Regulation of complementary medicines by the Therapeutic Goods Administration (TGA), which is also the regulator for medicines and medical devices in Australia, means that Australian complementary medicines have an enviable and well-established reputation for safety and quality.
This has led to export growth and, in particular, a strong demand from Chinese consumers. As a result, Australian manufacturing plants have been expanding their capacity and jobs have been boosted across the entire supply chain, including in scientific evaluation, research, packaging, logistics, and in raw material supply.
The Australian Government is looking towards 2030 with the recognition that expansion of the economy will need Australia to be competitive in a global innovation race, and supportive of high-growth industries and companies.
Passed into law earlier this month, the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, amends the Therapeutic Goods Act 1989 to support the continued implementation of the Government’s response to the Medicines and Medical Devices Review (MMDR). The MMDR was established to identify:
- areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and
- opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
The Bill establishes a list of ‘permitted indications’ for Aust L listed medicines, designed to simplify inclusion of a listed product on the Australian Register of Therapeutic Goods (ARTG) and help reduce inadvertent non-compliance.
It also establishes an intermediate pathway for complementary medicines sitting between Aust L listed products and Aust R registered products. This assessed pathway will offer the ability to make intermediate claims beyond the list of permitted indications up to health benefits for serious diseases.
When implemented, this will represent a unique opportunity for complementary medicine products to gain recognition for undergoing rigorous scientific assessment. It will also include a much needed and long overdue protection for propriety research and clinical trials.
However, I believe that a word of caution is needed here. As that ages-old idiom states: “The devil is in the detail.”
The implementation of these changes by the TGA is vital as it has the ability to impact the industry, either positively or negatively, for potentially the next twenty years.
Undue influence
In the Australian Government Guide to Regulation policy makers are reminded to consider the cost of regulating in proportion to the real-world risk and not to be unduly influenced by media interpretations or emotive stakeholder arguments.
Unfortunately, in Australia we have a few vocal critics of complementary and traditional medicines who are lobbying for the restriction of the ‘permitted indications’ list and removal of traditional claims. Not surprisingly, those same stakeholders are supportive of a negative disclaimer on products making claims based upon traditional medicinal use, to the effect that they are not supported by Western scientific evidence and that the products “do not work”.
Quite simply, this is not correct. All around the world, complementary medicines are used as an accessible, affordable, and culturally important element of healthcare. This use is based upon an ever-growing base of scientific research, use within traditional medicine systems that are founded in thousands of years of practical knowledge and experience, or a combination of both.
I believe it was stated best by Australian Minister for Rural Health, Senator Bridget McKenzie, when she said: “We, as a country, have endorsed the World Health Organisation position on the role of complementary medicines in the national medicines framework, and this position acknowledges that traditional medicines do have a valid function in the modern medicinal framework.”
“For some, particularly those using Chinese medicine, the history of practising in that traditional medicine paradigm goes back thousands of years. It’s been extensively refined, practised and documented and in many cases incorporated into mainstream medicine. So, a statement required by the Australian Government that the indication is not in accordance with modern medical knowledge and that there is no scientific evidence will be seen as arrogant and insensitive to those practising and using traditional Chinese medicines”.
Whilst it’s clear that the TGA faces pressures from these stakeholders, these groups do not have any real evidence of harmful or misleading use that requires increased regulation. In fact, the true challenge for the TGA will be to balance the real-world risk of complementary medicines with the need for a framework that supports a stronger, more productive and diverse industry where innovation, investment and jobs continue to be created.