On June 20, 2022, the Commission opened a formal investigation into Vifor Pharma for the possible anticompetitive disparagement of a rival’s iron medicine.[1] Although the Commission launched a disparagement investigation last year,[2] this is the first time that it opens an investigation based exclusively on a disparagement theory of harm, and in relation to two originator products at that.[3]
Background
The Commission’s investigation follows a complaint lodged by Pharmacosmos, whose iron deficiency treatment (Monofer) competes with Vifor Pharma’s Ferinject.[4] The Commission is investigating whether Vifor Pharma conducted a misleading communication campaign targeting healthcare professionals, and alleged safety issues with respect to Monofer, which might have hindered competition in the EEA.
Precedents
So far, there are no precedents sanctioning disparagement practices at the EU level.[5] The Commission considers that disseminating misleading information about competitors can amount to an abuse of dominant position infringing Article 102 TFEU. Based on national precedents to date, it appears that the legal framework for disparagement would involve sanctioning any statements about rival products that: (i) are based on unverified assertions; (ii) are likely to influence the structure of the market; and (iii) appear credible because of the company’s reputation and the trust placed in it by the market players.[6]
Implications
Either way, competition authorities seem to be increasingly keen to pursue disparagement cases. For example, the Commission initiated a similar investigation into Teva in March 2021,[7] and the French Competition Authority has sanctioned several companies on anticompetitive disparagement grounds since 2013.[8] Thus, companies (not only those in the pharmaceutical business) should exercise caution when commenting on rivals’ products, including in their marketing materials and if they do so, their statements had better be backed by, and extensively cite, solid scientific evidence.
Considering the precedents discussed above (which concerned the alleged disparagement of generic products), as well as DG COMP’s enforcement priorities for 2021,[9] a particular degree of caution was already advisable for companies facing competition from generic drugs. That said, as the Commission’s investigation into Vifor concerns two originator medicines, the present case will likely clarify whether and how the Commission’s framework of assessment will differ in situations where generic competition is not at stake.
[1] Commission Press Release IP/22/3882, “Antitrust: Commission opens investigation into possible anticompetitive disparagement by Vifor Pharma of iron medicine,” June 20, 2022.
[2] Commission Press Release IP/21/1022, “Antitrust: Commission opens formal investigation into possible anticompetitive conduct of Teva in relation to a blockbuster multiple sclerosis medicine,” March 4, 2021.
[3] Until recently, disparagement cases had been primarily tackled by national competition authorities. See our March 2021 EU Competition Law Newsletter, citing the fines imposed by the French Competition Authority on Sanofi-Aventis in 2013 (FCA Decision n°13-D-11 of May 14, 2013) and by the Italian Competition Authority on F. Hoffman-La Roche in 2014 (ICA Decision in the case 1760 of February 27, 2014), both for implementing a disparaging campaign against competitors.
[4] In parallel to this investigation, Vifor is being acquired by CSL Limited for approximately $11 billion.
[5] In one case, the Commission sanctioned “misleading misrepresentations” about a competitor. The context of that case was, however, different because the misleading statements were provided in a regulatory application (i.e., the case concerned an abuse of regulatory proceedings for patent approval related to a generic medicine). See AstraZeneca (Case COMP/A.37.507/F3), Commission decision of June 15, 2005. Additionally, in a preliminary ruling with respect to a cartel case, the Court of Justice held that the coordinated dissemination of misleading safety claims about a medicine’s off-label use, in a context of scientific uncertainty, is a by-object restriction of competition. See F. Hoffmann-La Roche and Others (Case C-179/16) EU:C:2018:25, as reported in our March 2021 EU Competition Law Newsletter.
[6] FCA Decision n°13-D-11, supra, paras. 367–369.
[7] As reported in our March 2021 EU Competition Law Newsletter.
[8] For instance, it fined Sanofi-Aventis in 2013, Jassen-Cilag in 2017, and Roche and Novartis in 2020 for disparaging competitors. See more detail in our October 2021 French Competition Law Newsletter.
[9] As noted in DG COMP’s 2021 Management Plan, “the Commission will continue investigating, for instance, the potential market foreclosure of generic or biosimilar versions of medicines.”