Danish researchers who want to use stem cells, xenotransplantation and gene therapy will have to wait until 2004 for parliament to pass legislation after a government committee raised significant concerns.
The committee on gene technology, which was set up last year to describe the potential benefits and risks surrounding stem cells, xenotransplantation and gene therapy but not to prepare legislation, said a number of areas needed clarifying.
In stem-cell therapy, a major concern is whether the possibility of developing medical treatments can justify the ethical doubts related to isolation of stem cells from embryos. The committee said that stem-cell isolation was permitted in Sweden and the UK, but that the situation in Denmark was unclear.
The law does not mention stem cells, but it does regulate the use of human embryos in research. Only research aimed at improving in vitro fertilisation and pre-implantation diagnosis is permitted. Such research must use only embryos left over from IVF treatment.
The committee said politicians must answer seven key questions: n Should basic research to explore the possibility of new treatments be permitted on stem cells derived from fertilised eggs or embryos left over from IVF treatment?
- Should the fertilisation of eggs using IVF technique be permitted, even though it is not part of a fertilisation treatment?
- Should there be specific rules for using embryonic stem-cell lines?
- Should the use of adult stem cells be further regulated?
- Should research on imported embryonic stem-cell lines be regulated?
- Should the formation of embryos through nuclear transfer from somatic cells be permitted?
- Should specific rules apply to information for and consent from people who might donate fertilised and non-fertilised eggs?
Treatment involving xenotransplantation is not permitted in Denmark. The committee said its future importance in clinical medicine was uncertain.
Xenotransplantation as part of a research project is allowed only with permission from the Danish Central Scientific Ethical Committee.