AUTH/1855/6/06: Novartis v Roche — CellCept booklet and GI complications claims | PMCPA Case

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Key facts

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Case number	AUTH/1855/6/06
Parties	Novartis Pharmaceuticals UK Ltd v Roche Products Limited
Material	CellCept booklet (ref P212582/1105) “Are you concerned about GI complications after transplantation?”
Therapy area	Transplant immunosuppression; GI adverse events/diarrhoea management
Complaint received	26 June 2006 (also stated as 27 June 2006 in the report)
Case completed	02 November 2006 (also stated as 3 November 2006 in the report)
Applicable Code year	2006
Breach clauses	two breaches of 7.2, plus breaches of 7.4, 7.8, 7.10 and 8.1
Key upheld issues	Misleading presentation of subset data/visuals (page 3); misleading overall impression in summary (page 9); disparagement of Myfortic (page 8, upheld on appeal)
Sanctions	Undertaking received; additional sanctions not stated
Withdrawal	Booklet withdrawn April 2006

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

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Novartis complained about a Roche promotional booklet for CellCept (mycophenolate mofetil) titled “Are you concerned about GI complications after transplantation?” (ref P212582/1105), used by hospital sales specialists with transplant specialists/health professionals.
Novartis alleged the booklet misrepresented the role of immunosuppression (and CellCept) in GI complications post-transplant and was inconsistent with the CellCept SPC, creating an impression that infection (not immunosuppression) was the main cause.
Key disputed elements included: (a) how causes of GI adverse events were listed (page 1), (b) quotations about ruling out infection before dose changes (page 2), (c) a “proven benefit” claim and a 92% graphic based on a small subset (page 3), (d) algorithms for infectious vs non-infectious diarrhoea (pages 4–5), (e) a table of diarrhoea rates across regimens including combinations not in indications (page 7), (f) statements about Myfortic/EC‑MPS having “no impact” and “no advantage” (page 8), and (g) a summary page implying most GI complications can be treated medically without stopping immunosuppression (page 9).
The booklet at issue was withdrawn in April 2006.
Roche appealed the finding on page 8; the appeal was unsuccessful.

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Breach found for misleading presentation/overall impression on certain pages (including a visually misleading graph and over-broad headings vs narrow data).
Breach found for disparagement of a competitor product (Myfortic) on page 8; upheld on appeal.
No breach rulings for several other challenged sections (including page 1 list of causes; page 2 quotations; pages 4–5 algorithm; page 7 table re unlicensed safety claim allegation; and no breach of high standards clause on page 3).
Panel did not rule the booklet prejudicial to patient safety and therefore did not apply Clause 2 as a sign of particular censure.

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