Teva: P3 Pharmacy interview article deemed promotional—missing PI, AE statement and black triangle; Copaxone indication overstated

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Key facts

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Case	AUTH/3656/6/22
Complainant	Health professional
Company	Teva
Publication/channel	P3 Pharmacy article (interview/profile)
Medicines mentioned	Ajovy (fremanezumab) and Copaxone (glatiramer acetate)
Main issues	Promotional article without PI, AE statement, Ajovy black triangle; not certified; “new” used for Copaxone; Copaxone indication implied too broad vs SPC
Applicable Code	2019
Complaint received	06 June 2022
Case completed	14 September 2023
Appeal	No appeal
Breach clauses	2, 3.2, 4.1, 4.9, 4.10, 7.11, 9.1, 14.1
No breach clauses (as ruled for specific allegations)	2, 3.2, 7.2, 7.4, 9.1
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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What happened

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A health professional complained about a P3 Pharmacy article (an interview/profile involving a Teva senior leader) that mentioned Ajovy and Copaxone.
Teva argued the piece was a third-party, biographical article initiated by P3 Pharmacy and therefore outside the Code; Teva said no payment was made and it did not receive the final item pre-publication.
The Panel reviewed correspondence showing Teva received a draft (25 Aug 2020) and suggested minor edits, indicating Teva was aware medicines would be referenced and had an opportunity to comment.
The Panel concluded the interview/article came within the scope of the Code and was promotional for Ajovy and Copaxone.
The article did not include prescribing information for either medicine, did not include the prominent adverse event reporting statement, did not include Ajovy’s black triangle, and had not been certified.
The article used the word “new” in relation to Copaxone despite long UK availability.
A statement implying Copaxone was for “multiple sclerosis” was found to imply a licence for all types of MS, inconsistent with the SPC (licensed for relapsing forms of MS).
Some challenged statements were found not proven to be in breach (Ajovy population description; pen convenience claim) due to lack of evidence from the complainant on those points.

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Outcome

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Breach rulings: Clauses 2, 3.2, 4.1, 4.9, 4.10, 7.11, 9.1, 14.1 (2019 Code).
No breach rulings (for specific allegations): Clauses 2, 3.2, 7.2, 7.4, 9.1 (2019 Code).
Panel view: omission of Ajovy’s black triangle was unacceptable and, combined with missing AE statement, warranted Clause 2 censure.
Case timeline: complaint received 6 June 2022; case completed 14 September 2023.
No appeal.

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Clauses

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Breach of Clause 3.2 Promoting a medicine in a manner that was inconsistent with the particulars listed in its summary of product characteristics.
Breach of Clause 4.1 Failing to include prescribing information
Breach of Clause 4.9 Failing to include the prominent adverse event reporting statement
Breach of Clause 4.10 Failing to include a black triangle
Breach of Clause 7.11 Referring to a product as ‘new’ when it has generally been available for more than twelve months in the UK
Breach of Clause 9.1 Failing to maintain high standards
Breach of Clause 14.1 Failing to certify promotional material
Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.2 Requirement that a medicine must be promoted in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics
No Breach of Clause 7.2 Requirement that claims/information/comparisons must not be misleading
No Breach of Clause 7.4 Requirement that claims/information/comparisons must be capable of substantiation
No Breach of Clause 9.1 Requirement to maintain high standards at all times.
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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Key facts

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