AUTH/3194/4/19: Anonymous v GlaxoSmithKline (sponsored COPD therapy review service) – No breach

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3194/4/19
PartiesAnonymous v GlaxoSmithKline UK Limited
ActivitySponsored COPD therapy review service (MEGS)
Therapy areaChronic obstructive pulmonary disease (COPD)
Key document citedInternal third-party email dated 14 August 2018 referencing “integrate client product/therapy priorities”
Applicable Code year2016
Clauses consideredClause 2; Clause 9.1; Clause 12.1; Clause 19.2
DecisionNo breach of the Code
AppealAppeal by complainants (re Clause 9.1) unsuccessful; no-breach ruling upheld
Complaint received30 April 2019
Case completed14 October 2020
Medicines mentionedSerevent, Seretide, Trelegy Ellipta, Relvar Ellipta
SanctionsNone stated

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

  • An anonymous contactable group (GPs, NHS leaders, pharmacists, NHS patients and current staff from a named third-party therapy review provider) complained about multiple pharma-sponsored therapy review services, including one sponsored by GlaxoSmithKline UK Limited (GSK) for COPD.
  • The complaint relied on an internal email (14 August 2018) from a senior employee at the third-party provider to its clinical team, describing client plans and including the phrase: “transition and integrate client product/therapy priorities into our internal resource and schedules”.
  • The email included a section stating the “GlaxoSmithKline COPD service continues to be universally welcomed…” and referenced scaling bookings and additional COPD training.
  • Complainants alleged the email showed commercial bias (therapy reviews linked to sponsor products/ROI), lack of transparency, and that this brought the industry into disrepute; they alleged a breach of Clause 2.
  • The Authority asked GSK to consider Clauses 2, 9.1, 12.1 and 19.2 (2016 Code).
  • GSK responded that the COPD Therapy Review Service was a non-promotional MEGS activity with governance controls: written protocol and pharmacist briefing, formulary screening to avoid situations where GSK products were the only option, recommendations at class level only (no product recommendation), GP retained full control and made final prescribing decisions, sponsorship disclosed to practices/patients, remuneration based on activity not outcomes/sales, and a 7-day promotion-free window around service delivery.
  • The Panel reviewed the email in full and noted it was concerning in how it could be perceived, but assessed the email’s impact against the documented arrangements for the GSK service.
  • The complainants appealed the no-breach finding on Clause 9.1 (high standards). The Appeal Board upheld the Panel’s decision.
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Outcome

  • No breach of Clause 19.2.
  • No breach of Clause 12.1.
  • No breach of Clause 9.1.
  • Consequently, no breach of Clause 2.
  • Appeal by complainants (on Clause 9.1) was unsuccessful; the no-breach ruling was upheld.
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