AUTH/3259/10/19: Complainant v Otsuka Europe — Jinarc (tolvaptan) risk minimisation materials (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3259/10/19
Company	Otsuka Europe
Product	Jinarc (tolvaptan)
Material type	Risk minimisation plan (RMP) / additional risk minimisation measures (aRMM) materials (health professional educational guide, prescribing checklist, patient alert card, patient education brochure)
Main allegations	Omission of pregnancy and dehydration information in updated centralised aRMM materials; lack of urgency/governance on patient safety
Key factual finding	Omission was identified during local affiliate review; rollout stopped; no erroneous materials were issued to HCPs/patients
Applicable Code year	2019
Clauses considered	Clauses 7.2, 7.9, 7.10, 9.1 and 2
Panel decision	No breach
Appeal	Appeal by the complainant; Appeal Board upheld no breach rulings
Complaint received	10 October 2019
Case completed	22 October 2020
Sanctions	None stated

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

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An employee complained about Otsuka Europe regarding EU risk minimisation plan (RMP) / additional risk minimisation measures (aRMM) materials for Jinarc (tolvaptan), alleging patient safety risk and lack of urgency.
The complainant alleged updated centralised aRMM materials omitted key safety content, specifically references to pregnancy prevention and dehydration, and that affiliates had raised concerns but the materials remained unchanged.
The complainant also alleged broader governance/urgency issues following a recent PMCPA audit (eg, senior leaders away, “pens/pencils down” confusion, lack of SOPs, and focus on social activities).
Otsuka explained the omission arose from an exceptional inconsistency between the EMA-approved European Tolvaptan RMP (version 14.1) and the marketing authorisation conditions (Annex IID) regarding what aRMMs must include.
Affiliates identified the omission during local review; Otsuka stopped rollout and instructed affiliates to pause local review against the revised central materials.
Otsuka stated that no erroneous aRMM materials were issued to health professionals or patients; the materials in use contained the pregnancy and dehydration information.
The complainant appealed most no-breach findings; the Appeal Board upheld the Panel’s rulings.

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No breach of the Code was ruled by the Panel.
The Appeal Board upheld the Panel’s rulings of no breach on the points appealed by the complainant.
The Appeal Board noted concern about the length of time to resolve the regulatory inconsistency, but accepted it was subject to regulator timescales and iterative process.

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