The Australian Pharmaceutical Manufacturers Association Code of Conduct1 provides guidelines for the ethical marketing and promotion of prescription pharmaceutical products in Australia. It complements the legal requirements of the Therapeutic Goods Regulations and the Therapeutic Goods AdministrationCompliance with the Code is a condition of APMA membership, and the Association's members represent more than 90% of pharmaceutical companies. The Code, established in 1960, is regularly revised.
The Code has two arms, a complaint driven mechanism and a monitoring function. Two independent committees are responsible for these functions. The Code of Conduct Committee considers complaints to determine whether a breach of the Code has occurred, and if so, the appropriate sanction that should be imposed. The most severe sanction is expulsion from the APMA, but this has never been used.2 Pharmaceutical companies can appeal against the decision of the Committee.
The Committee comprises representatives from industry and organisations such as the Consumers' Health Forum, a patient support organisation, the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, the Royal Australian College of General Practitioners and the Australian Medical Association.
The independent Monitoring Committee reviewed over 380 pieces of promotional material during the year for products in the systemic anti-infectives and antihypertensive therapeutic classes. Compliance with the Code of Conduct ranged from 82% to 95%. Advice regarding the outcomes of the Committee's deliberations was provided to the relevant companies to enhance their compliance with the Code.
Breaches of the Code (Table 1)
In the interests of transparency, the Code includes a requirement for regular publication of Code breaches in medical journals. This information includes the names of companies who have had complaints brought against them, a summary of the complaints and sanctions imposed.
In 2000-01 37 complaints were received. Most (22) of these were from pharmaceutical companies, but 10 were from health professionals. Four of the complaints were subsequently withdrawn, one was returned to the complainant. Three were resolved by inter company discussions and mediation. Two complaints were not considered because they were similar to previous complaints.
Of the 27 complaints evaluated by the Committee, 17 were found to be in breach of the Code. (The results of an appeal about one complaint are not yet known.)
Table 1 Efficacy of daclatasvir and sofosbuvir in hepatitis C
|Sanction imposed by Code of Conduct Committee|
|Bayer||1||Adalat Oros||nifedipine||Advertisements not to be used again|
|Withdrawal of poster|
|Eli Lilly||1||Zyprexa||olanzapine||Advertisements not to be used again|
|Glaxo Wellcome||4||Relenza||zanamivir||Advertisements not to be used again
Radio and television commercials not to be used again
|Flixotide||fluticasone||Advertisement not to be used again|
|$15 000 fine|
|1||Zocor||simvastatin||Corrective advertisment required|
|Organon||1||Livial||tibolone||Promotional mailer not to be used again|
|Corrective letter required|
|Promotional material not to be used again
Withdrawal of materials
|Solvay||4||Femoston||oestradiol with dydrogesterone||$5000 fine; withdrawal of promotional material|
|Duphaston||dydrogesterone||Promotional material not be used again|
|Teveten||eprosartan||$5000 fine; promotional material not to be used again|
|Promotional competition||Promotional material not to be used again|
The APMA Code of Conduct is available from:
Australian Pharmaceutical Manufacturers Association
Level 1, 16 Napier Close
DEAKIN ACT 2600
Tel: (02) 6282 6888
Fax: (02) 6282 6299
Web site: www.apma.com.au
- Australian Pharmaceutical Manufacturers Association. Code of Conduct of the Australian Pharmaceutical Manufacturers Association. 13th ed. Sydney: Australian Pharmaceutical Manufacturers Association Inc.; 2000.
- Roughead EE. The Australian Pharmaceutical Manufacturers Association Code of Conduct: guiding the promotion of prescription medicines. Aust Prescr 1999;22:78-80.