On 30 October 2024, Medicines Australia (MA) formally adopted a new edition (Edition 20) of the MA Code of Conduct (MA Code), which will take effect on 30 March 2025 (available here). Using a principles-based approach, the MA Code "sets an accountable standard for ensuring the Australian pharmaceutical industry acts with integrity and honesty to improve patient care". In Australia, all sponsors of prescription medicines, and any voluntary members of MA, must comply with the MA Code in relation to the promotion of prescription medicines. 

The adoption of Edition 20 of the MA Code follows a review with member companies and public consultation (including non-member companies, industry associations, healthcare professionals, the patient community, the Therapeutic Goods Administration (TGA) and global regulatory bodies).

Key updates in Edition 20 include:

• Minimum Product Information (which is required to be included pursuant to section 2.2 of Edition 19 of the MA Code) will no longer a requirement in promotional material.  This change was made to recognise that Product Information is easily accessible electronically;  
• An additional section on "balance", to emphasise the need for balanced information in promotional materials (see section 1.1), and explaining that balanced information provides proportionate weight to the benefits and risks of a product, and that product and risk information are as relevant as any therapeutic, promotional, or non-promotional claim;
• Provisions have been added to clarify when and how companies can make product-specific media statements to consumer media when the information is relevant to the Australian public (e.g. a new product or indication, or a PBS listing etc) (see section 10.1);
• "Other relevant stakeholders (such as payors, government officials)" are now included in the persons with whom a company may engage in scientific exchange, and the appropriate company personnel who may engage in scientific exchange relating to unregistered products has been expanded from only company medical department personnel to other non-promotional roles where appropriate (see section 7);
• Transparency reporting has been extended, to include grants and donations to healthcare organisations, and to provide consistency with international transparency reporting (see section 14.2); 
• Under Edition 19 of the MA Code, companies must first seek to resolve any company-initiated complaints through the intercompany dialogue process before lodging a complaint with MA.  In the new edition, the inter-company dialogue process is more clearly and specifically described in a new document entitled "Intercompany Dialogue Standards", to support more meaningful interaction between companies, and to discourage the making of MA Code complaints as a competitive tool;
• Where there is a complaint involving a non-member, a non-member company representative will be included on the Membership of the Code and Appeals Committees, to encourage engagement by non-members with MA's complaints process; and
• When lodging a complaint, non-member companies will be required to pay a bond of AU$20,000.  The bond will be refunded to the complainant where a complaint is upheld, and the subject company is found to be in breach of the MA Code.

Next steps

The new edition of the MA Code will come into effect on 30 March 2025. MA will also release its updated Code guidance and the Code Resource Toolkit in the first quarter of 2025. Stay tuned for further updates on the new MA Code over the coming weeks.