Sandoz Omnitrope patient support items: water bottle and rucksack ruled in breach (Clause 18.2), soft toy allowed

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Key facts

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Case number	AUTH/2451/11/11
Complainant	Merck Serono Limited
Respondent	Sandoz Ltd
Product	Omnitrope (somatropin)
Issue	Soft toy, water bottle and rucksack/backpack supplied as patient support items and referenced in promotional materials
Complaint received	03 November 2011
Case completed	17 January 2012
Applicable Code year	2011
Breach clauses	Clause 18.2 (x2)
No breach findings	Soft toy acceptable under Clause 18.2; cost threshold met (≤ £6 plus VAT per item)
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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Merck Serono complained about three items supplied by Sandoz as part of an Omnitrope (somatropin) patient support package (“Sproutz”): a soft toy, a water bottle and a backpack/rucksack.
The items were also referenced in Omnitrope promotional materials (including exhibition stand posters, a display unit containing the items, leavepieces and a video).
Merck Serono argued the items were not related to treatment of growth hormone deficiency and that there was no scientific evidence they improved adherence; it also questioned whether the backpack cost exceeded the “inexpensive” threshold.
Sandoz argued the items were provided only after Omnitrope had been prescribed, as part of a formal support programme intended to aid adherence and general health (comforter to reduce fear of injections; rucksack to help transport supplies; water bottle to support hydration/general health initiatives).
The Panel assessed each item individually against the Code requirements for patient support items (inexpensive and directly benefiting patient care, and part of a documented/certified programme).

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Soft toy: No breach of Clause 18.2 (on balance, could directly benefit patient care as a comforter to help children cope with daily injections and aid compliance).
Water bottle: Breach of Clause 18.2 (hydration is generally beneficial, but not shown to be directly related to growth hormone deficiency/patient care in this context).
Rucksack/backpack: Breach of Clause 18.2 (not appropriate for storing Omnitrope which required 2–8°C storage; therefore not sufficiently related to treatment or directly benefiting patient care).
Cost/inexpensive test: No breach—Sandoz invoices showed unit cost for each item was £6 or less plus VAT (i.e., within the “inexpensive” definition referenced by the Panel).
The Panel noted that the breach findings regarding the water bottle and rucksack would apply to any other materials referring to those items.
No appeal.

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