Gilead ruled in breach for failing to comply with an undertaking: Biktarvy tolerability claim remained on website

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Key facts

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Case number	AUTH/3282/11/19
Case reference	VIIV/DIRECTOR v GILEAD
Complainant	ViiV Healthcare UK Ltd; also taken up in the name of the Director
Respondent/company	Gilead Sciences Europe Ltd
Product(s)	Biktarvy (bictegravir/emtrictabine/tenofovir); Juluca (dolutegravir/rilpivirne)
Material/channel	UK-accessible website; password-protected health professional pages of Gilead’s hiv.eu website
Key issue	Continued publication of a claim previously ruled in breach after an undertaking was signed (breach of undertaking)
Dates (received/completed if stated)	Complaint received 21 November 2019; Case completed 29 January 2020
Appeal	Related claim was subject of an unsuccessful appeal in Case AUTH/3137/12/18; Appeal Board ruled breach on 9 October 2019
Code year	Not stated
Breaches/clauses	Clauses 29, 9.1 and 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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ViiV Healthcare UK Ltd alleged Gilead Sciences Europe Ltd breached an undertaking given in Case AUTH/3137/12/18 by continuing to use the claim that Biktarvy (bictegravir/emtrictabine/tenofovir) was “Better tolerated than DTG [dolutegravir] – containing regimens”.
The claim had been ruled in breach by the Code of Practice Appeal Board on 9 October 2019 (following an unsuccessful appeal by Gilead).
Gilead was informed of the appeal outcome on 6 November 2019 and provided an undertaking dated 18 November 2019 accepting the Appeal Board’s decision.
ViiV provided screenshots dated 20 November 2019 showing the claim still appeared on a UK-accessible website owned by Gilead.
The complaint was also taken up in the name of the Director because the Authority was responsible for ensuring compliance with undertakings.
Gilead investigated and identified similar material on password-protected health professional pages of its hiv.eu website; corrective action was taken on 22 November 2019 to remove the claims.

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The Panel ruled there had been a failure to comply with the undertaking given in Case AUTH/3137/12/18.
A breach of Clause 29 was ruled (as acknowledged by Gilead).
A breach of Clause 9.1 was ruled (as acknowledged by Gilead) because high standards had not been maintained.
The Panel ruled a breach of Clause 2, finding the failure to comply with the undertaking brought discredit upon, and reduced confidence in, the pharmaceutical industry.

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