Stem cell regulations in Norway

Norway is not considered a leading stem cell research country, possibly as a result of the limiting regulations set by the government. Neighboring countries such as Sweden, Denmark and England have allowed research on embryonic stem cells for several years, leaving Norwegian research behind (Solberg 2009). All though, cases in recent years have led to a slight loosening of the strict regulations, bringing optimism and enthusiasm about Norway’s stem cell research. The stem cell research is associated with high expectations, shown by the Norwegian government’s 28 million kroner investment in a public stem cell research center in 2008/2009 (Dagens medisin 2009).

Stem cell research concerning bone marrow, tissue and brain puts Norwegian scientist on the global map, while research on embryonic stem cells seems stalled. This might be due to a legislation from 2003 stating a strict ban towards research on fertilized eggs, an extension of a regulation accepted in 1994. The 1994 regulation was first changed in 2002, to ensure that the legislation also covered the ban of research on human embryos and cell lines originating from fertilized eggs or human embryos. The arguments supporting this ban were they believe in humans as well as the protection of the evolving human life. In 2008 a new legislation cancelled this ban and opened the possibility to perform research on redundant embryos (Helse og omsorgsdepartementet 2006-2007).

Redundant embryos appear as a result of fertilization of more eggs than needed for artificial insemination. In addition, appearance of low-quality eggs not suited for further insemination also goes to waste. It has been estimated that Norway annually destroys about 15000 redundant embryos (Dagens Næringsliv 2006). It is a paradox that Norwegian hospital workers are expected to perform high quality artificial insemination, without being allowed to practice on human fertilized eggs. It is reasonable to believe that Norwegian hospital workers have received their training outside of Norway (Berge 2009). One aim of the 2008 legislation is therefore to make it easier to improve skills and aim a higher degree of quality of artificial insemination.
Further, a case from 2004 became a trigger for a change included in the 2008 legislation. 2004 became a year with media storm followed by public debate as a result of the “Mehmet case” (Andersen 2004).

A six year old boy named Mehmet is born with the inherited disease Thalassami. The disease makes the boy dependent on monthly blood transfer, unfortunately resulting in accumulation of iron in target organs such as brain and liver. These circumstances give Mehmet a limited life expectancy of 40 years. The disease can be cured if the patient receives stem cells from a suitable donor, most likely a sibling (Andersen 2004). This case raised the ethical question: Is it acceptable to raise donor siblings? Mehmet could be saved if Norway allowed pre implantation genetic diagnosis (PGD). This means that in vitro (outside the body) fertilization must be performed, followed by selection of the most suitable embryo.

In this case, most suitable meaning an embryo genetically free of Thalassami combined with tissue matching Mehmets tissue. Despite split views among Norwegian politicians the government decided to allow PGD with the purpose to find suitable stem cell donors (Andersen 2004). The legislation came with a limitation though, each case must be considered independently by a selected committee before accepted. To be evaluated, one or both parents must genetically carry a seriously or possibly lethal disease. The legislation was officially accepted in 2007, and took effect 1^st of January 2008 (Norsk Lovdata 2007). Besides from improving skills on PGD and artificial insemination, the 2008 legislation states the allowance of research on stem cells with the aim of gained knowledge. This knowledge about stem cells might give clues in future treatment for diseases such as Alzheimer, Parkinson, diabetes and cancer. The 2008 legislation emphasizes that research on stem cells is only allowed for the mentioned purposes. Research resulting in inheritable genetically changes are still considered illegal (Norsk Lovdata 2007).

Norway’s stem cell research regulation might seem strict from a stem cell enthusiast’s view. But the Norwegian government’s regulation also seems to be precautionary and based on carefully evaluated decisions.

Sources:

1. Solberg Berge, 30.03.2009, ”Nasjonale lover og internasjonal forskning på stamceller”, Forskningsetisk bibliotek, Oslo

2. Dagens medisin, 27.11.2009, ”Åpner stamcelle-senter”, Dagens medisin.

3. Helse og omsorgsdepartementet, ”Om lov om endringer i bioteknologiloven (preimplantasjonsdiagnostikk og forskning på overtallige befruktede egg)”, nr. 26, 2006/2007, Oslo

4. Dagens næringsliv, 26.01.2006, ”egg og etikk”, Dagens næringsliv, Oslo

5. Andersen K. Elisabeth, 23.03.2004, ”Hva er det med Mehmet?”, Forskning.no, Oslo

6. Norsk lovdata. Nr.6-2007, lov nr 31, side 678: ”Lov om endring i bioteknologiloven”

~ by cupcakeswonderland on April 13, 2011.