A. Menarini Industrie Farmaceutiche Riunite Srl and Others v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-352/07), Sanofi Aventis SpA v Agenzia Italiana del Farmaco (AIFA) (C-353/07), IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA) (C-354/07), Schering Plough SpA v Agenzia Italiana del Farmaco (AIFA) (C-355/07), Bayer SpA v Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute (C-356/07), Simesa SpA v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-365/07), Abbott SpA v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-366/07), Baxter SpA v Agenzia Italiana del Farmaco (AIFA) (C-367/07) and SALF SpA v Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute (C-400/07).

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2008:622
• Docket Number: C-365/07,C-400/07,C-352/07,C-367/07,C-356/07,
• Celex Number: 62007CC0352
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Date: 13 November 2008

OPINION OF ADVOCATE GENERAL

TRSTENJAK

delivered on 13 November 2008 (1)

Joined Cases C‑352/07 to C‑356/07, C‑365/07 to C‑367/07 and C‑400/07

A. Menarini Industrie Farmaceutiche Riunite Srl (C‑352/07)

FIRMA Srl (C‑352/07)

Laboratori Guidotti SpA (C‑352/07)

Istituto Lusofarmaco d’Italia SpA (C‑352/07)

Malesi Istituto Farmacobiologico SpA (C‑352/07)

Menarini International Operations Luxembourg SA (C‑352/07)

Sanofi Aventis SpA (C‑353/07)

IFB Stroder Srl (C‑354/07)

Schering Plough SpA (C‑355/07)

Bayer SpA (C‑356/07)

Simesa SpA (C‑365/07)

Abbott SpA (C‑366/07)

Baxter SpA (C‑367/07)

SALF SpA (C‑400/07)

v

Ministero della Salute

and/or

Agenzia Italiana del Farmaco (AIFA)

Third parties:

Sanofi Aventis SpA

Baxter SpA

Merck Sharp & Dohme (Italia) SpA

(Reference for a preliminary ruling from the Tribunale amministrativo regionale del Lazio (Italy))

(Directive 89/105/EEC – Medicinal products for human use – Public health expenditure – Transparency of measures regulating prices – Article 4(1) and (2) – Meaning of ‘price freeze’ – Repetition and frequency of the measures – Reference to predicted or ascertained expenditure – Criteria for the review of the macro-economic conditions)

I – Introduction

1. Against the background of certain measures taken in 2006 and 2007 to reduce the retail price in Italy of medicinal products for human use which can be prescribed at the expense of the Servizio Sanitario Nazionale (National Health Service, ‘the SSN’), the questions arising in these joined cases concern the interpretation of Article 4(1) and (2) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems. (2) It may be concluded from the observations submitted to the Court and from other connected references for preliminary rulings which have been received that the present cases are clearly only a selection from the large number of cases concerning this subject before the Italian courts which have been stayed pending the Court’s judgment.

2. The objections which have been raised to the contested measures are, in particular, first, that they were adopted shortly after other measures having the same object and, secondly, which is fiercely disputed, that they are not corrective measures like the preceding ones, that is to say, they are not intended to rectify situations where maximum expenditure limits have actually been found to have been exceeded, but that they are of a preventive nature in so far as they are deemed to prevent predicted excesses over such limits. The central question of the present reference for a preliminary ruling and the observations relating to it submitted to the Court is whether those two aspects comply with Community law under Directive 89/105.

II – Legal context

A – Community law

3. The second recital in the preamble to Directive 89/105 states that Member States have adopted measures of an economic nature on the marketing of medicinal products in order to control public health expenditure on such products. According to that recital such measures include direct and indirect controls on the prices of medicinal products as a consequence of the inadequacy or absence of competition in the medicinal products market and limitations on the range of products covered by national health insurance systems.

4. The third recital states that the primary objective of such measures is the promotion of public health by ensuring the availability of adequate supplies of medicinal products at a reasonable cost; but that such measures should also be intended to promote efficiency in the production of medicinal products and to encourage research and development into new medicinal products, on which the maintenance of a high level of public health within the Community ultimately depends.

5. The fourth recital in the preamble to Directive 89/105 observes that disparities in such measures may hinder or distort intra-Community trade in medicinal products and thereby directly affect the functioning of the common market in medicinal products.

6. The fifth recital in the preamble to Directive 89/105 reads as follows:

‘Whereas 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; whereas this information should be public.’

7. The sixth recital in the preamble to Directive 89/105 provides as follows:

‘Whereas, 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.’

8. The first paragraph of Article 1 of that directive provides 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.’

9. Article 4 of that directive reads as follows:

‘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. The application shall contain an adequate statement of these reasons. Member States shall ensure that a reasoned decision on any such application is adopted and communicated to the applicant within 90 days. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information. Should the derogation be granted, the competent authorities shall forthwith publish an announcement of the price increase allowed.’

…’

B – National law

10. Directive 89/105 was transposed into Italian law by Legislative Decree No 79 of 27 January 1992 (‘Legislative Decree No 79/1992’). (3)

11. Article 7 of Legislative Decree No 79/1992, transposing Article 4 of Directive 89/105, provides as follows:

‘1. In the event of a price freeze on all medicinal products or on certain categories thereof the Comitato interministeriale dei prezzi [Joint Ministerial Committee for Prices] shall carry out a review, at least once a year, as to whether the macro-economic conditions justify the freeze being continued unchanged. Within 90 days of the start of such review any increases or reductions in prices shall be announced in the Gazzetta Ufficiale della Repubblica Italiana [Official Journal of the Italian Republic].

2. In exceptional cases, the holder of a marketing authorisation for a medicinal product may, by way of derogation from the price freeze, apply to the Comitato interministeriale dei prezzi – Servizio prodotti farmaceutici [Joint Ministerial Committee for Prices – Medicinal Products Service] for a price increase. The application must be supported by an appropriate statement of reasons including the particular reasons justifying that derogation.

3. If the information supporting the application is inadequate, the Committee shall forthwith notify the authorisation holder of what detailed additional information is required for the purposes of a final decision on the derogation sought.

4. If the derogation is granted, the Committee shall publish the decision in the Gazzetta Ufficiale della Repubblica Italiana, stating the permitted price.

5. The Committee’s reasoned decision on the application for derogation shall be adopted and the applicant notified of it within 90 days from the submission of the application or receipt of the additional information. In the event of an exceptionally large number of applications, the time-limit may be extended once only by 60 days. The applicant shall be informed of the decision to extend the period before the end of the original period.’

12. The referring court’s summary of the national legislation shows that the main proceedings concern medicinal products in Class A of the Italian Pharmacopoeia, that is to say, essential medicinal products and medicinal products for chronic illnesses, the cost of which is wholly to be borne by the SSN pursuant to Article 32 of the Italian Constitution. The price of those products is the same as the retail price because if the latter had to be set higher than that shown on the tariff established by the Agenzia Italiana del Farmaco (Italian Medicines Agency ‘the AIFA’), the AIFA would immediately transfer the medicinal product in question to Class C in the Italian Pharmocopoeia, which is the class...