We are working on a modern, comprehensive, cost effective regulatory regime for therapeutic products in New Zealand which will support consumer safety.
On this page:
- Therapeutic products
- Natural health products
- Common questions on the Bill
- Relevant documents
- Related information
Therapeutic products include medicines, medical devices and natural health products. These products are used by New Zealanders in their daily lives, and in all parts of the health system.
While therapeutic products have many benefits there are risks if they are used inappropriately or not for their intended purpose. Ensuring the benefits of therapeutic products outweigh possible harm to consumers is important and why New Zealand needs a regulatory regime for all therapeutic products.
The current way New Zealand regulates therapeutic products does not always meet the needs of consumers, patients, manufacturers or exporters. The Ministry has been leading work on a new Therapeutic Products Bill to address these issues.
Therapeutic Products Bill
The Therapeutic Products Bill was introduced to Parliament on 30 November 2022 and referred to the Health Select Committee.
The Committee called for submissions on 15 December 2022 and these closed on 5 March 2023. In total, the Committee received more than 16,500 written submissions, with some submitters providing supplementary submission material.
Oral hearings were held from 17 to 24 March 2023, and additional hearings took place on 28 and 29 March 2023. In all, 210 organisations and 127 individual submitters were heard.
The Committee will now review a detailed analysis of the submissions before reporting back to the House on 14 June 2023.
The aims of the Bill
- The purpose of the Bill is to protect, promote, and improve the health of all New Zealanders by providing for the:
- acceptable safety, quality, and efficacy of medicines
- acceptable safety, quality, and performance of medical devices
- acceptable safety and quality of natural health products, and that any health benefit claims are supported by scientific or traditional evidence
- It will regulate how products are manufactured, tested, imported, promoted, supplied, and exported. This will include medicines from general sale products like paracetamol to gene, cell and tissue therapies, and medical devices from tongue depressors to implantable pacemakers.
- Both medical devices and gene, cell and tissue therapies are currently not fully regulated in New Zealand so the Bill seeks to address this. The regulation of clinical trials will also be made more robust.
- The Bill provides a risk-proportionate approach. Pre-market controls will provide assurances that products are made to the proper standards, while in-market and post-market controls will enable a timely response if safety issues arise.
- The regime will deliver a regulator that is independent, transparent, accountable, able to sustain regulatory capability and capacity, and is responsive and flexible.
- Having flexible, risk-proportionate approval systems will also ensure New Zealand can access necessary life-saving medicines and respond to health emergencies, for example pandemics or natural disasters requiring a health response.
- The new regime will align with international best practice and it will be future-proofed so that new and emerging health technologies can be regulated appropriately.
Natural health products
In 2021, Cabinet decided to regulate natural health products under the Therapeutic Products Bill.
The Bill is not intended to stop people buying natural health products, unless there is robust scientific evidence to justify restricting it (e.g., certain parts of a plant may be toxic while other parts are fine, or the concentration of a product is too risky at a certain level to be available for general sale).
In developing the new regime, Manatū Hauora has drawn on previous work on natural health products, which included several rounds of consultation and significant input from stakeholders. Stakeholder hui were also held in November 2022 with representatives from key organisations.
Contrary to some recent reports on social media, there is no list of prohibited ingredients in the current Bill, and no proposal to ban common herbs and spices used in cooking. The impact of the Bill on any particular natural health product/ingredient would be determined via secondary legislation, following consultation with stakeholders. See Q&A below for more information.
About natural health products
Natural health products support health and wellness, and are made from natural ingredients, or synthetic equivalents such as synthetic vitamins.
This includes herbal remedies (in the form of capsules, tonics, and skin creams), vitamin and mineral supplements, traditional Māori remedies, traditional Chinese medicine, homeopathic remedies, and some remedies based on animal products, such as deer velvet and fish oil capsules.
Supplemented foods, such as bread or juice fortified with vitamins and minerals, are generally not considered natural health products. They are regulated by the Ministry for Primary Industries. Read more on the regulation of supplemented foods.
The need to regulate natural health products
It’s important people have the information they need to make informed decisions about the products they use, and have access to safe and high-quality products. Natural health products are not risk-free. They are generally lower risk products than medicines and higher risk than foods with similar ingredients.
Regulations can help ensure:
- products contain safe ingredients at a safe dose
- suitable quality manufacturing processes are in place to provide assurance that products are not contaminated
- product information is clear on the use and recommended dose
- health claims are based on evidence
- products made in New Zealand and exported overseas meet international standards.
What the Bill means for natural health products
In 2021, Cabinet decided to regulate natural health products under the Therapeutic Products Bill. The Bill makes it clear that natural health products are a different product category to medicines and medical devices. This reflects that, while there are many similarities between product types, there are also distinct differences.
Having a single Bill will help clarify the interface with other legislation. Currently natural health products must comply with the relevant parts of the Food Act 2014, particularly the Dietary Supplements Regulations 1985; the Hazardous Substances and New Organisms Act 1996, particularly the Cosmetic Group Standard 2017; the Medicines Act 1981; and/or the Animal Products Act 1999. Consumer laws also apply (e.g. the Fair Trading Act 1986 and the Consumer Guarantees Act 1993).
The Bill includes:
- a risk proportionate approach to the manufacture of natural health products
- requirements that support exports, taking relevant international standards and practice into account, and meeting New Zealand’s international obligations
- a definition for natural health products that differentiates them from food and medicines
- the ability to make health benefit claims that can be supported by scientific evidence, or evidence of traditional use
- labelling to support consumers to make informed choices about their own health and wellbeing
- enforcement provisions that include the recall of products where necessary.
Common questions on the Therapeutic Products Bill
A number of people and organisations have contacted the Ministry with questions about the Bill, in particular the proposal to regulate natural health products.
- Prohibited/permitted NHP ingredients
- Risk of harm of NHPs
- Access to NHPs
- Impact on costs
- Rongoā/Te Tiriti
- WHO report
Common questions on the Therapeutic Products Bill
See these previously released decision documents:
Released 17 January 2023
- Cabinet paper: Therapeutic Products Bill: Approval for introduction (PDF, 712KB)
- Legislation Committee minute: Therapeutic Products Bill: Approval for introduction (PDF, 672KB)
- Cabinet minute: Therapeutic Products Bill: Approval for introduction (PDF, 683KB)
Released 30 November 2022
- Regulatory Impact Statement: Therapeutic and Natural Health Products Regulation – Supplementary Analysis 2022 No 1
- Regulatory Impact Statement: Therapeutic and Natural Health Products Regulation – Supplementary Analysis 2022 No 2
- Cabinet paper: Pharmacy Ownership and Licensing (PDF, 663 KB)
- Cabinet minute: Pharmacy Ownership and Licensing (PDF, 660 KB)
- Regulatory Impact Statement: Pharmacy Ownership and Licensing
- Cabinet paper: Crown Liability under the Therapeutic Products Bill and Other Offence and Penalty Matters (PDF, 706 KB)
- Cabinet minute: Crown Liability under the Therapeutic Products Bill and Other Offence and Penalty Matters (PDF, 652 KB)
- Cabinet paper: Therapeutic Products and Natural Health Products Regulatory Scheme (PDF, 854 KB)
- Cabinet minute: Therapeutic Products and Natural Health Products Regulatory Scheme (PDF, 662 KB)
Released 17 March 2022
- Cabinet paper: Regulating Natural Health Products (PDF, 306KB)
- Cabinet minute: Regulating Natural Health Products (PDF, 144KB)
- Regulatory Impact Statement: Regulating natural health products (PDF, 398KB)
Released 14 December 2018
- Cabinet paper: Therapeutic Products Regulatory Scheme: Overview and Consultation on Bill Exposure Draft (PDF, 191 KB)
- Cabinet minute: Therapeutic Products Regulatory Scheme: Overview and Consultation on Bill Exposure Draft (PDF, 128 KB)
- Regulatory impact statement: Therapeutic Products Bill – Personal Import of Medicine by mail/courier (PDF, 56 KB), (Word, 40 KB)
Minutes from November 2015 and March 2016 Cabinet papers
- Cabinet minute: Therapeutic Products Regulation Paper 1: Context and Overview (PDF, 144 KB)
- Cabinet minute: Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (PDF, 141 KB)
- Cabinet minute: Therapeutic Products Regulation: Further Policy Approvals (PDF, 150 KB)
Released 28 April 2016
- Therapeutic Products Regulation Paper 1: Context and Overview (Word, 35 KB)
- Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (Word, 157 KB)
- Regulatory Impact Statement 1 (for Cabinet Papers 1 and 2) (Word, 130 KB)
- Therapeutic Products Regulation Paper 3: Further Policy Approvals (Word, 46 KB)
- Appendix 1 for Cabinet Paper 3: A3 (PowerPoint, 68 KB)
- Regulatory Impact Statement 2 (for Cabinet Paper 3) (Word, 114 KB)