AUTH/2644/10/13: Norgine v Galen — Prescribing policy for Laxido Orange (no breach; switch services allegation)

📅 2013 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2644/10/13
ComplainantNorgine Pharmaceuticals Ltd
RespondentGalen Limited
MaterialPrescribing policy document: “Prescribing policy: Laxido Orange … as a relatively straightforward QIPP saving opportunity – the process and the results” (ref PMR-APR-2013-0093)
ProductsMovicol (Norgine) and Laxido Orange (Galen)
Therapy area / useFaecal impaction and chronic constipation in adults and children over 12
Main allegationProhibited switch service/programme paid for or facilitated directly/indirectly by a company; high standards not maintained
Clauses cited9.1, 18.1, 18.4
Applicable Code year2012
Panel decisionNo breach of Clauses 18.1, 18.4, 9.1
AppealAppeal by complainant; unsuccessful; Appeal Board upheld no breach (noted “limits of acceptability”)
Complaint received21 October 2013
Case completed15 January 2014

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

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What happened

  • Norgine complained about a Galen-distributed prescribing policy document promoting switching patients from Movicol to Laxido Orange and describing the process and potential NHS savings.
  • The document stated Movicol and Laxido Orange had the same qualitative and quantitative active ingredients, and that Laxido Orange was ~20% less expensive.
  • The document included practical switching strategies, examples of savings achieved in some primary care organisations (PCOs/CCGs), and discussion of barriers (described as few/easily overcome).
  • It invited readers to contact any of five named NHS pharmacists/medicines management leads (authors) with questions, providing contact details.
  • Galen funded the work: a paid consultant (working for Galen) sourced and briefed five NHS pharmacists to write the document; each received a one-off honorarium at fair market value.
  • Galen reviewed the document for medical and grammatical accuracy and Code compliance, certified it, included Laxido Orange prescribing information, posted it on its trustsaver website, and used it in customer calls.
  • Norgine alleged the document and associated activity amounted to a switch service/programme paid for or facilitated (directly or indirectly) by Galen, and that high standards were not maintained.
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Outcome

  • No breach of the Code was ruled for Clauses 18.1, 18.4, and 9.1.
  • The Panel found the document promoted a switch, which could be acceptable, and concluded Galen did not provide a service to effect or facilitate the switch; any effort/cost to implement switching was borne by health professionals/PCOs.
  • On appeal, the Appeal Board upheld the Panel’s rulings; it noted the document was “on the limits of acceptability” but, on balance, did not constitute active assistance to implement switching.
  • Norgine’s appeal was unsuccessful.
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