Joined Cases C‑271/14 and C‑273/14

LFB Biomédicaments SA and Others

v

Ministre des Finances et des Comptes publics

and

Ministre des Cases sociales and de la Santé

(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(3) and (5) — Removal of medicinal products from a list of pharmaceutical proprietary products covered in addition to fixed payments in respect of hospital treatment — Obligation to state reasons’

Summary — Judgment of the Court (Eighth Chamber), 16 April 2015

Approximation of laws — Medicinal products — Directive 89/105 — Medicinal products for human use — Positive list of medicinal products covered by the national health insurance scheme — Decision amending the conditions or level of reimbursement of a medicinal product by excluding it from that list of medicinal products in addition to fixed payments in respect of hospital treatment — Obligation to state reasons

(Council Directive 89/105, Art. 6(3) and 5)

Article 6 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 provided for in Article 6(3) and (5) is applicable to a decision which restricts the conditions of reimbursement or reduces the level of coverage of a medicinal product by excluding it from the list of proprietary medicinal products covered by compulsory health insurance schemes in addition to services relating to hospital treatment covered by fixed payments in respect of periods of hospitalisation and hospital care.

It would be contrary to the objective of transparency to accept that such a decision 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.

(see paras 30, 31, operative part)

Joined Cases C‑271/14 and C‑273/14

LFB Biomédicaments SA and Others

v

Ministre des Finances et des Comptes publics

and

Ministre des Cases sociales and de la Santé

(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(3) and (5) — Removal of medicinal products from a list of pharmaceutical proprietary products covered in addition to fixed payments in respect of hospital treatment — Obligation to state reasons’

Summary — Judgment of the Court (Eighth Chamber), 16 April 2015

Approximation of laws — Medicinal products — Directive 89/105 — Medicinal products for human use — Positive list of medicinal products covered by the national health insurance scheme — Decision amending the conditions or level of reimbursement of a medicinal product by excluding it from that list of medicinal products in addition to fixed payments in respect of hospital treatment — Obligation to state reasons

(Council Directive 89/105, Art. 6(3) and 5)

Article 6 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 provided for in Article 6(3) and (5) is applicable to a decision which restricts the conditions of reimbursement or reduces the level of coverage of a medicinal product by excluding it from the list of proprietary medicinal products covered by compulsory health insurance schemes in addition to services relating to hospital treatment covered by fixed payments in respect of periods of hospitalisation and hospital care.

It would be contrary to the objective of transparency to accept that such a decision 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.

(see paras 30, 31, operative part)