Otsuka Europe: UK website product pages ruled to promote prescription-only medicines to the public

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Key facts

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Case number	AUTH/3203/6/19
Case reference	Anonymous employee v Otsuka Europe
Complainant	Anonymous employee (concerned health professional)
Respondent/company	Otsuka Europe (with Otsuka UK involved in response)
Product(s)	Abilify (aripiprazole); Samsca (tolvaptan); Jinarc (tolvaptan); Sprycel (dasatinib); Pletal (cilostazol)
Material/channel	Company website (Otsuka Europe website, Otsuka UK section; products page and related navigation)
Key issue	Whether listing POM names and indications on publicly accessible webpages amounted to promotion to the public and whether access controls/audience separation were required
Dates (received/completed if stated)	Complaint received 7 June 2019; Case completed 23 April 2020
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Breaches of Clauses 26.1, 26.2, 28.1 and 9.1; No breach of Clause 2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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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 employee (describing him/herself as a concerned health professional) complained that Otsuka UK webpages promoted prescription-only medicines (POMs) to the public.
The webpages were part of the Otsuka Europe website; the matter was taken up with Otsuka Europe (with a joint response from Otsuka Europe and Otsuka UK).
The complainant alleged the Otsuka UK products page listed brand names, non-proprietary names and indications for medicines sold by Otsuka UK, and did not specify the intended audience.
The complainant also alleged the site linked to a Japan website promoting products not available in the UK and linked to pipeline products which should not be aimed at the general public/patients.
Screenshots referenced Abilify (aripiprazole), Samsca (tolvaptan), Jinarc (tolvaptan), Sprycel (dasatinib) and Pletal (cilostazol).
Otsuka stated the page could be reached via links such as “Our Products in Europe” and via “What We Do For Patients”; the Panel also noted an apparent third route via right-hand navigation.
Otsuka said the page stated all medicines were prescription-only and directed readers to SPCs/PILs; it listed names, indications, and direct links to SPC/PIL on the Electronic Medicines Compendium, with no claims made for the medicines.
The Panel noted Otsuka’s March 2019 digital compliance monitoring report observed a risk that listing product name, generic name and indication could be seen as encouraging the public to ask for a specific medicine and as promotion to the public, recommending review/update of wording.

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Outcome

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Breach of Clause 26.1: The Panel ruled that, on balance, the webpage advertised prescription-only medicines to the public.
Breach of Clause 26.2: The Panel ruled that, on balance, the information might encourage members of the public to ask their health professional to prescribe a specific prescription-only medicine.
Breach of Clause 28.1: The Panel ruled access should have been restricted to health professionals/other relevant decision makers because the webpage promoted POMs and access was not restricted.
Breach of Clause 9.1: The Panel ruled Otsuka failed to maintain high standards.
No breach regarding pipeline link allegation: The Panel did not have the pipeline webpages; the complainant did not provide evidence that the pipeline page raised unfounded hopes; pipeline products were not classified as POMs and Clause 26.2 applied to POMs.
No breach regarding Japan website link allegation: The Panel considered the complainant had not established the link was inappropriate; a pop-up made clear the reader was leaving Otsuka Europe’s control and the link went to the Japan home page.
No breach of Clause 2: The Panel did not consider the circumstances warranted particular censure.

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Clauses

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Clause 26.1 (breach): Promotion of prescription-only medicines to the public.
Clause 26.2 (breach in relation to encouragement to request a POM): Information to the public must be factual/balanced and must not encourage the public to ask their health professional to prescribe a specific POM.
Clause 28.1 (breach): Internet material directed to a UK audience must comply with the Code; where promotional POM material is present, access should be restricted and/or audiences clearly separated as per supplementary information.
Clause 9.1 (breach): High standards.
Clause 2 (no breach): The Panel did not find the case warranted a Clause 2 ruling.

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Key facts

What happened

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