Merck Serono: iPad app used by reps before certification (AUTH/2804/11/15)

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Key facts

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Case	AUTH/2804/11/15
Parties	Anonymous health professional/Director v Merck Serono
Main issues	Call rates/pressure to attend meetings; use of uncertified promotional material (banner; iPad app; alleged congress stands)
Product referenced	Rebif (interferon beta-1a)
Complaint received	30 November 2015
Case completed	05 February 2016
Applicable Code year	2015
Breach clauses	Clause 2, Clause 9.1, Clause 14.1
No breach clauses considered	Clause 2, Clause 9.1, Clause 14.1, Clause 15.2, Clause 15.4, Clause 15.9, Clause 29 (no breach ruled for 15.2/15.4/15.9/29 and for certain 14.1 allegations)
Material identifiers	REB14-0067 (pull-up banner; not used); REB15-0004 (iPad app; uploaded before certification)
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal

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

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An anonymous, non-contactable complainant (self-described senior neurologist) alleged persistent rep approaches (including to MS nurses) and pressure to attend meetings with no information, and suggested targets would breach permitted call rates.
Because call rates had been an issue in a prior case (AUTH/2756/5/15), the complaint included an implied allegation of breach of undertaking (taken up by the Director).
The complainant alleged use of uncertified promotional materials, including: a pull-up exhibition banner for Rebif (REB14-0067) and an iPad app for neurology representatives (REB15-0004), plus uncertified stands at MS Trust and ABN congress.
Merck Serono stated the pull-up banner was never used (campaign cancelled; job withdrawn) and that materials at MS Trust/ABN were certified.
Merck Serono admitted the iPad app had been uploaded to representatives’ iPads before it was fully reviewed and certified; it was recalled on 1 September 2015. The email indicated the app had been launched to reps in March 2015.

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No breach was established for alleged over-calling/inconvenience and related allegations because the complainant provided no substantiating evidence and the Panel could not determine timing relative to the prior undertaking.
No breach of Clause 14.1 for the pull-up banner (REB14-0067) because it was not used and there was no evidence to the contrary.
Breach of Clause 14.1 for the iPad app (REB15-0004) being available to reps before certification.
Breach of Clause 9.1 (high standards) due to failure to certify the app.
Breach of Clause 2 (bringing discredit/reducing confidence) given the company’s poor record on certification, noted as particularly disappointing in light of prior issues.
Panel also noted concern that the undertaking in AUTH/2756/5/15 was signed 24 July 2015 but representatives were not re-briefed about calls until 16 September 2015 (requested the company be advised of this concern).

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