commentary

An ethical dilemma
The rise and fall of UmanGenomics — the model biotech company?

C. BREDBERG/NORRLANDIA
Hilary Rose
For the biotechnology industry, data that
cover the health and genetics of a popula-
tion can represent a treasure-trove of infor-
mation. But the marriage of business and
such public data is, at best, uneasy. Conflicts
over informed consent and privacy have, for
example, overshadowed plans by Reykjavik-
based deCODE Genetics to establish a
health-sector database covering most of
Iceland’s population. So it was with great
fanfare a few years ago that the leading
scientific press welcomed a new Swedish
biotechnology company: UmanGenomics1,2.
Promising that its foundations would be
based on popular consent, and pledging an
ethical approach to the data it would access,
including the public sharing of results,
UmanGenomics was promoted as “a model
of how public tissue banks should interact Valuable resource: Umeå’s hospital holds a tissue bank with samples and data from some 87,000 people.
with the biotech industry”2. The biobank in
question was created during a health-inter- biobanks. The contract drawn up to allow legal complaints by biobank colleagues of
vention campaign in the northern Swedish UmanGenomics access to the Västerbotten Hallmans were rejected and the case referred
county of Västerbotten. During the project, biobank recognizes only the county and the to the appeal court, where a judgement is still
clinical researchers at Umeå University col- university as “principals with rights of dis- pending. For a company founded so deter-
lected and collated lifestyle and health data, posal”over the data the bank holds.Hallmans, minedly on ethics,where did it all go wrong?
including blood samples, for a significant as the chief architect behind the biobank’s
proportion of the county’s population. creation,is challenging this interpretation. Building a biobank
UmanGenomics grew out of the shared The conflict has become bitter and there By 1998, it was obvious that the biobank
wish of the university and Västerbotten’s is little room for compromise. The university assembled by Hallmans and his colleagues,
county council to commercialize the biobank and the county see Hallmans as an impedi- and held at the county hospital in Umeå,
that had been created under their auspices. ment to their plans for scientific progress and was a potential gold-mine for genomics. To
The original plan was to “discover disease- high-tech industrial development in Umeå. capitalize on this amassed information, Umeå
related genes, explore their function and mar- Hallmans, supported by current and retired University and the county council of Väster-
ket this knowledge”. But just four years later, colleagues, is outraged that the contract botten decided to create a company that
the company has been more-or-less moth- between the county and the university has could make commercial use of the data. To
balled.No contracts have been secured,and no allegedly set aside pre-existing research con- those ends, Sune Rosell, then recently retired
revenue was achieved during 2001. At the end tracts; that UmanGenomics (like deCODE from drug firm Astra where he had sometime
of 2002 there were just 16 full-time staff — by in Iceland) has been granted monopoly com- been research director, was appointed as an
May 2003 this was down to two. mercial access to the biobank; that the con- adviser and chair of the biobank. In the light
Meanwhile, a furious row has broken out, tract ignores the fact that donors did not sign of his advice, the bank and the commercial
primarily between Umeå University as the up to have their samples exploited for private interests were split. Rosell was appointed
lead owner of the company and Göran Hall- profit; and that his intellectual property rights chief executive of the newly created
mans,the originator and initial director of the have been ignored. In October 2001, the first UmanGenomics, and the biobank remained
biobank.Not only has the conflict been played the university’s and county’s responsibility.
VF VÄSTERBOTTENS FOLKBLAD

out in two local newspapers, Västerbottens- Rosell’s plans for UmanGenomics were
Kuriren and Västerbottens Folkblad, with aca- developed within the framework of the ethi-
demics and even national politicians inter- cal guidelines for genetics drawn up by the
vening, it has also been followed closely by Swedish Medical Research Council and the
a multidisciplinary research team led by National Board of Health and Welfare’s pro-
bioethicist Mats Hansson of Uppsala Univer- posals for legislation on biobanks. In turn,
sity,which has published two reports3,4. the government made it clear that any such
A major stumbling block in the develop- legislation would need to be compatible with
ment of UmanGenomics was intellectual the 1997 European Convention on Human
property rights. Unlike many countries, Rights and Biomedicine to simplify eventual
Swedish law allows for ‘the teacher’s exception’, ratification. By contrast with deCODE
which gives academics ownership of the intel- Genetics, which claimed the genetic unique-
lectual property that they produce. But legally ness of the Icelandic population as the key
Göran Hallmans: helped create Umeå’s biobank.
it remains unclear how this exception relates to selling point for its biobank project, Rosell
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commentary
opted to place ethics at the heart of the sales
pitch for UmanGenomics.
But UmanGenomics soon ran into diffi-
culties. One early hiccup was the plan for a
public–private partnership to own the com-
pany. This provided for the university and
the county — as the perceived owners of the
biobank — to hold 51% of the shares and for
the rest to be privately held. But in Sweden,
public bodies cannot engage in commercial
activity. Fortunately, universities in Sweden,
as in many other countries, are encouraged to
stimulate industrial–academic links and ven-
tures. So to maintain the ethical-ownership
model for UmanGenomics, the university
became the sole public shareholder.
A second hitch was the marketing plan.
The company hoped to secure contracts with
the big ten drug companies that had funded
the SNP Consortium, an initiative to build a
publicly accessible database of human single-
nucleotide polymorphisms (SNPs). But in
the event,no such contracts were secured.
Third, UmanGenomics had to switch its
business plan from gene hunting to the newer,
hotter areas of functional genomics and pro-
teomics. Reorienting was costly and the com-
pany argued that it would need an additional
200 million Swedish kronor (US$23.5 mil-
lion) to achieve its goal. To secure this fresh
investment it claimed that the 51% public
ownership was unhelpful and that potential
investors were being scared off by the require-
ment that results had to be available to com-
petitors. Ethics, which had first been the sell-
ing point of UmanGenomics,now threatened
to drive the firm into bankruptcy. Fortunately
for the company, the Swedish biobanks law
introduced at the beginning of 2003 made it
possible to argue that the 51% public owner-
ship was no longer needed, and it was agreed
to negotiate a new contract.
A valuable collection
These difficulties were exacerbated by the
concurrent fight over access to the biobank.
This problem was inherent to the original
commercialization plans, which were devel-
oped as if the bank was simply the result of the
county’s health-promotion activities begin-
ning in the mid-1980s.Yet the objective of the
project was to reduce the levels of heart disease
and premature death in the county. All that
was needed for this was patient-based records
of lifestyle, health status and such measures as
lipid levels and blood pressure.Keeping blood
samples was not intrinsic to the project.
There are two issues that no one seems to
have taken fully on board at the outset. Who
had found the resources to run the biobank
over its 15-year existence? And what role
should those who established the bank play in
the new venture? It is acknowledged by all of
the players in this story that the biobank was
created by a number of clinical researchers,
with Hallmans as the key figure. Biobank
research was unfashionable until the mid-
124
On hold: UmanGenomics has been mothballed.
1990s when genomics came onto the agenda,
and so did not easily attract funds. But Hall-
mans secured several external grants, devel-
oped international collaborations and used
projects for unemployed people to train a
workforce to take care of the bank.
As the potential for genomics research
grew, Hallmans made an initial, unsuccessful
attempt in the early 1990s to use the biobank
for commercial research. Later, together with
his colleague Joakim Dillner, he proposed a
social-enterprise model in which ownership
would be vested in a foundation representing
the people of Västerbotten. This was to be
managed by the researchers, the county and
the university, as well as by potential funders
such as the Knut and Alice Wallenberg Foun-
dation. All profits were to be reinvested into
biobank research. Hallmans’ group saw this
as meeting the trust placed in them by the
donors, benefiting research and honouring
the bank’s commitments to its existing fun-
ders.But the plans drawn up by the university
and the county cut across this scheme.
As late as February 2003,Umeå University’s
ethics committee, in its invited comment on
the draft contract, was still insisting that the
biobank’s position in relation to both the
county and the university was unclear and
should be investigated. Further, it argued
that the proposal in the contract to appoint a
steering committee of just four people to set
the criteria for research using the bank’s sam-
ples breached both the committee’s and the
bank’s responsibilities under the Declaration
of Helsinki on medical research involving
human subjects. None the less, a month or
two later, Hallmans had been removed from
his post as director of the biobank.
Unless the court of appeal can find a
solution that will satisfy both sides, this is
a lose–lose story. There will be no dynamic
biotechnology company with an ethical
relationship to a public biobank for a small
Swedish city that could use some industrial
diversification. Instead there will be, at best,
a ‘virtual’biotech company.
Could it have been different? This account
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© 2003 Nature Publishing Group
draws attention to the difficulty of exploiting
VF VÄSTERBOTTENS FOLKBLAD
an existing public biobank through a start-up
biotech company without the involvement of
all of the relevant stakeholders — not least
the researchers who established the bank. This
point reinforces a conclusion from commer-
cial lawyers Urban Paulsson and Rebecka
Frisk, who observe:“Because it is uncertain in
Swedish law whether the biological research
results initially belong to the scientist or to the
university, our advice to an outside contract-
ing party … is to ensure that ownership is
assigned to both,”(ref.4,p.261).
Alternative approach
The preoccupation with ‘ethics’ at Uman-
Genomics seems to have led to the neglect
of both the researchers’ potential property
claims and the company’s needs for flexibil-
ity in a dynamic financial and scientific
context. Might the Hallmans–Dillner social-
entrepreneurial model have fared better?
Arguably, such an approach would more
likely have secured the support of all the
stakeholders, from donors to researchers to
the responsible authorities.
Less glitzy than the admired ethical model,
a social-entrepreneurial approach might have
been able to develop slowly and steadily from
the existing research base using both public
and foundation money. This could have been
helpful after the NASDAQ crash, which left
venture capital chary of biotechnology. Non-
commercial status, broadly echoing that of
Britain’s Biobank UK — with the difference
that Biobank Umeå would have been very
locally rooted — could have had advantages.
The idea of bottom-up growth has some
scientific attractions. Although there is con-
siderable enthusiasm in some quarters for
Biobank UK, there are also some within the
scientific community who are concerned not
only about whether the costs of setting up the
bank will take too large a slice of the research
budget, but whether the bank will be ade-
quately funded regardless. A bottom-up pro-
ject could bypass this problem, growing
within its strength, building on the existing
biobank resource, and expanding flexibly to
meet scientific and commercial opportunities
as they arise. In addition, a social-entrepre-
neurial model would have enabled biobank
research to be attentive to the interests of all,
and not just some, of the stakeholders. As
Umeå — company, county and university —
has sadly learnt, failing to keep all the stake-
holders on board is expensive. ■
Hilary Rose is a visiting research professor in
sociology at City University, 4 Lloyd Square,
London WC1X 9BA, UK.
e-mail: hilaryrose@blueyonder.co.uk
1. Abbott, A. Nature 400, 3 (1999).
2. Nilsson, A. & Rose, J. Science 286, 894 (1999).
3. Hansson, M. G. (ed.) The Use of Human Biobanks (Uppsala
Univ., Uppsala, 2001).
4. Hansson, M. G. & Levin, M. (eds) Biobanks as Resources for
Health (Uppsala Univ., Uppsala, 2003).
➧ www.umangenomics.com