International issues in the regulation of stem cell research

15 April 2008

There have been several recent international developments in stem cell regulation. On Friday 11 April, the Bundestag (lower house) of the German Parliament voted 346-228 to ease current legal restrictions on human embryonic stem (HES) cell research (see BBC news). Previously, German researchers have only been able to use HES cells harvested before January 2002, but now they will be free to use cells created up to May 2007. Germany has in general adopted a conservative approach towards controversial lines of medical research, but this latest move reflects concerns that their international scientific reputation could suffer if research is hindered by excessive regulatory burden.

Meanwhile, the UK National Stem Cell Network, which last week hosted its inaugural Annual Science Meeting in Edinburgh, has warned that the current status of the UK as a world leader in stem cell research will be in jeopardy in the absence of an increase in research funding in excess of £100 million. Professor Roger Pedersen said that the UK was at risk of being eclipsed by Germany and the US, both of which are investing heavily in this area (see Times Higher article).

A survey of public opinion on controversial work using human-animal hybrid embryos in the UK (see previous news) has suggested that 50% of respondents were in favour of the work, and of proposed legal amendments to facilitate such research (see The Times article)., A legal challenge has howeverbeen mounted by the UK Christian Legal Centre (CLC) against the decision of the Human Fertilisation and Embryology Authority (HFEA) to licence such research (see press release), on grounds that the 1990 Human Fertilisation and Embryology Act does not permit the creation of human-animal embryos. The 1990 Act has yet to besuperseded by amendments proposed by the Human Fertilisation and Embryology Bill, which are currently before Parliament.

In the US, a stem cell research advisory panel to the Food and Drug Administration (FDA) has been meeting recently to consider appropriate safeguards for potential use in clinical trials regarding new stem cell therapies on human subjects (see WebMD news). It is not clear whether these will be more rigorous than those applied to normal drug trials.

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