On 20 January 2015, the Department of Health announced that it is calling for submissions in relation to its review of the regulation of complementary medicines.
The review is being undertaken by an expert panel and forms part of a broader review of Australia’s regulation of medicines and medical devices, which focuses on the Therapeutic Goods Administration’s (TGA) regulation of prescription, over-the-counter medicines, complementary medicines and medical devices. A high-level overview of the regulation of medicines in Australia and the different frameworks that apply to the regulation of prescription and listed complementary medicines are discussed below.
The aim of the review is to identify areas of ineffective or duplicative regulation and opportunities to enhance Australia’s regulatory framework of medicines. The expert panel is encouraging stakeholders to participate in the complementary medicines review, with the deadline for submissions being 8 April 2015. A copy of the Terms of Reference and Review Discussion Paper for anyone wishing to make a submission can be found at The Department of Health’s website.
Overview of the regulation of medicines in Australia
In Australia, the TGA oversees the regulation of medicines under the Therapeutic Goods Act 1989 (Cth) (Act). A two-tiered system forms the basis of regulation of medicines in Australia and involves the classification of medicines according to risk.
- Higher risk medicines: must be registered on the Australian Register of Therapeutic Goods (ARTG). Registered medicines display an ‘AUST R’ on their label and have been assessed by the TGA for their quality, safety and efficacy.
- Lower risk medicines: must be listed on the ARTG. Listed medicines display an ‘AUST L’ on their label and have been assessed by the TGA for their quality and safety (but not efficacy).
In assessing the level of risk posed by a medicine, the TGA considers a number of factors, including whether the medicine:
- contains a substance scheduled in the Poisons Standard;
- can cause significant side effects;
- is used to treat a life-threatening or very serious illness; and
- has any adverse effects from prolonged or inappropriate use.
This risk-management approach underpins the TGA’s regulation of medicines.
The review of complementary medicines regulation
As identified by the expert panel, the regulation of complementary medicines in Australia has been the subject of debate. Complementary medicines, which are also sometimes referred to as ‘traditional’ or ‘alternative medicines’, include medicines that contain ingredients such as herbs, vitamins, minerals and include homeopathic and certain aromatherapy preparations. There are approximately 12,000 complementary medicines available in Australia and it is estimated that two thirds of Australians use complementary medicines from time to time.
The debate has involved consumers and industry, and has ranged from concerns regarding the safety and efficacy of listed complementary medicines, to criticisms about the overregulation of listed complementary medicines in Australia.
The four key themes that the expert panel are seeking submissions on for listed complementary medicines are:
- the duplication in the existing regulatory processes;
- whether the regulatory requirements are commensurate with risk;
- the complexity of the current regulatory framework; and
- the adequacy of the existing enforcement powers and penalty regimes under the Act, in particular whether the current regime adequately creates a deterrent effect.
With these themes in mind, key questions the expert panel have asked stakeholders to consider include:
- should ingredients that have been assessed and approved by another country be assessed by the TGA?
- can a ‘trusted’ international assessment standard be defined?
- should complementary medicines be regulated under a separate legislative framework?
- is it appropriate for complementary medicines to be regulated as ‘medicines’ under the Act?
- should certain vitamins, such as water soluble vitamins, be regulated as foods rather than as medicines?
- is the regulation of complementary medicines transparent enough? If not, how could it be improved?
- does the current legislative regime provide sufficient deterrents to prevent sponsors from knowingly listing non-compliant complementary medicines on the ARTG?
Regulation of prescription versus listed complementary medicines
Prescription medicines are medicines that are prescribed by a doctor or another authorised health care professional. Common examples of prescription medicines include antibiotics, strong painkillers and medicines for health conditions such as high blood pressure and diabetes.
While all prescription medicines are registered on the ARTG, the same is not true for complementary medicines. Although some complementary medicines are registered, the majority of such medicines need only to be listed on the ARTG. In general, the difference in the risk profile for prescription versus complementary medicines necessarily means that each is subject to different regulation.
Some of the key differences between the regulatory framework for prescription and listed complementary medicines relate to the ARTG application process.
- Prescription medicines: the registration of a prescription medicine is a time-consuming process, where the application procedure requirements vary according to the type of prescription medicine. All applications must be supported by quality, non-clinical and clinical data, and each data set is evaluated separately by the TGA (scientists and clinicians) who consider the quality, safety and efficacy of each prescription medicine. On average, the registration process for a new prescription medicine (a ‘new chemical entity’) takes 11 months.
- Listed complementary medicines: unlike registered prescription medicines, listed complementary medicines are considered by the TGA to be low risk medicines that are included on the ARTG as part of a streamlined process. At the time of listing, the TGA does not evaluate the complementary medicine, but rather, the sponsor (which is the company that supplies the medicine in Australia) certifies that that medicine meets all legislative requirements. This process allows listed complementary medicines to be marketed without delay. Post-listing, a proportion of listed complementary medicines are reviewed by the TGA as part of the TGA’s compliance reviews.
In relation to post-market monitoring and pharmacovigilance, the core requirements mandated by the Act equally apply to registered and listed medicines. In short, for medicines registered or listed on the ARTG, each sponsor must:
- have a contact person responsible for fulfilling the sponsor’s reporting requirements;
- submit adverse reaction reports to the TGA;
- notify the TGA if and when the sponsor becomes aware of any significant safety issues; and
- ensure that any request made by the TGA for information is answered fully and within the requested timeframe.
The failure of a sponsor to comply with the monitoring and pharmacovigilance requirements can constitute an offence under the Act and result in penalties and/or the removal of a medicine from the ARTG.
Rachelle DownieSolicitor, dispute resolution
+61 3 9288 1640