VOLUME 24 : NUMBER 2 : February 2001
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Aust Prescr 2001;24:42-3
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 Administration. The Code provides guidelines for promotional tools such as advertising, product starter packs (samples), mailings, gifts, trade displays, travel, sponsorship, entertainment, and the behaviour and training of medical representatives. It also covers relationships with health professionals, and most recently, information on the internet.
Compliance 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 depends on a complaints process.2 An independent 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 organisations such as the Therapeutic Goods Administration, Consumers' Health Forum, a patient support organisation - currently the Arthritis Foundation of Australia, the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, the Royal Australian College of General Practitioners and the Australian Medical Association.
|Company||Breaches||Drug - brand name||Drug - generic name||Sanction imposed by Code of Conduct Committee|
|Alcon||1||Betoptic S||betaxolol||Corrective letter to be sent to specialists|
|Boehringer Ingelheim||1||Persantin||dipyridamole||$5 000 fine; withdrawal of promotional material|
|Bristol-Myers Squibb||4||Pravachol||pravastatin||$12 500 fine for repeat of previous breach; withdrawal of material|
|Serzone||nefazodone||$5 000 fine|
|Iscover||clopidogrel||Withdrawal of promotional material|
|Eli Lilly||1||Evista||raloxifene||Withdrawal of promotional material|
|Galderma||1||Loceryl||amorolfine||Withdrawal of promotional material|
|Glaxo Wellcome||2||Relenza||zanamivir||Withdrawal of advertising|
|Pritor||telmisartan||Warning against future breach of Code; review of internal procedure|
|Merck Sharp & Dohme||4||Zocor||simvastatin||None|
|Fosamax||alendronate||$5 000 fine; withdrawal of advertising. Further $10 000 fine for repeat of previous breach|
|Vioxx||rofecoxib||$10 000 fine|
|Mundipharma||1||Oxycontin||oxycodone||Material not to be used again|
|Novartis||1||Lamisil||terbinafine||Withdrawal of material|
|Novo Nordisk||2||Kliogest||norethisterone/oestradiol||$5 000 fine; material not to be used again|
|Kliovance||norethisterone/oestradiol||Cessation of activity; corrective letter to be sent to prescribers|
|Pfizer||2||Zoloft||sertraline||$10 000 fine; withdrawal of material. Further $25 000 fine (including $10 000 fine for repeat breach); withdrawal of material|
|Pfizer/Searle||1||Celebrex||celecoxib||$10 000 fine; withdrawal of promotional material|
|Pharmacia & Upjohn||2||Fragmin||dalteparin||Withdrawal of promotional material|
|Caverject||alprostadil||Action to ensure use of correct font size in advertisements|
|Rhone-Poulenc Rorer||1||Clexane||enoxaparin||$15 000 fine; withdrawal of promotional material|
|Roche||1||Rocaltrol||calcitriol||$7 500 fine; withdrawal of advertising|
|Sanofi-Synthelabo||1||Plavix||clopidogrel||Withdrawal of material|
|Searle||1||Lomotil||atropine/diphenoxylate||Withdrawal of material; corrective advertisement placed|
|Wyeth||1||Premarin and Premia||conjugated oestrogens||Withdrawal of material|
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 1999-2000 44 complaints were received. (Six of these were subsequently withdrawn, one was referred elsewhere and three were returned to the complainant.) Of the 34 complaints evaluated by the Committee, 28 were found to be in breach of the Code. There was a variety of problems dealt with by the Committee (see box).
Two complaints were found not to be breaches of the Code, but prompted the APMA to consider modifications to the Code:
Examples of Code breaches
Statements in the promotional material overstated the attributes of oxycontin and promised more than the product could reasonably be expected to deliver. One statement was probably misleading because it implied that oxycontin is first-line therapy (contrary to the approved indications). Statements used in an unqualified manner may have encouraged excess usage of oxycontin and were therefore inappropriate and misleading.
Healthcare professionals were invited to participate in a project that was not clearly identified as market research. Offering payment for their participation in a Product Familiarisation Programme and giving them a three month free supply of Kliovance was not permitted under the Code.
N O T E
The APMA Code of Conduct is available from:
Australian Pharmaceutical Manufacturers Association
Level 7, 88 Walker Street
North Sydney NSW 2060
Tel: (02) 9922 2699
Fax: (02) 9959 4860