based on the difficulties to implement progress through personalization of medi-
cine, but even to a greater extent on the fear that personalized medicine will lead to
a considerable rise in health care expenditure. In this view, it is rather a new strategy
of providers, namely of the pharmaceutical industry, to advertise and marketize
their products.
Whether the hopes or the fears are well founded is a question that very much
depends in the first place on our understanding of personalized medicine. Before we
can assess a certain phenomenon, be it new or not, we have to make clear what we
are speaking about. Therefore, my first point will deal with the concept of person-
alized medicine (Sect. 2 ). After this rather short observation, I will come to the legal
questions that might be brought up by the introduction of personalized medicine as
defined before. There are two different sets of those questions: one concerns the
access to markets and to public health systems (Sect. 3 ); the other one is about data
protection (Sect. 4 ).
Before I start, I should add that my observations are mainly drawn from the
participation in an interdisciplinary project that has been founded by the German
Ministry for Education and Science and that has brought together researchers from
three different disciplines, medical ethics, economics, and law.^1 The main findings
of this project are based on our experiences with the German health care system, but
I will try to present them in a more general way in order to allow for some general
conclusions.
2 Concept and Appearance of Personalized Medicine
What is personalized medicine? A systematic review of the literature that has been
published over the last years and based on PubMed has led to the following result:
“Personalized medicine seeks to improve tailoring and timing of preventive and
therapeutic measures by utilizing biological information and biomarkers on the
level of molecular disease pathways, genetics, proteomics as well as
metabolomics.”^2
The main elements of this concept are information, based on biomarkers or other
biological information, on the one hand and a health care measure on the other.
Both elements have to be combined with each other in order to improve the effects
of the health care measure. The main ways to do so are to change the procedure in
which respective measures are being realized or to target health care measures to
certain individuals.
(^1) See the final report: Individualised Health Care: Ethical, Economic and Legal Implications for the
German Health Care System, Subproject C “LAW.” Available at:http://opac.tib.uni-hannover.de/
DB¼1/LNG¼DU/.
(^2) Schleidgen et al. ( 2013 ). The concept of Personalised Medicine varies broadly; see, for example,
FDA, Paving the Way for Personalized Medicine, 2013. Available at:http://www.fda.gov/
scienceresearch/specialtopics/personalizedmedicine/default.htm,p.7.
22 U. Becker