Feature
Health claims in relation to therapeutic goods
In brief: Following recent changes to the Therapeutic Goods Act which widened the definition of therapeutic goods under the Act, lawyer Clare Cunliffe and partner Guy Foster discuss the regulatory process in relation to therapeutic goods and the claims that can be made in relation to therapeutic goods.
- Overview
- Background: A change to the definition of Therapeutic Goods
- What are the limitations on advertising?
- What does it mean for manufacturers, suppliers and importers?
Overview
As discussed in recent editions, the Therapeutic Goods Administration (the TGA) is now able to designate certain items as therapeutic goods, regardless of whether those items are otherwise defined by the Australia New Zealand Food Standards Code (the Food Standards Code) as foods. Previously, goods included in the Food Standards Code could not be classified as therapeutic goods. (However some 'foods' which had a therapeutic use were not included in the Food Standard Code).
Manufacturers, importers and suppliers whose products may now be designated as therapeutic goods may need to review their regulatory processes, market surveillance and advertising strategies in relation to these products to ensure they meet the rigorous standards imposed by the TGA.
We explain the requirements in relation to therapeutic goods and their implications for manufacturers, importers and suppliers.
Background: A change to the definition of Therapeutic Goods
The Therapeutic Goods Act (the Act) provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in, imported into or exported from Australia. Therapeutic goods are broadly defined to be goods:
- which are represented as having a therapeutic purpose; or
- which are likely to be taken as having a therapeutic purpose; or
- which are declared by the TGA as having a therapeutic purpose.
(A therapeutic purpose is defined as a use in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury, or in connection with influencing or modifying a physiological purpose in humans or animals). All therapeutic goods which are manufactured in Australia or supplied for use in Australia must be entered on the Australian Register of Therapeutic Goods (the ARTG) unless those goods are exempt or are subject to an approval or authority under the Act, and the offence of importing, exporting, manufacturing or supplying unregistered therapeutic goods carries heavy penalties.
Products which fall under the broad definition of therapeutic goods and must therefore be entered on the ARTG fall within three categories. Goods classed as registered goods (for example, prescription medicines) must have demonstrated quality, safety and efficacy. Goods classed as listed goods (for example vitamins, sunscreens and basic medicated throat lozenges) must have demonstrated quality and safety. The Act also covers medical devices (like syringes).
Whether therapeutic goods should be classified as registered goods or listed goods is dictated by the Act. In either case, therapeutic goods will need to be entered on the ARTG unless they are exempt.
The provisions allowing for certain goods to be designated as therapeutic goods have so far had little if any use and we can only speculate on how those provisions may be used in the future. However, it is far more likely that a product previously regulated as a food, would be subject to listing rather than to registration.
Generally, if a product is classified as a therapeutic good, the product will be stringently assessed to establish its quality and safety (and, in the case of registered goods, its efficacy). Strict conditions will also apply to the manufacturing and post marketing surveillance of the product. In particular the TGA's guidelines apply to the reporting of adverse events and the TGA must be involved in all product recalls whether voluntary or compulsory. There are also significant restrictions on a manufacturer's right to market products.
What are the limitations on advertising?
Certain registered therapeutic goods, in particular prescription products, cannot be advertised directly to the public. Where advertising of therapeutic goods to the general public is permitted, advertisements in magazines or newspapers, electronic media, marketing displays, public transport, billboards, and other types of media must meet certain conditions. Advertisements which consist of more than simple product information (that is. brand name, price, type/style of goods, photographs of the product, location and availability of goods) must be approved by the Complementary Healthcare Council, in the case of complementary medicines and by the Australian Self-Medication Industry in the case of over the counter pharmaceuticals. Any advertisement which contains a therapeutic claim will be assessed by these bodies for its compliance with the TGA Advertising Code. Briefly:
- Unless a good is a registered good (that is, the safety, quality and efficacy of the product have been demonstrated by extensive and appropriately randomised, controlled and blinded clinical trials), advertisements may not make claims as to the product's efficacy in treating, curing, managing or preventing diseases, disorders or conditions, or as to the product's efficacy in the treatment of specific named diseases.
- If a good is a listed good (that is, the safety and quality of the product have been demonstrated by extensive clinical trials) and there is evidence available from well designed controlled trials or analytical studies as to the efficacy of the product, advertisements may make claims as to the product's utility in:
- reducing the risk of any disease, disorder or condition
- aiding or assisting in the management or relief of symptoms of any disease, disorder or condition
- health enhancement
- If a good is a listed good and there is limited evidence available from descriptive studies, case reports of relevant expert committees and reference texts, advertisements may make claims as to the product's use in:
- relief of symptoms which are not related to any disease, disorder or condition (for example 'relieves headaches')
- health maintenance, nutritional support, vitamin or mineral supplementation
Of course, advertisements for therapeutic goods will also be limited by more general advertising regulations, such as the Trade Practices Act, and by relevant codes of conduct for different industries, including the pharmaceutical industry and complementary/alternative medicines industry.
What does it mean for manufacturers, suppliers and importers?
Manufacturers, suppliers and importers should keep a close watch on developments in the area to ensure they are in a position to respond if products are declared to be therapeutic goods under the Act. In particular, manufacturers whose products are classified as therapeutic goods should ensure:
- that they obtain appropriate approvals from the TGA so that the products can be registered/listed on the ARTG as required;
- that they undertake adequate post-marketing surveillance of their products; and
- that all advertisements of therapeutic goods comply with the Act, as well as any other applicable legislation or industry standards.
