Introduction
Update February 2023
Update March 2023
Therapeutic Products Bill introduced to Parliament
As of 30 November 2022, the Therapeutic Products Bill was introduced to Parliament.
The Therapeutic Products Bill replaces the Medicines Act 1981 and Dietary Supplements Regulations 1985 with a comprehensive regulatory regime that Health Minister Andrew Little claims is fit for the future. The Bill will regulate natural health products, but in a separate category from medicines and medical devices.
This is a considerable milestone, and there are some key updates to share with you via the MoH Therapeutics Policy Team and New Zealand Legislation websites. These updates include information on the following:
• the new regulator
• cost recovery model
• offences and penalties framework
• natural health products (NHPs)
• rongoā Māori interests
• pharmacy ownership rules
• direct to consumer advertising of prescription medication (DTCA-PM)
Read the Therapeutic Products Bill here, you can also download a pdf version
Resources for further reading:
MoH Newsletter: Therapeutic & Natural Health Products update – November 2022
Minister Little’s Press Release: Therapeutic Products Bill introduced
Update February 2023: Submissions to the Therapeutic Products Bill
In our recent newsletter, we informed our members and iHemp community that the Therapeutic Products Bill was introduced to Parliament on November 30, 2022, the date for submission has now been extended to 5th March 2023.
The Therapeutic Products Bill will cover natural health products, which are currently regulated by the Dietary Supplements Regulations 1985, the aim is to provide an appropriate level of assurance that products imported and supplied in New Zealand are safe and made to the appropriate quality standards. Whilst regulating the health benefit claims made and providing a modern and flexible regime for NZ Exporters.
This could be an opportunity for Aotearoa New Zealand to have a thriving natural health foods sector that boosts economic growth and facilitates affordable and reliable means to improve consumers’ well-being, however, the current Bill lacks detail on how this will be achieved.
As a trade association representing large and small participants in the emerging low THC industrial hemp (iHemp) industry, we look forward to being part of this bill and understand the need for a regulatory framework to allow for export of NHP’s.
Currently, the Bill does not disturb regulatory arrangements relating to medicinal cannabis or drugs controlled under the Misuse of Drugs Act 1975 (MoDA), therefore we need to remove low THC industrial hemp (iHemp) from Moda and CBD as a prescribed medicine under the Medicinal Cannabis Scheme.
This is more impetuses to recognise iHemp as an arable and horticultural crop opportunity given our low levels of THC, we are not a drug!
The NZHIA has prepared the following response to the Therapeutic Products Bill, “here” we welcome the opportunity for you to have your say in this document by providing feedback to admin@nzhia.com by the end of February for submission on the 5th March 2023.
Useful links for more information:
- Our draft submission here
- Our background document here , extracts from TP Bill here
- Make your submission here
- The consultation information is here and other Ministry of Health documents relating to the regulatory regime are here
- The Therapeutic Products Bill is here
- Government commentary in parliament on the Bill is here and here
- The Ministry of Health disclosure statement on the bill, seeks to bring together in one place a range of information to support and enhance the Parliamentary and public scrutiny of that Bill and is available here.
Update March 2023: Therapeutic Products Bill consultation closed 5th March
Although low THC iHemp, as a controlled drug under Misuse of Drugs Act 1975 (MoDA) and CBD as a prescription medicine are not yet included in the Therapeutics Products framework, it we important the NZHIA made a submission, to ensure that the framework for Natural Health Products (NHP) was workable, inclusive and did not limit access to foods with therapeutic benefits.
We supported the Natural Health Products NZ submission stressing the light touch approach to regulation required for low risk NHP, both documents can be found here:
• NZHIA Submission
• NHPNZ Submission