Roche Pulmozyme cystic fibrosis adherence scheme: £10 vouchers for children led to Code breaches (AUTH/2165/9/08)

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Key facts

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Case	AUTH/2165/9/08
Parties	Anonymous employee v Roche Products Limited
Product	Pulmozyme (dornase alpha)
Therapy area	Cystic fibrosis
Activity	Patient adherence and incentive programme (ampoule tops for vouchers)
Incentive	£10 voucher/gift card for high street stores for every 30 ampoule tops returned
Target group	Children/teenagers (scheme aimed at ages 8–16)
Key control issue	Vouchers continued to be distributed until end of May 2008 despite instruction to close by September 2007
Complaint received	03 September 2008
Applicable Code year	2006
Breach clauses	Clause 2; Clause 9.1; Clause 20.2
No breach clauses	Clause 18.1; Clause 18.2
Panel escalation	Reported to Appeal Board under Paragraph 8.2 for consideration of additional sanctions
Undertaking received	17 October 2008
Appeal	No appeal (report by Panel to the Appeal Board)
Appeal Board consideration	13 November 2008

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

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An anonymous Roche employee complained about a cystic fibrosis (CF) patient adherence and incentive programme run since 2004 for Pulmozyme (dornase alpha).
Children/teenagers (aimed at ages 8–16) collected Pulmozyme ampoule tops; for every 30 returned to an agency acting for Roche, the patient received a £10 voucher/gift card for high street stores (eg Boots, Tesco, Toys R Us).
The complainant raised concerns that the scheme effectively paid children to continue using a prescription-only medicine, with no assurance the medicine was taken as prescribed (caps could be removed without dosing), creating potential patient safety and NHS waste concerns.
Roche said it decided in 2007 to replace the voucher scheme with an online educational programme and instructed the agency to close the voucher scheme by September 2007; no new patients were enrolled after September 2007.
Despite the instruction to close, vouchers continued to be processed and sent until the end of May 2008; Roche discovered this in June 2008, indicating a serious lack of control over the agency.
Roche representatives had cycle goals (2004/2005) to recruit patients to the programme and were initially financially rewarded based on the number of patients enrolled, raising concern about potential influence on prescribing.

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Applicable Code year: 2006 (using the 2008 Constitution and Procedure).
Breach found of Clause 20.2 (statements/activities encouraging members of the public to ask their health professional to prescribe a specific prescription-only medicine).
Breach found of Clause 9.1 (failure to maintain high standards).
Breach found of Clause 2 (bringing discredit upon and reducing confidence in the pharmaceutical industry).
No breach of Clause 18.1 (no gift/pecuniary advantage to health professionals as an inducement to prescribe etc).
No breach of Clause 18.2 (vouchers were not promotional aids to health professionals; however the Panel noted patient gifts should be inexpensive and related to the condition/general health and must meet Code requirements, particularly Clause 20).
Panel reported Roche to the Appeal Board for consideration of additional sanctions (Paragraph 8.2), citing the unacceptable scheme and continued voucher distribution after closure.
Roche accepted the Panel’s rulings and did not appeal.
Appeal Board expressed serious concerns (including lack of effectiveness measurement and lack of control over continued voucher distribution) but decided no further action was required regarding additional sanctions in the circumstances.

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