AUTH/2032/8/07: Bristol-Myers Squibb v Novartis — ENACT expanded access programme for investigational nilotinib (No breach) | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/2032/8/07
Complainant	Bristol-Myers Squibb Pharmaceuticals Limited
Respondent	Novartis Pharmaceuticals UK Ltd
Product / activity	ENACT (Expanding Nilotinib Access Clinical Trial) expanded access programme; ENACT website; investigational nilotinib
Therapy area	Chronic myeloid leukaemia (CML)
Main allegation	Disguised promotion of an unlicensed medicine via expanded access programme/website; related allegations under Clauses 9.1 and 2 flowed from that
Applicable Code year	2006
Complaint received	08 August 2007
Case completed	15 January 2008
Appeal	No appeal
Decision	No breach (Clauses 2, 3.1, 9.1, 10.1)
Sanctions	None stated

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

Bristol-Myers Squibb (BMS) complained that Novartis’ ENACT (Expanding Nilotinib Access Clinical Trial) expanded access programme for investigational nilotinib amounted to disguised promotion of an unlicensed medicine.
BMS pointed to ENACT website wording such as “created to provide early access to the drug’s promising effects during the regulatory review” and other positive statements as creating a promotional impression.
BMS also argued that UK entry criteria did not specify patients must be ineligible for Sprycel (dasatinib), a licensed alternative for imatinib-resistant/intolerant CML, suggesting promotional intent.
Novartis said the site was a global HCP-only website with prominent investigational/disclaimer statements on entry and on each page, and that eligibility was for patients with no other acceptable options as determined by investigators; the programme had ethics committee approval.
Following inter-company dialogue, Novartis asked global teams to remove reference to UK sites from the website listing.

⚖️

⌄

No breach of the Code was found.
The Panel considered the expanded access arrangements were subject to the Code, and noted it could be argued such a programme met the Code’s definition of promotion (Clause 1.2) because it promoted administration of nilotinib.
However, the Panel did not consider BMS had established that ENACT was disguised promotion; the absence of a statement that UK patients had to be resistant/intolerant to Sprycel did not suffice.
No breach of Clause 10.1 was ruled; it followed there was no breach of Clauses 9.1 or 2.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access