AUTH/3521/6/21 - Ex-employee v AstraZeneca

Alleged promotion of Calquence at a webinar

  • Received
    07 June 2021
  • Case number
  • Applicable Code year
  • Completed
    29 April 2022
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An ex-employee complained about an acalabrutinib (Calquence) Early Access Programme (EAP) Clinical Practice Learns (CPL) Webinar held on 11 May 2021 by AstraZeneca UK Limited.

The complainant alleged that this promotional event for Calquence had been disguised as a non-promotional webinar explaining key learns from the early access programme. Furthermore, the slides were not certified and had only been examined. This type of disguised promotion had a big impact on the way that pharmaceutical companies were perceived by health professionals.

The detailed response from AstraZeneca is given below.

The Panel noted that the webinar needs assessment internal form stated that, prior to Calquence receiving its marketing authorisation on 5 November 2020, AstraZeneca had initiated an early access programme (EAP) on 1 April 2020 which had enrolled approximately 600 patients in over 100 UK hospital centres. The webinar objectives were to provide an invitation only (closed) non-promotional educational forum for a clinical practice learns webinar to EAP enrolled consultant haematologists only. An objective of this meeting was to allow discussion, debate and to share clinical learns for the adverse event management of chronic lymphocytic leukaemia (CLL) and in particular, those haematologists who had prescribed acalabrutinib through the EAP.

The Panel noted that the footer of the first webinar slide stated, ‘This non-promotional webinar has been organised and funded by AstraZeneca UK’. The Panel noted that the second slide described the webinar as non-promotional and referred to AstraZeneca supporting an educational forum for consultant haematologists enrolled on the early access programme. The second bullet point stated that the agenda and content of the meeting had been developed in collaboration with the faculty. In relation to the faculty, the Panel noted AstraZeneca’s submission that having decided to address certain matters by holding a meeting, it then established a steering committee and selected and contracted with three haematologists, all of whom were participating in the EAP to become steering committee members. An additional speaker, recommended by one of the steering committee members, who also participated in the EAP, also presented.

The Panel noted that during the webinar, five patient case studies were shared by the four haematologists including treatment outcomes and key takeaways. The slides highlighted when a treatment approach was potentially inconsistent with the acalabrutinib SPC.

The Panel noted that there was no reference to prescribing information on the slides, however, the second slide contained an adverse event reporting statement.

The Panel considered that all the case studies presented, although discussing the management of side-effects, were overall positive about the use of acalabrutinib. The case studies were detailed and referred to treatment effectiveness in addition to the management of side-effects.

In the Panel’s view, AstraZeneca appeared to have classified the meeting in question as non-promotional in the same way that an investigator meeting for clinical trials might be classified; however, the Panel considered that there were fundamental differences between a meeting for investigators involved in a clinical trial and a meeting for health professionals who had previously been involved in an early access programme for a medicine which now had a marketing authorisation; one such difference being the current relationship between the company and the health professionals involved.

The Panel noted the broad definition of promotion in Clause 1.2 and considered that the proactive presentation of acalabrutinib data which, although mainly discussing the management of adverse events, shared overall positive experiences of acalabrutinib use, could not be anything other than the promotion of acalabrutinib. In the Panel’s view, neither the role of the Steering Committee nor that the audience was restricted to consultant haematologists who had participated in the EAP meant that the webinar was non promotional as implied by AstraZeneca. In the Panel’s view, the webinar slides were promotional material; the webinar slides had been examined and not certified and therefore a breach of the Code was ruled.

The Panel considered that in referring to the meeting as non-promotional in all of the associated materials, including the invitation to the meeting and the meeting slides, the promotion of Calquence had been disguised and the Panel ruled a further breach of the Code.