Personalized_Medicine_A_New_Medical_and_Social_Challenge

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and its potential side effects could be determined incomparably faster and with
greater security.^5
However, the greatest potential use of stem cells would, without a doubt, be in
the very treatment of numerous illnesses or serious injuries or in replacement of
damaged tissues. For this purpose, stem cells that would have greater histocompat-
ibility with the person in need of a treatment would have particular weight, such as
stem cells produced in the process of therapeutic cloning or parthenogenesis,
because there would presumably be lesser or no risk of transplant rejection due to
the reaction of the immune system. Many studies are currently directed at produc-
ing populations of certain types of histocompatible cells, which would then be
transplanted into the sick or damaged tissue of a particular patient for treatment. For
example, the goal is to produce heart muscle cells for the treatment of ischemic
heart disease, pancreatic islet cells for the treatment of diabetes, liver cells for the
treatment of hepatitis, neural cells for the treatment of degenerative brain diseases
such as Parkinson’s and Alzheimer’s, and specific cell types for the treatment of
some types of cancer.^6 Furthermore, stem cell transplantation could also help in
repairing spinal cord injuries due to road traffic crashes, falls, or violence. Some
even think that entire organs could be produced from stem cellsin vitroin the
foreseeable future, which would be a great advancement for medicine, particularly
considering the lack of organs for transplantation and the risk of transplant
rejection.^7


3 The Legality of Embryonic Stem Cell Research in the EU


There are several EU directives that have a certain effect on embryonic stem cell
research in the European Union, such as Directive 2004/23/EC of the European
Parliament and of the Council of 31 March 2004 on setting standards of quality and
safety for the donation, procurement, testing, processing, preservation, storage and
distribution of human tissues and cells (hereinafter: the Tissue and Cells Directive)
and Directive 98/44/EC of the European Parliament and of the Council of 6 July
1998 on the legal protection of biotechnological inventions (hereinafter: the Direc-
tive on Patents in Biotechnology), which will be discussed later in this chapter.
However, the legality of embryonic stem cell researchper seis not regulated at the
level of the European Union, even though embryonic stem cell research is eligible
for EU funding under the Horizon 2020 program, provided the research is legal in
the country where it takes place and has passed scientific and ethical review.^8 Each


(^5) For more on the use of stem cells for drug testing, see, e.g., DHHS ( 2001 ), pp. 17–18.
(^6) See EGE ( 2000 ), p. 9.
(^7) For more on the use of stem cells for treatment, see DHHS ( 2001 ), pp. 17–18 and 59–93.
(^8) Rabesandratana ( 2014 ).
56 J. Mutabžija

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