Therapeutic products regulatory regime

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 (NHPs).

On this page:

See also Questions and answers on rongoā.

Select Committee submitters

What did submitters say?

A considerable proportion of submitters stated their opposition to the Bill, or, in most cases, specific elements of the Bill, because of its:

  • inclusion of NHPs (9,042 submissions)
  • impact on rongoā Māori (731 submissions)
  • claimed inconsistency with Te Tiriti o Waitangi, The Treaty of Waitangi (157 submissions)

During Committee hearings, many submitters also raised concerns with proposed restrictions in the Bill on personal importation of prescription medicines, especially life-saving/extending medicines which are not available (or affordable) in New Zealand. 

How has Health Committee responded to submitters?

The Health Committee’s report on the Bill and recommended amendments (in the ‘revision-tracked’ version of the Bill) represents its response to feedback.

Parliament now has an opportunity to consider the Health Committee’s proposed amendments at the Bill’s ‘second reading’.

If the Bill passes its second reading, all Members of Parliament will have another chance to propose and debate changes to the Bill at the Committee of the Whole House stage of debate.

The Government plans to introduce an amendment to the Bill at this stage to create an exemption to enable many small-scale NHP manufacturers to make and supply NHPs directly to New Zealanders, without needing to apply for a market authorisation for each product, or a manufacturing licence.

The Government also intends to amend the Bill to remove most obligations that would otherwise apply to rongoā practitioners.

For further information see:

Exemption for small-scale manufacturers

What does the exemption mean for small scale NHP manufacturers?

The Bill is intended to support product safety, but it must be proportionate to the risk of harm. While NHPs are not risk-free, the evidence available suggests these products do not pose a significant public health risk. 

Under proposed changes to the Bill, small-scale NHP manufacturers will not need to obtain a product authorisation or manufacturing licence from the new regulator where their products are made and supplied in-person to customers in New Zealand. Product authorisation would still be required for imported NHPs.

Why regulate NHPs at all if small-scale manufacturers are exempt?

There is still a need to regulate NHPs as they are not risk-free. The scale of distribution combined with the risk posed by a NHP and its production are important factors in weighting up risk. The overall risk profile of distributing certain NHPs made in small amounts is sufficient to not warrant the regulatory requirements needed for most other NHPs. We have assessed other products in a similar way, such as low concentration NHPs, or those made by a practitioner as part of a consultation for a client.    

It is important people have the information they need to make informed decisions about NHPs. Regulations can help ensure:

  • products contain safe ingredients with information that is clear on the use and recommended dose
  • suitable quality manufacturing processes are in place to provide assurance that products are not contaminated
  • health claims are substantiated
  • products made in New Zealand and exported overseas meet international standards.

Other amendments

What has the Health Committee proposed around the importation of medicines?

During the Select Committee stage, the Committee addressed the issue of personal importation of medicines. The Committee recommends removing the ban on the personal importation of prescription medicines via the internet, so long as the medicines have been prescribed by a New Zealand health practitioner. Supply and other restrictions on personal importation of medicines remain to mitigate the risks of people buying contaminated and counterfeit goods.

Will the Bill prevent patient fundraising and advocacy in relation to unauthorised medicines? 

No. Under changes to the Bill proposed by Health Committee, people will still be able to use Give-a-Little and similar pages to fundraise for medicines which are not authorised in New Zealand, or which may not be publicly funded for their condition. They will also be able to publicly advocate for specific medicines to be publicly funded. 

Prohibited/permitted NHP ingredients

Does the Ministry of Health have a list of prohibited or restricted herbal ingredients?

No. The Ministry does not have a specific list of prohibited or restricted herbal ingredients, although some herbal ingredients are restricted under the Medicines Act for safety reasons (eg, Atropa belladonna and Datura species).

The Bill does not have a proposed list of prohibited or restricted herbal ingredients in it. If the Bill is passed, a list of recognised NHP ingredients would be developed as secondary legislation, in consultation with stakeholders.

What about the previous Permitted Substances list developed between 2013–2017?

There was an old draft Permitted Substances list for NHPs from 2013 to 2017, which was not finalised and never used. It is now of historical note only and has no legal standing.

Did the previous Permitted Substances list prohibit cinnamon, neem, coconut or tamarind?

No, it did not prohibit those substances.

Some reports on social media have referred to the draft Permitted Substances list as a ‘list of 300 prohibited or restricted herbal ingredients.’ Based on reports we have seen, the examples used of supposed prohibited ingredients are misleading and/or inaccurate. For example, the draft Permitted Substances list only proposed to limit the amount of cinnamon oil present in a NHP due to established toxicity at high levels. It is similar for neem.

Statements made about the previous, draft Permitted Substances list are misleading, in that they imply that the plant, herb or spice itself would be prohibited. Likewise, these statements usually omit that, where an ingredient was on the list, it was usually with reference to a specific form (eg, oil) and concentration.

There was no proposal to prohibit tamarind or to prohibit coconut from being included as part of a NHP.

Risk of harm

Aren’t NHPs risk free?

While overall the risks associated with NHPs are generally lower compared to medicines, NHPs are not risk-free. 

NHPs can be safe to use if they contain safe ingredients, are made appropriately, and are accompanied by accurate information that helps consumers make informed choices, including information on possible risks. 

When these conditions are not met, the risk of harm increases. Consumers have experienced a range of harms from NHPs – from mild discomfort to severe adverse reactions or dangerous interactions with medicines. 

Inaccurate or unsubstantiated (ie, unsupported) information about NHPs (eg, health claims) may also delay people seeking treatment for serious conditions that are best treated with conventional medicines. 

What evidence of harm does the Ministry hold on NHPs?

The Ministry commissioned Sapere to conduct a rapid literature review on the evidence of harm in relation to NHPs to help support the Health Committee in its consideration of the Bill.

The review found that the safety and efficacy of NHPs are not always guaranteed. The reviewed studies identified adverse events associated with the use of NHPs, particularly in relation to some studies finding that herbal products are associated with liver injury. The incidence of serious adverse events was generally low. However, it is unclear if the low incidence of adverse events is due to their good safety profile or underreporting and limited investigations.

For more information see Appendix 6 (Literature Review – Evidence of harm from NHPs) (PDF, 428 KB).

What is an example of harm caused by a NHP?

In 2018, Medsafe issued an alert communication in relation to Arthrem, a product which was linked to serious cases of liver harm.

For further information, see Artemisia annua (Sweet wormwood, Sweet Annie, Qing hao) extract marketed as Arthrem: risk of harm to the liver – statement under section 98 of the Medicines Act 1981 on the Medsafe website.

Data on adverse reactions to dietary supplements and herbal products from 2013–2021 can be found in a proactively released OIA response letter (PDF, 3.1 MB).

Access to NHPs

Will the Bill control/limit the availability and access to NHPs?

The Bill is not intended to stop people buying NHPs, unless there is robust scientific evidence to justify restricting it (eg, certain parts of a plant may be toxic while other parts are fine, or the concentration of a product is too risky to be available for general sale).

Won’t NHPs be regulated the same as medicines? Will people need a prescription to access NHPs?

Under the Bill, NHPs are not medicines. If the Bill passes, separate regulations will be developed for medicines and NHPs, and will be publicly consulted on.

People will not need a prescription to access a NHP. In some instances though, some products that people may think of as a NHP may need a prescription, For example, Atropa belladonna (commonly known as deadly nightshade) is a prescription medicine in some circumstances. In other circumstances, where the risk is lower, it is a pharmacy-only medicine. This is to protect people from consuming too much of the toxic alkaloids in the plant that can cause serious illness or death.  

Costs

Will consumers see an increase in the costs of NHPs?

One of the principles of the Bill is that regulation should be proportionate to the risks posed by the products. That will apply to NHPs and will generally be reflected in costs. Lower-risk products requiring less regulatory oversight will incur lower costs. 

The Regulator will be able to recover costs from businesses and it will be up to the businesses to determine whether they pass on or absorb the costs. It is fair that businesses that stand to gain financially from having their products on the market contribute to the cost of the system that keeps everyone safe.

The types of activities businesses will likely be charged for, include:

  • obtaining a ‘market authorisation’ for an NHP.
  • seeking a licence to manufacture, import, or export a NHP in the course of business.

These fees are intended to support a range of activities including the regulator’s assessment of applications for market authorisation, maintaining a public register of therapeutic products and licence holders, and post-market surveillance activities, such as investigating whether there is a problem with a specific product and issuing a recall.

Fees and charges will be set out in secondary legislation (regulations) and the Bill requires consultation on the regulations.

Won’t extra red tape and increased costs have a big impact on small businesses already struggling?

Fees, charges, and levies will be determined after the Bill is passed, following further consultation with the sector. In setting fees and charges, the Regulator will need to consider whether costs are equitable, efficient, justifiable, and transparent. We will be working to ensure all regulatory requirements are proportionate to keeping products safe and high quality.  

The new scheme includes a market authorisation pathway for NHPs where products are registered by self-registration, rather than requiring an evaluation by the Regulator. This should result in lower costs for NHP manufacturers than for manufacturers of medicines and some medical devices. There will be some exceptions to registration, such as products that have extremely low concentrations and natural health practitioners who manufacture their own products during or following consultations. 

Manufacturing requirements will also be risk proportionate and lower risk products such as NHPs may not always need to meet the same manufacturing standards as medicines. All exported products, however, will likely need to meet the internationally recognised Good Manufacturing Practice standards, as it is difficult to meet an importing countries’ requirements without it. 

All businesses, small and larger, will be able to make health benefit claims, provided they can substantiate their claims with sound evidence. Some higher-level claims may also be provided for by the Regulator, and applications will be able to be made to include further claims. 

By being able to provide consumers with a greater understanding of what their products can do for them, they will be able to boost product viability and in turn, boost sales. 

WHO report

Why does the WHO Global Report on Traditional and Complementary Medicine 2019 state that some NHPs are regulated in New Zealand under the Medicines Act?

The wording in the WHO report is potentially misleading without additional context. This report was published in 2019 and includes information from surveys taken back as far as 2005. The reference in the report to ‘natural health product’ may be to the product category as proposed in the Natural Health and Supplementary Products Bill which lapsed in 2017. 

Under the Medicines Act, there is currently no legislative provision for a product to be marketed in New Zealand as a ‘natural health product’. However, as per the WHO report, some products that may be considered ‘natural health products’ in other jurisdictions are currently being supplied in New Zealand as dietary supplements, related products, or medicines.

There is legislative provision for products that meet the definition of ‘dietary supplement’, as per the Dietary Supplements Regulations 1985, and which comply with the requirements specified in the Regulations, to be marketed in New Zealand. There is no pre-market assessment or approval of dietary supplements. It is the responsibility of the supplier to the market to ensure compliance.

Page last updated: 14 June 2023

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