APMA Code of Conduct

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.

Table 1
Breaches of the Code of Conduct July 1999 - June 2000

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:

  • a complaint about using a telemarketing campaign to advise prescribers of a change in the availability of Losec
  • a complaint about sending letters to patients encouraging them to lobby their Members of Parliament to support the listing of Aricept on the Pharmaceutical Benefits Scheme.

Examples of Code breaches

Oxycontin

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.

Kliovance

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.

References

  1. Australian Pharmaceutical Manufacturers Association. Code of Conduct of the Australian Pharmaceutical Manufacturers Association. 13th ed. Sydney: Australian Pharmaceutical Manufacturers Association Inc.; 2000.
  2. Roughead EE. The Australian Pharmaceutical Manufacturers Association Code of Conduct: guiding the promotion of prescription medicines. Aust Prescr 1999;22:78-80.

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
http://www.apma.com.au



First published online: February 2001