European Commission Market Tests Commitments Offered by Vifor Regarding Messaging Involving Intravenous Iron Treatment of Rival

• 22/04/2024
• News

On 19 April 2024, the European Commission (the Commission) started to market test commitments offered by Vifor Pharma (Vifor) regarding its messaging in relation to Monofer®, the intravenous iron treatment of Pharmacosmos, which competes with its own intravenous iron deficiency treatment Ferinject® (see, attached press release). The Commission had accused Vifor of disparaging Monofer® by disseminating misleading information among healthcare professionals regarding the safety of Monofer® (see, Van Bael & Bellis Life Sciences News & Insights, 20 June 2022). This would have hindered the uptake of Monofer® in the European Economic Area. The Commission focused on 9 Member States in which it considered Vifor to have a dominant position in the national market for intravenous iron treatment. According to the Commission, the use of the disparaging statements amounted to an abuse of that dominant position in breach of Article 102, Treaty on the Functioning of the European Union (TFEU).

To address the Commission’s concerns, Vifor has now offered three series of commitments (see, attached Proposed Commitments): 

• First, Vifor will undertake a multi-channel clarifying communication campaign conveying the messages that Ferinject® has no superior safety profile compared to Monofer® and that the available evidence does not allow to call into question the safety profile of Monofer®. The messages will also clarify that Monofer® is not based on dextran and does not present an increased risk of hypersensitivity reaction compared to Ferinject®. The messages will be spread by e-mail, by conventional mail and in in-person meetings. They will also feature on Vifor’s website and in leading medical journals. Third parties, including Pharmacosmos, will be permitted to use such types of communication as well.
• Second, during the next 10 years Vifor promises only to communicate regarding the safety of Monofer® on the basis of the Summary of Product Characteristics of Monofer® or of information resulting from clinical head-to-head trials.
• Third, Vifor will implement a series of safeguards to ensure compliance of promotional and medical communications and of internal training materials. Staff will be given training and compliance will be certified. 

Vifor’s commitments will be monitored by a monitoring trustee appointed by Vifor who will have to report to the Commission for a period of 10 years.
 
The commitments are based on Article 9(1) of Regulation 1/2003 which allows the Commission to end infringement proceedings by accepting binding promises on the part of the firm targeted by the Commission’s investigation. For its part, the firm whose conduct is under review does not have to recognise an infringement of competition law. This is why the Proposed Commitments expressly indicate that Vifor contests that it is dominant on any plausible market or that it engaged in conduct that is in breach of Article 102, TFEU.
 
If the market test does not give rise to meaningful protests from third parties, Vifor will be able to avoid the sort of fine which national competition authorities meted out in similar cases (see, Van Bael & Bellis Life Sciences News & Insights, 20 June 2022). At the same time, Vifor still has to contend with a parallel case which the Competition and Markets Authority started in the United Kingdom earlier this year (see, Van Bael & Bellis Life Sciences News & Insights, 1 February 2024