# C_2016222EN.01000401.xml

| 20.6.2016 | EN | Official Journal of the European Union | C 222/4 |
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20.6.2016

EN

Official Journal of the European Union

C 222/4

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Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 25 March 2016 — F. Hoffmann-La Roche AG, La Roche SpA, Novartis AG and Novartis Farma SpA v Autorità Garante della Concorrenza e del Mercato

(Case C-179/16)

(2016/C 222/05)

Language of the case: Italian

Referring court

Consiglio di Stato

Parties to the main proceedings

Appellants: F. Hoffmann-La Roche AG, La Roche SpA, Novartis AG and Novartis Farma SpA

Respondent: Autorità Garante della Concorrenza e del Mercato

Questions referred

| 1. | On a proper construction of Article 101 TFEU, can the parties to a licensing agreement be regarded as competitors if the licensee company operates on the relevant market concerned solely by virtue of that agreement? Do possible restrictions of competition between the licenser and the licensee in such a situation, although not explicitly provided for in the licensing agreement, fall outside the scope of Article 101(1) TFEU or fall within the scope of the exception set out in Article 101(3) TFEU and, if so, within what limits? |
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1.

On a proper construction of Article 101 TFEU, can the parties to a licensing agreement be regarded as competitors if the licensee company operates on the relevant market concerned solely by virtue of that agreement? Do possible restrictions of competition between the licenser and the licensee in such a situation, although not explicitly provided for in the licensing agreement, fall outside the scope of Article 101(1) TFEU or fall within the scope of the exception set out in Article 101(3) TFEU and, if so, within what limits?

| 2. | Does Article 101 TFEU allow the National Competition Authority to define the relevant market autonomously vis-à-vis the content of marketing authorisations (MAs) for medicinal products granted by the competent pharmaceutical regulatory authorities (the Agenzia Italiana del Farmaco and the European Medicines Agency), or must the relevant market for the purposes of Article 101 TFEU instead be held to be primarily shaped and established in respect of the authorised medicinal products by the appropriate regulatory authority in a way binding on the National Competition Authority also? |
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2.

Does Article 101 TFEU allow the National Competition Authority to define the relevant market autonomously vis-à-vis the content of marketing authorisations (MAs) for medicinal products granted by the competent pharmaceutical regulatory authorities (the Agenzia Italiana del Farmaco and the European Medicines Agency), or must the relevant market for the purposes of Article 101 TFEU instead be held to be primarily shaped and established in respect of the authorised medicinal products by the appropriate regulatory authority in a way binding on the National Competition Authority also?

| 3. | In the light of the provisions of Directive 2001/83/EC, (1) in particular Article 5 thereof, which relates to marketing authorisations for medicinal products, does Article 101 TFEU allow a medicinal product used off-label and a medicinal product that has received an MA in respect of the same therapeutic indications to be regarded as interchangeable and, thus, to be included in the same relevant market? |
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3.

In the light of the provisions of Directive 2001/83/EC, (1) in particular Article 5 thereof, which relates to marketing authorisations for medicinal products, does Article 101 TFEU allow a medicinal product used off-label and a medicinal product that has received an MA in respect of the same therapeutic indications to be regarded as interchangeable and, thus, to be included in the same relevant market?

| 4. | Pursuant to Article 101 TFEU, for the purposes of defining the relevant market, is it important to establish, in addition to the essential fungibility of pharmaceutical products on the demand side, whether or not those products have been supplied on the market in accordance with the regulatory framework concerning the marketing of medicinal products? |
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4.

Pursuant to Article 101 TFEU, for the purposes of defining the relevant market, is it important to establish, in addition to the essential fungibility of pharmaceutical products on the demand side, whether or not those products have been supplied on the market in accordance with the regulatory framework concerning the marketing of medicinal products?

| 5. | In any event, can a concerted practice intended to emphasise that a medicinal product is less safe or less effective be regarded as intended to restrict competition, when the idea that that product is less effective or less safe, although not supported by reliable scientific evidence, cannot, in the light of the level of scientific knowledge available at the time of the events in question, be indisputably excluded either? |
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5.

In any event, can a concerted practice intended to emphasise that a medicinal product is less safe or less effective be regarded as intended to restrict competition, when the idea that that product is less effective or less safe, although not supported by reliable scientific evidence, cannot, in the light of the level of scientific knowledge available at the time of the events in question, be indisputably excluded either?

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(1)  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 (OJ 2001 L 311, p. 67).

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