Disparagement Alleged in Iron Medicine Market: EU Commission Seeks Public Feedback on Company’s Proposed Commitments

The European Commission on April 19 opened a public consultation on commitments proposed by Vifor Pharma in response to a formal investigation into allegations of anticompetitive practices related to disparaging claims about an intravenous iron medicine supplied by a competitor. This investigation focuses on concerns that Vifor may have restricted competition by disseminating potentially misleading information about the safety of an iron deficiency treatment from Pharmacosmos, Vifor's main competitor in this sector.

Initiated on June 20, 2022, the investigation focuses on Vifor's alleged dominant position in the intravenous iron medicine market across several EU countries, including Austria, Finland, Germany, Ireland, Portugal, Romania, Spain, Sweden, and the Netherlands.[1] According to the Commission, preliminary findings suggest that Vifor's actions, particularly targeted at healthcare professionals, could have unjustly hindered the uptake of Pharmacosmos’ treatment Monofer in the European Economic Area, potentially affecting market competition.

Background

This case is governed by Article 102 of the Treaty on the Functioning of the European Union (TFEU), which prohibits the abuse of a dominant market position, including by seeking to exclude competitors from the market. It is processed under Regulation 1/2003, which allows companies to offer commitments to rectify any competitive concerns, potentially resolving disputes without a formal finding of an infringement.

Proposed Commitments

In response to these concerns, Vifor has offered several commitments to rectify the alleged misinformation, including the following:

• Corrective communication campaign: Vifor to implement a comprehensive campaign across multiple channels to correct previous statements made about Monofer, involving direct communications to a substantial number of healthcare professionals in the impacted Member States via email, direct mail, and personal meetings. Publications on Vifor’s website and in leading medical journals are also planned.
• Promotional restrictions: Vifor proposes to abstain for a decade from any promotional or medical communications that negatively affect Monofer’s safety profile without solid evidence based on the product's Summary of Product Characteristics or derived from randomized, controlled clinical trials.
• Oversight and compliance measures: Vifor proposes to establish rigorous internal controls to ensure compliance with the commitments, including the verification of promotional and training materials before use, annual training for staff, and a system to certify compliance.

If the commitments are adopted, a monitoring trustee will oversee these measures and report to the Commission for 10 years.

Invitation to Comment

The Commission invites all stakeholders to comment on whether Vifor's proposed measures would adequately address the competition concerns. Feedback can be provided by May 20 (i.e., within one month from the date of publication of the commitments’ summary in the EU's Official Journal).

Significance for the Pharmaceutical Industry

This investigation is the second the Commission has opened more recently in the pharmaceutical sector regarding the apparent disparagement of competitors’ products. The Commission addressed similar issues in October 2022, when it sent a Statement of Objections to another pharmaceutical company alleging disparagement of a competing multiple sclerosis medicine and misuse of its patent system.[2] These investigations indicate a heightened regulatory focus on disparagement and the misuse of regulatory procedures in the pharmaceutical sector as a means of hindering market entry and the uptake of competing products.[3]

These cases serve as a reminder of the critical need for companies to implement robust compliance measures and of the importance of companies maintaining transparent, fair marketing practices, including by adhering to the product's Summary of Product Characteristics and results from controlled clinical trials in its external dealings.

The opportunity for stakeholders to comment on proposed commitments during the market test phase is an important component of the regulatory process. While this mechanism helps in shaping the final decisions of the Commission, it also enables market participants to have a say.