Otsuka: Jinarc training portal held to be non-promotional (no breach) (AUTH/3217/6/19)

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Key facts

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Case	AUTH/3217/6/19
Parties	Health professional v Otsuka Pharmaceuticals (UK) Limited
Product	Jinarc (tolvaptan)
Material	Jinarc training website / training portal (ARMM educational programme)
Main allegations	Website was promotional; implied MHRA endorsement; links to order; prescribing information not clear/prominent/direct and SPC route lacked PI elements such as price
Company position	Non-promotional MHRA-agreed ARMM/RMP training; link was to SPCs (not prescribing information); Clause 4.1 and 9.5 not applicable
Panel finding	Site not promotional; no requirement for prescribing information; MHRA reference restriction did not apply
Clauses considered	Clause 4.1; Clause 9.5
Outcome	No breach
Complaint received	19 June 2019
Case completed	9 January 2020
Applicable Code year	2019
Appeal	No appeal

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

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What happened

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A health professional complained that the Jinarc (tolvaptan) training website was promotional but did not meet Code requirements for promotional material.
The complainant alleged the site implied MHRA endorsement, contained links to order the medicine, and did not provide prescribing information via a clear, prominent, direct single link (and the SPC route did not include all PI elements such as price).
Otsuka explained the site was part of MHRA-agreed Additional Risk Minimisation Measures (ARMMs) under a Risk Management Plan (RMP), requiring prescribers to complete safety training and register as certified prescribers.
The Panel assessed whether the site was promotional, noting supplementary information that MHRA-approved risk minimisation materials are exempt from the definition of promotion.
The Panel noted the site gated access by asking users to confirm they were health professionals; “No” users were redirected to Otsuka UK and eMC links, with an SPC link at the bottom.
The training portal described MHRA requirements, provided safety-focused training (slides), and required completion of an enrolment form for prescriber certification.
“Additional Resources” included safety materials, the Jinarc SPC, a Patient Alert Card, and (towards the end) a link to prescribing/ordering information and a downloadable “Jinarc request form – to be sent with all Jinarc orders”. The Panel noted there was no ability to order directly from the link and the request form was not specifically highlighted.

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Outcome

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The Panel did not consider the site to be promotional as alleged.
No breach of Clause 4.1 was ruled (prescribing information requirements for promotional material did not apply).
No breach of Clause 9.5 was ruled (prohibition on MHRA references in promotional material did not apply because the material was not promotional).
No appeal.

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