9 Conclusion
Most authors who advocate medical and economical advantages of personalized
medicine point out numerous benefits of personalized medicine: detection of illness
at its earliest stage, which is a prerequisite for a more efficient treatment; selection
of optimal therapy and reduction of trial and error in prescribing medicines;
reduction of adverse drug reactions; increase of patient compliance with therapy;
improvement of the selection of targets for drug discovery; reduction of time, cost,
and failure rate of clinical trials; revival of drugs that failed clinical trials or were
withdrawn from the market; avoidance of withdrawal of marketed drugs; shifting of
emphasis in medicine from reaction to prevention; and the reduction of overall
costs of health care.^81
It is impossible to predict with precision the future regulatory development.
Possible scenarios indicate conceivable dynamic of development, whose ambiva-
lence arises out of the specificity of medical concept. It is therefore necessary to
adequately maneuver between promises and risks of the new possibilities. Perhaps
the GermanGendiagnostikgesetzof 2010 could serve as a useful model for regu-
latory approach to this delicate issue. It upholds the fundamental principles of the
protection of human dignity and of informational self-determination, i.e., the right
to know and the right not to know are equally protected and depend on individual
choice. Its objective is to avoid the possibility of genetic discrimination while at the
same time preserving the chances for application of new discoveries.
There is a tendency of relatively stronger burdening of potential and actual risk
carriers through increased responsibility, as opposed to the weakening of the
obligation of solidarity. The requirement of equality and equal treatment with all
predictive health information holds a prominent role.
Although predictive genetic tests are not exceptional, they nonetheless display
very particular features because they have the effect of accumulating or summa-
rizing a great quantity of health information. Establishing a legal concept of
“predictive health information” is therefore a prerequisite for framing adequate
legislative responses.
With the expansion of available genetic tests, societal and institutional expecta-
tions could lead to the development of the right to know into a routine in conformity
with the development of medical technology, and to attenuation of the right not to
know. It is therefore all the more important to explore the concept of personalized
medicine and “personalized prediction” and to reevaluate the interdependency of
developmental potentials of medical technology and sensitive legal issues sur-
rounding it. Personalized medicine can remain the “carrier of hope” but be legally
regulated in the manner that will preserve human dignity and bring medical, as well
as societal gains.
(^81) Personalized Medicine Coalition ( 2014 ).
48 N. Bodiroga-Vukobrat and H. Horak