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Medicines Australia Code of Conduct: breaches

(Aust Prescr 2007;30:153-5)

Medicines Australia has a Code of Conduct to guide the promotion of prescription drugs by pharmaceutical companies in Australia. A new edition of the Code has recently been approved.1 Complaints are considered by the Code of Conduct Committee and the results are published in its annual report. The report for 2006-07 is available on the Medicines Australia website.2

This year's report contains detailed information about 41 complaints. In fourteen cases no breach of the Code was found. Table 1 shows the 27 complaints in which at least one breach of the Code was found. As usual, most of the complaints were made by rival pharmaceutical companies, but 12 were made by health professionals.

Most of the breaches were for using misleading information in promotional material. Some of the larger fines were imposed on companies that had allowed the public to be exposed to their promotions. Two complaints related to a company which sponsored the national conference of a patient support group. An article, originally drafted for health professionals, but published in Reader's Digest, clearly breached the Code. Another breach, identified by several complaints, was offering a 'money-back guarantee' to patients being treated for erectile dysfunction.

The information in the report reveals some of the sophisticated strategies companies can use. One company had used a public relations consultant to manage a campaign about a medicine which had yet to be approved in Australia. This included sponsoring a journalist to attend an overseas conference about the drug. Issuing a media release on an unapproved drug was considered to be promotional activity which breached the Code.

The Committee had to grapple with what constitutes excessive hospitality. One company was fined for providing a function that was not 'simple or modest', while a function at the Crown Towers in Melbourne was ruled to be 'not extravagant'. Perhaps the new requirement for companies to disclose the cost of their promotional functions will help the Code of Conduct Committee decide what is appropriate.

Table 1 Breaches of the Code of Conduct July 2006 - June 2007 Company Drug Sanction imposed by Code of Conduct Committee brand name generic name Abbott Australasia Lucrin leuprorelin Withdraw material Corrective letter $10 000 fine Alcon Laboratories DuoTrav timolol maleate/ travoprost Cease program $10 000 fine Allergan Australia Lumigan bimatoprost Withdraw material Corrective letter $15 000 fine AstraZeneca Crestor rosuvastatin Withdraw promotional materials Corrective letter $75 000 fine reduced on appeal to $40 000 Nexium esomeprazole Withdraw materials $75 000 fine Bayer Healthcare Levitra (four complaints) vardenafil Withdraw money-back guarantee offer Corrective letters Corrective advertisement Boehringer Ingelheim Buscopan hyoscine Withdraw material $25 000 fine reduced on appeal to $10 000 Mobic meloxicam Withdraw materials Corrective letter $25 000 fine CSL Limited Biostate factor VIII $5000 fine dropped on appeal Behaviour of company representative Withdraw training material $15 000 fine GlaxoSmithKline Australia Rotarix rotavirus vaccine Withdraw materials Corrective letter $25 000 fine Tykerb lapatinib Provide no media releases until medicine registered $40 000 fine Janssen-Cilag Pariet rabeprazole Withdraw material $100 000 fine Pariet rabeprazole Withdraw material Other sanctions covered in previous breach Merck Sharp & Dohme Fosamax Plus alendronate Withdraw materials Octapharma Octanate factor VIII Withdraw materials Corrective letter $100 000 fine reduced on appeal to $10 000 Pfizer Australia Celebrex celecoxib Withdraw materials $100 000 fine Celebrex celecoxib Article not to be published again for general public $100 000 fine Xalacom latanoprost/ timolol maleate Withdraw material Corrective letter $50 000 fine Roche Products Hospitality $75 000 fine Sanofi-Aventis Stilnox zolpidem Withdraw materials $5000 fine Schering Betaferon interferon beta-1b Withdraw materials Corrective letters $150 000 fine Betaferon interferon beta-1b Withdraw materials Letter to Multiple Sclerosis Society $100 000 fine Angeliq drospirenone/ oestradiol Cease distribution of trade packs

References

1. Medicines Australia. Code of Conduct. 15th ed. 2006. Amended Aug 2007. http://www.medicinesaustralia.com.au [cited 2007 Nov 12]

2. Medicines Australia Code of Conduct Annual Report 2006/2007. Canberra: Medicines Australia; 2007. http://www.medicinesaustralia.com.au [cited 2007 Nov 12]