Opinion of the Advocate General — ECLI:EU:C:2001:309
Date: 2001-05-31
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Procedure: Action for failure to fulfil obligations - successful;Action for failure to fulfil obligations - inadmissible
Origin: Austria

Summary of the Judgment 
1. Approximation of laws — Proprietary medicinal products — Directive 89/105 — 
Medicinal products for human use — Cost automatically borne or reimbursed by the 
national health insurance scheme — Conditions 
(Council Directive 89/105, Arts. 1 and 6) 
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SUMMARY — CASE C-424/99 
2. Approximation of laws — Proprietary medicinal products — Directive 89/105 — 
Medicinal products for human use — Decision refusing to include a medicinal product 
on a list of medicinal products covered by the national health insurance scheme — 
Right of legal action — National legislation providing only for appeals to bodies 
consisting of independent experts — Not permissible 
(Council Directive 89/105, Art. 6(2)) 
1. It is clear from Article 6 of Directive 
89/105, relating to the transparency of 
measures regulating the prices of med­
icinal products for human use and their 
inclusion in the scope of national 
health insurance systems, that that 
provision is intended to apply where 
inclusion of a medicinal product on a 
list means that its cost will automati­
cally be reimbursed or borne by the 
scheme. Thus, the fact that in a Mem­
ber State there is a register and not a 
'positive list' and that, in that State, the 
cost of medicinal products not included 
on the register may likewise be borne 
by the scheme if the medicinal product 
prescribed by the doctor is necessary 
for the condition affecting the patient 
in no way detracts from the sole 
determining factor, namely that inclu­
sion of a medicinal product on the 
register normally means that its cost 
will automatically be borne by the 
scheme. 
That interpretation is, moreover, cor­
roborated by the purpose of the direc­
tive which, under Article 1 thereof, is 
to ensure that any national measure to 
control the prices of medicinal pro­
ducts for human use or to restrict the 
range of medicinal products covered by 
national health insurance systems com­
plies with the requirements of the 
directive. 
(see paras 29-30) 
2. The requirement of judicial review 
reflects a general principle of Commu­
nity law stemming from the constitu­
tional traditions common to the Mem­
ber States and enshrined in Articles 6 
and 13 of the European Convention for 
the Protection of Human Rights and 
Fundamental Freedoms. 
National legislation providing for 
appeals to independent experts satisfies 
neither that requirement nor the provi­
sions of Article 6(2) of Directive 
89/105 under which persons concerned 
must be able to avail themselves of 
remedies ensuring effective legal pro­
tection against a decision not to include 
a medicinal product in the list of 
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COMMISSION v AUSTRIA 
products covered by the health insur­
ance system. Such appeals are to super­
visory bodies made up of experts 
belonging to the Member State con­
cerned, and thus to an administrative 
authority and not to genuine judicial 
bodies. Moreover, since those bodies 
can issue only recommendations they 
have no decision-making power, which 
rests with the Member State concerned. 
(see paras 42-45) 
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