AUTH/3399/10/20 - Voluntary admission by Novartis

Conduct of a representative

  • Received
    07 October 2020
  • Case number
  • Applicable Code year
  • Completed
    05 March 2021
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

Novartis Pharmaceuticals UK Limited voluntarily admitted that one of its representatives had failed to maintain high standards with regard to discussions about Piqray (alpelisib) with two different clinicians.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Novartis.

Novartis explained that in June 2020, a representative held conversations with two separate customers regarding the wording of the Committee for Medicinal Products for Human Use’s (CHMP’s) published recommendation for Piqray which, at the time, had not been granted a licence from the European Medicines Agency (EMA). The intention was to gather insights as to the clinicians’ interpretation of the CHMP’s recommended wording.

An internal investigation identified that a marketing employee was also aware of the plans for the representative to hold these customer discussions.

The detailed response from Novartis is given below.

The Panel noted that the CHMP had adopted a positive opinion on 28 May 2020 and on 27 July 2020 the European Commission approved Piqray in combination with fulvestrant for use in certain patients with breast cancer.

The Panel noted Novartis’ submission that a marketing employee, after discussion with his/her line-manager, had asked the representative in question to arrange meetings with certain breast cancer clinicians for the purpose of introducing the employee in marketing to these clinicians and to gather insights on the CHMP recommendation for Piqray. The Panel noted Novartis’ submission that both the marketing employee and the representative had planned to attend these meetings.

The Panel noted Novartis’ submission that the marketing employee, following a conversation with a medical adviser who informed him/her that this activity should not be undertaken due to the commercial nature of the marketing employee and representative’s roles and that they must not discuss alpelisib with clinicians ahead of any licence being granted, sent two text messages to the representative to ‘hold off’ regarding the planned meetings. The Panel was concerned that despite this instruction from the marketing employee, the representative continued to have discussions with the marketing employee’s line manager about the feasibility of repurposing the meetings. Four meetings were scheduled by the representative and the Panel noted that two of these meetings were held by the representative alone in June during the course of which two clinicians were asked for their thoughts and insights as to the clinical implications of the CHMP recommendation for alpelisib.

In the Panel’s view, the proactive discussion by any company employee about its unlicensed medicine would likely be seen as promotion although there were certain exemptions set out in the Code. An employee’s role was an important consideration in determining whether an activity would be likely to be viewed as promotional. Perception was also important. Companies should be extremely careful to ensure that promotional activity was very clearly separated from non-promotional activity and that this distinction was clear to health professionals.

The Panel noted that the representative had proactively approached the two health professionals and in that regard the Panel considered that alpelisib had been promoted prior to the grant of its marketing authorisation and a breach of the Code was ruled.

The Panel noted that the first text message from the marketing employee to the representative stated ‘…we might not be able to collect feedback now..’ and the second text message, stated ‘We’ve been told by medical not to ask from the commercial side do [sic] we might need to hold off until we get insights on their side/we receive the EMA license….’. The Panel was very concerned that the representative, with the agreement of the marketing employee’s line manager, went ahead with the meetings and insight gathering despite the marketing employee’s messages but queried why clearer instructions were not given to the representative and in particular noted the use of the word ‘might’. Furthermore, the Panel was extremely concerned about the lack of Code understanding demonstrated by senior marketing individuals. The Panel considered that high standards had not been maintained and a breach of the Code was ruled as acknowledged by Novartis.

The supplementary information to Clause 2 stated that ruling of a breach of Clause 2 was a sign of particular censure and activities that were likely to be in breach of Clause 2 included promotion prior to the grant of a marketing authorisation. The Panel also noted its comments above particularly in relation to its ruling of a breach of Clause 9.1 and considered that Novartis’ activity in this regard brought discredit upon, and reduced confidence in, the industry. A breach of Clause 2 was ruled.