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8-Humans: The Estonian Gene Bank Project - an overt business plan

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TITLE:  The Estonian Gene Bank Project - an overt business plan
SOURCE: openDemocracy, UK, by Tiina Tasmuth
DATE:   May 29, 2003

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The Estonian Gene Bank Project - an overt business plan

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The Estonian Genome Project Foundation tried to build on the experience
of Iceland's innovative, contested genetic research project (analysed by
Skuli Sigurdsson in openDemocracy ). Did the small Baltic state learn
from Iceland's mistakes?
A research fellow and close observer of the Estonian initiative tells the
fascinating, melancholy story - which challenges the corporate interests
involved to respond.

Iceland was the first to undertake the creation of a database of the
health records of its 275,000 people. Its founders boasted about the
homogeneity of the DNA of its small population, descended from the
Vikings, and its detailed genealogical records, dating back hundreds of
years. But Skúli Sigurdsson has shown that what was once the centrepiece
of perceived national progress has in fact turned into a fading mirage as
numerous promises made by the state and the company entrusted with the
enterprise have been broken.

Estonia started a similar project in 1999, which promised to be even
bigger. Estonia's population is five times larger than Iceland's.
However, the clinical records are not up to Icelandic standards. Estonia
has a long history of being overrun and plundered by others, including
the Danes, the Swedes, the Germans, the Poles and the Russians. The
country gained independence only in 1991, when the Soviet Union collapsed.

Scientists in Estonia admittedly got the idea for the Estonian Gene Bank
from Iceland but wanted to improve it. One of the first comments made by
the Estonian Genome Project Foundation (EGF ) was that they would not
repeat the mistakes of Iceland. Public outrage arose in Iceland after the
licensing of Iceland's health records database to deCODE Genetics Inc., a
Reykjavik-based company that received anonymous health and genetic data
without citizens' consent.

Andres Metspalu , a professor of biotechnology at the University of Tartu
who proposed the Estonian DNA database in 1999, said that Estonia would
not give the DNA to private companies. According to the leaders of the
Estonian Gene Bank Project (EGBP), their project meets the requirements
of 'informed consent' in accordance with Estonian legislation. In
Estonia, unlike Iceland, he promised, participating DNA donors would
receive feedback.

Scientific myth

In May 2003, one of the family doctors trained to counsel participants in
the Estonian Gene Bank Project (EGBP) confessed in the main national
newspaper that her sole motivation in taking part was the chance to
acquire her own personal gene card/map in three years' time.

According to Krista Kruuv, Chairman of the Management Board of the EGF,
the planned genotyping will enable more exact and efficient diagnoses of
illnesses, determination of development risks thereof, and improvements
in treatment. Kruuv, and Dagni Krinka, head of the Estonian Genome
Project's laboratory, said that the DNA donors would however have to wait
for at least three and maybe up to five years to receive such a personal
gene card/map (see The Chronicle of Higher Education (Volume 49, Issue
33, page A16).

Kruuv also wrote in various Estonian newspapers that people should be
motivated to participate in the project because although they may be well
today, some day they may fall ill. Donors would have an advantage, as in
case of illness there would be no need to examine them so thoroughly:
important information would already be available on their personal gene
card/map. To my knowledge, this is not yet possible, and is moreover
unlikely to be so for the foreseeable future.

It is evidence, however, of the careful path to recruitment being
prepared by those who have been employed to facilitate the informed
consent of donors to the Estonian Gene Bank. The personal gene card/map
is a small but important part of a myth created in order to persuade
Estonians that their health is going to be vastly improved, with the help
of a gene card they can start queuing up for now.

Doctors have been promised that they will receive 10% extra pay in return
for high quality work for the EGBP. One family doctor who will fill in
the questionnaires asking donors about their health, genealogy,
lifestyle, nutrition, work habits, environment, said that if the donors
did not know the answers to all the questions, it did not matter: blood
samples would be taken anyway. My question is: will such an approach
really provide the necessary data for a modern, evidence-based databank
which Estonians could rely on one day to tailor drugs and treatments to
their personal genetic profile?

A slice of history

The Estonian Genome Project Foundation (EGF) was founded in 2001 by the
Government of the Republic of Estonia for the preparation and
implementation of the Estonian Gene Bank Project.

The Estonian Gene Bank has started to build an extensive file of health
questionnaires and blood samples. This information regarding three
quarters of the 1.4 million citizens is entrusted to a central electronic
database. The project is expected to take around five years to complete.
The plan is also to include children between 7-15 years of age, which
contradicts the Declaration of Helsinki and other international documents.

According to Andres Metspalu, the key figure in developing the idea of
the EGF and EGBP, the two main goals of the project are:
1. to identify disease genes within a group of patients with a given disease;
2. to help to create an Estonian health database with personal gene data
to which each participant in the project shall have access.

Metspalu and others hope that all the hard work will be rewarded by
genetically tailored treatments for both those who donated their blood
and others.

Researchers proposed the EGBP to the government before there was any
public debate. The project has been approved neither by the Faculty of
Medicine at Tartu University, the only medicine faculty in the state, nor
by the board of the Estonian Academy of Sciences. When asked about the
project, Andres Lehtmets, the then president of the Estonian Medical
Association said that his association had no official opinion at all.

The Estonian health care system is chronically underfunded, while the
majority of the Estonian population is oppressed by poverty and the
problems of everyday life. Yet for many years, millions of Estonian
crowns were poured into the account of the EGBP, at the expense of
overall health care.

However, the Estonian Gene Bank was established by the Estonian Human
Genetics Research Act of 2000. In the same year, the private US company
Egeen was founded (Andres Metspalu is its Chief Scientific Officer) to
finance the project and commercialise its results for drug and diagnostic
developments. EGF is the owner of the database, and acts as the public
service front for a commercial enterprise. EGeen is the exclusive
commercial licensee of the database. The company holds exclusive rights
to money-making ventures that rely on the data for the next twenty-five
years. It will give a percentage of its profits back to the Estonian
Genome Project Foundation to run the project.

Incentives and consent

The pilot phase of the sample collection was launched in three counties
in October 2002. The pilot study - largely financed by investors of EGeen
International - was used to evaluate the overall feasibility of the
larger project. According to the original schedule the Pilot Project
should have involved 10 000 donors. Recently the EGF has reported that
the number of gene donors was only a tenth, nearly one thousand at the
end of the pilot project. At present the plan is to include the other
counties of Estonia gradually.

During the pilot phase, those family doctors trained for participation in
the EGBP sent the completed consent forms and blood samples of gene
donors to the Estonian Gene Bank by courier. Doctors received 250 crowns,
i.e. US-$17, for each interview with a donor lasting about an hour. (The
basic salary of a doctor is 42 crowns per hour.) The compensation per
donor increased in proportion to the overall number of consenting donors,
and created its own partial interests. The economic benefit entices the
physician to get involved in the project: the more patients he convinces
to become donors, the better for him.

Donors' family members are not required to give their consent to be part
of the EGBP, but the questionnaires also contain questions about them.
Doctors are asked to draw up the family tree for each donor. (See:
Estonian Human Genetics Research Act , chapter 3, §14, 3). Questionnaires
containing health and genealogy data are sent to the Estonian Gene Bank
electronically, where the data is encoded and the consent forms archived.
Blood samples are sent directly to the laboratory. The DNA separated from
the blood samples will be preserved in the storage facilities of the
Estonian Gene Bank.

Secrecy and exploitation

The EGBP has no organised opposition. Such information about the Estonian
Gene Bank as does surface in the national media is clearly propaganda.
Within the Estonian Gene Bank, in fact, a department for public relations
was set up in its earliest days. At first, it was kept secret that the
Bank had a commercial plan.

Only now is the consent form informing donors that their tissue donations
may have some commercial value, and that their anonymous data may be
commercially exploited. Foreign newspapers on the other hand have been
pointing to the commercial significance of the EGBP. (See: Andreas
Weber's article "Sold nation" in Süddeutsche Zeitung, 23 November 2001).

The initiators of the EGBP pledged themselves to acting in accordance
with such generally recognised codes of ethics as those contained in the
Human Genes Research Act, the Convention on Human Rights and Biomedicine
of the Council of Europe plus its Additional Protocols, the Helsinki
Declaration of the World Medical Association, and the Universal
Declaration on the Human Genome and Human Rights of Unesco.

Participants in the Estonian Gene Bank may not withdraw their data at any
time as required by the ethical documents mentioned. The Estonian Human
Genetics Research Act, chapter 2, §12, 7 declares for example that 'a
gene donor has the right to withdraw his or her consent until his or her
tissue sample or the description of his or her state of health is coded.'

The EGBP has chosen to ignore many of the basic requirements of medical
ethics. Even today, the EGBP has undergone no appraisal by an independent
ethical committee. The Estonian Gene Bank has an ethical committee whose
members are appointed by the Estonian Gene Bank Board. The leaders of the
EGBP say that the independence of the EGBP ethics committee is guaranteed
by the state salary being paid to its members. Nevertheless, members may
be removed by the Estonian Gene Bank Board at its own discretion (See:
Estonian Human Genetics Research Act, chapter 6, §29, 4,5).

Unfortunately, Estonian medicine has no previous track record in informed
consent. Its physicians have for years taken paternalistic decisions
regarding the examination and treatment of their patients. Counselling
does not flourish in Estonia in the way it might be understood in the
western world.

Did Estonia learn from Iceland's mistakes?


European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
Kleine Wiese 6
D - 38116 Braunschweig

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