The proposed joint regulatory scheme for complementary medicines
Australia and New Zealand – working together to safeguard public health and safety both now and into the future
Fact sheet
January 2007
What are complementary medicines and why do we need to regulate them?
Complementary medicines include herbal medicines, homoeopathic medicines, traditional medicines, aromatherapy products, vitamins, minerals and nutritional supplements.
In general, complementary medicines contain active ingredients that are derived from nature such as from plants and herbs and have a history of human use. However, just because a complementary medicine is made from ingredients derived from nature it does not necessarily mean that it is free from risk.
How are complementary medicines currently regulated?
In New Zealand there is currently no requirement for dietary supplements to undergo any independent scrutiny of quality and safety before they enter the marketplace which is out of line with international best practice.
In Australia, complementary medicines are currently regulated under the Therapeutic Goods Act 1989 which requires them to meet safety and quality standards before and after the products enter the marketplace and requires sponsors of complementary medicines to hold evidence to support any therapeutic claims made for their products.
What type of regulation is being proposed?
It is proposed that the Australia New Zealand Therapeutic Products Authority (ANZTPA) would regulate the safety, quality and effectiveness of therapeutic products including their manufacture, supply, import, export and promotion in both Australia and New Zealand.
The proposed scheme is based on categories or scales of risk. In simple terms this means that a lighter level of regulation is being proposed for lower risk therapeutic products, which includes most complementary medicines. Stricter regulations are being proposed for higher risk therapeutic products such as prescription medicines and some medical devices such as pace makers and heart valves.
What are the key elements of the proposed regulatory scheme for complementary medicines?
For low risk or Class 1 complementary medicines, the product sponsor or manufacturer would be required to licence their product before it is sold to consumers. They would do this by entering information into an online database and declaring that the product meets certain standards for safety and quality.
The sponsor would be required to certify that they hold the necessary information or documentation to support their declaration about the product including evidence to support any therapeutic claims made for the product.
Low-risk medicines that are self-certified in this way will only be allowed to contain ingredients from a "permitted ingredients list" and restrictions would ensure only limited and truthful therapeutic claims could be made about a complementary medicine.
What is a permitted ingredients list?
The permitted ingredients list is a list of ingredients which have been assessed and approved for use in the manufacture of Class 1 complementary medicines. Work is underway to assess ingredients in products currently on the New Zealand market that are not approved for use in low risk medicines under the current Australian therapeutic products regulatory scheme. This work is ongoing.
An Interim Joint Expert Advisory Committee on Complementary Medicines has been appointed to provide advice to the Therapeutic Products Interim Ministerial Council about complementary medicines and their active ingredients.
Will consumers still be able to buy a range of complementary medicines?
Yes. Under the proposed joint regulatory scheme consumers will continue to have access to a wide range of complementary products, with the sort of products currently sold through retail outlets such as supermarkets and health food stores continuing to be available in this way.
In Australia complementary medicines are already regulated by the Therapeutic Goods Administration (TGA) and Australian consumers have a choice of over 17,000 complementary medicines containing around 2,200 active ingredients
Under the proposed joint regulatory scheme consumers would have an assurance of the quality and safety of complementary medicines and would be provided with truthful information about a product's therapeutic health benefits to help them make more informed choices.
Will the proposals affect natural health practitioners and traditional healers?
Products made or compounded by practitioners for supply to individual patients will not be regulated by the Authority, including traditional Maori or Chinese healers and the products they supply. In addition, the Authority will not regulate the cultivation of herbs or plants for personal use in preventing or treating ailments.
Common misconceptions about the proposed regulation of complementary medicines in New Zealand
"New Zealand should go it alone"
New Zealand's current regulatory framework around therapeutic products is outdated and out of line with international best practice. In addition New Zealand's current regulatory capacity is not sustainable even in the short to mid-term. Establishing a joint Authority with Australia has advantages for both countries around efficiencies, technical expertise resources and costs. Significant and ongoing consultation on the proposal is being undertaken with industry, other stakeholders and the public.
"The decision about the joint regulatory scheme is already agreed under an agreement or Treaty"
The Authority is being established under an international agreement or Treaty signed between New Zealand and Australia in December 2003. This agreement sets out the mechanisms under which each county will have an equal voice in the Authority. The agreement does not set up or establish the detail of the proposed regulatory scheme, which is still in development and will be made available for public consultation. The agreement would need to be ratified after the passing of legislation in both countries.
"New Zealand won't have a say in operation of the joint Authority"
This is untrue. New Zealand will have equal say in the setting up and running of the joint Authority which will be equally accountable to the Health Ministers and Parliaments of both countries. These governance and accountability arrangements have been agreed under an international agreement or Treaty signed by both countries.
"The Managing Director of the new Authority can make changes without the agreement of New Zealand"
No one person will have the power to make changes to the regulatory framework that will be set out in Rules and Orders, once the Authority is established. As set out under the international agreement or Treaty, the Board of the joint Authority and its Managing Director will be appointed by the agreement of the Ministerial Council which will comprise the New Zealand and Australian Ministers of Health. The Managing Director and the Board are accountable to the Ministerial Council and the Parliaments of both Countries. New Zealand consumers and industry would be able to influence the operation of the Authority in a number of ways, including public consultation processes. Secondly, because the Authority would be accountable to the New Zealand Minister of Health, the Australian Minister for Health and Ageing and to the New Zealand and Australian Parliaments; companies and consumers would be able to raise any issues of concern with their Minister or with their Member of Parliament.
"Complementary medicines are natural and safe because they are made from plants and naturally occurring substances"
The term "complementary medicine" covers herbal medicines, homoeopathic medicines, traditional medicines, aromatherapy products, vitamins, minerals and dietary supplements. In New Zealand these products are not required to go through any pre-market assessment or ingredient approval process before they are sold to consumers. Complementary medicines generally contain active ingredients that are found in nature or are identical to substances found in nature. This however, does not necessarily mean they are safe.
"Dietary supplements should not be regulated in the same way as over-the-counter medicines and prescription medicines"
The proposed joint regulatory scheme is a based on categories or scales of risk. In simple terms this means that a lighter level of regulation is being proposed for lower risk therapeutic products, which includes most complementary medicines. Tighter regulations are being proposed for higher risk therapeutic products such as prescription medicines and some medical devices such as pace makers and heart valves which would go through pre market evaluation by the Authority.
It is also proposed that for lower risk complementary medicines, suppliers and manufacturers will be able to self assess or certify their products by entering information into an online web based data base to gain a product licence. The declarations made about a product would be subject to audit. There would be a separate office of complementary medicines within the joint Authority, which will have offices bases in Wellington and Canberra.
"Consumers have rights to access natural health products and complementary medicines"
Consumers will continue to have access to a wide range of complementary medicines, with the sort of products currently sold through retail outlets continuing to be available in this way. When purchasing these products, consumers have a right to expect they will be safe and of high quality, while maintaining choice. The main aim of the proposed joint regulatory scheme for therapeutic products is to safeguard public health and safety.
"The proposals will restrict the use of Rongoā Māori"
Rongoā Māori will not be regulated by the new Authority and will not be subject to the requirements of the proposed joint regulatory scheme for therapeutic products.
"Small businesses may go under if regulation is introduced"
Suppliers and manufacturers, regardless of their size, should be required to provide assurances to consumers about their products including that they are safe , that they meet quality standards and that any therapeutic claims are backed by evidence. It is recognised that some New Zealand industry sectors will be moving from a lower level of regulation into a greater one and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) will work to support industry through this process.
URL: http://www.anztpa.org/cm/fs-cm.htm