AUTH/3658/6/22: Complainant v Novartis (Mayzent) — email invite to promotional symposium (No breach) | PMCPA Case

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Key facts

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Case	AUTH/3658/6/22
Company	Novartis
Medicine	Mayzent (siponimod)
Material	Email/mailing distributed by a multiple sclerosis independent education provider about a Novartis promotional satellite symposium (mailing reference/job code: UK \| September 2021 \| 151725)
Main allegations	Promotion outside licence (unqualified “Mayzent for SPMS with Active Disease”); not certified; not clear from the start it was for health professionals only
Applicable Code	2021
Clauses considered	2, 5.1, 8.1, 11.2
Decision	No breach of Clauses 2, 5.1, 8.1, 11.2
Appeal	No appeal
Complaint received	13 June 2022
Case completed	19 June 2023

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

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An anonymous, contactable complainant (a health professional) complained about an email distributed by a multiple sclerosis independent education provider inviting recipients to a webinar that included a Novartis promotional satellite symposium for Mayzent (siponimod).
The complainant alleged the phrase “Mayzent for SPMS with Active Disease” promoted Mayzent outside its licensed indication because it did not include “adult patients” or specify “evidenced by relapses or imaging features of inflammatory activity”.
The complainant alleged the material was not certified because it did not show a date of production or unique code.
The complainant alleged it was not made clear from the start that the webinar was only for health professionals.
Novartis said the email carried a preparation date and unique code (UK | September 2021 | 151725), had been certified by a final signatory (a UK-registered pharmacist), included a link to prescribing information, and stated the promotional satellite symposium was for “UK Healthcare Professionals only”.
The Panel considered the complaint related to the email/mailing (reference 151725) rather than the meeting itself or other materials, and ruled on that basis.

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No breach of Clause 8.1 (certification) — the complainant did not establish the email was not certified.
No breach of Clause 11.2 (promotion inconsistent with SPC) — the complainant did not establish that “Mayzent for SPMS with Active Disease” promoted Mayzent inconsistently with the SPC in the context of the mailing.
No breach of Clause 5.1 (high standards) — the complainant did not establish the claim was unqualified as alleged, and did not establish the material failed to make clear it was for health professionals only.
No breach of Clause 2 (discredit) — consequential on the above no-breach findings.
No appeal.

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Clause 2 — Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry (No breach)
Clause 5.1 — Requirement to maintain high standards (No breach)
Clause 8.1 — Requirement to certify promotional material (No breach)
Clause 11.2 — Requirement not to promote a medicine in a manner that was inconsistent with its SPC (No breach)

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