capability to develop further and to cover a much broader field of applications. Yet
it is already there—which leads to the question how it can get on the markets and to
the patients.
3 Access to Health Care Systems
As far as the access to the market in general and the public health care systems in
particular is concerned, there are two points worth to be mentioned.
First, the simple fact that personalized medicine in most cases consists of a
combination of a diagnostic measure and a pharmaceutical one causes difficulties
for many public health care systems. The background for these difficulties is that
there are certain pathways into the systems that differ from one member state of the
EU to another, albeit the existing EU legislative framework on medicinal products
as the centralized Community authorization procedure established by Regulation
No. 2309/93,^9 the Directive 2001/83 on the Community code relating to medicinal
products for human use,^10 or Council Directive 89/105/EEC relating to the trans-
parency of measures regulating the prices of medicinal products for human use and
their inclusion in the scope of national health insurance systems,^11 which is under
revision at the moment. Those pathways do, generally speaking, concentrate on one
type of medical measure: be it a medical product, a pharmaceutical, or a particular
method of treatment.
If we take Germany as an example, the access of a pharmaceutical to the market
has to be granted on the basis of the law on pharmaceuticals (Arzneimittelgesetz).^12
In order to gain this marketing authorization, a pharmaceutical has to be beneficial
in terms of health and, therefore, to fulfill certain requirements concerning thera-
peutic efficacy, safety, and quality.^13 For patent-protected drugs, it is up to the
producer to set up the marketing prize—which is, by the way, an important factor
for marketing within the EU as some member states take these prize tags as a
referential basis for their prize regulation. In order to enter the statutory health care
insurance, no further admission is necessary. According to the existing rules,^14
(^9) Available at:http://ec.europa.eu/health/files/eudralex/vol-1/reg_1993_2309/reg_1993_2309_en.
pdf.
(^10) Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol2012/dir
2001_83_cons_2012_en.pdf.
(^11) Available at: http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/pricing-reim
bursement/transparency/index_en.htm.
(^12) AMG of 12.12.2005 (BGBl. I, p. 3364).
(^13) §§21 et seq. of Pharmaceutical Act (Arzneimittelgesetz): the marketing authorization shall only
be refused if documents provided by the applicant are not in accordance with§25 par. 2 AMG; for
the centralized procedure, see Regulation (EC) No. 726/2004. Available at:http://eur-lex.europa.
eu/LexUriServ/LexUriServ.do?uri¼CONSLEG:2004R0726:20120702:EN:PDF.
(^14) §31 par. 1 s. 1 of Social Code (Sozialgesetzbuch) V.
24 U. Becker