Update on the European Court Ban on Patenting Embryonic Stem Cell Lines

Alas, I haven't had the time or energy yet to carefully read the entire decision of the European Court to ban the patenting on human embryonic stem cell (hESC) lines, that I posted about the other day. However, some of my colleagues have indeed made more extensive comments:

Julian Savulescu (Uheiro Centre for Practical Ethics, University of Oxford). I made some input in the commentary thread there as well.

Kenan Malik (writer, lecturer, broadcaster, a presenter of Analysis, on BBC Radio 4, and a panelist on The Moral Maze, also on Radio 4).

Other commentators so far make more predictable and less reflective responses, such as those of hESC scientists and overt or covert pro-life campaign organisations. To me, these are of less interest since they mainly repeat dogmatic stances that were set in stone decades back.

Hopefully, I'll be back with my own analysis and comments not too soon.

Court Acquits Swedish Neonatal Doc Charged with Murdering Newborn Baby in Controversial Case

Today, the verdict was announced in a very controversial case in my country regarding a neonatal intensive care doctor, who has been charged with murdering a newborn baby by administrating high doses of sedatives (here, here, here, here, here, here, here, here). The doctor is acquitted of the charges of manslaughter. It remains to be seen if the prosecutor decides to take the case further to appellate court.

The case has sparked heated discussions and not so little confusion in the medical, political and ethics expert community. Leading voices of medicine have somewhat lost their marbles and made megalomaniac claims about doctors being immune from prosecution whatever they do to their patients in the name of best practice. There has also been rather peculiar criticism about the prosecutor taking a long time bringing the case to court, where the unspoken message seems to be that medical doctors should somehow be treated differently than other people in criminal proceedings - reminding a bit about how Julian Assange or Mr. Strauss-Kahn have been reasoning around their own persons in relation to the rape charges they are or have been facing.

All of this has, to my mind, been sheer nonsense. Of course, it is immensely burdensome for anyone to face serious criminal charges. Even more so if your own view is that you have made nothing wrong, but rather the best you can. It is also completely understandable and justifiable that the legal defense and friends of those charged do their best to have the person charged described as innocent in media. However, the principle of equality before the law stands far above any such individual consideration. Take a deep breath and think about for a moment how society would look like if we let that principle slide and this should be crystal clear to anyone.

Now, there have been several attempts to make a spin on the case settled today according to which it is not about a real legal issue, but rather about a more hazy underlying problem of an ethical nature. The idea has been that the critical issue is whether doctors are allowed to take risks in order to achieve effective pain reduction in dying patients. However, albeit indeed being an interesting issue in its own right, that has never been the centre of discussion in the present case. Doctors are allowed to take such risks according to Swedish law, end of story. But they are not allowed to murder people as this is defined in criminal law. It is the latter that has been the base for the prosecutor's claim in the case decided today. 


Instead of making my own explanations of how I read the court's decision, I have made a quick translation of the court's own press summary. The Swedish original is here. Read for yourself and make up your mind!

Solna District Court today acquitted the doctor who was prosecuted for manslaughter or attempted manslaughter of an infant at Astrid Lindgren's hospital in Solna fall of 2008. The district court has not found it proven that a crime has been committed. The district court has not found it proven that the doctor has done something that was not be medically justified.
The district court has not found the evidence sufficient for showing beyond reasonable doubt that a crime has been committed. The prosecutor's claim is based on an analysis of forensic evidence, which has demonstrated an exceptionally high concentration of thiopental in the blood from the deceased child. The district court has not considered this result to be sufficiently reliable to fully serve as the basis of a conviction. The district court does not believe that one can draw any more far-reaching conclusion of the analysis results than the one that thiopental, although observed in a high concentration, it is unclear how high the concentration was. Given this uncertainty about how high the concentration was, it is conceivable that the occurrence can be explained by the fact that the child had received thiopental on previous occasions during hospitalisation. This means that there is no evidence that a crime has been committed and the doctor is already on this ground freed of the charges made.
 The district court has not considered that the prosecutor with sufficient certainty has proven that the doctor has acted in any way that was not medically justified when the child died.
In the debate related to this case, it has been claimed that the case concerns the distinction between what a doctor can and cannot do when it comes to relieving pain and anxiety in end of life care. This is not correct. The prosecutor's contention is rather that the child has been poisoned, that the child has been receiving a very high lethal dose of thiopental administered in order to effect that the child would die, not in order to relieve pain or distress. There is no doubt that such conduct, if it had occurred, is punishable as manslaughter under Swedish law, whether or not it had been prompted by reasons of compassion and whether or not the child would have died anyway within a very short time. As has just been said, however, the district court did not consider it proven that such a criminal act had in fact taken place.

European Court Rules Against (almost all) Patenting of Embryonic Stem Cells

Yesterday, the European Court publicized its ruling on the controversial case of the patentability of human emryonic stem cell lines (hESC) in European law. I have discussed this issue in two former posts: here and here. The complete ruling can be found here and is quite long, but the conclusions are clear:

On those grounds, the Court (Grand Chamber) hereby rules:

1.      Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:

–        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’;

–        it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.

2.      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.

3.      Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

In short, hESC lines can indeed be patented, but as part of a procedure for "for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it". In other words, patenting of hESC lines for the purpose of regenerative medical purposes or research is ruled out within the jurisdiction of European patent law.