Personalized_Medicine_A_New_Medical_and_Social_Challenge

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member state of the EU therefore has the discretion to allow or ban embryonic stem
cell research as it sees fit.
This discretion is qualified to an extent in those EU member states that have
signed and ratified an important transnational legal instrument—the Convention for
the Protection of Human Rights and Dignity of the Human Being with regard to the
Application of Biology and Medicine: Convention on Human Rights and Biomed-
icine from 1997 (hereinafter: the Convention)^9 and its Additional Protocol on the
Prohibition of Cloning Human Beings from 1998 (hereinafter: the Protocol).^10
Article 18 paragraph 2 of the Convention prohibits the creation of human embryos
for research purposes. Since the Convention does not provide a definition of the
term “human embryo,” the reach of this provision regarding human embryonic stem
cell research most likely depends on the country where it is applied. The European
countries have failed to reach a consensus on the definition of an embryo while
negotiating the Convention, and it was left to the parties of the Convention to
regulate this question in their respective national laws.^11 This also implicitly
follows from the Explanatory Report to the Convention.^12 Even though Article
29 of the Convention allows the possibility of requesting the European Court of
Human Rights’advisory opinion on legal questions concerning the interpretation of
the Convention, the Court allows the relevant countries to regulate controversial
questions for which there is no consensus themselves, under the so-called margin of
appreciation doctrine.^13 Given that the Court had previously refused to interpret the
term “human embryo” in the context of the question when life begins, explicitly
stating that “[a]t best, it may be regarded as common ground between States that the
embryo/fetus belongs to the human race,”^14 even if such request is made in the
context of the Convention, it is relatively certain that the Court would refuse to give
a definition of the human embryo. Therefore, if in a given country party to the
Convention an embryo is defined to encompass only traditional embryos, created by
in vivoorin vitrofertilization of an egg cell with sperm, then Article 18 paragraph
2 would not prohibit the creation of embryos by somatic cell nuclear transfer or


(^9) As of 9 June 2015, the Convention was signed and ratified by the following EU member states:
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary,
Latvia, Lithuania, Portugal, Romania, Slovakia, Slovenia, and Spain; it was signed but not ratified
by the following EU member states: Italy, Luxembourg, Netherlands, Poland, and Sweden; it was
neither signed nor ratified by Austria, Belgium, Germany, Ireland, Malta, and the United
Kingdom.
(^10) As of 9 June 2015, the Protocol was signed and ratified by the following EU member states:
Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Greece, Hungary, Latvia, Lithuania,
Portugal, Romania, San Marino, Slovakia, Slovenia, and Spain; it was signed but not ratified by the
following EU member states: Denmark, France, Italy, Luxembourg, Netherlands, Poland, Sweden;
it was neither signed nor ratified by Austria, Belgium, Germany, Ireland, Malta, and the United
Kingdom.
(^11) See EGE ( 1998 ).
(^12) See Council of Europe ( 1998 ), paras 16–20.
(^13) See Pattinson and Caulfield ( 2004 ).
(^14) See ECHR ( 2004 ).
Embryonic Stem Cell Patents and Personalized Medicine in the European Union 57

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