Recent medicine reforms, in particular those for complementary medicines, make manufacturers more accountable for product claims, writes Deon Schoombie
Complementary medicines are regulated as medicines under the Therapeutic Goods Act 1989, which outlines basic characteristics such as safety, quality and efficacy that therapeutic goods must demonstrate before they can be lawfully imported, manufactured, or supplied in Australia.
Lower risk medicines are listed on the Australian Register of Therapeutic Goods (ARTG). The medicine sponsor (or sponsor) is required to hold evidence to support their indications (conditions for which the medicine should be used) for low-level conditions.
They are not individually evaluated by the Therapeutic Goods Administration (TGA) prior to being entered on to the ARTG, but the evidence can be called in once the product is on the market – and the product may be cancelled if evidence is lacking. Higher-risk medicines must be registered, which involves a higher standard of product evaluation before they are put on the market. Any complementary medicine that refers to symptom relief must include a label statement saying, ‘if symptoms persist or worsen, consult your doctor’.
The TGA reports that there are roughly 11,000 listed medicines on the ARTG. Fewer than 200 complementary medicines are registered on the ARTG–it is commonly estimated that up to 70% of Australians use complementary medicines.
While critics have made fun of some of the less conventional phrasing in a very small minority of the permitted indications, let’s look at what this list replaces. Namely, a ‘free text’ mechanism where medicines sponsors could say whatever they wanted about a product when they listed it on the ARTG, as there was no pre-vetting of these claims. Now sponsors can only choose from a dropdown list of defined indications that only refer to low-risk symptoms and conditions.
In a discussion on Radio National, the head of the TGA, Professor John Skerritt, explained: “It’s been really hard to police indications to date because companies have been able to essentially make up their own. Now, by law, they will only be able to use the indications that are on those lists.”
The benefits of these controls have often been misunderstood when it comes to the small proportion of listed medicines (about 5%) included on the register that refers to traditional-use products. These medicines may not hold a Western standard of scientific evidence, but they do need to hold evidence of more than three generations’ use and can only be made from substances on a list of permitted ingredients that have evidence of their safety.
They are also required to include a statement on the label and a statement in the ARTG that they are based on traditional use. Like all complementary medicines sold in Australia, the medicines must be made in manufacturing facilities that have been inspected for good manufacturing practices.
Suggestions that these traditional medicines make a mockery of the permissible indications list because of funny sounding names or oddly-worded indications (which may be a straight English translation of an Ayurvedic or Traditional Chinese Medicine) smacks of cultural insensitivity. We do live in a multicultural society with a large Chinese and Asian population who often have a deep and long connection to the herbs and the indications used in these products.
In Traditional Chinese Medicine (TCM), for instance, medicinal herbs that have been around for thousands of years are widely used today in hospitals in China. In Australia, most of the traditional-use products listed on the ARTG, are actually provided through a traditional medicine practitioner. We often forget that the board that regulates pharmacists, GPs and other health professionals, also recognises and regulates TCM practitioners.
All complementary medicines sold in Australia, including those based on traditional indications, must be formulated from ingredients that have positive evidence of safety and have been approved by the TGA. It is also a requirement that these medicines are made in licensed manufacturing facilities, which have been inspected for good manufacturing practices.
The remainder of the complementary medicines listed on the ARTG – the vast majority – are required by law to hold scientific evidence to support the indications they have chosen to use. This means that they must hold data that is consistent with modern scientific methods, such as human clinical trials.
Assessed Listed Medicines
The reforms also introduced a new level of medicines called Assessed Listed Medicines (AUST L(A), which fall between the ‘listed’ and ‘registered’ medicines on the ARTG. Medicines included may make reference to more specific and higher-risk conditions, including some serious diseases, but their evidence must be assessed by the TGA before they go to market.
This will encourage industry to conduct further high-quality clinical trials, while providing consumers with the option to choose a broader range of high quality, scientifically verified, complementary medicines.
Consumer protection also will be improved through a strengthened system for reporting adverse events to the TGA and better IT to analyse potential medicine interactions. John Skerritt is also on record saying that the TGA will significantly step-up its compliance activity, doubling the number of products it will investigate.
With such a large proportion of the population seeking to better self-manage their own health, we support actions that help consumers make better-informed health decisions through a stronger evidence base for these complementary medicines that millions of people choose to use.
These changes go one-step further to consolidate Australia’s position as having some of the highest standards of complementary medicines regulations in the world. Consumers should take much confidence from these changes when they buy Australian-approved products.
Deon Schoombie is the CEO of the Australian Self Medication Industry.
This is an edited extract of an article that appeared in the April issue of Post Script.