AUTH/3873/01/24: Complainant v Bayer (Eylea website and public access to SmPC) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/3873/01/24
Parties	Complainant v Bayer plc
Product	Eylea (aflibercept)
Issue	Public access to SmPC via Bayer-owned Eylea website patient section (linking to eMC)
Applicable Code year	2021
Clauses considered	Clause 5.1; Clause 26.2
Decision	No breach of Clause 5.1; No breach of Clause 26.2
Panel rationale (high level)	Clear separation of HCP vs public sections via gateway; supplementary information to Clause 26.2 supports providing SmPC as minimum reference information on public sites
Complaint received	24 January 2024
Case completed	6 January 2025
Appeal	No appeal
Sanctions	None stated (no breach)

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

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An anonymous, non-contactable complainant (self-described health professional) said a patient brought a printout of the Eylea Summary of Product Characteristics (SmPC/SPC).
The patient allegedly found it via Google and then via a Bayer-owned Eylea website, using the “patient” option which “prominently” directed to the SmPC.
The concern was that the SmPC stated it was “for use by healthcare professionals only” and therefore should not have been accessible from patient pages.
Bayer explained the site used an “honesty box” gateway separating UK healthcare professional promotional content from public non-promotional content, and that the public pages linked out to the Electronic Medicines Compendium (eMC) for the patient leaflet and SmPC.
Bayer noted the site had a major update on 30 January 2024 (after the complaint) due to a new 8mg dose marketing authorisation, but provided certification for the version relevant to the complaint.

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No breach of Clause 26.2.
No breach of Clause 5.1.
The Panel considered the complainant had not established, on the balance of probabilities, that providing the SPC via a link on patient webpages was inappropriate in the circumstances.

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Clause 5.1 Requirement to maintain high standards at all times
Clause 26.2 Requirement that information about prescription only medicines which is made available to the public must be factual, balanced, must not raise unfounded hopes of successful treatment or encourage the public to ask their health professional to prescribe specific prescription only medicine

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