Personalized_Medicine_A_New_Medical_and_Social_Challenge

(Barré) #1

best that this legal instrument is thoroughly amended, or at least that all terms
contained therein are clearly defined by the CJEU in decisions that will be issued
following further referrals, which will almost certainly ensue. Particularly, the
CJEU must determine in which point in time does an embryo, regardless of the
method of its creation, becomes a human being—albeit solely for the purposes of
the Directive. One possibility here would be choosing a point in time before neural
development begins. It also must clarify whether the “inherent capability” to lead to
a human being exists in organisms created in the process of therapeutic cloning or
somatic cell nuclear transfer.
In conclusion, one has to ask, what is the intention of prohibiting the patentabil-
ity of most human embryonic stem cell inventions and even the research in certain
EU member states when their commercial exploitation is not prohibited? It has to be
borne in mind that the prohibition of research and patentability of these inventions
does not simultaneously mean they will not be applied in practice. Without
prohibiting both research and commercial exploitation, there is no doubt that
these inventions will be marketed in the EU member states, regardless of their
patentability. The only consequence is that they will have not been developed and
produced in the European Union but will have been imported from countries that
adequately encourage research through patent laws, such as the United States of
America. In other words, theordre publicand morality clause could significantly
slow down the European Union in the development of personalized medicine
treatments. Therefore, if there is worry about the moral acceptability of such
inventions, then the research in these areas of human biotechnology should be
absolutely prohibited on the level of the EU, as well as their production and
commercialization. Before that, it seems to be meaningless to prohibit their
patentability.


References


Council of Europe (1998) Explanatory report to the additional protocol to the convention on
human rights and biomedicine on the prohibition of cloning human beings.http://conventions.
coe.int/Treaty/EN/Reports/Html/168.htm. Accessed 12 June 2015
Council of the European Union (1998) Common position EC No 19/98 adopted by the Council on
26 February 1998. Official Journal of the EC, C110/17.http://eur-lex.europa.eu/legal-content/
EN/TXT/?uri¼celex:51998AG0408%2802%29. Accessed 12 June 2015
Court of Justice of the European Union (CJEU) (2011) Judgement of the Court (Grand Chamber)
of 18 October 2011. C 34/10 Oliver Br€ustle v Greenpeace eV.http://curia.europa.eu/juris/
document/document.jsf?text¼&docid¼111402&pageIndex¼0&doclang¼en&mode¼lst&
dir¼&occ¼first&part¼1&cid¼ 693037. Accessed 12 June 2015
Court of Justice of the European Union (CJEU) (2014) Judgement of the Court (Grand Chamber)
of 18 December 2014. C 364/13 International Stem Cell Corporation v Comptroller General of
Patents, Designs and Trade Marks. http://curia.europa.eu/juris/document/document.jsf?
text¼&docid¼160936&pageIndex¼0&doclang¼en&mode¼req&dir¼&occ¼first&part¼1&
cid¼ 44741. Accessed 12 June 2015


Embryonic Stem Cell Patents and Personalized Medicine in the European Union 77

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