American Journal of Law & Medicine

Iceland's Health Sector Database: A Significant Head Start in the Search for the Biological Grail or an Irreversible Error?

I. INTRODUCTION

In December 1998, Iceland's Parliament, the Althing,(1) passed the Act on a Health Sector Database (the Database Act or Act), a highly controversial law authorizing the development of a Health Sector Database (the Database) to collect genetic and medical information already contained in various locations around Iceland as part of Iceland's national health system.(2) As a result of the Database Act, Iceland is the only country in the world with laws authorizing collection and storage of the genetic heritage of an entire population by a private biotechnology corporation with rights to exploit the data as a commercial commodity. Many databases now exist in Iceland as individual and segregated entities that contain detailed medical information about every Icelandic person, both living and dead, dating back to 1915 when the recording commenced.

The existing databases will now be linked together in a single centralized electronic database created and operated by a private biotechnology company, deCODE Genetics (deCODE),(3) pursuant to an operating license agreement with the Icelandic Government. In fact, deCODE has recorded a vast amount of genealogical information in order to facilitate the research and the use of genetic information.(4) The entering of data into the Database was to commence six months after the enactment of the Database Act.(5) According to deCODE, it will take at least two years to make the Database available once the license has been granted.(6)

The Database Act has stimulated great excitement among both domestic and international researchers from its inception, but it is also one of the most criticized pieces of legislation in Iceland's history. Some researchers warn about the project's dangers and proclaim it unethical and damaging both to Iceland and to international scientific research.(7) The Database Act's introduction basically divided Icelandic citizens into two opposing groups: academics and scientists. Academics and scientists are engaged in a fuming debate about the value of the project to the nation and to science.(8) Foreign scholars and scientists have also contributed significantly to the debate, both as individuals and through professional associations.

This paper will address the most controversial points of the Database Act and it will analyze the Act based on the relevant legal and ethical principles in both the domestic and international contexts. In Part II, the paper will discuss international and national efforts to address the issues raised by genetic science including international treaties and national legislation. In Part III, this paper will address Iceland's recent "solution" to some of the issues raised by genetic science--the Database Act. Among the topics to be discussed are: the origins of the Database Act, including the reasons why Iceland developed the first system to store the genetic information of an entire population; the Act's requirements; and controversies surrounding the Act's provisions, especially the issues raised by Iceland's decision to license a private corporation to create and maintain the Database. The paper concludes that Iceland's decision to license a private corporation to create a national genetic database was sound and that the Database Act generally, is in compliance with internationally accepted protocols

II. GENETIC SCIENCE AND INTERNATIONAL EFFORTS TO ADDRESS ITS POTENTIAL EFFECTS

A. GENETIC SCIENCE

The Human Genome Project, an international effort to sequence the human genome that originated in the United States, has led to extensive developments in the field of molecular biology.(9) The power of molecular genetics and biotechnology to generate diagnostic, predictive and life-enhancing tools is taking medicine in new directions.(10) Proponents of new genetic technology expect and hope that the technology will bring revolutionary benefits for mankind. However, some critics do not share their sometimes overzealous optimism and they warn that care and balance are crucial elements to successful use of genetic technology. But care and balance are one thing, and a conservative disposition that might impede scientific progress is another.

B. THE COUNCIL OF EUROPE AND THE BIOETHICS CONVENTION

1. The Council of Europe

The international community must examine the pertinent legal, ethical and social implications of genetic science as science uncovers the miracles of the human genome. To realize the prospects of future betterment for mankind while avoiding the potential threats to society presented by genetic science, our social principles must be as sophisticated as the science itself. The Council of Europe (the Council) is a pioneer in addressing these issues in an international context.(11) The Council has debated human rights issues in the context of biomedical sciences, especially with regard to human genetics, for nearly two decades.(12) The Council broke new ground with respect to the biomedical sciences with the establishment of the Steering Committee on Bioethics (the Steering Committee).(13) The Steering Committee has engaged in extensive work on different legal aspects of human genome research, and it has provided significant insight into various legal aspects of genetic science affecting the individual.(14)

2. The Bioethics Convention Debate

The conflicting philosophical views surrounding genetic science are probably best described by looking at the ethical background to the Council's Convention on Human Rights and Biomedicine (the Convention).(15) The Convention is the first legally-binding international text designed to preserve human dignity, rights and freedoms through a series of principles and prohibitions against the misuse of biological and medical advances.(16) The Convention was signed on April 4, 1997, and Iceland was among the signatories at the conference. However, Iceland has not yet ratified the Convention. The Bioethics Convention is one of the Council's most significant accomplishments.

The Convention's significance lies, inter alia, in its nature as a convention, which means that it confers certain legal obligations on the Member States.(17) Moreover, the Convention is important because it addresses the human genome in a series of provisions.(18) In spite of being regional in character, the Convention is open and relevant to all nations of the world and will thus have significant influence outside Europe.(19)

According to the Convention, the interests of human beings must come before the interests of science or society.(20) The Convention lays down a series of principles and prohibitions concerning subjects such as bioethics, medical research, consent, rights to private life and information, organ transplantation and public debate.(21) It bans all forms of discrimination based on a person's genetic make-up and only allows predictive genetic tests for medical purposes.(22) It allows genetic engineering only for preventive, diagnostic or therapeutic reasons and only where the genetic engineering is not used to change the genetic make-up of a person's descendants.(23) Furthermore, the Convention sets out detailed and precise conditions for medical research, especially for people who cannot give their consent.(24)

The Convention requires express consent to treatment, in advance (except in emergencies) and authorizes withdrawal of consent at any time.(25) A person unable to consent may only be treated if the treatment could produce real and direct benefit to his or her health.(26) The Convention stipulates that all patients have a right to be informed about their health, including the results of predictive genetic tests.(27) The Convention states that scientific research in the field of biology and medicine shall be carried out freely, subject to the Convention's provisions and the other legal provisions ensuring the protection of human beings.(28) Participants in the Convention can only restrict the Convention's rights and protections if such restrictions are prescribed by law and necessary in the interest of public safety, for the prevention of crime, for the protection of public health, or for the protection of the rights and freedoms of others.(29)

The Council's Member States took more than ten years to adopt the Convention because of its controversial subject matter.(30) The subject matter divided experts into two groups over the ten-year period.(31) The conservative or fundamentalist group held that the application of genetic technology to human embryos or germ cells should be forbidden.(32) The group based its fear of genetic manipulation on the notion that relaxed ethical standards would cause moral standards to deteriorate.(33) The essence of the conservative view is that moral responsibility should be modeled on reverence for the image of man.(34) Germans were particularly receptive to emotional arguments against genetic science.(35)

In contrast to the conservative group, the liberals or gradualists contended that human beings constantly change their environment in order to survive and secure a better way of life.(36) They argue that technical innovations, whether primitive tools in ancient times or sophisticated modern technology, always bring some degree of risk.(37) The liberals argue that the negative aspects of genetic technology should be acknowledged and addressed, but that the mere chance of undesirable consequences should not eliminate the possibility of taking advantage of technology that helps mankind survive.(38) The Icelandic Government holds the liberal view(39) as well as countries including Britain, France and Belgium.(40)

The Convention had to balance the views of conservative countries like Germany with the views of liberal nations like Britain. The conservative position of nations like Germany is understandable when considered in an historical perspective. For example, the Nazi's horrendous experiments on concentration camp prisoners and the Nazi's gross abuse of medical and scientific ethics make genetic technology a much more sensitive issue for the Germans. However, Germany's conservative position is questionable because it is inconsistent to argue against the use of genetic technology on moral grounds and at the same time enjoy the medical and business benefits of genetic technology. The international community cannot maintain individual attitudes toward genetic technology. An international consensus must be established to correlate ethical and commercial standards for genetic science. The Convention is a significant step toward harmonizing the differences in this area among the individual European nations.

Some European countries use legislation to regulate issues stemming from genetic technology.(41) Germany,(42) Austria,(43) Italy(44) Spain(45) France(46) United Kingdom,(47) Norway(48) and Denmark,(49) have all enacted various laws on different aspects of the subject. The Swiss Federation enacted a genetic privacy amendment to its Constitution.(50) Many of these countries have special advisory bodies that contribute valuable ethical input and create guidelines for legal reflection and legislative purpose.(51) Generally, European countries have not dealt with genetic privacy through broadly drafted genetic privacy laws. Instead, they have commonly enacted general data protection laws and targeted specific areas of health care including "genetic fingerprinting," prenatal testing and the application of genetic data to employment practices.(52)

3. Iceland's Approach

Iceland does not have any legislation specifically addressing genetic research. Perhaps Iceland sees international treaties such as the Convention as restrictive enough to eliminate the need for national legislation.(53) Iceland's Act on the Rights of Patients (the Patient Act), discussed infra, is Iceland's fundamental law regulating medical research in general, but it does not specifically address genetic research.(54) In any event, the Icelandic Parliament, the Althing, is currently discussing a bill to regulate the scope and extent of the gathering, storage, appropriation and utilization of human tissue samples in order to secure personal privacy.(55) The bill also states that the utilization of the tissue samples serves scientific and medical purposes and contributes to the public's health.(56) The bill does not specifically address genetic research, nor does it regulate genetic science.(57)

II. ICELAND'S DATABASE ACT

A. BEGINNINGS

The Icelandic Government acknowledges that the initiative for the Database Act is primarily attributable to Kari Stefansson, the Chief Executive Officer of deCODE Genetics.(58) In 1997, Stefansson presented a plan to the Icelandic Government to create a centralized electronic database containing health data about Iceland's entire population.(59) Stefansson proposed to fund the database if deCODE received exclusive commercial exploitation for a specified period.(60) In fact, Stefansson was not the first person to suggest a centralized database. In 1975 and 1976, proposals to create a centralized database surfaced but were considered impractical due to the lack of funding and sophisticated information technology.(61) In addition, some people expressed concerns about confidentiality.(62) Iceland abandoned the project but resumed the project in the late 1990s with sufficient funding from deCODE and the availability of advanced computer technology.

DECODE chose Iceland as a venue for promoting the creation of a genetic and medical database for two primary reasons. First, the Icelandic population is probably more genetically homogeneous than any other industrial society thanks to 1,100 years of relative isolation.(63) Icelanders descended from ninth and tenth century Norse settlers and were almost completely isolated from the rest of the world until the beginning of the Twentieth Century.(64) Until Iceland declared independence from the Danish Crown in 1944, Icelanders interacted almost exclusively with the Danes and the Norwegians.(65) A strongly restrictive immigration policy, in addition to thousands of years of plagues, epidemics, earthquakes and volcanic eruptions have weeded out the population in accordance with Darwinian principles, and has kept the gene pool at close to original condition.(66) According to scientists, the Icelandic population reflects the gene pool of Northern Europe as it existed in about A.D. 800.(67) Some scientists even assert that the nation is comprised of the most genetically similar people on earth.(68)

When the British army occupied Iceland after World War II, it brought foreign influence to the country. At that time, Icelanders vigorously implemented the western world's culture into their society.(69) Icelanders have always been reluctant to agree to extensive immigration of people from different ethnic origins and cultures--a conservative view has dominated the country's immigration policy.(70) Cultural and ethnic diversity is rarely found in Icelandic society to the extent that it can be found in other Nordic countries such as Denmark or Sweden.(71)

Second, deCODE's choice was influenced by the popularity of genealogy in Iceland. The recording of genealogical information in Iceland dates back to the literary and historical depiction of early Icelandic society in the Sagas.(72) Some consider the extensive genealogical information in the country to be of significant value in genetic research. The widespread availability of genealogical information enables scientists to link together genealogy and medical records and thus identify and compare genetic lineage in a way that is not available elsewhere.

In addition, Iceland is a small country with a Parliamentarian power structure. The nature of the political system requires a legislative majority as a prerequisite for the formation of a Government; therefore, the Government controls the Legislative Branch as well as the Executive Branch. If deCODE, or anyone else for that matter, sells an idea to the Government, the legislative process becomes more or less a formality. In addition, the small size of the society makes the authorities extremely susceptible to lobbying through an integrated network of power typical in smaller societies.

In early 1998, deCODE issued a new series of class B shares, solely for sale in Iceland.(73) DECODE sold all of the class B stocks to domestic investors.(74) Without the Database Act the prospects for deCODE's future would be seriously jeopardized. The price of deCODE's stock has steadily increased since the enactment of the Database Bill. DeCODE's class B stock originally sold for five U.S. dollars per share. In March of 1999, however, deCODE stock sold for twenty-four U.S. dollars per share on the Icelandic stock market. Whether the decision to sell all of the stocks to domestic investors was a calculated move to gain a further endorsement for the proposed Database Bill, or whether deCODE just used the stock offering to raise capital for deCODE's operations is a matter of speculation. However, common sense suggests that the domestic investors concerned have definitely promoted the Bill with a view to giving their investment greater value.

B. OBJECTIVES OF THE DATABASE

Iceland, like most other European nations with a national system of health insurance, must address two competing factors. On the one hand there is an ongoing demand for more sophisticated health care services. On the other hand there is an increasing demand to reduce health care expenditures. Iceland's national health system provides health care that is considered to be one of the best among the Organization for Economic Co-operation and Development's twenty-nine member nations.(75) The cost of maintaining the Icelandic health care system is constantly increasing and health care is the nation's second most expensive item when it comes to Government expenditures.(76)

The Government has at least four goals for the creation of the Database. First, the Database Act states that the extensive medical records kept by the national health system are a national resource that must be preserved and utilized in the best possible way.(77) The available data are the result of combined efforts of the health care personnel, patients and Icelandic scientists. Patients and other clients of the national health system have given extensive information about their health to health care personnel to receive clinical treatment or to participate in various research projects. Health care personnel have made great efforts to ensure the quality of the information gathered over many decades.

The Government explicitly rejects the concept that recorded medical information submitted to the Database can be subject to legal principles of proprietary rights, especially when the creation and maintenance of the data was financed by public funding.(78) The ownership of medical data, as such, can be attributed to neither legal entities nor individuals.(79) Therefore, the Database gives the nation the opportunity to use existing comprehensive data to improve medical services for the sake of the Icelandic people.

Second, in recent years the Government made an extensive effort to computerize the health care system.(80) In 1997, the Ministry of Health and Social Security (the Ministry) issued a policy statement regarding the future of information technology within the national health system.(81) One of the most urgent tasks implicit in the Ministry's statement is the development of a synchronized patient data system that could gradually create many dispersed and segregated personal databases with the possibility of linkage.(82) The linked database would accommodate the appropriation of medical records and scientific research in fields such as epidemics, demographics and genetic diseases.(83) According to the Ministry, however, such a database is so comprehensive and costly that funding from the national budget is neither a feasible nor a realistic option.(84) DeCODE's participation will make the database possible.

Third, the Government sees the advent of the Database as an opportunity for highly-qualified Icelandic scientists and scholars to return to an environment worthy of their talents. …

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