drugs that have received market authorization automatically become part of the
benefits package of the insurance system.^15 Yet there is a specific procedure of
benefit assessment in order to regulate the prize of the pharmaceutical.^16
Up to now, no similar provisions exist for companion diagnostics. Some argue
that these diagnostics would have to be dealt with as an integral part of the
respective drug,^17 but this is not a common opinion and especially not followed
in practice. That leads on the one hand to the problem that the combination as such
is never subject to an assessment of the competent authorities—although diagnos-
tics can be rather complex in not only few cases, and the prescription of the drug
concerned is always closely linked to the results of the diagnostics. Or, as the US
American FDA has put it: “The specific challenges for any particular set of products
depend in part on the nature of their relationship to each other.”^18 This is why in the
USA the regulatory framework has recently undergone changes.^19 The draft of a
Regulation on in vitro diagnostic medical devices as proposed by the European
Commission^20 also addresses companion diagnostics.^21
On the other hand, the separation of companion diagnostics and companion
drugs regarding the access to the health care system also means that diagnostics do
not receive a specific tariff position on the list of medical treatments. This may seem
to be a simple technicality, but it means that the companion diagnostics, though a
necessary measure in order to apply the pharmaceutical, will not be paid for—at
least when the patient does not stay in a hospital. Also with respect to reimburse-
ment, it is quite clear that a procedure is needed that pays attention to the combi-
nation of two otherwise separated medical measures.
Second, also the evaluation of an individualized treatment or pharmaceutical
may lead to new problems. Today, most health care systems follow the idea of
evidence-based medicine.^22 The necessary evidence can be derived from testing
that follows certain standards. As a rule, the assumption that a pharmaceutical or
other therapy is effective has to be based on a sufficient number of cases. But
personalized medicine reduces the cases: as we have seen, it tries to target a therapy
(^15) See for more details German Federal Social Court (Bundessozialgericht), Dec. of 28.2.2008, B
1 KR 16/07 R, and Dec. of 3.7.2012, B 1 KR 23/11 R (www.juris.de).
(^16) §35a of Social Code (Sozialgesetzbuch) V.
(^17) Huster and Gottwald ( 2013 ), pp. 16 et seq.
(^18) FDA, Paving the Way for Personalized Medicine (footnote 2), pp. 32/33.
(^19) Sawyers and van’t Veer ( 2014 ), Waltz ( 2014 ), and Noweski et al. ( 2013 ). See also the
nonbinding recommendations of the U.S. Department of Health and Human Services, Food and
Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evalua-
tion and Research, Center for Drug Evaluation and Research, In Vitro Companion Diagnostic
Devices: Guidance for Industry and Food and Drug Administration Staff of 6.8.2014. Available at:
http://www.fda.gov/ScienceResearch/SpecialTopics/PersonalizedMedicine/ucm372544.htm.
(^20) COM(2012) 541 fin.
(^21) See Art. 2 (6) of the Draft: “companion diagnostic means a device specifically intended to select
patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy.”
(^22) Prasad ( 2013 ), Smith ( 2014 ), and Greenhalgh et al. ( 2014 ).
Legal Aspects of Personalized Medicine 25