The Sanctity of the Human Embryo v Commercial Research: The Brüstle Decision

The Sanctity of the Human Embryo v Commercial Research:
The Brüstle Decision 

By Fellows and Associates’ independent correspondent Samuel Ali.

The recent European Court decision in Brüstle v Greenpeace
received initial vociferous criticism for outlawing the patenting of embryonic
stem cell techniques which involve the destruction or modification of an embryo.
The fear expressed by scientists and researchers was that lack of patent
protection for stem cell research will discourage investment and, therefore,
stifle the development of new therapies for human diseases. The European
biotechnology industry will be weakened as a result, some have argued. Whilst
many of these concerns have subsequently been countered by the industry itself,
suggesting that the initial outcry was overstated, there remain questions about
the reasoning behind the decision.

Brüstle was referred to the European Court by a German court
to clarify a number of questions about the EU legal restrictions on patenting
elements of the human body. The Biotechnology Directive (98/44/EC) requires
that patent law respect the “fundamental principles safeguarding the dignity
and integrity of the person.” In this respect it states that the human body, at
any stage of development, cannot be patented – specifically, the use of human
embryos for industrial or commercial purposes; for this would be contrary to
public order or morality.

The Court took the opportunity to clarify, for the purposes
of patent law, what a human embryo was, what is meant by “use of human embryos”
and whether scientific research fell into the prohibited industrial or
commercial purpose.

In most regards, the Court’s decision was relatively
unsurprising. It found that that which is capable of commencing the process of
development of a human being is an embryo, for patent law. So, a human ovum, as
soon as fertilised, is a human embryo whose use is protected from patenting.
And that, a patent covering scientific technique involving an embryo was a
commercial purpose and, therefore, prohibited.

The express basis of protecting the fertilised ovum from
patenting, even in scientific process, is the principle of the dignity of the
person. Whilst the fertilised egg cannot be considered a person, it does
commence the development of life. Therefore, though not expressed by the Court,
it is, perhaps, better to express the moral principle invoked by the Court as
the ‘sanctity of human life.’ The idea being that human life, even at the
earliest stage, should not be reduced to a commodity.

The “sanctity of life” argument suggests that, though
fertility treatment clinics do routinely use embryos for use in IVF treatments
and do destroy embryos that are not passed on to medical researchers, this is
morally distinct from commodification. The use and destruction is a practical
and moral imperative for the humans involved in IVF, donor and donee, which
overrides the respect for the sanctity of life of the embryo. However,
patenting of processes that use or destroy human embryos renders the embryo
mere property, open to mass commercial farming, and there is no overwhelming
overriding principle to justify this. After all, human embryos can be used for
research without patents and patenting a process is far-removed from the
realisation of useable human treatments.

This moral argument is a controversial one but, nonetheless,
it has some coherence. However, the Court’s most controversial decision in the
case appears to undermine this coherence. The Court found that any process that
was linked to the destruction or modification of a human embryo was also
non-patentable. This is even if the link is indirect, for example, because the
stem cell line (not human embryos themselves) which the process uses originally
involved the destruction of a human embryo.

Here, the commodification argument against patenting does
not seem to follow. If stem cell lines, which can reproduce infinitely, are in
existence and these can be legal controlled to be used for research, no further
human embryos will be required for research on stem cells. Yes, one embryo has been
‘sacrificed’ to create the stem cell line but there will be no further use of
embryos.

Yet, the decision finds that that one human embryo once
destroyed in the past precludes the patenting of any process that uses any of
the stem cells since derived from it. They are all tainted by lineage and
patenting would disrespect the sanctity of that one embryo from which they
came. The problem with this argument is that, if extended to the sanctity of
human consent, it would, prohibit the patenting of any treatment developed
through much more morally suspect means – for example, that of the HeLa cell
type. This cancer cell type was taken, in the early 1950s, without consent by a
doctor treating a woman, Henrietta Lacks, who was dying of cervical cancer.  The cell line proved “immortal” reproducing
infinitely and went on to be used to develop the polio vaccine and be applied
in cancer research, AIDS research, gene mapping and many other scientific
purposes.

There are certainly ethical concerns about the sanctity of
human embryos and their use in stem cell research. But the Court’s most controversial
finding was not coherently justified. This has led some to suggest that the
Court used this moral argument to, in fact, deal with a market problem, namely,
that in stem cell research, patents are inefficient – there are other
protections in place which protect inventions and the patents merely act as a
barrier to entry to the market. This position is leant some weight by the
industry voices who have argued that the Brüstle decision does not affect them
very much because of, amongst other things, protection provided by the
regulatory framework, availability of patents in other regions and ‘downstream’
inventions developed from unpatented research.

It is arguable the Brüstle decision does not have the
damaging impact initially feared. Not just because non-patent protections exist
for embryonic stem cell research but also because this type of research is not
common. Out of 2,000 clinical trials underway on stem cells in Europe, only two
involve embryonic stem cells. Nonetheless, the decision’s reasoning, at least
in its prohibition on patenting techniques that are indirectly linked to embryo
use, is logically suspect.