AUTH/2852/6/16: Ex-employee complaint about MSL proactive targeting at Grünenthal (No breach)

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Key facts

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Case number	AUTH/2852/6/16
Complainant	Anonymous, contactable ex-employee
Company	Grünenthal Ltd
Issue	MSL working practices; alleged proactive targeting of oncology/palliative care HCPs and alleged disguised/off-licence promotion of Palexia Oral Solution (tapentadol)
Medicine(s) mentioned	Palexia Oral Solution (tapentadol); Palexia SR; Palexia tablets; Versatis
Complaint received	20 June 2016
Case completed	14 September 2016
Applicable Code year	2016
Clauses considered	2, 3.2, 9.1, 11.1, 12.1, 15.2, 15.4, 15.9
Outcome	No breach
Appeal	No appeal

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

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An anonymous, contactable ex-employee complained about Grünenthal’s medical science liaison (MSL) working practices and alleged increasing commercial pressure in 2015.
The complainant alleged the MSL team (described as reactive and non-promotional) was required to work “100% proactively” with “every day is a field day”, targeting oncology and palliative care health professionals.
The complainant provided two emails: one sharing an oncology/palliative target list (top 100) and stating it would form part of end-of-year assessments; another (dated 2 June 2015) reminding MSLs to update calendars for field activity.
The complainant alleged MSLs were instructed verbally to steer conversations towards products (particularly Palexia Oral Solution (tapentadol)) and that this amounted to disguised promotion and off-licence promotion.
Grünenthal denied any instruction to discuss products, stated proactive activity was limited to introducing the MSL role, and cited internal policies allowing proactive role introduction while prohibiting proactive discussion of specific medicines.
Grünenthal acknowledged a lack of written briefing documents and absence of meeting minutes, describing this as not good business practice, and said future meetings would be documented.
The Panel noted the broad definition of “promotion” and considered elements of the MSL role could be promotional, meaning Code requirements for representatives could apply in practice.

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No breach of the Code was ruled in relation to the allegations.
The Panel considered the complainant had not proven, on the balance of probabilities, that MSLs were briefed to promote products or that off-licence/disguised promotion occurred.
The Panel noted the lack of written records was regrettable because it left the company without evidence to support its position, but the burden of proof remained with the complainant.

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