FWD: THE ICELANDIC DATABASE CONTROVERSY: Nature Biotechnology, May 1999 IE:

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From: Jón Erlendsson <joner@hi.is>
Date: Mon, 03 May 1999 12:41:29 +0100
THE ICELANDIC DATABASE CONTROVERSY: Nature Biotechnology, May 1999
Volume 17 Number 5 p 407 IE:
Nature Biotechnology, May 1999 Volume 17 Number 5 p 407
Decoding developments in Iceland
Bernhard Palsson and Snorri Thorgeirsson
As we write these comments, a 12-year license, which grants exclusive
rights to Iceland's entire health care database, is about to be given
to an American company, with a majority ownership of American venture
capital funds that also hold a majority on its board of
directors. This license would contain highly controversial conditions
such as "presumed consent" that would allow the company to use the
personal data of any individual in the database without their
permission or "informed consent."  Iceland's sovereignty is
effectively at stake.
How did this remarkable turn of events come to pass? In August of
1996, deCODE Genetics Inc. was founded and incorporated in the state
of Delaware. The company issued 20 million shares and sold 12 million
to a group of seven American venture funds at a $1 per share. A wholly
owned Icelandic subsidiary was established, and with $12 million the
company started operations in Iceland. By the end of 1997 it had 45
employees, a number that has grown to 250 today. In early 1998, deCODE
signed the largest deal at that time in genomics with
Hoffmann-LaRoche, valued at up to $200 million over a five-year
period. This partnership was focused on linkage studies in 12
diseases. deCODE then sold an additional 2 million shares to Icelandic
investors at $5 per share. These shares trade publicly in Iceland, and
have recently been trading at more than $22 per share, bringing the
market capitalization of deCODE to close to $500 million.
By all measures deCODE was a roaring success, and it was initially
well received in Iceland, bringing the benefits of high-paying jobs in
a high-tech industry. Its energetic president and CEO received
manifold praise and recognition for his accomplishments, including a
nomination in the magazine Red Herring in 1998 as one of the world's
top 10 entrepreneurs.
However, deCODE's troubles began in March of 1998, when it helped
formulate a bill introduced into the Icelandic Parliament,
Althingi. Established in 930, Althingi is the world's oldest
legislative body, and this bill is probably the most complex matter it
has confronted in its more than 1,000-year history. It authorizes the
establishment of a centralized health care database, which includes
detailed health care records and the ability to correlate them with
genealogical and genotypic information1. One controversial part of the
bill is that it includes the provision that in exchange for paying for
the construction of the database-estimated to cost over $100
million-an exclusive 12-year license would be granted for its use. The
proposed law included a number of features that were unprecedented, to
say the least, with regard to prior general medical, scientific, and
ethical practices in the conduct of R&D of health care products.
Naturally enough, the bill attracted considerable attention and there
was and is a strong opposition to it both domestically and
internationally. Coverage of this issue has been extensive2. In brief,
a battle raged in Iceland over this legislation throughout 1998 until
its eventual passage at the end of the year. Although the bill did not
pass the Althingi until December of 1998, deCODE had been talking
about having an exclusive license to such a database even before its
original introduction in March 1998.
This database will contain genotypic data, and thus the most intimate
information about the individuals who will provide tissue samples for
the database. With advances in human genomics being so rapid, it is
hard to tell how much will be read (correctly or not) into genotypic
information obtained over the coming 12 years. Although we are
promised that maximum effort to maintain privacy will be made, in a
small country like Iceland, the individuals in the database can be
identified with as little as three pieces of readily available
information (such as gender, date of birth, parent's date of birth).
deCODE plans to go public. Thus, all the information in the
centralized database and its intrinsic value will be traded as a
commodity on international markets.  Comprehensive hereditary and
health care information for a whole nation, in a format in which every
individual and his/her characteristics can most likely be identified!
Nothing less than Iceland's national identity is at stake. The board
of directors at deCODE holds all the cards, since it must approve and
consent to all the actions that deCODE takes. Realizing this, a group
of Icelandic physicians in an open letter3 made a plea to the board to
reconsider its actions just before the passage of the bill, in which
they cited severe criticisms of all or parts of the bill by no less
than 30 Icelandic ethical and scientific associations. Their effort
was predictably to no avail-perhaps understandably, as it is the
venture funds that stand to gain the most, well over $200 million if
the current share price holds up. Their capital gains, if and when
realized, will not even be taxed in Iceland, and it is unclear what
long-term benefit if any the Icelandic nation will receive from this
process.
Since Iceland is only a thousandth the size of the US, 250 high-paying
jobs there are equivalent to 250,000 high-paying jobs in the US. The
creation of a significant number of good jobs is every politician's
dream. In this light, the actions of Althingi can be understood. Of
course an exclusive license will not guarantee the existence of these
jobs; only real scientific performance of the company in the highly
competitive world of genomics will.
Needless to say, human genetic research can be conducted in Iceland as
elsewhere without implementation of controversial
issues. Interestingly, such research can be performed without the
creation of such a centralized database and an infringement on the
exclusive license. Many genealogical databases exist in private hands,
as do patients' registries (and some are explicitly excluded in the
bill) and disease-specific physician-patient groups and societies. The
authors are scientists of Icelandic origin who have worked in the US
for over 20 years. In response to the unacceptable, and to us
embarrassing, situation that has developed in Iceland, we have chosen
to participate in the founding of another Icelandic biotechnology
company. We hope that this company can diversify job creation in
Iceland and bring generally accepted international standards of
medical research to the burgeoning industry there.
REFERENCES
1. English version of the legislation is found on
brunnur.stjr.is/interpro/htr/htr.nsf/pages/gagnagr-ensk
2. Hodgson, J. Nat. Biotechnol. 16, 896-897 and 16, 1017-1021 (1998);
see also Nat.  Genet. 20(2), 99-101 (1998), Science 280,
890-891(1998), Sci. Am. February 1998, p.  24.
3. See www.mannvernd.is/english/index.html, item 12.12.98.
1. Bernhard Palsson is professor of bioengineering and adjunct
professor of medicine, University of California, San Diego, La Jolla,
CA. 2. Snorri Thorgeirsson is laboratory chief, experimental
carcinogenesis, National Cancer Institute, Bethesda, MD. 3. The views
expressed here are the authors' own, and do not reflect the opinions
of their home institutions. e-mail: bpallson@be-research.ucsc.edu.


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