The European Commission invites comments on commitments offered by Vifor to address competition concerns over the alleged disparagement of its closest - and potentially only – competing treatment in Europe for intravenous iron treatment, Pharmacosmos' Monofer.
The Commission's investigation
Following the opening of a formal investigation in June 2022, the Commission preliminarily found that Vifor is 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 Vifor may have restricted competition in the market for intravenous iron treatment by illegally disparaging Monofer, an iron deficiency treatment by its closest competitor in Europe, Pharmacosmos.
The Commission has indications that for many years, Vifor may have disseminated potentially misleading information regarding Monofer's safety, primarily targeting healthcare professionals, which may have unduly hindered Monofer's uptake in the European Economic Area ('EEA'). Vifor's conduct appears to be aimed at hindering competition against its own blockbuster high-dose intravenous iron treatment medicine, Ferinject.
The Commission's preliminary view is that Vifor's conduct may restrict competition in the market for intravenous iron treatment and amount to an abuse of dominant position, in breach of Article 102 of the Treaty on the Functioning of the European Union ('TFEU').
The proposed commitments
To address the Commission's competition concerns, Vifor has offered the following commitments:
- 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 it is 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.
- For a period of 10 years and across the entire European Economic Area, 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 Summary of Product Characteristics nor derived from randomised, controlled clinical head-to-head trials.
- 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 commitments offered by Vifor would be monitored by a monitoring trustee appointed by Vifor, who would report to the Commission for a period of 10 years.
The Commission invites all interested parties to submit their views on Vifor's proposed commitments within one month from the publication of a summary of the proposed commitments in the EU's Official Journal. The full text of the commitments will be available on the Commission's competition website.
Background
Iron helps producing healthy red blood cells that move oxygen across the body. Iron deficiency is quite common, especially among women and persons who have too little iron in their diet, but also amongst persons that suffered from a blood loss after, for example, an accident. 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.
The investigation follows a complaint filed with the Commission by Pharmacosmos.
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.
On 20 June 2022, the Commission opened a formal antitrust investigation to assess whether Vifor Pharma may have restricted competition by illegally disparaging its closest competitor in Europe on the market for intravenous iron treatment, Pharmacosmos.
On 8 April 2024, the Commission adopted a Preliminary Assessment summarising the main facts of the case and identifying the preliminary competition concerns.
Article 102 TFEU, which can also be applied by 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 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 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 ("the market test").
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 them legally binding on Vifor. Such a decision would not conclude that there is an infringement of EU antitrust rules but would legally bind Vifor to respect the commitments it has offered.
If Vifor does not honour such commitments, the Commission could impose a fine of up to 10% of the company's worldwide turnover, without having to find an infringement of the EU antitrust rules.
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.
