AUTH/2927/1/17: BBC ‘landmark’ headline for unlicensed ocrelizumab trials – no breach (Roche) | PMCPA Case

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Key facts

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Case number	AUTH/2927/1/17
Company	Roche
Complainant	Anonymous, non-contactable (stated co-owner of a healthcare PR company)
Material	BBC website article (22 December 2016) and Roche UK press release relating to NEJM publication
Medicine	Ocrelizumab (unlicensed at the time)
Therapy area	Multiple sclerosis (primary progressive MS; relapsing remitting MS)
Key issue	Whether company activity amounted to impermissible public promotion / unbalanced information (focus on “landmark” tone)
Applicable Code year	2016
Clauses considered	2, 9.1, 26.2
Decision	No breach
Complaint received	04 January 2017
Case completed	07 February 2017
Appeal	No appeal

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

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An anonymous, non-contactable complainant challenged a BBC website article (22 Dec 2016) titled ‘Multiple sclerosis drug “a landmark”’ about two Phase III trials of Roche’s unlicensed medicine ocrelizumab (primary progressive MS and relapsing remitting MS).
The complainant questioned whether the results described (eg deterioration 39% to 33%; relapse rate “half” vs another drug) justified “landmark” language and how this could be permitted as public promotion pre-licence.
Roche UK had issued a press release timed to NEJM publication and provided it (under embargo) to a BBC journalist on request; Roche also facilitated access to Professor Giovannoni.
The BBC article included “landmark/big news” language and quotes attributed to the MS Society and an NEJM editorial by Dr Calabresi; Roche stated it did not provide those quotes and did not use “landmark” in its press release.
The Panel assessed the company material that might have prompted the article (the Roche press release and related emails), not the BBC’s independent journalism.

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No breach of the Code (Applicable Code year: 2016).
No breach of Clause 26.2 (on the narrow ground alleged).
No breach of Clause 9.1.
No breach of Clause 2.
The Panel noted it could not consider Clauses 26.1 or 3.1 because the company had not been asked to respond on those clauses.

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