The European Commission has made commitments offered by Vifor legally binding under EU antitrust rules. The commitments address the Commission's competition concerns relating to Vifor's potential disparagement of Monofer, the closest - and potentially only – competitor of Vifor's flagship intravenous iron medicine in Europe, Ferinject.
The Commission's preliminary concerns
The Commission preliminarily found that Vifor may be dominant in several national markets for the provision of intravenous iron medicines, namely in Austria, Finland, Germany, Ireland, Portugal, Romania, Spain, Sweden and the Netherlands.
The Commission is concerned that for many years, Vifor may have restricted competition in the above markets for intravenous iron treatment by disseminating potentially misleading information about the safety of Monofer, an iron deficiency treatment marketed by Vifor's closest competitor in Europe, Pharmacosmos. Vifor's messages, primarily targeting healthcare professionals, may have unduly hindered Monofer's uptake in the European Economic Area ('EEA'). They appear to be aimed at shielding Vifor's own blockbuster high-dose intravenous iron treatment medicine, Ferinject, from competition.
The Commission's preliminary view is that Vifor's conduct may have restricted competition in the market for intravenous iron treatment and potentially amount to an abuse of dominant position, in breach of Article 102 of the Treaty on the Functioning of the European Union ('TFEU').
The commitments
To address the Commission's preliminary concerns, Vifor offered certain commitments. Between 22 April and 22 May 2024, the Commission market tested those commitments and consulted all interested third parties to verify whether the commitments would remove its competition concerns. In light of the outcome of this market test, Vifor adjusted the initially proposed commitments and offered the following:
- To launch 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. In particular, Vifor commits to: (i) disseminate via email, mail and in-person meetings a succinct and factual clarificatory communication to a significant number of healthcare professionals in the nine Member States where the Commission preliminarily found Vifor may be dominant; (ii) to publish such communication prominently on its website; (iii) to publish such communication in leading medical journals in each of the Member States concerned; and (iv) to allow third parties, including Pharmacosmos, to use such communication when contacting healthcare professionals.
- Not to engage in external promotional and medical communications, in writing or orally, about Monofer's safety profile using information that is neither based on Monofer's label nor derived from clinical trials specifically designed to compare Ferinject and Monofer across the entire EEA.
- To implement a number of measures and safeguards to ensure compliance, including internal mechanisms to ensure that all relevant external promotional and medical communications as well as internal training materials are in line with the commitments prior to their use, as well as annual internal trainings of staff and a system of certification of compliance.
The Commission concluded that Vifor's final commitments would address its competition concerns over Vifor's potential disparagement of Monofer. It therefore decided to make them legally binding on Vifor.
The implementation of the commitments offered by Vifor will be monitored by a monitoring trustee appointed by Vifor and will last for a period of 10 years.
Background
Iron helps producing healthy red blood cells that move oxygen across the body. Iron deficiency is quite common, especially among women and persons suffering from chronic inflammatory diseases, cancers and blood losses (for example, after an accident or during surgery). In severe cases, iron deficiency can cause serious complications, such as heart failures, lung problems, pregnancy complications, as well as poor cognitive and motor development in children. It is a major cause of morbidity and mortality worldwide.
Vifor Pharma's Ferinject and Pharmacosmos' Monofer high-dose intravenous iron medicines are indicated for the treatment of iron deficiency when, for instance, oral preparations are ineffective or cannot be used.
Vifor is a global pharmaceutical company part of the biotechnology group CSL that develops, manufactures and markets worldwide pharmaceutical products to treat iron deficiency, nephrology and cardio-renal therapies. Pharmacosmos, a Danish family-owned specialist pharmaceutical company, focuses on the treatment of iron deficiency conditions.
The Commission opened a formal antitrust investigation into Vifor's behaviour in June 2022, following a complaint filed with the Commission by Pharmacosmos. In February 2024, Vifor and Pharmacosmos reached a confidential commercial settlement agreement on this matter, which was taken into consideration by the Commission in its decision to explore the commitments procedure in this case. In April 2024, the Commission adopted a Preliminary Assessment summarising the main facts of the case and identifying the preliminary competition concerns.
Article 102 of the TFEU, which can also be applied by the national competition authorities, prohibits the abuse of a dominant position that may affect trade within the EU and prevent or restrict competition. The implementation of this provision is defined in Regulation No 1/2003.
Article 9(1) of Regulation 1/2003 enables companies investigated by the Commission to offer commitments in order to meet the Commission's concerns and empowers the Commission to adopt a decision to make such commitments binding on the companies. Article 27(4) of Regulation 1/2003 requires that before adopting such decision the Commission shall provide interested third parties with an opportunity to comment on the offered commitments.
If the market test indicates that the commitments are a satisfactory way of addressing the Commission's competition concerns, the Commission may adopt a decision making the commitments legally binding on the company concerned. Such a decision would not conclude that there is an infringement of EU antitrust rules but would legally bind the company to comply with the commitments it has offered.
If the company concerned does not honour such commitments, the Commission may impose a fine of up to 10% of its total annual turnover, without having to find an infringement of EU antitrust rules, or a periodic penalty payment of 5% per day of its daily turnover for every day of non-compliance.
This is the Commission's second investigation into potential abuses relating to exclusionary disparagement of competing products in the pharmaceutical industry. In October 2022, the Commission sent a Statement of Objections to Teva over misuse of the patent system and disparagement of a competing multiple sclerosis medicine with a view to hinder its market entry and uptake.
