- the amounts of premiums may be combined in various benefits packages; the
amount would be calculated in accordance with the risk, i.e., corresponding
package and corresponding benefits.^52
Thus, a differentiation of risk is made so that an individual with higher risk will
be offered insurance services according to his “risk profile.” It seems that the best
metaphor for the entire process is that the risk differentiation will lead to “margin
erosion” (Margenverfall).^53 Main prerequisites for this process exist even now. As
Feuerstein et al. claim, appropriate instruments, such as obligation of disclosure,
higher premiums for higher risk, or denial of applicants with certain risk, are
already in use.^54
The speed of reaction of private insurers, and also the possibility of offering
additional benefits, raises the questions and controversies regarding accessibility, as
well as debates under which conditions and to which extent can genetic and
predictive genetic information serve as precondition for conclusion of such con-
tracts. There is a pressing need for legal regulation of these issues.^55
7 Regulation at the EU Level
EU regulation of new medical technologies and personalized medicine is based on
the balance between risks and benefits. This balance is crucial and serves as a base
for ensuring patients’and consumers’confidence in new products on the market and
thus for optimizing their production. It is also established to provide support for the
industry placing new products on the market.
It seems that the existing risk as well as the security of patients and access to new
markets and technologies in the global context can complement and support each
other, with observance of the highest ethical principles.
The issue of risk of new medical technologies shapes the specific construction of
the EU market for those technologies. The underlying question is how to frame a
safe market for consumers/patients. The EU regulatory framework for medicinal
products and for medical devices, including diagnostics, currently differs: central-
ized procedures are envisaged for authorization of marketing of medicinal products,
whereas diagnostics are reviewed under a decentralized system involving indepen-
dent European notified bodies.^56 Different regulatory pathways for diagnostic
medical devices and marketing of medicinal products are justified by the different
nature of the products, but both frameworks aim to ensure a high level of public
(^52) Deutscher Bundestag ( 2009 ), p. 145.
(^53) Deutscher Bundestag ( 2009 ), p. 145.
(^54) Feuerstein et al. ( 2002 ).
(^55) Damm ( 2007 ).
(^56) European Commission ( 2011 ), p. 12.
42 N. Bodiroga-Vukobrat and H. Horak