among EU member states there is no consensus on the issue of therapeutic cloning,
it being expressly allowed in some countries,^36 expressly forbidden in the other,^37
and completely unregulated in the third,^38 whereas the consensus exists in relation
to reproductive cloning, which is prohibited in all member states, and considering
recital 40 of the Directive, it can be concluded that therapeutic cloning is not
encompassed by Article 6 paragraph 2 item (a) of the Directive. Namely, recital
40 states that there is a consensus within the Community that cloning of human
beings offendsordre publicand morality. Since the consensus truly exists only in
relation to reproductive cloning, this could be read to mean that therapeutic cloning
is not embraced by the provision.
If we were to interpret Article 6 paragraph 2 item (a) of the Directive by applying
the cloning definition given in recital 41, a definitive answer to the question is that
therapeutic cloning covered by this provision or not could only be given if two
additional terms are clarified—the terms “human being” and “embryo.” If the term
human being covers only born human beings, the provision would not embrace
therapeutic cloning because the aim of therapeutic cloning is not the creation of a
human being with the same nuclear genetic information as another living or
deceased human being but the creation of human embryonic stem cells or tissues
and organs with the same nuclear genetic information as another living human
being. If, on the other hand, the term “human being” would be interpreted so as to
include an embryo as well, then the previous statement might not be correct since in
the process an embryo,i.e.a human being, is created, although the goal is the
creation not of a functional human being but of embryonic stem cells. However, this
latter interpretation additionally requires the definition of the term embryo.
Namely, it would hold water only if an embryo is defined so as to include not
only entities created by fertilization but also those created by somatic cell nuclear
transfer, parthenogenesis, and in similar processes. Conversely, if an embryo is
defined traditionally, so as to include only entities created by fertilization, then the
statement that in the process of therapeutic cloning a human being is not created, so
therapeutic cloning is not covered by Article 6 paragraph 2 item (a) of the Directive,
would be correct after all.
Another item on the list, which has a great effect on the issue of patentability of
human embryonic stem cell inventions, is item (c), according to which uses of
human embryos for industrial or commercial purposes are not patentable. To
determine the reach of this provision, the following concepts have to be clarified:
“industrial or commercial purposes,” “embryo,” and “the use of human embryos.”
Considering that the intention of commercially exploiting an invention is nec-
essarily connected to filing a patent application^39 and that, according to the general
(^36) For example, United Kingdom, Belgium, Sweden, and Spain.
(^37) For example, Denmark, Germany, Poland, and France.
(^38) For example, Romania, and Bulgaria.
(^39) Although the grant of a patent does not convey to the patent holder the right to implement the
invention but only the right to exclude others from exploiting the invention, the historical function
Embryonic Stem Cell Patents and Personalized Medicine in the European Union 65