Population Genetic Databases: A Comparative Analysis of the Law in Iceland, Sweden, Estonia and the UK
Kaye, Jane, Helgason, Hordur Helgi, Nomper, Ants, Sild, Tarmo, Wendel, Lotta, Trames
The first population genetic database proposed in the world was the Icelandic Health Sector Database (HSD) in 1998, followed by the Umangenomics proposal in Sweden, the Eesti Geenivaramu in Estonia and the UK Biobank. It is only in Estonia and Iceland where specific legislation has been enacted to cover these population genetic databases. (1) These genetic databases have been established with the primary goal of carrying out genetic research on populations to determine the functionality of genes, as well as the relationships between genes, lifestyle and environment. In order to achieve this population genetic databases combine DNA samples, personal information from interviews and medical records, as well as genealogies and family histories. This variety of information and the issues that are raised by its use, such as ownership, consent, feedback, benefit sharing and access to the database, have caused a heated debate in many countries. The purpose of this paper is to discuss the way in which the law in each of these jurisdictions deals with these issues through specialist legislation and how these issues challenge existing legal precedents.
Ownership is an internationally recognized legal concept that embraces several aspects related to control over a 'thing'. Its historical roots in the Roman law are so strong that the later national developments in various countries have not triggered any international attempt to harmonise the property law or tackle mutual recognition issues, with the exception of intellectual property law. (2) However the European Parliament and the Council of Europe have recently called for research to be undertaken in the fields of tort law and property law in order to determine whether the differences in Member States' legislation constitute obstacles to the proper functioning of the European internal market. (3) The following sections present a short analysis of the ownership of the contents of the population genetic database such as DNA samples, personal information and genealogies, as well as the discoveries or inventions resulting from the research.
The importance of ownership
Along with the growth in biotechnology, genetic resources have taken on an increasing scientific and commercial value for a wide range of stakeholders. In the context of population genetic databases, one could view ownership as:
a) an instrument to grant control over the things--i.e. the institutionalised owner is entitled to determine by whom, when, how and on what purposes the thing is to be used; and
b) an instrument to make the thing subject to commercial transactions (sales, pawn, rent, licensing etc) and give rise to financial gain.
Although there are differences in the national rules on the transference of property, the substantive differences reveal themselves in careful analysis of the 'new' property that has emerged in relation to genetic databases. These 'new' objects include biological samples such as DNA samples, genealogies and health data from particular individuals as well as the genetic database as a whole. The DNA samples and genealogies are new because traditionally there has been no research 'market' for them i.e. they could not be considered as 'genetic goods'. Health data is used for diagnosis of patients or medical research, but it is the potential of genetic research that requires a second look at the regulations. Population genetic databases are a structured collection of material and discoveries or inventions are already covered by ordinary regulations on data collection and intellectual property. The novel aspect of population genetic databases is the altruistic participation of many people, sharing a common heritage, with the potential for the results of the research to benefit society in a number of ways. There are few examples such as this where there is a mass contribution to a project conducted by a small number of researchers where the intellectual property benefits will be concentrated in the hands of a small number of patent holders (unless this is otherwise agreed by contractual means). …