Provisional text

JUDGMENT OF THE COURT (Seventh Chamber)

22 December 2022 ( * )

(Reference for a preliminary ruling – Medicinal products for human use – Directive 89/105/EEC – Transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems – Article 4 – Price freeze imposed on all medicinal products or on certain categories of medicinal products – National measure concerning only certain medicinal products, on an individual basis – Setting a maximum price for sales to health establishments of certain medicinal products)

In Case C‑20/22,

REQUEST for a preliminary ruling under Article 267 TFEU from the Conseil d’État (Council of State, France), made by decision of 30 December 2021, received at the Court on 10 January 2022, in the proceedings

Syndicat Les Entreprises du médicament (LEEM)

v

Ministre des Solidarités et de la Santé,

THE COURT (Seventh Chamber),

composed of M.L. Arastey Sahún, President of the Chamber, N. Wahl (Rapporteur) and J. Passer, Judges,

Advocate General: M. Campos Sánchez-Bordona,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

– the syndicate Les Entreprises du médicament (LEEM), by E. Nigri, avocat,

– the French Government, by G. Bain and J.-L. Carré, acting as Agents,

– the European Commission, by A. Sipos and C. Valero, acting as Agents,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

Judgment

1 This request for a preliminary ruling concerns the interpretation of 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 (OJ 1989 L 40, p. 8).

2 The request has been made in proceedings between the syndicate Les Entreprises du médicament (LEEM) and the Ministre des Solidarités et de la Santé (Minister for Solidarity and Health, France) concerning the validity of décret n o 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) (JORF of 25 November 2020, Text No 29) (‘the decree at issue’).

Legal context

European Union law

3 The fifth and sixth recitals of Directive 89/105 state:

‘… the objective of this Directive is to obtain an overall view of national pricing arrangements, including the manner in which they operate in individual cases and all the criteria on which they are based, and to provide public access to them for all those involved in the market in medicinal products in the Member States; …

… as a first step towards the removal of these disparities, it is urgently necessary to lay down a series of requirements intended to ensure that all concerned can verify that the national measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto; whereas, however, these requirements do not affect the policies of those Member States which rely primarily upon free competition to determine the price of medicinal products; whereas these requirements also do not affect national policies on price setting and on the determination of social security schemes, except as far as it is necessary to attain transparency within the meaning of this Directive’.

4 Article 1(1) of that directive is worded as follows:

‘Member States shall ensure that any national measure, whether laid down by law, regulation or administrative action, to control the prices of medicinal products for human use or to restrict the range of medicinal products covered by their national health insurance systems complies with the requirements of this Directive.’

5 Article 2(1) of that directive provides:

‘The following provisions shall apply if the marketing of a medicinal product is permitted only after the competent authorities of the Member State concerned have approved the price of the product:

1. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 90 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. …’

6 Article 3(1) of that directive states:

‘Without prejudice to Article 4, the following provisions shall apply if an increase in the price of a medicinal product is permitted only after prior approval has been obtained from the competent authorities:

1. Member States shall ensure that a decision is adopted on an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation to increase the price of a medicinal product and communicated to the applicant within 90 days of its receipt. The applicant shall furnish the competent authorities with adequate information including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. …’

7 Article 4 of Directive 89/105 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 price freeze if this is justified by particular reasons. …

…’

8 Article 6 of that directive is worded as follows:

‘The following provisions shall apply if a medicinal product is covered by the national health insurance system only after the competent authorities have decided to include the medicinal product concerned in a positive list of medicinal products covered by the national health insurance system.

1. Member States shall ensure that a decision on an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation to include a medicinal product in the list of medicinal products covered by the health insurance system is adopted and communicated to the applicant within 90 days of its receipt. …

…

2. Any decision not to include a medicinal product in the list of products covered by the health insurance system shall contain a statement of reasons based upon objective and verifiable criteria, including, if appropriate, any expert opinions or recommendations on which the decision is based. In addition, the applicant shall be informed of the remedies available to him under the laws in force and of the time limits allowed for applying for such remedies.

3. Before the date referred to in Article 11(1), Member States shall publish in an appropriate publication and communicate to the [European] Commission the criteria which are to be taken into account by the competent authorities in deciding whether or not to include medicinal products on the lists.

4. Within one year of the date referred to in in Article 11(1), Member States shall publish in an appropriate publication and communicate to the Commission a complete list of the products covered by their health insurance system, together with their prices fixed by the national competent authorities. This information shall be updated at least once every year.

5. Any decision to exclude a product from the list of products covered by the health insurance system shall contain a statement of reasons based on objective and verifiable criteria. Such decisions, including, if appropriate, any expert opinions or recommendations on which the decisions are based, shall be communicated to the person responsible, who shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying for such remedies.

6. Any decision to exclude a category of medicinal products from the list of products covered by the health insurance system shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication.’

French law

9 Article L. 162-16-4-3 of the code de la sécurité sociale (French Social Security Code), as amended by loi n o 2019-1446, du 24 décembre 2019, de financement de la sécurité sociale pour 2020 (Law No 2019-1446 of 24 December 2019 on social security funding for 2020) (JORF of 27 December 2019, Text No 1) (‘the Social Security Code’), 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, will foreseeably 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 present its observations:

…

III. The detailed rules for the implementation of this Article shall be defined by decree of the Conseil d’État [(Council of State, France)].’

10 Article R. 163-11-2 of that code, as inserted by Article 1 of the decree at issue, states:

‘I. When the Ministers responsible for health and social security consider setting a maximum price for sales to health establishments of a proprietary medicinal product or another health product pursuant to Article L. 162-16-4-3, they shall inform the undertakings using the health product concerned thereof by any means which enables the date of receipt of that information to be known with certainty. They shall specify the health products concerned, the reasons for setting a maximum sale price, and the intended price.

…

II. Maximum sale prices set pursuant to Article L. 162-16-4-3 may be changed by decree of the Ministers responsible for health and social security, either at the request of the undertaking using the health product concerned or on their own initiative, in accordance with the following procedures:

1. Where the change is the result of the Ministers’ initiative, it shall be made in accordance with the procedure laid down in [paragraph] I;

2. Where the request for a change of price is made by the user undertaking, that undertaking shall send its request to the Ministers, together with a file containing the information necessary for the assessment of that request. …

…’

The dispute in the main proceedings and the question referred for a preliminary ruling

11 On 25 January 2021, the syndicate LEEM brought an action for annulment of the decree at issue before the Conseil d’État (Council of State, France).

12 The decree at issue and Article L. 162-16-4-3 of the Social Security Code, which that decree is intended to implement, provide, according to the request for a preliminary ruling, for a mechanism for setting a maximum price for sales of certain medicinal products or health products in order to reduce the significant difference in price which can sometimes be observed between different health establishments in respect of the same medicinal product included in the list of proprietary medicinal products approved for use by public bodies or in respect of the same health product.

13 In support of its action, the syndicate LEEM submits, inter alia, that the decree at issue and Article L. 162-16-4-3 of the Social Security Code infringe Article 4 of Directive 89/105. It has thus argued before the referring court that the mechanism for capping the sale price of certain medicinal products put in place by that provision of national law constitutes a mechanism for imposing a ‘price freeze … on all medicinal products or on certain categories of medicinal products’ within the meaning of Article 4 of Directive 89/105. Therefore, that mechanism should, in accordance with that provision of EU law, (i) be subject to an annual assessment of the macro-economic conditions justifying that the price freeze at issue be continued and (ii) enable the person using the proprietary medicinal product concerned to benefit, in exceptional cases and if this is justified by particular reasons, from a derogation from that price freeze, failing which the mechanism would be unlawful.

14 The referring court considers that the response to the plea alleging infringement of Article 4 of Directive 89/105 and, consequently, the outcome of the dispute in the main proceedings depend on the question whether the concept of a ‘price freeze … on all medicinal products or on certain categories of medicinal products’ referred to in Article 4 of Directive 89/105 must be interpreted as applying to a measure whose purpose is to control the prices of certain medicinal products, on an individual basis. Thus, the Conseil d’État (Council of State) interprets the mechanism for capping the price for sales to health establishments put in place by Article L. 162-16-4-3 of the Social Security Code as a mechanism which concerns only certain medicinal products, on an individual basis, and which is, consequently, not intended to apply to all medicinal products or even to certain categories of medicinal products.

15 The referring court adds that the assessment at least annually of the macro-economic conditions justifying that the price freeze be continued unchanged, provided for in Article 4(1) of Directive 89/105, seems, in the present case, to be meaningless, since a measure taken pursuant to Article L. 162-16-4-3 of the Social Security Code is not of a macro-economic nature, but is based on the sale prices observed for the medicinal product concerned, considered alone or in the light of comparable medicinal products. Similarly, the possibility for the holder of a marketing authorisation to apply, in exceptional cases, pursuant to Article 4(2) of that directive, for a derogation from a price freeze if this is justified by particular reasons seems to be pointless, since a measure taken under Article L. 162-16-4-3 of the Social Security Code will take the form of an individual decision.

16 In those circumstances, the Conseil d’État (Council of State) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:

‘Must Article 4 of [Directive 89/105] 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 measure as defined by that article appear, for such a measure, meaningless and pointless?’

Consideration of the question referred

17 By its question, the referring court asks, in essence, whether Article 4(1) of Directive 89/105 is to 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 certain medicinal products, on an individual basis.

19 As regards the wording of Article 4(1) of Directive 89/105, it should be recalled that that provision refers to price-freezing measures imposed by the authorities of a Member State in respect of ‘all medicinal products or … certain categories of medicinal products’. As the concept of ‘categories of medicinal products’ is not defined by that directive, it is important to take account of its usual meaning in everyday language (see, by analogy, judgment of 16 July 2020, AFMB and Others , C‑610/18, EU:C:2020:565, paragraph 52 and the case-law cited).

20 In that regard, it should be pointed out that the concept of ‘category’ implies, in everyday language, the existence of a set of objects which share one or more characteristics (see, by analogy, judgment of 12 October 2017, Shields & Sons Partnership , C‑262/16, EU:C:2017:756, paragraph 47). Accordingly, the concept of ‘categories of medicinal products’ within the meaning of Article 4(1) of Directive 89/105 does not refer to individual medicinal products but only to groups of medicinal products that have one or more shared characteristics.

21 As regards the context in which Article 4 of Directive 89/105 occurs and the objectives pursued by that directive, it should be noted that that directive has as its underlying principle the idea of minimum interference in the organisation by Member States of their domestic social security policies (judgment of 14 January 2010, AGIM and Others , C‑471/07 and C‑472/07, EU:C:2010:9, paragraph 16 and the case-law cited). Pursuant to the sixth recital of Directive 89/105, the requirements arising from that directive do not affect the Member States’ policies for determining the prices of medicinal products; nor do they affect national policies on price setting or on the determination of social security schemes, except as far as it is necessary to attain transparency within the meaning of that directive.

22 Consequently, the concept of a ‘price freeze … on all medicinal products or on certain categories of medicinal products’ within the meaning of Article 4(1) of Directive 89/105 must be interpreted as covering all medicinal products or groups of medicinal products that have one or more shared characteristics and, thus, as excluding individual price-freezing measures relating to individual medicinal products.

23 In the second place, such an interpretation of Article 4(1) of that directive is supported by the scheme of that provision.

24 That provision specifies that ‘in the event of a price freeze … on all medicinal products or on certain categories of medicinal products’, the Member States are required to review ‘whether the macro-economic conditions justify that the freeze be continued’. However, as both the French Government and the Commission have emphasised in their written observations, such an obligation to review the macro-economic conditions makes sense only where there are measures concerning all medicinal products or categories of medicinal products. Continuing a measure that freezes the price of an individual medicinal product cannot be justified by macro-economic conditions, since such a measure is not likely to have any macro-economic effect. Consequently, that obligation necessarily means that price-freezing measures concerning individual medicinal products do not fall within the scope of Article 4(1) of Directive 89/105.

25 Furthermore, the fact that Article 4(2) of that directive provides for the possibility of applying for a derogation from a price freeze confirms that the EU legislature intended to exclude price-freezing measures concerning individual medicinal products from the scope of that article. Unlike an exemption, a derogation implies different and individual treatment by way of which the applicant escapes, subject to compliance with certain conditions, the requirements laid down by a general rule.

26 Thus, the scheme of Article 4(1) of that directive cannot allow for a reading of the concept of ‘category of medicinal products’ within the meaning of that provision as covering price-freezing measures adopted not in respect of a category of medicinal products, but in respect of an individual medicinal product.

27 In the third and last place, it is apparent from a systematic reading of Directive 89/105 that when the EU legislature intended to refer to individual price-freezing measures, it expressly did so.

28 In that regard, Articles 2 and 3 of that directive, which concern, respectively, situations in which approval of the price of a medicinal product is required before it is marketed and situations in which an increase in the price of a medicinal product is subject to prior approval, refer to the ‘price which may be charged for the medicinal product concerned’ and the ‘price of the medicinal product’. It follows that the EU legislature intended to remove any doubt as to the fact that those articles are applicable only to measures concerning individual medicinal products.

29 Moreover, when the EU legislature intended a provision of Directive 89/105 to concern both measures that are of general application and individual price-freezing measures, it ensured that this was clear from the wording of that provision. Thus, Article 6 of that directive, which lays down the procedural provisions applicable to the inclusion of medicinal products in the list of products covered by the national health insurance system, refers, in paragraphs 1 to 5 thereof, to applications for inclusion of ‘a medicinal product’, while paragraph 6 of that article lays down specific provisions concerning any decision to exclude ‘a category of medicinal products’ from that list.

30 Consequently, by referring to the concept of a ‘price freeze … on all medicinal products or on certain categories of medicinal products’ within the meaning of Article 4(1) of Directive 89/105, the EU legislature excluded any individual price-freezing measures from the scope of that article.

31 Having regard to the foregoing considerations, the answer to the question referred is that Article 4(1) of Directive 89/105 must be interpreted as meaning that the concept of a ‘price freeze … on all medicinal products or on certain categories of medicinal products’ does not apply to a measure whose purpose is to control the prices of certain medicinal products, on an individual basis.

Costs

32 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (Seventh Chamber) hereby rules:

Article 4(1) 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’ does not apply to a measure whose purpose is to control the prices of certain medicinal products, on an individual basis.

[Signatures]

* Language of the case: French.