Insight contacted the TGA in regards to the episode, Integrating Natural Medicines. A spokesperson from the TGA provided Insight with the below statement.
What response does the TGA have to critics who say the organisation does not place enough emphasis on efficacy when approving a product?
The Therapeutic Goods Administration’s (TGA) regulatory framework is established under an Act of Parliament – the Therapeutic Goods Act 1989 – and this Act of Parliament determines whether medicines need to be approved by the (TGA ) prior to sale or can be listed on the register without pre-market assessment of the particular product (including without pre-market assessment of efficacy). As a government regulator, the TGA’s function is to administer the current regulatory frameworks as laid down in law.
Medium to high risk medicines – ranging from analgesic products sold in supermarkets through to cancer medicines only available on a doctor’s prescription – are termed registered medicines and require extensive evaluation by the TGA of efficacy, safety and quality prior to them being permitted for sale in Australia.
In contrast, certain low risk medicines such as herbal or (lower dose) vitamins and minerals and certain low risk traditional medicines are not required by Australian law to be evaluated for efficacy prior to marketing.
There are some products that can be purchased without consultation from a healthcare professional (or self-selectable medicines) that make traditional indications. This is only a proportion of what ‘traditional medicines’ encompasses, as most aspects of traditional medicines are ensured by a health practitioner, and or systems that may be in place to regulate the practitioner. The TGA does not regulate health practitioners or their practices.
Many self-selectable medicines that have traditional indications are listed medicines. Listed medicines are low risk medicines and sponsors (the legally responsible entities for these medicines) must certify that they meet certain legal requirements to be included in the ARTG and permitted for sale in Australia. This includes that the medicine:
- only contains low risk ingredients from a TGA approved list of ingredients
- only makes low-level indications (e.g. cannot refer to treatment of serious conditions and preventing/curing any condition) from a list of TGA approved indications
- has evidence that supports all indications and claims made for the medicine
- is manufactured in accordance with the principles of good manufacturing practice
The Therapeutic Goods Act requires a post-market monitoring system be in place for these and all other medicines, and that the TGA reviews certain listed medicines in the marketplace for compliance with the regulatory requirements.
Is the TGA being overly permissible by allowing medicines to cite “traditional evidence” and not “scientific evidence” as proof of efficacy?
The Parliament, not the TGA sets the regulatory framework through the Therapeutic Goods Act 1989 – it is not a case of the TGA being excessively permissive or restrictive – the TGA administers the laws as they are in force.
The Act requires regulation of medicines according to risk, so the level of evidence required depends on the “indications” being made by the product (i.e. the condition to be treated).
The law specifies that traditional indications used in listed medicines can only be low risk (e.g. traditionally used to relieve constipation) and they need to be supported by evidence of an extensive history of traditional use. This provides an accumulated repository of systematic observations and underpins the use of these medicines in a traditional setting. By law, these traditional indications also cannot refer to serious conditions that would be inappropriate for self-diagnosis or self-management, or if use of the medicine may delay consumers seeking necessary medical treatment.
It is also a legal requirement that the relevant traditional paradigm (e.g. Traditionally used in Chinese Medicine) is clearly disclosed on the label to allow consumers to make an informed choice.
It is also a requirement that traditional indications do not use misleading terminology that are not envisaged within the traditional paradigm; for example:
- reference to modulation of biomarkers such as ‘haemoglobin’
- use of qualifiers that would require scientific substantiation such as ‘increases bone density by 10%’
- imply scientific efficacy such as being ‘clinically tested’
It would be inappropriate for traditional indications to also need to be substantiated by scientific evidence, however scientific evidence may be used as additional support to the extensive history of use.