Case C‑310/13

Novo Nordisk Pharma GmbH

v

S.

(Request for a preliminary ruling from the Bundesgerichtshof)

‛Reference for a preliminary ruling — Directive 85/374/EEC — Consumer protection — Liability for defective products — Material scope of the directive — Special liability system existing on the date of notification of that directive — Permissibility of a national liability system enabling information on the adverse effects of pharmaceutical products to be obtained’

Summary — Judgment of the Court (Fourth Chamber), 20 November 2014

Approximation of laws — Liability for defective products — Directive 85/374 — Scope — Special liability system existing on the date of notification of that directive — National liability system enabling information on the adverse effects of pharmaceutical products to be obtained — Lawfulness

(Council Directive 85/374, Art. 13)

Directive 85/374 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, as amended by Directive 1999/34, must be interpreted as not precluding national legislation establishing a special liability system for the purposes of Article 13 of that directive under which, in consequence of an amendment to that legislation made after the directive had been notified to the Member State concerned, the consumer has the right to require the manufacturer of the medicinal product to provide him with information on the adverse effects of that product.

Neither that right nor the scope of the information that the consumer could require the manufacturer of that product to provide are covered, as such, by Directive 85/374 and, accordingly, fall outside the scope of that directive.

(see paras 25, 29, 33, operative part)

Case C‑310/13

Novo Nordisk Pharma GmbH

v

S.

(Request for a preliminary ruling from the Bundesgerichtshof)

‛Reference for a preliminary ruling — Directive 85/374/EEC — Consumer protection — Liability for defective products — Material scope of the directive — Special liability system existing on the date of notification of that directive — Permissibility of a national liability system enabling information on the adverse effects of pharmaceutical products to be obtained’

Summary — Judgment of the Court (Fourth Chamber), 20 November 2014

Approximation of laws — Liability for defective products — Directive 85/374 — Scope — Special liability system existing on the date of notification of that directive — National liability system enabling information on the adverse effects of pharmaceutical products to be obtained — Lawfulness

(Council Directive 85/374, Art. 13)

Directive 85/374 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, as amended by Directive 1999/34, must be interpreted as not precluding national legislation establishing a special liability system for the purposes of Article 13 of that directive under which, in consequence of an amendment to that legislation made after the directive had been notified to the Member State concerned, the consumer has the right to require the manufacturer of the medicinal product to provide him with information on the adverse effects of that product.

Neither that right nor the scope of the information that the consumer could require the manufacturer of that product to provide are covered, as such, by Directive 85/374 and, accordingly, fall outside the scope of that directive.

(see paras 25, 29, 33, operative part)