MHRA v Grünenthal: pre-licence “softening the market” for tapentadol via HELMs (AUTH/2327/6/10)

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Key facts

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Case number	AUTH/2327/6/10
Complainant	Medicines and Healthcare products Regulatory Agency (MHRA)
Company	Grünenthal
Medicine	Tapentadol (trade name Palexia)
Issue	Promotion of an unlicensed medicine prior to marketing authorisation via HELM activities, briefings and formulary mapping
Applicable Code year	2008
Complaint received	25 June 2010
Undertaking received	7 September 2010
Completed	22 March 2012
Breach clauses	Clause 2, Clause 3.1, Clause 9.1
PMCPA process note	PMCPA report to the Appeal Board; no appeal hearing
Sanctions	Audits and re-audits; public reprimand; undertaking
Key compliance theme	Pre-authorisation “softening the market” and inadequate governance/certification of market access activity

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

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What happened

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The MHRA alerted the PMCPA that it was concerned Grünenthal was promoting unlicensed tapentadol (Palexia) to health professionals before marketing authorisation.
MHRA knew from earlier correspondence that HELMs had contacted around 3,000 health professionals about tapentadol’s budgetary implications pre-authorisation; MHRA deemed that activity promotional and had previously censured the company.
An anonymous allegation to MHRA claimed Grünenthal continued targeting health professionals, with call rates and supporting materials (including slides) for proactive NHS discussions.
After January 2010, Grünenthal’s HELMs undertook “formulary mapping” and were briefed with materials that included tapentadol-related content and questions designed to elicit views on where tapentadol/new pain drugs would fit (eg analgesic ladder, value, attitudes).
HELMs visited NHS medicines approval/purchase stakeholders and also promoted Grünenthal’s licensed pain products (Tramacet, Versatis, Zydol), meaning customers would likely perceive them as promotional representatives.
Briefing slides suggested “Basic tapentadol information can be given verbally” and included examples comparing tapentadol with oxycodone (marked “not approved for distribution”), without clear boundaries on what could/could not be said.
The Panel considered this activity amounted to “softening of the market” for an unlicensed medicine and noted inadequate written instruction to HELMs, despite MHRA concerns.
The Appeal Board was also concerned that presentations/briefing materials for HELMs had not been certified and questioned senior management control of a newly appointed market access team working on an unlicensed medicine.

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Outcome

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Breach found: the Panel ruled that asking formulary mapping questions about tapentadol/new pain drugs amounted to promotion prior to marketing authorisation.
Breach found: high standards were not maintained.
Breach found: the conduct brought discredit upon and reduced confidence in the industry (Clause 2).
The Panel reported the company to the Code of Practice Appeal Board (Paragraph 8.2 of the Constitution and Procedure).
The Appeal Board required an Authority-led audit of Grünenthal’s Code procedures, followed by multiple re-audits.
Following later audits, the Appeal Board issued a public reprimand relating to misinformation in Grünenthal’s response to the Authority (in the context of audit follow-up).
After a fourth audit (February 2012), the Appeal Board noted cultural and senior staff changes and decided no further action was required, provided continual improvement continued.

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Key facts

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