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Romania - Roche Fails in Attempts to Have Findings of Abusive Behaviour in relation to Oncology Medicines Overturned

  • 16/10/2024
  • News

The Romanian Competition Council (Consiliul Concurenţei or CC) published last week the attached press release indicating that it had prevailed in litigation with Roche over a decision which it took at the end of 2019 to fine Roche for abusive behaviour to protect part of its oncology franchise (MabThera® (rituximab) and Herceptin® (trastuzumab)) against both other sources of the reference medicines and several biosimilar versions (see, Van Bael & Bellis Life Sciences News & Insights of 23 January 2020). According to the CC, Roche had placed its distributors for the reference products in a price squeeze, thus preventing them from competing effectively in public procurement procedures. CC added that, in taking this approach, Roche had also deprived the distributors from the opportunity to replace a possible winning lot of the reference medicines with a biosimilar version, thus hindering biosimilar market entry.   
 
The CC saw off Roche’s challenges of its decision before the Bucharest Court of Appeal and the High Court of Cassation and Justice.
 
In last week’s press release, the CC also claimed victory in a case in which it had found Roche guilty of preventing sales of generic medicines containing the active substance erlotinib by steering patients to its reference product Tarceva®, a medicine indicated for the treatment of specific forms of non-small cell lung cancer and pancreatic cancer. Roche’s strategy thus caused the government payor to spend more on erlotinib-based medicines than would have been necessary under normal competitive conditions. Following Roche’s appeal, the Bucharest Court of Appeal again sided with CC, but the case is still pending before the High Court of Cassation and Justice.   

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