Napp: asthma therapy review service upheld, but Remsima “advisory board” ruled disguised promotion (AUTH/2808/12/15)

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Key facts

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Case	AUTH/2808/12/15
Complainant	Anonymous, non contactable
Respondent	Napp Pharmaceuticals Limited
Activities	ORCA asthma therapy review service; Remsima (infliximab) advisory board in London
Applicable Code year	2015
Complaint received	7 December 2015
Case completed	18 May 2016
No breach clauses	Clause(s) 2, 9.1, 18.1 and 19.1
Breach clauses	Clause(s) 2, 9.1, 12.1, 18.1 and 23.1
Appeal	Appeal by respondent (Napp); breaches upheld
Sanctions applied	Undertaking received; Advertisement

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

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An anonymous, non-contactable complainant raised concerns about two activities by Napp Pharmaceuticals Limited under the 2015 ABPI Code.
Therapy review service (ORCA): The complainant alleged the ORCA asthma therapy review service was aligned to sales targets and only offered where a switch to Napp’s product was guaranteed.
ORCA (started Feb 2015) was funded by Napp and delivered by third-party respiratory nurse advisors, with practices selecting/confirming treatment protocols and GPs authorising any patient-level treatment changes.
The Panel noted concerns about internal documentation that appeared to link ORCA to Flutiform performance, and queried aspects of governance (eg, what was certified, fee structure, and whether Napp had sufficient detail on nurse training/initial meetings at certification).
Advisory board (Remsima): The complainant alleged a London Remsima (infliximab) advisory board after Napp won a London tender was held to generate sales and break down barriers to prescribing, with attendees paid to be promoted to.
The advisory board (Nov 2015, 6pm–7.30pm) had four substantial objectives, a Chairman presentation titled “The clinical perspective on using Remsima in Rheumatoid Arthritis”, and discussion that included gain-share/cost-saving implications of switching.
The Panel (and later the Appeal Board) considered the arrangements did not amount to a genuine advisory board and that the meeting effectively promoted Remsima.

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ORCA therapy review allegations: No breach of Clauses 2, 9.1, 18.1 and 19.1 (complaint not proven on the balance of probabilities).
Remsima advisory board: Breach of Clauses 2, 9.1, 12.1, 18.1 and 23.1.
Napp appealed the advisory board rulings; the Appeal Board upheld the breaches (appeal not successful).

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