CELEX: 62013CJ0691
Reference for a preliminary ruling
Medicinal products for human use
Directive 89/105/EEC
Article 6(2)
Establishment of a list of medicinal products reimbursed by the health insurance funds
Amendment of the conditions of reimbursement of a medicinal product when renewing its inclusion in such a list
Obligation to state reasons

This request for a preliminary ruling concerns the interpretation of Article 6(2) 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
).
The request has been made in proceedings between Les Laboratoires Servier SA (‘Servier’), on the one hand, and the Ministre des Affaires sociales et de la Santé (Minister of Social Affairs and Health) and the Ministre de l’Économie et des Finances (Minister for the Economy and Finance), on the other hand, concerning the amendment by those ministers of the conditions of reimbursement of a medicinal product by the health insurance system.
Legal context
Directive 89/105
Recital 5 in the preamble to Directive 89/105 states that its objective ‘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; … this information should be public’.
Recital 6 in the preamble to Directive 89/105 states that ‘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’.
Under Article 1(1) of Directive 89/105:
‘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.’
Article 2(1) and (2) of Directive 89/105 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. The applicant shall furnish the competent authorities with adequate information. 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. In the absence of such a decision within the abovementioned period or periods, the applicant shall be entitled to market the product at the price proposed.
(2)
Should the competent authorities decide not to permit the marketing of the medicinal product concerned at the price proposed by the applicant, the decision shall contain a statement of reasons based on objective and verifiable criteria. In addition, the applicant shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying for such remedies.’
Article 6(1) to (3) of Directive 89/105 provides:
‘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 systems is adopted and communicated to the applicant within 90 days of its receipt. Where an application under this Article may be made before the competent authorities have agreed the price to be charged for the product pursuant to Article 2, or where a decision on the price of a medicinal product and a decision on its inclusion within the list of products covered by the health insurance system are taken after a single administrative procedure, the time-limit shall be extended for a further 90 days. The applicant shall furnish the competent authorities with adequate information. If the information supporting the application is inadequate, the time-limit shall he suspended and the competent authorities shall forthwith notify the applicant of what detailed additional information is required.
Where a Member State does not permit an application to be made under this Article before the competent authorities have agreed the price to be charged for the product pursuant to Article 2, the Member State concerned shall ensure that the overall period of time taken by the two procedures does not exceed 180 days. This time-limit may be extended in accordance with Article 2 or suspended in accordance with the provisions of the preceding subparagraph.
(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 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.’
French law
Article L. 162-17 of the Code de la sécurité sociale (Social Security Code) makes the payment for or reimbursement of medicinal products by the health insurance system, where they are distributed through retail pharmacies, subject to their inclusion in a list.
Article R. 163-2 of the Code de la sécurité sociale provides:
‘Medicinal products ... cannot be reimbursed or paid for by Social Security bodies, upon medical prescription, … or be bought, supplied or used by those bodies, unless they are included in the list of reimbursable medicinal products established by joint decision of the Minister responsible for Health and the Minister responsible for Social Security. That decision shall indicate the only therapeutic indications that give rise to entitlement to payment or reimbursement in respect of medicinal products. ...’
In accordance with Articles L. 161-37 and R. 163-15 of the Code de la sécurité sociale, a commission of the Haute Autorité de santé (National Health Authority), known as the transparency commission, is to deliver opinions on proprietary medicinal products as regards their potential inclusion or re-inclusion in the list of proprietary medicinal products eligible for reimbursement to persons insured under the social security scheme and to establish the conditions of reimbursement.
Heading I of Article R. 163-3 of the Code de la sécurité sociale provides:
‘Medicinal products shall be included in the list provided for in the first subparagraph of Article L. 162-17 in the light of the assessment of the medical benefit provided by each indication. That assessment shall take into account the effectiveness and the undesirable effects of the medicinal product, its place in the therapeutic strategy, in particular with regard to other available therapies, the seriousness of the condition which it is intended to treat, the preventative, curative or symptomatic nature of the medicinal treatment and its public health interest. Medicinal products whose medical benefit provided is insufficient with regard to other medicinal products or available therapies shall not be included in the list.’
The dispute in the main proceedings and the question referred for a preliminary ruling
Servier sells Protelos in France, a medicinal product for the treatment of osteoporosis in post-menopausal women.
By an opinion of 11 May 2011, the transparency commission took the view that the inclusion of Protelos in the list of reimbursable medicinal products was justified, but limited the extent to which it is covered by the health insurance system.
By Ministerial Decision of 12 September 2011 (‘the contested decision’), Protelos was reinstated in the list of reimbursable medicinal products, the coverage by the health insurance system of that medicinal product being however limited to prescriptions of that product to patients who cannot be treated, due to a contraindication or an intolerance, by bisphosphonate-based medicinal products or who do not present any risk factor for a venous thromboembolic event, such as, in particular, persons of more than 80 years of age.
Servier brought an action against that decision to the Conseil d’État. In support of its action, Servier claims that the statement of reasons for the contested decision does not comply with the requirements of Article 6(2) of Directive 89/105. Servier essentially considers that that provision requires that reasons be stated for decisions modifying the conditions of inclusion in the list of reimbursable proprietary medicinal products (judgment in
Commission
v
Finland
, C‑229/00,
EU:C:2003:334
). Since the contested decision merely refers to the opinion given by the transparency commission, Servier considers that its statement of reasons is not compatible with the requirements of Directive 89/105.
In those circumstances, the Conseil d’État decided to stay the proceedings and to refer the following question to the Court for a preliminary ruling:
‘Does Article 6(2) of [Directive 89/105] require that reasons be stated for decisions as to inclusion or re-inclusion in the list of medicinal products eligible for reimbursement by the health insurance funds which — by limiting, in comparison with the application made, the therapeutic indications giving rise to eligibility for reimbursement, or by making that reimbursement subject to conditions relating to, inter alia, the qualifications of the prescribing doctors, the organisation of care or the follow-up of patients, or in any other way — make the reimbursement by the health insurance funds available to only some of the patients liable to benefit from the medicinal product or only in certain circumstances?’
The question referred for a preliminary ruling
By its question, the referring court asks, in essence, whether Article 6(2) of Directive 89/105 must be interpreted as meaning that the obligation to state reasons set out in that provision is applicable to a decision which reinstates a product in the list of medicinal products covered by the health insurance system, but which limits the reimbursement of that product to a specific category of patients.
Servier, the Portuguese Government and the European Commission propose that the question referred be answered in the affirmative, an outcome which is opposed by the French and Spanish governments, which contend that that provision must be interpreted literally. Its scope of application may not be extended to decisions other than those providing that a medicinal product is not to be included in the list of medicinal products covered by the health insurance system. The Swedish Government considers that it is difficult to give a single answer to a question which covers a wide variety of different situations.
It should be noted that Article 6(2) of Directive 89/105 requires that ‘any decision not to include a medicinal product in the list of products covered by the health insurance system [is to] contain a statement of reasons based upon objective and verifiable criteria’.
In this case, a decision such as that at issue in the main proceedings does not constitute a refusal to include in the list of products covered by the health insurance system, which is the only type of act expressly envisaged in Article 6(2) of Directive 89/105. Nevertheless, a decision of that nature amounts, at the time of reinstatement in the list, to an exclusion, with respect to patients who fail to satisfy certain conditions, of the reimbursement of a medicinal product covered by the health insurance system. Consequently, such a decision has the result of producing, having regard to the situation of those patients, similar effects to those resulting from a partial refusal to include in the list of products covered by the health insurance system.
It should be noted that the purpose of Directive 89/105, according to Article 1 thereof, is to ensure that any national measure to control the prices of medicinal products for human use or to restrict the range of medicinal products covered by the national sickness insurance systems complies with the requirements of that directive (judgments in
Commission
v
Austria
, C‑424/99,
EU:C:2001:642
, paragraph 30, and
Commission
v
Finland
,
EU:C:2003:334
, paragraph 37).
According to the sixth recital in the preamble to that directive, ensuring the effectiveness of that directive also requires that the persons concerned can verify that the official entry of medicinal products on the list corresponds to objective criteria and that there is no discrimination between national medicinal products and those from other Member States (judgment in
Commission
v
Finland
,
EU:C:2003:334
, paragraph 39).
In accordance with the fifth recital in the preamble to Directive 89/105, the purpose of that directive is to ensure transparency of pricing, including the manner in which it operates in individual cases and the criteria on which it is based, and to provide public access to pricing arrangements for all those involved in the market in medicinal products in the Member States (see, to that effect, judgment in
Pohl-Boskamp
, C‑317/05,
EU:C:2006:684
, paragraph 29).
In view of the foregoing, it would be contrary to the objective of transparency to accept that a decision such as that at issue in the main proceedings may be exempt from the obligation to state reasons provided for in Article 6(2) of Directive 89/105, which seeks to allow interested parties to verify whether decisions relating to the pricing of medicinal products and their inclusion in national health insurance systems are taken on the basis of objective criteria and do not discriminate between national medicinal products and those originating in other Member States.
In the light of the foregoing considerations, the answer to the question referred is that Article 6(2) of Directive 89/105 must be interpreted as meaning that the obligation to state reasons set out in that provision is applicable to a decision which reinstates a product in the list of medicinal products covered by the health insurance system, but which limits the reimbursement of that product to a specific category of patients.
Costs
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 (Third Chamber) hereby rules:

Article 6(2) 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 obligation to state reasons set out in that provision is applicable to a decision which reinstates a product in the list of medicinal products covered by the health insurance system, but which limits the reimbursement of that product to a specific category of patients.

[Signatures]
(
*1
)	Language of the case: French.