by means of stratification. The existence of subgroups of patients also means that
there are subgroups of indications. In turn, this may not only raise the sheer number
of studies needed in order to prove the effectiveness of a given therapy but also
make the burden of proof more difficult.^23 Whether this is the case or not is
disputed—and it only becomes a legal problem in an indirect way and as far as
the legal requirements refer to the standards of evidence-based medicine.
4 Data Protection
Specific legal questions are at stake when it comes to data protection. This is very
obviously an issue with personalized medicine as the respective measures are based
on individual biological information, and on genetic information in most cases.
Also in this respect, two different aspects need to be mentioned. The first deals with
the protection of the right to privacy in the context of individual medical measures,
the second with the collection of data for the purpose of further research.
As far as the first point is concerned, it is essential to notice that most applica-
tions of personalized medicine rely on genetical information.^24 Those information
have to be qualified as personal data that may only be used if the person whose data
are concerned has given his or her consent. The use of genetical data is strictly
limited under the existing laws. This concerns the collection of data as well as
further processing. Furthermore, most jurisdiction draws a distinction between
genetic data in general and those genetic variants that are inherited.^25 The use of
the latter data falls under even stricter requirements and is subject to stricter
prohibitions than the former ones.^26
Future legislation will have to take two aspects into account. As we have seen,
personalized medicine is often used to combat diseases in a more effective way, and
to this end, it will in many cases need to identify acquired genetic disorders and the
specific features of tumor cells. When those examinations will become more and
more common and widespread than today, we might have to rethink the vulnera-
bility of the respective genetic data in order to make health care systems more
effective. On the other hand, advanced personalized medicine—especially when it
is used for preventive care—will also deploy new diagnostic procedures that
supposedly reveal which individuals are more likely to develop a severe disease
(^23) Hardenberg and Wilman ( 2013 ), p. 79.
(^24) Bericht des Ausschusses f€ur Bildung, Forschung und Technikfolgenabscha ̈tzung v. 17.2.2009,
BT-Drs. 16/12000, p. 153, Hardenberg ( 2014 ), p. 115.
(^25) See, e.g., for Switzerland the Human Genetic Testing Act (Bundesgesetz€uber genetische
Untersuchungen beim Menschen—GUMG) of 8.10.2004 and the Regulation on Human Genetic
Testing (Verordnung€uber genetische Untersuchungen beim Menschen—GUMV) of 14.2.2007;
for Austria the Genetic Engineering Act (Gentechnikgesetz—GTG) of 1.1.1995.
(^26) See for Germany§3 of Genetic Diagnostic Act (Gendiagnostikgesetz).
26 U. Becker