Sunday, 1 May 2011

Bad Arguments on All Sides in the European Embryonic Stem Cells Legal Circus, part 2

So, this is the second part of a post begun a few days ago. I'll repeat the bare bones of what it's all about:
In March, Nature News reported, a judge at the European Court of Justice (the decisions of which are binding for all EU member countries) named Bot (forename unknown) brought forth the proposal that patenting embryonic stem cell lines would be unlawful, since they have been produced through a process involving the destruction of embryos. Thus, the judge argued, (as reported by Nature News) "they are tantamount to making industrial use of human embryos", which (quoting the judge) would be contrary to "ordre public and morality". The proposal follows a motion made by Greenpeace to repeal a patent application made by German researcher Oliver Brüstle. The European court is expected to make a ruling "in a couple of months".
In my former post, I analysed the proposal of ECJ judge Bot in quite negative terms – concluding it to be a covert attempt to smuggle into European case law legally unsupported and controversial views on the moral status of embryos. However, I also stressed that the many faults of that proposal did not imply that the idea of patenting embryonic stem cell lines is a very good one. To get to the reasons why that is so, I'll now have a look at the response to Bot's proposal from the embryonic stem cell research crowd.

April 27, BBC reported that leading European researchers in the embryonic stem cell field have protested against judge Bot's proposal in a letter to Nature. According to this report, the researchers make three arguments against the proposal – two of a pragmatic nature, and one factual. The pragmatic arguments are that a patent ban on the basis suggested by the judge would imply a disparaging moral message about embryonic stem cell researchers and their activities, and that the ban would undercut investor interest in research on stem cell based therapies, which is now entering the stage of clinical trials. I'll get back to these arguments in a moment.

 The factual argument is that, contrary to what the judge seems to assume, therapeutic procedures involving the use of embryonic stem cell lines would in fact not imply any "industrial use of human embryos". This since the lines are already in existence and that, therefore, all that is needed for the continued use of them is the proliferation of the cell lines themselves. For sure, once upon a time, a number of embryos were destroyed to create these lines, but once that was done any further destruction of embryos is unnecessary. Now, while this argument seems to be sound and valid as regard the particular patent application of Brüstle, it is limited as a response to the principled claims made by judge Bot in his proposal. What the factual argument implies is that this proposal may not apply to Brüstle's application and possible other applications for about 100 cell lines already in existence. However, if the proposal was to pass the ECJ, it would seem to apply to all future attempts to secure patent protection in conjunction with the launching of attempts to produce new embryonic stem cell lines. That is, the factual argument may perhaps get Brüstle and a number of other potential patent applicants in the stem cell field off the hook, but it would allow judge Bot's main idea that producing stem cell lines through the destruction of embryos equals the exploitation of mass murder for organ trafficking purposes to pass into European case law. So, let's move over to the two pragmatic arguments.

Both these arguments seem to me rather weak as they stand. First, if the judge were right about the moral status of embryos according to European law (which he is not, see part 1, but that is not argued by the researchers), sending a disparaging moral message about embryonic stem cell researchers would not seem misplaced. In other words, this argument presumes an argument to the effect that Bot's claim regarding the moral and legal status of embryos is mistaken, but no such argument is given by the researchers.

Second, it is highly debatable if it is actually true that patenting of stem cell lines is either a necessary or a sufficient form of commercial protection for private investors to be attracted to funding the development of stem cell based therapies. What these investors need are patents guaranteeing the exclusive commercial rights to the product ensuing from such research and development, that seems to be true. However, while patenting of cell lines might provide such protection in some cases, they need not do so in all cases – it all comes down to what the product turns out to be. If the product involves using said cell lines, there will be protection. However, the product may also turn out to be a procedure not involving the use of any cells at all (rather, these cells have been a research tool for discovering mechanisms which the product – e.g. a drug – is able to manipulate). More important, even when the product in fact would involve using the cell line in question, the cell line is not identical to the product – the product is the entire procedure in which the cell line is used. In other words, what is necessary is to patent that procedure (insofar as it meets the criteria for European patent protection). This, however, is compatible with having the cell lines themselves unprotected, and thus freely available for use by others for other purposes, such as important basic research.

This brings me to why I actually strongly oppose the idea of allowing patents for all stem cell lines – be it embryonic or adult. First, stem cells are not inventions, they are naturally occurring phenomena – just as (non-synthetic) genes are. The mere fact that the cells have been moved from their original location inside an embryo or the body of an adult doesn't change that. If I move a flower found in the forest into my garden, the flower has not thereby been transformed into a human invention. I may claim, of course, that my garden or the entire flowerbed is my invention – but that does not imply anything about the flower itself. Likewise, if I happen to have developed a unique method for moving the flower, that method is my invention, but the flower is not, wherever it happens to be located as a result of using the method. So, once again, in analogy, while it makes sense to allow patents for various procedures involving stem cells, or whereby stem cells may be transformed into useful products, this does not imply that the patenting of the cells themselves is warranted.

In addition, as we have seen, whatever procedures that may be coming out of stem cell research, it can have its (pragmatically) necessary commercial protection without having any cells or cell-lines patented (unless, of course, all processes are already in the public domain). In fact, granting patents for cells or cell-lines would, in fact, be a disservice both to society and to medical research. Just as we have seen so many nasty examples of in the case of patent on genes in the US, awarding commercial exclusivity rights with regard to "stuff" rather than processes and procedures leads to the result where research and innovation is halted rather than stimulated. The only benefit of such patents befall those individual parties owning the patent and while it may be understandable that, as a friend of mine put it, potential landowners endorse the idea that they may bar parts of the commons for their own private enjoyment, it is hard to see why society should allow – let alone assist – them in realising that ambition.

This brings me to my final point, which is connected to the fact that the ones that seem most enthusiastic about the idea of patenting cells and cell-lines are themselves belonging to a group – representing a field – that I just claimed have the most to loose from having such patents granted. It is actually rather strange to have esteemed scientists and research institutions cheering at the notion of making (a) medical research more difficult and expensive, and (b) thus less likely to produce new breakthroughs (using the resource of stem cells and cell lines). Perhaps they have been blinded by the false idea that cell or cell-line patents are a necessary evil if innovative therapies are to ensue? Or is it perhaps, that they happen to be sitting on some of these precious cell-lines and have let the prospect of making a buck shield their mission as scientists? The gene patent morass in the US has for sure exposed enough of the latter, but there is still time for the European stem cell science community to demonstrate that they are, in fact, better in that respect.