DeCODE Iceland and genetic databanks: where ‘consent’ to genetic research means patenting a nation’s genes

AUTHOR
Maria Canellopoulou-Bottis

ABSTRACT

In 1998 Iceland passed a bill that gave a biomedical company the right to combine all of the country’s genetic, medical and genealogical information in one database. This bill was the Health Sector Database Act. This project has probably been the largest, in health informatics of this kind, as Iceland’s total population is about 270.000 people. Iceland had in its possession an almost unimaginable medical record: tissue samples of the entire population. The final database would contain a combination of the genealogical database, the genetic database and the medical database, of all past, present and future medical records from the entire population, living and dead.

The project was based at the uniqueness of Iceland’s population: relatively small, almost obsessed with issues of genealogy, in isolation geographically and with little migration-a homogeneous people, whose tissues have been stored with great care since 1915. Scientists have sustained that this is an ideal pool (a ‘good’ population) for genetic research on a great number of diseases, from Alzheimer to cancer, manic depression, asthma, multiple sclerosis cardiopulmonary diseases, metabolic diseases and others.

DeCODE Genetics ‘won’ the contract with the Icelandic state (actually, the bill was drafted by deCODE and deCODE was the only company competent, under the terms of the bill, to contract with Iceland). DeCODE was granted an exclusive license to use the nation’s existing databases (and construct the Health Sector Database) for 12 years with the possibility of renewal. The Icelanders’ consent to the use of their tissue samples and their genetic data by deCODE was just presumed. Only after a later amendment (due to plain outrage) an opt-out clause was inserted in the bill and any Icelander who does not wish her information to be processed by deCODE must file an opting-out form with the Director of Public Health. Genetic information of children or dead persons became instantly part deCODE’s research material.

DeCODE has stated that the database (which has not been concluded yet) is its own intellectual property, as the idea and the whole effort into this project was indeed, deCODE’ s. It therefore claims the right to patent the process to find particular genes and the means to amplify genes. What the Icelanders will receive for their contributions to the research (their genetic and medical information) is free drugs, if these drugs are developed due to deCODE’s research and its collaboration with giant pharmaceutical companies as Hoffman La Roche. But this ‘deal’ does not seem fair enough. The Icelanders most probably should have a share in the profits these companies plan to receive, using, as raw invaluable material, their genes. Perhaps if Icelanders knew that this DNA database has been estimated, as an initial estimate, up to 14 billion dollars, then they would not accept the possibility of free drugs as their only remuneration. Even though, relatively new legal rules have allowed the commodification of genetic data internationally, as new life forms, like the Oncomouse, have been in fact patented, after a long intellectual property law history, which was steadily against patenting life.

Another intellectual property question, aside of patents to genes, is the rights deCODE shall enjoy, as a maker of this database. The rather new sui generis right to a database, after a European Directive, is in effect a perpetual right against extraction and reuse of a substantial (and sometimes, insubstantial) part of a protected database, if this database has been the result of substantial investment (quantitatively or qualitatively). Iceland is not a member of the European Union, but this could happen anytime; one wonders whether it is a coincidence that the first bill on the Icelandic database, drafted by deCODE, contained a definition of the Icelandic database worded verbatim after the Directive’s definition of a protected database (and that subsequent definitions follow this wording very closely).

DeCODE assured Icelanders that their information would remain in the strictest confidence. Actually, a complicated encryption system has been established used to ensure that no employee of deCODE would have the keys to unlock and see whose the particular medical/genetic data are. But many Icelanders do not believe in this anonymity and a report by a Cambridge computer expert on this sensitive point helped intensify their fears. Researchers have also characterized this system, in terms of confidentiality, as ‘a bad joke’. In a rather small place like Iceland, knowing one’s occupation, age, height, sex, residence, in short everything but a name means only that you known the name as well.

It seems, then, that a genetic treasurehouse has become a commercial monopoly. It also seems that this monopoly used Icelanders’ love for genealogy, their positive feelings over the progress of science and their nation’s contribution to scientific evolutions and their assents, for profit. This looks like the perfect example of the breach of Kant’s imperative, use people as ends and never as means. In the meantime, deCODE’s stock has been falling incessantly and resulting into grave losses for the untutored financially Icelanders who bought it.

It follows then that we are in a sort of crossroads. People support science, even if scientific research has had its very dark pages in the past. But whether a private company may exploit a whole nation’s most valuable and most intimate asset in the name of science research, under terms, which clash to the most important international instruments on medical research, this is quite a different question. It demands such a strong justification in terms of humanity welfare that it is almost impossible to develop, given the sad fact that, as things are now, we may have been betrayed by the promise of genetic research to cure illnesses and that the gene myth may have been almost exploded. The story of Iceland and deCODE Genetics is a clear example of how careful we have to be, before we grant dangerous and, in the end, not so promising privileges.

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