Boehringer Ingelheim: Global LinkedIn InMail promoting Giotrif reached UK recipients without UK certification or mandatory information (AUTH/2738/10/14)

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Key facts

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Case number	AUTH/2738/10/14
Company	Boehringer Ingelheim Limited (UK responsible for UK use); email created/distributed by Boehringer Ingelheim Corporate (Germany)
Product	Giotrif (afatinib)
Channel	LinkedIn InMail (global email to LinkedIn members)
Headline/content	“Read new data on treatment outcomes with Giotrif”; ASCO 2014 abstract results; Giotrif ad; link to press release marked “For Ex-US and Ex-UK Media Only”
Key issues	Not UK certified; missing prescribing information; missing AE reporting statement; missing inverted black triangle; unbalanced data/subgroup OS emphasis; misleading artwork; likely reached some with no interest and on balance of probabilities a UK member of the public; POM promotion to public
Complaint received	31 October 2014
Case completed	9 January 2015 (PMCPA page lists completed 09 February 2015)
Applicable Code year	2014
Breach clauses	4.1, 4.10, 4.11, 7.2, 7.8, 7.10, 9.1, 11.1, 14.1, 23.1, 23.2
No breach clauses	2, 4.6, 4.9, 9.10
Sanction	Undertaking received
Appeal	No appeal

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

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Boehringer Ingelheim Corporate (Germany) sent a LinkedIn InMail on 13 August 2014 to a global audience (including some UK recipients) headed “Read new data on treatment outcomes with Giotrif”.
The InMail included results from an ASCO 2014 abstract (Yang et al 2014), a Giotrif (afatinib) advertisement, and a link to a Giotrif press release marked “For Ex-US and Ex-UK Media Only”.
Targeting relied on LinkedIn filters (medical/oncology and not opted out), but these were not restrictive enough to exclude UK non-health professionals.
The email/materials were not UK approved or certified and did not include obligatory UK information (including prescribing information, adverse event reporting statement, and inverted black triangle).
Another UK pharmaceutical company raised the issue; intercompany dialogue led Boehringer Ingelheim to self-report to the PMCPA. The communication was withdrawn from UK LinkedIn members.
Boehringer Ingelheim acknowledged the presentation was unbalanced (subset OS data only) and that artwork could mislead about the basis of the licence; tolerability information was absent.

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Breach rulings: Clauses 4.1, 4.10, 4.11, 7.2, 7.8, 7.10, 9.1, 11.1, 14.1, 23.1 and 23.2.
No breach rulings: Clauses 2, 4.6, 4.9 and 9.10.
The Panel emphasised that UK companies are responsible for overseas affiliate activity where it comes within the scope of the Code (here, sending to UK recipients).
The Panel queried whether “not opting out” on LinkedIn is sufficient consent for receiving promotional material (Clause 9.9 was discussed but not ruled upon in this case).

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