AUTH/3217/6/19: Health professional v Otsuka (Jinarc training website) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/3217/6/19
Complainant	Health professional (described themself as a concerned health professional)
Company	Otsuka Pharmaceuticals (UK) Limited
Product	Jinarc (tolvaptan)
Material	Jinarc training website / training portal (www.jinarctraining.co.uk/uk/introduction)
Main allegations	Website was promotional without compliant prescribing information; implied MHRA endorsement; contained links to order medicine
Applicable Code year	2019
Clauses considered	Clause 4.1; Clause 9.5
Panel decision	No breach (site considered non-promotional risk minimisation material)
Complaint received	19 June 2019
Case completed	9 January 2020
Appeal	No appeal
Sanctions	None

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

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A health professional complained that Otsuka’s Jinarc (tolvaptan) training website for UK health professionals was promotional but did not meet Code requirements for promotional material.
The complainant alleged the site implied MHRA endorsement and included links to order Jinarc.
The complainant also alleged the prescribing information link was not clear/prominent or a direct single link, and that the linked SPC selection page did not include all prescribing information requirements (eg price).
Otsuka stated the website delivered MHRA-approved Additional Risk Minimisation Measures under a Risk Management Plan, including mandatory education and prescriber registration, and was therefore non-promotional.
The Panel assessed whether the site was promotional, noting supplementary information that MHRA-approved risk minimisation materials are exempt from the definition of promotion.

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No breach of Clause 4.1.
No breach of Clause 9.5.
The Panel concluded the training portal was not promotional (risk minimisation/ARMMs), so it did not require prescribing information as promotional material would.
Because the material was not promotional, the prohibition on MHRA references in promotional material did not apply.

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