The sale and marketing of therapeutic goods in Australia is a heavily regulated industry. The rules and regulations which apply are designed to protect consumers when they purchase drugs and other medicines which affect or can affect the body’s functioning and physiological processes. The definitions of such goods are explained below, followed by a brief summary of what the goods can and can’t be advertised.
What are therapeutic goods?
A therapeutic good is defined in Australia as something that can treat an illness or ailment. Goods are used by and for humans (a good is not therapeutic if it is used solely for animals) in relation to:
- alleviating or diagnosing a defect, ailment, disease or injury;
- inhibiting or changing a physiological process;
- testing the susceptibility of individuals to a disease or ailment;
- influencing or controlling conception; or
- testing for pregnancy.
The broadness of this definition means that most of the common medicines, drugs and therapies we use today can be defined as such goods. The definition of therapeutic goods can be found in section 3 of the Therapeutic Goods Act 1989 (Cth).
What rules and regulations apply?
Advertising therapeutic goods are regulated by a combination of statutory measures (the Therapeutic Goods Act 1989 (Cth) and the Competition and Consumer Act 2010 (Cth) as well as self-regulation through Codes of Practice administered by relevant therapeutic goods industry associations. Every good needs to be listed on the Australian Register of Therapeutic Goods (ARTG).
The Poisons Standard (forming part of the Therapeutic Goods Act) classifies drugs/ingredients into different schedules depending on the strength of the impact of the ingredient and therefore whether it needs to be sold with greater or lesser restrictions.
Schedule 2 poisons must not be sold by a person, other than a pharmacist unless licensed to do so (section 34 Poisons Standard). Schedule 3 of the Poisons Standard sets out medicines that are pharmacist only medicines. These medicines can be sold without a prescription, but only from a pharmacist. Only pharmacists and medical practitioners can sell Schedule 4 poisons.
What can be advertised?
Only goods listed on the ARTG can be advertised. Goods which are listed in Schedules 3, 4 or 8 of the Poisons Standard can’t be advertised to consumers.
If medicines are to be advertised on TV, radio, newspapers, etc. then these advertisements need approval before they are publicised (this is stipulated by Part 2 Division 2 of the Therapeutic Goods Regulations 1990 (Cth)).
Advertising medicines for sale in Australia comes with a number of strict rules and regulations. The rules and regulations are designed so that medicines which can have a serious impact on the body are not advertised as easily obtainable or applicable to every Australian’s condition or ailment. If you want to sell and advertise medicines in Australia, be prepared to familiarise yourself with the Therapeutic Goods Act 1989 (Cth) and the other statutory instruments which apply. If you have any questions, get in touch.