Case C‑29/17

Novartis Farma SpA

v

Agenzia Italiana del Farmaco (AIFA) and Others

(Request for a preliminary ruling from the Consiglio di Stato)

(Reference for a preliminary ruling — Medicinal products for human use — Directive 2001/83/EC — Article 3(1) — Article 6 — Directive 89/105/EEC — Regulation (EC) No 726/2004 — Articles 3, 25 and 26 — Repackaging of a medicinal product for use as a treatment not covered by its marketing authorisation (off-label use) — Reimbursement by the national healthcare insurance system)

Summary — Judgment of the Court (First Chamber), 21 November 2018

See the text of the decision. (see paras 48 -51)

Article 3(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, must be interpreted as meaning that Avastin, after being repackaged according to the conditions laid down by the national measures at issue in the main proceedings, falls within the scope of Directive 2001/83, as amended by Directive 2012/26. The Court must therefore hold that the exclusion from the scope of Directive 2001/83 set out in Article 3 thereof covers only medicinal products ‘prepared’ in a pharmacy, that is to say those produced in a pharmacy, namely magistral formulas and officinal formulas. Avastin does not fall within either of those categories. It is not produced in dispensing or hospital pharmacies, but industrially in Roche’s laboratories, which holds its MA. It is also clear from the file before the Court that the processes for repackaging Avastin undertaken in accordance with the national measures at issue in the main proceedings do not significantly change the composition, form or other fundamental characteristics of that medicinal product. Those repackaging processes cannot be regarded as the ‘preparation’ of a new medicinal product derived from Avastin by means of a magistral formula or an officinal formula. They do not therefore fall within the scope of Article 3 of Directive 2001/83. (see paras 57, 58, 65, operative part 1)

Article 6 of Directive 2001/83, as amended by Directive 2012/26, must be interpreted as not precluding national measures such as those at issue in the main proceedings which lay down the conditions under which Avastin may be repackaged in order to be used for the treatment of ophthalmological indications not covered by its market authorisation. In a case similar to that at issue in the main proceedings, the Court held that the repackaging of Avastin for off-label use in the treatment of eye diseases did not require a new MA, provided that that process does not result in any modification of the medicinal product and that it is carried out solely on the basis of individual prescriptions making provision for that process (judgment of 11 April 2013, Novartis Pharma, C‑535/11, EU:C:2013:226, paragraph 42). Subject to factual findings to be made by the referring court, the repackaging of Avastin under the conditions laid down in the national measures at issue in the main proceedings, does not therefore require an MA to be obtained in so far as that process is prescribed by a doctor by means of an individual prescription and undertaken by pharmacists for that medicinal product to be administered in hospitals. (see paras 72, 75, 79, operative part 2)