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
|