on the other side. Crucial factors affecting the development and application of
personalized medicine are, among others, regulatory framework and ethical, legal,
and social issues.^63 Bearing in mind that the development and application of
personalized medicine occurs in three precisely defined phases, it should be pointed
out that the first phase, apart from education, is comprised of regulatory framework.
Although the 2009 Report of the National Academy of Sciences^64 points to the need
for further advancement of personalized medicine and individualized approach to
patients and treatment, more than 50 % of prescribed medicines in practice are not
efficient, and there are more than 770,000 cases of adverse effects reported per year,
which is estimated to cost up to USD 5.6 million each year per hospital.^65
If the promises of personalized medicine fully materialize, personalized medi-
cine has the potential of affecting the health protection in the United States.
What are the reasons for imperfect implementation of personalized medicine in
practice?
The pharmaceutical industry refuses to adapt since the results and impacts of
personalized medicine reduce the size of the market and profits of pharmaceutical
companies, achieved on the basis of “one-size-fits-all” solutions. Insurers are
resisting to changes because there is no return on investments in expensive diag-
nostics and treatment. Doctors are not ready to practice personalized medicine since
the best diagnostic and treatment strategies are not supported in clinical studies, i.e.,
they are not fully scientifically proven. Patients appear as a potential propelling
force, but there are still no organized groups advocating personalized medicine.
Regulators debate about the best solutions for this situation and the extent to which
the agencies are authorized to create new rules.^66
Numerous questions arise in practice.
Who should control the access to new pharmacogenetic and pharmacogenomic
tests, as well as the pertaining diagnostics? Patients, doctors, or governments can be
conceived as the most likely agents of supervision. The next logical question is,
under which criteria? In addition, issues regarding the use of tests, licensing,
reimbursement of costs, right to information, right to privacy, and third party rights
are constituent parts of this debate.
Another question is whether the principle of equity ensures fair distribution of
benefits and burdens of personalized medicine.
(^63) Pavelic ́et al. ( 2015 ), p. 2.
(^64) National Academy of Sciences ( 2009 ).
(^65) Agency for Health Care Research and Quality ( 2001 ).
(^66) Vogenberg et al. (2010a), p. 626.
44 N. Bodiroga-Vukobrat and H. Horak