Regulation of use of human cells
In Norway, the use of cells for clinical diagnostics and therapy is regulated by, inter alia, Behandlingsbiobankloven (the Act on biobanks for therapeutic purposes) (7); Blodforskriften (the Regulations on the withdrawal, testing, processing, storage, and distribution of human blood and blood components, and on the handling of health data in blood donor registers) (8); and Forskrift om krav til kvalitet og sikkerhet ved håndtering av humane celler og vev (the Regulations on quality and safety requirements for the handling of human cells and tissues) (9). Both these latter sets of regulations stipulate that donation shall be based on written, informed consent.
The use of cells for research purposes is regulated by the Health Research Act (3). Neither in the Act nor in its preparatory works is there any mention of cell lines or immortalised cells. The Biotechnology Act does, however, specify that it is prohibited «to carry out research on cell lines derived from human embryos by cloning» (10).
The Act relating to transplantations, hospital autopsies and the donation of bodies etc. states, inter alia, that «the commercial exploitation of organs, parts of organs and cells and tissues as such from humans is prohibited» (11). This provision concerning the exploitation of organs for commercial purposes has generally been regarded as including the use of cells and tissues in all contexts. The prohibition does not, however, extend to intellectual property rights or services related to the use of human biological material. Issues concerning the commercialisation of human biobanks are discussed specifically in a report from The Research Council of Norway (12).
Our search in the Norwegian biobank registry has revealed only a few research biobanks which deal with cell lines alone. The number of registered research biobanks cannot, in our opinion, be representative of the amount of research using cells, including immortalised cells, which actually takes place in Norway. Nor have we been able to locate any views expressed on the ethical aspects of such research by bodies such as the Norwegian Directorate of Health, The National Committee for Medical and Health Research Ethics (NEM), or the Regional Committees for Medical and Health Research Ethics (REC).
Society has a legitimate need for openness and transparency with regard to problems and issues related to research (13). We must expect to see an increase in the use of human cells in both therapies and research. We believe, therefore, that it would be in society’s interests to define and clarify the requirements that should be imposed for research on human cells and immortalised cells.