AUTH/3213/6/19: Anonymous v Janssen — alleged off-licence promotion at prostate cancer summit (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3213/6/19
Complainant	Anonymous, non-contactable (described themselves as a health professional)
Company	Janssen
Allegation	Alleged off-licence promotion; misleading/indirect promotion; disguised promotion at a Janssen-sponsored oncology meeting
Products mentioned	Zytiga (abiraterone); Erleada (apalutamide)
Event	“8th Prostate Cancer Summit, Digital revolution: emerging evidence and technologies for tomorrow’s clinical practice” (1–2 March 2019, Park Plaza Riverbank Hotel, London)
Attendance	~275 health professionals (including faculty); 5 signed in for pilot live stream component
Applicable Code year	2019
Clauses considered	2, 3.1, 3.2, 9.1, 12.1
Panel decision	No breach of the Code
Key reasoning	Complainant did not specify the slides/statements or explain why they breached the Code; burden of proof not met. Janssen’s involvement was considered clear; promotional nature not disguised as alleged.
Complaint received	20 June 2019
Case completed	10 June 2020
Appeal	No appeal
Sanctions	None stated

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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, non-contactable health professional complained about alleged off-licence promotion at a Janssen-sponsored oncology meeting (1–2 March 2019, London) titled “8th Prostate Cancer Summit, Digital revolution: emerging evidence and technologies for tomorrow’s clinical practice”.
The complainant alleged an external speaker acting on behalf of Janssen discussed “off-licence” castrate resistant prostate cancer (CRPC) treatment on the afternoon of 2 March, using “at least 7–10 slides of unlicensed information”, disseminated to a wide UK audience and broadcast via a webinar.
The complainant said the content was misleading, indirectly promotional, and inappropriate for a meeting advertised as a medical educational event.
Janssen said the meeting was clearly initiated and funded by Janssen, with visible branding, and that an independent faculty determined the structure and scientific content.
Janssen reviewed the CRPC sessions that were live streamed (morning of 2 March) and said it could not identify off-licence promotion of its medicines (Zytiga/abiraterone; Erleada/apalutamide) and that references were within licence.
Janssen acknowledged a speaker discussed Radium-223 in combination with Zytiga in mCRPC, noting negative trial results and that the Radium-223 label was updated to contraindicate the combination; Janssen characterised this as a safety message rather than promotion.
Janssen provided additional information that the afternoon session was not live streamed and confirmed none of the afternoon slides were disseminated to delegates or to webinar participants/broader audiences.

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Outcome

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No breach of the Code was ruled.
The Panel found the complainant did not specify which slides/statements were at issue or why they breached the Code, and therefore did not discharge the burden of proof on the balance of probabilities.
The Panel did not consider the meeting’s promotional nature was disguised, given Janssen’s involvement was stated on materials and visible via logos/branding.
No breach of Clause 2 was ruled (the circumstances did not warrant a Clause 2 finding).

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AUTH/3213/6/19: Anonymous v Janssen — alleged off-licence promotion at prostate cancer summit (No breach)

Key facts

What happened

Outcome

Clauses

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