Pharmaceutical Sector: Can Non-Authorised Products be Included in the Relevant Market for the Assessment of Alleged Anticompetitive Conduct? A Short Analysis of the Recent Italian Avastin-Lucentis Decision

摘要

In the Avastin-Lucentis decision, the AGCM's conclusion that Roche and Novartis allegedly infringed Article 101 TFEU by colluding to create an artificial product differentiation between their two products arguably disregards the fundamental difference between an authorised indication and an off-label use in terms of safety and regulatory guarantees. In so doing, the AGCM failed to recognise that the type of competition that the decision states is normal market reality runs against the whole logic of the pharmaceutical regulatory system. For these reasons, the AGCM decision can be criticised for finding that a pharmaceutical product was safe to use beyond its authorised indications and questioning the price validated by the competent regulatory authorities. In that regard, the AGCM decision arguably constitutes the latest example of competition authorities trespassing on the expert competence of regulatory authorities.