Roche: £10 vouchers for children in Pulmozyme adherence programme (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
Issue	Patient adherence programme offering £10 high-street vouchers for returning 30 ampoule tops; concerns about incentivising children/teenagers and lack of assurance medicine was taken
Programme start	Developed June 2004; live September 2004
Intended closure	By September 2007 (moved to online education); no new patients enrolled after September 2007
Vouchers continued until	End of May 2008 (discovered June 2008)
Applicable Code	2006
Breach clauses	Clause 2, Clause 9.1, Clause 20.2
No breach clauses	Clause 18.1; Clause 18.2
Panel view	Incentive scheme “totally unacceptable”; likely to lead patients to ask doctor to prescribe Pulmozyme; brought discredit on industry; serious lack of control as vouchers continued after closure instruction
Appeal	No appeal; Panel report to Appeal Board
Appeal Board	Concerned about lack of effectiveness measurement and continued voucher distribution after withdrawal; no further action on additional sanctions
Complaint received	03 September 2008
Undertaking received	17 October 2008
Completed	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, a £10 voucher/gift card for high-street stores (eg Boots, Tesco, Toys R Us) was sent.
The complainant alleged the scheme effectively paid children to continue a prescription-only medicine, with no assurance the medicine was taken as prescribed (caps could be removed without dosing), raising patient safety and NHS waste concerns.
Roche said no new patients were enrolled after September 2007 and the voucher scheme was intended to close by September 2007, but vouchers continued to be processed and sent until end of May 2008 due to agency continuation.
Roche representatives had cycle goals (2004/2005) to recruit patients; representatives were initially financially rewarded based on number of patients enrolled.
The Panel considered the case under the 2006 Code (using the 2008 Constitution and Procedure).

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Breach found of Clause 20.2 (patients likely to ask their doctor to prescribe Pulmozyme once enrolled and aware of vouchers).
Breach found of Clause 9.1 (incentive scheme deemed totally unacceptable; high standards not maintained).
Breach found of Clause 2 (arrangements brought discredit upon and reduced confidence in the pharmaceutical industry).
No breach of Clause 18.1 (benefit was to patients, not health professionals or administrative staff, so not an inducement to prescribe etc).
No breach of Clause 18.2 (vouchers were not promotional aids for health professionals; Panel noted vouchers did not meet supplementary information expectations for gifts to patients, but Clause 18.2 itself related to promotional aids to health professionals).
Panel reported Roche to the Appeal Board for consideration of additional sanctions (Paragraph 8.2), partly due to continued voucher distribution after closure instructions.
Roche accepted the Panel’s rulings; no appeal. Appeal Board considered the report and decided no further action was required regarding additional sanctions.

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