8 JULY 2021

Australia rightly seems consumed by discussions about the Covid vaccine rollout and the benefits versus risks considerations for the Astra Zeneca and Pfizer vaccines.

With a federal election looming sometime in the next 10 months, politicians have entered the fray variously seeking to take credit for the rollout (when things are going well) or trying to make sure that blame for the slow rollout and increased frequency of Covid outbreaks lands on their political opponents – or at least on another tier of government.

For people living with pain conditions and their health practitioners trying to work through what is safe and effective to put into our bodies, it is the regulators and the experts, rather than the politicians to whom we should turn to in order to seek guidance and reassurance.

The Therapeutic Goods Administration (TGA) is the body responsible for regulating vaccines as well as the use and sale of goods in Australia that claim to have a health or therapeutic benefit.

Therapeutic goods are products that are used in humans in connection with:

• preventing, diagnosing or treating an illness or injury
• altering a physiological process
• testing a person’s susceptibility to an illness
• affecting conception
• testing for pregnancy or
• replacing or modifying part of someone’s anatomy.

Therapeutic goods include a wide range of items, from products that could be purchased in a supermarket such as bandages, condoms, vitamins and supplements to over-the-counter (OTC) and prescription medicines, through to complex medical devices such as pacemakers.

In order to sell or make available therapeutic goods in Australia, makers or sponsors are required to gain approval from the TGA for the product to be included on the Australian Register of Therapeutic Goods (ARTG).

For medicines, the TGA has two broad categories, which vary on the degree of scrutiny required based on the potential risk to consumers.

Medicines that carry the highest potential risk are required to be ‘registered’ and gain an AUST R number on their label.

Registered products go through a rigorous assessment process prior to registration. This includes the need to provide detailed evidence from clinical trials covering large population sizes over long timeframes testing the safety, quality and efficacy of the product. An important criterion for registration is the requirement for the sponsor to provide evidence not only that the product is safe but that it actually provides the beneficial effect that it claims to have. This evidence is tested by the TGA prior to registration.

With the exception of some OTC medicines, such as paracetamol and ibuprofen, registered medicines can only be accessed by having a prescription from an approved health professional such as a doctor or dentist.

Listed products, which have an AUST L number do not undergo the same degree of scrutiny as a registered product. This category covers most complementary medicines. ‘Low-risk’ medical devices are similar to AUST L medicines (no pre-market evaluation) but these are ‘included’ on the ARTG, not ‘listed’. Many transcutaneous electrical nerve stimulation (TENS) devices used to manage pain are in this category – see Can a few zaps a day keep the pain away? - (medreach.com.au).

Listed products are required to use low risk, pre-approved ingredients and can only be used for relatively minor conditions. While these products do not have to provide evidence that is assessed by the TGA to show that they have the beneficial effect that is claimed, sponsors are required to hold evidence of its efficacy and may have to provide this in a post-market review.

Consumers are able to purchase listed products off the shelf in pharmacies, supermarkets and health food shops without needing a prescription.

A newly introduced category of listed medicines – AUST L(A) now includes the capacity for the efficacy of the complementary medicine product to be assessed by the TGA prior to gaining that designation and allows the products to be labelled as “TGA assessed”.  There have only been two listed medicines given this designation to date.

I have taken a bit of time to briefly explain the categories of medicines listed on the ARTG as many readers of this blog and most consumers have only a limited understanding of Australia’s complex regulation of therapeutic products.

At Painaustralia, we have a very high regard for the work of the TGA, but we think it is important to acknowledge that there are many products on the ARTG, and therefore available for sale, that have not been through the same degree of rigorous testing as required of registered medicines.

The trust the public associates with TGA approval is undoubtedly commercially valuable for the rapidly growing complementary medicines industry.

According to the complementary medicine industry’s own data, the industry sells over $5bn worth of products each year. This includes over $3bn in vitamin and dietary supplements, around $1.1bn in sports nutrition products and around $800m in herbal and traditional remedies[1]. Most complementary medicines are sold through pharmacies (around $3bn) and another $1bn through supermarkets.

The complementary medicines industry is undoubtedly a significant industry in Australia and its products are used by over 70% of Australians each year.[2]

A number of commentators, while praising the TGA’s regulation of registered medicines, have  raised concerns that listed products pretty much get a free pass once they are on the register.

In comments recently attributed to Dr Ken Harvey in the on-line AJP journal he has stated that the TGA does well when regulating prescription medicines and vaccines:

“But they (TGA) do a terrible job on complementary medicines labelled (AUST L) which they use as a cash cow without providing commensurate regulation or consumer protection.

“There are over 10,000 listed medicines (mainly complementary medicines) on the Australian Register of Therapeutic Goods (ARTG) with around 2000 new listings each year.

 “An application for listing costs $860, the annual charge to keep it on ARTG is $1,160, hence the TGA’s annual income from listed products is $1,720,000 + $11,600,000, i.e., $13,320,000.”

“Despite the figure of 75% of products evaluated being non-compliant – “mainly because companies were unable to produce evidence to substantiate claims for efficacy” – the TGA takes only token action. He said the regulator has also “given up on complaints”.

“Which raises the question, why is the TGA so lax in regulating complementary medicines?”[3]

Dr Harvey and Professor John Dwyer have also critiqued the evidence used to support TGA’s decision to grant the first herbal complementary listing under the new AUST L(A) designation to Caruso’s Prostate EZE Max . [4] In doing so, they have also observed that with only two products listed under the AUST L(A) designation, the complementary medicines industry sees better value in gaining celebrity endorsements rather than undertaking research into their products.

The Australian public have placed a great deal of trust in their regulators to keep us safe. As we are seeing with Covid vaccines, trust is a precious asset – hard to win and easily lost.

However, with 75% of ‘listed’ products being found to be non-compliant when followed up with a post-market compliance review, there is a real risk that public’s trust in the wider TGA processes may not be maintained.

It is in everybody’s interest, including ultimately the medicines industry itself, for the trust and credibility of the TGA to be maintained.

Carol Bennett, CEO