AUTH/3404/10/20: Indivior v Camurus — Buvidal guidelines and webinars treated as promotional; public access and missing safety info | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/3404/10/20
Parties	Indivior v Camurus
Medicine	Buvidal (buprenorphine, prolonged-release solution for injection)
Indication (as stated)	Treatment of opioid dependence within a framework of medical, social and psychological treatment; adults and adolescents aged 16 years or over
Materials	Booklet: “Clinical guidelines for the use of depot buprenorphine (Buvidal) in the treatment of opioid dependence” and related webinars
Key compliance issues	Guidelines and webinars treated as promotional; missing prescribing information, missing INN at first mention, missing adverse event reporting statement; lack of certification; disguised promotion; inadequate sponsorship declaration (webinars); promotion of POM to the public due to access failures
Applicable Code year	2019
Complaint received	22 October 2020
Case completed	22 June 2021
Appeal	No appeal
No breach	Clause(s) 9.10 (guidelines)
Breach clauses	2, 4.1, 4.3, 4.9, 9.1, 9.10, 12.1, 14.1, 26.1, 26.2, 28.1
Sanctions	Undertaking received; Additional sanctions: Advertisement

Download the full case report (PDF)

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

What happened

⌄

Indivior complained about Camurus’ promotion of Buvidal (buprenorphine, prolonged-release solution for injection) via a 54-page booklet of “clinical guidelines” and related webinars hosted by a registration body and network for addiction professionals.
Buvidal was indicated for treatment of opioid dependence within a framework of medical, social and psychological treatment, for adults and adolescents aged 16 years or over.
The Panel found Camurus was closely linked to the production of the guidelines via a consultancy agreement (including rights to comment and review for Code compliance), so the guidelines were, in effect, Camurus’ promotional material.
The guidelines omitted required elements for promotional material: prescribing information, the non-proprietary name alongside the brand name at first prominent mention, and the adverse event reporting statement; and they were not certified in final form.
The Panel found the way Camurus’ involvement was presented was not sufficiently clear, so the promotion was disguised.
Two webinars (7 and 14 May 2020) were found to be, in effect, promotional material for Buvidal for which Camurus was responsible; they also omitted prescribing information, INN at first mention, and the adverse event reporting statement, and were not certified.
The sponsorship declaration for the webinars did not fairly reflect Camurus’ role/responsibility.
Access controls failed: the first webinar appeared not restricted to health professionals; recordings were accessible via a public YouTube page and could be found via standard search terms, with no clear statement that content was for health professionals—resulting in promotion of a prescription-only medicine to the public.

⚖️

Outcome

⌄

Breaches ruled for multiple clauses relating to missing obligatory information, disguised promotion, lack of certification, promotion to the public, high standards, and bringing discredit to the industry.
No breach of Clause 9.10 was ruled for the guidelines (the Panel considered Clause 9.10 not relevant because the guidelines were commissioned promotional material rather than sponsored material).
Breach of Clause 9.10 was ruled for the webinars (declaration did not fairly reflect Camurus’ role/responsibility).
Case completed 22 June 2021; no appeal.

🔒

Unlock the full case analysis

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access

AUTH/3404/10/20: Indivior v Camurus — Buvidal guidelines and webinars treated as promotional; public access and missing safety info

Key facts

What happened

Outcome

Clauses

Unlock the full case analysis

AQP Flagship Path — the complete UK ABPI signatory programme

📰 Weekly PMCPA Case Breakdown