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By object restrictions of competition in the pharmaceutical industry in the context of off-label use of medicines (CJEU preliminary ruling in F. Hoffmann-La Roche and Others v Autorità Garante della Concorrenza e del Mercato)

26 Ianuarie 2018   |   Georgeta Dinu, Partener, Head of Copetition, State Aid and EU Law & Alexandru Șotropa, Associate - NNDKP

In order to determine that the agreement represents a restriction of competition 'by object', the Court ruled that "a national competition authority may include in the relevant market, in addition to the medicinal products authorised for the treatment of the diseases concerned, another medicinal product whose marketing authorisation does not cover that treatment but which is used for that purpose and is thus actually substitutable with the former".

Georgeta Dinu, Partener, Head of Copetition, State Aid and EU Law, Alexandru Sotropa, Associate - NNDKP

 
 
The Court of Justice of the European Union (CJEU) ruled on 23 January 2018 in Case F. Hoffmann-La Roche and Others v Autorità Garante della Concorrenza e del Mercato (C-179/16) that "an arrangement between two undertakings marketing two competing products which concerns the dissemination, in a context of scientific uncertainty, to the European Medicines Agency, healthcare professionals and the general public of misleading information relating to adverse reactions resulting from the use of one of those medicinal products for the treatment of diseases not covered by the marketing authorisation of that product, with a view to reducing the competitive pressure resulting from such use on the use of the other product, constitutes a restriction of competition ‘by object’ for the purposes of [Art. 101 TFEU]".


The question was raised in the context of proceedings brought in Italy for fines imposed in 2014 by the competition authority to companies in Roche and Novartis groups as a result of finding a market-sharing agreement. Roche was entrusted the commercial exploitation of Avastin (whose marketing authorization - MA - covered the treatment of certain tumorous diseases), while Novartis of Lucentis (whose marketing authorization covered the treatment of eye diseases). Avastin however was prescribed by doctors for eye diseases, even if such an indication was not covered by the marketing authorization (off-label). According to the Italian competition authority's decision, the market-sharing agreement "was intended to produce and disseminate opinions which could give rise to public concern regarding the safety of Avastin when used in ophthalmology" and also related to "proceedings for amendment of the summary of Avastin's characteristics that were pending before the EMA and to the sending of a subsequent formal communication to healthcare professionals", which had resulted in a drop of Avastin sales and a shift in demand towards Lucentis.

In order to determine that the agreement represents a restriction of competition 'by object', the Court ruled that "a national competition authority may include in the relevant market, in addition to the medicinal products authorised for the treatment of the diseases concerned, another medicinal product whose marketing authorisation does not cover that treatment but which is used for that purpose and is thus actually substitutable with the former".

The Court noted the fact that pharmaceutical products are manufactured or sold illegally prevents them, in principle, from being regarded as substitutable, but EU rules on pharmaceutical products prohibit neither the off-label prescription of a medicinal product nor its repackaging for such use, under certain conditions. Also, the Court noted that no unlawfulness of the conditions under which Avastin was repackaged and prescribed for off-label use had been established by national authorities or courts.

The Court further ruled that such a restriction is not ancillary to the licensing agreement and therefore does not fall outside the scope of Art. 101 TFEU - it was designed to restrict the conduct of third parties, in particular healthcare professionals, it was not objectively necessary for the implementation of the licensing agreement, as it was agreed upon several years after.
 
 

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