Ethical stem-cell research unaffected by European Court of Justice ruling

"A process which involves removal of a stem cell from a human embryo at the blastocyst [early embryo] stage, entailing the destruction of that embryo, cannot be patented."

The European Court of Justice has ruled that stem cells derived from human embryos may not be patented, that is to say, made the intellectual property of an individual or company, because to do so is a contravention of European law. However, ethical and effective stem-cell alternatives are unaffected and will continue to make progress.

Additional Reuters reporting here.

The Court found that the legal definition of a human embryo did include embryos created by means other than the fertilisation of an egg by a sperm (e.g. by somatic cell nuclear transfer), and therefore that Directive 98/44/EC of the European Parliament and the Council, which forbids the use of human embryos for purposes of scientific, commercial or industrial research, does apply to all embryos.

"Any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo'".

The ruling went on to say that, because "the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable."

What this means is that, since barely any embryo research has as its aim the wellbeing of the individual embryo being experimented upon, the European Union's highest Court has effectively declared all existing embryonic stem-cell research to be out of bounds for patenting. This supports the restrictions on human research envisaged in the European Convention on Human Rights and Biomedicine, a crucial document which almost all countries in Europe have ratified - though not Britain.

Given that it is likely to reduce severely the amount of research being done on embryos, this is obviously a great result for all those who argue for the inviolability of the human embryo and believe that human life should not be used as a means to an end, treated as a mere thing. The Court has affirmed the importance of embryonic life.

Cue a storm of protest from some parts of the media and from certain scientists. This will be the end of stem-cell research, they cry; this BBC story contains some such complaints. But what's missing from the coverage is a sense of perspective. As Fergus Walsh, the BBC medical correspondent admits, there are at present only two clinical trials involving embryonic stem cells, compared with hundreds involving adult stem cells. Embryo research has yet to provide any tangible benefits for human treatments, and is far away from the point where it is likely to do so. Many researchers in the field have expressed doubt about whether it will ever provide the promised benefits on a significant scale.

By contrast, studies involving adult stem cells and induced pluripotency, which are unaffected by this ruling, are making progresss, and are entirely ethical. There are dozens of working treatments for humans derived from adult stem cells.

There are ethically sound and effective alternatives to extracting stem cells from embryos. Professor Shinya Yamanaka of Japan was among the pioneers of induced pluripotent stem (iPS) cells, which take adult human somatic cells and reprogramme them to an “embryo-like” state, thus enabling the extraction of powerful stem cells without the ethical difficulties of destroying embryos (it also avoids many of the numerous practical problems with embryo research). Since its discovery in 2007, this technique has swiftly become the most exciting area of regenerative medicine; although it is still in its infancy and is not without its own technical challenges, it has attracted an increasingly large proportion of funding and growing numbers of researchers.  The journal Science declared iPS cells the Scientific Breakthrough of the Year 2008.

Even Professor James Thomson, the man who first isolated human embryonic stem cells, believes that the progress in iPS cells means that the whole debate over embryo research may soon be redundant, commenting that “a decade from now, this [i.e. embryo research] will be just a funny historical footnote.”  Many other observers support the view that the considerable and still unresolved technical problems of embryo research, as well as its ethical difficulties, mean that it is becoming increasingly irrelevant to the future of regenerative medicine. Sir Martin Evans, for instance, a Noble Laureate and another pioneer of embryonic stem-cell research (in mice), has suggested that iPS cells represent "the writing...on the wall" for research using embryos.