AUTH/3172/3/19 - Anonymous v Sandoz

Conduct of a representative

  • Received
    18 March 2019
  • Case number
  • Applicable Code year
  • Completed
    18 September 2019
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2020 Review

Case Summary

An anonymous health professional complained about the questions asked of the speakers by a Sandoz medical science liaison (MSL) at a Sandoz-sponsored meeting.  Sandoz marketed the biosimilars Zessly (infliximab) and Hyrimoz (adalimumab).

The complainant explained that in February 2019, he/she attended an educational event run by Sandoz in Glasgow and connected to a venue in London via a video link.  The event was advertised as non-promotional and health professionals spoke about diseases, treatment and therapeutic drug monitoring.  The meeting ended with a multidisciplinary panel discussion from some of the remaining speakers.  The purpose of the discussion was for attendees to ask the speakers more in depth questions.  There were no questions from the audience so the Sandoz representatives asked questions.  The complainant stated that he/ she was concerned about the motive behind one of the named representative’s questioning.  The representative asked questions about switching and biosimilars such as how to do a successful switch, and then went on to mention therapeutic drug monitoring and how important it was.  Upon discussions with his/her colleagues, the complainant had learned that Sandoz offered free therapeutic drug monitoring with some of its biosimilars.  In that regard the complainant alleged that the representative had tried to influence the attendees into doing biosimilar switching and in turn switching to a Sandoz biosimilar due to the therapeutic drug monitoring offerings.

The detailed response from Sandoz is given below. 

The Panel noted Sandoz’s submission that it made funding available for therapeutic drug monitoring (TDM) services for its infliximab and adalimumab products on a reactive basis only.  Its availability was not publicised and there was no proactive offer of the service.  Sandoz submitted that while TDM was included as a topic on the agenda there was no mention at any time of Sandoz’s involvement in the provision or funding of TDM services.

The Panel noted that the stated purpose of the meeting titled ‘Biologics and co-morbidities in Autoimmune Disease: What can we learn from each other?’ was to facilitate discussion around the approaches to patient management within the different therapy areas, to gain insight into co-morbidities and other challenges faced by health professionals who managed patients with autoimmune diseases and prescribed biologic therapies. 

The Panel noted that the therapeutic drug monitoring presentation was delivered by an independent scientist and discussed drug levels in relation to infliximab and adalimumab, immunogenicity and measurement platforms.  The presentation did not refer to funding or Sandoz’s position on reactive funding.  The Panel noted that other presentations during the day also referred to TDM, for example, the specialist gastro pharmacist’s presentation on his/her role in biologics referred to TDM studies with infliximab and adalimumab.  None of the presentations referred to Sandoz’s position on reactive funding for TDM services for its biosimilars infliximab and adalimumab.  The Panel noted that a nurse requested to change his/her presentation to ‘How to implement biosimilars’ which Sandoz agreed to; this presentation referred to infliximab and adalimumab but made no specific reference to Sandoz’s biosimilars, Zessly and Hyrimoz.

The Panel noted that at the question and answer session at the end of the meeting, according to Sandoz, neither the panel nor the audience asked questions and thus the MSLs chairing the meeting asked a number of questions.  The Panel noted that the MSL in question asked 4 questions and only the fourth question referred to therapeutic drug monitoring.  The MSL’s fourth question referred to a clinician who was ‘… really invested in things like TDM and levels and TNF …’ and referred to the pressure across all specialities to use anti-TNF first line due to cost and queried whether, due to the potential for an immune shift, if it was always the best biologic to choose, finishing by asking the panel what practice they used to select a biologic and if they agreed with using anti-TNF first line due to its cost.

The Panel noted that the question at issue focussed on anti-TNF biologics and that there were many biosimilars within that class.  The Panel did not consider on the evidence before it that the MSL in question had tried to influence attendees to switch to a Sandoz biosimilar due to its therapeutic drug monitoring offerings as alleged.  In that regard, the therapeutic drug monitoring had not been referred to by the MSL as an inducement to prescribe and the Panel ruled no breach of the Code.

The Panel considered that the complaint solely concerned the questions asked by the MSL.  Given its ruling and comments above the Panel considered that the fourth question which referred to therapeutic drug monitoring did not constitute a disguised promotional activity and no breach was ruled.  Similarly given its comments and rulings above the Panel did not consider that either the company or the MSL had failed to maintain high standards in this regard and no breach of the Code was ruled including Clause 2.