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Posted 1 May 2024 AM
CSL Vifor has proposed a marketing campaign in the European Union to address concerns of possible anticompetitive disparagement of a competitor's product.
The European Commission opened an antitrust investigation into Vifor in June 2022, right when it was in the process of being acquired by CSL. Vifor's intravenous iron treatment, Ferinject, was dominant in several national markets including Austria, Finland, Germany, Ireland, Portugal, Romania, Spain, Sweden, and The Netherlands.
The Commission said it has indications that for many years Vifor "may have disseminated potentially misleading information" regarding the safety of Pharmacosmos' competing product, Monofer, primarily targeting healthcare professionals, which "may have unduly hindered Monofer's uptake in the European Economic Area".
"CSL Vifor acknowledges that the European Commission has initiated a formal market test as part of the EC's investigation into potential anti-competitive conduct of Vifor Pharma, and published CSL Vifor's proposed commitments on their website," a CSL Vifor spokesperson said.
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"The commitment proposal reflects several months of detailed discussion with the European Commission. CSL Vifor is pleased to be taking this important step towards resolution of the Commission's investigation. Conducting a formal market test does not mean any admission of liability on our part."
The commitments included launching a "comprehensive and multi-channel communication campaign to rectify and undo the effects of the potentially misleading messages previously disseminated by Vifor regarding the safety of Monofer".
CSL Vifor will send emails, mail, and meet in-person with a significant number of healthcare professionals in the nine Member States where it is dominant to provide a "succinct and factual clarificatory communication". That will also be published prominently on its website, in leading medical journals, and third parties such as Pharmacosmos will be able to use it when contacting HCPs.
It also committed to not engage in external promotional and medical communications about Monofer's safety profile using information that is neither based on Monofer's Summary of Product Characteristics nor derived from randomised, controlled clinical head-to-head trials, for a period of 10 years. Measures and safeguards to ensure compliance to this are also mooted.
The Commission is seeking feedback on the proposals.
James Quintana Pearce
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