Medicines Australia Code of Conduct
Medicines Australia is the peak body for the research-based pharmaceutical industry in Australia. All members are required to adhere to the Medicines Australia Code of Conduct.
What is the Medicines Australia’s Code of Conduct?
The Medicines Australia’s Code of Conduct sets the standards for the ethical marketing and promotion of prescription pharmaceutical products in Australia. It complements the legislation requirements of the Therapeutic Goods Regulations and the Therapeutic Goods Act. The Code has been in existence since 1960 and has evolved over time.
How does the most recent edition of the Code of Conduct differ from previous editions?
The 19th edition of The Code, follows a principles-based approach. It maintains the same ethical and transparency reporting standards as previous editions of The Code. However, the onus is now on member companies to effectively interpret the principles.
What are the principles in the Code of Conduct?
Briefly, the 10 overarching principles of the Code of Conduct state that:
1. All company activities must support the quality use of medicines.
2. Companies are transparent in their interactions with healthcare professionals and other stakeholders.
3. Companies are responsible for providing current, accurate, balanced, and scientifically valid information on their products to support their appropriate use, and in all their communications.
4. All employees receive training on The Code and maintain high ethical standards.
5. The company does not offer anything may have an inappropriate influence on the approval, recommendation, prescribing, or use of products.
6. All interactions are always professional, consistent with legislative requirements, and appropriate to the audience.
7. All promotional materials clearly communicate information that is relevant to prescribing. Further, all promotional materials should support the assessment of product risks and benefits.
8. All promotional claims are consistent with the Australian Product Information.
9. All events, initiated or sponsored by companies, are reasonable and appropriate with respect to hospitality, travel and accommodation.
10. The company clearly identifies all activities by including the company’s name and city/town of the company’s Australian office.
(Source Medicines Australia Code of Conduct, Edition 19, 2020.)
What does Medicines Australia’s Code of Conduct say about promotion of medicines to healthcare providers?
In Australia, prescription medicines can be promoted only to registered healthcare professionals. However, companies are allowed to make comparative claims with regards to competitor products. All claims, must be:
- balanced with respect to efficacy and safety information
- consistent with the TGA approved Product Information
- consistent with the body of evidence
QR codes can link to mandatory prescribing information. Also, materials should include information on the reimbursement status of the product. This can be via a link to the PBS website.
What does Medicines Australia’s Code of Conduct say about promotion of medicines to consumers?
Pharmaceutical companies in Australia must not promote prescription products to consumers. However, they can run appropriate disease awareness campaigns. The purpose of these campaigns must be educational and encourage patients to seek further information from their healthcare provider.
How can WriteSource Medical help you with Code compliance?
- draft Code compliant promotional, educational and medical materials;
- review and approve all company promotional, educational, and medical materials;
- provide advice on the interpretation of the principles of The Code.
Our medical writers have extensive experience providing medical compliance and promotional review functions for pharmaceutical companies.