In this regard, personalized medicine has nothing to do with a person as such, or
to put it in other words, it has nothing to do with the personality of a patient. It is
about a specific biological predisposition that can be found in a specific person. This
is why we have chosen the term individualized health care^3 instead of personalized
medicine, although the bulk of the medical literature quite obviously would use
both terms in the same way. And in a more technical but less appealing way,
personalized medicine can be regarded as a strategy of stratification: because it
aims at detecting subgroups of patients who benefit from a certain measure.
As a result, two points need to be stressed: on the one hand, the concept is
somewhat restricted. Personal preferences are not taken into account, and the very
interesting questions of whether medical treatments can be improved by more and
better communication between the medical personnel and patients^4 are cut down to
the question how far the consent of patients is needed in order to gather the
information necessary for personalized medicine. On the other hand, personalized
medicine can cover a broad range of medical interventions. It may be used in order
to prevent people from a certain illness. In this sense, it can be seen as a specific
preventive measure. And it can consist of the combination between diagnostics and
a therapeutic measure. This measure as such may consist in a specific medical
method or in the mere prescription of a drug.
If we look at the current situation, it becomes clear that the state of personalized
medicine is a rather limited one.^5 By far, most of its applications cover pharma-
ceutical therapies, and the main field to which these therapies belong is oncology. In
its present core, personalized medicine is a pharmacogenomical instrument. This is
why personalized medicine is tightly combined with the fight against cancer and has
gained much attention last year in the context of the WHO’s predicament that our
globe is facing a “tidal wave” of cancer.^6 It is not by chance thatJames Watson,
codiscoverer of the double helix and Nobelist, wrote an article in the New York
Times in 2009 under the heading “To Fight Cancer, Know the Enemy”^7. And some
oncologists even state that “the concept of personalized medicine demands that
every cancer has to be treated uniquely”.^8 This level of individualism is far from
being realistic at the moment. But it is evident that medical treatment tailored
according to genetic information becomes more and more important in the fight
against cancer and some other diseases. Personalized medicine probably has the
(^3) See also for the term individualised medicine Fischer et al. ( 2014 ), Grabe et al. ( 2014 ), and Ma
and Lu ( 2011 ).
(^4) W€ohlke et al. ( 2013 ), p. 25, Nekhlyudov et al. ( 2014 ), Ullrich et al. ( 2014 ), Alvarado et al. ( 2014 ),
and Denford et al. ( 2014 ).
(^5) Although the US American FDA states that “the era of personalized medicine has clearly
arrived”; see FDA, Paving the Way for Personalized Medicine (footnote 2), p. 54.
(^6) So Bernhard Stewart, one of the editors of the World Cancer Report 2014. Available at:http://
http://www.iarc.fr/en/publications/books/wcr/wcr-order.php.
(^7) Published: August 5, 2009. Available at:http://www.nytimes.com/2009/08/06/opinion/06watson.
html?pagewanted¼all&_r¼ 0.
(^8) Mehta et al. ( 2011 ), pp. 20–26.
Legal Aspects of Personalized Medicine 23