GSK diabetes partnership contract and voicemail implied funding was linked to Avandamet protocol placement

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Key facts

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Case number	AUTH/2101/2/08
Case reference	Anonymous employee v GlaxoSmithKline
Complainant	Anonymous employee of GlaxoSmithKline (Diabetes First Associate)
Respondent/company	GlaxoSmithKline UK Ltd
Product(s)	Avandamet (rosiglitazone and metformin)
Material/channel	Internal voicemail (September 2007) and contract for Diabetes Healthcare Partnership/Diabetes Intermediate Service
Key issue	Whether funding/support for a diabetes service was linked to inclusion of Avandamet as first choice on a diabetes protocol (implied linkage in voicemail and contract wording)
Dates (received/completed if stated)	Complaint received 20 February 2008; case completed 1 July 2008
Appeal	Yes. Clause 18.4 breach upheld; Clause 9.1 breach overturned (no breach on appeal).
Code year	Not stated
Breaches/clauses	Breach: Clause 18.4 (upheld on appeal). No breach: Clause 18.1, Clause 2. Panel breach of Clause 9.1 overturned on appeal.
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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An anonymous employee of GlaxoSmithKline (GSK) complained about arrangements for a Diabetes Healthcare Partnership (HCP) between GSK and a primary healthcare service company delivering services under practice based commissioning (PBC).
The complaint was prompted by a voicemail (September 2007) describing a “business-to-business relationship” and stating GSK contributed to the cost of running a diabetes service while the primary healthcare service company agreed to select Avandamet as first medicine in its class on its diabetes protocol for appropriate patients.
A contract dated 3 September 2007 included wording that the project was sponsored by GSK and, “as a consequence” of the primary healthcare service company’s decision to place GSK’s product on the protocol, GSK agreed to provide funding (up to £29,250).
The contract also stated the primary healthcare service company agreed to select AVANDAMET as a first choice medicine in its therapy class for the appropriate patient group on the protocol, while also stating funding was not conditional on prescription and that GPs retained clinical freedom.
GSK provided the diabetes protocol (dated March 2007, due for review March 2008) during the investigation; it appeared inconsistent with the contract wording because it referred to generic names and positioned rosiglitazone as second line, with combination tablets (such as Avandamet) only for compliance problems.
The Panel considered joint working was not prohibited, but arrangements that increased prescribing of one specific product were likely unacceptable; it assessed the service as described in the voicemail and contract.

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Outcome

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The Panel ruled the diabetes service as described in the voicemail and contract was inappropriate because it linked provision of a service to a medicine; breach of Clause 18.4 was ruled.
The Panel also ruled a breach of Clause 9.1 (high standards) but ruled no breach of Clause 18.1 (inducement) and no breach of Clause 2 (discredit).
On appeal, the Appeal Board upheld the breach of Clause 18.4, finding a “very definite, unequivocal link” between funding and inclusion of Avandamet on the protocol as described in the voicemail and contract.
On appeal, the Appeal Board overturned the Panel’s breach of Clause 9.1 (no breach of high standards).

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Clauses

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Clause 18.4: Breach ruled by the Panel and upheld by the Appeal Board (funding/service provision linked to a specific medicine via voicemail and contract wording).
Clause 9.1: Breach ruled by the Panel; overturned on appeal (no breach ruled by the Appeal Board).
Clause 18.1: No breach ruled by the Panel (on balance, arrangements did not amount to an inducement under the Code).
Clause 2: No breach ruled by the Panel (on balance, GSK had not brought discredit upon, or reduced confidence in, the industry).

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GSK diabetes partnership contract and voicemail implied funding was linked to Avandamet protocol placement

Key facts

What happened

Outcome

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