AUTH/2587/3/13: Anonymous gastroenterology consultant v Almirall (Constella) – no breach over alleged free stock inducement | PMCPA Case

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Key facts

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Case number	AUTH/2587/3/13
Complainant	Anonymous, non-contactable gastroenterology consultant
Company	Almirall Limited
Medicine	Constella (linaclotide)
Allegation	Free stock offered as a “trial” to support a formulary application (alleged inducement)
Complaint received	13 March 2013
Case completed	9 April 2013
Applicable Code year	2012
Clauses considered	Clause 2, Clause 9.1, Clause 15.2, Clause 18.1
Outcome	No breach of the Code
Appeal	No appeal
Sanctions	None stated

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

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An anonymous, non-contactable gastroenterology consultant alleged an Almirall representative told a colleague that free stock of Constella (linaclotide) could be offered as a trial to support a formulary application.
The complainant said they opposed this type of promotion and felt their department was compromised by the alleged inducement; they also alleged the offer had been made across other UK trusts.
The PMCPA asked Almirall to respond in relation to Clauses 2, 9.1, 15.2 and 18.1 (Code year 2012).
Almirall stated no sales representatives were yet promoting Constella; activity sat with healthcare development managers (HDMs) and a senior medical advisor in a non-promotional capacity.
Almirall described a process to provide limited free stock between licensing (Nov 2012) and planned launch in 2013, in response to clinician requests and subject to local trust governance (including formulary application and trust agreement).
The complainant was not present at the alleged interaction and provided no documentation; the Panel could not seek further details because the complainant was non-contactable.

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No breach of the Code was ruled.
The Panel did not consider the complainant had shown, on the balance of probabilities, that free stock was offered as an inducement to submit a formulary application.
No breach of Clause 18.1 was ruled; consequently no breach of Clauses 9.1 and 15.2 was ruled.
No breach of Clause 2 was ruled.

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