Medicines Australia is the peak body representing the innovative, research-based, medicines industry in Australia. Our members develop, manufacture, and supply innovative medicines, biotherapeutics and vaccines to the Australian community available on the Pharmaceutical Benefits Scheme (PBS) and the National Immunisation Program (NIP).
These medicines keep Australians out of hospital, prevent disease and play a pivotal role in ensuring a productive and healthy community.
Medicines Australia has a Code of Conduct which provides the principles-based framework for appropriate and ethical decision making by Companies when promoting prescription products to healthcare professionals, and other interactions with healthcare professionals, health consumer organisations and the general public. Medicines
Australia established the Code in 1960 and has continued to revise and develop it ever since in consultation with the Department of Health and at times with the ACCC. The current Code is Edition 19 and has been effective from 2020. It is found on the Medicines Australia website here.
Key Fact:
Pharmaceutical companies must adhere to a regularly updated Code of Conduct which has been in existence for over 60 years
The Medicines Australia Code of Conduct
Advertising prescription medicines to consumers is not permitted under the Therapeutic Goods Act 1989. However, advertising to healthcare professionals is permitted within the scope of the legislation. Unregistered therapeutic goods, not entered on the Australian Register of Therapeutic Goods (ARTG) may not be advertised in Australia to either consumers or healthcare professionals1.
The Code of Conduct is a self-regulatory standard, meaning that the industry has agreed upon a set of standards and practices with which Medicines Australia members must comply. It sets the parameters for ethical conduct, marketing and promotion of prescription pharmaceutical products in Australia, and complements the legislative requirements of the Therapeutic Goods Act and the Therapeutic Goods Regulations 1990. It is a TGA imposed condition of registration of therapeutic goods that the promotion of all prescription products (whether by a member company of Medicines Australia or nonmember) complies with the requirements of the Medicines Australia Code of Conduct.
Operation of the Code of Conduct
Medicines Australia member companies are subject to the Medicines Australia Code of Conduct. Where a breach of the Code of Conduct is suspected, a complaint can be lodged with the Code of Conduct Committee. The Code of Conduct Committee is an independent body chaired by a trade practices lawyer. Companies found to have breached the Code of Conduct can be fined up to $300,000 depending on the circumstances and nature of the infringement.
In addition to this robust complaints mechanism, compliance is also proactively monitored through the review activities of an independent Monitoring Committee.
- Under the Code, conduct by a Company must not have an inappropriate influence on the approval, recommendation, prescribing or use of any medicine. This includes inappropriate influence of healthcare professionals. For example, provision of gifts, inducements, entertainment, and lavish hospitality to healthcare professionals are banned
- Promotional materials that inaccurately represent the data about a prescription product’s quality, safety and efficacy are banned
- Activities that encourage patients to seek a prescription for a medicine are banned
A commitment to transparency
Medicines Australia is a strong advocate for transparency. There are 3 areas in which Medicines Australia member companies are required to report their interactions with healthcare professionals and consumers:
- Payments and transfers of value to healthcare professionals;
- Sponsorship of third party educational meetings; and
- Support for Health Consumer Organisations (HCOs).
1. Payments to healthcare professionals
Healthcare professionals provide the pharmaceutical industry with valuable, independent and expert knowledge and this expertise contributes towards quality use of medicines and improved patient care.
It is reasonable for healthcare professionals to be fairly compensated for legitimate expertise and services provided to the industry, and that such compensation be publicly disclosed by the pharmaceutical industry. This disclosure helps the general public to better understand the nature and extent of programs that companies support the advancing patient care and supporting local communities.
Member Companies provide notice to all healthcare professionals prior to any engagement, advising them that details of their engagement will be publicly disclosed, with their identity published. All payments are published to an online searchable database which is available at www.disclosureaustralia.com.au
2. Support provided to third-party educational events
The Code affirms it is reasonable for the pharmaceutical industry to financially support the education of healthcare professionals through sponsorship of meetings and symposia organised by third parties, and that such support is publicly disclosed. These educational activities are primarily offered by learned societies, conference organisers, colleges, universities and other recognised healthcare professional organisations.
Member companies report sponsorships for these educational meetings on the Medicines Australia website.
3. Health consumer organisations
The Code also affirms that it is reasonable for companies to provide financial support and/or significant direct or indirect non-financial support to organisations that work to benefit Australian patients (rather than healthcare professionals), and it is appropriate for these activities to be reported.
These Health Consumer Organisations (HCOs) are not-for-profit organisations that represent the interests and views of patients and consumers of healthcare. Member companies report any such support for these patient- centred organisations on the Medicines Australia website.
Companies may enter into relationships with HCOs with the objective of enhancing the quality use of medicines and supporting better health outcomes for the Australian community. Through collaboration, the “Working Together – A Guide to relationships between Health Consumer Organisations and Pharmaceutical Companies” is available to guide these relationships.
Key Fact:
Through the Code requirements, member companies transparently report all payments and transfers of value to healthcare professionals, along with other forms of support provided to health consumer organisations and independent education events targeting healthcare professionals. All reports are published online through the Medicines Australia website.