What happened

• 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.

Outcome

• 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.

Clauses

• 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.

Sanctions

No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

ABPI signatory lens

Why this matters: Corporate websites are routinely accessed by the public. If POM names and indications are presented in a way that creates an overall promotional impression (especially where users can easily see multiple products), it can be ruled as advertising to the public and trigger both POM-to-public and digital access-control breaches.

Where teams typically slip up (interpretation):

• Assuming “reference information” is automatically acceptable for public pages, without testing the overall impression and user journey (what a user sees first, and what else they see while searching).
• Listing multiple POMs and indications together in a way that resembles a product catalogue, even if each entry is factual and links to SPC/PIL.
• Relying on a general “POM” disclaimer while leaving the content openly accessible, rather than separating audiences and restricting access where the content is judged promotional.

The control that would have prevented it: A pre-publication digital compliance review that includes a “public first-click experience” test (including navigation paths and what appears within one screen), with a clear decision tree for when POM content must be moved behind HCP gating or restructured to avoid promotional impression.

What I’d check in an audit:

• Evidence of periodic website compliance monitoring and documented remediation when risks are identified (including ownership, timelines, and verification of changes).
• Information architecture showing separation of public vs HCP content, and whether any POM content is access-restricted where required.
• Screenshots/records of the live pages at approval time, including above-the-fold content and the user pathways to reach product pages.
• Governance for external links (e.g., global parent sites) including use of exit pop-ups and review of link destinations.

What the sanctions tell you (interpretation):

• The absence of explicit additional sanctions suggests the published outcome focused on the breach findings rather than escalated penalties.
• Even without Clause 2, multiple clause breaches (POM-to-public plus digital access controls plus high standards) indicate the regulator expects robust website governance.
• Prior internal monitoring noting the same risk can be viewed as a warning sign: once a risk is identified, timely corrective action becomes critical.

3 questions to ask your team this week:

1. If a member of the public lands on our site looking for one medicine, what other POM names/indications do they see within one screen and along the path?
2. Do we have a documented rule for when POM-related pages must be HCP-gated versus when public reference information is acceptable, and is it consistently applied?
3. When our monitoring identifies a “risk of promotion to the public,” how quickly do we remediate and how do we evidence that the fix worked?

Key facts

Download the full case report (PDF)

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