Case C-29/17: Judgment of the Court (First Chamber) of 21 November 2018 (request for a preliminary ruling from the Consiglio di Stato — Italy) — Novartis Farma SpA v Agenzia Italiana del Farmaco (AIFA), Roche Italia SpA, Consiglio Superiore di Sanità (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)
Date: 2018-11-21
Institutions: Court of Justice
Subjects: European Medicines Agency, cancer, drug surveillance, health care system, market approval, pharmaceutical product, therapeutics








C_2019025EN.01000402.xml










21.1.2019   


EN


Official Journal of the European Union


C 25/4






Judgment of the Court (First Chamber) of 21 November 2018 (request for a preliminary ruling from the Consiglio di Stato — Italy) — Novartis Farma SpA v Agenzia Italiana del Farmaco (AIFA), Roche Italia SpA, Consiglio Superiore di Sanità
(Case C-29/17) (1)

((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))
(2019/C 25/05)
Language of the case: Italian

Referring court

Consiglio di Stato

Parties to the main proceedings


Applicant: Novartis Farma SpA

Defendants: Agenzia Italiana del Farmaco (AIFA), Roche Italia SpA, Consiglio Superiore di Sanità

intervening parties: Ministero della Salute, Regione Veneto, Società Oftalmologica Italiana (SOI) — Associazione Medici Oculisti Italiani (AMOI), Regione Emilia-Romagna

Operative part of the judgment







1.


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.










2.


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.










3.


Articles 3, 25 and 26 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012, must be interpreted as not precluding a national measure such as that taken pursuant to Article 1(4)bis of decreto-legge 21 ottobre 1996, n. 536, recante ‘Misure per il contenimento della spesa farmaceutica e la rideterminazione del tetto di spesa per l'anno 1996’, convertito dalla legge del 23 dicembre 1996, n. 648 (Decree-Law No 536 of 21 October 1996 on ‘Measures for containing pharmaceutical expenditure and for adjusting the maximum level of expenditure for 1996’, converted into statute by Law No 648 of 23 December 1996), as amended by decreto-legge del 20 marzo 2014, n. 36, convertito dalla legge del 16 maggio 2014, n. 79 (Decree-Law No 36 of 20 March 2014, converted into statute by Law No 79 of 16 May 2014) which authorises the Agenzia Italiana del Farmaco (AIFA) (Italian Medicines Agency (AIFA)) to monitor medicinal products such as Avastin the off-label use of which is reimbursed by the Servizio Sanitario Nazionale (National Health Service, Italy) and, where relevant, to introduce measures necessary to safeguard patient safety.






(1)  OJ C 195, 19.6.2017.