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Document 52024XC02877

    Communication from the Commission published pursuant to Article 27(4) of Council Regulation (EC) No 1/2003 in Case AT.40577 – VIFOR (IV iron products)

    C/2024/2659

    OJ C, C/2024/2877, 22.4.2024, ELI: http://data.europa.eu/eli/C/2024/2877/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ELI: http://data.europa.eu/eli/C/2024/2877/oj

    European flag

    Official Journal
    of the European Union

    EN

    C series

    C/2024/2877

    22.4.2024

    Communication from the Commission published pursuant to Article 27(4) of Council Regulation (EC) No 1/2003 in Case AT.40577 – VIFOR (IV iron products)

    (C/2024/2877)

    1.   Introduction

    (1)

    		 According to Article 9 of 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 (1), the Commission may decide – in cases where it intends to adopt a decision requiring that an infringement is brought to an end and the parties concerned offer commitments to meet the concerns expressed to them by the Commission in its preliminary assessment – to make those commitments binding on the undertakings. Such a decision may be adopted for a specified period and shall conclude that there are no longer grounds for action by the Commission. According to Article 27(4) of the same Regulation, the Commission shall publish a concise summary of the case and the main content of the commitments. Interested parties may submit their observations within the time limit fixed by the Commission.

    2.   Summary of the case

    (2)

    		 On 8 April 2024 the Commission adopted a preliminary assessment within the meaning of Article 9(1) of Regulation (EC) No 1/2003 concerning an alleged infringement of Article 102 of the Treaty on the Functioning of the European Union (‘TFEU’) by Vifor Pharma Ltd., Vifor Pharma Management Ltd. and Vifor Pharma Deutschland GmbH (together referred to as ‘Vifor’).

    (3)

    		 According to the preliminary assessment, Vifor is dominant in a number of national markets within the European Economic Area (‘EEA’) for the provision of intravenous (‘IV’) iron medicines, including Austria, Germany, The Netherlands, Sweden, Spain, Finland, Ireland, Portugal and Romania (the ‘Relevant Member States’). The Commission has concerns that Vifor may have abused its dominant position according to Article 102 of the TFEU by disseminating to healthcare professionals and payers misleading information about the safety of a competing supplier’s IV iron medicine – namely Monofer sold by Pharmacosmos A/S (‘Pharmacosmos’) – thereby hindering its market entry and/or market uptake. The evidence on the Commission’s file suggests that Vifor’s conduct started in 2010.

    (4)

    		 Ferinject (ferric carboxymaltose), commercialised by Vifor, and Monofer (ferric derisomaltose or iron (III) isomaltoside 1000), commercialised by Pharmacosmos, are both IV iron medicines for the treatment of iron deficiency and iron deficiency anaemia. They are the only IV iron medicines marketed in the EEA that can be administered rapidly and in high doses by fast infusion or injection and are, as such, considered each other’s direct and closest competitors.

    (5)

    		 The Commission has concerns that, when Pharmacosmos launched Monofer in Europe in 2010, Vifor developed a communication campaign with the purpose of leading healthcare professionals and payers into believing that administering Monofer could entail serious health risks and that Monofer had a worse risk profile compared to Ferinject. The Commission’s investigation has shown that, to promote this overarching perception, Vifor disseminated two main messages implying that (i) Monofer bears the serious safety risks historically associated with IV iron dextran compounds, in particular high molecular weight IV iron dextrans, which were withdrawn from the European markets in the 1990s as a result of safety issues; and (ii) Monofer provokes hypersensitivity reactions more frequently than Ferinject.

    (6)

    		 The Commission’s preliminary assessment was that such messages are misleading as they are based on inaccurate and/or incomplete information that is capable of confusing its addressees and of discrediting a competing product and of foreclosing competition without an objective justification. In the Commission’s preliminary view, Vifor’s communication campaign could therefore have qualified as an abuse of a dominant position under Article 102 TFEU.

    3.   The main content of the offered commitments

    (7)

    		 Whilst not agreeing with the Commission’s preliminary assessment, Vifor nevertheless offered commitments pursuant to Article 9 of Regulation (EC) No 1/2003, to meet the Commission’s preliminary competition concerns. The proposed commitments consist of two main obligations, i.e. the so-called ‘Required Conduct’ and the ‘Prohibited Conduct’ which can be summarised as follows:

    (a)

    The Required Conduct is a comprehensive, multi-channel communication campaign, the main purpose of which is to rectify and undo the effects of the potentially misleading messages previously disseminated by Vifor regarding the safety of Monofer. As part of the Required Conduct, Vifor commits to (i) disseminate a succinct and factual clarificatory communication (the ‘Stakeholder Communication’) to a significant number of healthcare professionals and payers in the Relevant Member States via email, mail and in-person meetings; (ii) publish prominently on Vifor’s website(s) the Stakeholder Communication for a period of 36 months; (iii) publish the Stakeholder Communication in leading medical journals in each of the Relevant Member States; and (iv) allow third parties to use the Stakeholder Communication.

    (b)

    The Prohibited Conduct prevents Vifor, for a period of 10 years across the entire EEA, from engaging in external promotional and medical communications, in writing and orally, about Monofer’s safety profile containing information that is neither based in Monofer’s Summary of Product Characteristics (‘SmPC’) nor derived from randomised, controlled clinical head-to-head trials. In addition, Vifor commits to implement a number of measures and safeguards to ensure compliance with the Prohibited Conduct, including setting up (i) 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; (ii) internal mechanisms to address any isolated unauthorised miscommunications; (iii) a dialogue process between Vifor and Pharmacosmos, as well as the trustee in charge of monitoring Vifor’s compliance with the commitments, to enable Pharmacosmos to raise and discuss any potential breach of the commitments and (iv) annual internal compliance trainings and annual certification of compliance with the Prohibited Conduct.

    (8)

    		 These commitments should address the Commission’s concerns identified in the preliminary assessment. In particular, the Required Conduct is designed to rectify and undo the effects of the previous messages disseminated by Vifor regarding Monofer’s safety, whereas the Prohibited Conducted is designed to prevent similar messages from being disseminated in the future.

    (9)

    		 The commitments are published in full in English on the website of the Directorate-General for Competition at:

    https://ec.europa.eu/competition-policy/index_en

    4.   Invitation to make comments

    (10)

    		 Subject to market testing, the Commission intends to adopt a decision under Article 9(1) of Regulation (EC) No 1/2003 declaring binding the commitments summarised above and published on the internet, on the website of the Directorate-General for Competition.

    (11)

    		 In accordance with Article 27(4) of Regulation (EC) No 1/2003, the Commission invites interested third parties to submit their observations on the proposed commitments. These observations must reach the Commission not later than one month following the date of this publication. Interested third parties are also asked to submit a non-confidential version of their comments, in which any information they claim to be business secrets and otherconfidential information should be deleted and replaced as required by a non-confidential summary or by the words ‘business secrets’ or ‘confidential’.

    (12)

    		 Answers and comments should preferably be reasoned and should set out the relevant facts. If you identify a problem with any part of the proposed commitments, the Commission would also invite you to suggest a possible solution.

    (13)

    		 Observations can be sent to the Commission under reference number AT.40577 – VIFOR (IV iron products) either by e-mail (COMP-GREFFE-ANTITRUST@ec.europa.eu) or by post, to the following address:

    European Commission

    Directorate-General for Competition

    Antitrust Registry

    1049 Bruxelles/Brussel

    BELGIQUE/BELGIË

    (1)   OJ L 1, 4.1.2003, p. 1. With effect from 1 December 2009, Articles 81 and 82 of the EC Treaty have become Articles 101 and, respectively, 102 of the TFEU. The two sets of provisions are in substance identical. For the purposes of this notice, references to Articles 101 and 102 of the TFEU should be understood as references to Articles 81 and 82 of the EC Treaty when applicable.

    ELI: http://data.europa.eu/eli/C/2024/2877/oj

    ISSN 1977-091X (electronic edition)

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