Sandoz: Omnitrope cool bag exceeded £10 limit and withdrawal not communicated proactively (AUTH/3685/8/22)

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Key facts

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Case	AUTH/3685/8/22
Parties	Complainant v Sandoz
Medicine	Omnitrope (somatropin)
Issue	Provision of an Omnitrope cool bag above the “inexpensive” limit and lack of proactive transparency when withdrawing the cool bag
Item cost	Net £13.66 in 2022 (also stated: 13.91 EUR prior to 2019)
Relevant requirement	“Inexpensive” patient support item defined as cost to company no more than £10 excluding VAT (supplementary information to Clause 19.2)
Withdrawal timing	April 2022
Complaint received	18 August 2022
Case completed	22 August 2023
Applicable Code year	2021
Breach clauses	Clause 19.2; Clause 5.1
No breach clauses	Clause 19.1; Clause 2
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions: Not stated

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

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A health professional complained after patients reported Sandoz had stopped providing an Omnitrope insulated cool bag (with six cool packs) previously included in a “starter pack”/package deal.
Omnitrope (somatropin) is a cold-chain medicine requiring storage/transport at 2–8°C; the cool bag helped patients transport medicine.
Sandoz said the cool bag cost was net £13.66 in 2022 (and had been 13.91 EUR prior to 2019), and a final medical signatory flagged it might be a patient support item above the Code’s £10 limit.
Sandoz withdrew the cool bag from the package deal in April 2022; it briefed sales internally and provided a template email for external use, but only on a reactive basis.
The Panel considered that for items ultimately owned by patients/carers, compliance with both package deal principles and patient support item rules (including the financial limit) was required.
The Panel found it appeared Sandoz did not communicate the withdrawal proactively to purchasers of the package deal or to health professionals prescribing Omnitrope; the complainant learned initially from patients.

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Breach of Clause 19.2 Providing an item for patient support that did not meet the Code definition of ‘inexpensive’
Breach of Clause 5.1 Failing to maintain high standards
No Breach of Clause 19.1 Requirement that no gift, pecuniary advantage or benefit may be supplied, offered or promised to health professionals or other relevant decision makers in connection with the promotion of medicines, or as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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