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David E. Winickoff
Genome and Nation
Iceland’s Health Sector Database and its Legacy
Iceland is a small democratic state of nearly 300,000 inhabitants that sits in the
North Atlantic between the continents of Europe, America, and the Arctic.1
Although it may seem an unlikely place for innovation of global significance, el
small island nation of Iceland has assumed near iconic status in one field in par-
particular: genomics. Aided by recent advances in genetic technologies and by a bold
entrepreneurial vision, Iceland’s genomic innovations have helped transform med-
ical and genealogical information into a new type of global commodity.
Además, these innovations—or more precisely, the controversies they have
spawned—have helped precipitate the development of global norms governing the
relationship between citizens, medical information, markets, and the state.
Iceland’s public–private partnership has become a common reference point for
other major population genomics initiatives—such as those in Sweden, los unidos
Kingdom, Canada and the United States—but there is often an intriguing gap
between what it stands for and what it has become. A November 2005 perspectiva
piece in the New England Journal of Medicine is a good example of how in many
accounts of Iceland, important details get lost. In this article, the authors argue that
generating the next round of genetic discoveries will require a large number of
“health information altruists” to supply health and DNA data and DNA. And they
cite the Icelandic government’s ability to construct a “national genomic databank,"
in collaboration with deCODE Genetics Inc., as an example of the public’s altru-
ism.2
This sort of statement is not uncommon in articles written about Iceland, pero
one problem remains: the country’s Health Sector Database, an international sym-
bol of the new state-led genomics and the biotechnological frontier, was never
construido. Ten years ago, Kari Stefansson, an Icelandic neurologist turned biotech entre-
preneur, co-founded deCODE Genetics and began operating in the suburbs of
Iceland’s capital. Eight years ago, Iceland passed the Health Sector Database (HSD)
Acto, which authorized the construction of the national database. Hoy, a pesar de
deCODE continues to announce discoveries,3 the controversial idea to allow the
David E. Winickoff is Assistant Professor of Bioethics and Society at University of
California, berkeley. He teaches and has published widely on bioethics, law and the
life sciences and holds degrees from Yale University, Cambridge University, y
Harvard Law School.
© 2006 Tagore LLC
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Genome and Nation
company access to the national health record data without consent of individuals
(the core of the national database legislation) is dead. Did all the sound and fury
swirling around the HSD Act ultimately signify nothing?
a través de
Iceland’s public–private
partnership has become a
common reference point for
other major population
genomics initiatives… [Todavía]
the country’s Health Sector
Database, un internacional
symbol of the new state-led
genomics and the
biotechnological frontier,
was never built.
To the contrary, 10 years after the founding of deCODE, with the Health Sector
Database relegated to the dustbin of history, it is more important than ever to
probe a series of questions about the
Iceland case. This article tracks the
history of Iceland’s National Health
Sector Database, seeking to clarify two
critical questions: how could a statute
authorizing the transfer of personal
medical records to a private corpora-
ción, without informed consent of
el
pass
individuos,
Icelandic Parliament in 1998? Eso es,
how did the HSD Act—an unprece-
dented achievement combining both
technological, political, and norma-
tivo
en
innovation—ever come
ser, and what does it tell us about
the innovation–governance nexus?
Segundo, why did the Health Sector
Database itself never come into being?
The Health Sector Database Act
ultimately came into being because it
seemed to address the central political
problem of Iceland as it was entering
the twenty-first century. This was the
problem of how such a small and remote society might remain a viable nation in
the emerging global order. The national database failed to materialize because the
act triggered an international controversy and could not, al final, satisfy an
emerging consensus about the appropriate rules for governing this new type of
investigación. Despite its failure, Iceland’s Health Sector Database remains critical case
study for understanding the practices of biotechnology today: in its failures as
much as its successes, the Health Sector Database became an important channel
through which key aspects of bioethics, individual rights, and global governance
were clarified and reframed in relation to genomics and the new life sciences.
ICELAND’S HEALTH SECTOR DATABASE ACT
Iceland’s national parliament, called the Althing, was established around 930 A.D.,
apenas 60 years after Iceland began to receive Norwegian settlers and their Celtic
slaves. In these early years, the Althing was an annual outdoor assembly where the
country’s most powerful leaders met to decide on legislation and dispense justice.4
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David E. Winickoff
Hoy, Iceland is a constitutional democracy with its 63-member Althing and a
president, although a prime minister leads the governing coalition in Parliament
and is by far the most powerful politician in Iceland. In December 1998, el
Althing passed the Health Sector Database Act by a vote of 37 a 20, con 6 absten-
ciones. The act set out a new regime for the control of citizen health information in
a modern democracy. Such information was at once declared a “national resource”
to be controlled by the state and allocated to private industry for inclusion into a
commercial genomic database of national scope. The act immediately took on
international significance and
has been written about widely
by journalists and scholars
alike.5
In December 1998, the Althing
passed the Health Sector
Database Act by a vote of 37 a
20, con 6 abstentions. The act
set out a new regime for the
control of citizen health
information in a modern
democracy.
The core of the HSD Act
was the authorization of the
database’s creation and oper-
ation in Iceland by a private
sector licensee, with the com-
puterized health data to revert
to the state after the license
term.6 The license to operate
the database could be granted
for a renewable term of no
más que 12 años. El COM-
compañía
deCODE Genetics
secured the license to create
and operate the database in 2000, but this was a fait accompli from bill’s earliest
días. Notes from the bill state that the idea for the database initiated with deCODE
and Kari Stefansson, and the company reportedly drafted the first version of the
bill as early as the summer of 1997.7 deCODE’s plans to link the health data with
genetic and genealogical information were widely known, although the act itself
said nothing about biological samples or DNA, and it did not mention genealogi-
cal records.
The act authorized the licensee to use the data for profit, but it provided for the
protection of privacy in a number of ways. Primero, the licensee could not grant direct
access to the database or information it contained to third parties. Segundo, it would
have to process the information itself in ways that could not be linked to identifi-
able individuals. The act provided that the licensee could be civilly liable for neg-
ligent disclosure of information, and the act authorized other penalties, incluido
fines, imprisonment, and possible revocation of the license for violations of the
act, the license, or government regulations under the act.
The HSD Act’s most controversial provision authorized the transfer of all med-
ical record data to the licensee for commercial development without the express
consent of individuals, by invoking a rule of “presumed consent.” In addition,
information on deceased individuals would be automatically included, a pesar de la
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Genome and Nation
potential privacy interests of relatives and individuals. According to the terms of
the Act, Icelanders would have six months from the construction of the database
to opt out unconditionally, a provision that had only been added to the act after an
earlier draft of the legislation drew significant criticism for its lack of informed
consent.8 The final version of the act also specified a more rigorous encryption
architecture for the health information, and it provided for lower fees for non-
commercial access to the database.
The HSD Act’s most
controversial provision
authorized the transfer of all
medical record data to the
licensee for commercial
development without the
express consent of
individuos, by invoking a
rule of “presumed consent.”
A small and vocal percentage of
Icelandic civil society objected to
the legislation, and strenuously. El
leadership of the Icelandic Medical
Association publicly opposed the
HSD Act for what it saw as its ethi-
cal short comings: the failure to pro-
tect the rights of research subjects to
have informed consent, the lack of a
mechanisms for subjects to with-
draw from the database once they
were entered in, and the monopolis-
tic
license.9
in October 1998, a
Además,
small network of physicians, científico-
tistas, human rights activists, intel-
lectuals,
and patient activists
formed a group in opposition to the
HSD Act,
called Mannvernd.
Mannvernd’s English subtitle was the Association of Icelanders for Ethics in
Science and Medicine. The Icelandic word mannvernd means “human protection,"
and this captures the organizing idea of the group, namely that the HSD Act
“infringes on human rights, personal privacy, and on accepted medical, scientific
and commercial standards.”10
aspects of
el
Despite the development of this loosely organized opposition, the law passed.
By claiming the authority to transfer to a commercial entity the medical informa-
tion of all Icelandic citizens, the government imposed a new regime of control over
Icelandic medical records. One important legal effect was to sever the ability of
doctors to prevent their health institutions from handing over patient medical data
without their authorization. The directors of health institutions were to be
empowered to negotiate all transfers of information, without review by any inde-
pendent ethics committee (the normal ethical requirement for accessing medical
records for research). Al mismo tiempo, the government claimed the power to pro-
vide access to the medical information, and indeed to license it for commercial use.
The government asserted that because the state paid for the medical care giving
rise to the data, the state could control and “exploit” those data for the benefit of
Iceland. Rhetorically, the act denies that medical data can be owned, but this lan-
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David E. Winickoff
guage is a mere formality—access, usar, and control are nothing if not the tradi-
tional components of property.11 In effect, the state reduced the complex web of
legal interests around the medical data by cutting off the doctors and asserting the
power to license, which is a property interest.12
By December 1998, the critics had been effectively neutralized by the passage
of the HSD Act. The path was paved for deCODE’s exclusive commercial access to
the trove of medical data on all Icelanders, and the essential conditions for con-
struction of the Health Sector Database had been established.
ORIGINS OF THE HEALTH SECTOR DATABASE
The passage of the Health Sector Database Act was a watershed event, as much for
the fields of genomic research, venture capital, and bioethics as it was for Icelandic
sociedad. In one unprecedented stroke, a national parliament authorized the trans-
fer of citizen medical information to a private corporation for commercial
exploitation and development, without the a priori permission of individual citi-
zens. Such a coup for Kari Stefansson, CEO of deCODE, could only be achieved
through the effective enrollment of Iceland’s natural and social history in its busi-
ness plan.13 With a national heritage in tow, the business narrative would in turn
have to persuade American venture capitalists and their scientific advisors, a
majority of Icelandic Members of Parliament, and the public itself that their inter-
ests necessarily lay in the passage of the Health Sector Database Act. The effective-
ness of Stefansson’s pitch lay in its versatile ability to address the most pressing
problems of these key constituencies.
Enrolling Iceland’s Natural and Social History
Stefansson’s genomic vision of Iceland was predicated upon a single compelling
theory, namely that Iceland was likely to be a very valuable place to hunt for genet-
ic factors of common human diseases. This hypothesis was supported by a set of
foundational claims about Iceland’s natural and social history. First and foremost
was the idea that Icelanders were a genetically homogeneous people because of
their historic isolation. In a 1995 business plan, and in language that would be
echoed throughout the debates about the HSD Act, Stefansson wrote,
Iceland is a small island in the North Atlantic which was inhabited
between the years 870 y 930 A.D., mostly by Norwegian entrepreneurs
and Irish slaves. The year 1000 ANUNCIO. [sic], the population was around
70,000 but around the year 1410 ANUNCIO. the Plague had reduced it down to
aproximadamente 30,000. The population had again grown to about 70,000
when at 1700 ANUNCIO. Hekla, the most powerful volcano in the history of
Europa, spew lava and ash all over Iceland, which led to a famine that
reduced the population again down to approximately 30,000. Hoy, el
population of Iceland is 270,000 and they are almost all derived from the
original settlers or 30,000 of their descendants who lived in the country
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Genome and Nation
around the year 1410 ANUNCIO. and another 30,000 who lived in the country
around the year 1710 ANUNCIO. Por lo tanto, the Icelanders are genetically a
homogeneous people, and they display a strong founder effect; by follow-
ing genetic markers, it is possible to trace a common origin of a large pro-
portion of them.14
This was not a simple claim of genetic homogeneity, but one embedded in a
colorful natural history of the Icelandic genome replete with plagues, volcanic
eruptions, and famines. Stefansson drew a powerful connection between the
founder effect that helps make Iceland attractive for gene hunting, y el
founders themselves.15 Although the
“facts” of Icelandic homogeneity
later became contested within the
pages of top science journals as the
Health Sector Database controversy
desarrollado,16 the idea of homogene-
ity played powerfully both inside
and outside Iceland.17
If all three resources—
Icelanders’ DNA,
genealogies, y el
phenotypic data—could be
linked together, it would
create a uniquely powerful
tool for conducting genetic
linkage studies as well as
allelic association studies.
Stefansson’s second foundation-
al claim was the existence in Iceland
of intricate and detailed genealogi-
cal records. In its early business
planes, Stefansson touted the exis-
tence of a lineage database for 100
percent of Icelanders back to 1910
y 85 percent of Icelanders back to
1800. He explained that this record-
ed lineage would make it “relatively
easy to determine relationships between participants or subjects in genetics stud-
ies done in Iceland.”18 A third foundational claim was the existence of high-quali-
ty medical records dating back to the 1920s, many of which were “centralized and
accessible.” Hence, the business plan explained, “it is relatively easy to find a match
between genotypes of Icelanders and whatever genetic traits are reflected in their
diseases or health.”
As Stefansson and company representatives explained over and over again to
Icelanders, foreigners, and investors alike, these factors gave Iceland an advantage
for discovering new genetic factors for disease. If all three resources—Icelanders’
DNA, genealogies, and the phenotypic data—could be linked together, it would
create a uniquely powerful tool for conducting genetic linkage studies as well as
allelic association studies. This tripartite and integrated database was the techno-
logical bore to locate genetic diamonds in the rough. The scientific logic was sim-
por ejemplo: with fewer variations in alleles because of genetic homogeneity, it would be
easier to identify candidate genetic variations that were associated with disease.
And the idea of folding health data, genetic data, and genealogical information—
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David E. Winickoff
compiled through generations of Icelanders—into a single resource was as cultur-
ally compelling to venture capitalists as it was to Icelanders. It was a powerful sym-
bol of Iceland itself.
Enrolling Venture Capitalists
The mid-1990s were boom years for venture capital, and biotech investors and
their scientific advisors were looking for big ideas that would solve big problems.
One of the big scientific and political problems facing genetics in the mid-1990s
involved how to translate the massive amount of new genetic code being generat-
ed by the public human genome projects into discoveries and therapies. Gene
hunting was turning out to be harder than anticipated: it proved to be difficult to
identify specific genetic variants that caused common diseases, thus shifting the
understanding of disease to polygenic and epigenetic models of causation. Alguno
argued that in order to sort out more complex mechanisms, larger populations of
people manifesting both health and illness would need to be sequenced, studied,
and compared. Taking a “population” approach to genomics would not have been
imaginable even a few years previously, as doing such studies at the desired scales
required recent advances in DNA sequencing and information technology that
gave birth the nascent field of “bioinformatics.”19
What was needed were promising populations of research subjects upon which
these new tools could be turned. As Stefansson put it in his business plan, “it is a
commonly held view that the next big steps in the genetics of human diseases will
be taken by those who have access to the most suitable populations, rather than by
those who ask questions or develop new technologies.” Stefansson was correct that
major powerhouses of human genetics, both in academia and in industry, eran
searching for the appropriate populations on which to apply these new tools. Él
also was correct that Icelanders would be an appealing population source. In a now
famous 1995 letter to Stefansson, Kevin J. Kinsella, the President and CEO of
Sequana Therapeutics (which was already involved in the gene hunting business)20
adopted Stefansson’s naturalized account of Iceland’s genomic potential:
As we discussed, Iceland is perhaps the ideal genetic laboratory since
there has been virtually no immigration, … it is of manageable size
(200,000+ inhabitants), is an island expected to have many founder
efectos, has high quality national healthcare—from which we can expect
excellent disease diagnosis, has formidable genealogies and the popula-
tion is Caucasian—of most interest to pharmaceutical companies.21
Iceland has persistently captured the Western imagination, whether due to its
literary tradition, geology and volcanoes, the Cold War, or even the World Chess
Championship in 1972 between Boris Spassky vs. Bobby Fischer.22 Now, the idea of
the “unique” genetic endowment of its population captured investors. Stefansson
allegedly raise $12 million in U.S. venture capital in an initial round, and on this strength, otro $25 million from Icelandic institutional investors.23 In 1996, el
prominent U.S. technology business magazine Red Herring declared Stefansson
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Genome and Nation
one of its “entrepreneurs of the year,”24 and deCODE became a Delaware corpora-
ción. Stefansson’s ability to raise this seed money indicates that the biotech venture
firms and their scientific advisors were convinced that Iceland’s population was
potentially a unique resource for untangling the complex genetic factors of disease,
and for addressing the translation problem.
Presenting Iceland as a promising solution to the problem of finding a popu-
lation was perhaps enough to achieve a first round of major venture funding, pero
that raised another problem that would have to be solved before large institution
investors came on board: the problem of enclosure.25 In short, even if the Icelandic
population—with its comparative homogeneity, its genealogies, and its health
records—presented a promising opportunity to find disease factors when all the
contributing components were thrown
together, how could these common
resources be packaged in such a way as
to attract investment? What would give
deCODE an advantage over some other
highly capitalized biotech firm that
might also want to engage in this gene-
hunting venture?
[S]ome sort of exclusive
privatization agreement
with Iceland’s government
authorities would be an
indispensable piece of any
business plan.
Stefansson realized that some sort of
exclusive privatization agreement with
Iceland’s government authorities would
be an indispensable piece of any busi-
ness plan—and therein lay deCODE’s
particular competitive advantage. Just
exactly what that arrangement would look like became clear when the firm report-
edly faxed the first draft of the Health Sector Database Act to Iceland’s Ministry of
Health in 1997:26 the authorization of the Icelandic government granting an exclu-
sive licensee the power to create and operate a database containing health record
information of all Icelandic citizens for commercial biomedical research, y el
now famous regime of “presumed consent.” Other companies would have had to
work through individual informed consent, a much more time-consuming process
likely yielding fewer participants. Stefansson’s ingenious proposal was not a direct
act of enclosure, because the medical records in paper form would still be freely
available to other researchers. But the Health Sector Database Act amounted to an
indirect act of enclosure—a regulatory subsidy that would cost the nation nothing
out of pocket, yet would confer deCODE unique terms of access to a newly imag-
ined commons.
In the fall of 1997, the draft of the Health Sector Database legislation had not
been made public, but Iceland’s Prime Minister David Oddsson, a childhood
schoolmate of Stefansson’s, knew of and supported the legislation.27 In February
1998, deCODE struck a deal with Hoffmann-LaRoche, then the fourth largest
pharmaceutical company in existence, for rights to discoveries derived from
deCODE’s existing work. David Oddsson “passed the pen” between the two com-
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David E. Winickoff
panies for their meeting in Reykjavík. This deal was worth a reported $200 million in benchmark payments over five years, giving deCODE and Stefansson national celebrity status and global recognition.28 But the challenge remained to convince the Icelandic Parliament and the Icelandic public that granting access and use rights to deCODE on an exclusive and “presumed consent” basis was a good idea. Enrolling U.S. venture capital and global pharmaceutical giants went a long way towards this challenge. Enrolling Politicians and the Public Commentaries regarding the passage of the HSD Act have espoused different the- ories as to why the majority coalition carried it through the Althing, and why the Iceland people seemed to go along with the legislation. deCODE was better able to control the public discourse through a U.S.-style publicity campaign in which critics were out-muscled and out-maneuvered, and passage reflected the conflu- ence of strong lobbying by deCODE, a strong parliamentary majority, and party discipline.29 But to read the passage of the act merely as a case of special interest politics would miss something crucial. Específicamente, it would miss the important ways in which deCODE’s rhetoric addressed the central political problem of Iceland as it looked towards the twenty-first century. This was the pressing prob- lem of survival itself: how could such a remote island society best leverage its nat- ural and social resources to remain a viable sovereign nation in the global order? Icelandic society has sought independence throughout its long history. Whether it has been the Norwegian or Danish monarchy, raiding Vikings, or the modern behemoths of the European Union and the United States, Iceland has struggled with foreign political determination.30 The HSD Act passed because deCODE’s theory spoke boldly to the nation’s deepest aspirations and fears about survival and independence in the global economy. Durante algunos años, fishing has pro- vided 70 percent of export earnings and employed 4 percent of the work force. The Icelandic economy remains vulnerable to declining fish stocks as well as to fluctu- ations in world prices for its major exports: fish and fish products, aluminum, and ferrosilicon. Since the mid-1990s, Iceland had started a concerted campaign to develop new economic sectors such as information technology, financial services, tourism, and large-scale hydropower. Biotechnology was emblematic of the sort of new indus- try that Iceland’s Independence Party viewed as a solution, and deCODE was poised to launch this sector. And for its part, the Progressive Party in Iceland, which controlled the Ministry of Health and was part of the majority coalition, was more than willing to be led by this vision, perhaps convinced that this was a cheap way to computerize Iceland’s health system. For the majority coalition, the Health Sector Database project was actually the second and smaller of two controversial policy initiatives aimed at economic growth and revitalization. The other was the Kárahnjúkar Hydropower Project, a massive system of dams, reservoirs and tunnels planned in Northeast Iceland.31 88 innovaciones / primavera 2006 Descargado de http://direct.mit.edu/itgg/article-pdf/1/2/80/704267/itgg.2006.1.2.80.pdf by guest on 08 Septiembre 2023 INNOV0102_06-05-31_FINAL.qxd 6/6/2006 5:46 Página PM 89 Genome and Nation Civic protests mounted against this massive project around 1998, and continue to mount, focusing on the environmental impact of this project to tap the most pow- erful glacial rivers in Iceland. As a pair, both the HSD and the hydropower projects underscore the 1998 coalition government’s overriding commitment to creating a viable economic future given scarce natural resources. Politicians could also make the argument that building a strong deCODE would stem the tide of brain drain of highly-educated workers that many feared was weakening the island nation. Stefansson had created his commercial laborato- ry near Reykjavík by November 1997 to be operated under deCODE’s Iceland sub- sidiary, Íslensk erfðagreining, and in a short amount of time the company had spent more on research than the Icelandic government’s entire annual research budget, apenas $65 millón.
The consequences of brain drain are
not only economic, por supuesto, pero también
social: families find themselves pulled
the tri-partite
apart. The idea of
genomic database—weaving together
individuals and families, past and
present, into a single entity—present-
ed a potent symbol of collective
strength. The theme of solidarity,
through the idea that deCODE could help keep families together, was invoked to
outweigh abstract notions of autonomy, patient–doctor confidentiality, and ero-
sion of scientific integrity.
[t]he database’s narrative
of aggregation and social
linkage provided a powerful
cultural symbol of an
integrado, independiente,
and modern people.
The HSD Act’s critics had trouble effectively countering the economic, politi-
California, and cultural strength of the deCODE–government alliance. When Minister of
Health Ingibjörg Pálmadóttir introduced the first version of the bill to the Althing,
some members of parliament highlighted concerns about citizen privacy, monop-
olistic private control of the database, and lack of a priori consent, and a number
of prominent leaders of the Icelandic Medical Association agreed with these criti-
cisms. Mannvernd argued that the Act was illegal under both Iceland’s constitu-
tional right to privacy32 and international human rights norms that required
informed consent in human subjects research—drawn from the Helsinki
Declaration and the Nuremberg Code. Sin embargo, deCODE simply built a larg-
er network of supporters in Parliament and Icelandic society than Mannvernd,
largely because of its demonstrated ability to raise investment capital, y el
power of its economic promises.
But not only so. deCODE’s successful appropriation of cultural tropes and
resources re-imagined Iceland, while simultaneously constructing a future for it. En
political debates and interviews, Stefansson could invoke the historic struggles
between the Icelandic people and a brutal physical environment, and he could give
these common histories new meaning and new value. Within this narrative, estos
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David E. Winickoff
same hardships now made the Icelandic genome a valuable commodity in the
global economy. What might seem to outsiders as a peculiar practice, the tracing
of genealogical connections through countless generations, now became a lynch-
pin of a cutting-edge biomedical technology. A common set of Icelandic founders
had passed their genetic markers down through the generations, producing a key
element in a new collective history of Iceland. But just as importantly, los datos-
base’s narrative of aggregation and social linkage provided a powerful cultural
symbol of an integrated, independiente, and modern people.
SHELVING THE HEALTH SECTOR DATABASE
In light of the development of our business since the Agreement was
entered into, the lack of the required agreement with the [National
University Hospital], and the fact that the Icelandic Data Protection
Authority has not issued the required security certification, we do not
expect to operate the IHD [es decir., the combined database] under the terms
of the Agreement.33
–deCODE Genetics in its SEC financial disclosure statement
for the fiscal year ending December 31, 2003
By June 2001, apenas 20,000 Icelanders or roughly 7 percent of the population
had opted out of the Health Sector Database.34 While this was taken as a signal of
general discontent by Mannvernd, and it certainly surprised government officials,
it is unlikely that this fact would have shaken deCODE. Sin embargo, little more
than three years later, deCODE disclosed to its public investors that it had no
expectation of ever constructing or operating either the Health Sector Database or
the tri-partite “minable” database containing health, genealogical, and genetic
datos. Although the company publicly blamed the National University Hospital and
the Data Protection Commission, the failure to reach deals with these institutions
were only the proximate cause of the failed Health Sector Database. The national
database failed to materialize because the act triggered an international normative
controversy and could not, al final, satisfy an emerging consensus within and
without Iceland about the norms that should govern the new population genom-
ic research. This in turn caused crucial members of deCODE’s assemblage to drop
out of the network required to produce the database.
The Critics’ Network Expands Internationally
While the network of critics of the Health Sector Database bill had been insuffi-
ciently strong to sway the Independence Party–Progressive Party majority or to
galvanize the Icelandic public against the bill, the passage of the HSD Act helped
trigger a small explosion of international scrutiny and criticism. An early salvo
came in a New York Times op-ed by the eminent Harvard population geneticist
Richard Lewontin, who provocatively declared that Iceland had just transformed
“its entire population into a captive biomedical commodity.”35 As major news out-
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lets covered the story of the law, a volley of criticism came in the form of letters to
the editor and editorials, many of them from Icelandic expatriates.36 By April 1999,
leadership of the Icelandic Medical Association had taken the case of the HSD Act
to the World Medical Association, and at a meeting in Chile the World Medical
Association declared that it stood “fully behind the position taken by the Icelandic
Medical Association in opposing the Icelandic Healthcare Database legislation
recently passed by the Icelandic Parliament.” The World Medical Association gov-
erning council underscored “the need to protect the integrity of patient data and
to have open access to all scientific data,” and it urged “all national medical associ-
ations and governments to ensure that science is furthered by continued research
that in no way breaches medical ethics and patient confidentiality.”37
By the summer of 1999, claims and counterclaims by company officials and
HSD Act critics filled the opinion pages of the elite international science maga-
zines.38 The network of critics had become international, and the debate became
distinctively normative: were there existing standards of informed consent that
applied to this type of research? Did the act really commodify the bodies of
Icelanders in an ethically problematic way, and was the ethos of sharing health data
in biomedical research under attack? During this period, both sides of the debate
attempted to master the intricacies both of existing international rules and of
information encryption architectures. And although the debate began to play out
at a high level of technicality, at stake was the very reformulation of sovereign
fuerza, individual rights in personal medical information, and the claims of
patient–doctor confidentiality.
Normative Ambiguity and the Proliferation of Debate
Although those on both sides of the debate tried to claim traditional bioethical
norms to support their positions, a few years of hindsight have made one thing
obvious: information “mining” proposed by deCODE was a new sort of research
that did not fall comfortably within pre-existing bioethical norms of informed
consent or pre-existing legal rules on the protection of personal data. A high pro-
file exchange in the New England Journal of Medicine from the summer of 2000
between the top deCODE officers and George Annas, an internationally known
professor of bioethics and law from Boston University, illustrates the terms of the
emerging international debate.
On one side of the debate, Kari Stefansson and Jeffrey Gulcher, then the Chief
Scientific Officer of deCODE, argued forcefully that “presumed consent” with the
opt-out provision was justified and legitimate in Iceland for three main reasons.
Primero, they argued that an exogenously imposed notion of individual consent
should not trump the democratic will of a sovereign nation: the passage of the act
after “vigorous debate in Icelandic society” indicated the “community consent” to
the opt-out compromise. En esencia, they argued from a position of cultural speci-
ficity rather than universality, stating that “norms may vary from one society to
another and may change with time,” and that democratic will should rule.39
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David E. Winickoff
Segundo, they argued that “presumed consent is the standard used in research on
health care data that is produced in the process of delivering medical service,"
adding that “it is not certain that we would have health care as we know it today if
explicit consent had been a prerequisite for the use of medical data.” Third, ellos
argued that privacy concerns could be managed effectively through information
encryption technologies rather than the use of individual rights as prophylaxis.
They asserted that because the social identification numbers from the medical
records would be encrypted, the information would actually be more protected
than it was in non-encrypted paper form, sitting in files within health institutions.
George Annas, a strong advocate of the special sensitivity of genetic informa-
tion and proponent of genetic privacy in the United States, argued against
Stefansson and Gulcher to a large extent. He acknowledged that “research on data
from medical records that cannot be linked to individual patients has often been
considered an exception” to the general rule of informed consent for all human
subjects research. En este sentido, he admitted that the project did not break (al menos
in a flagrant way) existing bioethical norms. Sin embargo, he also stated that the “com-
mercial nature of the data bank and its for-profit agenda” militated for the require-
ment of explicit informed consent in this case. De este modo, Annas seemed to stake out a
more moderate position than Mannvernd and the Icelandic Medical Association
with respect to the pre-existing requirements of informed consent for the use of
health records from the medical record. His position was predicated on the
assumption that the information banked in the database would be “unlinkable”
back to the medical record. Because the Health Sector Database Act seemed to
authorize the use only of “non personally identifiable health data” by the licensee,
this was a fair assumption.
Icelandic critics of the HSD Act were operating under a different assumption,
one derived from plans for data protection publicly released by the government in
the legislative appendix to the act. The Icelandic Medical Association commis-
sioned Ross Anderson, a Lecturer in the Cambridge University Computer
Laboratory, to analyze the proposed design for the database in fall 1998. anderson
concluded that as a matter of logic, deCODE and the Data Protection Commission
would be using a system of coded identifiers that necessarily allowed linkage: if the
planned database was to be updated on an ongoing basis, the linkage had to be pre-
served.40 This longitudinal updating of the database was one of the key features
touted by the company, for in this way the database could track disease progression
and differential response to pharmaceuticals over time. Además, anderson
emphasized an inherent limitation of de-identified databases, namely that many
patients could be identified by partial information of their circumstances, especial-
ly for a database that would contain comparatively few individuals and also would
link genealogical records. If the information turned out to be linkable without an
unreasonable amount of effort, then existing international informed consent stan-
dards would seem to apply.
Ross Anderson’s opinion came in the context of politicized debates over tech-
nical aspects of both the proposed encryption technology and the proper legal
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standard governing the use of “non-identifiable personal information.” In a series
of law articles written at the time, legal experts came to different opinions on the
question of the HSD Act’s legality, in part because of ambiguity with respect to
three issues. Primero, what was the proper standard of de-identification required
under the HSD Act? Segundo, what was the standard of de-identification of person-
al data required to avoid needing a priori consent under European data protection
laws? Tercero, did the encryption architecture proposed by deCODE meet both of
these standards? Reasonable disagreement existed among knowledgeable jurists
within and without Iceland on all three of these issues.41 The Health Sector
Database Act was based on the premise that all data would be made “non person-
ally identifiable,” which usually means coded but linked to identifiers. Pero, el
Notes to the Bill evince an assumption that all banked data would lack a coding
“key,” and would therefore effectively be anonymous.42 Furthermore, legal experts
disagreed as to whether the proper criterion of non-identifiability under the
European law was anonymity, which seemed to require the complete absence of
any possibility of direct or indirect linkage, or merely “reasonableness”—under
which data would be considered non-identifiable if identification required an
“unreasonable amount of time and manpower.”43 In this context, Ross Anderson’s
expert assessment was important because he denied that the proposed architecture
could possibly satisfy even the lesser “reasonableness” interpretation of non-iden-
tifiability.
deCODE received the operating license in January 2000. In that same year,
relations began to become tense between the company and the Icelandic Data
Protection Commission. The commission was responsible for overseeing rights of
privacy and data protection in Iceland, and under the terms of the regulations
promulgated under the HSD Act was in charge of setting the technology, seguridad,
and organizational terms under which the database would be constructed and
used by deCODE.44 By 2002, the company was struggling with the commission’s
data protection requirements, stating in its annual Securities and Exchange
Commission 10-K filing that these requirements were proving to be “expensive and
time consuming and may delay the development of the Icelandic Health Sector
Database and the deCODE Combined Data Processing system or make such devel-
opment more expensive than anticipated.”45 One important area of disagreement
lay in how deCODE’s customers would access the data. deCODE’s business plans
called for the marketing of access to the Health Sector Database by pharmaceuti-
cal and biotechnology firms directly over the Internet. The Data Protection
Commission refused to authorize the release of data for this purpose, on the
grounds that the proposed Web-based searching tool would insufficiently protect
the identities of the data sources. The commission predicted that the system would
allow users to deduce the identities of individuals through data linkages to
genealogies and through non-coded demographic information.46 This was precise-
ly the concern raised by the Icelandic Medical Association and Ross Anderson
years before, but now it was threatening to stall the implementation of the HSD
Act indefinitely.
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David E. Winickoff
A Shifting Business Paradigm
The company’s failure to bring the Data Protection Commission and the Icelandic
Medical Association leadership into line certainly was an impediment to con-
structing the database, but the company might have been looking for a way out of
its obligations under the HSD license. En 2000, deCODE had described itself as a
“genomics and health informatics company” for which the Health Sector Database
would be a central selling point for investors. Por 2002, deCODE was actively
repackaging itself in face of real financial hardship.47 Although the database and
bioinformational services side of its busi-
ness were still discussed in its annual
informe, deCODE’s more traditional fami-
ly-linkage studies had been scientifically
productive, yielding a number of poten-
tial new genetic factors involved in
peripheral arterial occlusive disease,
schizophrenia, and stroke. deCODE had
some cash on hand, and it was looking to
acquire smaller biotech companies that
were selling at discount amidst the tech-
nology flop. That year, the company
acquired MediChem Life Sciences,
Emerald BioStructures, and Encode—
companies that provided fee-for-service
work in the drug discovery process,
including running clinical trials—as part of a shift in strategy to capture more of
the upstream value from these research efforts. deCODE began describing itself as
a diversified “biopharmaceutical company” with greater vertical integration in the
drug discovery chain, and in which the future potential of operating the Health
Sector Database was a smaller part.
By the time [deCODE]
filed its 10-K for 2002, él
was still touting the
advantages of gene
hunting in Iceland, pero un
remarkable shift had
taken place.
The somewhat vague conception of how the national database itself would
actually generate revenue must have seemed much less attractive to biotech
investors after the dot-com bubble burst. Many biotech companies with large and
speculative research investments, floated on hype and speculation, had folded or
been acquired by larger pharmaceutical companies as debt accumulated and rev-
enue failed to materialize. At some point, deCODE must have realized that its core
research efforts should focus on its traditional family linkage studies that were still
yielding some results, rather than on building an expensive database with only
speculative value.
Además, deCODE had found a way to amass large amounts of health
information and samples by traditional methods—methods that did not require
building the HSD architecture for Iceland. By the time the company filed its 10-K
para 2002, it was still touting the advantages of gene hunting in Iceland, but a
remarkable shift had taken place. Instead of speaking about the national three-part
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database whose centerpiece was the Health Sector Database license, deCODE
explained that in addition to assembling a computerized genealogical database, él
had assembled a large set of “genotypic and detailed medical data from more than
90,000 volunteers, one of the world’s highest-throughput genotyping facilities, y
statistical algorithms and software systems … developed for storing this data and
mining it for correlations between genetic variation and disease.” Rather than try-
ing to rely on health institutions to transfer the medical data, the company
explained that “all genetic and medical data being used in the company’s gene
research has been obtained under the strictest standards of informed consent” and
that “approximately 95 percent of all those who are asked to take part in our genet-
ic studies agree to do so.”48 This 2002 10-K filing illustrates an important reason
why the company could declare its willingness to abandon hopes of building the
Health Sector Database: the company was compiling a large trove of medical infor-
formación, but only through the more tedious and piecemeal process of getting indi-
vidual consent.
The Icelandic Supreme Court
The Health Sector Database and its regime of presumed consent may have received
its death knell on November 27, 2003, the day the Icelandic Supreme Court ren-
dered judgment in the case of Gudmundsdóttir vs. Iceland.49 The case concerned a
young woman who wrote a February 2000 letter to the Icelandic Ministry of
Health requesting that the information contained in her father’s medical records,
and any genealogical or genetic data on him that might exist, not be transferred to
the Health Sector Database. The Medical Director of Health had obtained a legal
consultation by government lawyers, and based on this opinion denied her request:
the HSD Act text was silent on this issue, but the Notes on the Bill had stated that
it was not the legislative intent to allow children to opt-out their deceased parents.50
Gudmundsdóttir initiated legal proceedings in April 2001, claiming that she had a
personal interest in preventing the transfer of data from her father’s medical
records to the database “as it is possible to infer, from the data, information relat-
ing her father’s hereditary characteristics which could also apply to herself.” The
Icelandic District Court ruled that the medical information included in the data-
base was not personally identifiable and that Gudmundsdóttir lacked standing to
challenge the inclusion of her father’s information in the database.
The Icelandic Supreme Court reversed the lower court on the standing issue,
granting that she had a personal privacy interest in her father’s medical data. Pero
the court went much further. Noting that Icelandic medical records were required
by law to contain extensive information on people’s health, their medical treat-
mento, lifestyles, social circumstances, employment, and family, the court held that
“it is unequivocal that the provisions of Paragraph 1 of Article 71 del
Constitution—the provision that ‘everyone shall enjoy freedom from interference
with privacy, home, and family life’51—apply to information of this kind and …
guarantee protection of privacy in this respect.” Although the Icelandic Supreme
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David E. Winickoff
Court agreed with the district court’s conclusion that the “one-way encryption dis-
cussed in” the HSD Act “could be carried out so securely as to render it virtually
impossible to read the encrypted information,” the act made no indication “as to
what information from medical records must be encrypted in this manner prior to
transfer.” The annex to the operating license “impl[ied] that only the identity num-
ber of the patient will be encrypted in the database and that the name, both of the
patient and his family, together with the precise address will be omitted.” However,
the “vague limits” set by the provisions of the Health Sector Database Act inade-
quately provided for the protection of Gudmundsdóttir’s constitutional right to
privacy, and therefore her right to opt-out her deceased father’s health information
was affirmed.
[t]he national database to be
constructed through presumed
consent and transfer of health
information was a dead letter.
Less than four months later, deCODE filed its annual report for 2003, en el cual
it stated it did not plan to operate the Health Sector Database under the terms of
the Health Sector Database Act
and the license. Effectively, el
national database to be construct-
ed through presumed consent
and transfer of health informa-
tion was a dead letter. The demise
of the database was certainly pre-
cipitated by the recalcitrance of
the National University Hospital,
the Icelandic Medical Association,
and the failure of the company to
reach agreement with the Data Protection Commission. The company’s diminish-
ing estimation of the national database’s business value was also a likely factor.
Sin embargo, the construction of the Health Sector Database under the terms
of the act was ultimately undone by the emergence of consensus, in both local and
external institutions, that a priori consent of patients should be indispensable for
engaging in this type of research in all but the rarest exceptions. These were not
simply technical disputes, but cut to the core of the relationships among individu-
como, clinical health institutions, markets, and the state.
LEGACY AND IMPLICATIONS
OF THE HEALTH SECTOR DATABASE CONTROVERSY
On January 16, 2006, the New York Times reported on its front page that deCODE
Genetics had discovered a gene variant that leads to a sizable extra risk of type 2
diabetes.52 Since discoveries are being made, one could easily conclude that the
story of Icelandic Health Sector Database is now moot. Además, the compa-
ny has built a large archive of DNA samples, with attendant health information,
using traditional recruitment and a priori consent for use of data and DNA for
research purposes.53 However, deCODE’s current practices were contingent on the
passage of the Health Sector Database Act, and they were shaped in important
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ways by the failed gestation of the Health Sector Database itself. En efecto, the histo-
ry of the Health Sector Database carries important theoretical and practical impli-
cations for understanding the current practices of population genomics, for it
helped produce the technological, political, and normative terrain of all large-scale
genomics initiatives today, not just Iceland’s. Además, Iceland provides an
important window on the process of innovation in the life sciences, illustrating the
ways in which technological, normative, and politico-economic changes occur
within a mutually dependent system.
Multiple Innovations of Global Significance
Many nationally focused genomic projects have been drawn up in an explicit
attempt to follow Iceland’s lead.54 For instance, the CARTaGENE project in Canada
plans to sample one percent of all Quebec citizens between the ages of 25 y 74
to represent “the entirety of the population” for a study of “the genetic contribu-
tion to the health and illness of the entire Quebec population.”55 In 2002, el
United Kingdom, the Medical Research Council, the Wellcome Trust (a private
charitable organization), and the Department of Health funded the creation of
“UK Biobank,” a longitudinal prospective population genomics study to involve
apenas 500,000 UK adults aged 45–69. En 2006, the Department of Veteran Affairs
in the United States announced its plans to amass a genomic biobank of millions
of veteran samples to be combined with its computerized medical records.56
As other countries sought to enter the population genomics game in various
configuraciones, at least one aspect was constant: Iceland’s Health Sector Database
Act was invoked as a bad model for handling consent and other ethical and legal
aspects of state-sponsored genomics. But this is only part of the important con-
structive role the HSD Act played in producing the normative conditions in which
genomics operates today. As policy consultants for UK Biobank observed in 1999,
“much of the recent international discussion of the issues raised by the use of bio-
logical sample collections has been stimulated by developments in Iceland ….”57
En efecto, the Iceland debates became an important channel through which the
stakes of individual consent and patient–doctor confidentiality were clarified and
reframed in relation to issues that were new to the world of biomedical research.
The novel contexts presented by population genomics included the linkage of
different forms of personal information, exclusive commercial licensing of data
and databases, encryption architectures, and propriety claims by the state over
medical information. There was no pre-existing answer to the question of how the
traditional principle of informed consent should have been adapted to the
genomics context, even though parties to the Icelandic Health Sector Database dis-
pute claimed otherwise. Bastante, they would have had to emerge through legalistic
interpretación, technological specification, and active negotiation and deliberation
between disparate groups at different scales of governance.
This process of norm construction and development was not linear, and inter-
action through social networks at national and international levels operated as a
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David E. Winickoff
dynamic system. Before the regime of presumed consent had been rejected within
Iceland itself, it had helped precipitate an emerging global consensus that the
“technological fix” of a thick encryption architectures would not replace affirma-
tive consent from individuals prior to their enrollment in population genomics
projects. As an indicator of the development spurred by the HSD Act, the World
Medical Association promulgated a “Declaration on Ethical Considerations
Regarding Health Databases” that attempted to codify these emergent norms in
2002.58 These emergent norms of
personal control of medical
information fed back into the
Iceland debate, and they likely
helped persuade
the Data
Protection Commission as well
as the Icelandic Supreme Court
that Iceland’s presumed consent
regime was incompatible with
the operation of the national
database as originally conceived.
In the process, the Icelandic
Supreme Court took up the
mantle of innovation: its recog-
nition of the collateral privacy
rights of Gudmundsdóttir in the
health data of her father was a
bold legal innovation that has
been noted in international legal
circles.59 For these reasons, uno
could be completely justified in
the view that the Iceland Health Sector Database case has as much a globally
important normative legacy, as a technological one.
Whereas one vision argued that
what the nation needed was to
take bold collective action to
provide the optimal economic
and regulatory conditions for
one biotechnology company to
take root, the other vision saw
ético, social, and political
costs of leveraging Icelandic
biotechnology in this way.
The extent to which the Health Sector Database controversy reached distant
shores, and activated international commentaries that in turn fed back into
national and international bioethical debates, demonstrates how the database
became an experimental site not only for genomics, but for genomic governance.
In this sense, both these new genome projects and their normative maps are an
important piece of the database’s legacy.
Society in Technology
Within technology policy circles, there persists a view that technology exerts
autonomous force on society, and that technological development occurs on a
matierally-determined and linear path. Sin embargo, scholarship within the field of
science and technology studies (STS) has for some time been demonstrating that
technologies cannot be seen in isolation from the social relations that shape them,
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whether they be political, económico, normative, or psychological.60 The history of
the Health Sector Database helps underscore this point. The precise form that
technology takes in the world is contingent on the kinds of social work that go into
él. The same powerful narrative that helped persuade the majority coalition in the
Althing to support the Health Sector Database Act had already drawn venture cap-
italists into its fold. As Stefansson realized, establishing the exclusivity which the
act seemed to allow the company to attract international attention and more
investors. Without national sponsorship of the project,
it is doubtful that
Stefansson would have been able to raise the large amounts of speculative capital
necessary to set up his genomic laboratories in the suburbs of Reykjavík.
In Iceland, we have seen how governance and technology were produced
together in a system of feedback loops. Por último, the network of actors and tech-
nologies failed to hold together in face of various normative and political forces,
but these oppositional forces nevertheless shaped genomic technology in Iceland
as much as the passage of the HSD Act. Resistance to the regime of presumed con-
sent envisioned by the Act helped give rise to new encryption technologies and a
string of associated privacy commentaries. Más, the fact that many doctors
refused to relinquish control of the data for ethical reasons, and that the Data
Protection Commission ended up enforcing a stricter view on encryption than the
company anticipated, forced the company back to more traditional familial link-
age approaches, rather than the non-hypothesis driven shot-gun correlation
approach associated with the tri-partite database. This strategy has become the
most fruitful research path for deCODE scientifically, and the expensive construc-
tion of a national-level database with the greater degree of de-identification
demanded by the act would have set the company on an alternative, and arguably
less promising, trajectory.
Biotechnology and Nation in the Global Order
Finalmente, there is a deeper story that the Iceland experience tells about the interpen-
etration of science, tecnología, and society—one that is relevant to the politics of
the nation state in an era of globalization. The story of the Health Sector Database
manifests the extent to which science and technology have become, or are at least
widely seen to be, constitutive of modern nationhood itself. For the majority par-
liamentary coalition, the HSD Act was part of a larger strategy for nation building
and for maintaining national independence in the face of a global economy and
global politics that threatening to engulf Iceland. En efecto, the debates between pro-
ponents and opponents of the Health Sector Database Act were arguing not only
over technicalities of encryption architectures and European Data Protection law,
but also over different visions of the nation itself.
At the turn of the twenty-first century, proponents of the Health Sector
Database Act were drawn to the ways in which the legislation promised to reinvent
the nation by drawing together existing cultural resources (common histories, cul-
tural practices like genealogy, traditions of science, fierce independence) and trans-
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David E. Winickoff
posing them into a new key. They argued that in order to underwrite future eco-
nomic growth and survival, a bold new reconfiguration of state-science-market
needed to be born in Iceland—only through this alchemy could Icelandic genes
have been transformed into the next national resource. The act, with its regime of
presumed consent, exclusivity and privatization, were a simultaneous means of
creating the new resources and maximizing its extraction value to Iceland.
For its critics, the Health Sector Database Act represented a critical departure
from the very codes that constituted its civilization–the codes of modern science
and modern democracy. Adherence to these codes accounted for the impressive
standing Iceland already enjoyed at the international level as a viable modern
democracy, one capable of producing top scientific researchers and an enviable
health care system. As a general matter, critics within the medical and scientific
establishment in Iceland looked to an idealized ethos of science as a model for the
Icelandic polity.61 Traditional scientific ideals of skepticism, disinterestedness,
shared property, and universalism created optimal conditions for preserving indi-
vidual freedom and organizing collective action.62 For the members of Mannvernd,
most of whom were scientists and physicians, the Health Sector Database Act sig-
naled the state-sanctioned departure from these ideals, because the plan danger-
ously embraced a naive scientific hype, commercial dominance, and the privatiza-
tion of common cultural and scientific resources. Many critics saw within the
attack on this scientific order a correlative erosion of Icelandic democratic order,
and corruption of the state within the corruption of science. For some, science and
state were being reconfigured in such a way that threatened to destabilize the very
orders that underpinned Iceland’s claim as a Western liberal democracy and that
helped knit Iceland into the fabric of global political culture.
Whereas one vision argued that what the nation needed was to take bold col-
lective action to provide the optimal economic and regulatory conditions for one
biotechnology company to take root, the other vision saw ethical, social, and polit-
ical costs of leveraging Icelandic biotechnology in this way. The fact that these two
visions for Iceland clashed so starkly should not overshadow what they had in
common: for both proponents and opponents, science and technology were both
symbolic and practical resources for the production of the polity. This powerful
insight animates political struggles in many other nations as they look to the fron-
tiers of the life sciences, both scientific and ethical, as opportunities and vehicles
for nation building.63 Stem cells in South Korea and the creation of “Biopolis” in
Singapore are just two other recent examples. The Icelandic Health Sector
Database controversy certainly prefigures these emerging cases. It also underscores
how smaller nations and their innovations, not just those of the major powers, poder
and do become critical sites for the formation of global order.
Agradecimientos
This article is in part based on the field work conducted in Iceland in the sum-
mer of 2000 and in August 2003. The field work was supported by the Program
100
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on Science, Technology and Society at Harvard University. Thanks to Bogi
andersen, Heather Butterfield, Jóhann Pétur Hardarsson, Einar Árnason, Pétur
Hauksson, Skúli Sigurdsson, and Phil Auerswald for their helpful contributions
to this article. All errors left are of course my own.
We invite reader comments. Correo electrónico
1. De hecho, the ancient site of the Icelandic Parliament, the Althing, sits at a spot called Thingvellir
where the fault line between the European and American tectonic plates meet.
2. Isaac S. Kohane and Russ B. Altman, “Health-information Altruists–A Potentially Critical
Resource,” New England Journal of Medicine, 353(2005): 2074-2077.
3. Por ejemplo, deCODE was recently described as doing “exciting work” by Francis Collins, cabeza
of the Human Genome Research Institute in the United States, and by other prominent geneti-
cists. Michael D. Lemonick, “The Iceland Experiment,” Time (Febrero 12, 2006).
4. Richard F. Tomasson, Iceland: The First New Society (Iceland Review, 1980), Ch. 1.
5. Dr. Skúli Sigurdsson, an Icelandic historian of science and member of the act’s opposition, tiene
been a meticulous analyst and bibliographer of the database controversy. Ver, p.ej., Skúli
Sigurdsson, “Bioethics Lite™: Two Aspects of the Health Sector Database Controversy,” In
Tillmann Hornschuch, Kirsten Meyer, Gerlind Rüve, and Miriam Voß, editores., Schöne—Gesunde—
Neue—Welt? Das Humangenetische Wissen und seine Anwendungen aus philosophischer, soziologis-
cher and historischer Perspektive (Bielefeld 2002) (IWT-Paper 28). See also Sigurdsson’s highly use-
ful bibliography of the database controversy, “Biography for Studying the HSD deCODE
Controversy,"
6. Act on a Health Sector Database no. 139/1998 (Passed by Parliament at 123rd session, 1998–99).
Article 1.
7. The Health Sector Database bill was first submitted to the Althing in March 1998, and it was
debated at several sessions. There was immediately strong opposition to the bill from large sec-
tions of the clinical and biomedical research communities in Iceland, which led to withdrawal of
the bill. A second draft of the bill was introduced in late June 1998, with a number of changes.
This second version was the one that was enacted in December 1998.
8. Because official construction of the database never began, the opt-out period remained open
indefinitely.
9. Tómas Zoëga, interview for the Science Channel in the Netherlands conducted by Paul Wouters,
1999. Transcript on file with the author. Zoëga was Chair of the Ethical Council of the Icelandic
Medical Association (IMA) at the time. In response to the association’s opposition to the bill in
el verano de 1998, David Oddsson “remarked that privacy standards were so lax in Icelandic
health institutions that it was hypocritical of the IMA to oppose the HSD bill on the grounds that
it threatened the doctor–patient confidentiality. See Skúli Sigurdsson, “Yin-Yang Genetics, or the
HSD deCODE Controversy,” New Genetics and Society 20 (2001), 103–117, pag. 106.
10. Mannvernd web page, “What is Mannvernd?"
11. The notes to the bill state that “due to the nature of the data and their origin [Icelandic health
records] cannot be subject to ownership in the usual sense. Instituciones, companies or individuals
cannot therefore own the data [because t]hey exist primarily due to the treatment of patients.” Bill
on a Health Sector Database (Submitted to Parliament at 123rd session, 1998–99).
12. David E. Winickoff, “Governing Population Genomics: Law, Bioethics, and Biopolitics in Three
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David E. Winickoff
Case Studies,” Jurimetrics 43 (Invierno 2003), 187–228.
13.The tale of the passage of the Health Sector Database Act has been told many times, but seldom
Bueno. For important exceptions, see Hilary Rose, The Commodification of Bioinformation: El
Icelandic Health Sector Database (Forward by Marilyn Strathern) (The Wellcome Trust, 2001);
Skúli Sigurdsson, “Yin-Yang Genetics, or the HSD deCODE controversy,” New Genetics and Society
20 (2001): 103–117; Skúli Sigurdsson, “Decoding Broken Promises,” openDemocracy (Marzo 6,
2003)
Michael Fortun, “Iceland Cometh to Commercial Genomics: From the Individual as Biomass to
the Nation as Database,” Talk presented at the American Anthropology Association annual meet-
En g, Chicago IL, November 17–19, 1999.
14. Kari Stefansson, “deCODE Inc.,” unpublished business plan, 1994. On file with the author.
15. The “founder effect” was defined by Ernst Mayr in 1963 to be the genetic effect of establishing
a new population by a small number of individuals. This subset of individuals carries only a small
fraction of the original population’s genetic variation, and the new population may be distinctively
diferente, both genetically and phenotypically, to the parent population from which it is derived.
16. While Stefansson used claims about Iceland’s genetic homogeneity to naturalize his business
narrative, some Icelandic geneticists criticized these claims as inaccurate, both in public talks and
scientific studies. See Einar Árnason, et al., “Genetic Homogeneity of the Icelanders: Fact or
Fiction?” Nature Genetics 25 (Agosto 2000), 373–374; Einar Árnason, “Genetic Heterogeneity of
Icelanders,” Annals of Human Genetics 67 (2003), 5-dieciséis; Alison Abbott, “DNA Study Deepens Rift
over Iceland’s Genetic Heritage," Naturaleza, 421 (Febrero 13, 2003), 678. deCODE’s scientists coun-
tered with more of their own studies. See A. Helgason, et al., “A Reassessment of Genetic Diversity
of Icelanders: Strong Evidence from Multiple Loci for Relative Homogeneity Caused by Genetic
Drift,” Annals of Human Genetics 67 (2003): 281–297.
17. For more analysis deCODE’s myth-making, and its uptake by an eager foreign media, see Skúli
Sigurdsson, “Bioethics Lite™.”
18. Stefansson, “deCODE Inc.,” 8. These records already existed due to what one Icelandic anthro-
pologist has described as an extreme Icelandic “fascination” with genealogical trees and See Gísli
Pálsson, “The Life of Family Trees and the Book of Icelanders,” Medical Anthropology 21(2002),
337–367.
19. These technologies included polymerase chain reaction (PCR) and high-through-put sequenc-
En g. See Paul Rabinow, Making PCR: A Story of Biotechnology (Chicago University Press, 1996);
Michael Fortun, “Projecting Speed Genomics,” In Michael Fortun and Everett Mendelsohn, editores.,
Practices of Human Genetics: International and Interdisciplinary Perspectives, Sociology of the
Sciences Yearbook Vol. 19. (Desorden, 1999), 25-48.
20. Sequana Therapeutics at that time was a young biotechnology company with a strong venture
component. It merged with Arris in 1997 to form AXYS Pharmaceuticals, which in turn was
acquired by Celera Genomics.
21. Letter from Kevin J. Kinsella, President and CEO of Sequana Therapeutics, to Kari Stefansson,
Puede 26, 1995. On file with the author. Also quoted in, Tómas Zoëga and Bogi Andersen, "El
Icelandic Health Sector Database: deCODE and the ‘New’ Ethics for Genetic Research,” In Linda
Nielsen and Claus Holm, editores., Who Owns Our Genes? (Nordic Council of Ministers, 2000), 33-64.
22.Skúli Sigurdsson, “Island Histories: How Science and Technology Came to Iceland,” in Reinhard
Siegmund-Schultze and Henrik Kragh Sørensen, editores., Science in Scandinavia Around 1905 (Novus
Forlag, 2005).
23. deCODE Genetics, public corporate summary sheet, 2000. On file with the author. The initial
A NOSOTROS. venture firms to commit included Advent International, Alta Partners, Atlas Venture, Arch
Partners, Falcon Technologies, Medical Science Partners, and Polaris Venture Partners.
24. Rose, Commodification of Bioinformation, 11.
25. For a useful account of the enclosure movement in its historically land-oriented form and in
its recent expansion into informational realms, see James Boyle, “The Second Enclosure
Movement and the Construction of the Public Domain,” Law & Contemporary Problems 66(2003):
33–74.
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26. The information in the faxed draft of the act is contained in Gudni Jóhannesson’s treatment of
the deCODE history in Icelandic. Kári í jötunmód: Saga Kára Stefánssonar og Íslenskrar erfða-
greiningar (Reykjavík, 1999).
27. Rose, Commodification of Bioinformation.
28. Benchmark payments are by definition conditional upon achieving certain goals, although this
$200 million was often spoken of as if it were hard cash. The company actually received only just over one third of this amount, failing to reach expected goals. See note 5, Sigurdsson, “Bioethics Lite™” (calculating from deCODE’s SEC 10-K statements that Hofmann-LaRoche ultimately transferred only $74.3 million under the terms of the deal).
29. Anthropologists Gísli Pálsson and Paul Rabinow consider the 9-month debate leading up to
the passage of the act to be a model in terms of democratic engagement and deliberation. See Gísli
Pálsson and Paul Rabinow, “Iceland: The Case of a National Human Genome Project,"
Anthropology Today 15(5; 1999): 14–18. See also Gísli Pálsson and Paul Rabinow. “The Icelandic
Genome Debate,” Trends in Biotechnology 19 (2001), 166–171. Other commentators have been
deeply critical of this position, especially Skúli Sigurdsson, in “Yin-Yang Genetics.” See also
Michael Fortune, “Open Reading Frames: The Genome and the Media” speech at Princeton
University in March 2001 (stating that “the vast majority of those hundreds of media accounts
that are cited as evidence of a democratic debate in Iceland were little more than dressed-up
deCODE press releases issued on a regular basis, passing on messages about jobs for Icelanders,
predictions of wealth in the national coffers, and pieties about how Iceland would contribute to
the improvement of world health and the universal progress of biomedical research.”). Reprinted
in After the Fact, the publication of the Institute for Science and Interdisciplinary Studies
(Verano 2001) and by the Council for Responsible Genetics,
30. The most famous novel of Icelandic Nobel Laureate Haldór Laxness, Independent People, deals
with this theme, linking one farmer’s struggles to remain financially independent to questions of
national character and collective independence. See Einar Árnason and Frank Wells, “Iceland and
deCODE: A Critique,” in Encyclopedia of the Human Genome (Macmillan, 2003), 1–5, who men-
tion Iceland’s “fear of engulfment.”
31. See website of Iceland’s National Power Company (Landsvirkjun),
the late 1990s, the power economy was and is probably more important in terms of scale than
biotech.
32. Icelandic Constitution, Article 71, estados: “everyone has the right to respect for his private and
family life and his home.”
33. deCODE Genetics, Cª, Form 10-K (fiscal year ending December 31, 2003), 49 (annual report
filed with the U.S. Securities and Exchange Commission (SEC) pursuant to the Securities
Exchange Act of 1934, §§13, 15(d)).
34. After the initial rate of opt-outs dropped off, the rate of opting out rose again after deCODE
received the Health Sector Database operating license in January 2000. The rate of opting out
dropped again by summer 2000. See graph of “Opt outs from Icelandic Health Sector Database,"
35. Richard C. Lewontin, “Op-ed/People Are Not Commodities,"El New York Times, Enero 23,
1999, A19.
36. Por ejemplo, see Bogi Andersen, “Letter/Hijacked Medical Records,” The Washington Post, A20,
Febrero 6, 1999.
37. World Medical Association, Press Release, Abril 16, 1999.
38. Ver, Por ejemplo, Bogi Andersen and Einar Árnason. “Letter/Iceland’s Database Is Ethically
Questionable,” British Medical Journal 318 (Junio 5, 1999): 1565; Jeff Gulcher and Kari Stefansson,
“Letter/Ethics of Population Research," Naturaleza 400 (Julio 22, 1999): 307–308; Ruth Chadwick, "El
Icelandic Database: Do Modern Times Need Modern Sagas?” British Medical Journal 319 (Agosto
14, 1999): 441–444 (but see also Ruth Chadwick, “Correction,” British Medical Journal, 320
[Enero 22, 2000]: 234). But see also one such letter published quite a bit earlier: Bogi Andersen,
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David E. Winickoff
“Letter/Icelandic Health Records," Ciencia 282 (December 11, 1998): 1993.
39. Notablemente, this idea of cultural context and democratic will was adopted by a pair of cultural
anthropologists studying the controversy, one from the University of Iceland, the other from
Universidad de California, berkeley. See note 29.
40. The Icelandic Medical Association had commissioned Ross Anderson in the fall of 1998, y
the report he issued soon after was influential in the debates leading up to the Act’s passage. Él
later published his opinion in R. anderson, “Iceland’s Medical Database Is Insecure,” British
Medical Journal 319 (Julio 3, 1999): 59.
41. For an overview of the thorny legal questions and conventions involved, see Oddny Mjöll
Arnardóttir, Davíd Thór Björgvinsson, and Vidar Már Matthíasson, “The Icelandic Health Sector
Database,” European Journal of Health Law 6 (1999): 307–362; Henriette Abbing and D.C. Roscam,
“Central Health Database in Iceland and Patient’s Rights,” European Journal of Health Law 6
(1999): 363–371.
42. The proposed encryption architecture was contained in Appendix VI of the Health Sector
Database bill, and it had been prepared by an Icelandic information technology company, Stiki hf.
See Arnodóttir, pag. 332, fn.73.
43. This standard comes from Recommendation R (97) 5 on the Protection of Medical Data, pur-
suant to the 1981 Council of Europe Convention for the Protection of Individuals with regard to
Automatic Processing of Personal Data.
44. Icelandic Government Regulation on a Health Sector Database, Article 30.
45. deCODE Genetics, Cª, Form 10-K (fiscal year ending December 31, 2002), 19.
46. Personal interview with Data Protection Commission staff, Reykjavík, Agosto 2003.
47. See Skúli Sigurdsson, “Bioethics Lite™,” for more detail on the struggles of deCODE around
esta vez.
48. deCODE Genetics, Cª, Form 10-K (fiscal year ending December 31, 2002), 7.
49. Gudmundsdóttir v. the State of Iceland, No. 151/2003 (Nov. 27, 2003) (Ice.).
30, 2004, by court-authorized translator), accessed May 17, 2006.
50. Gudmundsdóttir v. the State of Iceland, §I.
51. Icelandic Constitution, Article 71.
2006).
52. The finding of the genetic variant, which had just been published in Nature Genetics, hecho
front-page American news because the variant is reportedly carried by a third of the American
población. Nicholas Wade, “Gene Increases Diabetes Risk, Scientists Find,” New York Times, A1,
(Ene. 16, 2006). deCODE first found the gene in Icelanders and subsequently in both an American
and Danish population.
53. In its annual report for 2005 filed in March 2006, the company reported that it had “gathered
genotypic and medical data from more than 110,000 volunteer participants in our gene research
in Iceland—over half of the adult population.” deCODE Genetics, Cª, Form 10-K (fiscal year
ending December 31, 2005), 4. The company is not clear about whether volunteers have signed
broad consent for multiple research studies. The Data Protection Commission would have to
approve such a departure from normal practice. Id. en 23.
54. j. Kaiser, “Population databases boom, from Iceland to the U.S," Ciencia 298(2002): 1158–1161.
55. CARTaGENE,
56. Cory Reiss, “Agency To Seek DNA Of All U.S. Veterans,” The Ledger (Abril 23, 2006).
57. Paul Martin and Jane Kaye, The Use of Sample Collections and Personal Medical Information in
Human Genetics Research (The Wellcome Trust, Noviembre 1999).
58. In this declaration, the World Medical Association affirmed as its first principle that “the right
to privacy entitles people to exercise control over the use and disclosure of information about
them as individuals,” and that “the privacy of a patient’s personal health information is secured by
the physician’s duty of confidentiality.” Further, it was affirmed that as a general rule, “patients’
consent is needed if the inclusion of their information on a database involves disclosure to a third
party or would permit access by people other than those involved in the patients’ care.”
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59.As an example of the ruling’s international reach, the Harvard Law Review featured an extend-
ed case note on the case, heralding the fact the “Gudmundsdottir Court appears to be the first to
recognize that someone other than the source of genetic information—the proband—has a legally
cognizable privacy interest in the proband’s information.” Recent Cases, Harvard Law Review
118(2004): 810–817.
60. Ver, Por ejemplo, Langdon Winner, The Whale and the Reactor: A Search for Limits in an Age of
High Technology (University of Chicago Press, 1986); Wiebe E. Bijker and John Law, editores., Shaping
Technology/Building Society: Studies in Sociotechnical Change (CON prensa, 1992). See also work on
“path dependence.”
61. For the classic statement of the thesis that “science” is a model polity, see M. Polanyi, "El
Republic of Science,” Minerva 1(1962): 54–73.
62. These idealized norms were classically formulated by the sociologist Robert K. Merton in his
essay, “The Normative Structure of Science” [1942], reprinted in R.K. Merton, The Sociology of
Ciencia: Theoretical and Empirical Investigations (University of Chicago Press, 1973), 267–278. Para
excellent modern treatments on the constitutive role of science in modern democratic order, ver
Yaron Ezrahi, The Descent of Icarus: Science and the Transformation of Contemporary Democracy
(Prensa de la Universidad de Harvard, 1990).
63. Ver, p.ej., Sheila Jasanoff, Designs on Nature (Prensa de la Universidad de Princeton, 2005).
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