Case C‑691/13

Les Laboratoires Servier SA

v

Ministre des Cases sociales and de la Santé

and

Ministre de l’Économie et des Finances

(Request for a preliminary ruling from the Conseil d’État (France))

‛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’

Summary — Judgment of the Court (Third Chamber), 26 February 2015

Approximation of laws — Medicinal products — Directive 89/105 — Medicinal products for human use — 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

(Council Directive 89/105/EEC, Art. 6(2))

Article 6(2) of Directive 89/105 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.

Although such a decision 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, it amounts, nevertheless, 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.

(see paras 20, 25, operative part)

Case C‑691/13

Les Laboratoires Servier SA

v

Ministre des Cases sociales and de la Santé

and

Ministre de l’Économie et des Finances

(Request for a preliminary ruling from the Conseil d’État (France))

‛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’

Summary — Judgment of the Court (Third Chamber), 26 February 2015

Approximation of laws — Medicinal products — Directive 89/105 — Medicinal products for human use — 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

(Council Directive 89/105/EEC, Art. 6(2))

Article 6(2) of Directive 89/105 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.

Although such a decision 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, it amounts, nevertheless, 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.

(see paras 20, 25, operative part)