Consultation of the European Commission on Vifor's commitments concerning the potential abuse of dominant position due to possible anticompetitive disparagement of iron medicine
In response to the Preliminary Assessment stating the potential abuse of its dominant position, Vifor proposed several commitments to rectify the potential competition law infringement. The European Commission had initiated an antitrust investigation in June 2022 against Vifor to determine if it unfairly disparaged its competitor, Pharmacosmos, by spreading misleading information about the safety of its product, Monofer. Vifor Pharma, dominant in several EEA markets, faces accusations of abusing its position, potentially violating competition law. In its proposal, Vifor proposed several commitments including a communication campaign, refraining from certain promotional activities, and implementing compliance measures. If accepted, these commitments would become legally binding, avoiding formal charges but requiring Vifor to adhere to them under penalty of fines. Interested parties have been invited to provide feedback on Vifor's proposals.
Background
In June 2022, the European Commission opened a formal investigation to assess whether Vifor has restricted competition by illegally disparaging its closest competitor in Europe, Pharmacosmos.
Vifor is a global pharmaceutical company located in Switzerland with different subsidiaries in the European Economic Area (EEA). Vifor, and its biotechnology group CSL, manufacture and market pharmaceutical products to treat different conditions. One of which is Monofer high-dose intravenous iron medicine which is a treatment for iron deficiency when oral preparations are ineffective or cannot be utilised. Vifor is dominant in several national markets within the EEA for the provision of intravenous iron medicines, including Austria, Germany, The Netherlands, Sweden, Spain, Finland, Ireland, Portugal and Romania.
On 8 April 2024, the European Commission adopted a Preliminary Assessment summarising the facts and identifying the preliminary competition concerns regarding the alleged violation of Article 102 of the TFEU and Article 54 of the EEA Agreement.
According to the European Commission’s preliminary assessment, the Commission believes that Vifor is accused of disparaging Monofer by spreading misleading information regarding its safety by targeting healthcare professionals, which may have unduly hindered Monofer’s uptake in the EEA. Therefore, the European Commission considered that due to its potential behaviour, Vifor may have abused its dominant position and infringed Article 102 of the Treaty on the Functioning of the European Union (TFEU) and Article 54 of the EEA Agreement.
Vifor’s proposed commitments
As it is permitted in article 9(1) of the Council’s Regulation 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty, when the European Commission intends to adopt a decision requiring that an infringement be brought to an end, the undertaking concerned may offer commitments to meet the concerns expressed to them by the European Commission in its preliminary assessment.
Referring to its rights, Vifor proposed different commitments to address the European Commission’s competition concerns regarding competition law infringement:
- Vifor will launch a comprehensive and multi-channel communication campaign to rectify and undo the potential effects of misleading information. Vifor proposes several actions:
- to disseminate a succinct and factual clarificatory communication to a significant number of healthcare professionals and payers in the states where Vifor is dominant via email, mail and in-person meetings;
- to publish prominently on Vifor’s website(s) the Stakeholder Communication for a period of 36 months;
- to publish the Stakeholder Communication in leading medical journals in each of the states where Vifor is dominant; and
- to allow third parties to use the Stakeholder Communication.
- Vifor also proposed not to engage in external promotional and medical communications (in writing or orally) about Monofer’s safety for 10 years in the EEA.
- Lastly, Vifor undertakes to implement measures and safeguards to ensure compliance with the commitments (e.g. internal mechanism of relevant external promotional and medical communications, international training materials, …).
Vifor’s commitments would be followed and reported by a monitoring trustee appointed by Vifor for 10 years.
Third parties were able to submit their comments on the proposed commitments to the Commission for one month of publication of the summary in the Official Journal of the EU, which took place on April 22, 2024. The Commission will now examine the comments on the proposed commitments and, if it considers them satisfactory, will adopt a decision formalizing them. Vifor will thus be obliged to comply with them for the period indicated, under penalty of a fine.
The text of the proposed commitments is available via this link.
Conclusion
In conclusion, the European Commission has invited all interested parties to submit their views on Vifor’s proposed commitments within one month of their publication. If this test indicates that the commitments satisfy the addressed European Commission’s competition concerns, they could become legally binding by the European Commission. As such, this decision does not recognize an infringement of Competition law by the European Commission, but it obliges the company to respect its commitments. Vifor will have to honour them or could be charged with a fine of up to 10% of the company’s worldwide turnover.
