Roche: Xenical supplied to private diet clinics and £55,000 clinic funding linked to prescribing (AUTH/2099/2/08 & AUTH/2100/2/08)

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Key facts

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Company	Roche Products Limited
Medicine	Xenical (orlistat)
Case numbers	AUTH/2099/2/08 and AUTH/2100/2/08
Complainant	Former employee (AUTH/2099/2/08); Financial Times article taken up under the Code (AUTH/2100/2/08)
Main issues	Supply of a prescription only medicine to a private clinic where the owner was not a health professional; funding of a clinic purchase (£55,000) found linked to Xenical prescribing
Funding amount	£55,000 proposed (two instalments: £20,000 Aug 2004; £35,000 Jan 2005). Roche stated only £20,000 paid; second payment halted after MHRA contact.
Applicable Code(s)	2001 and 2003 Codes (rulings made in relation to the 2003 Code using Constitution and Procedure in the 2006 Code)
Breach clauses	2, 9.1 and 18.1
Notable finding	By end of May 2003 Roche should have strongly suspected prescribing/supply at the clinic was inappropriate and possibly prejudicial to patient safety; payment for clinic purchase was clearly linked to prescribing Xenical
Sanctions	Public reprimand; reported to ABPI Board with recommendation of suspension; ABPI membership suspended for six months from 14 July 2008 (re-entry conditional upon satisfactory audit)
Complaint received	19 February 2008
Undertaking received	9 June 2008
ABPI Board consideration	17 June 2008
Published	August 2008 Code of Practice Review

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

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What happened

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A former Roche employee complained about (1) supply of Xenical (orlistat) to a bogus health professional/private diet clinic set-up and (2) Roche funding a further clinic.
A Financial Times article (12 Feb 2008) alleged Roche sold large quantities of Xenical to a chain of private UK diet clinics despite suspicions it was being sold illegally/into the “grey market”, and agreed to provide £55,000 to support purchase of another diet clinic (taken up as a separate Code complaint).
Roche validated the supervising doctor’s GMC number on an account proposal form, but did not confirm the professional status/registration of the clinic owner who claimed to be a pharmacist (but was not).
Roche sent an employee to the clinic in May 2003 posing as a patient; the employee was seen by the owner and obtained a pack of Xenical for £75. The visit report suggested the owner could “have passed as a doctor”.
Despite the May 2003 visit and ongoing concerns about unusually high volumes, Roche continued supply (with a cap) until MHRA involvement in March 2005 (MHRA asked Roche to continue supplying during the investigation).
Roche agreed to sponsor purchase of another clinic for £55,000 in two instalments (£20,000 in Aug 2004; £35,000 in Jan 2005). Roche said only £20,000 was paid; the second payment was halted after MHRA contact.
An internal “Private Clinic Funding Proposal” (undated) included sales analysis showing return on a £55,000 “investment” and described the clinics as a “real Xenical success story”, with expectations of rapid switch to Xenical and high monthly pack volumes.
Roche argued commercial supply was outside the Code’s scope; the Appeal Board Chairman ruled the supply relationship in these facts fell within the Code’s definition of promotion (Clause 1.2 scope point considered as a jurisdiction issue).

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Outcome

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Breaches were ruled for failures around supply to the clinic and for the clinic funding arrangement.
Roche’s appeals on the supply-related breaches (Clauses 2 and 9.1) were unsuccessful; rulings were upheld.
In relation to discounts/contract pricing, the Panel ruled no breach of Clause 18.1 (discounts excluded as terms of trade in regular use by a significant proportion of the industry on 1 January 1993).
The Appeal Board considered the payment for purchase of the clinic was clearly linked to prescribing Xenical and “totally unacceptable”.
The Appeal Board decided the case warranted additional sanctions and reported Roche to the ABPI Board of Management with a recommendation of suspension.
The ABPI Board suspended Roche from ABPI membership for six months from 14 July 2008, with re-entry conditional upon a satisfactory audit.
The Appeal Board decided that once the cases were completed, the case report and the FT article should be sent to the GMC due to patient safety concerns.

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Key facts

What happened

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