Roche: UK press release linked to US public website about Herceptin (AUTH/1857/6/06)

📊

Key facts

⌄

Case	AUTH/1857/6/06
Parties	A Consultant in Public Health Medicine v Roche
Product	Herceptin (trastuzumab)
Main issue	Alleged pre-authorisation promotion for adjuvant early breast cancer; and public promotion via link to US-facing website
Applicable Code year	2003
Complaint received	29/30 June 2006 (reported as 29 June 2006 on case page; 30 June 2006 in report)
Case completed	11/12 January 2007 (reported as 11 January 2007 on case page; 12 January 2007 in report)
Breach	Clause 20.1
No breach	Clauses 2, 9.1, 20.4
Sanctions	Undertaking received; additional sanctions not stated
Trigger for breach finding	Roche UK press release (13 May 2005) aimed at lay UK media referenced HER2status.com, a US-aimed public site inferred to promote POMs

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

📋

⌄

A consultant in public health medicine alleged Roche promoted Herceptin (trastuzumab) for adjuvant treatment of HER2-positive early breast cancer before the UK marketing authorisation.
Allegations included: funding HER2 testing creating patient expectation of Herceptin; links/support to a patient group campaigning for access; direct-to-patient advertising via the HER2status.com website; and media activity (including an International Herald Tribune article).
Roche said HER2 testing was clinically important (including for the already-licensed metastatic indication) and that its support was a permissible NHS service (citing Clause 18.4) and not linked to promotion.
Roche said the HER2status.com website was developed in Switzerland and aimed at US citizens (where DTC promotion is permitted), and that Roche UK had no input into it.
On appeal, it was established that a Roche UK press release dated 13 May 2005 (circulated to the lay UK media and archived on Roche UK’s website) included the HER2status.com address under “further information”.

⚖️

⌄

Breach found (on appeal): Clause 20.1.
No breach: Clauses 2, 9.1 and 20.4 (and, in relation to alleged direct patient contact, no breach of Clauses 20.1 and 20.2 was upheld).
The Appeal Board inferred, on the balance of probability, that the US-aimed website promoted prescription only medicines to the public; referencing it in a UK press release aimed at lay media amounted to promotion of a prescription only medicine to the public.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access