Last updated 16 August 2016
Most people at some stage in their life will use medicines of some description to relieve symptoms of an illness or require a medical device to improve the quality of their life. In Australia, the Therapeutic Goods Administration (TGA) is responsible for the regulation and safety of medicines and medical devices (therapeutic goods) available in Australia. Legislation administered by the TGA governs the manufacture, supply, advertising and ongoing monitoring of therapeutic goods in Australia to ensure they are safe and fit for their intended purpose. The applicable legislation includes the:
- Therapeutic Goods Act 1989 (Cth)
- Therapeutic Goods Regulations 1990 (Cth)
- Therapeutic Goods (Medical Devices) Regulations 2002 (Cth)
- Therapeutic Goods Advertising Code 2015 (Cth).
Medicines, whether prescribed by a doctor, recommended by a pharmacist or bought at a supermarket, can include things such as paracetamol, vitamins and antibiotics. Medical devices may include artificial knees and hips. A therapeutic good will also include human blood, blood products and tissues.
Most therapeutic goods must be entered on the Australian Register of Therapeutic Goods before they can be supplied in Australia. Therapeutic goods are usually required to be accompanied by consumer information stating what the goods are used for and how they work, contraindications, precautions and possible side effects, guidelines for proper use and storage, and unwanted effects or overdose and what to do in such situations.
Problems with medicines or medical devices should be reported to the TGA. The problems may relate to safety of the product or issues regarding the quality or effectiveness of the product. Recalling the product is one regulatory response to a therapeutic good that may be unsafe to consumers.
Unfortunately, recalling a product does not always occur in time and many people have suffered serious and sometimes permanent injury as a result of an adverse reaction to a medicine or a faulty medical device. These people may have a legal right to seek compensation from the supplier or manufacturer and anyone else involved in the design, testing, production and marketing of the product.
The law in this area is complex and people are encouraged to seek legal assistance if they have been adversely affected by a therapeutic good.