Technology Transfer in BioBanking: Credits,Debits,and Population Health Futures

See generally Guttmacher A. E. and Collins F. S. , “Welcome to the Genomic Era,” N. Eng. J. Med. 349 (2004): 996–98, available at <www.nejm.org>. See also Noah L. , “The Coming Pharmacogenomics Revolution: Tailoring Drugs to Fit Patients' Genetic Profiles,” Jurimetrics: The Journal of Law, Science, and Technology 43 (2002): 4–11, at 1; Malinowski M. J. , “Law, Policy, and Market Implications of Genetic Profiling in Drug Development,” Houston Journal of Health Law & Policy 2 (2003): 31–63, at 31–43.

See generally Noah , supra note 1; Malinowski , “Genetic Profiling,” supra note 1.

See generally Buchanan A. , “An Ethical Framework for Biological Samples Policy,” in National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Volume II, Commissioned Papers (Rockville, Maryland: January 2000), available at <http://www.georgetown.edu/research/nrcbl/nbac/hbmII.pdf> (last visited February 18, 2005).

See generally Proceedings, The Genomics Revolution: Law, Science and Policy (February 4–6, 2003) (transcripts and audio tapes on file with the author).

The United States has distinguished itself globally through federal policy that releases IP funded with taxpayer dollars to academic institutions for commercial application. See generally Malinowski M. J. , “Biotechnology in the USA: Responsive Regulation in the Life Science Industry,” International Journal of Biotechnology 2 (2000): 16–26. This policy is a complement to receptiveness to the patentability of biotechnology, aggressive federal funding of basic research, significant investment in federal-state technology programs, and regulatory responsiveness to biotechnology commercial applications through modernization of the FDA. See generally Malinowski M. J. , Biotechnology: Law, Business and Regulation (Gaithersburg: Aspen 1999).

See generally Juma C. , “Global Governance of Technology: Meeting the Needs of Developing Countries,” International Journal of Technology Management 22 (2001): 629–648, at 646; Sachs J. D. , “Balms for the Poor,” The Economist, August 14, 1999, at 63.

See generally General Accounting Office, “Report to Congressional Committees: Technology Transfer, Administration of the Bayh-Dole Act by Research Universities, GAO/RCED-98-126” (May 1998) [hereinafter “GAO Report”], available at <www.access.gpo.gov> (last visited February 18, 2005); Piercey L. , “Technology Transfer Goes Professional,” Bioventure View, December 1998, at 9–11; Press E. and Washburn J. , “The Kept University,” Atlantic Monthly, (March 2000): At 39–42, 45–48, 50–54. See also Blumenthal D. , “Participation of Life-Science Faculty in Research Relationships with Industry,” N. Eng. J. Med. 335 (1996): 1734–39. Cf. Department of Health and Human Services, National Institutes of Health, NIH Response to the Conference Report Request for a Plan to Ensure Taxpayers' Interests are Protected (July 2001) [hereinafter “NIH Report”], available at <http://www.nih.gov/news/070101wyden.htm> (last visited February 18, 2005).

See generally GAO Report, supra note 7.

This observation is based upon the author's personal experience as an attorney engaged in biotechnology R&D in the MA area during the 1990s, and as an employee of the Massachusetts Biotechnology Council (MBC) responsible for government affairs and communications in 1997–1998. For example, significant controversy arose in 1997–1998 over the terms of technology transfer deals entered into by the University of Massachusetts in the early 1990s.

See Lawler A. , “Last of the Big-Time Spenders?” Science 299 (2003): 330–333, available at <www.sciencemag.org> (last visited February 18, 2005) (reporting with hindsight on the positive university impact of major industry-funded deals entered in the 1990s, including a highly-debated deal between Novartis and the University of California at Berkeley).

See generally GAO Report, supra note 7.

See supra note 7.

See generally Washburn , supra note 7; Blumenthal , supra note 7.

See generally “Symposium, Conflicts of Interest in Clinical Research,” Widener Law Journal 8 (2001): ii-152; Cho M. K. , “Policies on Faculty Conflicts of Interest at US Universities,” JAMA 284 (2000): 2203–08; See Korn D. , “Conflicts of Interest in Biomedical Research,” JAMA 284 (2000): 2234–37.

See generally Eisenberg R. S. , “Patents, Product Exclusivity, and Information Dissemination: How Law Directs Biopharmaceutical Research and Development,” Fordham Law Review 72 (2003): 477–91; Andrews L. B. , “The Gene Patent Dilemma: Balancing Commercial Incentives with Health Needs,” Houston Journal Health Law and Policy 2 (2002): 65–101. Affymetrix, arguably the world's leading bioinformatics company and an aggressive for-profit commercial entity, shares many of these sentiments. See Wells R. , Presentation, “Intellectual Property/Ownership Issues,” The Genomics Revolution? Science, Law and Policy, February 5, 2004 (transcript on file with author). With the state of the art in biotechnology advancing in an explosive manner and the life of patents extending twenty years from the date of filing, applications of the patent criteria and determinations of patentability made even in the late 1990s often appear questionable today. The U.S. Patent and Trademark Office acknowledged as much when it issued new guidelines on utility and novelty in gene patenting in 2001, largely in response to patent applications filed for expressed sequence tags (ESTs). See Utility Examination Guidelines, 66 Fed. Reg. 1092–99, 1097–99 (January 5, 2001); “Written Description” Requirement, 66 Fed. Reg. 1099 (2001). Although the USPTO has discretion to initiate reexamination proceedings to revisit issued patents, it typically relies on others to do so. Malinowski , Biotechnology, supra note 5, at 2–30. Presumably, if the market impediments suggested by Professors R. Eisenberg, L. Andrews and others are realized, the USPTO will have to exercise more self-initiative. Similarly, the U.S. may have to start exercising federal technology transfer “march-in” rights to reclaim interests in patented intellectual property not actually being applied commercially. U.S. Patent Act, 35 U.S.C. § 202(c)(4)(2000). See also 35 U.S.C. § 210(c) (2000).

See generally infra note 123. For example, Myriad Genetics' test for BRCA1 and BRCA2, genetic alleles associated with breast and ovarian cancers, is priced at $3,850, which has resulted in a dispute between Myriad and the Canadian provinces of Alberta and Ontario. See “Gene-Patent Policy Review Urgently Needed,” The Edmonton Journal (2003) (no author identified and page numbers unavailable), available at <http://www.canada.com/health/story/html?id=%7BEDD607C3-E3F4-423E-BADF-9336B11BDDC7%7D> (last visited February 18, 2005).

See generally Blumenthal , supra note 7.

According to the University of California, Berkeley's internal review of its 1998, five-year, $25 million deal with Novartis, the collaboration was “a smashing success….the university's academic soul was never for sale and…the only real drawback was the negative publicity generated by critics of the high-profile collaboration.” Lawler A. , “Berkeley Review Dismisses Critics' Fears,” Science 299 (2003): At 332, available through <www.sciencemag.org> (last visited February 18, 2005).

See generally GAO Report, supra note 7 (citing supportive studies by the Massachusetts Institute of Technology and others); Boston Consulting Group, The Pharmaceutical Industry Into Its Second Century: From Serendipity to Strategy (1999).

See generally GAO Report, supra note 7; NIH Report, supra note 7.

The National Science Foundation, which tracks science trends, has recognized that: (1) the extent to which the U.S. “out-patents” other countries is lessening, (2) publication of American science papers has slipped from sixty-one percent in 1983 to twenty-nine percent in 2003 (publication by Americans peaked in 1992), and (3) the number of Americans winning Nobel Prizes has fallen from a position of clear domination to fifty-one percent in the 2000s. See Broad W. J. , “U.S. Is Losing Its Dominance in the Sciences,” New York Times, May 3, 2004, at A1, A19. The U.S. also faces a serious shortage of scientists attributable to international competition and too few Americans entering technical fields. See Broad W. J. , “National Science Panel Warns of Far Too Few New Scientists,” New York Times, May 5, 2004, at A18 (reporting that the U.S. ranks seventeenth among nations surveyed, behind Taiwan and South Korea, in the share of eighteen-to twenty-four-year-olds who earn degrees in natural science and engineering). Moreover, the U.S.'s restrictive policy on stem cell research (as of May 2004, federal funding was limited to research on nineteen available cell lines and excluded new lines created in South Korea and other countries) has seriously impeded the progress and global participation of federally funded researchers in arguably the most important field of research for human health. See Stolberg S. G. , “Limits on Stem-Cell Research Re-Emerge as a Political Issue,” New York Times, May 6, 2004, at A1, A23.

Admittedly, commercial application is not necessarily synonymous with health care improvements. For example, in spite of exciting clinical data, Iressa, a small cell lung cancer treatment developed by AstraZeneca, was deemed effective in just ten percent of a small clinical trial. See Pollack A. , “An F.D.A. Advisory Panel Rejects 2 Cancer Drugs,” New York Times, May 4, 2004, at C2. But see Pollack A. , “Genetic Link Seen in Cancer Drugs' Power,” New York Times, April 30, 2004. In May 2004, the FDA Advisory Panel rejected two biotech cancer drugs — Genasesne, developed by Genta Inc. and RSR13 developed by Allos Therapuetics. See Pollack , “F.D.A. Advisory Panel,” supra, at C2.

Visit <www.bio.org> (last visited February 18, 2005), the Internet site of the Biotechnology Industry Organization (“BIO”), the world's largest biotechnology trade organization. BIO's site contains numerous links (regional, national, and international) that help to network commercial biotechnology globally, as well as industry reports and data.

See generally GAO Report, supra note 7; NIH Report, supra note 7.

Unfortunately, academic universities have failed miserably in developing policies and enforcement mechanisms to address resulting conflicts of interest. See generally Cho , “Policies,” supra note 15.

See Association of University Technology Managers, at <http://www.autm.net/index_ie.html> (last visited January 6, 2005).

See Licensing Executives Society, “About LES,” at <http://www.usa-canada.les.org/aboutus/> (last visited January 6, 2005).

See generally Part II (“BioBanking in Contemporary Biomedical R&D”), infra.

See supra note 1 and accompanying text. HGP was driven to completion years ahead of schedule through competition between industry and government-led teams that ultimately joined forces to declare a joint victory. See generally Science 291 (February 16, 2001): 1145–1265 (issue entitled “The Human Genome”); Nature 409 (2001): at 745 (issue dedicated to the release of a draft map of the human genome).

The SNPs Consortium is discussed infra at notes 41–42 and in the accompanying text.

Pollack A. , “Three Universities Join Researcher to Develop Drugs,” New York Times, July 31, 2003, at C1, C2. The consortium, PharmaStart (also known as the “West Coast Clinical Trial Initiative”), was inspired by the reluctance of venture capitalists and pharmaceuticals to invest in the clinical development of academic research – especially for rare diseases. Id. at C2. Similarly, in the area of screening of potential drug targets with a focus on rare diseases (e.g., Huntington's and amyotrophic lateral sclerosis), Harvard (Cambridge, MA) has established the Laboratory for Drug Discovery in Neurodegeneration, and the City of Hope National Medical Center (Duarte, CA) has established a factory to make experimental drugs for use in clinical trials. “Beyond academic centers, patient advocacy groups are also taking a much more active role in sponsoring or doing research aimed at finding cures for specific diseases. And nonprofit drug organizations, backed by contributions from philanthropists, have arisen to try to develop drugs for diseases in developing countries, like malaria and tuberculosis, which tend to be neglected by pharmaceutical companies.” Id. at C2.

See Pollack A. , supra note 31, at A13 (“Saying the development of crops that could feed millions of people is being choked off by biotechnology patents held by large corporations, several leading universities are joining to share information on their patented technologies and make them more widely available”) Participants in this free exchange of seeds and technology that could improve crop breeding include Cornell, the University of California, the University of Florida, Michigan State, Rutgers, and the University of Wisconsin, with support from the Rockefeller Foundation and the McKnight Foundation. The methodology includes reservation of some rights for humanitarian uses-applications and pooling patents into packages to reduce transaction costs for crop developers. “Corporations seeking to generate support for biotechnology have become more willing to provide royalty-free licenses to their patents for humanitarian purposes. The major companies agreed to cooperate with the African Agricultural Technology Foundation, formed this year by the Rockefeller Foundation to speed the transfer of biotechnology to Africa.” Id. at A13.

This coalition, led by Dr. H. Varmus, former director of NIH, seeks to create the Public Library of Science (PLoS) to overcome impediments to distribution of knowledge attributable to the cost of research publications. See Editorial, “Open Access to Scientific Research,” New York Times, August 7, 2003, at A24. The PLoS methodology is to establish a new series of peer-reviewed journals that will be available on the Internet free of charge and that increase dissemination of data about research. See Goldberg C. , “Scientists Seek Open Access to Medical Research,” Boston Globe, August 14, 2003, at A1, A17.

The case studies include the disease group PXE and Howard University's biobanking initiative, which are discussed infra at notes 63–66 and in the accompanying text.

The time to develop innovative pharmaceuticals has been estimated to reach fifteen years, and much of the HGP-related commercial biotechnology was undertaken during the 1990s. Tufts Center for the Study of Drug Development, Backgrounder: How New Drugs Move through the Development and Approval Process (November 1, 2001), available at <http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=4> (last visited February 18, 2005). Moreover, heavy pharmaceutical investment in biotechnology took place in the mid and late-1990s. See Boston Consulting Group, supra note 20, at 38–39. Commercial life science therefore is in an awkward R&D transition period that includes clinical disappointments, adverse events, and considerable second-guessing. Notable examples include the FDA's recent call for more studies on the anemia drugs Procrit by Johnson & Johnson and Aransesp by Amgen in response to concerns that these drugs, prescribed often in conjunction with cancer treatment and among the best selling drugs in the world, actually make cancer worse. See Pollack A. , “F.D.A. Wants More Study on 2 Drugs for Anemia,” New York Times, May 5, 2004, at C8. The impact of genetic precision in drug development on access, cost, and overall medicinal practicality also is a basis for question. See generally Malinowski , supra note 1. This issue has been raised recently by the FDA's approval of AstraZeneca's Iressa, a treatment for non-small-cell lung cancer but one that shrank tumors in only 10 percent of patients in a small trial. See supra note 23.

See generally Noah , supra note 1; Malinowski , supra note 1; Yoon P. W. , Presentation, “Risk Prediction for Common Diseases,” The Genomics Revolution? Science, Law and Policy (February 5, 2004) (transcript on file with author); Woodcock J. , Presentation, “Law/Regulatory Issues Affecting the Pace of Advancement of this Field,” The Genomics Revolution? Science, Law and Policy (February 5, 2004) (transcript on file with author). See generally Watson J. D. , DNA: The Secret of Life (2003). Cf. World Health Organization, Genomics and World Health: Report of the Advisory Committee on Health Research (World Health Organization 2002, released April 30, 2002) (fully recognizing the impact of genomics on the practice of medicine in developed economies). Genetic testing is entering the medical setting as an accompaniment to drug delivery. Malinowski , supra note 1; Noah , supra note 1. Examples include the market entry of Herceptin accompanied by a test to screen for over-expression of Her2-neu and genotyping kits for HIV that assist doctors in making best use of available medicines. For discussion of these and additional examples, see Noah , supra note 1, at nn.26–39 and accompanying text.

See generally Proceedings, The Genomics Revolution? Science, Law and Policy (February 4–6, 2004) (transcripts on file with author). Bioinformatics is the integration of biology and information technology to identify gene and protein structure and function, usually with the ultimate objective of discovering drug targets. See Winickoff D. E. , “Governing Population Genomics: Law, Bioethics, and Biopolitics in Three Case Studies,” Jurimetrics: The Journal of Law, Science, and Technology 43 (2003): 187–209, 189. See also Noah supra note 1; Malinowski , supra note 1; Pharmaceutical Research and Manufacturers of America, 2004 Industry Profile (2004), available at <http://www.phrma.org/publications/> (last visited February 18, 2005);Pharmaceutical Research and Manufacturers of America, 2003–04 Annual Report (2003), available at <http://www.phrma.org/publications/publications//2003-11-20.870.pdf> (last visited February 18, 2005); Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2001: A Century of Progress 14 (2001), available at <www.phrma.org> (last visited February 18, 2005); Pharmaceutical Research and Manufacturers of America, The Pharmaceutical Industry Profile (2000). See generally Ernst & Young , Convergence: The Biotechnology Industry Report (2000).

Affymetrix and several other companies now offer commercial chips that contain the entire human genome. Wells R. , Presentation, supra note 16. In fact, bioinformatics is necessitating the creation of new numbers. Beyond terabytes (a trillion bits of genetic data), these measurements include “petabytes (equivalent to half the contents of all academic libraries in America), exabytes, yottabytes and zettabytes. All the words ever uttered by everyone who ever lived would amount to five exabytes.” Gibbs N. , “The Secret of Life,” Time (February 17, 2003): At 42–45.

Buchanan , supra note 3; Noah , supra note 1. The pharmaceutical sector has embraced research and development methodology centered on gene and protein function and put into a motion “[a] shift from decades of dependence on approximately 3,000 relatively crude pharmaceuticals derived from 483 drug targets for the treatment of all human diseases to identification of 10,000 or more drug targets for use in developing potentially tens of thousands of drugs.” Malinowski , supra note 1.

All human variation is attributable to environmental factors and 0.1 percent of DNA, meaning 3,000,000 base pairs. See SNP Consortium, at <http://snp.cshl.org> (last visited February 18, 2005). See also Brooks L. and Guyer M. , National Human Genome Research Institute (HGRI), Resource for Studying Human Genetic Variation (March 1998), available at <www.georgetown.edu/research/nrcbl/nbac/transcripts/mar98/hbmr_spkrs.htm> (last visited February 18, 2005). However, in July 2004, researchers studying genes linked to cancer risk, how much people eat, and reactions to drugs, discovered significant genetic differences among healthy people – i.e., researchers found that some of these people are missing large portions of DNA, while others have extra copies of entire stretches of DNA. Sebat J. , “Large-Scale Copy Number Polymorphism in the Human Genome,” Science 305 (2004): 525–28.

See SNPs Consortium, supra note 41; Brooks, Guyer , Resource, supra note 41. Just as disparate and competing interests came together to create a biocommons in the form of the map of the human genome, a well-financed and diligent consortium orchestrated largely by the SNPs Consortium Ltd is constructing a much more expansive SNPs biocommons see The SNP Consortium Ltd., at <http://snp.cshl.org> (last visited February 18, 2005). See also Malinowski M. J. , “Separating Predictive Genetic Testing from Snake Oil: Regulation, Liabilities, and Lost Opportunities,” Jurimetrics: The Journal of Law, Science, and Technology 41 (2000): 32–43, at 32–33. The SNPs consortium draws together pharmaceutical, biotech, and academic participants – many market competitors in other contexts – with the unified mission of identifying connections between variations of single letters in the genetic code and human health characteristics, such as adverse drug reactions. See SNP Consortium, supra note 41. The entity at the center of the SNP Consortium is Orchid Bio-sciences, Inc., and information about the effort is available at <http://www.orchid.com>. The databases presently are being utilized for drug development, but they ultimately also will be used to personalize health care delivery. “Subscriber services to inform individuals about the latest SNP identifications that could impact their responses to commercially available drugs and drug interactions in an ongoing manner are already under development.” See Malinowski , supra note 1.

See Brooks Guyer , supra note 41. The International HapMap Project involves identifying genetic variations that travel with populations. See Recer P. , “International Project to Map Genome Called a Step Toward Finding Genes that Trigger Diseases,” Toronto Star, November 3, 2002, available at 2002 WL 101966302. The effort is premised on the observations that SNPs are organized into DNA neighborhoods called haplotype blocks comprising about 10,000 or more base pairs, and that many people share the same haplotype blocks and common variations. For more information about the HapMap project, visit the HapMap Data Coordinating Center at <http://hapmap.cshl.org/> (last visited February 18, 2005). Proponents contend that hapmapping will introduce collective medical benefits based upon genetic subtleties. For example, “Some studies show that 40 percent of African-Americans compared to 60 percent of Caucasians responded well to beta blockers, a class of drugs for lowering blood pressure.” Pollack A. , “Big DNA Files to Help Blacks Fight Diseases,” N.Y. Times, May 27, 2003, at A1, A20. However, this methodology is not beyond reproach: “It is not known to what extent such differences in health arise from genetic, environmental or social factors. Some scientists say that race is not a useful concept in medicine, and that genes can vary as much within races as between them. Other experts say that genetic variations tend to cluster in ethnic groups and that it is foolhardy to ignore such differences.” Id. Detractors of the methodology point out that there is ten times more difference between a Caucasian husband and wife than between white and African American populations of the same gender. Id. See generally Kidd K. , “Commentary: Haplotype Mapping – Tensions in Process and Discovery” The Genomics Revolution? Science, Law and Policy (Conference, February 6, 2004).

See Johnston J. , “Resisting a Genetic Identity: The Black Seminoles and Genetics Tests of Ancestry,” Journal of Law, Medicine & Ethics 31 (2003): 262–71 (Seminole Indians case study: Use of genetic testing to ostracize Freedmen from the tribe after centuries of integration in response to land reparation payments).

See Winickoff , supra note 38, at 187, 189.

In sum, ongoing scientific and commercial enthusiasm at the forefront of life science now centers on technical capabilities – microarrays, DNA chips, and other enabling technologies – that exponentially increase the number of human biological samples that can be run and the amount of data that can be generated and processed. The capability to run thousands of genetic comparisons in the matter of minutes has jolted scientific and commercial demand to access and compile large-scale population databases.

Malinowski , supra note 1, at 45.

See Andrews L. and Nelkin D. , Body Bazaar (2001, Crown Publishers): at 26.

See Geron, at <http://www.geron.com/> (last visited January 6, 2005).

As observed by L. Andrews and D. Nelkin,

In recent years, biotechnology techniques have transformed human body tissues into marketable research materials and clinical products…. The catalog from the American Type Culture Collection lists thousands of people's cell lines that are available for sale. Umbilical cord blood is a source of valuable stem cells that are useful for bone marrow transplantation. Blood has become one of the most valuable commodities on earth. While refined petroleum sells for $40 a barrel, an equivalent quantity of blood products is worth $67,000.

See Andrews and Nelkin , supra note 46, at 24–41.

Korn D. , “Contribution of the Human Tissue Archive to the Advancement of Medical Knowledge and the Public Health,” in National Bioethics Advisory Commission, (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Vol. II Commissioned Papers (Rockville, Maryland January 2000): E-4, available at <http://www.georgetown.edu/research/nrcbl/nbac/hbmII.pdf> (last visited February 18, 2005).

See generally infra notes 117, 127–130 and accompanying text.

See Appendix. See also Press Release, Department of Health and Human Services, Secretary Shalala Bolsters Protections for Human Research Subjects (May 23, 2000), available at <http://www.hhs.gov/news/press/2000pres/20000523> (last visited February 18, 2005); Shalala D. , “Protecting Human Subjects – What Must Be Done,” N. Engl. J. Med. 343 (2000): 808, at 809.

Masi J. A. Hansen R. W. , and Grabowski H. G. , “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics 22 (2003): 151–185, available through <http://csdd.tufts.edu/InfoServices/PublicationsResults.asp> (last visited February 18, 2005).

Examples of these commercial suppliers include The First Genetic Trust, see First Genetic Trust, at <www.firstgenetic.net> (last visited February 18, 2005), and Genomics Collaborative, Inc., see Genomics Collaborative, at <www.dnarepository.com> (last visited January 6, 2005). See Krasner J. , “Gene Pooling: Company Builds World's Largest Library of Genetic Material,” Boston Globe, August 22, 2001, at F1, F4. As addressed in Part II, many of the hundreds of millions of samples held in preexisting repositories were collected during the course of routine diagnostic and other medical procedures under a theory of medical waste and donor abandonment, and without meaningful consent. See National Bioethics Advisory Commission, Recommendations: Ethical and Policy Issues in Research Involving Human Participants (May 18, 2001).

See generally Greely H. T. , “Iceland's Plan for Genomics Research: Facts and Implications,” Jurimetrics: The Journal of Law, Science, and Technology 40 (2000): 153–91. Iceland is making the DNA and medical records of its citizenry commercially available through deCODE Genetics, Inc., a private company founded in 1996. For information about this company and its endeavor, visit <www.deCode.com> (last visited February 18, 2005).

Knoppers B. M. , Presentation, Of Populations, DNA Bankings, and Ethics (LSU Law Center Apr. 12, 2003) (slides on file with the author).

Eesti Geenikeskus: Estonian Genome Foundation, at <www.genomics.ee/index.php?lang=engvisit> (last visited January 6, 2005). See King S. , “Genome Project in Estonia Shows Rapid Progress,” WMRC Daily Analysis, December 20, 2002, (available through Westlaw at 2002 WL 104096346) (reporting that the project is expected to encompass 70% of the Estonian population, take five years to complete, and be used to develop a number of targeted treatments, including anti-depressant drugs).

The U.K. project's backers have pledged $65.6 million (45 million British Pounds) to build a biobank with samples from 500,000 Britons, thereby establishing the world's largest genetic database. See “Genetic Database Receives Funding,” Wall Street Journal, April 30, 2002, at 2002 WL-WSJ 3393326 (no author identified) (samples to be gathered from volunteers age 45 to 69 and held in public ownership); “UK Genetic Database to Rival Iceland's Set Up,” Marketletter, May 6, 2002 (available through Westlaw at 2002 WL 7179539) (no author identified).

See infra Appendix.

See Furrow B. R. , Health Care Law (West 2001, Supp. 2003) (“Bioethics”): 22–23.

Academics and academic institutions are showing renewed interest in biobanking after a false start in the early 1990s with the Human Genome Diversity Project (HGDP). See Reardon J. , “The Human Genome Diversity Project: A Case Study in Coproduction,” Journal of Social Studies and Science 31 (2001): 357–358; Lock M. , “Genetic Diversity and the Politics of Difference,” Chicago-Kent Law Review 75 (1999): 83–111, at 92; Cavalli-Sforza L. L. , “Call for a Worldwide Survey of Human Genetic Diversity: A Vanishing Opportunity for the Human Genome Project,” Genomics 11 (1991): 490–492, at 491.

Hospitals are uniquely situated to engage in biobanking because of their access to and trust from patients. See Winickoff , supra note 38, at 214; Krasner J. , “Partners Healthcare Planning Tissue Bank: Hospital Group Cites Research Potential,” Boston Globe, September 4, 2001, at D1; Pollack , “Big DNA Files,” supra note 43, at A1, A20 (“Hospitals are a natural place to gather such samples and medical information; several are starting such DNA or tissue banks”) In fact, research trends and market forces are driving them to do so: “In the United States, where health institutions have come upon difficult financial times, hospitals are beginning to explore ways to generate revenue by tapping into the financial promise of the biotechnology industry. In particular, hospitals have begun to realize that they are uniquely poised to be the suppliers of tissue and medical information for the new industry.” Winickoff , supra note 38, at 207; Pollack , “Big DNA Files,” supra note 43, at A1, A20 (reporting on biobanking initiative launched by the Long Island Jewish Hospital).

The political success of AIDs, breast cancer and other disease group activists during the late 1980s and 1990s, increased investment in biomedical R&D, and global communication have inspired extensive disease group organization. See Winickoff , supra note 38, at 222–23. Some of these groups now are creating tissue banks to advance research and control research design, implementation, and allocation of benefits. See id. Such initiatives may prove essential for very small disease groups where commercial incentives are marginalized.

Id. at A20.

Pollack , “Big DNA Files,” supra note 43, at 20.

See id. See also Cancer Web, On-line Medical Dictionary, “PXE” at <http://cancerweb.ncl.ac.uk/cgi-bin/omd?PXE> (last visited January 6, 2004). For discussion of PXE International and its approach to technology transfer, see Winickoff , supra note 38, at 207. See also 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, 315–24.

Pollack , “Big DNA Files,” supra note 43, at 20.

BI serves more than 500,000 patients annually and is the third largest recipient of National Institutes of Health biomedical research funding. Winickoff , supra note 38, at 207. For information about BI, visit <http://www.bidmc.harvard.edu/general_info.asp> (last visited February 18, 2005).

BI announced its biobanking effort with Ardais in September 2000, and the collaboration was expanded subsequently to include Duke University Medical Center, Maine Medical Center, and the University of Chicago. See Donors & Institutions, at the internet site of Ardais Corporation, at <http://www.ardais.com/donor_overview.asp> (last visited January 14, 2005). Ardais is a private company based in Lexington, MA. See id. Ardais' growing collection exceeds 160,000 samples and is attracting significant users, such as Xantos Biomedicine AG of Munich, which is using Ardais' bank to validate drug targets in inflammatory and degenerative diseases. “German Firm to Use Ardais's Tissue Bank,” Boston Globe, May 14, 2003, at C4. Ardais is representative of an emerging biobanking commercial sector. This sector includes The First Genetic Trust (“First Genetic”), located in Chicago, Illinois, and Genomics Collaborative, Inc. in the Boston area. Like Ardais, First Genetic collects and organizes genetic information while concealing patients' identities, and one of First Genetic's ongoing projects is to create GRAD Biobank to research African diaspora. See First Genetic Trust, at <www.firstgenetic.net> (last visited January 6, 2005); Pollack , “Big DNA Files,” supra note 43, at 20. Similarly, Genomics Collaborative, Inc. is building a global repository of tissue and white blood cell samples. See Krasner J. , “Gene Pooling: Company Builds World's Largest Library of Genetic Material,” Boston Globe, August 22, 2001, at F1, F4. The company creates serum by removing all cells from blood samples, which it freezes at minus 80 degrees Celsius, and stores tissue and white blood cell samples at minus 160 Celsius in liquid nitrogen. See id.

Winickoff , supra note 38, at 207–08 (internal citations omitted).

See DeCode Genetics, at <http://www.decode.com> (last visited February 18, 2005).

See First Genetic Trust, supra note 68. First Genetic Trust has developed the enTRUST Genetic Banking System, which consists of “two powerful web-based applications for investigators and institutions involved in genomic research: enTRUST® Study Management and enTRUST Genetic Bank.” First Genetic Trust also has developed algorithms for biobanking and bioinformatics with the objective of offering users research support “while addressing human subject protection, data privacy, and ethical issues associated with this research.” Id.

See Ardais, at <http://www.ardais.com> (last visited February 18, 2005). Ardais portrays itself as “a leading clinical genomics company that is dedicated to enhancing and accelerating biomedical research by applying actual human disease as the discovery model in pharmaceutical research.” Id.

See DeCode Genetics, supra note 70.

The company's major engagements include: a collaboration with Affymetrix to develop DNA-based tests to predict responsiveness to treatments for common diseases; a strategic alliance with Emory University School of Medicine in clinical as well as laboratory research; an alliance with Merck to develop treatments for obesity; an alliance with Pharmacia to identify genetic influences on advanced heart disease; an alliance with Roche to develop treatments for common diseases; an alliance with Roche Diagnostics to develop integrated diagnostic tools, services and software; a collaboration with Vertex to gather and analyze pharmacogenomic data in conjunction with clinical trials carried out by Encode – a deCode subsidiary; and a collaboration with Wyeth centered on a candidate drug for the treatment of respiratory disease. See DeCode Genetics, supra note 70.

See “deCODE and IBM to Form Strategic Alliance,” January 23, 2003 (available through Westlaw at 2003 WL 4565891). According to deCode, CGM Discovery TM is a “unique data management and bioinformatics tool, which allows researchers to integrate their own genotypic, phenotypic and pedigree data and to mine this information for knowledge on human disease.” See DeCode Genetics, supra note 70.

Malinowski , “Genetic Profiling,” supra note 1.

See, e.g., Andrews and Nelkin , supra note 46.

Andrews and Nelkin , supra note 46.

See, e.g., Korn , supra note 49, at E-4.

See id.

The ethical, social, and legal implications of the collection and use of human biological materials was addressed somewhat thoroughly by the NBAC, which resulted in a comprehensive written compilation of commissioned papers and its own Report and Recommendations, which in turn generated extensive debate and publication. See NBAC, Recommendations, supra note 3.

These issues are summarized in the Appendix to this article. A more direct and detailed treatment of these issues is contained in other articles in this symposium. See also Greely H. L. , Presentation, “Population Participation and Other Factors that Impact the Compilation and the Utility of Resulting Databases,” The Genomics Revolution? Science, Law and Policy (Conference, February 5, 2004) (transcript on file with author).

See generally Watson , supra note 37; Yoon , Presentation, supra note 37; Woodcock , Presentation, supra note 37; Noah , “Pharmacogenomics,” supra note 1; Malinowski , “Genetic Profiling,” supra note 1. See also WHO, Genomics and World Health, supra note 37.

See generally Watson , supra note 37; Robbins-Roth C. , From Alchemy to IPO: The Business of Biotechnology (Cambridge, MA: Perseus Publishing, 2000): 73–78, 225 tbl. B.1; Yoon , Presentation, supra note 37; Woodcock , Presentation, supra note 37; Noah , supra note 1; Malinowski , supra note 1.

This assessment is based upon an inventory of samples and calculated rate of ongoing sample collection by authors commissioned by the National Bioethics Advisory Commission who relied heavily on 1996 data. See Buchanan A. , “Ethical Framework,” supra note 3; Korn D. , supra note 49; Eiseman E. , “Stored Tissue Samples: An Inventory of Sources in the United States,” in National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Vol. II Commissioned Papers (Rockville, Maryland January 2000), available at <http://www.georgetown.edu/research/nrcbl/nbac/hbmII.pdf> (last visited February 18, 2005). Based on 1996 data: “A conservative estimate is that there is a total of more than 282 million specimens form more than 176.5 million cases of stored tissue in the United States, with cases accumulating at a rate of more than 20 million per year.” Eiseman , supra, at D-38 and D-39 & Tables 8 (“Sources of Stored Tissue Samples in the United States) & 9 (“Summary of Stored Tissue Samples in the United States”).

See supra notes 63–66 and accompanying text.

But see generally Gitter , “Ownership,” supra note 65 (discussing instances where research participants have not negotiated and established written contractual property rights in advance of participating and later claimed interests).

Cf. Juma , “Global Governance of Technology,” supra note 6; Sachs , “Balms,” supra note 6.

See supra note 54 and accompanying text.

NOVA, Cracking the Code of Life (2001, WGBH video). This is a commonsensical expectation given that the Icelandic population is relatively homogenous and their shared genetic identity and medical history are the research subject matter, but only time will tell.

A meaningful quid pro quo for participation has been realized by PXE and has been proposed in virtually all proposed guidances. See supra notes 65–66 and accompanying text (PXE case study).

See supra note 60 and accompanying text.

For example, hospitals could make access to database and DNA chip technologies for their researchers a quid pro quo for access to their biobanks, along the lines of PXE's successful negotiations. See supra notes 65–66.

See Appendix.

See generally Malinowski M. J. , “Choosing the Genetic Makeup of Our Children: Our Eugenics Past – Present, and Future?” Connecticut Law Review 36 (2003): 125–224; Michalczyk J. J. , “Nazi Medicine: In the Shadow of the Reich” (First Run Features 1997) (video documentary on the origins of the eugenics movement and Nazi medicine); Annas G. J. and Grodin M. A. eds., The Nazi Doctors and The Nuremberg Code (New York: Oxford University Press, 1992).

Malinowski , Choosing Genes, supra note 96.

See supra note 65–66 (PXE case study).

See supra note 63 (Howard University case study).

See supra note 67 (BI case study).

NIH Report, supra note 7 and accompanying text and infra at Appendix; GAO Report, supra note 7; WHO, Genomics and World Health, supra note 37; Boston Consulting Group, “Pharmaceuticals,” supra note 20.

Arguably, the United States has been applying its patent criteria too loosely in the midst of an explosion in the state of the art in genetics and, therefore, has been over patenting – i.e., what appeared to constitute innovation in genetics five years ago often is readily recognized by many in the science communities as insignificant, which is a serious problem given the duration of patent life is twenty years from the date of issuance. Agreement on Trade Related Aspects of Intellectual Property Rights, April 15, 1994; Agreement on Trade Related Aspects of Intellectual Property Rights, April 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments – Results of the Uruguay Round, vol. 31, 33 I.L.M. 81, 84 (1994) (expressing a desire to reduce obstacles to international trade through protection of intellectual property rights). This author has previously recognized that, in light of this problem, reexamination perhaps should be expanded and implemented more broadly in the context of genetics-based patents. See Malinowski , supra note 1, at n.167. The USPTO has essentially admitted as much with the 2001 release of heightened standards for utility and written disclosure in the context of genetic innovations. In January 2001, the agency announced new “Utility Examination Guidelines” and “Written Description Guidelines” intended to make it more difficult to patent genes. See Utility Examination Guidelines, 66 Fed. Reg. 1092–1099, 1097–99 (January 5, 2001) (setting forth specific standards); Guidelines for Examination of Patent Applications Under the 35 U.S.C. § 112, P1, “Written Description” Requirement, 66 Fed. Reg. 1099 (2001). These guidelines clarify that a claimed invention must have a specific and substantial utility that is credible or a readily apparent, well-established utility. See 66 Fed. Reg. at 1092–99.

See generally, Symposium, “Conflicts of Interest,” supra note 15.

See id. See also Malinowski , “Genetic Profiling,” supra note 1, at 47–49.

See generally Symposium, “Genes and Disability: Defining Health and the Goals of Medicine,” Florida State University Law Review 30 (2003); Symposium, “Genetic Enhancement in the Twenty-First Century,” Wake Forest Law Review 34 (1999). See also Andrews and Nelkin , supra note 46; Fukuyama F. , Our Posthuman Future: Consequences of the Biotechnology Revolution (N. Y.: Farrar, Straus & Giroux, 2002): At 72–83; Kass L. , Life, Liberty and the Defense of Dignity: The Challenge for Bioethics (San Francisco: Encounter Books, 2003): At 130; Stock G. , Redesigning Humans: Our Inevitable Genetic Future (Boston: Houghton Mifflin Company, 2002); Frontline , Making Babies (1999, PBS Home Video); Nova , 18 Ways to Make a Baby (2001, WGBH); The Learning Channel (TLC), How to Build a Human: Predictor (2002, BBC video).

See generally, Symposium, “Conflicts of Interest,” supra note 15. See also Malinowski , Choosing Genes, supra note 96, at 168–169; Malinowski , supra note 1, at 47–49.

As observed by another author,

First, innovations in informed consent have limited the capacity of individuals to make meaningful choices about control of their bioinformation. Second, problems of representation, accountability, and conflicts of interest have undermined the political legitimacy of ethical review boards. Third, the prospect of commercial benefits and the commodification of bioinformation have complicated traditional bioethics risk-benefit analysis by introducing resource allocation decisions that are politically charged. Problems in the genomics areas have also highlighted more general problems with existing systems of research oversight, most significantly the inadequacy of governance structures in terms of representation, participation, and accountability. In the face of novelty, principles of autonomy, justice, and beneficence are being reconstructed in narrow ways by institutions with particular commercial and research interests.

Winickoff , supra note 38, at 228.

See supra notes 63–66 and accompanying text. Contractual property rights established through technology transfer are, of course, only as sound and valuable as the agreements entered into. Case studies such as PXE on foundations of meaningful technology transfer negotiation and agreements are juxtaposed against case studies to the contrary where people were subjected to research and later claimed rights. See, e.g., Moore v. Regents of the University of California, 793 P.2d 479, 497 (Cal. 1990); Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003; Gitter , “Ownership,” supra note 65, at 325–338 (discussing the Greenberg case).

See generally Part II.

See supra note 43 and accompanying text.

These guidelines were developed under the auspices of the United Nations Development Programme/World Bank/WHO Special Program for Research and Training in Tropical Diseases, available at <http://www.who.int/tdr/publications/publications/ethics.htm> (last visited January 6, 2005).

The Guidelines are available at <http://ich.org> (last visited January 14, 2004). These guidelines were issued with the goal of facilitating mutual acceptance of clinical data by regulatory authorities in participating jurisdictions (U.S., E.U., and Japan).

1993 Council for International Organizations of Medical Science.

See, e.g., Kidd K. K. , supra note 43.

See generally Clayton E. W. , Presentation, “Implications for Existing Law/Regulations,” The Genomics Revolution? Law, Science, and Policy, (Conference, February 2, 2004) (transcript on file with author); Ossorio P. N. , Presentation, “The Concept of Race in Social, Cultural and Political History, and the Potential Impact of Haplotype Mapping on the Future,” The Genomics Revolution? Law, Science, and Policy, (Conference, February 2, 2004) (transcript on file with author).

See generally Clayton , supra note 115; Ossorio , supra note 115.

As stated by Clayton Dr. , unless DNA is deemed not personal, protected information under HIPAA, “genetics research is going to come to a screeching halt….” Clayton, Presentation, supra note 115.

Malinowski , Choosing Genes, supra note 96, at 160–72.

This position is supported by Dr. G. Koski, former Director of the Office for Human Research Protections (OHPR) in HHS, who called for the introduction of universal standards for IRBs. See DHHS, Office for Human Research Protections, at <http://ohrp.osophs.dhhs.gov/> (last visited January 6, 2004). IRBs will be expected to shoulder many novel questions associated with biobanking. See Rothstein M. A. , “The Role of IRBs in Research Involving Commercial Biobanks,” Journal of Medicine & Ethics 30 (2002): 105–112.

See generally “Government Cooperative Technology Programs and Tax Incentives,” in Malinowski , Biotechnology, supra note 5, at 7–1 to 7–171.

See generally WHO, “Report,” supra note 137.

Buchanan , supra note 3, at B-9 to B-10. These concerns have been raised frequently by R. Eisenberg, L. Andrews, D. Nelkin, and others. See supra notes 16, 46, and accompanying text.

As explained by this author, Myriad Genetics' test for BRCA1 and BRCA2, genetic alleles associated with breast and ovarian cancers, is priced at $3,850, which has resulted in a dispute between Myriad and the Canadian provinces of Alberta and Ontario. See supra note 17. The European Union Patent Office preempted such a dispute by revoking the patent issued to Myriad Genetics, stating that the work was not inventive enough to qualify for patent protection. See Pollack A. , “Patent on Test for Cancer is Revoked by Europe,” New York Times, May 19, 2004, at C3. While there is ample recognition that intellectual property rights are a prerequisite for research and development (“R&D”) to make genetic tests, some commentators are asserting that intellectual property rights in genotype-phenotype linkages are impeding access to resulting genetic tests for medical use-an argument substantiated by the Myriad dispute. See Cho M. , “Special Article: Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services,” Journal of Molecular Diagnostics 5, no. 1 (February 2003): 3–8 (“We conclude that patents and licenses have had a significant effect on the ability of clinical laboratories to develop and provide genetic tests.”); Minwalla S. , “A Modest Proposal to Amend the Patent Code 35 U.S.C. § 287(c) to Allow Health Care Providers to Examine their Patients' DNA,” Illinois University Law Journal 26 (2002): 471–504 (proposing to expand the provision in the Patent Act that protects physicians from infringement actions for performing medical procedures to include genetic tests). See Robertson J. A. , “Debate, Extending Preimplantation Genetic Diagnosis: The Ethical Debate, Ethical Issues in New Uses of Preimplantation Genetic Diagnosis,” Human Reproduction 18, no. 3 (2003): 465–71, 467 (discussing Myriad Corp's patent on the BRCA1 and 2 genes). However, in the context of genetic testing, an argument can be made that problems of access are temporal – a reflection of the fact that we presently are in an “awkward period in which a relatively limited number of commercially available genetic tests is giving way to a deluge of genetic screening capabilities based upon the extensive compilations….” Malinowski , Choosing Genes, supra note 96, at n.5. Affymetrix, a pioneer in bioinformatics and leader in the field, has broken rank with much of the commercial sector and raised concerns that patenting in gene-based invention is raising transaction costs that impede invention. See Wells , supra note 16. These concerns also have been articulated by members of the biomedical research community and others. For example, as stated by L. Andrews and D. Nelkin:

To accommodate the social values affecting the use of body tissue, the U.S. Patent and Trademark Office should revise its position on patenting human genes. Patents should be allowable for products based on genes, such as diagnostic test kits for a particular disease or a specific gene therapy procedure that has proven effective. But the current approach of patenting human genes (and tying up all subsequent uses) not only turns traditional patent law on its head, it may also impede the development of truly useful diagnostics and therapeutics.

Andrews and Nelkin , supra note 46, at 178.

Nevertheless, the practical effect ofMoore v. The Regents of the University of California et al., 793 P.2d 479 (Cal. 1990), widely recognized as standing law on the subject, absent an agreement to the contrary, is that “To agree to participate in research through the use of one's tissue samples is effectively to abandon any property right in such materials; signing a consent form allowing researchers to study one's samples creates a de facto gift of all property rights in the samples as well.” Winickoff , supra note 38, at 210. The practical situation for an individual patient is to refuse to consent, or consent and have no control over subsequent use. Id. at 211.

See, e.g., deCode, discussed supra note 73–75 and in accompanying text.

Winickoff , supra note 38, at 196 (concerns influential in the HGDP debate).

Pollack , “Universities,” supra note 32, at A13.

See Buchanan , supra note 3, at B-4; Rothstein , supra note 119, at 107 (“The most important factor affecting the confidentiality of information obtained as a result of biobank research is whether research results are placed back in the clinical record of the individual”)

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), H.R. 3103, Pub. L. No. 104-191.

See supra note 29 (PhRMA estimates that during the 1990s the time required to develop a new drug stretched to 15 or more years). See supra note 36.

Malinowski , supra note at 46.

See Rothstein , supra note 119, at 106 (internal citations omitted).

Buchanan , supra note 3, at 20.

Informed consent is the means to protect individuals from nonconsensual invasions of their bodies and thereby avoid dignatory harms: “Because the right of informed consent, which includes the right to refuse treatment, allows the individual to decide whether the risk of these harms is worth taking, it can also protect individuals from other tangible harms that may result from the bodily invasion, if the individual refuses to give consent.” Buchanan , supra note 3, at B-10. According to Prof. Buchanan, when an individual gives a blanket consent to future uses of her tissue, her choice is not likely to reflect a reasonable estimate of what is good for her on balance because the information she has about possible future risks is too indeterminate. Prof. Buchanan has concluded, therefore, that “blanket consent requirements will not provide protection against most of the more tangible and serious harms that might occur from the uses of stored biological.” Id. at B-18.

Tuskegee, a study spanning decades in which a group of African-American males was deprived treatment for syphilis, is perhaps the most cited and infamous example of discrimination against African Americans in the context of biomedical research. Price-waterhousecoopers LLP, Institutional Review Board (IRB) Reference Book, Russell-Einhorn M. K. and Publisihed T. eds., (2001): 11–12.

Countries with developing economies already have contributed much to contemporary medical care: “Hundreds of important and efficacious drugs have already been developed from plants found in developing countries. In fact, four-fifths of all drugs have their basis in nature plant resources.” Heald P. J. , “Traditional Knowledge, Intellectual Property, and Indigenous Culture,” Cardozo Journal of International and Comparative Law 11 (2003): 519–546, at 531, citing Brush and Stabinsky , Valuing Local Knowledge (1996). Others have estimated that “two-thirds of the drugs sold in pharmacies are of natural origin. They account for some $30 billion in sales every year.” Gulerin C. , “Out of the Forest and Into the Bottle,” Unesco Courier, May 1, 2000, at 30. Unfortunately, many of these contributions have not been made voluntarily and with full informed consent, thereby giving rise to the concept of “biopiracy.” Winickoff , supra note 38, at 200–01. Well-reported case studies include a patent application submitted by the U.S. Department of Commerce in the early 1990s whereby the DOC sought to establish intellectual property rights in the cell line of a women who was a citizen of Guaymi, an indigenous group in Panama. Lock , “Genetic Diversity,” supra note 60, at 99–100. “The woman who was illiterate and unschooled, was said to have given ‘informed oral consent’ to the research, even though neither the tribe nor the woman knew anything about the development of the cell line or the patent application. RAFI and the Guaymi demanded the withdrawal of the application, and the Department of Commerce acquiesced.” Winickoff , supra note 38, at 200 (internal citations omitted). Another well-reported case study involves an attempt by NIH biomedical researchers to patent the T-lymphotrophic virus, which is found in the blood of the Hagahai people in Papua New Guinea. Ching K. H. , Note, “Indigenous Self-Determination in an Age of Genetic Patenting: Recognizing an Emerging Human Rights Norm,” Fordham Law Review 66 (1997): 687–730, 702. The researchers believed that they could develop related research into a diagnostic tool or vaccine for defined types of leukemia. Id. They allegedly negotiated a profit-sharing agreement with the Hagahaia – a tribe that had no contact with outsiders until 1984, when tribal members sought help for illness that afflicted the group. Id. RAFI deemed the arrangement human bioprospecting, and NIH relinquished rights to the patent.

See, e.g., Editorial, “Bayer's Bad Medicine,” Boston Globe, June 2, 2003, Al2 (reporting that Cutter Biological, a division of Bayer, after switching to heated version for customers in North America, continued to sell unheated med. in Asia and Latin America knowing it might be spreading the virus).

See Cavalli-Sforza L. L. , Genes, Peoples and Language (New York: North Point Press, 2000). See supra note 60.

See generally Sachs , supra note 6; Cavalli-Sforza , supra note 137.

See generally Malinowski , supra note 1; Annas and Grodin , eds., supra note 96; Buchanan , supra note 3, at B-7. For example, African Americans typically suffer certain harms because they are identified as African Americans: others often perceive African American individuals through the distorted lens of negative racial stereotypes. The harm of negative racial stereotyping is a harm to individuals, but it befalls individuals because of their ascriptive group identity. The term ascriptive here indicates that the identity in question is assigned by others, independently of the choice of the individual thus identified. Individuals who are vulnerable to ascriptive identify harms have a special interest in avoiding situations in which information obtainable from their biological samples may contribute to the reinforcement of harmful group stereotypes, not only because they themselves may be harmed but also because they may wish to avoid harm to other members of their ascriptive group. As pointed out by Tom Caskey, genetic information gleaned from biological samples might be used in research on the role of genotype in criminal behavior or in intelligence. In the past, such research has sometimes both embodied and been taken to validate negative racial stereotypes. See generally Caskey Thomas C. , Presentation, “Haplotype Mapping: Where will Haplotype Mapping Take Us?” The Genomics Revolution? Science, Law and Policy (Conference, February 6, 2004) (transcript of file with author).

See generally Sachs , supra note 6.

See supra note 60.

See generally Winickoff , “Case Studies,” supra note 38, at 190.

As observed by one who has surveyed biobanking case studies: The impact of these studies on the populations tested, and the reaction of other groups to the results, has varied. For some groups, the tests merely confirm what they already believed to be true. For others, it shakes the foundation of their collective narrative. In some cases, the results have caused a third party to regard the study population in a different way.

Johnston , supra note 44, at 268. Also, one must presume that testing for genetic commonalities associated with race will be put to use where there is an opportunity for commercial or other gain. In fact, such testing already is commercially available – e.g., Genealogy by Genetics, Ltd. (Texas) is in the business of providing “genealogical information.” See Family Tree DNA, at <http://www.familytreedna.com> (last visited January 6, 2004). See also Johnston at 267. The company engages in Y-chromosome testing on men to trace their paternal lineage and analysis of mitochondrial DNA, which is inherited only from one's mother (distinguishable from DNA forming the nucleus of each cell, which is inherited from both parents). See Family Tree DNA, supra. For $299, company performs genetic testing for Native American ancestry. See id. The company relies upon five distinct maternal lineages and 2 Y-chromosome markers for Native American lineage testing and, according to the company, 95% of Native American males have one or both of these markers. See id..

Johnston , supra note 44, at 268 and n.61 (providing many citations that reference studies). Cavalli-Sforza , supra note 137, at 209–14. For example, studies have been undertaken to locate the ancestral home of African-Americans, trace the ancestry of Melungeons (American southeast population) and Mohegans (tribe on the upper Hudson River in Connecticut), and to confirm a legend that the Maori arrived in New Zealand in one planned migration. Johnston , supra note 44, at 262, 268; Kahn C. , “Appalachian ‘Melungeons’ Use DNA as Evidence of Exotic Heritage,” Associated Press, July 9, 2001. Some of these studies are generating fundamental understanding about who we are as a species – e.g., that language evolved only in the last 100,000 years or so, making it a very recent development on the evolutionary time scale. Wade N. , “Language Gene Is Traced to Emergence of Humans,” New York Times, Aug. 15, 2002, at A18.

See supra notes 60, 93, and accompanying text.

Agreement on Trade Related Aspects of Intellectual Property Rights, April 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments – Results of the Uruguay Round, vol. 31, 33 I.L.M. 81 (1994), reprinted in Malinowski M. J. , Biotechnology: Law, Business, & Regulation app. (1999 & supps. 2001, 2002).

See generally Watson , supra note 37; Fukuyama , supra note 105; Stock , supra note 105.

See generally WHO, “Genomics,” supra note 37; Malinowski , supra note 1.

See generally Tufts , supra note 52; Rowland C. , “Clinical Trials Seen Shifting Overseas,” Boston Globe, July 11, 2003, C1, C4.

See generally Tufts , supra note 52; Rowland , “Overseas,” supra note 150, at C4. According to the study released July 10, 2003 by the Tufts Center for the Study of Drug Development, there are about 1,000 CROs worldwide with combined revenues of $6–7 billion. Some of these CROs practice regional specialization, such as Evidence Clinical and Pharmaceutical Research (Los Altos, CA), which has offices in Moscow, Siberia and Tbilisi, Georgia. Evidence Clinical and Pharmaceutical Research, at <http://www.evidence-cpr.com/ieo/index.html> (last visited February 18, 2005).

See generally Tufts , supra note 52.

Rowland , “Overseas,” supra note 149, at C4.

CenterWatch Clinical Trials Listing Service, at <http://www.centerwatch.com/> (last visited February 18, 2005); Rowland , “Overseas,” supra note 149, at C4.

A noted example is the gene study undertaken by Harvard researchers in China, in conjunction with Brigham and Women's Hospital and the Massachusetts Mental Health Research Corp., which resulted in a reprimand from the administration of two premier researchers and a three-year federal investigation by the Office of Human Research Protections (OHRP). Harvard Researchers to Restart Gene Studies, N.Y. Times, June 4, 2003, A8 (no author identified). Another is a pediatric study on meningitis carried out in Nigeria by Pfizer:

In 1996, researchers tested an experimental antibiotic developed by Pfizer Inc. on Nigerian children suffering from meningitis. Eleven children died, and others suffered permanent injuries. While Pfizer has denied its drug caused any of the problems, lawyers for the victims and their families have accused the company in a lawsuit of failing to follow proper ethical safeguards. In 2001, a report by the inspector general for the Department of Health and Human Services said the FDA was unable to ensure that clinical study review boards operated by foreign governments were performing their jobs correctly. Id..