It is important to analyze disputes regarding personalized medicine that arise not
only in the fields of medical sciences, biotechnology, and nanotechnology but also
in the fields of social law and economy, where the consequences of medical
activities are manifested, as well as legal relations in connection therewith. This
task basically entails identification and differentiation of personal interests of
patients, probands, and persons displaying certain risks on the one side and third
parties’interests on the other. Benefits and risks of the new approach are in the
focus of the 2004 Report on benefits, risks, ethical, legal, and social aspects of
nanotechnologies.^7 Although it emphasizes the benefits of convergence between
nanotechnologies and biotechnology for individualized health care, the Report
stresses that their use raises profound social, ethical, and regulatory issues, which
are yet to be addressed. In other words, the luring promise of a patient-oriented
“lab-on-a-chip” diagnostic, which could optimize medical therapy with the least
side effects, is a legally and ethically uncharted territory.
Personalized medicine goes hand in hand with predictive medicine; the latter
actually forms part of the former. The term patient here does not always imply a
person who is ill and receives medical treatment. Essentially, predictive examina-
tions are often directed not at patients with illness at all but at those who are
potentially affected, or the so-called risk carriers, who are in human genetics
sometimes referred to as “clients.”
With predictive medicine, one should be careful not to cross the line between
two conceivable types of prevention. The first type is genotypic prevention, aimed
at interrupting the inheritance or transmission of genetic predispositions for illness,
by testing the carrier status, family planning and counselling, prenatal diagnosis,
and termination of pregnancy. Its moral boundaries, especially if it is construed as a
public health measure, are more than obvious, and it is mostly associated with
eugenics movement at the beginning of the twentieth century. Phenotypic preven-
tion, on the other hand, is aimed at prevention of genetic diseases in an at-risk
patient. Phenotypic prevention can be performed by changing disease-causing
factors (environmental factors, lifestyle, etc.), by measures of early diagnosis, and
preventive interventions.^8
Predictive health information is essential for personalized medicine, which
means that “genome-based tests, genetic diagnostic and particularly predictive
genetic tests have a prominent spot in personalized medicine.”^9 This is partly
referred to as “personalized prediction.”
In a joint statement from 2010, the three German scientific academies have
addressed some of the controversial issues surrounding the predictive genetic
diagnostics.^10 The intention of the statement was to promote a responsible approach
to the emerging genetic knowledge, through a total of 22 clearly formulated
(^7) The Royal Society and the Royal Academy of Engineering ( 2004 ).
(^8) See, e.g., Juengst ( 1995 ); Khoury et al. ( 2000 ), p. 6; Nordgren ( 2001 ), p. 159.
(^9) Deutscher Bundestag ( 2009 ) (authors’translation from German).
(^10) German Academy of Sciences Leopoldina et al. ( 2010 ).
34 N. Bodiroga-Vukobrat and H. Horak