Napp: BuTrans promotional emails sent without confirmed recipient permission via tele/e-detail agency (AUTH/2616/7/13)

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Key facts

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Case number	AUTH/2616/7/13
Company	Napp Pharmaceuticals
Product	BuTrans (buprenorphine patch)
Issue	Promotional emails sent where consent to receive promotional emails was uncertain; one doctor emailed without prior permission
Channel	Contract tele/e-detail calls and follow-up emails with promotional PDF attachments
Complainant	Director treated voluntary admission as a complaint (Paragraph 5.6)
Complaint received	19 July 2013
Case completed	12 September 2013
Applicable Code year	2012
Clauses considered	9.1, 9.9, 15.2
Findings	No breach for two practice manager incidents; breach of Clauses 9.1, 9.9 and 15.2 for the doctor incident
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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Napp voluntarily reported three incidents linked to a contract tele/e-detail sales agency working on BuTrans (buprenorphine patch).
After scheduled web-based e-detail/telephone calls, additional BuTrans promotional materials were emailed using a Napp-approved template, but Napp was uncertain whether recipients had consented to receive promotional emails.
The agency’s call notes were persistently poor, making it difficult to evidence whether consent had been obtained.
Incident 1: A practice manager received BuTrans materials by email and later said she had not requested any information.
Incident 2: A practice manager received BuTrans materials by email and replied that she had not had the “online conversation” referenced and queried whether it was sent to the right person.
Incident 3: A doctor received BuTrans materials by email and replied that he had not had an online conversation and did not wish to receive information; he queried how his contact details were obtained. Napp’s investigation suggested consent was likely not given by the doctor.
Napp suspended services during investigation and later terminated the agency contract (July 2013). The agency dismissed the representative involved; disciplinary action was pending against the project manager.

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The Director treated the voluntary admission as a complaint (Paragraph 5.6 of the Constitution and Procedure for the PMCPA).
Panel assessed each incident separately.
Incidents 1 and 2 (practice managers): No breach ruled because it was impossible to know whether the practice managers had provided their email addresses and permission for promotional use.
Incident 3 (doctor): Breach ruled because the doctor was emailed promotional material without his prior permission; permission could not be granted by a third party (eg practice manager).
Panel also raised general concerns about very poor quality call notes and asked that these concerns be drawn to Napp’s attention.

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