On 21 September 2017, Advocate General Saugmandsgaard Øe delivered his Opinion in Case C-179/16 Hoffmann-La Roche, finding that licensed and unlicensed medicinal products used for the same indication may fall within the same relevant product market.

Background

Genentech’s drugs Avastin (which is licensed to Roche) and Lucentis (licensed to Novartis) are based on different active substances but are derived from the same antibody and have similar mechanisms of action. Avastin obtained marketing authorisation first, for treatment of certain types of cancer and Lucentis later obtained marketing authorisation for treatment of certain ophthalmologic conditions. However, during the interval between grant of the two marketing authorisations, a number of medical practitioners used Avastin in smaller doses to treat ophthalmologic conditions. Furthermore some practitioners have continued to use Avastin even after grant of marketing authorisation for Lucentis because of the substantially lower treatment cost of Avastin.

Preliminary reference

In early 2014, the Italian competition authority (AGCM) found that Roche and Novartis had conspired to communicate to the pharmaceutical regulatory authorities, medical professionals and the general public, statements to the effect that the use of Avastin in the eye was less safe than the use of Lucentis. According to the AGCM, the undertakings had no scientific evidence to support these statements and had made them with the aim of discouraging the use of Avastin and consequently increasing sales of Lucentis.

Roche and Novartis challenged the AGCM’s decision in the Italian courts, Having failed at first instance, the companies appealed and the Italian Council of State made a reference to the Court of Justice of the EU (CJEU).

Opinion

The referring court asked the CJEU, inter alia, whether in the pharmaceutical sector the definition of the relevant product market for the purposes of competition law is limited to those therapies that have a marketing authorisation for the indication in question, or may also include unlicensed products. In the latter case, the unlicensed Avastin and the licensed Lucentis would both fall within the same product market for treatment of the relevant ophthalmologic conditions.

Starting from the clear principle that a relevant product market comprises all those products which are regarded as interchangeable or substitutable, the Advocate General (AG) elaborated that the definition of the relevant product market depends not on the regulatory limitations, but on the objective characteristics of the products and on the actual competitive conditions of the market. The AG stated that the limitations of the marketing authorisation are not unsurmountable and therefore are not necessarily decisive in the definition of the relevant product market.  There is effective demand-side substitutability between the products because  some medical practitioners use Avastin and some use Lucentis to treat the same ophthalmologic conditions. In light of that finding, the AG concluded that Avastin and Lucentis belong to the same product market.

The AG recognised that the presence of a marketing authorisation is likely to guide medical practitioners in their choice of the appropriate treatment for patients. However, the actual practice of medical practitioners, coupled with administrative decisions concerning reimbursement are critical to determine whether two medicinal products are  interchangeable.  In the present case the AG concluded that Avastin was very often prescribed for, and was at the time reimbursable for, the relevant ophthalmologic conditions in Italy.  Therefore Avastin and Lucentis fall within the same product market.

The AG reinforced his conclusion by stating that if the definition of the relevant product market were systematically linked to marketing authorisations, pharmaceutical companies would have “carte blanche” to reach agreements to share markets by ensuring that there was no overlap between the therapeutic indications covered by the respective marketing authorisations of products that were not yet placed on the market.

The AG’s Opinion is consistent with the importance of substitution as the basis for market definition. Although the normal methodology for assessing substitutability are not easily applied in relation to reimbursed pharmaceuticals, the European Commission and national competition authorities and courts are moving away from formalistic approaches, such as the use of the Anatomic Therapeutic Chemical Classification, to a more sophisticated review of the dynamics of competition.

 

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