health protection and to promote the functioning of the internal market.^57 Diagnos-
tic is covered by the legislation governingin vitrodiagnostic medical devices.^58
Regulation of medicinal products is especially concerned with marketing authori-
zation,^59 clinical trials,^60 and data protection.^61
Actually, somewhat stronger accent on market than on risk can be recognized
from legislative instruments, whereas risk is more accentuated in soft law and
policy discussion papers.^62 However, law and ethics should not be forgotten in
the overall context.
It would be useful at this point to turn to and investigate the regulatory frame-
work for personalized medicine in the United States as a point of reference.
8 Issues Surrounding the Legal Nature in the Implementation
of Personalized Medicine: The Regulatory Framework
in the United StatesPersonalized medicine offers new patterns for the development of medicines and
medical practice. Potential advantages of personalized medicine are realized
through more efficient and safer medicines on one side, whereas disadvantages
and weaknesses mainly include uncertain regulatory requirements, insufficient
compensation for diagnostic tests, imperfect legal protection in the prevention of
genetical discrimination, shortcomings in the technology of comprehensive system
of health care, and lack of systematic education of doctors in personalized medicine
(^57) European Commission ( 2013 ), p. 16.
(^58) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on
in vitrodiagnostic medical devices. The pending Commission’s Proposal for a revision of this
Directive and adoption of a Regulation onin vitromedical devices of 2012 explicitly includes
diagnostics used in the context of personalised medicine in the definition of an IVD. See European
Commission (2012b).
(^59) Directive 2001 /83/EC on the Community code relating to medicinal products for human use.
(^60) The new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical
trials on medicinal products for human use, and repealing Directive 2001 /20/EC, entered into force
on 16 June 2014 but will apply no earlier than 28 May 2016. In the transition period, all clinical
trials in the EU are to be performed in accordance with Directive 2001 /20/EC of the European
Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and
administrative provisions of the Member States relating to the implementation of good clinical
practice in the conduct of clinical trials on medicinal products for human use. The new Clinical
Trials Regulation is aimed at facilitating the conduct of clinical trials, particularly for personalised
medicines, where diseases are increasingly narrowly defined. See more in European Commission
( 2013 ), p. 19.
(^61) Data Protection Directive 95/46/EC.
(^62) See, e.g., European Commission ( 2010 ), p. 7: “Personalised medicine needs to be developed and
be introduces into clinical practice in line with the two core principles of European health systems:
health equity and universal access...” See also European Commission ( 2011 ).
Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions 43