Final Report of the Hearing Officer – Case AT.40577 —VIFOR (IV iron products)
Date: 2024-07-05
Institutions: Directorate-General for Competition, European Commission
Subjects: EU competition policy, European Economic Area, control of restrictive practices, dominant position, health risk, iron, medicinal product, product safety








C_202406859EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/6859


15.11.2024






Final Report of the Hearing Officer (1)

Case AT.40577 —VIFOR (IV iron products)
(C/2024/6859)


1.   

The present report relates to a draft commitment decision pursuant to Article 9(1) of Regulation No 1/2003 (2) (the ‘Draft Decision’) addressed to Vifor Pharma Participations Ltd. (as the economic successor of Vifor Pharma Ltd.), Vifor Pharma Management Ltd. and Vifor Pharma Deutschland GmbH (together referred to as ‘Vifor’), in relation to the potential disparagement of the intravenous (‘IV’) iron treatment competing most closely with Vifor’s flagship product in Europe.



2.   

On 20 June 2022, the Commission initiated proceedings within the meaning of Article 11(6) of Regulation No 1/2003 and Article 2(1) of Regulation No 773/2004 (3).



3.   

On 8 April 2024, the Commission adopted a preliminary assessment within the meaning of Article 9(1) of Regulation No 1/2003, in which it set out its preliminary competition concerns.



4.   

Specifically, the Commission came to the preliminary conclusion that Vifor may have abused its dominant position in a number of national markets within the European Economic Area (‘EEA’) (4) for the provision of IV iron medicines, by disseminating to healthcare professionals information that may have been objectively misleading about the safety of a competing IV iron medicine – namely Monofer, sold by Pharmacosmos A/S – thereby hindering its market entry and/or market uptake. According to the preliminary assessment, Vifor’s conduct raised concerns as to its compatibility with Article 102 TFEU. As for the duration, Vifor’s conduct started in 2010 and was ongoing at least until 2022.



5.   

On 16 April 2024, Vifor submitted commitments (the ‘Initial Commitments’) to the Commission in response to the preliminary assessment.



6.   

On 22 April 2024, the Commission published a notice in accordance with Article 27(4) of Regulation No 1/2003, inviting comments from interested third parties on the Initial Commitments. On 8 and 27 May 2024, the Commission informed Vifor of the observations received following the publication of the notice.



7.   

On 13 June 2024, Vifor submitted an amended proposal for commitments (the ‘Final Commitments’).



8.   

The Draft Decision makes the Final Commitments binding upon Vifor and concludes that there are no longer grounds for action by the Commission in this case as regards the concerns set out in the preliminary assessment.



9.   

I have not received any request or complaint concerning the commitment procedure pursuant to Article 15(1) of Decision 2011/695/EU. In view of the above, I consider that the effective exercise of the procedural rights has been respected in this case.




Brussels, 5 July 2024.

Eric GIPPINI FOURNIER
               





(1)  
            1 Pursuant to Articles 16 and 17 of Decision 2011/695/EU of the President of the European Commission of 13 October 2011 on the function and terms of reference of the hearing officer in certain competition proceedings (OJ L 275, 20.10.2011, p. 29) (‘Decision 2011/695/EU’).

(2)  Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (OJ L 1, 4.1.2003, p. 1) (‘Regulation No 1/2003’).

(3)  Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles 81 and 82 of the EC Treaty (OJ L 123, 27.4.2004, p. 18) (‘Regulation No 773/2004’).

(4)  Namely Austria, Germany, The Netherlands, Sweden, Spain, Finland, Ireland, Portugal and Romania.


ELI: http://data.europa.eu/eli/C/2024/6859/oj
ISSN 1977-091X (electronic edition)