envisages the adoption of a directly applicable data protection regulation^21 that
would replace the Data Protection Directive, thus resolving the practical issues
regarding diverse interpretation and transposition of certain provisions of the
Directive in national legislations.^22 Another regulation within the package is
aimed at sanctioning violations.^23 The application of unified rules requires, how-
ever, significant investment in the development of new information systems and
technologies, which would be capable of supporting the anticipated dramatic
changes.^24 The proposed regulation reinforces the subject’s right to access personal
data and change and delete them,^25 including the “right to be forgotten.”
In Croatia, the universal right to health care in conformity with law is constitu-
tionally protected.^26 The Constitution also incorporates additional guarantees
regarding the right to a healthy life and protection of human health, nature, and
environment.^27
4 How to Understand Personalized Medicine in the Social
and Legal Context
The answer to the question “Do we understand the personalized medicine para-
digm?” asked by authors Pavelic ́et al.^28 seems to rightly start with the assumption
that personalized medicine is a new attitude in medicine but that it also presents
new social, bioethical, legal, and philosophic challenges and concerns. C. Li is
rightly suspicious of the “euphoric optimism” that technological advancements and
inexpensive tests will make the promise of personalized medicine a reality.^29 In
fact, as the same author concludes, it seems that “[...] making sense of the
enormous amount of genomic data is a far bigger hurdle.”^30
From the legal point of view, one can detect problems in relation to companies
gathering personal data in these sensitive areas, especially in view of possible
(^21) European Commission (2012a).
(^22) Eecke et al. ( 2012 ), pp. 19–22.
(^23) Gilbert ( 2012 ).
(^24) Gilbert ( 2012 ), p. 21.
(^25) Numerous cases of the European Court of Human Rights, e.g.,S. and Marper v. the United
Kingdom, ECHR App. No. 30562/04 and 30566/04, Judgement of 4.12.2008, point to the need for
a clearer definition of the right of a person to seek deletion of his personal data from public
registers, etc. See also a recent Judgment (13.5.2014) of the Court of Justice of the EU in the case
C-131/12Google Spain SL, Google Inc. v. Agencia Espanola de Proteccion de Datos, Mario
Costeja Gonzales.
(^26) Constitution of the Republic of Croatia, Article 59.
(^27) Constitution of the Republic of Croatia, Article 70.
(^28) Pavelic ́et al. ( 2015 ).
(^29) Li ( 2011 ), p. 403.
(^30) Li ( 2011 ), p. 403.
Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions 37