Questions & answers about regulating complementary medicines
October 2006
What's wrong with the current dietary supplement legislation in New Zealand?
The New Zealand Dietary Supplements Regulations (1985) are outdated. This means that under current dietary supplement legislation, the safety and quality of dietary and nutritional supplements are not regulated and consumers cannot be certain that:
- the ingredients of the dietary supplements or the products themselves are safe and effective; and
- adequate steps have been taken to ensure product quality – for instance, that products contain only the stated ingredients in the quantities specified on the label, and that they are free from contamination with micro-organisms and heavy metals.
Many New Zealanders use dietary supplements and other complementary medicines. When purchasing these products, consumers have a right to expect they will be safe and of a high quality, while maintaining choice.
An effective regulatory scheme would:
- Protect consumers by ensuring products are safe from contamination with potentially harmful ingredients;
- Ensure that consumers are provided with factual information about the therapeutic health benefits of a product;
- Include pre-market safety checks of the ingredients used in complementary medicines; and
- Require assurances of quality manufacturing processes.
What is the purpose of defining herbal products and dietary supplements as complementary medicines?
The term complementary medicine covers herbal medicines, homoeopathic medicines, traditional medicines, aromatherapy products, vitamins, minerals and nutritional supplements represented to be for therapeutic use, including claiming therapeutic health benefits.
The proposed regulatory scheme has adopted this definition to distinguish complementary medicines from pharmaceuticals. According to the World Health Organisation (WHO) the term complementary medicine is used inter-changeably with traditional medicine in some countries. Other terms used to describe complementary medicines include natural medicines, alternative medicines and holistic medicines.
How would suppliers and manufacturers wishing to introduce a new ingredient or raw material into the marketplace prove it’s safe?
The Authority will have extensive guidelines available outlining the process and data requirements for a sponsor of a new ingredient or raw material to be able to demonstrate that it is appropriate for use in low-risk complementary medicines.
Safety data and information about substances can often be obtained through researching the international literature or by manufacturers commissioning their own research into the safety of the substance.
For substances proposed for use in Class 1 medicines that are not listed on the Permitted Ingredients List it is proposed that suppliers would submit an application to the Authority to evaluate the substance. The application would contain information about the substance, its use including traditional use, and any safety studies and data about its therapeutic benefits and or risks. Guidance documents will be available to help sponsors with their application.
The quality and safety of the substance would then be assessed by the Authority and a report provided to an independent expert committee, the Complementary Medicines Expert Advisory Committee. The Committee would then recommend to the Authority whether or not they consider the substance is suitable for inclusion on the Permitted Ingredients List.
How do complementary medicine products get issued with interim product licences?
Products being legally supplied in New Zealand and listed on the COMET database at the time the Authority commences operation, will automatically be issued, free of charge, with an interim product licence.
Products supplied in Australia and included on the Australian Register of Therapeutic Goods (ARTG) at the time the Authority commences operation will automatically be issued, free of charge, with an interim product licence.
It is important to note that an interim product licence allows the product to continue to be supplied only in the country in which it has previously been lawfully supplied during the proposed three year transition period.
Will New Zealand native herbs and plants be added to the permitted ingredients group list?
A project to evaluate some New Zealand substances for possible inclusion in the Permitted Ingredients List for low-risk Class 1 medicines is underway. The Interim Joint Expert Advisory Committee on Complementary Medicines will meet to review safety data and evaluation reports for these ingredients and will make recommendations as to whether they should be included on the Permitted Ingredients List for Class 1 medicines.
What is the timeframe for confirming the new Australia New Zealand permitted ingredients group list?
Initial details of the Permitted Ingredients List (PIL) project are expected to be published around October 2006. Thereafter ingredients being evaluated as part of the PIL project will continue to be added to the PIL in accordance with the recommendations of the Interim Joint Expert Advisory Committee on Complementary Medicines.
Will tinctures and oils made or mixed together by practitioners for individual patients come under the new Rules?
No. Tinctures and oils or other complementary medicines made up or compounded by a practitioner for an individual patient after consultation with that patient aren’t covered by the proposed regulatory scheme and will not be regulated by the Authority, although they may be required to meet other jurisdictional requirements.
Will most complementary medicines be listed as Class 1 or low risk products?
Yes. Most complementary medicines are expected to fall into the lowest risk category or Class 1.
What sort of therapeutic claims will suppliers and manufacturers be able to make about complementary medicines under the proposed Rules?
It is proposed that sponsors will be able to make claims about the therapeutic benefits of a complementary medicine where that claim is backed up by appropriate data or evidence. Therapeutic claims will be required to be supported by appropriate evidence, including evidence of traditional use. Draft Guidelines outlining the range of proposed therapeutic claims and the levels and kinds of evidence needed to support each type of claim are expected to be released for consultation in the near future. There will be certain restrictions on the types of claims permitted for Class 1 medicines.
Why do we need this regulatory scheme when adverse reactions caused by prescription medicines are far worse than for any complementary medicine?
The proposed regulatory model for the Authority recognises the unique nature of complementary medicines including their inherent low-risk. As such, the proposed scheme intends to apply a risk-based approach to the regulation of medicines. This will mean higher risk medicines such as prescription medicines will be subjected to full pre-market evaluation of quality, safety and efficacy data by the Authority prior to a product licence being granted. However, for low-risk Class 1 medicines, which will include most complementary medicines, product sponsors will apply for a product licence via an electronic on-line system which will require a legally binding declaration that the product meets certain quality, safety and efficacy standards.
How can the Crown guarantee that Rongoā will still be able to be practiced?
Rongoā Māori will not be affected because traditional Rongoā Māori will not come under the proposed Authority and will not be regulated by the proposed regulatory scheme. Traditional healers and the products they prepare for individual patients will not be regulated by the Authority.
Will Chinese herbalists and acupuncturists be affected?
Practitioners, such as Chinese herbalists, naturopaths and acupuncturists, will not be regulated by the proposed scheme and will continue to be able to provide advice and prepare products for individual patients following consultation with the patient.
Is there any division between medicines and dietary supplements under the proposed regulatory scheme?
Yes. In New Zealand dietary supplements are currently regulated under food legislation. Under the proposed scheme those existing dietary supplements whose presentation and use is for therapeutic purposes will fall under the category of complementary medicines and will be subjected to the regulations of the Authority. Food type dietary supplements will continue to be regulated under New Zealand food legislation. As outlined above, it is expected that most complementary medicines will fall into the lowest risk medicine category or Class 1.
How will the members of the expert advisory committees be picked? Will there be an expert in traditional Chinese medicines appointed?
The Ministerial Council will have responsibility for jointly appointing all members of the Authority’s expert advisory committees. The Authority will request CVs from a range of potential candidates whose qualifications and experience are relevant and applicable to the various positions. In addition, the peak industry bodies will also be requested to nominate individuals through this process. Once nominations are received, the Ministerial Council will select individuals who are most suitable for the role.
The Complementary Medicines Expert Advisory Committee’s proposed terms of reference is set out in the 'Draft Administration Rules' released in May 2006.
Given the large range of modalities in the complementary medicines area, the Complementary Medicines Expert Advisory Committee will also be able to seek advice and information from a range of expert advisors when issues relating to specific modalities arise and fall outside the collective expertise of the Committee.
Industry realises that there needs to be regulation, but is this the right regulation to adopt?
New Zealand’s regulatory framework for therapeutic products is outdated and unsustainable, therefore updating it is necessary to ensure New Zealand is able to meet internationally recognised best practice standards for therapeutic product regulation. Notably, New Zealand does not currently require complementary medicine suppliers or medical device suppliers to show that their products are safe and effective before they can be sold, something which is out of step with international best practice. New Zealand has analysed a range of options and concluded the most sustainable, efficient and cost effective approach is to work towards establishing a new regulatory scheme for therapeutic products with Australia. The new scheme will provide a means of maintaining an effective and sustainable regulatory capacity for New Zealand and Australia into the future.
Will there be mutual recognition of labelling requirements?
No. Mutual recognition doesn’t occur for food labelling and it is not appropriate for complementary medicines and other therapeutic products. The Authority will create a Managing Directors Order that will outline the requirements for labels for medicines.
Will there be any exceptions made for ingredients such as selenium and copper that can be toxic in large doses?
Ingredients such as selenium and copper can be permitted ingredients providing their levels are safe and fall within the allowable and recommended levels. This ensures consumers’ safety is protected.
Will there be any restrictions when the scheme starts up for the export between New Zealand and Australia of raw ingredients, such as phosphate powder, used in foods or therapeutic products?
No, there will not be restrictions placed on the export of raw ingredients under the scheme, provided they are not packaged for a therapeutic purpose.
What happens in the case where a product is legally on sale in New Zealand but is not on sale in the Australian market?
During the proposed transition period the product can continue being sold in New Zealand only. By the end of the proposed transition period of three years a product sponsor would be required to have applied for an Authority product licence which, if approved, will authorise the sale of the product in both Australia and New Zealand.
Is it possible to sell a product which has the same name and packaging but different ingredients in both countries under the proposed scheme?
No. This does not however, mean companies will be required to change trade names as it will be possible to ‘name’ a product so that it is readily identifiable from other similar products. Individual products would require an ANZTPA product licence to continue being sold after the proposed three year transition period.
If a person or company applies to have a new ingredient listed on the Permitted Ingredients List can anyone then use that ingredient or is it patent protected for a period of time?
If a supplier applies and pays a fee to have a new Class 1 ingredient evaluated for inclusion on the Permitted Ingredients List and it is approved for use, there is no proposal in the draft Rule to restrict which company could use that new ingredient.
Will intellectual property rights of traditional herbs used by healers be protected?
It is important to note that the new scheme does not deal with the intellectual property rights of herbs used by healers and there is no intention in the proposals for intellectual property rights of traditional herbs or plants to be covered by the new regulatory scheme. Intellectual property rights and any claims about their standing are handled through different regulatory channels in each country. For example, in New Zealand, Māori claims about the role or use of certain intellectual property rights are often dealt with through the Treaty of Waitangi claim process. Therefore, intellectual property rights are considered to be separate from the regulation of therapeutic products and would remain that way under the proposals.
How will sole traders be affected?
In Australia, the definition of a sole trader is an Australian business which is not incorporated, does not supply pharmaceutical products to the Pharmaceutical Benefits Scheme and does not trade Inter-State.
Currently sole traders are not regulated under the Australian Therapeutic Goods Act 1989 however it is proposed that they would be regulated under the scheme. Therapeutic products that a sole trader supplies would therefore, be required to be licensed and meet the proposed standards for safety, quality and effectiveness.
Will tamper evident packaging be mandatory in New Zealand?
Tamper evident packaging in Australia and New Zealand is currently encouraged but it is not a mandatory requirement. At this stage no decisions have been made around whether tamper evident packaging should be mandated under the new scheme.
URL: http://www.anztpa.org/cm/cmqaphase1.htm