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PMCPA Case

GSK joint working project: materials certified 7–8 months after project start (AUTH/2649/10/13)

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2649/10/13
CompanyGlaxoSmithKline
Case typeVoluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
IssueRetrospective certification of joint working project materials after project start
Project areaJoint working with NHS organisations in one area to improve COPD healthcare; goal to reduce hospital admissions and outpatient referrals; automated patient audit tools in 27 practices funded/implemented by GSK (per business case)
Project datesOctober 2011 to October 2012
Certification timingBusiness case certified 15 May 2012; executive summary certified 29 June 2012
Complaint received31 October 2013
Completed08 January 2014
Applicable Code year2012
No breach clausesClause 14.1
Breach clausesClauses 2, 9.1 and 14.3
AppealAppeal by respondent; Clause 2 breach upheld (appeal unsuccessful)
SanctionsUndertaking received; Additional sanctions: Advertisement

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

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What happened

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  • GlaxoSmithKline (GSK) made a voluntary admission that materials for an NHS joint working project were certified after the project had started.
  • The joint working project ran from October 2011 to October 2012 and related to improving local COPD healthcare (aim: reduce hospital admissions and outpatient referrals).
  • Key documents (business case and executive summary) were used after project commencement but were not certified until May 2012 (business case) and June 2012 (executive summary), around 7–8 months into the 12-month project.
  • The issue was identified via an internal mini-audit during a UK reorganisation; corrective action was taken and materials were retrospectively certified.
  • GSK said the failure to certify on time was an administrative error by an ex-employee; the Zinc system showed the business owner initiated certification but later cancelled the job (29 Feb 2012) for unknown reasons while the project proceeded.
  • At the time, the field-based employee could start the project and draw down funds based on verbal confirmation from head office that certification was complete; no documentation was required and the field employee had no access to Zinc to verify certification status.
  • The Panel noted the executive summary was not made publicly available before the arrangements were implemented (the Panel referenced this as required by Clause 18.5).
  • The Appeal Board was concerned that none of the signatories immediately reported the retrospective approval to senior colleagues, and that senior managers only became aware later in connection with another matter; the voluntary admission was made in late October 2013.
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Outcome

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  • Breach ruled of Clause 14.3 (other material, including joint working material, must be certified before use).
  • No breach of Clause 14.1 (Panel considered the material was not promotional, so Clause 14.1 did not apply).
  • Breach ruled of Clause 9.1 (high standards not maintained due to use of uncertified material).
  • Breach ruled of Clause 2 (bringing discredit upon, and reducing confidence in, the pharmaceutical industry).
  • GSK appealed the Clause 2 ruling; the Appeal Board upheld the breach and the appeal was unsuccessful.
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