Background: In recent years, personalized medicine (PM) has become
a highly regarded line of development in medicine. Yet, it is still
a relatively new field. As a consequence, the discussion of its
future developments, in particular of its ethical implications, in
most cases can only be anticipative. Such anticipative discussions,
however, pose several challenges. Nevertheless, they play a crucial
role for shaping PM's further developments. Therefore, it is vital
to understand how the ethical discourse on PM is conducted, i.e. on
what - empirical and normative - assumptions ethical arguments are
based regarding PM's current and future developments. Methods: To
gather this information, we conducted a qualitative interview study
with stakeholders in the German health care system. Our purposive
sample included 17 representatives of basic research, clinical
research, health economics, regulatory authorities, reimbursement
institutions, pharmaceutical industry, patient organizations, as
well as clinicians and legal experts involved in PM developments or
policy making. We used an interview guide with open-ended questions
and analyzed transcriptions of the interviews by means of
qualitative content analysis. Results: The respondents addressed a
multitude of concerns in the context of research on as well as
application of personalized preventive and therapeutic measures
both on the individual and on the societal level. Interestingly,
regarding future developments of PM the ethical evaluation seemed
to follow the rule: the less likely its application, the more
problematic a PM measure is assessed. The more likely its
application, on the other hand, the less problematic it is
evaluated. Conclusions: The results of our study suggest
re-focusing the ethical discourse on PM in Germany towards a
constructive ethical monitoring which ensures to include only,
nevertheless all of the actual and/or potential concerns that are
ethically relevant in order to allow balancing them against the
actual and potential ethically relevant benefits of PM measures. To
render this possible, we propose a strategy for evaluating ethical
concerns in the context of PM.
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