Article
Medicines Australia Code of Conduct: breaches
- Aust Prescr 2004;27:176
- 1 February 2004
- DOI: 10.18773/austprescr.2004.004
Medicines Australia (formerly the Australian Pharmaceutical Manufacturers Association) has a code of conduct to guide the promotion of prescription drugs in Australia.1,2
The report of the Code of Conduct Committee for 2003 says that 48 new complaints about drug promotion were received. Five complaints were withdrawn and some are unresolved, so the report details the assessment of 36 cases.3
Most of the complaints came from rival pharmaceutical companies, but 11 came from health professionals, five were made by the Therapeutic Goods Administration and one by a consumer organisation. Seven complaints were found not to involve a breach of the Code of Conduct and one was dismissed by the Code of Conduct Appeals Committee. This leaves 28 complaints in which at least one breach of the Code was found (Table 1).
The Medicines Australia Code of Conduct is available from:
Medicines Australia
Level 1, 16 Napier Close
DEAKIN ACT 2600
Tel: (02) 6282 6888
Fax: (02) 6282 6299
Web site: www.medicinesaustralia.com.au
1. Roughead EE. The Australian Pharmaceutical Manufacturers Association Code of Conduct: guiding the promotion of prescription medicines. Aust Prescr 1999;22:78-80.
2. Medicines Australia. Code of Conduct. 14th ed. Canberra: Medicines Australia; 2003.
3. Medicines Australia. Code of Conduct Annual Report 2003. Canberra: Medicines Australia; 2003.
Table 1
Breaches of the Code of Conduct July 2002 - June 2003 |
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| Company | Complaint | Sanction imposed by Code of Conduct Committee |
|
|---|---|---|---|
|
|
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| Drug - brand name |
Drug - generic name |
||
|
|
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| Alcon | Travatan | travoprost | Withdrawal of promotional material. Corrective letter $10 000 fine |
| Travatan | travoprost | $45 000 reduced to $7500 on appeal | |
| Travatan | travoprost | Withdrawal of promotional material $60 000 fine |
|
| AstraZeneca | Arimidex | anastrozole | Withdrawal of promotional material $7500 fine |
| Nexium | esomeprazole | Withdrawal of promotional material | |
| Aventis Pasteur | Vaxigrip | influenza vaccine | Withdrawal of patient leaflet |
| Aventis Pharma | Clexane | enoxaparin | Withdrawal of promotional material Publication of erratum notice |
| Baxter | NeisVac-C | meningococcal vaccine | Withdrawal of promotional material Corrective advertisement |
| NeisVac-C | meningococcal vaccine | Withdrawal of promotional material | |
| NeisVac-C | meningococcal vaccine | Withdrawal of promotional material $5000 fine |
|
| Bayer | Adalat Oros | nifedipine | Withdrawal of promotional material Corrective advertisement $15 000 fine |
| Boehringer Ingelheim | Mobic | meloxicam | Withdrawal of promotional material $15 000 fine |
| Bristol-Myers Squibb | Pravachol | pravastatin | Withdrawal of promotional material |
| CSL | Tramal | tramadol | Withdrawal of promotional material Corrective advertisement |
| CSL web site | Withdrawal of promotional material | ||
| Eli Lilly | Evista | raloxifene | Withdrawal of promotional material Corrective advertisement |
| Mayne Pharma | Pamisol | pamidronate | Inappropriate delivery of promotional material not to be repeated |
| Merck Sharp & Dohme | Fosamax | alendronate | Withdrawal of promotional material Corrective letter $25 000 fine |
| Mundipharma | Oxycontin | oxycodone | Withdrawal of promotional material |
| Novo Nordisk | Vagifem | oestradiol | Withdrawal of promotional material Amendments to web site |
| Public awareness campaign and web site | $20 000 fine | ||
| Organon | Livial | tibolone | Withdrawal of promotional material $10 000 fine |
| Pfizer | Viagra | sildenafil | Withdrawal of promotional material |
| Public advertisement | $10 000 fine | ||
| Viagra | sildenafil | $10 000 fine | |
| Pharmacy poster | |||
| Roche | Healthy Weight Taskforce web site | $75 000 fine reduced to $50 000 on appeal |
|
| Sanofi-Synthelabo | Stilnox | zolpidem | Advertisement not to be used again in lay media $50 000 fine |
| Schering-Plough | Elocon | mometasone | Withdrawal of promotional material |
| Wyeth | Efexor | venlafaxine | No further appearance of promotional material |
| Efexor | venlafaxine | No further appearance of promotional material |
|
Editorial Comment
A new edition of the Code of Conduct was implemented in 2003. Although there has not been a dramatic increase in complaints the Code of Conduct Committee has imposed more fines. Although these fines would be substantial for an individual they are relatively small in comparison to the companies' advertising budgets.
Readers of Australian Prescriber have expressed an interest in knowing more about the background of the complaints. More detail can be found in the report of the Code of Conduct Committee, but a common theme this year was the promotion of prescription medicines to the public.
Direct-to-consumer advertising is not allowed in Australia, so drug companies have to be careful that their information campaigns, such as disease-awareness activities, do not advertise their products.4Three of the breaches involve companies which provided information on web sites.
Novo Nordisk, which produces Vagifem (oestradiol) pessaries, promoted a web site about atrophic vaginitis, through hairdressers. While the hairdressers' capes, which displayed the web site address, were not considered to be educational material, the Code of Conduct Committee concluded that the information on the web site was sufficient to allow a woman to seek a prescription for a specific product.
Roche was found to have breached the code as it was not clear that it was the sponsor of the web site of the Healthy Weight Taskforce. It was also considered that Roche should take more responsibility for the activities of the Healthy Weight Taskforce, to ensure prescription medicines were not promoted to the public.
The Therapeutic Goods Administration complained about the CSL web site. This was found to contain information which could promote particular products to the public.
Other breaches of the code involved written material for consumers. A pharmacy poster about Pfizer's sildenafil was a serious breach, as was an in-flight magazine advertorial by Sanofi-Synthelabo. A pamphlet produced by Aventis Pasteur for patients to receive after influenza immunisation was considered to be promoting a particular product.
Two of the unsuccessful complaints involved competitions. The two companies involved had offered hand-held computers as prizes. As the Committee considered that the perceived value of the prizes was close to the limit of what might withstand public and professional scrutiny, no breaches were found.