Hilary Rose

For the biotechnology industry, data thatcover the health and genetics of a popula-tion can represent a treasure-trove of infor-mation. But the marriage of business andsuch public data is, at best, uneasy. Conflictsover informed consent and privacy have, forexample, overshadowed plans by Reykjavik-based deCODE Genetics to establish ahealth-sector database covering most ofIceland’s population. So it was with greatfanfare a few years ago that the leading scientific press welcomed a new Swedishbiotechnology company: UmanGenomics1,2.

Promising that its foundations would bebased on popular consent, and pledging anethical approach to the data it would access,including the public sharing of results,UmanGenomics was promoted as “a modelof how public tissue banks should interactwith the biotech industry”2. The biobank inquestion was created during a health-inter-vention campaign in the northern Swedishcounty of Västerbotten. During the project,clinical researchers at Umeå University col-lected and collated lifestyle and health data,including blood samples, for a significantproportion of the county’s population.

UmanGenomics grew out of the sharedwish of the university and Västerbotten’scounty council to commercialize the biobankthat had been created under their auspices.The original plan was to “discover disease-related genes, explore their function and mar-ket this knowledge”. But just four years later,the company has been more-or-less moth-balled.No contracts have been secured,and norevenue was achieved during 2001. At the endof 2002 there were just 16 full-time staff — byMay 2003 this was down to two.

Meanwhile, a furious row has broken out,primarily between Umeå University as thelead owner of the company and Göran Hall-mans,the originator and initial director of thebiobank.Not only has the conflict been playedout in two local newspapers, Västerbottens-Kuriren and Västerbottens Folkblad, with aca-demics and even national politicians inter-vening, it has also been followed closely by a multidisciplinary research team led bybioethicist Mats Hansson of Uppsala Univer-sity,which has published two reports3,4.

A major stumbling block in the develop-ment of UmanGenomics was intellectualproperty rights. Unlike many countries,Swedish law allows for ‘the teacher’s exception’,which gives academics ownership of the intel-lectual property that they produce. But legallyit remains unclear how this exception relates to

biobanks. The contract drawn up to allowUmanGenomics access to the Västerbottenbiobank recognizes only the county and theuniversity as “principals with rights of dis-posal”over the data the bank holds.Hallmans,as the chief architect behind the biobank’s creation,is challenging this interpretation.

The conflict has become bitter and there is little room for compromise. The universityand the county see Hallmans as an impedi-ment to their plans for scientific progress andhigh-tech industrial development in Umeå.Hallmans, supported by current and retiredcolleagues, is outraged that the contractbetween the county and the university hasallegedly set aside pre-existing research con-tracts; that UmanGenomics (like deCODE in Iceland) has been granted monopoly com-mercial access to the biobank; that the con-tract ignores the fact that donors did not signup to have their samples exploited for privateprofit; and that his intellectual property rightshave been ignored. In October 2001, the first

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legal complaints by biobank colleagues ofHallmans were rejected and the case referredto the appeal court, where a judgement is stillpending. For a company founded so deter-minedly on ethics,where did it all go wrong?

Building a biobankBy 1998, it was obvious that the biobankassembled by Hallmans and his colleagues,and held at the county hospital in Umeå,was a potential gold-mine for genomics. Tocapitalize on this amassed information, UmeåUniversity and the county council of Väster-botten decided to create a company thatcould make commercial use of the data. Tothose ends, Sune Rosell, then recently retiredfrom drug firm Astra where he had sometimebeen research director, was appointed as anadviser and chair of the biobank. In the lightof his advice, the bank and the commercialinterests were split. Rosell was appointedchief executive of the newly createdUmanGenomics, and the biobank remainedthe university’s and county’s responsibility.

Rosell’s plans for UmanGenomics weredeveloped within the framework of the ethi-cal guidelines for genetics drawn up by theSwedish Medical Research Council and theNational Board of Health and Welfare’s pro-posals for legislation on biobanks. In turn,the government made it clear that any suchlegislation would need to be compatible withthe 1997 European Convention on HumanRights and Biomedicine to simplify eventualratification. By contrast with deCODEGenetics, which claimed the genetic unique-ness of the Icelandic population as the keyselling point for its biobank project, Rosell

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

Göran Hallmans: helped create Umeå’s biobank.

Valuable resource: Umeå’s hospital holds a tissue bank with samples and data from some 87,000 people.

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opted to place ethics at the heart of the salespitch for UmanGenomics.

But UmanGenomics soon ran into diffi-culties. One early hiccup was the plan for apublic–private partnership to own the com-pany. This provided for the university and the county — as the perceived owners of thebiobank — to hold 51% of the shares and forthe rest to be privately held. But in Sweden,public bodies cannot engage in commercialactivity. Fortunately, universities in Sweden,as in many other countries, are encouraged tostimulate industrial–academic links and ven-tures. So to maintain the ethical-ownershipmodel for UmanGenomics, the universitybecame the sole public shareholder.

A second hitch was the marketing plan.The company hoped to secure contracts withthe big ten drug companies that had fundedthe SNP Consortium, an initiative to build apublicly accessible database of human single-nucleotide polymorphisms (SNPs). But inthe event,no such contracts were secured.

Third, UmanGenomics had to switch itsbusiness 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 additional200 million Swedish kronor (US$23.5 mil-lion) to achieve its goal. To secure this freshinvestment it claimed that the 51% publicownership was unhelpful and that potentialinvestors 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 threatenedto drive the firm into bankruptcy.Fortunatelyfor the company, the Swedish biobanks lawintroduced at the beginning of 2003 made itpossible to argue that the 51% public owner-ship was no longer needed, and it was agreedto negotiate a new contract.

A valuable collectionThese difficulties were exacerbated by theconcurrent fight over access to the biobank.This problem was inherent to the originalcommercialization plans, which were devel-oped as if the bank was simply the result of thecounty’s health-promotion activities begin-ning in the mid-1980s.Yet the objective of theproject was to reduce the levels of heart diseaseand premature death in the county. All thatwas needed for this was patient-based recordsof lifestyle,health status and such measures aslipid levels and blood pressure.Keeping bloodsamples was not intrinsic to the project.

There are two issues that no one seems tohave taken fully on board at the outset. Whohad found the resources to run the biobankover its 15-year existence? And what roleshould those who established the bank play inthe new venture? It is acknowledged by all ofthe players in this story that the biobank wascreated by a number of clinical researchers,with Hallmans as the key figure. Biobankresearch was unfashionable until the mid-

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 usedprojects for unemployed people to train aworkforce to take care of the bank.

As the potential for genomics researchgrew, Hallmans made an initial, unsuccessfulattempt in the early 1990s to use the biobankfor commercial research. Later, together withhis colleague Joakim Dillner, he proposed asocial-enterprise model in which ownershipwould be vested in a foundation representingthe people of Västerbotten. This was to bemanaged by the researchers, the county andthe university, as well as by potential funderssuch as the Knut and Alice Wallenberg Foun-dation. All profits were to be reinvested intobiobank research. Hallmans’ group saw thisas meeting the trust placed in them by thedonors, benefiting research and honouringthe bank’s commitments to its existing fun-ders.But the plans drawn up by the universityand the county cut across this scheme.

As late as February 2003,Umeå University’sethics committee, in its invited comment onthe draft contract, was still insisting that thebiobank’s position in relation to both thecounty and the university was unclear andshould be investigated. Further, it arguedthat the proposal in the contract to appoint asteering committee of just four people to setthe criteria for research using the bank’s sam-ples breached both the committee’s and thebank’s responsibilities under the Declarationof Helsinki on medical research involvinghuman subjects. None the less, a month ortwo later, Hallmans had been removed fromhis 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 dynamicbiotechnology company with an ethical relationship to a public biobank for a smallSwedish city that could use some industrialdiversification. Instead there will be, at best,a ‘virtual’biotech company.

Could it have been different? This account

draws attention to the difficulty of exploitingan existing public biobank through a start-upbiotech company without the involvement ofall of the relevant stakeholders — not least the researchers who established the bank.Thispoint reinforces a conclusion from commer-cial lawyers Urban Paulsson and RebeckaFrisk, who observe:“Because it is uncertain inSwedish law whether the biological researchresults initially belong to the scientist or to theuniversity, our advice to an outside contract-ing party … is to ensure that ownership isassigned to both,”(ref.4,p.261).

Alternative approachThe preoccupation with ‘ethics’ at Uman-Genomics seems to have led to the neglect of both the researchers’ potential propertyclaims 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 morelikely have secured the support of all thestakeholders, from donors to researchers tothe responsible authorities.

Less glitzy than the admired ethical model,a social-entrepreneurial approach might havebeen able to develop slowly and steadily fromthe existing research base using both publicand foundation money. This could have beenhelpful after the NASDAQ crash, which leftventure capital chary of biotechnology. Non-commercial status, broadly echoing that ofBritain’s Biobank UK — with the differencethat Biobank Umeå would have been verylocally rooted — could have had advantages.

The idea of bottom-up growth has somescientific attractions. Although there is con-siderable enthusiasm in some quarters forBiobank UK, there are also some within thescientific community who are concerned notonly about whether the costs of setting up thebank will take too large a slice of the researchbudget, 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 existingbiobank resource, and expanding flexibly tomeet scientific and commercial opportunitiesas they arise. In addition, a social-entrepre-neurial model would have enabled biobankresearch to be attentive to the interests of all,and not just some, of the stakeholders. AsUmeå — 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 insociology at City University, 4 Lloyd Square,London WC1X 9BA, UK.e-mail: hilaryrose@blueyonder.co.uk1. 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

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On hold: UmanGenomics has been mothballed.

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