Judgment;Summary — ECLI:EU:C:2022:1028
Date: 2022-12-22
Language of the case: French
Court formation: Seventh Chamber
Subject matter: Approximation of laws;Public health;Social security for migrant workers
Procedure: Reference for a preliminary ruling
Origin: France

Summary C-20/22 – 1 
Case C-20/22 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged:  
10 January 2022 
Referring court:  
Conseil d’État (France) 
Date of the decision to refer:  
30 December 2021 
Applicant:  
Syndicat Les Entreprises du Médicament (LEEM) 
Defendant:  
Ministre des Solidarités et de la Santé 
  
1. Subject matter and facts of the dispute:  
1 The loi du 24 décembre 2019 de financement de la sécurité sociale pour 2020 
(Law of 24 December 2019 on social security funding for 2020) inserted into the 
Code de la sécurité sociale (Social Security Code) Article L. 162-16-4-3, which 
gave the Ministers responsible for health and social security the authority to set, in 
given circumstances, for certain medicinal products or health products, a 
maximum price for sales to health establishments. 
2 By application of 25 January 2021, the applicant seeks annulment of the decree 
implementing that article. 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-20/22 
 
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2. Provisions at issue:  
EU law 
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency 
of measures regulating the pricing of medicinal products for human use and their 
inclusion in the scope of national health insurance systems 
3 Article 4 provides: 
‘1. In the event of a price freeze imposed on all medicinal products or on certain 
categories of medicinal products by the competent authorities of a Member State, 
that Member State shall carry out a review, at least once a year, to ascertain 
whether the macro-economic conditions justify that the freeze be continued 
unchanged. Within 90 days of the start of this review, the competent authorities 
shall announce what increases or decreases in prices are being made, if any. 
2. In exceptional cases, a person who is the holder of a marketing authorisation for 
a medicinal product may apply for a derogation from a prize freeze if this is 
justified by particular reasons. […]’. 
French legislation 
Social Security Code 
4 Article L. 162-16-4-3, inserted by Law No 2019-1446 of 24 December 2019 on 
social security funding for 2020, provides: 
‘I. The Ministers responsible for health and social security shall be entitled to 
set by decree, for certain medicinal products […] or for certain health products 
[…], a maximum price for sales to health establishments, in one or more of the 
following situations: 
1. Where there is a risk of unjustified expenditure, including in the light of a 
significant increase in the sale prices observed or in the light of the prices of 
comparable health products; 
2. In the case of health products which, per unit or taking into account their total 
volume, foreseeably will be, or have been observed to be, particularly expensive 
for certain establishments. 
II. The maximum price provided for in [paragraph] I shall be set, after the 
undertaking has been given the opportunity to comment: 
[…] 
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III. The detailed rules for the implementation of this Article shall be defined by 
decree of the Conseil d’État [(Council of State, France)].’ 
Décret no 2020-1437 du 24 novembre 2020 relatif aux modalités de fixation du 
prix maximal de vente aux établissements de santé d’un produit de santé (Decree 
No 2020-1437 of 24 November 2020 relating to the detailed rules for setting the 
maximum price for sales to health establishments of a health product) 
3. Position of the applicant:  
5 By means of a plea of illegality, the applicant maintains that the contested decree, 
and Article L. 162-16-4-3 of the Social Security Code, which it implements, 
infringe Article 4 of Directive 89/105. According to the applicant, the mechanism 
which Article L. 162-16-4-3 puts in place for capping the sale price of certain 
medicinal products constitutes a mechanism for a ‘price freeze […] on all 
medicinal products or on certain categories of medicinal products’ within the 
meaning of Article 4 of Directive 89/105. It was therefore required to provide for 
an annual assessment of the macro-economic conditions justifying that the ‘freeze 
be continued unchanged’ and for the possibility for the party exploiting a 
proprietary medicinal product to benefit from a derogation ‘in exceptional cases’ 
and ‘if this is justified by particular reasons’.  
4. Assessment of the Council of State:  
6 In the context of a reference by the Italian Council of State, which was ruling on 
legislation which offered the possibility, for the Minister responsible for health, to 
set an overall cap on pharmaceutical expenditure incurred as part of national 
health expenditure without a prior decision to freeze prices having formally been 
taken, the Court of Justice ruled in its judgment of 2 April 2009, A. Menarini 
Industrie Farmaceutiche Riunite and Others (C-352/07 to C-356/07, C-365/07 to 
C-367/07 and C-400/07, EU:C:2009:217, paragraph 29), that ‘the meaning of a 
“price freeze … on all medicinal products or on certain categories of medicinal 
products” in Article 4(1) of Directive 89/105 encompasses all national measures 
controlling the prices of medicinal products even if those measures are not 
preceded by a freeze on those prices’. The Court of Justice based that 
interpretation on the general scheme of Directive 89/105 and its effectiveness in 
enabling the persons concerned to verify that the official listing of medicinal 
products corresponds to objective criteria and that there is no discrimination 
between national medicinal products and those from other Member States. The 
Court of Justice, however, also recalled, in paragraphs 35 and 36 of that judgment, 
that under the sixth recital of Directive 89/105, the requirements of that directive 
affect neither the Member States’ policies for determining the prices of medicinal 
products nor national policies on price setting or the determination of social 
security schemes, except as far as it is necessary to attain transparency for the 
purposes of that directive, which has as its underlying principle the idea of 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-20/22 
 
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minimum interference in the organisation by Member States of their domestic 
social security policies.  
7 The response to the plea in law alleging infringement of Article 4 of Directive 
89/105 depends on the question of whether the concept of a ‘price freeze […] on 
all medicinal products or on certain categories of medicinal products’ appearing in 
Article 4 of Directive 89/105 must be interpreted as applying to a measure whose 
purpose is to control the prices of medicinal products but which concerns only 
certain medicinal products, on an individual basis. In the present case, the 
mechanism which Article L. 162-16-4-3 puts in place for capping the price for 
sales to health establishments, whilst it seeks to control the prices of the medicinal 
products to which it is applied, relates only to certain medicinal products, on an 
individual basis, in the event of the fulfilment of one or more of the conditions 
which it sets down. It is not, therefore, intended to apply to all medicinal products 
or even to certain categories of them. Moreover, the assessment at least annually 
of the macro-economic conditions justifying that the freeze be continued 
unchanged, provided for by Article 4(1) of the directive, seems, in the present 
case, to be meaningless since, as already stated, the conditions set down by Article 
L. 162-16-4-3 of the Social Security Code for the measure for which it provides to 
be taken are not of a macro-economic nature but are based on the sale prices 
observed for the medicinal product concerned, considered alone or in the light of 
comparable medicinal products. Similarly, the possibility which, pursuant to 
Article 4(2) of the directive, must be offered to the holder of a marketing 
authorisation for a medicinal product to apply, in exceptional cases, for a 
derogation from a price freeze if this is justified by particular reasons seems 
pointless as regards a mechanism designed to take the form of individual 
decisions. 
8 That question, which plays a decisive role in the resolution of the dispute, presents 
serious difficulties. It is necessary, consequently, to refer it to the Court of Justice. 
5. Question referred for a preliminary ruling:  
9 The proceedings brought by the syndicate Les Entreprises du médicament are 
stayed until the Court of Justice of the European Union has ruled on the question 
of whether 
Article 4 of Council Directive 89/105/EEC of 21 December 1988 relating to the 
transparency of measures regulating the pricing of medicinal products for human 
use and their inclusion in the scope of national health insurance systems must be 
interpreted as meaning that the concept of a ‘price freeze […] on all medicinal 
products or on certain categories of medicinal products’ applies to a measure 
whose purpose is to control the prices of medicinal products but which concerns 
only certain medicinal products, on an individual basis, and is not intended to 
apply to all medicinal products or even to certain categories of them, when the 
safeguards which that article attaches to the existence of such a price-freezing 
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measure as defined by that article appear, for such a measure, meaningless and 
pointless.