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PMCPA Case

CSL Vifor: Uncertified global invite to UK HCP for overseas CKD-aP meeting (difelikefalin) breached certification and mandatory info rules

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/3833/10/23
CompanyCSL Vifor
Case typeVoluntary admission
IssueUncertified invitation to an overseas meeting sent to a UK HCP; promotional content referencing difelikefalin without mandatory information; overseas meeting arrangements not appropriately certified
Meeting / context“Clinical Expert Exchange Meeting on CKD-associated pruritus” (16 June 2023) and symposium at a named European congress (17 June 2023)
Product mentionedDifelikefalin
Complaint received09 October 2023
Applicable Code year2021
Panel outcomeBreach of Clauses 5.1, 8.1, 8.2, 12.1, 12.9, 12.10
Sanctions appliedUndertaking received
AppealNo appeal
Case completed17 December 2024

Download the full case report (PDF)

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

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What happened

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  • CSL Vifor’s global team organised a “Clinical Expert Exchange Meeting on CKD-associated pruritus” at a named European congress (Milan), scheduled for 16 June 2023, the evening before a company symposium.
  • A UK employee emailed a UK health professional (HCP) on 3 April 2023 to gauge interest in attending an evening dinner/meeting (described internally as a “save the date”).
  • On 12 April 2023, a global employee (email signature: “CSL Vifor Difelikefalin team”) sent a formal email invitation to the UK HCP; the agenda referenced “Real world experience sharing on CKD-aP and its treatment” and “complimentary hospitality within the applicable meal limits”.
  • The invitation email included an attached symposium flyer for 17 June 2023 that referenced the prescription-only medicine difelikefalin and CKD-associated pruritus (the Panel considered the email + attachment promotional).
  • The invitation/material and the overseas meeting arrangements were not certified in advance by the UK final medical signatory / appropriately qualified person.
  • A UK-based medical employee became aware around 31 March 2023 that an invitation had been sent without prior certification but did not seek further details at the time; escalation to a UK senior medical employee occurred on 7 June 2023.
  • Corrective action: the invite was retracted on 8 June 2023 and a compliant, certified invitation including mandatory information was issued on 14 June 2023.
  • It was unclear whether the UK HCP attended and whether there were other UK attendees.
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Outcome

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  • Breach of Clause 5.1 Failing to maintain high standards
  • Breach of Clause 8.1 Failing to certify promotional material
  • Breach of Clause 8.2 Failing to certify events/meetings involving travel outside the UK UK
  • Breach of Clause 12.1 Failing to include prescribing information
  • Breach of Clause 12.9 Failing to include an adverse event reporting statement
  • Breach of Clause 12.10 Failing to include a black triangle
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