Icelandic Genetics Database

In 1998, the Althingi (Iceland's parliament) passed the Act on a Health Sector Database (No. 139) authorizing a centralized database of nonpersonally identifiable health data for all Icelanders. The Althingi subsequently granted the firm deCODE genetics, Inc. (henceforth, deCODE) an exclusive license to establish and operate the database. Combined with pedigrees and biological samples, deCODE aimed to use the database to identify alleles of genes that predispose Icelanders to specific diseases. This project was the first large-scale commercial attempt to combine population genomics and epidemiological genetics. The history and implementation of the Act is of great interest as a case study for epidemiological genetics and the issue of genetic discrimination and as what constitutes fair commercial use of publicly contributed and controlled data.

The objective of the bill was to establish a new central database of medical records, with the goal of improving public health in Iceland. The legislation intentionally did not apply to existing collections of medical records or the curating of biological samples. The Act mandated that the Health Sector Database be created and maintained in Iceland by a single licensee, with the licensee paying all associated costs. Standards for maintaining anonymity were described, and, while any Icelander could proactively opt not to be included in the database or be removed at any time by contacting the Icelandic Director General of Public Health, all Icelanders were presumed to grant informed consent. Quite simply, the bill authorized a licensee to enter extant medical records of all Icelanders into a single database. No licensee was specified in the bill.

The history of the Act on a Health Sector Database is inextricably tied to the company deCODE. Founded in 1996 by Ka´ri Stefa´nsson and Jeffrey Gulcher, deCODE has its headquarters in Reykjavik, Iceland. An Icelander himself, Ka´ri Stefa´nsson played a key role in initiating the creation of the legislation, and deCODE was subsequently granted the license to establish the Health Sector Database. The stated business goal of the company is to discover, develop, and commercialize drugs to treat common diseases. Research operations were begun in Iceland with the intent to use population genetics and genomics theory to mine the Icelandic population for disease-causing genetic polymorphisms. The significance of the Health Sector Database for deCODE is that the medical records can be meshed with detailed genealogical information and supplemented with genetic data for specific samples of Icelanders.

Opposition within Iceland to the Act and the intentions of deCODE was spearheaded by Mannvernd (Association of Icelanders for Ethics in Science and Medicine). Mannvernd opposed the Act for two primary reasons: (1) Icelanders were presumed to grant consent regarding inclusion in the database and were required to proactively decline to participate, and (2) the exclusive license granted to deCODE would constitute a virtual monopoly on research concerning medical genetics of Icelanders. With regard to the former objection, in 2003, the Icelandic Supreme Court ruled that certain provisions of the Act pertaining to privacy and informed consent were unconstitutional. [Page 522]With regard to the latter objection, the license to establish the Health Sector Database does not preclude other medical and scientific investigations concerning Icelanders. However, in a small isolated population, the presence of such a large commercial research entity may inhibit the funding and operation of smaller academic or commercial research endeavors. It is too soon to gauge the impact of the project with regard to the issue of genetic discrimination either at the level of an individual or in a population.

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