n.31 (1988)). See also Mary Taylor Danforth, Cells, Sales, and Royalties: The Patient's Right to a Portion of the Profits, 6 Yale L. & Pol’y Rev. 179, 198-201 (1988).

38 E. Richard Gold has advocated a more comprehensive legislative scheme for the treatment of human tissue that would address both contributors’ financial compensation and their non-economic interests, such as rights to direct research or publish its results, while avoiding resort to property-rights language and concepts. E. Richard Gold, Body Parts: Property Rights and the Ownership of Human Biological Materials 176-77 (1996).

39 The precise formulation of standards should be based on information and examples from practice, which can be brought forward in legislative hearings. While difficult, the question is considerably less complicated than one already familiar to the field of biotechnology licensing. When one company or academic institution provides another entity with research materials of human or animal origin, materials which are deemed to be owned by the provider, the question arises as to how ownership, rights of use and rights to future royalties should be allocated between the parties in the event the recipient makes an invention using the provider’s materials, or commercializes new or modified materials that are derived from the provider’s materials. See, e.g., Nat’l Inst. of Health, Working Group on Research Tools, Report of the National Institutes of Health Working Group on Research Tools (1998) (seeking fewer restrictions on academic research), at http://www.nih.gov/ news/researchtools/index.htm; Eliot Marshall, Need a Reagent? Just Sign Here…...,278 Science 212, 212 (1997) (citing one company’s requirement that academic scientists “surrender … all property rights on discoveries ‘contingent upon’ the use” of the company’s materials.). See also Arti Kaur Rai, Regulating Scientific Research: Intellectual Property Rights and the Norms of Science, 94 Nw. U. L. Rev. 77 (1999). Two important differences between that debate and the present issue should be noted. First, the proposal advanced here regarding treatment of tissue contributors would not apply directly to academic research, except to the extent it required the maintenance of links between tissue samples and their contributors, see Section III infra. Second, the industry debate involves questions of ownership and control not implicated in the proposal made here, which relates only to compensation; the larger questions would, however, necessarily arise if a property right in the human tissue contributor were recognized.

40 See Nuffield Council on Bioethics, Human Tissue §§ 13.24, 13.38 (1995). The council generally opposes financial compensation for tissue removed in clinical settings, but recommends special ethics committee consideration regarding tissues of “special interest for research or for commercial development.” Id. § 13.38.

41 The idea of assigning differential rewards to contributors of tissues with varying utility is similar in principle to the distinction made in the patent law between scientific contributions that constitute inventorship and contributions that have a lesser role in the patented invention. Only individuals meeting the statutory definition of inventorship are entitled to patent rights. Other contributors ordinarily receive no valuable legal rights, even though they may have contributed ideas or skills that helped enable the discovery. See Irah H. Donner, Patent Prosecution: Practice & Procedure Before the U.S. Patent Office 123-33 (2d ed., 1999).

42 Horton & Weir, supra note 14, at 1.

43 Nat’l Comm’n for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research 4 (1979).

44 See Immanuel Kant, Groundwork of the Metaphysics of Morals 37-40 (Mary Gregor trans., 1997).

45 U.S. Cong. Office of Tech. Assessment, New Developments in Biotechnology: Ownership of Human Tissues and Cells 143 (1987) [hereinafter OTA: New Developments]; H. Hathout, Islamic Concepts and Bioethics, in Bioethics Yearbook, 114-16 (B. A. Lustig ed., 1991). In some traditions, including Judaism, the permissibility of research use per se may be in question. For a brief account of such issues in Judaism, Christianity, Islam, Hinduism, Buddhism and Native American religions, see Courtney S. Campbell, Research on Human Tissue: Religious Perspectives, in Nat’l Bioethics Advisory comm’n, 2 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, C-l to C-2 (1999) [hereinafter NBAC Rep. 2].

46 Goldner, supra note 6, at 398; Horton & Weir, supra note 14, at 1.

47 Goldner, supra note 6, at 396.

48 Id. at 394-96.

49 Kolata, supra note 13.

50 NBAC REP. 1, supra note 3, at 50.

51 Lori B. Andrews, My Body, My Property, Hastings Ctr. Rep., Oct. 1986, at 28.

52 See supra note 26.

53 See Miles v. Scripps Clinic and Research Found., 810 F. Supp. 1091, 1097 (S.D. Cal. 1993) (quoting Moore v. Regents of Univ. of Cal., 793 P.2d 479, 487 (Cal. 1990)).

54 Knoppers, supra note 24, at 25.

55 Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Science 698 (1998).

56 See Garrett Hardin, The Tragedy of the Commons, 162 Science 1243 (1968).

57 Id.

58 Heller & Eisenberg, supra note 55, at 699.

59 Id.

60 See Charlotte H. Harrison, Industry-Sponsored Academic Research in the Health Sciences: Regulatory, Policy and Practical Issues in Contract Negotiations, 2 J. BlOLAW & BUS. 9, 12 (1999).

61 Id. at 10.

62 Berg, supra note 34, at 241.

63 Horton & Weir, supra note 14, at 8; Robert J. Levine, Research that Could Yield Marketable Products from Human Materials: The Problem of Informed Consent, IRB, Jan.-Feb., 1986, at 6.

64 OTA: New Developments, supra note 45, at 134; see also Guido Calabresi, The Simple Virtues of the Cathedral, 106 Yale L.J. 2201, 2205-06 (1997).

65 The distinction among these rules was articulated in Guido Calabresi & A. Douglas Melamed, Property Rules, Liability Rules, and Inalienability: One View of the Cathedral, 85 HARV. L. Rev. 1089 (1972). The rule of inalienability that is applicable to the present discussion is not the rule of pure inalienability expounded in the original article by Calabresi and Melamed, which would prohibit any transfer of tissue by gift or sale. The option taken by the Moore court is closer to a rule of market inalienability, in which entitlements may be given away but not sold. The term market inalienability was coined by Margaret Jane Radin. See Radin, Margaret J., Market-Inalienability, 100 Harvard L. Rev. 1849 (1987)Google Scholar. For a fuller discussion of the three regimes in relation to tissue source compensation, see generally Section IIIA infra.

66 See supra note 39.

67 Moore v. Board of Regents of Cal., 793 P.2d 479, 487 (Cal. 1990).

68 Stephen R. Munzer, An Uneasy Case Against Property Rights in Body Parts, 11 Soc. Phil. & Pol’y 259, 286 (1994).

69 See supra note 26.

70 OTA: New Developments, supra note 45, at 131.

71 Id. at 132.

72 I assume here that a liability rule applying to one kind of tissue need not commodify other kinds of tissue, to the extent that it has a commodifying effect at all, and, similarly, that people can satisfy their moral beliefs by making independent choices about the terms on which to treat their own tissue, regardless of the choices of others. As Radin explains, some would contest the latter point: it is possible that people’s feelings may be so contaminated by knowledge of commodification in which they do not participate that, “as an empirical premise … a non-market regime cannot coexist with a market regime.” Margaret J. Radin, Contested Commodities 100 (1996). Radin does not consider the effect of a liability rule in this regard.

73 Munzer, supra note 68, at 260, 276.

74 Courtney S. Campbell, Religion and the Body in Medical Research, 8 Kennedy Inst. Ethics J. 275, 285 (1998).

75 See supra Part II.A. 1 and infra Part III.D.

76 Radin, supra note 72, at xiii.

77 Id. at 109-14.

78 Munzer, supra note 68, at 281.

79 Id. (citing N.Y. Workers’ Compensation Law § 15.3 (1993)). In this example, the weekly “compensation” amount constitutes two-thirds of the employee’s average weekly wages. Id.

80 Munzer, supra note 68, at 280-81.

81 Id. at 259.

82 See Dorothy Nelkin & Lori Andrews, Homo Economicus: The Commercialization of Body Tissue in the Age of Biotechnology, Hastings Ctr. Rep., Sept.-Oct., 1998, at 30, 38.

83 Goldner, supra note 6, at 380.

84 Id. at 395; Horton & Weir, supra note 14, at 8; see generally Neal Dickert & Christine Grady, What’s the Price of a Research Subject? Approaches to Payment for Research Participation, 341 New Eng. J. Med. 198 (1999).

85 See, e.g., David J. Rothman, The International Organ Traffic, N.Y. Rev. BOOKS, Mar. 26, 1998, at 14, 15; P.J. Morris & R.A. Sells, Paying for Organs from Living Donors, reprinted in The Ethics OF Organ Transplants: The Current Debate 229 (Arthur L. Caplan & Daniel H. Coelho eds.,1998). But see J. Radcliffe-Richards et al., The Case for Allowing Kidney Sales, 352 The Lancent 1950 (1998), reprinted in The Ethics of Organ Transplants: the Current Debate 224 (Arthur L. Caplan & Daniel H. Coelho eds., 1998). See generally Paul T. Menzel, Strong Medicine: The Ethical Rationing of Health Care 183-85 (1990).

86 Nat’l Research Council Comm, on Human Genetic Diversity, Human Rights and Human Genetic Variation Research, in Health And Human Rights: A Reader 380 (J. Mann et al. eds., 1999).

87 Kolata, supra note 13.

88 Fleischer, supra note 26, at 87. Participants in clinical trials related to cancer and other diseases thought to have a genetic component are frequently asked to contribute samples for further research on their disease.

89 For a debate regarding the effect of compensation on such altruism in the context of blood for transfusion, see generally Richard M. Titmuss, The Gift Relationship: From Human Blood to Social Policy (1970); Kenneth J. Arrow, Gifts and Exchanges, 1 Phil. & Public Affs. 343 (1972).

90 Campbell, supra note 45, at C-10.

91 Personal communication from Fr. Kevin D. O’Rourke, Neiswanger Inst, for Bioethics and Health Policy, Stritch School of Med., Loyola Univ. of Chicago (May 2001).

92 Campbell, supra note 45, at C-10 to C-l 1.

93 The Pope also expressed concern about abuses of financial reward. See Tissue Transplantation (May 14, 1956), reprinted in Medical Ethics: Sources of Catholic Teachings 287 (Kevin D. O’Rourke & Philip Boyle eds., 3d ed. 1999).

94 See Andrew Kimbrell, the Human Body Shop: the Engineering and Marketing of Life 18 (1993).

95 In lieu of altruism people might contribute samples on the basis of a calculation that, even without receiving compensation for their contribution, they are likely to benefit from the resulting facilitation of research, particularly if others choose the same course.

96 It should be noted that even if the option to receive payment is acceptable to many religious people or secular altruists, it may be neither necessary nor sufficient to satisfy their goals in contributing tissue. Other important considerations may include the allocation of researchers’ resources to serve the good of particular patient populations or the public as a whole.

97 See Calabresi & Melamed, supra note 65, at 1106-15.

98 Radin, supra note 72, at 22-23.

99 Calabresi & Melamed, supra note 65, at 1092.

100 Id. at 1093.

101 Id. at 1092 n.7, 1097, 1106.

102 Carol M. Rose, The Shadow of the Cathedral, 106 YALE L.J. 2175, 2184, 2197 (1997).

103 Id. at 2198.

104 One category of benefits is intended to replace lost income; another provides fixed awards “for the loss or loss of use of certain body parts and functions.” Peter M. Lencsis, Workers Compensation: A Reference and Guide. 52-55 (1998). The statutes also provide other benefits such as medical and rehabilitation expenses, and survivors’ expenses. Id. at 51-56.

105 Id. at 62.

106 17 u.s.C.A. § 119 (West 2001). The current structure replaces the previous Copyright Royalty Tribunal, which is described in Alvin Deutsch, Play it Again, Sam: Collecting Societies in the United States and the Functions of the Copyright Royalty Tribunal, in Collecting Societies in the Music Business 29 (David Peeperkom & Cees van Rij, eds., 1989).

107 Although it could be objectionable on grounds of commodification, such a negotiation would not implicate concerns about doctor-patient or researcher-subject relationships because it would take place not with the doctor at the medical facility who originally collected the sample, but with a company that had no fiduciary relationship to the contributor. These transactions would be more efficient than the up-front negotiations involved in a private market in tissue, since they would be confined to selected parties and a single issue.

108 In both workers’ compensation and compulsory licensing arrangements, liability rules provide a party with redress for a taking or loss that he or she did not authorize. In the case of research tissue, the initial temoval of the tissue would not constitute an unconsented loss: in all events it would be authorized by informed consent, and in some cases it might be affirmatively desired for independent purposes, as when a tumor is removed to improve a patient’s health. Compensation would be directed rather to the loss of the opportunity to sell the tissue in a private market, which would be prohibited by law under the scheme outlined here. For a discussion of the interaction of consent and economic utility in liability rules, see Jules L. Coleman & Jody Kraus, Rethinking the Theory of Legal Rights, 95 YALE L.J. 1335, 1363-64 (1986).

109 Regarding the adequacy of current provisions for informed consent in this area, see generally NBAC REP. 1, supra note 3; see also Henry T. Greely, Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information, 34 Wake Forest L. Rev. 737 (1999).

110 Alternatively, the statutory standards could be applied by a court. Concerns about efficiency and predictability in this highly technical area seem to favor a regulatory approach.

111 When repeat transactions make it worthwhile, which is unlikely to occur here, liability rules may also be developed by private contract. See Robert P. Merges, Contracting into Liability Rules: Intellectual Property Rights and Collective Organizations, 84 Cal. L. Rev. 1293, 1319 (1996).

112 As an example, the eligibility criterion for compensation of a tissue contributor might be that a particular marketed product could not have been conceived, developed or made without use of the tissue. Intuitively, the argument for sharing benefits with tissue contributors is particularly strong in the case where a discovery leading to a profit “could not have been made without [the contributor’s] cooperation.” Berg, supra note 34, at 241. See also Moore v. Regents of Univ. of Cal., 793 P.2d'479, 511 (Cal. 1990) (Mosk, J., dissenting), in which the importance of such “but-for” contribution is emphasized: “but for the cells of Moore’s body taken by defendants, there would have been no Mo cell line.” See also supra notes 39-41 and accompanying text. The calculation of compensation would, of course, be a separate matter from the prior determination whether a given type of tissue, such as embryonic stem cells, should be alienable, or alienable for money, at all. That prior determination would remain the province of Congress and state legislatures.

113 Organizations such as PXE International are already modeling this strategy. Fleischer, supra note 26, at 98, 100.

114 If the names of true inventors are omitted in bad faith, the patent claims may be held invalid. Donner, supra note 41, at 171 ; Harold C. Wegner, Patent Law in Biotechnology Chemicals & Pharmaceuticals 47 (2d ed. 1994).

115 The legislature could consider requiring that compensation from the patentee or another party be owed at the patenting stage itself, on the rationale that significant economic value had been conferred already.

116 See supra note 39.

117 See Fleischer, supra note 26, at 87.

118 See Merges, supra note 111, at 1299, 1308; Julia Black, Regulation as Facilitation: Negotiating the Genetic Revolution, 61 MODERN L. Rev. 621, 650-60 (1998). If the process were known to be biased against tissue sources, the cynicism that might otherwise have been directed against doctors and researchers in a regime of property or market inalienability might appropriately be transferred to the legislature, unless the bias were attributed to lobbying by medical interests.

119 See Bartha M. Knoppers et al., Commercialization of Genetic Research and Public Policy, 286 Science 2277,2277 (1999). Of course, some countries may prefer to protect their populations, and their national interest, in a different way from that suggested here. See Interim Measures, supra note 25 (requiring advance negotiations over intellectual property rights and other terms for the use of genetic material taken from the country).

120 The range of collective structures used, their relative merits, and the varying degree to which the rights involved are private or public, are described in David Sinacore-Guinn, Collective Administration of Copyrights and Neighboring Rights: International Practices, Procedures, and Organizations (1993). See also the more recent J. A. L. Sterling, World Copyright Law §§ 10.15-10.16, 12.21-12.27 (1999), and the more theoretical Richard Watt, Copyright and Economic Theory: Friends or Foes? (2000).

121 See Troyen A. Brennan, Proposed Revisions to the Declaration of Helsinki-Wili They Weaken the Ethical Principles Underlying Human Research?, 341 New Eng. J. Med. 527, 528 (1999).

122 Concerns regarding developing nations are discussed in Council for Int’l Orgs. of Med. Sciences, supra note 23; Glantz et al., supra note 23; Human Genome Org. Ethics Comm., supra note 23; Nelkin & Andrews, supra note 82, at 34.

123 Bartha M. Knoppers et al., Ethical Issues in International Collaborative Research on the Human Genome: The HGP and the HGDP, 34 Genomics 272, 275 (1996).

124 David Dickson, Whose Genes Are They Anyway, 381 Nature 11, 13 (1996) (quoted in Bartha Maria Knoppers, Human Genetic Material: Commodity or Gift?, in Stored Tissue Samples: Ethical, Legal and Public Policy Implications 230 n.20 (Robert E. Weir ed., 1998)).

125 Nelkin & Andrews, supra note 82, at 36, 38.

126 Matt Crenson, Iceland's Genetic Powerhouse; Doubts Clouding deCODE's Mission, CHICAGO TRIB., Apr. 2, 2001, at B6. Crenson suggests that the prospect of company profit-making is also a concern among Icelanders. For a detailed description of the deCODE database project and its context, see generally Hrobjartur Jonatansson, Iceland's Health Sector Database: A Significant Head Start in the Search for the Biological Grail or an Irreversible Error?, 26 Am. J. Law & Med. 31 (2000). See also Ethics Briefings: The Icelandic Database, 26 J. Med. Ethics 216 (2000).

127 Council of Europe, Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and Biomedicine, art. 21, reprinted in 7 Kennedy Inst. Ethics J. 277, 284 (1997).

128 UNESCO, Universal Declaration on the Human Genome and Human Rights, art. 4 (1997).

129 Human Tissue, supra note 40, § 13.8.

130 Law No. 94-654 of 29 July 1994 on the Donation and Use of Elements and Products of the Human Body, Medically Assisted Procreation, and Prenatal Diagnosis, reprinted in 45 INT’L DIG. Health LEGIS. 473, 473-82 (1994); Marie Hirtle, Civil Law and the Status of Human Genetic Material, in Legal Rights and Human Genetic Material 114 (Bartha M. Knoppers et al. eds., 1996).

131 Hirtle, supra note 130, at 96.

132 Human Tissue, supra note 40, § 13.38.

133 Gerald Dworkin & Ian Kennedy, Human Tissue: Rights in the Body and its Parts, 1 Med. L. Rev. 291, 319 (1993) (delineating tort actions pursuant to which Moore might have won “something akin to a royalty” for the use of his tissue).

134 Council Of Europe Comm, Of Ministers, Explanatory Report To The Convention For The Protection Of Human Rights And Dignity Of The Human Being With Regard To The Application Of Biology And Medicine: Conventionc on Human Rights and Biomedicine, ch. VII, art. 21 (Jan. 9, 1997) (explaining that the sale of discarded tissue “is not an affront to human dignity’’); Hirtle, supra note 130, at 91 (Quebec), 115 (The Netherlands). These categories may include blood, bone marrow and tissue excised for therapeutic purposes.

135 Convention on the Grant of European Patents, art. 53(a), 1065 U.N.T.S. 255, 272, 13 I.L.M. 270, 286 (1974); see Black, supra note 118, at 644-45, 648.

136 Council Directive 98/44, 1998 O.J. (L213) art. 6.1; Council Directive 98/44, 1998 O.J. (L 213) para. 26.

137 The directive is silent on this point.

138 Group of Advisers on the Ethical Implications of Biotechnology of the European Comm’n, Opinion On Ethical Aspects of Patenting Inventions Involving Elements of Human Origin, Opinion no. 8, § 2.3 (Sept. 25, 1996), reprinted in 48 Int’l Dig. Health Legislation 423 (1997).

139 Hirtle, supra note 130, at 89, 115-16.

140 Id. at 110-12.

141 European Group on Ethics in Science and New Technologies, Ethical Aspects of Human Tissue Banking, ch. VII, § 1.10, (July 21, 1998); HUMAN TISSUE, supra note 40, §§ 13.9, 13.24.

142 See European Group on Ethics in Science and New Technologies, Ethical Aspects of Human Tissue Banking § 2.8 (July 21,1998).

143 Knoppers, supra note 24, at 25.

144 Personal communication, January 2002. See also id.

145 See Berg, supra note 34, at 242-43. On the difficulties associated with defining or compensating communities see C. Weijer, Benefit-Sharing and Other Protections for Communities in Genetic Research, 58 Clinical Genetics 367 (2000).

146 See, e.g., UNESCO, Universal Declaration on the Human Genome and Human Rights, art. 18-19. The HUGO Ethics Committee has recommended a commitment by pharmaceutical companies and other profit-making groups to “dedicate a percentage (e.g., 1-3%) of their annual net profit to healthcare infrastructure and/or to humanitarian efforts.” HUGO ETHICS Comm., supra note 23, at 71; HUGO Ethics Comm., HUGO Urges Genetic Benefit-Sharing, 3 COMMUNITY GENETICS 88 (2000).

147 Merges, supra note 111, at 1306-07.

148 See Mark M. Hanson, Biotechnology and Commodification Within Health Care, 24 J. Med. & Phil. 267, 277 (1999).

149 See Nelkin & Andrews, supra note 82, at 30.

150 In a seven-city NBAC-sponsored focus group study of beliefs about human tissue research, only a small minority of participants expressed the view that they should share in commercial proceeds from their tissue; however, most said they had not thought about the question before the focus group session. NBAC Rep. 1, supra note 3, at 77-79.