AUTH/3682/8/22 - Complainant v Accord

Conduct of a representative in relation to off-licence promotion of Methofill

  • Received
    05 August 2022
  • Case number
  • Applicable Code year
  • Completed
    14 July 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case concerned the conduct of a representative in relation to the off-licence promotion of Methofill (methotrexate).

The Panel ruled a breach of the following Clauses of the 2021 Code because in failing to inform a children’s gastroenterology nurse that use of Methofill in the treatment of Crohn’s Disease in children was outside of licence on receipt of the email request for materials and training devices, which the representative provided to the nurse later that day, the representative had promoted Methofill outside the terms of its marketing authorisation:

Breach of Clause 11.2

Promoting a medicine outside the terms of its marketing authorisation

Breach of Clause 17.2

Representative failing to maintain a high standard of ethical conduct

Accord appeared to have been let down by one employee; there was no evidence before it that similar interactions by other representatives had taken place.  In this regard, and noting the actions of Accord once it was made aware of the representative’s actions which included immediately instructing the representative to contact the nurse to clarify the licence of Methofill, prior to the patient being seen in clinic, the Panel ruled no breach of the following Clauses of the 2021 Code:   

No Breach of Clause 5.1

Requirement to maintain high standards

No Breach of Clause 2

Requirement that activities must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

This summary is not intended to be read in isolation.
             For full details, please see the full case report below.