Partnership in U.K. Biobank: A Third Way for Genomic Property?

See, e.g., Ong A. Fs S. J. , Global Assemblages: Technology, Politics, and Ethics as Anthropological Problems (Malden, MA: Blackwell, 2005).

See Winickoff D. E. Neumann L. , “Towards a Social Contract for Genomics: Property and the Public in the ‘Biotrust’ Model,” Genomics, Society and Policy 1, no. 3 (2005): 8–21.

I say comparatively ignored, for there are important works dealing with these issues in the field. See, e.g., Marchant G. E. , “Property Rights and Benefit-Sharing for DNA Donors?” Jurimetrics 45, no. 2 (2005): 153–178; Greely H. T. , “Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information,” Wake Forest Law Review 34 (1999): 737–66; Merz J. F. , “Protecting Subjects' Interests in Genetics Research,” American Journal of Human Genetics 70, no. 4 (2002): 965–971; Laurie G. , Genetic Privacy: A Challenge to Medico-Legal Norms (Cambridge: Cambridge University Press, 2002); Bovenberg J. , “Whose Tissue Is It Anyway?” Nature Biotechnology 8, no. 23 (2005): 929–933; Rose H. , The Commodification of Bioinformation, Wellcome Trust, 2001; Hoeyer K. , “The Emergence of an Entitlement Framework for Stored Tissue: Elements and Implications of an Escalating Conflict in Sweden,” Science Studies 17, no. 2 (2004): 62–82.

See Winickoff Neumann , supra note 2.

See, e.g., the recent legal cases in the U.S. regarding ownership of biobank collections between donors, research institutions, and researchers: Greenberg v. Miami Children's Hospital, 264 F. Supp. 2d 1064 (S.D. Fla. 2003) and Washington University v. William J. Catalona, et al., Case No. 4:03CV01065-SNL (E.D. Mo. March 31, 2006). These issues have emerged with force in the professional medical literature. See Alta Charo R. , “Body of Research – Ownership and Use of Human Tissue,” New England Journal of Medicine 355, no. 15 (2006): 1517–1519. See also an important recent account in the popular media, Skloot R. , “Taking the Least of You: The Tissue Industrial Complex,” New York Times Magazine, April 16, 2006.

See Winickoff D. E. Winickoff R. N. , “The Charitable Trust as a Model for Genomic Biobanks,” New England Journal of Medicine 349, no. 12 (2003): 1180–84. For a recent critique of this model, see Boggio A. , “Charitable Trust and Human Genetic Databases: The Way Forward?” Genomics, Society and Policy 1, no. 2 (2005): 41–49; for a response to this critique, see Winickoff Neumann , supra note 2. Cf. Knoppers B. M. , “Biobanking: International Norms,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 7–14, at 7 (discussing a similar idea for a “trusted intermediary” to control access to data and samples).

For a recent overview of alternative property regimes proposed in this context, see Bovenberg , supra note 3. For good examples, see Human Genome Organization (HUGO) Ethics Committee, Statement on Benefit Sharing, 2002 [hereinafter cited as HUGO]; Harrison C. H. , “Neither Moore Nor the Market: Alternative Models for Compensating Contributors of Human Tissue,” American Journal of Law and Medicine 28, no. 1 (2002): 77–105; Gitter D. M. , “Ownership of Human Tissue: A Proposal for Federal Recognition of Human Research Participants' Property Rights in Their Biological Material,” Washington & Lee Law Review 61 (2004): 257–345. There is an extensive older literature on “profit sharing” with regard to tissue donation for research that emerged around the Moore v. Regents case. See, e.g., Danforth M. T. , “Cells, Sales, and Royalties: The Patient's Right to a Portion of the Profits,” Yale Law & Policy Review 6 (1988): 179–201. For a critique of the market-dominated nature of most benefit-sharing proposals, see Hayden C. , “Taking as Giving: Bioscience, Exchange, and the Politics of Benefit-Sharing,” Social Studies of Science (forthcoming, 2007).

See, e.g., Barbour V. , “U.K. Biobank: A Project in Search of Protocol?” Lancet 361, no 9370 (2003): 1734–38; Giles J. , “Huge Biobank Project Launches Despite Critics,” Nature 440, no. 7082 (2006): 263; Wallace H. , “The Development of U.K. Biobank: Excluding Scientific Controversy from Ethical Debate,” Critical Public Health 15, no. 4 (2005): 323–333; but see also Collins F. S. , “The Case For a U.S. Prospective Cohort Study of Genes and Environment,” Nature 429, no. 6990 (2004): 475–77 (invoking U.K. Biobank to help justify a similar projects in the U.S.)

U.K. Biobank, U.K. Biobank Gets Unanimous Backing from International Experts after Piloting Phase , Press Release, August 21, 2006, available at <http://www.eurekalert.org/pub_releases/2006–08/ub-ubg082006.php> (last visited June 4, 2007).

In famous words spoken in the House of Commons in 1947, Winston Churchill said that “no one pretends that democracy is perfect or all-wise. Indeed, it has been said that democracy is the worst form of government except all those other forms that have been tried from time to time.” Raymond W. J. , Dictionary of Politics: Selected American and Foreign Political and Legal Terms (Lawrenceville, VA: Brunswick Pub. Corp., 1992): at 124.

The Medical Research Council (MRC) is a publicly funded organization dedicated to improving human health, the rough equivalent of the National Institutes of Health in the United States. The MRC receives annual funding from Parliament through the Department of Trade and Industry. See Medical Research Council Web site, “About Us,” available at <http://www.mrc.ac.uk/AboutUs/FactsFigures/index.htm> (last visited June 19, 2007).

The Wellcome Trust is a private charity and the U.K.'s largest non-governmental source of funds for biomedical research, dispersing roughly 300 million pounds per year. See Welcome Trust Web site, “About Us,” available at <http://www.wellcome.ac.uk/aboutus/index.html> (last visited June 19, 2007).

Newton J. , U.K. Biobank Briefing Note, 2004, at 1 (on file with author).

E.g., a proposal to compile a for-profit genomics database with the Framingham Heart Study population fell apart due to disagreements between private funders, university sponsors, and government agencies over data sharing and intellectual property. The Human Genome Diversity Project failed when resistance to the project developed among the indigenous communities to be sampled, and project ethicists failed to find an acceptable solution to the problem of obtaining group consent. The Iceland Health Sector Database was never built. The Estonian Genome Project failed to find a sustainable and ethically acceptable partnership with industry.

Winickoff D. E. , “Genome and Nation: Iceland's Health Sector Database and its Legacy,” Innovations 1, no. 2 (2006): 80–105.

Act on a Health Sector Database, 123rd session, no. 139, passed by the Parliament of Iceland (the Althingi) December 17, 1998. Notes to the Bill state that “recorded data on the health of the Icelandic people is a national resource, which should be preserved and used to yield benefits as far as possible.” For analysis of this language, see Winickoff D. E. , “Governing Population Genomics: Law, Bioethics, and Biopolitics in Three Case Studies,” Jurimetrics 43 (2003): 187–228.

See, e.g., Palsson G. Rabinow P. , “Iceland: The Case of a National Human Genome Project,” Anthropology Today 15, no. 5 (1999): 14–18; Greely H. T. , “Iceland's Plan for Genomics Research: Facts and Implications,” Jurimetrics 40 (2000): 153–191; Annas G. J. , “Rules for Research on Human Genetic Variation – Lessons from Iceland,” New England Journal of Medicine 342, no. 24 (2000): 1830–33, at 1830; Fortun M. , Promising Genomics (forthcoming, University of California Press); Sigurdsson Skúli Dr. , an Icelandic historian of science and member of the Act's opposition, has been a meticulous analyst and bibliographer of the database controversy. See his publications and highly useful bibliography of the database controversy, available at <http://www.raunvis.hi.is/∼sksi/kit.html> (last visited June 5, 2007).

See Act on a Health Sector Database, supra note 16, at Article 1, available at <http://ministryofhealth.is/laws-and-regulations/nr/659#allt> (last visited June 5, 2007).

Notes from the Bill state that the idea for the database initiated with deCODE and Kari Stefansson, and the company reportedly drafted the first version of the Bill around December 1997. See Rose , supra note 3.

Lewontin R. C. , “People Are Not Commodities,” New York Times, Op-ed, January 23, 1999, at A19.

See Winickoff , supra note 15.

House of Lords Science and Technology Committee, Human Genetic Databases: Challenges and Opportunities , 4th Report, Session 2000–2001, Chap. 7, paragraph 7.16 [hereinafter cited as Human Genetic Databases].

Martin P. Kaye J. , The Use of Biological Sample Collections and Personal Medical Information in Human Genetics Research , The Welcome Trust, 1999, at 62, available at <http://www.wellcome.ac.uk/assets/WTD003283.pdf> (last visited June 5, 2007).

Martin P. Memorandum , The Industrial Development of Human Genetic Databases, October 2000, written evidence to Select Committee on Science and Technology (on file with author).

See Winickoff Winickoff , supra note 6.

See Human Genetic Databases, supra note 22.

Singer J. W. , Entitlement: The Paradoxes of Property (New Haven: Yale University Press, 2000): at 29.

The English word “partner” derives from the 12th-century Anglo-Normon parcener, meaning parsoner, participant, part-owner or coheir. Oxford English Dictionary, 3rd ed.

Id., at s.v. “partnership.”33. Partnership Act, 1890, 53 and 54 Vict., c.39, § 1(1) (Eng.)

Uniform Partnership Act , § 6(1) (1914).

See, e.g., id. at § 18 (a), (e); and Partnership Act (Eng.), supra note 33, at (2)-(7).

Meinhard v. Salmon , 164 N.E. 545 (N.Y. 1928).

Thanks to Prof. Jon Hanson for making this case and its remarkable language such a central theme (and a bizarre form of entertainment) in his Law of Corporations class at Harvard Law School.

O'Neill O. , Autonomy and Trust in Bioethics (Cambridge: Cambridge University Press, 2002).

See Petersen A. , “Securing Our Genetic Health: Engendering Trust in U.K. Biobank,” Sociology of Health and Illness 27, no. 2 (2005): 271–292 (stating at 279 that “above all, U.K. Biobank is promoted as a significant resource for research.”) See also, Bosch X. , “Beset by Practical Hurdles, U.K. Biobank Moves at Sluggish Pace,” Nature Medicine 11, no. 7 (2005): At 696 (quoting Yusuke Nakamura, the director of the $180 Japan Biobank initiative, as saying that “‘we can accelerate drug development if public universities and industry realize the value of the resource.’”)

See Newton , supra note 13.

See U.K. Biobank, supra note 9.

Ostrom E. , Governing the Commons: The Evolution of Institutions for Collective Action (Cambridge: Cambridge University Press, 1990).

A common-pool resource, often called a common property resource, is a type of good consisting of a resource system, whose characteristics make it difficult, but not impossible to prevent users from obtaining benefits from its use. Unlike pure “public goods,” common pool resources are subject to overuse, the so-called “tragedy of the commons” because they are subtractable, but are capable of yielding benefits in a sustainable flow. Id.

Common pool resource theory is currently being extended beyond the treatment of common pool natural resources, such as fisheries and water. Recently, scholars have been applying Ostrom's theory to informational, jointly managed intellectual property, and other kinds of resources. See, e.g., Hess C. Ostrom E. , “Ideas, Artifacts, and Facilities: Information as a Common-Pool Resource,” Law and Contemporary Problems 66, Supplement (2003): 111–146.

Resource system refers to things capable in favorable conditions of producing a sustainable flow of resources without harm to the resource system, e.g., fishing grounds, grazing areas, or bridges. In contrast, resource units refer to what may be appropriated or harvested by individuals from the resource system. See Ostrom , supra note 42, at 30.

U.K. Biobank, Ethics and Governance Framework, Version 2, 2006, at 3, available at <www.ukbiobank.ac.uk/docs/EGF_Version2_July%2006%20most%20uptodate.pdf> (last visited June 20, 2007) [hereinafter cited as EGF].

U.K. Biobank, “Setting Standards: The U.K. Biobank Ethics and Governance Framework,” in EGF Summary document, September 24, 2003 (on file with author). The EGF was developed with the advice of a ten-member Interim Advisory Group (IAG), composed of experts in research ethics, philosophy, law, science and social science, and consumer representation. The funders charged the IAG to advise them on “best ethical practice” in order to “provide a sound basis for fostering public trust and confidence in the project.” The IAG was established in February 2003, and the first public draft of the EGF was published for comment on September 24, 2003. The IAG's deliberations were informed by “public consultations” carried out at several stages during the development of the project to identify concerns and priorities. However, the EGF was officially “prepared by the U.K. Biobank Funders and is their document.” See U.K. Biobank Ltd's public memo on the IAG (on file with author).

See EGF, supra note 46, at 6.

Id., at 3.

Id., at 14.

Id., at 3.

Id., at 12.

Id., at 14.

Id., at 9 (stating that “regular communication will be important to inform participants of general findings from research based on the resource and to encourage continued participation” and that “…a variety of media, such as websites, helplines, newsletters, and public meetings will be used to inform participants about the development and use of the resource, and of ways to contact U.K. Biobank”).

Reports of consultations available at <http://www.ukbiobank.ac.uk/ethics/consult.php> (last visited June 20, 2007).

See EGF, supra note 46, at I.B.4 (stating that “U.K. Biobank may also establish a participants' panel with a clear remit that it is as representative as possible of the U.K. Biobank population and able to express views typical of the participants generally. U.K. Biobank will also maintain procedures for responding in a timely fashion to any inquiries or complaints”). A Participants' Panel existed at one point, but was disbanded sometime in 2005.

Ethics and Governance Council Web site, available at <http://www.egcukbiobank.org.uk/index.html> (last visited June 5, 2007).

U.K. Biobank, Ethics and Governance Framework: Summary of Comments on Version 1.0 , May 2004, at 35, available at <www.wellcome.ac.uk/assets/WTD003285.pdf> (last visited June 19, 2007) (“Whilst there was a view that the Ethics and Governance Council was acceptable, a number of respondents commented that its powers might not be sufficient in relation to individual uses of the resource, investigation of compliance, and procedures for addressing concerns.”) See also, Tutton R. Kaye J. Hoeyer K. , “Governing U.K. Biobank: The Importance of Ensuring Public Trust,” Trends in Biotechnology 22, no. 6 (2004): 284–5.

Offering ethical and political critique across cultures is deeply problematic. Immediately one must interrogate the standards against which one is measuring an arrangement in the world; this is where Winston Churchill's quotation to reference note 10 becomes especially pertinent. Those critics measuring worldly efforts against abstract ideals do have recourse to the comparative mode, which can ground one's analysis and make it more responsive to the pragmatic.

See Winickoff Winickoff , supra note 6.

For instance, in the United States, it has not been uncommon for Academic Medical Centers to broker tissue and health information of patients to profit-making genomic biobanks in exchange for equity. Here I refer in particular to the arrangements between Beth Israel Hospital, Maine Medical, Chicago and Duke with Ardais Corporation. See Winickoff , supra note 15.

See supra note 5 on the Greenberg and Catalona cases that have come out against enforcing such rights of tissue donors.

See Wallace , supra note 8, at 328.

Nowotny H. Scott P. Gibbons M. , Re-thinking Science: Knowledge and the Public in an Age of Uncertainty (Cambridge, U.K.: Polity Press, 2001).

See generally the excellent work of Helen Wallace at Gene-Watch U.K., e.g., Wallace H. , “U.K. Biobank: Good for Public Health?” OpenDemocracy, July 24, 2003, available at <http://www.opendemocracy.net/theme_9-genes/article_1381.jsp> (last visited June 5, 2007).

See, e.g., Collins , supra note 8.

This study, and other important long-term epidemiological studies around the world, have closely tracked cohorts over multiple generations and have re-emerged as important models for conducting a genomic cohort study. For an insider's history of this study, see Levy D. Brink S. , A Change of Heart: How the People of Framingham, Massachusetts, Helped Unravel the Mysteries of Cardiovascular Disease (New York: Knopf, 2005).

People Science and Policy Ltd, BioBank U.K.: A Question of Trust: A Consultation Exploring and Addressing Questions of Public Trust , March 2002, available at <http://www.ukbiobank.ac.uk/ethics/consult.php> (last visited, June 20, 2007).

U.K. Biobank, Ethics and Governance Framework: Summary of Comments on Version 1.0, supra note 60, at 28.

Id., at 26.

This study involved ten focus groups chosen to reflect a range of demographics (gender, ethnicity, and age), interests (patient, voluntary, and civic groups), and localities (rural, semi-rural or urban). Haddow G. Laurie G. Cunningham-Burley S. Hunter K. , “Tackling Community Concerns about Commercialisation and Genetic Research: A Modest Interdisciplinary Proposal,” Social Science and Medicine 64, no. 2 (2007): 272–282.

Id., at 275.

Id., at 276.

Id., at 277.

Levitt M. Weldon S. , “A Well Placed Trust? Public Perceptions of the Governance of Genetic Databases,” Critical Public Health 15, no. 4 (2005): 311–321, at 311.

Hoeyer K. , “The Ethics of Research Using Biobanks: Is Informed Consent Donors' Main Interest?” Archives of Internal Medicine 165, no. 1 (2005): 97–100.

Hoeyer K. Lynöe N. , “Motivating Donors in Genetic Research? Anthropological Reasons to Rethink the Role of Informed Consent,” Medicine, Health Care, and Philosophy 9, no. 17 (2006): 13–23; see also Hoeyer K. , “Studying Ethics as Policy: The Naming and Framing of Moral Problems in Genetic Research,” Current Anthropology 4 (2005): S71–S90.

See Hayden , supra note 7.

See Dahl R. A. , On Democracy (New Haven: Yale University Press, 1998): 35–61.

See U.K. Biobank, Policy on Intellectual Property and Access , Draft, January 11, 2005 (on file with author) (stating that it “will encourage and provide access to the Resource and the results that flow from it as widely and openly as possible in order to maximize its use and value for research. This will include access for researchers from the academic, commercial, charity and public sectors, both in the U.K. and overseas.”) Nota bene, a new draft of the policy is due soon, likely by the end of 2007.

Board members include the Principal and Vice Chancellor of the University of Dundee, Chair of the Scottish Institute for Enterprise (Chair); a professor of clinical medicine at Oxford who built up the “largest biomedical research department in the U.K.”; a partner in a large accountancy firm, and a consultant to various large corporations and government, who played a “role in the privatisation of British Telecom in 1984”; Head of Department for Pathogens, Immunology and Population Studies at The Wellcome Trust; the Director of Corporate Affairs at the U.K. Medical Research Council; a professor of General Practice and Community Health Sciences in the University of Nottingham; and the Head of Research Policy in the R&D Directorate of the Department of Health. For more detail on the biographies of the individuals serving on the seven-member board, see <http://www.ukbiobank.ac.uk/about/team/directors.php> (last visited June 20, 2007).

See the public biography of Sir Alan Langlands, available at <http://www.ukbiobank.ac.uk/about/team/directors.php#langlands> (last visited June 20, 2007).

Reardon J. , Race to the Finish (Princeton: Princeton University Press, 2004).

Such groups might include disease families or ethnic-cultural groups. How exactly this principle should be implemented has remained deeply contested. See Greely H. T. , “The Control of Genetic Research: Involving the Groups Between,” Houston Law Review 33, no. 5 (1998): 1397–1430. But see also Juengst E. , “Groups as Gatekeepers to Genomic Research: Conceptually Confusing, Morally Hazardous, and Practically Useless,” Kennedy Institute of Ethics Journal 8, no. 2 (1998): 183–200.

See, e.g., Winickoff D. E. , “Health-Information Altruists,” Letter, New England Journal of Medicine 354, no. 5 (2006): 530–31; see Winickoff Neumann , supra note 2.

See, e.g., HUGO, supra note 7; Merz , supra note 3.

Pullman D. Latus A. , “Benefit Sharing in Smaller Markets: The Case of Newfoundland and Labrador,” Community Genetics 6, no. 3 (2003): 178–181.

See Haddow , supra note 73, at 279.

Id., at 280.

Solidarity was the name of the famous trade union movement that helped overthrow the ruling socialist state in Poland. See, e.g., Ash T. G. , The Polish Revolution: Solidarity (New Haven: Yale University Press, 2002).

Fortun M. , “Towards Genomic Solidarity: Lessons from Iceland and Estonia,” OpenDemocracy, July 10, 2003, available at <http://www.opendemocracy.net/content/articles/PDF/1344.pdf> (last visited June 5, 2007).

Id., at 3. Fortun invokes solidarity in a decidedly different way than bioethicists Chadwick and Bere in the U.K. Biobank context. These bioethicists use solidarity to emphasize the communitarian obligations of individuals towards the collective public health and biomedical research enterprise to argue against the need for burdensome procedures of going back to individuals everytime a new research protocol was proposed for studying the biobank material; Chadwick R. Bere K. , “Solidarity and Equity: New Ethical Frameworks for Genetic Databases,” Nature Reviews Genetics 2, no. 4 (2001): 318–321. Chadwick and Bere use solidarity to make a communitarian defense of open-ended consent so that biobank research can proceed with less hindrance; Fortun uses it with neo-Marxian and Habermasian inflections.

Id., at 3.

James Boyle makes this point in his useful discussion of John Moore's famous spleen. Boyle J. , Shamans, Software and Spleens: Law and the Construction of the Information Society (Cambridge: Harvard University Press, 1997).

Terry S. F. , “Learning Genetics,” Health Affairs 22, no. 5 (2003): 166–71.

PXE International's homepage can be found at <http://www.pxe.org/> (last visited June 5, 2007).

See Gutmann A. Thompson D. , Democracy and Disagreement (Cambridge: Harvard University Press, 1996): 1–53 (presenting a useful account of the necessary conditions for a meaningful deliberative political process).

See Winickoff Neumann , supra note 2.

Personal communication with D. Levy, Director of the Framingham Heart Study (June, 2005). See also supra note 63.

See Winickoff Neumann , supra note 2.