Originally published July 2005
- The Government will introduce greater regulation of the industry, particularly product quality and evidence for claims.
Following the Pan Pharmaceuticals product recall in April 2003, the Commonwealth Government established an Expert Committee to report on the adequacy of the current regulation of complementary medicines. The Committee handed down its report in September 2003, recommending tighter regulation of the industry. Since then the Government has consulted widely on the report, reviewing 90 submissions from stakeholders. In March of this year, the Government handed down its response to the recommendations. It mainly supported the Committee's recommendations and has agreed to take a number of actions to "further develop consumer awareness of and confidence in complementary medicines".
Current regulatory framework for complementary medicines
A complementary medicine is defined in the Therapeutic Goods Act 1989 (The Act) as a therapeutic good consisting wholly or principally of one or more designated active ingredients (outlined in Schedule 14 of the Therapeutic Goods Regulations), each of which has a clearly established identity and a traditional use or any other use prescribed in the Regulations. Complementary medicines include herbal medicines; vitamin and mineral supplements; other nutritional supplements; traditional medicines such as Ayurvedic medicines and traditional Chinese medicines; homoeopathic medicines; and aromatherapy oils.
The Therapeutic Goods Administration ("TGA") is currently responsible for regulating the supply of Complementary Medicines in Australia. A complementary medicine must be listed on the Australian Register of Therapeutic Goods ("ARTG") before it can be supplied in Australia.
Complementary medicines are listed on the ARTG by an electronic application process. The system enables timely market access for sponsors of complementary medicines and other goods, which can be listed on the ARTG.
Although not tested for efficacy before listing on the ARTG, sponsors of complementary medicines are required to hold evidence supporting the claims made with respect to their products, including therapeutic claims. Any application for listing of a complementary medicine must be accompanied by a statutory declaration by the sponsor stating that such evidence is held.
The Act requires the evidence held by sponsors to be sufficient to substantiate that the indications and claims are true, valid and not misleading. As the types and levels of evidence considered necessary for this purpose are not currently specified in legislation, there is a concern in relation to the adequacy of the evidence held by sponsors supporting therapeutic claims.
The Committee's findings and the Government's response
The Committee made 49 recommendations about the regulation of complementary medicines. The Government consulted widely on the Report and handed down its response in March 2005. It agreed with the majority of the 49 recommendations. Some key recommendations agreed to by the Government are set out below.
Development of quality standards for ingredients in complementary medicines
The quality of herbal substances contained in complementary medicines, including the level of any toxic substance that may be present, can vary widely and depends on many factors including the method of its preparation.
In terms of the regulation of preparation methods and quality standards for ingredients, the Act defines the British Pharmacopoeia ("BP") as the source of acceptable standards for therapeutic goods, unless another defined standard applies to a particular substance. However, while compliance with the BP and other defined standards is mandatory, only a limited number of herbal substances are listed in the BP. As such, there is currently no way for consumers to know by what method a complementary medicine product has been prepared.
The Committee recommended, and the Government has agreed, that legally enforceable quality standards should be developed for complementary medicines. These will be developed in consultation with stakeholders such as industry groups, consumers, government, and sponsors who will be given adequate time to comply with the new compositional standards before they become mandatory.
Compliance with "Standards of Evidence Required to Support Claims" to become mandatory
As noted above, the majority of complementary medicines are not required to be tested for efficacy prior to listing on the ARTG. Sponsors are merely required to provide a statutory declaration stating that they hold sufficient evidence to support their claims made with respect to their products.
Sponsors are given guidance on the types and levels of evidence required to support health-related claims made for their products by the Guidelines for Levels and Kinds of Evidence to Support Indications and Claims (the Guidelines) published by the TGA in 2000. The Guidelines indicate that evidence to support the claims of complementary medicines can be based on scientific or traditional use. At present, compliance with the Guidelines is not mandatory.
The Committee recommended, and the Government has agreed, that the Guidelines should be prescribed as mandatory. This will provide an equitable and enforceable basis for the type and level of evidence considered necessary to support indications and claims for complementary medicines.
New requirement for sponsors to submit "summary of evidence" for complementary medicines
The Government accepted the Committee's recommendation that sponsors of complementary medicines should submit to the TGA a summary of the evidence they hold to support the efficacy of their products prior to ARTG listing.
Developing the format and content for the summaries of evidence will be undertaken in consultation with stakeholders in both Australia and New Zealand, and will be introduced under arrangements for the proposed trans-Tasman agency which will regulate therapeutic products in Australia and New Zealand. There will be an adequate timeframe allowed for sponsors to comply with the new requirements.
Increased auditing by the TGA
The Committee recommended and the Government has accepted that there should be increased random and targeted auditing by the TGA of sponsors of complementary medicines to ensure that sufficient evidence supporting claims is held by sponsors.
Review considering regulation of homoeopathic preparations
Homoeopathic preparations, assuming they meet certain criteria, are not required to be listed on the ARTG and rarely come to the attention of the TGA.
In recent times however there have been concerns about the quality of homoeopathic preparations and whether they are being prepared in accordance with homoeopathic principles or practice. Therefore, the Government has supported the Committee's recommendation for a proposed review of the regulation of homoeopathic preparations and related remedies making therapeutic claims.
Increased penalties for sponsors who fail to provide information
The Committee proposed, and the Government has accepted in principle, the recommendation to increase the penalty for offences for refusal to provide relevant information regarding a product. Increased penalties will more accurately reflect the seriousness of a failure to both possess and provide information necessary to confirm the quality, safety and efficacy of a product.
Any increase in penalties will be implemented as part of the proposed trans-Tasman agency.
Measures to increase reporting of adverse drug reactions to complementary medicines
Reports to the TGA of adverse reactions occurring as a result of consumption of complementary medicines currently comprise only a small proportion (about three percent) of total reports received. This may be in part because sponsors of complementary medicines have been unaware of their reporting obligations. Another reason may be that adverse reactions occur at a much lower rate than other therapeutic goods listed or registered on the ARTG, such as prescription medicines.
The Government has accepted that there is a need to encourage the reporting by health professionals and consumers of suspected adverse reactions to complementary medicines which do occur, to improve the TGA's ability to identify products or ingredients in complementary medicines which might be implicated in causing adverse reactions.
Ramifications for industry
The Government's endorsement of the majority of recommendations by the Committee is a clear message to sponsors that further regulation of the complementary medicines industry is to come in order to ensure quality of ingredients used in complementary medicines, substantiation of claims made, and safety of these products supplied in Australia.
It is important to note however that any proposed implementation of change to the current Australian regulatory environment will require consultation with New Zealand, in line with the proposal to establish the trans-Tasman agency on or about 1 July 2006.
In light of the impending establishment of the trans-Tasman agency, there will be no or little opportunity to amend the current Australian legislation to implement any of the Committee's recommendations. Any of the recommendations that require legislative change will need to be implemented through the rules for the joint scheme, which will be developed by the Ministerial Council, consisting of the Australian and New Zealand Health Ministers. We will update you on any developments in future editions of Insights.
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