AUTH/2619/7/13 - Novo Nordisk v Sanofi

Breach of undertaking

  • Received
    22 July 2013
  • Case number
  • Applicable Code year
  • Completed
    10 September 2013
  • Breach Clause(s)
    2, 9.1 and 25
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    November 2013

Case Summary

​Novo Nordisk alleged that a Lyxumia (lixisenatide) press release on Sanofi's website; breached the undertaking given by Sanofi in Case AUTH/2604/5/13.

As the complaint concerned an alleged breach of undertaking; it was taken up by the Director as it was the Authority's responsibility to ensure compliance with undertakings.

The detailed response from Sanofi is given below.

The Panel noted that an undertaking was an important document. Companies had to give an undertaking that the material in question and any similar material; if not already discontinued or no longer in use; would cease forthwith and give an assurance that all possible steps would be taken to avoid similar breaches of the Code in the future. It was very important for the reputation of the industry that companies complied with undertakings.

The Panel noted that Case AUTH/2604/5/13 concerned an advertisement which featured the claims 'Lyxumia leads to even greater costs savings of' and 'Turn to the GLP-1 that minimises costs'. Novo Nordisk had alleged that the claims did not take into account the differences in efficacy and safety between Lyxumia and similar treatments. Sanofi had acknowledged that the claims might imply wider savings beyond the acquisition cost and had committed to amend such claims. However; a press release issued after the completion of intercompany dialogue featured the claim 'Lyxumia is a new; cost-effective option….'. The Panel considered that the term 'cost-effective' clearly implied savings beyond the acquisition cost alone and in that regard inter-company dialogue about the advertisement had been unsuccessful. The Panel had considered that without the benefit of more information; it was not clear that the claims in the advertisement were only based on acquisition costs and not a cost-effectiveness analysis or similar. The Panel considered that the claims were misleading and breaches of the Code were ruled.

In Case AUTH/2604/5/13 when considering the inter-company dialogue; the Panel referred to the press release now at issue in Case AUTH/2619/7/13 noting that it featured the claim 'Lyxumia is a new; cost-effective option'. In Case AUTH/2604/5/13; the Panel disagreed with Sanofi's submission that the press release made no explicit or implicit claim that Lyxumia would achieve 'cost savings' or 'cost minimisation' beyond the cost of the medicine itself. The Panel considered that the term 'cost-effective' clearly implied savings beyond the acquisition cost alone.

The Panel noted Sanofi's submission in Case AUTH/2604/5/13 that it had examined the press release before it was issued to ensure that; as per the company's inter-company commitment; claims; implicit or explicit; for wider savings than the cost of Lyxumia alone were not included.

Turning to the present case; Case AUTH/2619/7/13; the Panel noted that the heading of the press release stated that Lyxumia '… could save the NHS millions offering value and choice'. The first paragraph stated 'costing over 25% less than similar treatments…'. The claim 'Lyxumia is a new; cost-effective option' and 'The price is one that represents real value to both the NHS and Sanofi' appeared in the penultimate and final paragraph respectively. The Panel noted that Sanofi had removed the press release from the press section of its website. The Panel noted Sanofi's detailed account of its review and withdrawal of material which it undertook and completed following resolution of matters during inter-company dialogue and prior to notification of the ruling and provision of the undertaking in Case AUTH/2604/5/13. It appeared that when Sanofi provided its undertaking in Case AUTH/2604/5/13 it did not revisit the decisions it had made when it withdrew material following inter-company dialogue. The Panel was concerned that the press release in question had remained in the press section of the Sanofi website.

The Panel noted that there were differences between the claims at issue in the press release and those previously at issue in the advertisement. However; the Panel considered that neither of the claims at issue cited by Novo Nordisk 'Lyxumia is a new cost effective option' and 'The price is one that represents real value to both the NHS and Sanofi' in the press release made it sufficiently clear that it was based on the acquisition cost of the medicine alone. The term cost-effectiveness implied that indirect costs and efficacy had been taken into account and that was not so. The Panel considered that as the press release did not make it sufficiently clear that the claims in question related solely to the acquisition cost of Lyxumia; they were sufficiently similar to those at issue in Case AUTH/2604/5/13 to be covered by the undertaking in that case. The Panel therefore considered that each claim breached the undertaking previously given and a breach of the Code was ruled. High standards had not been maintained;a further breach of the Code was ruled.

The Panel was concerned that the documents provided to the Authority indicated that only promotional material was examined during the withdrawal of material following successful intercompany dialogue and that Sanofi had not reviewed these initial withdrawal decisions when it provided its undertaking to the Authority. In particular; thePanel had noted that the press release in question was highlighted in the previous case wherein the similarity of the claims in the press release to those in the advertisement at issue was noted. In these circumstances the Panel was thus very concerned that Sanofi considered that the press release was beyond the scope of the undertaking. The Panel noted that the company's submission in this regard was inconsistent with its submission in Case AUTH/2604/5/13 wherein it stated that it had examined the press release prior to issue to ensure that it adhered to the company's commitment made in inter-company dialogue. The Panel noted its comments above about the importance of compliance with undertakings. The Panel considered that the conduct of Sanofi in this regard had brought discredit upon; and reduced confidence in; the pharmaceutical industry. A breach of Clause 2 was ruled.