Case C- 179/16 F. Hoffmann-La Roche and Others [Archived]
Case C- 179/16 F. Hoffmann-La Roche and Others [Archived]

The following Competition practice note provides comprehensive and up to date legal information covering:

  • Case C- 179/16 F. Hoffmann-La Roche and Others [Archived]
  • Case facts
  • Timeline
  • Commentary
  • Related/relevant cases


ARCHIVED–this archived case hub reflects the position at the date of the decision of 23 January 2018; it is no longer maintained.

See further: timeline, commentary and related/relevant cases

Case facts

OutlineNational reference from the Consiglio di Stato (Italian Council of State) to the Court of Justice requesting a preliminary ruling under Article 267 TFEU seeking clarification regarding the interplay between the regulatory framework for the placing of drugs on the market and EU competition law. In particular, the Court of Justice was requested to clarify to what extent, and on what basis, the legal uncertainty regarding the lawfulness of prescribing and marketing a drug with a view to its ‘off-label’ use and the scientific risks associated with such use come into play in the application of Article 101 TFEU.

OutcomeOn 23 January 2018, the Court of Justice issued its judgment, and ruled that an agreement between two pharmaceutical companies to restrict ‘off-label’ use of certain pharmaceutical products, through the manipulation of the perceived risks of one drug over other another without scientific evidence to support such allegations, constitutes a restriction of competition by object within the meaning of Article 101(1) TFEU, where those allegations are misleading.

Parties• F. Hoffmann-La Roche AG (Roche), a Swiss–based multinational healthcare company—appellant in national proceedings

• La Roche SpA (Roche Italia), a wholly owned subsidiary of

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