CORPORATE GENOMICS: DECODE'S EFFORTS AT DISEASE MAPPING IN ICELAND FOR THE ADVANCEMENT OF SCIENCE AND PROFITS

Ashok M. Pinto*

Biotechnology has been a potent element of the early twenty-first century economy. Advances in scientific techniques combined with the landmark discoveries of the Human Genome Project have allowed scientists to push forward into areas of disease discovery that were previously uncharted. The burgeoning field of bioinformatics has endeavored to interpret the vast quantities of data that such research yields. Many companies have made huge fortunes as a result of these scientific breakthroughs. This biotechnology gold rush has brought with it myriad moral, ethical, and legal challenges. This Note begins by introducing the basic science that underpins biotechnology. Next, it examines the case of deCODE Genetics, an Iceland-basedbiotechnology firm seeking to use the unique gene pool of Icelanders to better understand disease and identify potential drug therapies. The company met with strong resistance because of its policies regarding consent and its overall goal to commercialize and ultimately profit from Icelanders'genomes. By identifying the relevant legislation, regulations, and licensing agreements, the author seeks to place the social, moral, and ethical issues into context. Analyzing deCODE's business strategy, which is innately linked to its scientific strategy, is also essential in order to understand the complex issues that surroundthe company's research. In addition, opinions regarding deCODE's research have ranged from ringing endorsements to vehement opposition. Other similar genetic research projects, in remote places such as Tonga, Norfolk Island, and Tristan da Cunha, offer important comparisons to the deCODE model. Recent developments in the deCODE story highlight the fast pace of genetic discovery and the high expectations of scientists, government officials, investors, and the public at large. Ultimately, the author argues that conformation to global standards for data

* J.D., University of Illinois College of Law, 2003; A.B., Stanford University, 1996. The author wishes to acknowledge Professors Dan Nicolae and Hank Greely for sharing their insights, and Scott Clair and Professor John Gueguen, who kindly agreed to review drafts of this Note and offer their comments. Of course, any errors or omissions are my own. Special thanks to Eustace, Jacqueline, Jayant, and Susanna for their love and constant support. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002

processing, privacy, and benefit sharing are critical to the validity of deCODE's efforts to mine Iceland's vast genetic wealth. deCODE possesses a unique opportunity to set a high standard for genetic research that is scientifically and ethically valid, important to the world in curing disease, and valuable to its investors.

I. INTRODUCTION

In the evolving field of genomics research, companies and researchers diligently pursue breakthroughs in the analysis of genetic data in the hope of finding cures for diseases.' Cutting-edge science and technology combined with the possibility of fantastic wealth have created a competitive landscape in this arena. Indeed, companies invest millions of dollars in promising efforts with the intention of securing a multi-fold return on their seed money. This cash infusion is reflected by the surge in the number of patents issued for medical devices and pharmaceuticals in recent years.2 Indeed, securing rights for innovation in biotechnology has become increasingly intricate.3 The intersection of computer science and biology has spawned the field of bioinformatics, the only way to interpret effectively the enormous volume of data that genetic research yields.4 The bioinformatics market is estimated to be worth $38 billion by 2006.' Along the way, these companies have encountered complex legal, moral, and societal issues. A key participant in this quest for profitable genetic discovery is deCODE Genetics ("deCODE"), an Iceland-based company that conducts human genomic research. Part II of this Note will introduce genomic research in general and will discuss deCODE's unique story. The company has a unique agreement with the government of Iceland that gives it an exclusive 12-year license to compile a genetic database using both volunteer patient subjects and medical histories. The coming

1. The publication of the sequence of the mouse genome, which bears remarkable similarity to the human genome, provides researchers with a means of understanding human disease progression. Mouse Genome Sequencing Consortium, Initial Sequencing and Comparative Analysis of the Mouse Genome, 420 NATURE 520 (2002): Modest Mouse: A Draft Sequence of the Mouse Genome Has Been Published, ECONOMIST, Dec. 7,2002, at 77. 2. See Biotech/Chem/Pharm Customer Partnership Meeting, Tech. Ctr. 1600, Util. Examination Guidelines & Written Description Examination Guidelines (Aug. 20-24, 2001) (documenting the steady increase in biotechnology patents), at http://www.uspto.gov/web/patents/biochempharml roadshow.htm. See also Number of Patents for Medical Devices & Pharm., Public Agenda Online, at http://www.publicagenda.org/issues/factfiles-detail.cfm?issue-type=medical-research&list=9 (last visited Mar. 20,2002). 3. The Supreme Court paved the way for patenting of biological organisms in 1980. See Diamond v. Chakrabarty, 447 U.S. 303, 316 (1980). For a thorough analysis of biotechnology patents, see Linda J. Demaine & Aaron Xavier Fellmeth, Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent,55 STAN. L. REV. 303,312-65 (2002). 4. Bioinformatics: The Race to Computerise Biology, ECONOMIST TECH. QUARTERLY, Dec. 12, 2002, at http://www.economist.com/science/tq/displayStory.cfm?story-id=1476685. 5. Id. No. 21 CORPORATE GENOMICS

years are increasingly critical because deCODE's research has met with criticism both within Iceland and around the world. Part III of this Note traces deCODE's progress over the last few years by analyzing recent developments in law and public policy and compares deCODE's case to similar plans that have begun to crop up in other parts of the world. Prior works of scholarship on this subject both support the creation of the database and find ethical problems in the research arrangement.6 Recent developments in the deCODE story include publication of the terms of the licensing agreement in January 2000,' enactment of an Act on Biobanks in May 2000 and accompanying Regulations following in 2001,' a lawsuit challenging the constitutionality of the Act on a Health Sector Database,' ° a lawsuit alleging copyright infringement against deCODE," a lawsuit seeking a certificate for shares and damages by one of deCODE's co-founders, 12 and a proposed bill authorizing the government to guarantee bonds for the financing of deCODE's activities in Iceland. 3 These developments underscore the challenges that deCODE continues to face in undertaking such pioneering efforts in relatively uncharted waters, as the relevant legislation is so recent and has not been substantially tested. This Note acknowledges the vast potential of genetic research using the Health Sector Database to find cures for many diseases. However, in Part IV it contends that only if certain key issues are addressed will the deCODE model of using human genetic data for profit be valid, ethical,

6. See generally Henry T. Greely, Iceland's Plan for Genomics Research: Facts and Implications, 40 JURIMETRICS J. 153 (2000); Hrobjartur Jonatansson, Iceland'sHealth Sector Database:A Significant Head Start in the Search for the Biological Holy Grail,Or An IrreversibleError?, 26 AM. J.L. & MED. 31 (2000). Interestingly, Mr. Jonatansson is an Icelander. 7. See infra Part II.C 8. See infra Part II.B.4. 9. See infra Part II.B.5. 10. See infra Part II.B. 11. See infra Part n.B. 12. deCODE's SEC filings detailed the nature of this action: In April 2000, Ernir Snorrason, an original stockholder of deCODE, filed a complaint in the Court of Chancery of the State of Delaware for New Castle County alleging that deCODE improperly exercised an option to repurchase 256,637 shares of common stock that deCODE issued to Mr. Snorrason in 1996 pursuant to a Founders' Stock Purchase Agreement and seeking an order requiring deCODE to recognize Mr. Snorrason as the owner of these shares. In June 2001, the parties settled the matter without admission or adjudication of any issue of fact or law and 166,814 shares of deCODE common stock were issued to Mr. Snorrason for $0.001 per share, the par value, with the resulting loss ($1,292,642) being recorded as a general and administrative expense at that time. DECODE GENETICS, INC., FORM Q, QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934, FOR THE QUARTERLY PERIOD ENDED SEPT. 30, 2001, available at http://www.sec.gov/Archives/edgar/data/1022974/000089322001500894/0000893220-01-500894.txt (last visited Mar. 20, 2003). 13. Press Release, deCODE, ICELANDIC GOVERNMENT MOVES TO SUPPORT FINANCING OPPORTUNITIES FOR DECODE's DRUG DEVELOPMENT STRATEGY (Apr. 9, 2002), at http://www.decode.com (available in the "News & Investors" section of the Web site). E-mail from Ingvi M~ir Pilsson, LL.M, Dep't of Taxation and Legal Affairs, Ministry of Finance, Iceland, to Ashok M. Pinto (Sept. 4,2002,09:51 CST) (on file with author). JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002 and worthwhile. Conforming to global standards for data processing, privacy, and benefit sharing will ensure that deCODE protects all the interests at stake and will confirm the validity and appropriateness of its research. As these types of research initiatives propagate worldwide, the lessons learned from deCODE will become increasingly instructive.

II. BACKGROUND

A. A Word on Genomic Research A basic understanding of the concepts and significance of human genomic research is necessary to examine the legal issues of this field." The human genome is comprised of all the DNA in an organism, including its genes.15 Genes carry information for making all the proteins required by an organism and determine its characteristics. DNA is composed of Adenine (A), Thymine (T), Cytosine (C), and Guanine (G), four chemicals commonly referred to as "bases." The human genome has 3 billion base pairs, though only a small fraction of these base pairs belong to genes. The structure of DNA is a double helix, in which two complementary strands bond with each other due to the pairing of bases, A with T and C with G. The order of these base pairs is critical in determining the species and characteristics of an organism. 6 The interrelation of organisms through similarities in the sequence of base pairs allows scientists to gain information from other genomes useful in the study of human biology. 7 The Human Genome Project ("HGP") is the seminal research effort relating to the human genome. Its efforts have set the stage for the explosion of biotechnology research around the world today. The HGP started in 1990 as a joint effort of the Department of Energy and the National Institutes of Health, and will be completed in 2003, two years ahead of the original 15-year schedule. 8 In June 2000, the first version of the entire human genome sequence was announced. A competing

14. See generally U.S. Dep't of Energy, To Know Ourselves (Oct. 2001) (providing an overview of the basic science behind the project as well as its ethical, legal, and social implications), available at http://www.ornl.gov/hgmis/publicat/tko/; Dr. Salil D. Patel & Dr. Sunil Maulik, GeneEd Biotechnology Glossary, at http://www.celera.com/corplmages/geneed/glossary/glossary_50.htm (last visited Mar. 20, 2003). 15. About the Human Genome Project, Human Genome Project Information, at http://www.oml.gov/hgmis/project/about.html (last modified Feb. 18,2002). 16. Id. 17. Id. 18. Human Genome Project Information, at http://www.ornl.govIrechResources/ HumanGenome/home.html (last modified Mar. 17, 2003) [hereinafter Project Information]. The project's goals are as follows: [To] identify all the approximately 30,000 genes in human DNA, determine the sequences of the 3 billion chemical base pairs that make up human DNA, store this information in databases, improve tools for data analysis, transfer related technologies to the private sector, and address the ethical, legal, and social issues (ELSI) that may arise from the project. Id. No. 21 CORPORATE GENOMICS private effort to sequence the genome was published simultaneously with the government effort in February 2001.19 Significantly, the U.S. government has licensed the data and related technologies of the HGP to the private sector. This has strengthened the biotechnology industry and fostered advances in medical technologies.' The possibilities that result from the HGP are staggering. One example is the burgeoning field of pharmacogenetics, which aims to match drug treatment to the individual genetic makeup of a particular patient to minimize side effects and amplify drug effectiveness. Genomics research has shifted from the study of Mendelian diseases, which involve a single gene and are relatively few in number, to complex diseases,2" which result from more than one gene. Many analytical and scientific challenges are present in the pursuit of complex disease mapping, including complex hereditary patterns and environmental factors.22 The difficulty of studying polygenic disorders is to produce a study "large enough to disentangle the relevant genes and tease out the environmental factors in question."23 Some have suggested that a study of an entire national population would go far in gathering information about a host of polygenic diseases.24

B. The Case of deCODE Genetics

"[A]lthough many genomics firms will no doubt go belly-up, some may yet make their masters into billionaires."'

1. Iceland and deCODE's CorporateHistory

Iceland is a large island in the North Atlantic Ocean, northwest of the United Kingdom between Greenland and Scandinavia.2 6 In July 2001, its population was estimated at 277,906, and its total area is 103,000 km2, smaller than that of Kentucky.27 Iceland gained independence from Denmark on June 17, 1944, and has a civil law system based on Danish

19. Id. Celera genomics was responsible for this private effort. See J. Craig Venter et al., The Sequence of the Human Genome, 291 SCIENCE 1304, 1305 (2001). 20. Project Information, supra note 18. 21. See generally A Survey of the Human Genome: Ingenious Medicine, ECONOMIST, July 1-7, 2000, at 5 (discussing the shift in genomics research to the study of polygenic disorders); The Human Genome: Think of a Number, Then Double It, ECONOMIST, July 14-20, 2001, at 74 (discussing the challenges researchers face in identifying genes and their functions). 22. See A Survey of the Human Genome, supra note 21, at 5; Birgid Schlindwein's Hypermedia Glossary Of Genetic Terms, at http://hal.weihenstephan.de/genglos/asp/genreq.asp?nr=167 (last modified June 7, 2002). 23. A Survey of the Human Genome, supra note 21, at 5. 24. Id. 25. Id. at 6. 26. CIA, THE WORLD FACT BOOK 2002, available at http://www.cia.gov/cia/publications/ factbook/geos/ic.html (last modified Mar. 19, 2003) [hereinafter CIA WORLD FACT BOOK]. 27. Id. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002

law. 8 Iceland has a unicameral Parliament, the Althingi, with 63 seats; the Althingi's members are elected by popular vote to serve four-year terms.29 The judicial branch has a Supreme Court, or Haestirettur, with justices holding life appointments from the president. The government continues to oppose membership in the European Union ("EU") because of fear that its fishing industry will suffer.3 Instead, Iceland is associated with Switzerland, Norway, and Liechtenstein in the European Economic Area ("EEA"). t In spite of being heavily dependent on the fishing industry, the nation is technologically savvy. For example, its mobile phone and computer usage rates are the highest in the world.32 In addition, Reykjavik, Iceland's capital, was named a European City of Culture in 2000."3 Iceland appeals to genetic researchers because of its nearly homogeneous population. Ever since the Vikings settled Iceland in 874 A.D., it is thought that Icelanders' genetic code has barely changed over the past 1,100 years.3 In addition, there has been little immigration to alter the gene pool.35 Iceland's National Health Service has detailed medical records on the population dating back more than 80 years. Additionally, Icelanders have high life expectancies - 76.5 years for males and 81.3 years for females.36 Moreover, the passion for genealogical record-keeping that exists in Iceland makes for a uniquely rich knowledge base on which to pursue genetic research.37

28. Id. Its chief of state is President Olafur Ragnar Grimsson, in office since August 1, 1996, and its head of government is Prime Minister David Oddsson, who has served as Iceland's Prime Minister since April 30, 1991. Id. The Independence Party, of which Oddsson is a member, has enjoyed significant political power for the last 50 years. David Oddsson, Iceland's Eurosceptic Leader, ECONOMIST, Apr. 14-20, 2001, at 52. 29. CIA WORLD FACT BOOK, supra note 26. 30. David Oddsson, Iceland's Eurosceptic Leader, supra note 28, at 52. Indeed, Iceland's economy is largely dependent on fishing, which accounts for 70% of export earnings and 12% of the work force. CIA WORLD FACT BOOK, supra note 26. Elections were last held on May 8, 1999, and will next be held in April 2003. Id. 31. EEA member nations agree to follow many EU policies, but have no role in making these policies. See GEORGE A. BERMANN ET AL., CASES AND MATERIALS ON EUROPEAN UNION LAW 1057-63 (2d ed. 2002). 32. Joel Baglole, Iceland Transforms Itself Into a Hotbed for New Industries, WALL ST. J., Mar. 13, 2001, at A21. In addition, its economy has grown 25% since 1995, its unemployment rate is an enviable 1%, and the Icelandic Government will be debt-free by 2004. David Oddsson, Iceland's EuroscepticLeader, supra note 28, at 52. 33. European Cities of Culture, LE MAGAZINE (2000), at http://europa.eu.int/comm/dgs/ education_culture/mag/13/villesen.html. 34. Sarah Lyall, A Country Unveils Its Gene Pool and Debate Flares,N.Y. TIMES, Feb. 16, 1999, at Fl. See generally ORNOLFUR THORSSON, ED., THE SAGAS OF ICELANDERS (2000) (surveying Icelandic history in the context of its saga literature). 35. See Lyall, supra note 34. 36. Ministry of Health & Social Security, The Icelandic Health Care System: An Overview, http://www.heilbrigdisraduneyti.is/interpro/htr/htr.nsf/pages/info (last visited Mar. 20, 2003). 37. DECODE GENETICS, 2001 ANNUAL REPORT 3 (2002). No. 21 CORPORATE GENOMICS

deCODE Genetics is based in Reykjavik and was incorporated in Delaware in 1996.38 Its principal aim is to make genetic discoveries that will be useful in drug development.3 9 Its principal alliance is with the Swiss pharmaceutical company Hoffman-LaRoche ("Roche"), which agreed to pay deCODE $200 million over five years for the genetic identification of 12 diseases.4" In addition, Roche has promised to give Icelanders free of charge any drugs it may develop as a result of the research. deCODE also has partnership agreements with a number of other pharmaceutical companies and health care institutions, including Genmab, Applied Biosystems, Partners HealthCare (formed by the Massachusetts General Hospital and Brigham and Women's Hospital, both located in Boston), and Affymetrix, Inc.41 Kari Stefansson, deCODE's Chief Executive, is the driving force behind the creation of the Health Sector Database. 2 Known as a forceful personality, Dr. Stefansson places scientific progress first and questions his critics' perceived "right to deny science the ability to use information about us to help future generations."43

2. Laws and Regulations There are several laws and regulations that are relevant to an analysis of the Iceland Health Sector Database ("IHD"): the Act on a

38. Although previous drafts of the Act on a Health Sector Database, discussed infra, called for the database licensee to be an Icelandic legal entity, the final version only required that the database be exclusively located in Iceland. Bill on a Health Sector Database, art. 5 (submitted to Parliament at 123d session, 1998-99) (Ice.), http://www.raduneyti.is/interpro/htr/htr.nsf/pages/gagnagr-ensk [hereinafter Bill on a Health Sector Database]; Principal Amendments from the Bill on a Health Sector Database, art. 3 (submitted to the 122nd session of Parliament) (Ice.), http://www.raduneyti.is/interpro/htr/htr.nsf/pages/gagnagr-ensk. 39. deCODE distinguishes its methodology as being superior to that of its competitors: The human genetics approach used by deCODE also offers a potentially more accurate and efficient method for identifying drug targets. Unlike prevailing strategies based solely on studies of the expression and function of selected genes, deCODE aims first at pinpointing the key mutated genes within the entire genome. New and more effective treatment regimes can thus be built from the bottom up, focusing directly on the full gamut of possible genetic factors behind a given disease. Company Profile, deCODE Genetics, at http://www.decode.com/company/profile/ (last visited Mar. 20,2003). On July 18, 2000, the company held its initial public offering of 9.6 million shares at $18 per share on the NASDAQ exchange. See New Securities Issues, WALL ST. J., July 19, 2000, at C24; Genome Offerings Surge, N.Y. TIMES, July 19, 2000, at C8. deCODE's trading symbol isDCGN. The share price rose $7.4375, to $25.4375, on the first day of trading. Id. 40. See Clive Cookson, Roche in Iceland Research, FIN. TIMES (London), Feb. 3, 1998, at 27. 41. Company: Partners, deCODE Genetics, at http://www.decode.com/company/ (last visited Mar. 20,2003). 42. Bill on a Health Sector Database, Notes to the Bill, § I. 43. Andrew Pollack, Company Seeking Donors of DNA for a "Gene Trust", N.Y. TIMES, Aug. 1, 2000, at Al. Dr. Stefansson was a professor of Neurology, Neuropathology, and Neuroscience at Harvard University. He was also Director of Neuropathology at Beth Israel Hospital in Boston, Massachusetts. In addition, he has also been a member of the faculty at the University of Chicago. An Icelander, Dr. Stefansson received his M.D. and Ph.D. from the University of Iceland. See Company: Management, Dr. Kari Stefansson, deCODE Genetics, at http://www.decode.com (last visited Mar. 20, 2003). JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002

Health Sector Database, the Regulation on a Health Sector Database, the Regulation on Scientific Research in the Health Sector, the Act on Biobanks, and the Regulation on the Keeping and Utilization of Biological Samples in Biobanks. By outlining the relevant provisions of each one, it is possible to understand the critical issues that surround the IHD.

a. Act on a Health Sector Database The Althingi passed the Act on a Health Sector Database on December 17, 1998," which provided for the creation of the IHD. The nationwide database aims to catalog information from "anonymized" patient records from Iceland's national health service and analyze these data by cross-referencing them with genomic information obtained from Icelandic donors. Using these two sources of information, deCODE created a Combined Data Processing System." The cost of creating the database was estimated to be between 10.5 and 19.3 billion Icelandic Kronas ("ISK," approximately $100 million to $190 million).46 The aim of the database is to "improve health and human services."47 To further this end, the Act provides for the grant of an operating license to a licensee (deCODE) for a period of twelve years.' The licensee is required to maintain the database in Iceland and to meet the requirements of Iceland's Data Protection Commission.49 The Act also creates a Monitoring Committee consisting of three people - a health care worker trained in epidemiology, a computer science/information technology expert, and a lawyer serving as chair - appointed to four-year terms to oversee the creation and operation of the database." Patients may choose not to have their information included in the database." Anyone not expressing such a desire is presumed to consent to having their information included. However,

44. Act on a Health Sector Database, No. 139/1998 (123rd sess., 1998-1999) (Ice.), http://www.stjr.is/interpro/htr/htr.nsf/pages/gagngr-log-ensk [hereinafter Act on a Health Sector Database]. 45. The company believes that this technology and methodology will open up new avenues of medical research and facilitate the development of technologies leading to: Faster diagnostics, allowing for earlier treatment or changes in lifestyle. Customized treatments, specific to disease subtype and with a lower risk of side-effects. Better-informed, more cost-effective disease management strategies. More accurate drug-targeting, leading to more effective, tailor-made treatment regimes. Resources, The Icelandic Health Sector Database, deCODE Genetics, at http://web.archive.org/web/ 20011123163257/http://www.decode.com/resources/ihd/ (last visited Apr. 3, 2003). 46. Bill on a Health Sector Database, Notes to the Bill, § I, art. 2. 47. Act on a Health Sector Database, art. 1. 48. Id. at art. 5. 49. Id. 50. Id. at art. 6. 51. Id. at art. 8. 52. Presumed consent is defined in terms of organ donation, under which the term seems to arise frequently, as follows: No. 2] CORPORATE GENOMICS

the bill envisions two sets of data: one with personally identifiable information and one with non-personally identifiable information; while the former would require informed consent, the latter would not.53 Icelanders also cannot "refuse to allow data on their deceased parents to be entered on the database."54 A bill provision stating that scientists may gain access to data from the database for research purposes provided that such access will not have "an adverse effect upon the licensee's commercial interests" was excluded from the Act as passed by Parliament.5 The Bill presented to the Althingi notes that "[r]ecorded 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."56 While citing the risks of confidentiality problems and the misuse of data, the Bill cites the "development of high-technology industry in Iceland, and thus employment for a highly-educated sector of society," and the possibility of attracting new business to Iceland as key benefits of creating the database.57

b. The Regulation on a Health Sector Database Following the 1998 Act, the Ministry of Health and Security issued the Regulation on a Health Sector Database on January 22, 2000. The regulation provides further detailed information and specific requirements for the creation, maintenance, and supervision of the database. 8 It requires a security assessment by an independent expert before proceeding with the database. 9 The licensee must segregate its health database operations financially from any other activities with

Public policy based on presumed consent would offer every adult the opportunity to express and have recorded by publicly accountable authorities his or her refusal to be a donor of solid organs and tissues. A clinically and legally indicated candidate for cadaveric organ and tissue recovery is presumed to have consented to organ and tissue recovery if he or she had not registered a refusal. J. Michael Dennis, et al., An Evaluation of the Ethics of Presumed Consent and a ProposalBased on Required Response: A Report of the Presumed Consent Subcommittee and United Network for Organ Sharing Ethics Committee, at http://www.unos.org/resources/ bioethics.asp?index=l (last visited Mar. 20, 2002). Contrast this with the definition of informed consent: Informed consent is comprised of two legal duties imposed on physicians - to inform patients about treatment and to obtain their consent for it. These duties are imposed in order to insure that a person's right to self-determination - that is, the right of all free citizens to govern their own destiny - may be maintained in one particular sphere of human activity, the acquisition of medical care. Alan Meisel, Informed Consent: Who Decides for Whom?, in MEDICAL ETHICS AND THE LAW: IMPLICATIONS FOR PUBLIC POLICY 198 (Marc D. Hiller, ed. 1981). 53. Bill on a Health Sector Database, art. 3. 54. Id. at art. 8. 55. Id. at art. 9. 56. Id. at art. 2. 57. Id. 58. Gov't Reg. on a Health Sector Database, No. 32/2000 (Jan. 22, 2000) (Ice.), ch. I, General Provisions, http://www.stjr.is/interpro/htr/htr.nsf/pages/Govreg32-2000. 59. Id. at art. 5. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002 which it is involved.' Patients' requests to have their personal information withheld are to be honored, even after their deaths.61 The Monitoring Committee retains the authority to supervise agreements between the licensee, healthcare providers, and institutions, as well as to oversee day-to-day database operations.62 This regulation clarified and expanded the provisions of the 1998 Act.

3. The Regulation on Scientific Research in the Health Sector Enacted in July 1999, the Regulation on Scientific Research in the Health Sector established a National Bioethics Committee, comprised of five individuals serving four-year terms, to oversee scientific research in Iceland's health sector.63 Furthermore, the regulation established ethics committees for Iceland's three major hospitals - the National University Hospital, the Reykjavik Hospital, and the Akureyri Central Hospital - and instructs these committees to report to the National Bioethics Committee. The Regulation requires any study using human subjects or human tissue samples to be approved by the National Bioethics Committee, and by the Data Protection Commission with regard to access to clinical records.' It gives priority to the interests of the individual "over the interests of science or of society as a whole" and requires "formal consent prior to participation in scientific research."'65

4. Act on Biobanks Passed on May 13, 2000, and effective on January 1, 2001, the Act on Biobanks was designed to provide privacy safeguards to those individuals providing biological samples for use in scientific research.' The Act promises that "[t]he interests of science and of the community shall never be given priority over the interests of the donor of a biological sample."'67 The Act sets forth terms under which a license may be obtained to create a biobank. 6 Importantly, it explicitly defines "free, informed consent" and "assumed consent": 5. Free, informed consent: consent granted in writing of the person's own free will, after the donor of a biological sample has been

60. Id. at art. 7. The regulation also states that "[t]he license and the Health Sector database are neither assignable nor subject to the enforcement of claims. The Operating License and the Database may not be pledged against any financial liability." Id. at art. 38. 61. Id. at art. 12. 62. Id. at art. 16, 17. 63. Reg. on Scientific Research in the Health Sector, No. 552/1999 (July 29, 1999) (Ice.), art. 1, (English translation Dec. 9, 2000), http://www.stjr.is/interpro/htrhtr.nsf/pages[Regulation-552-1999. 64. Id. at art. 4. 65. Id. at art. 4,5. 66. Act on Biobanks, No. 110, art. 1 (2000) (Ice.), http://www.stjr.is/interpro/htr/ htr.nsflpages/Act-biobanks (English translation Dec. 9, 2000). 67. Id. 68. Id. at art. 4. No. 2] CORPORATE GENOMICS

informed of the purpose of taking the biological sample, its usefulness, risks attendant upon the process, and that the biological sample will be permanently preserved in a biobank for use under the terms of art. 9. 6. Assumed consent: Consent that consists in the donor of a biological sample not expressing any unwillingness for a biological sample taken from him/her for a clinical test to be permanently preserved in a biobank for use by the terms of art. 9, information in writing on this possibility having been available to him/her.69 This is the first instance in which the Icelandic government has defined consent with regard to the health database. Free and informed consent in writing is required of a donor where his or her sample is to be preserved in the biobank.7° Any samples given must be destroyed if consent is withdrawn at a later date.7 However, "[m]aterial that has been produced from a biological sample by performance of a study or the results of studies already carried out shall ... not be destroyed."72 Furthermore, if samples have been taken for clinical tests or treatment, a presumed consent standard applies for including this material in the biobank. In short, the Act distinguishes between samples obtained for health care and samples obtained for research purposes. The Director of General Health in conjunction with the National Bioethics Committee and the Data Protection Authority exercise regulatory authority and supervisory powers over the operation of any such biobank.73 While the biobank licensee does not have any ownership rights over the samples themselves, it may collect a fee for access to a biological sample.74 It may not, however, pass along samples to a third party, or use the samples to secure a debt.75 All those working in or around the biobank must maintain strict confidentiality, both during and after their employment.76 Samples may be used for a purpose other than the original one for which the sample was collected, "provided that important interests are at stake, and that the potential benefit outweighs any potential inconvenience to the donor of a biological sample or other parties."77 It further prohibits discrimination against the donor based on any data derived from the sample.78

69. Id. at art. 3. 70. Id. at art. 7. 71. Id. 72. Id. 73. Id. at art. 9. 74. Id. at art. 10. 75. Id. 76. Id. at art. 11. 77. Id. at art. 9. 78. Id. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002

5. The Regulation on the Keeping and Utilization of Biological Samples in Biobanks

The Regulation on the Keeping and Utilization of Biological Samples in Biobanks provides further detailed information regarding the Act on Biobanks.79 Effective on February 6, 2001, the regulation provides that the "results" that are not destroyed, discussed in Article 7 of the Act on Biobanks, are "results of all kinds; written text, numerical values, measurements, graphs and pictures." I Also included are "molecules or molecule fragments... in the form of stripes or spots in gel, on membrane or on glass slides," as well as "tissue cultures, gene sequences, isolated genes or isolated molecules, original or mutated."81 The regulation further states that all elements of personal identification are to be removed from these samples so that they cannot be traced back to their individual donors.82 Presumed consent is the applicable standard for clinical tests, and a sample from a deceased individual is included in the biobank unless he or she withdrew consent prior to death.83 Survivors have no power to request removal of the samples of their deceased relatives.' In addition, even if a donor withdraws assumed consent, "the biological sample shall not be destroyed, but preserved for use in the interest of the donor of a biological sample .... "85 Section V of the Regulation is the first instance in which the government has used "opt-out" language relating to the collection of biological samples.86 It obliges the Director of Health to create "a coded register of donors who have opted out."'87

C. The Licensing Agreement

On January 22, 2000, the Icelandic Government awarded Islensk erf6agreining ehf., the Icelandic subsidiary of deCODE, a twelve-year license to build and run the IHD. The license is subject to review no later than October 1, 2008, and expires on January 21, 2012.' It states that the purpose of the database is "increasing knowledge for the improvement of health and the promotion of health services," as well as

79. Regs. on the Keeping and Utilisation of Biological Samples in Biobanks, No 134 (2001) (Ice.), http://www.stjr.is/interpro/htr/htr.nsf/pageslawsandregs0001. 80. Id. at art. 7. 81. Id. 82. Id. 83. Id. atart. 8. 84. Id. 85. Id. at art. 9. 86. Id. at art. 10. 87. Id. 88. Operating License, Issued to fslensk erf~agreining ehf., State Reg. No. 691295-3549, Lynghals 1, Reykjavik, for the Creation and Operation of a Health Sector Database, Ministry of Health and Social Security (Jan. 2000) (Ice.), art. 15, http://www.raduneyti.is/ interpro/htr/htr.nsf/Files/oplic$file/oplic.pdf. No. 21 CORPORATE GENOMICS

"serving the health system as a whole, individual health institutions, self- employed health service workers and the nation as a whole."89 It holds that all data is "the common property of the Icelandic nation."' The license also includes a comprehensive definition of "genetic data."91 The database will assemble anonymized, encrypted data from patient records from Iceland's national health service in a secure computer system. The IHD will enable users, including doctors in Iceland's national health system, to conduct population analyses of longitudinal healthcare data and trends on, for example, clinical measurements and basic lifestyle information, disease diagnoses, treatments and outcomes. deCODE believes that this system will provide valuable resource[s] for better understandign [sic] the environmental components that, along with genetic factors, lie behind the onset of common diseases.92 In its agreement with the Government of Iceland, deCODE agreed to pay a licensing fee of ISK 70,000,000 (approximately $650,000) each year, with adjustments made for changes in the consumer price index.93 The Icelandic government also receives an additional payment of 6 percent of deCODE's pre-tax profits, never to exceed ISK 70,000,000. 94 After six years, the licensee may request review of this fee; however, the annual fee can never be lower than ISK 50,000,000 (approximately $460,000). 91 If the licensee and the government cannot reach an agreement upon reviewing the annual fee, the case is referred to an arbitration tribunal, whose decision is final.96 The matter may not be referred to the public courts.97 The government is to use the funds received from the licensee to "promote health services, research and development."98 While deCODE did not have any ownership rights to the data, it was able to commercially market the propriety software it

89. Id. at 3. 90. Id. at 4. 91. The operating license defines genetic data as follows: "Genetic data" means any data pertaining to the inheritable features of an individual or the hereditary pattern of such features within a group of related individuals, and furthermore all data pertaining to features which determine the diseases and health of individuals and groups of related individuals, regardless of whether such features can be identified or not. Id. at 4. 92. Science & Research, The deCODE Population Approach, Unique Resources, deCODE Genetics, at http://www.decode.com (last visited Mar. 20, 2003). 93. Agreement between The Minister for Health and Social Security and Islensk erfoagreining ehf. Related to the Issue of an Operating License for the Creation and Operation of a Health Sector Database (Ice.), art. 5 (unofficial translation Feb. 2000), http://www.mannvernd.is/ english/articles/agreement.html. 94. Id. at art. 6. 95. Id. at art. 5. 96. Id. at art. 14. 97. Id. 98. Operating License, supra note 88, § 10.6. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002 used to analyze the data. deCODE partnered with Applied Biosystems to market this software.99

D. The Proposed Bill for Bond Financing In April 2002, deCODE announced that the Icelandic government was planning to introduce a bill allowing for bond guarantees to finance the expansion of the company's operations in Reykjavik."° These bonds would be convertible into shares of deCODE stock priced at $18 per share, the price from deCODE's July 18, 2000 Initial Public Offering. 0' The bill received final approval from the Althingi on May 3, 2002.12 A draft of the bill translated into English provides in pertinent part: The Minister for Finance, acting for the Government of Iceland, is authorised, for the purpose of promoting the development of high- tech industry in drug development in Iceland, to provide a guarantee of collection in respect of bonds, issued by the parent company of Islensk erfoagreining ehf., deCODE Genetics Inc., in an amount of up to USD 200 million for the purpose of financing new activities of Islensk erfoagreining ehf. in the area of drug development. The Minister will provide the guarantee subject to the appropriate conditions established at his discretion. 3 The unofficial translation of the bill is short and does not contain many details. The bond guarantee demonstrates a remarkable level of support for deCODE from within the Icelandic parliament. This large cash infusion is a huge boon to deCODE in a flagging economy that has seen the company's share price flag.

III. CHALLENGES TO DECODE'S RESEARCH Iceland's health database has sparked international interest, resulting in many articles about the perceived merits and flaws of such research. The Institute of Anthropology at the University of Iceland and the Department of Anthropology at the University of California at Berkeley have jointly created a Web site dedicated to this issue and its

99. Tom Abate, Bay Area Biotech Markets Gene-Sifting Software, SAN FRANCISCO CHRON., July 19, 2001, at B2. 100. Press Release, deCODE Genetics, supra note 13. 101. Id. 102. Press Release, deCODE Genetics, Icelandic Parliament Passes Legislation Authorizing Government Guarantee for deCODE Convertible Bond (May 3, 2002), at http://www.decode.coml main/view.jsp?branch=5026&e342RecordlD=581&e342DataStorelD=3917&uid=30143. 103. Legislative Bill for an Act Authorising the Minister for Finance, on Behalf of the Government of Iceland, to Guarantee Bonds for the Purpose of Financing of New Activities of Islensk erfoagreining ehf (Ice.) (Submitted to the Althingi at its 127th Session, 2001-2002) (unofficial translation); E-mail from Ingvi Mir PAisson, LL.M, Dep't of Taxation and Legal Affairs, Ministry of Finance, Iceland to Ashok M. Pinto (Sept. 4, 2002, 09:51 CST) (on file with author). No. 21 CORPORATE GENOMICS

implications in order to foster active debate." 4 Prior to the enactment of the 1998 Act, the Nordic Committee on Bioethics expressed concern about inadequate protection of privacy,105 consent issues, and restrictions on the freedom of scientific research.

A. Willingness of Doctors to Provide Patient Data Many doctors have been unwilling to cooperate with the provisions of the 1998 Act. In particular, Dr. Haraldur Briem, State Epidemiologist, Infectious Disease Control, in Iceland's Directorate of Health, refused to turn over information regarding his patients to the health database without written consent from each patient."° Additionally, Arni Bjbmsson, a retired chief of plastic surgery, refused to hand over confidential records from his practice at St. Joseph's Hospital in Hafnarfjordur to the health database. 7 Nearly 180 physicians have reported that they will not report patient data to the health database without specific written consent from each patient.108

B. Litigation Legislation regarding the IHD has led to litigation in Iceland. A science and medical ethics organization called Mannvernd is the primary opponent of the database in Iceland and has expressed its intention to test the constitutionality of the Act on a Health Sector Database."9 Additionally, in early 2000, authors of genealogical information alleged copyright violations against deCODE and sought some $9 million in damages.1"0

104. Mapping the Icelandic Genome, at http://sunsite.berkeley.edu/biotech/iceland/ (last updated July 19, 1999). 105. Press Release, Nordic Committee on Bioethics, Ethical Concerns Over Licensing Health Data (Oct. 27, 1998), at http://www.ncbio.org/Html/eng-index.htm. 106. See Directorate of Health (Iceland), General Information, at http://www.landlaeknir.is/ templatel.asp?PagelD=597 (last visited Apr. 30, 2003); letter from Haraldur Briem, M.D., Ph.D., to Sigmundur Gurbjarnason, M.D., Ph.D., Chairman of Mannvernd (Mar. 18, 1999), available at http://www.mannvernd.is/english/index.html. 107. See Letter from Arni Bjornsson, M.D., Consulting Physician, St. Joseph's Hospital, Hafnarfjordur, Ice., to Board members, St. Joseph's Hospital (Jan. 26, 1999), available at http://www.mannvernd.is/english/index.html. 108. See Stand of Individual Doctors & Lists of Doctors Who Refuse to Hand Over Data about Their Patients, at http://www.mannvernd.is/english/index.html (last visited Mar. 20, 2003). Doctors have reported this information to the Icelandic MedicalJournal or to Mannvernd directly. Id. 109. See infra Part III.C.1. 110. deCODE's securities filings described the infringement suit: In January 2000, Porsteinn Jonsson and Genealogia Islandorum hf., the alleged holders of copyrights to approximately 100 books of genealogical information, commenced an action against deCODE in the District Court of Reykjavik in Iceland. They allege that deCODE's genealogy database infringes their copyrights and seek damages in the amount of approximately $9,000,000 and a declaratory judgment to prevent deCODE from using the allegedly infringing data. SEC Form 10-Q, http:l/www.sec.gov/Archives/edgar/data/1022974/000089322000000955/0000893220- 00-000955.txt. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002

C. Opposition Groups deCODE's efforts have not gone unchallenged. There is vocal opposition both within Iceland and in other parts of the world. Critics point out that deCODE is a Delaware corporation, and that Kari Steffansson is the only Icelander serving on its Board of Directors."' One observer wryly noted that, "[a]t least the modem Icelanders' Viking ancestors made no pretense that their raids and piratical activities were in the public interest.""' The criticism and controversy surrounding the IHD has brought the difficult issues of privacy, consent, and freedom of scientific research to the fore.

1. Mannvernd: A ConstitutionalChallenge Mannvernd is the Association of Icelanders for Ethics in Science and Medicine. Its mission statement makes its opposition to the IHD abundantly clear." 3 Einar Arnason, a genetics professor and co-founder of Mannvernd, observed that "[t]he interests of the individual which should be first are being put second and the interests of the company are being put first in order to make money.""' In a press conference in February 2000, Mannvemd unveiled its plans to file suit against the government of Iceland, deCODE, and Islensk erfoagreining ehf.,

111. deCODE Genetics, Company: Management, Board of Directors, at http://www.decode.com/ main/view.jsp?branch=21956 (last visited Mar. 20, 2003). 112. R.C. Lewontin, Editorial, People Are Not Commodities, N.Y. TiMEs, Jan. 23, 1999, at A19. Lewontin is a Professor of Biology at Harvard University and a member of the Council on Responsible Genetics. Id. 113. Mannvemd's mission statement provides: MANNVERND is the Association of Icelanders for Ethics in Science and Medicine. MANNVERND is the organized opposition to the Icelandic government's Act on a Health Sector Database (HSD). The HSD is slated to contain all medical records for the entire population of Iceland. Included will be the present records, all future records and records ranging back at least 30 years. The Act permits the interconnecting of the medical records to the extensive Icelandic genealogical database as well as to a database of individual DNA genotypes. The HSD will be privately established and operated under a monopoly presumably by the American genomics company Decode Genetics of Delaware, USA, or its subsidiary, and would facilitate the company's business plan. MANNVERND believes that this Act infringes on human rights, personal privacy, and on accepted medical, scientific and commercial standards. We believe that the Act has world-wide implications and that stopping the law should be given a high priority by the world human-rights community. The government of Iceland should be encouraged in the strongest possible terms to reconsiderthis legislation,and suspend its enactment immediately. Mannvemd is a grass roots organization founded by scientists, doctors and other concerned citizens with the aim of standing guard for the rights of the citizenry. The name MANNVERND means Human Protection. Mannvernd, What is Mannvernd?, at http://www.mannvernd.is/english/aboutmv.html (last visited Mar. 20,2003) (emphasis in original). 114. Catherine Goldwater, Iceland Exploits Its Genetic History, BBC News, Feb. 4, 2000, at http://news.bbc.co.uk/hi/engish/sci/tech/newsid_- 630000/630961.stm. In a paper published in the Icelandic Medical Journal, Dr. Arnason asserts that the data in the IHD is personal information for which informed consent must be obtained. E. Arnason, Personal Identifiability in the Health Sector Database,ICELANDIC MED. J., 87:807-816 (2001). No. 21 CORPORATE GENOMICS deCODE's Icelandic subsidiary. " 5 Ragnar Adalsteinsson, a Supreme Court lawyer and well-known human rights lawyer in Iceland, was placed in charge of the case. 6 However, while the lawsuit was actually filed in April 2001, deCODE was not a named party."7 In fact, as of the publication date of deCODE's 2001 annual report, the suit had not been brought against it."8 The lawsuit raises certain intriguing issues regarding the inclusion of genetic information of the deceased in the IHD. Birna Thordardottir filed the lawsuit on behalf of her daughter, Ragnhildur Gudmundsdottir, a minor, against Sigurdur Gudmundsson, Iceland's Director General of Public Health."9 The suit challenges the decision of the Office of the Director General, which denied the plaintiff's request that no information about her deceased father, Gudmundur Ingolfsson, should be included in the IHD.2 ° Ingolfsson died in 1991, prior to any legislation regarding the database. 2' The defendant cites a right to privacy as the basis of her lawsuit. On February 16, 2000, the plaintiff requested that her father's medical records not be transferred to the IHD. The defendant rejected this request on February 21, 2001, stating that the Act on a Health Sector Database did not contain a "provision for an individual to refuse to permit the transfer to the database of information about his/her deceased parents.' 122 The lawsuit challenges the constitutionality of the Act by specifically alleging that it fails to protect the right of privacy guaranteed by the Icelandic Constitution: It has not been shown that the proposed transfer of data to the database is of indisputable scientific value, nor that it is not possible to achieve the desired objectives by any other means, let alone that

115. Press Release, Ass'n of Icelanders for Ethics in Science and Medicine, Lawsuits Against the State of Iceland to Test Constitutionality of the Health Sector Database Act, Mannvernd Announces Lawsuit at Press Conference on Feb. 4, 2000, at http://www.mannvernd.is/english/lawsuits/ mv-pressrelease.html (last visited Mar. 20, 2003). 116. Id. Mannvernd intends "to halt the construction and/or operation of the database and to prevent information flowing from the database until the law is changed to comply with the Constitution and Iceland's international commitments .... The lawsuit will test fundamental human rights issues." Id. Mannvemd indicated that it hopes to halt the construction and/or operation of the Icelandic Health Sector Database. In April 2001, a lawsuit was filed against the Icelandic Directorate of Public Health but Mannvernd has not commenced litigation against deCODE. Id.; SEC Form 10- Q, http://www.sec.gov./Archives/edgar/data/1022974/000089322001500894/w54670e1O-q.txt (last visited Mar. 20,2003). 117. Id. 118. SEC Form 10-K, http://www.sec.gov/Archives/edgar/data/1022974/000089322001000311/ w45228e10-k.txt (last visited Mar. 20,2003). 119. Summons in the First Suit on the Act on the Health Sector Database, Birna Thordardottir, on behalf of her daughter, a minor, files suit before the Civil Court of Reykjavik against Sigurdur Gudmundsson, Director General of Public Health, representing the Office of the Director General of Public Health (Apr. 30, 2001), at http://www.mannvernd.is/english/news/summons-bthdgph.html. 120. Id. 121. Id. 122. Id. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002

the scientific value is so great that it is justified to set aside the fundamental principles governing the protection of privacy. 123 The summons contends that the right to scientific research would not be adversely affected by requiring patients' informed consent. 24 It further alleges that the information in the database is personally identifiable, because a decryption key exists, thus making it possible to trace genetic data back to an individual."2 Particularly, the plaintiff in this lawsuit fears that inferences may be drawn about her private life from the data obtained from her father. She challenges Mr. Gudmunsson to provide a "lawful objective" for transferring the medical records of a deceased individual to the IHD.'26 The Supreme Court of Iceland remanded the case to the Reykjavik District Court, and oral arguments were heard on February 6, 2003.127

2. Icelandic Medical Association The Icelandic Medical Association ("IMA") strongly opposed the creation of the IHD in the form dictated by the 1998 Act. 28 IMA invited Ross Anderson, a computer security expert at the University of Cambridge Computer Laboratory, 9 to analyze deCODE's proposal for the IHD prior to the enactment of the database legislation. Anderson found that deCODE's plan "creates a serious conflict with medical ethics and with data protection principles, both of which demand that with few exceptions, patients' consent be sought for the use of their personal health information."'3 ° After conducting a detailed review of the proposal and interviewing deCODE's security expert, he was unable to "accept deCODE's claim to have adequate expertise in computer security, or their claim that they do have adequate security plans but that these have simply not been disclosed to me."' 3 In particular, Anderson

123. Id. 124. Id. 125. Id. 126. Id. 127. Many of the opinions in this case have not been translated from Icelandic into English. For a chronology of the case and a description of its major milestones, see Mannvernd, Status of Lawsuits against the Health Sector Database Act and Related Matters, at http://www.mannvernd.is/ english/index.html (last visited Mar. 20, 2003). 128. The Icelandic Psychiatric Human Rights Group also opposed the creation of the Health Sector Database. It posted a petition on the Internet that encouraged visitors to petition the Prime Minister of Iceland to reconsider the database legislation. Iceland Psychiatric Human Rights Group Needs Your Help: Request Global Pressure to Prevent Government from Creating Huge Health Database That Violates Privacy, at http://www.oikos.org/iceland.htm (last visited Mar. 20, 2003). 129. Anderson leads the Security Group at the University of Cambridge Computer Laboratory. He is a Reader in Security (faculty member). Further information about Dr. Anderson's research and publications can be accessed on the Internet, at http://www.cl.cam.ac.uk/-rjal4/ (last visited Mar. 20, 2003). 130. Ross Anderson, The DeCODE Proposal for an Icelandic Health Database 1 (Oct. 20, 1998), at http://www.ftp.cl.cam.ac.uk/ftp/users/rja14/iceland.pdf. 131. Id. at 7. No. 21 CORPORATE GENOMICS found that the proposal lacked the requisite level of detail to demonstrate competence in maintaining data security. Anderson's observations highlight an underlying factor in the health database legislation: "[t]here thus remains serious concern that if deCODE were to construct a database which supported only very restrictive queries then they might find it uneconomic and would be forced to extend its functionality to that originally envisaged [in the proposal]. ' 132 In short, Anderson raised serious concerns about the bill and the database: In my opinion, the privacy protection which the deCODE database appears likely to provide falls well short of the minimum standards demanded elsewhere in the developed world, and supplying information to it will thus raise severe ethical problems... There is also a grave risk that this bill, if enacted, will undermine confidence in Iceland's ability to be trusted with the processing of personal information from other countries. This would isolate Iceland from the EU's information economy, and may well impose costs on the Icelandic economy which will greatly exceed any benefits.133 Responding to documents prepared for the Data Protection Commission entitled "Security Targets for an Icelandic Health 1 34 ' Database 1 and "Approval Process Methodology" 35 in a subsequent analysis, Anderson found security problems to be so egregious that his ultimate recommendation was for Iceland's Data Protection Commission to "appoint a new consultant with the appropriate skills and start afresh." '136 Alarmingly, he found that the security target 137 "completely fails to inspire confidence. In both its 1999 and 2000 annual meetings, IMA strongly opposed the database in its present form.138 This vocal opposition led to

132. Id. at 8. Anderson objected to deCODE's deferral of detailed design of the database: I understand that DeCODE decided to delay the detailed design of the database until after the bill was passed. In my view, this is unacceptable. It is unclear that a database can be built that is simultaneously ethical and useful for the purposes DeCODE claim to have in mind. If the bill is passed, and it turns out that an ethical useful database is impossible, then a likely outcome is an unethical but useful database. Even if an ethical useful database is possible, parliamentary endorsement of DeCODE's current plans might embolden its management to cut corners in order to save money. Id. at 9-10. 133. Id.at 11. 134. JOHN ARNOLD ET AL., SECURITY TARGETS FOR AN ICELANDIC HEALTH DATABASE, Doc. No. 7163/T/1 (Jan. 2000). Admiral Management Services Ltd. of the United Kingdom was contracted for security consulting on the Health Sector Database. See id. 135. CLAIR GROOM ET AL., APPROVAL PROCESS METHODOLOGY, Doc. No. 7163fT/2 (Jan. 2000). 136. Ross Anderson, Comments on Security Targets for the Icelandic Health Database § 3, http://www.ftp.cl.cam.ac.uk/ftp/users/rjal4/iceland-admiral.pdf (last visited Mar. 20,2003). 137. Id. 138. The meeting's resolutions were as follows: The Annual Meeting of the Icelandic Medical Association, held in Isatlordur, Iceland on August 25-26, 2000, reaffirms the position of last year's Annual Meeting that legislation on the Health Sector Database is inadequate, as there is no provision for a written consent by the JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002

discussions with deCODE on how to improve methods and processes to better protect patient privacy and the doctor-patient relationship.'39 Negotiations between deCODE and the Icelandic Medical Association, which began in February 2000 and concluded in August 2001, resulted in a Joint Statement of the Icelandic Medical Association and deCODE on the IHD.' 4 The statement clarified procedures for those individuals wishing to opt out of the database and made provisions for flexibility in changing the law so as to better protect individual citizens.14' Mannvernd reports that over 20,000 people have opted out of the database as of November 2001.42 However, Kari Stefansson noted that deCODE did

patient. The legislation can therefore undermine the necessary confidence between physician and patient. The meeting urges parliament to amend the legislation. [The Annual Meeting] fully supports its board in its work to convince those who are licensed to operate the Health Sector Database to gather data for the database in an acceptable manner. The meeting affirms the opinion of IMA's board that it will accept nothing less than personal permission to transfer health information on those individuals that are to form the database. [The Annual Meeting] authorises its board to look for new ways of seeking consent for medical research on data in medical records. Its basis will be that after a given date a written consent by patients will allow the use of information in medical records for medical research and that methods will be developed to delete data from databases as requested by individuals or their custodians. The Annual Meeting entrusts the board with taking into consideration in its work the Medical Director's proposal, which has been presented to the meeting and the accompanying report and suggestions by IMA's chairman, dated May 25, 2000, approved at a board meeting on May 30, 2000. Resolutions of the Annual Meeting of the Icelandic Medical Association, Official IMA translation (Aug. 25-26, 2000), at http://www.mannvernd.is/english/news/IMAResolutions.htni. 139. Press Release, Joint Statement of the Icelandic Medical Association and deCODE Genetics on the Health Sector Database (Aug. 27,2001), at http://www.decode.com/news/releases/. 140. Id. 141. The statement, translated into English and posted on deCODE's corporate Web site, declared as follows: If information on a patient's health, contained in medical records and stored in healthcare institutions or by independent physicians, has been transferred to a Health Sector Database according to the legislation on such a Health Sector Database and the patient wishes that this information be deleted from the database, it shall be done immediately after the wish has been put forth. The operator of a Health Sector Database shall develop methods to delete information from the database and pledges not to commence the transfer of health information into the database until they have been fully developed. A demand for the deletion of a patient's health information from the Health Sector Database shall be addressed to the Medical Director, who shall see to it that the demand is implemented. deCODE genetics will pay the costs incurred in processing and executing such demands.

If necessary, both deCODE and the Board of the IMA will urge that amendments be made to the law on the Health Sector Database No. 139/1998 to ensure the law's conformity with these rules. Id. However, there was some dispute as to the language used when the statement was translated from Icelandic into English. Specifically, the Icelandic version said that the talks "covered the content and have been to the point," as compared to the characterization of the discussions as "both positive and productive" in English on the deCODE Web site. Alison Abbott, Iceland's Doctors Rebuffed in Health Data Row, 406 NATURE 819 (2000), available at http://mannvernd.is/english/ news/IMA.rebuffed.html. 142. Mannvernd was highly critical of the protocols for "opt-outs": The Director General of Public Health in advertisements in the newspapers states that opt-outs will be possible for a while longer or until the database starts operation. This will not happen immediately, only after some months. The advertisements state that after operation of the database starts, information will be entered irrevocably into the database. By opting out after the No. 21 CORPORATE GENOMICS not need IMA approval to proceed with the database and stated that he intended to proceed on the basis of presumed consent.'43

3. Outside Experts Opposition to the IHD has also come from the United States. Notably, Henry Greely, a law professor at Stanford University and Ethics Chair of the North American Committee of the Human Genome Diversity Project, has spoken openly about his concerns regarding the IHD.144 His concerns focus on the ill effects of such research studies on human subjects, and stem from the fact that Iceland possesses a unique opportunity to set the standard for conducting ethical genomic research.'45 In a letter co-authored with Mary Claire King, a noted geneticist and Professor of Anthropology at the University of Washington, Greely urged the Icelandic government to reconsider the current structure of the database from the standpoints of consent, confidentiality, financial returns, and scientific openness."' The letter finds the concept of consent in the health database legislation to be "too broad" and notes that provisions to maintain data security "cannot guarantee true confidentiality."' 47 Furthermore, Greely and King believe that the licensing fees "will not be a net benefit to Iceland" and that, overall, "the Icelandic people deserve a larger share in the potential commercial value of this resource, created from their own medical

start of operation of the database an individual can stop entry of further data onto the database but previously entered data will still be used. They will not be removed and an individual can thus not stop participation in research for those data already entered. Mannvernd considers this to be in direct opposition to the Helsinki Declaration of the World Medical Association which states that individuals must be able to quit participation in research at any time. Opt-outs from Icelandic Health Sector Database, at http://www.mannvernd.is/english/optout.html (last visited Mar. 20, 2003). 143. Alison Abbott, Iceland's Doctors Rebuffed in Health Data Row, 406 NATURE 819 (2000), available at http://mannvernd.is/english/news/IMA.rebuffed.html. 144. Greely is a Professor of Law at Stanford University, Director of the Stanford Program in Law, Science & Technology, a Professor (by courtesy) of genetics, co-director of the Stanford Program on Genomics, Ethics, and Society, and the Ethics chair of the North American Committee of the Human Genome Diversity Project. Stanford Law School, Faculty Profiles, Henry T. Greely, at http://www.law.stanford.edu/faculty/greely/Greely-CV.htn-l (last visited Mar. 20,2003). 145. Professor Greely expressed serious concerns about deCODE's research and the IHD in a newspaper interview: "Advances in the speed and cost of genetic analysis are about to make it possible to collect huge amounts of clinic and genetic data from hundreds of thousands of people and process it through powerful computers. Iceland is the first example we've got of this kind of large scale correlation of data, and I'd like to see it done in a way that was ethically right."

Science has a lot at stake in making sure that people don't feel cheated and embittered when they take part in research ....I worry that there will be an episode which leaves the research subjects unhappy, mistreated, resentful and burned." Lyall, supra note 34. 146. Letter from Dr. Henry T. Greely, Professor of Law at Stanford [sic] University and Dr. Mary Claire King, Professor of Anthropology at the University of Washington, to the Government of Iceland, http://mannvernd.is/english/articles/greely_&._king-e.html (last visited Mar. 20, 2003). 147. Id. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002 histories." '148 The tone of the letter is a combination of excitement at the potential scientific and medical value of this research and concern regarding the current form of the database and legislation, which, in essence, gives a for-profit corporation control over the use and benefits of the database.

IV. A GLOBAL SEARCH FOR GENES Genetic research in Iceland has been the touchstone for other ambitious genetic research projects around the globe. Currently, many private companies are engaging in the practice of "'bioprospecting'- looking at the genetics of small, homogeneous populations in order to locate medically significant genes."'49 Because it is much easier for geneticists to study these small, inbred populations, examining these groups makes it possible to more easily track chromosome markers and correlate these markers with disease traits.5'

A. Estonia: "[T]he [M]ore [R]esponsible [A]pproach"?15 The former Soviet republic of Estonia also has embarked on an effort to catalog and analyze the genetic data of its citizens.152 The Estonian Parliament passed the Human Research Act in December 2000, paving the way for genetic research through the creation of a gene bank.' Created on March 26, 2001,"'1 the Estonian Genome Project differs from Iceland's in that the Estonian government will control the data obtained from Estonia's 1.4 million inhabitants through a non-profit entity, the Estonian Genome Project Foundation.'55 The Government of Estonia established EGeen, a public company, to handle project financing issues.'56 The cost of this project is estimated at $100 million.'57

148. Id. 149. Norse Code: A Fierce Debate in Iceland over Genetics Foreshadows Many Future, Similar Battles Elsewhere, ECONOMIST, Dec. 5, 1998, at 99. Scientists have also engaged in bioprospecting at Yellowstone National Park in the hopes of identifying a lucrative microbe. Yellowstone has not benefited from any such discoveries. See Yellowstone National Park, Thermophiles, at http://www.nps.gov/yell/nature/thermophiles/biopro.html (last updated Feb. 7, 2001). Environmental groups and Yellowstone visitors sued the National Park Service, alleging that the agreement allowing the San Diego-based Diversa Corporation to bioprospect for microbes violated federal law. The United States District Court for the District of Columbia upheld the agreement. See Edmonds Institute v. Babbit, 93 F. Supp. 2d 63 (D.D.C. 2000). 150. See Norse Code, supra note 149. 151. See Lone Frank, Estonia Prepares for National DNA Database, 290 SCIENCE 31 (Oct. 6, 2000). 152. Id. 153. ESTONIAN GENOME PROJECT FOUNDATION, ESTONIAN GENOME PROJECT 3, http://www.geenivaramu.ee/mp3/trykisENG.pdf (last visited Mar. 20, 2003) [hereinafter ESTONIAN GENOME PROJECT]. 154. Id. 155. Vijai Maheshwari, Estonia Touts Its Genetic Credentials, FINANCIAL TIMES, Nov. 1, 2000, at http://globalarchive.ft.com/globalarchive/article.html?id=001101001566. 156. ESTONIAN GENOME PROJECT, supra note 153, at 3. No. 2] CORPORATE GENOMICS

Informed consent is required of all persons donating samples to become part of the Gene Bank.'58 Moreover, Estonian citizens will have access to the data they furnish and will ultimately be educated in the uses of this genetic research. 159

B. Tonga and Newfoundland In late 2000, Autogen, an Australian concern, acquired exclusive rights to conduct genetic research based on the inhabitants of Tonga. 6 ' Tonga is an archipelago of approximately 170 islands located in the South Pacific, with a population of approximately 100,000.161 Autogen carefully laid out its aim for this project: the identification of genes that cause common diseases, using the "unique population resources in the Kingdom of Tonga. ''16 2 Specifically, its statement of ethical standards and planned benefit-sharing indicates that the Tongan government and its citizens will share in the benefits of any future drug discoveries. 63 In contrast, scientists from Baylor College of Medicine in Texas allegedly failed to provide local physicians and patient subjects with any substantial information after they went to Newfoundland to study a rare

157. Maheshwari, supra note 155. 158. ESTONIAN GENOME PROJECT, supra note 153, at 7. 159. The Estonian Genome Project asserts that "every person, despite the fact whether he/she participates in the Project or not, will receive general knowledge of genetics, either through the contribution of the media or directly from a doctor." ESTONIAN GENOME PROJECT, supra note 153, at 4. See also Frank, supra note 151, at 31 (comparing the Estonian Genome Project to the Icelandic project). 160. John Duce, Tonga Gene Pool Rights Acquired, BBC NEWS, Nov. 22, 2000, at http://news.bbc.co.uk/l/hi/world/asia-pacific/1035686.stm. 161. Country Profile: Tonga, BBC News, at http://news.bbc.co.uk/hi/english/world/asia- pacific/country-profiles/1300742.stm (last updated Mar. 10, 2003). 162. Press Release, Autogen Limited, Autogen Announces New Gene Discovery Initiative in the South Pacific Island of Tonga (Nov. 17, 2000), at http://www.autogenlimited.com.au/ir.html. Autogen described the agreement with the Tongan Ministry of Health as follows: This new initiative will establish a genetics based research facility in Tonga with the aim of developing a major health database for the purpose of identifying disease-causing genes. The Kingdom of Tonga has a population of around 108,000 people of Polynesian descent. The unique family structure and isolation of this population together with the high prevalence of a variety of diseases represents a major resource for geneticists to identify genes that predispose people to these diseases. Under the terms of the agreement, any serum or DNA samples collected in Tonga shall remain the property of Tonga and Autogen will provide the resources to establish a health database and create a major research facility in Tonga. The collection of DNA and medical information will be in accordance with the highest ethical standards. In return for access to these samples and data, Autogen will provide annual research funding to Tonga's Ministry of Health in addition to paying net royalties on revenues generated from any discoveries that are commercialised. These funds will be of great benefit to the people of Tonga. Id. 163. See id.; see also Autogen Limited, Ethical Standards for Research (discussing Autogen's research ethics), available at http://www.autogenlimited.com.au/research.html (last visited Mar. 20, 2003). JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002 congenital heart disease that affects its inhabitants."6 Some Newfoundlanders refer to the incident as an act of "biopiracy," alleging that their genetic information was being exploited for the benefit of foreigners.165

C. Tristan da Cunha, Norfolk Island, and Gioi A group of researchers from the University of Toronto targeted the tiny South Atlantic island of Tristan da Cunha to search for genetic links to asthma."6 These academic researchers, led by pulmonologist Arthur Slutsky, collaborated with Sequana Genetics in conducting this research.167 Most inhabitants trace their roots to 15 settlers, who came to the island in the early nineteenth century."6 Of the 300 residents, approximately 57 percent suffer from some form of asthma.169 These circumstances favored the research and made the possibility of a 1 7 scientific breakthrough more likely. 1 On May 21, 1997, Sequana Therapeutics, based in La Jolla, California, and allied with Boehringer Ingelheim, a German pharmaceuticals company, announced that its collaborative research effort had discovered a gene responsible for 17 asthma. 1 Critics have referred to the announcement as "genetics by press release,1 72 pointing out that it was not accompanied by specifics detailing the finding. 73 To date, this gene has not been identified publicly. This instance demonstrates that when dealing with corporations in the business of for-profit genetics research, the high cost of operations and the pressure to meet Wall Street expectations lead to less traditional methods of scientific discovery and reporting.

164. Sarah Staples, Newfoundland's 300-Year-Old Genetic Legacy Has Triggered a Gold Rush, TORONTO GLOBE & MAIL, Aug. 25, 2000, at 116. 165. Id. 166. Gretchen Vogel, A Scientific Result Without the Science, 276 SCIENCE 1327 (May 30, 1997). 167. Id. 168. Id. 169. Id. 170. See id. In addition, Sequana planned to conduct asthma studies with its academic partners in southern India and on Easter Island in the South Pacific. See Eliot Marshall, Human Genetics: Gene Prospectingin Remote Populations,278 SCIENCE 565 (Oct. 24, 1997). 171. Press Release, Axys Pharmaceuticals, Sequana Discovers Asthma Gene (May 21, 1997), at http://www.schizophrenia.coninewletter/697news52.htm#Theraputics%20 %2Discovers%2OAsthma %20Gene,%20Working%20on. Due to competition and consolidation in the biotechnology industry, there is a now circuitous path leading to what was originally Sequana. In November 1997, Sequana announced that it would merge with Arris Pharmaceutical Corporation to form a new company, Axys Pharmaceuticals. Press Release, Sequana, Arris and Sequana Merge to Form New Company, Axys Pharmaceuticals (Nov. 3, 1997), at http://www.nextwavestocks.com/ m&al197.html#Arris-Sequana. Four years later, Celera Genomics acquired Axys. Press Release, Celera Acquisition of Axys Pharmaceuticals Approved (Nov. 16, 2001), at http://www.applera.com/ press/prccorplll601.html. Celera is an operating unit of the Applera Corporation, which also operates Applied Biosystems. Celera Genomics, Corporate Information: Overview, at http://www.celera.com/company/home.cfm (last visited Mar. 20,2003). 172. Vogel, supra note 166. 173. See id. No. 2] CORPORATE GENOMICS

Researchers from Griffith University in Queensland, Australia, conducted a similar study aimed at discovering the genetic predispositions to high blood pressure.'74 Scientists collected blood samples from the inhabitants of Norfolk Island, located in the South Pacific east of Australia, with a population of under 1,900. "7 In 1856, the British government relocated the descendants of mutineers from the HMS Bounty from Pitcairn Island to Norfolk Island. 71 6 Two-thirds of the island's current inhabitants can trace their ancestry to the mutineers. 177 Finally, a similar study has begun recently in the Italian village of Gioi, 65 miles south of Naples with a population of 1,600.1s A plague in 1556 kept the inhabitants, who speak an obscure dialect of Italian more similar to Latin, isolated from the outside world. 179 Thus, Gioi is an isolated population with few genetic variations, making it another ideal location for a genetic study.

D. Great Britain In the United Kingdom, the National Health Service ("NHS") possesses 50 years of data, including patient records and tissue samples, which have enormous potential value for genetic research."8 To tap this potential, the Medical Research Council and the Wellcome Trust have proposed the creation of the UK Population Biomedical Collection, to be composed initially of a study population of 500,000.18' However, British scientists and lawmakers have been cautious to avoid the notoriety that has plagued Iceland.'82 One model that has been suggested is a "precompetitive public-private consortium requiring a fusion of technologies (particularly biomedical, informatics, and communications disciplines), involving multiple companies, universities, medical research charities, and government."' 83 The Human Genetics Commission also emphasized public awareness by publishing a document discussing the basics of genetic research and its implications." 4 In addition, privacy and

174. Steve Connor, How the Mutiny on the "Bounty" May Help Scientists' Quest for a Heart Disease Cure, INDEPENDENT, July 3, 2000, http://www.independent.co.uk/story.jsp?story=3097. 175. CIA WORLD FACT BOOK, supra note 26. 176. Connor, supra note 174. 177. Id. 178. James Charles, Lost Village Could Hold Key to Cures, THE EXPRESS, Jan. 3,2001. 179. Id. 180. Robin Fears & George Poste, Health Care Delivery: Building Population Genetics Resources Using the U.K. NHS, 284 SCIENCE, 267,267-68 (Apr. 9, 1999). 181. John A. Robertson, Privacy Issues in Second Stage Genomics, 40 JURIMETRICS J. 59, 75 (1999); RHYDIAN HAPGOOD ET AL., THE WELLCOME TRUST, CONSULTATION WITH PRIMARY HEALTH PROFESSIONALS ON THE PROPOSED UK POPULATION BIOMEDICAL COLLECTION (Apr. 6, 2001), at http://www.wellcome.ac.uk/en/images/GPreportFinaldoc_3984.pdf. 182. Fears & Poste, supra note 180, at 267-68. 183. See id. 184. Human Genetics Commission, Whose Hands On Your Genes? A Discussion Document on the Storage, Protection, and Use of Personal Genetic Information, at http://www.hgc.gov.uk/ businessconsultations2maintext.pdf (last visited Mar. 20, 2003). JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002 consent are major concerns. A government report found that the Data Protection Act of 1998, which makes it illegal to identify specific patients without their personal consent, provided adequate safeguards for processing personal genetic data and did not deem further protection necessary.'85 Furthermore, the Human Genetics Advisory Commission and the Advisory Committee on Genetic Testing have been involved in devising guidelines for non-medical uses of genetic information."8

V. RECENT DEVELOPMENTS AND RECOMMENDATIONS A. Recent Developments deCODE's recent discoveries underscore the tremendous potential of the IHD. An alliance with Affymetrix, creator of the gene-chip technology, enables deCODE to link its efforts to the developing field of "personalized" medicine." In May 2001, deCODE identified a gene thought to be involved in triggering strokes and mapped another gene thought to be linked to adult-onset diabetes."8 New alliances with Genmab, Applied Biosystems, and Roche were announced in June and July of 2001.189 The company also announced that it successfully mapped the obesity gene in conjunction with Roche."9 In late October 2001, it announced that it had discovered the location of a gene thought to be involved in late-onset Parkinson's Disease. 9' In November 2001, deCODE revealed its discovery of 350 genes with targets for potential drugs and reported that it had filed U.S. patent applications on these targets. 19'

185. See Data Protection Act, 1998, c. 29 (Eng.), http://www.hmso.gov.uk/acts/ acts1998/19980029.htm; Science and Technology Committee, Fourth Report, Mar. 20, 2001, § 3.17, http://www.publications.pariament.uk/pa/ld20000l/ldselect/ ldsctech/57/5705.htm#a26. 186. Fears & Poste, supra note 180, at 267-68. 187. Vanessa Fuhrmans, DNA Test for Drug Responses Planned, WALL ST. J., July 25, 2001, at B7. 188. Vanessa Fuhrmans, DeCode, Roche Identify Genes Involved in Strokes and Diabetes, WALL ST. J., May 23,2001, at B19. 189. Press Release, deCODE Genetics, deCODE Genetics and Applied Biosystems in Alliance to Build Systems for the Next Generation of Genotyping Studies (July 19, 2001), at http://www.decode.com; Press Release, deCODE Genetics, deCODE and Roche Sign Landmark Alliance to Develop Integrated DNA-Based Diagnostic Tools and Related Services and Software (July 2, 2001), at http://www.decode.com; Press Release, deCODE Genetics, deCODE and Genmab Announce Major Alliance to Turn Population Genomics Discoveries Into Human Antibody Therapeutics (June 12, 2001), at http://www.decode.com; Press Release, deCODE Genetics, deCODE Genetics and Genmab Announce Pharmacogenomics Alliance in Rheumatoid Arthritis (June 12, 2001), at http://www.decode.com (all press releases available in the "News & Investors" section of the Web site). 190. Press Release, deCODE Genetics, deCODE and Roche Announce the Location of Genes Linked to Obesity and Anxiety (Sept. 11, 2001), at http://www.decode.com. 191. Vanessa Fuhrmans, Decode Maps Gene Thought to Have Parkinson'sRole, WALL ST. J., Oct. 24, 2001, at B2. 192. Decode Uncovers Genes With Drug Targets, WALL ST. J., Nov. 7, 2001, at B4; Press Release, deCODE Genetics, deCODE Files Patents on 350 Drug Targets - All with Population Linkage Data No. 2] CORPORATE GENOMICS

deCODE marked the start of 2002 by announcing new strategic alliances with Pharmacia and Roche.193 It also announced the planned acquisition of MediChem Life Sciences, a biopharmaceuticals company based in Woodridge, Illinois, in a stock-for-stock exchange. 94 The Federal Trade Commission approved the transaction in February and the acquisition was completed in March.195 April and May saw the approval of legislation in Iceland to guarantee convertible bonds to finance deCODE's expansion.' In June and July, deCODE published a high- resolution map of the human genome and announced the results of studies in the areas of asthma, drug-resistant bacteria, hypertension, and schizophrenia.197 Thus, it is evident that deCODE's initial efforts have already resulted in significant discoveries. It remains to be seen whether these discoveries will translate into effective drug therapies or cures.

B. Recommendations and Conclusion To determine whether deCODE's database and research are consistent with ethical norms for scientific research, it is necessary to examine the World Medical Association Declaration of Helsinki, adopted in 1964 and amended most recently in 2000.198 The Declaration provides that "[m]edical research is subject to ethical standards that promote respect for all human beings and protect their health and rights."'" It obliges researchers to abide by the research standards of

in Major Diseases (Nov. 7, 2001), at http://www.decode.com ("deCODE has applied for patents on the targets identified and has included the relevant disease linkage data in its applications."). 193. Press Release, deCODE Genetics, deCODE and Roche Unveil New Alliance in Drug Discovery and Development (Jan. 29, 2002), at http://www.decode.com; Press Release, deCODE Genetics, deCODE and Pharmacia Form Pharmacogenomics Alliance (Jan. 15, 2002), at http://www.decode.com. 194. Press Release, deCODE Genetics, deCODE Genetics to Acquire MediChem Life Sciences (Jan. 8, 2002), at http://www.decode.com. 195. Press Release, deCODE Genetics, deCODE Genetics and MediChem Life Sciences Receive Early Hart-Scott-Rodino Clearance (Feb. 21, 2002), at http://www.decode.com/news/releases/ older/?year=2002; Press Release, deCODE Genetics, deCODE Announces Completion of MediChem Acquisition (Jan. 1, 2002), at http://www.decode.com. 196. See supra text accompanying notes 100-03. 197. Press Release, deCODE Genetics, deCODE Publishes Landmark Study Linking the Neuregulin 1 Gene to Schizophrenia (July 24, 2002), at http://www.decode.com; Press Release, deCODE Genetics, deCODE Announces Fundamental Discoveries in the Genetics and Pharmacogenomics of Asthma and Allergy (July 17, 2002), at http://www.decode.com; Press Release, deCODE Genetics, deCODE and Elitra Advance Alliance to Discover Novel Antibiotics to Fight Drug-Resistant Bacteria (July 1, 2002), at http://www.decode.com; Press Release, deCODE Genetics, deCODE Announces Mapping of a Hypertension Gene on Chromosome 18 (June 26, 2002), at http://www.decode.com; Press Release, deCODE Genetics, deCODE Publishes High-Resolution Genetic Map of the Human Genome (June 9, 2002), at http://www.decode.com. 198. 52nd WMA General Assembly, World Medical Assn. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2000), adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and most recently amended by the 52nd WMA General Assembly, Edinburgh, Scotland, Oct. 2000, available at http://www.wma.net/e/policy/17- c_e.html 199. Id. at art. 8. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002 their own countries, as well as generally accepted international norms, setting baseline requirements that neither national legislation nor regulations should undermine."°° Articles 21 and 22 are particularly relevant to deCODE: 21. The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on... the personality of the subject. 22. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed."° In light of these provisions, the deCODE plan does not adequately safeguard individual privacy. Its attempts to proceed on presumed consent do not meet the conditions of Article 22.22 This failure to comply with international standards has caused dissent and controversy regarding the IHD since it was first proposed. The Icelandic government's support of deCODE, as demonstrated by its rapid enactment of the 1998 Act, has fostered allegations of collusion and corruption. The government allegedly accepted a $250,000 contribution from deCODE during the ratification process.203 Further, it has been alleged that the Independence Party and the Progressive Party accepted 20 million ISK (approximately $200,000) and 17.5 million ISK (approximately $170,000), respectively, from deCODE to ensure the passage of the 1998 Act.2°4 No disclosures have been made to confirm or deny these alleged contributions from deCODE. °5 Prime Minister Oddsson has opposed efforts to make political parties disclose

200. Id. at art. 9. 201. Id. at arts. 21-22. 202. It may also be useful to evaluate deCODE's actions based on the European Parliament's Directive on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data. See Council Directive 95/46/EC, 1995 O.J. (L 281) 31. 203. Kristen Philiposki, Genetic Scandal Inflames Iceland, WIRED (Mar. 20, 2000), at http://www.wired.com/news/politics/0,1283,35024,00.html. 204. Valdimar Johannesson, Are Icelandic Politicians For Sale?, Morgunblaoio, Nov. 2, 1999, at http://www.mannvernd.is/english/articles/forsale.html. 205. Philiposki, supra note 203. No. 2] CORPORATE GENOMICS

donations.2 6 In addition, an Icelandic newspaper reported that deCODE bought a building for its headquarters from a company called Hans Petersen, owned by the family of Astridur Thorarensen, wife of Prime Minister David Oddsson.2° According to the article, Thorarensen is a shareholder and director of the company.2 8 Thus, deCODE appears to be "the favorite child of the ministers [of Parliament]. ' 2° The company must take steps to address these apparent improprieties in an enterprise in which ethical conduct is paramount. While there has been significant opposition and controversy surrounding the IHD, there are compelling reasons to support the research. The government sees two critical benefits to the research. First, the creation of a cutting-edge computer records system, available to all health care institutions in the country, will improve the quality of health care for all Icelanders. Second, deCODE employs some 600 scientists, effectively reversing the "brain drain" of Iceland's top scientific minds, who previously went to Europe and the United States to pursue their careers. Furthermore, from a policy perspective, one must take into account the cultural climate in Iceland. Its citizens may very well have a different attitude towards medical research and the advancement of science than American citizens. Indeed, there has been some resistance to the opposition to deCODE's research that comes from abroad, particularly from Europe and the United States. 10 Because the enterprise may not afford useful - and hence profitable results - deCODE and its shareholders shoulder enormous financial risk. Icelanders also bear substantial risk given the aforementioned privacy concerns they face, because it is their genetic data that make the research possible, and because of the financial and institutional support that their government has provided to deCODE. Thus, perhaps the most appropriate form of risk/benefit sharing would involve a percentage stake by the Icelandic government in the corporation itself, or an agreement which stipulated that the Government of Iceland would receive a fixed percentage of deCODE's profits. This would enable the Icelandic government to share in the potential rewards if and when they materialize.

206. Id. 207. Id. 208. Id. 209. Honesty and Trust: The Icelandic Newspaper Dagur Asks David Oddsson: "Has the Independence Party Accepted Money From the Icelandic Subsidiary of deCODE Genetics or it's [sic] Partners?", DAGUR (Icelandic newspaper), Dec. 11, 1998, at http://www.mannvernd.is/english/ news/dagur.um.greidslur.ensk.html. 210. Gisli Palsson, director of the Institute of Anthropology at the University of Iceland, expressed her skepticism of foreign opinion regarding the health database: People adopt a view from afar and think they understand what's going on in a place that's culturally very different from their own ....But there was a fierce debate for months, with public participation, and one has to conclude that it has been an informed and lengthy discussion, a democratic process. Lyall, supra note 34. JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2002

The question of who may ultimately gain access to IHD information points to a larger tension between medical and commercial uses for genetic information. Indeed, patients may not want their employers or insurers to possess the same breadth of information as their doctors.1 Should insurance companies gain substantial amounts of genetic data as customers of end products that deCODE might market as a result of its research using the IHD, they may no longer offer the type of comprehensive health coverage offered today. Two possible alternatives - the creation of medical treatment funds or the creation of state-run health care systems - could be used to avoid this situation.212 While these solutions would go far to offset any unfair advantage that insurers might obtain, they represent potentially expensive and administratively burdensome remedies that may be more easily said than done. The Icelandic Health Sector Database created by deCODE is a bold step in using genetic research to understand and ultimately cure disease. New human genomic research conducted throughout the world will likely use Iceland as a template. Although this scientific investigation's to be implications are not yet fully quantifiable, they have the potential213 far-reaching. Therefore, "[a]s Iceland goes, so may go the world.

211. Who Owns Your Genes? Not All the Questions Raised by Genomics are Scientific Ones, ECONOMIST, June 29, 2000, available at http://www.economist.com/displayStory.cfm?Story-id=2859. 212. See id. 213. Norse Code, supra note 149.