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Therapeutic & Natural Health Products update - March 2022on 17 March
Welcome to our latest update on the progress of the Therapeutic Products Bill.
Since the consultation ended back in 2019, we’ve obviously been impacted by COVID-19, but the team has been busy in the background progressing the policy work, particularly over the last year.
Reform of the therapeutic products regulatory regime and natural health products (NHPs) is a key priority for the Government this year, and our team is ready for the challenge.
We’re aiming for the Bill to be introduced to Parliament before the end of the year. There’s a lot of drafting to be done in between, but we’re confident with the timeframes that need to be met.
The other key bit of news, which some of you may already know, is that NHPs are going to be included under the Bill. See the NHP section below for more detail.
We want to support consumer safety by ensuring that NHPs are safe and high quality, while at the same time, support industry and the export process.
It’s important to note that NHPs won’t be regulated as therapeutic products or as foods, they will have their own regulations under the Bill.
Drafting the legislation is a very complex piece of work, but it’s an exciting stage to be in. The Bill will also take on board learnings from COVID-19, and will enable service innovation, particularly in primary care and community settings.
Additionally, integration with the Pae Ora (Healthy Futures) Bill is also important as the new regulatory scheme will need to operate as part of a transformed health and disability system.
Finally, please forward our newsletter to your colleagues who’d be interested. We plan to do an update every two months. If you want to get in touch with the team, you can email us at: email@example.com.
Therapeutics Policy Team
Bill due to be introduced by end of 2022
During the last couple of years, the team’s been working hard behind the scenes on some of the outstanding policy details and addressing issues raised by stakeholders in their submissions, as well as preparing the Bill for introduction to Parliament.
Thanks to those of you who took the time to send in a submission or get in touch. We acknowledge the mahi by the sector and a lot of your feedback has been carried over into the work that we’re doing. Your feedback is an essential part of the process and will help to ensure we have a robust new regime.
The Bill covers a diverse and large range of products and is also technically and legally complex to draft. We have taken particular care in how we’ve included natural health products.
A number of revisions to the Bill are still needed and some areas require further work - such as biologics, Te Tiriti provisions, market authorisation and post-market measures.
With the Bill planned for introduction to Parliament later in the year, we have a tight schedule of legislative drafting to complete over the coming months.
When the Bill reaches Select Committee stage, possibly by the end of the year or early next year, there will be another opportunity for people to submit feedback.
Once the Bill receives Royal Assent, there will be another two to three years before the scheme commences and the regulations are set.
Natural health products are being included
As mentioned, the Government has decided to include natural health products (NHPs) as part of the Bill, and it’s been good to get that certainty.
The Bill will put in place robust, modern regulations, with specific regulations tailored to NHPs.
While the Bill will provide a comprehensive approach to both therapeutic products and NHPs, we will ensure it’s clear that NHPs are not therapeutic products.
What will the new NHP scheme do?
- support consumer safety – by providing acceptable product safety and quality, and access to reliable information to enable people to make informed choices about their health and wellbeing.
- support industry development and exports – by establishing a well-functioning, risk-proportionate and cost-effective regulatory scheme that provides clarity and certainty to the sector, and enables new market opportunities through establishing an internationally-recognised regulatory scheme.
What will the scheme include?
- a definition for NHPs that differentiates them from therapeutic products and foods
- a risk proportionate approach to the manufacturing requirements for NHPs
- a self-declaration pathway for registering NHPs
- the ability to make health benefit claims that can be substantiated by robust scientific or traditional evidence
- recognition and protection of rongoā Māori
- requirements that support exports, takes relevant international standards and practices into account, and meets New Zealand’s international obligations
- labelling to support consumers to make informed choices
- enforcement provisions that include the recall of products where necessary.
Why have NHPs been included in the Bill?
As NHPs are generally lower risk than therapeutic products (but not without some risk), the Government is proposing a regulatory regime to address these risks through regulation on importing and supplying NHPs, while avoiding unnecessary costs to consumers or sellers.
NHPs are being included as there are similarities between NHPs and therapeutic products, even though there are also differences.
Regulatory scheme similarities include for example:
- supporting consumer safety
- supporting an open, well-functioning market, including innovation and exports
- applying a risk-proportionate approach to regulation that includes market authorisation of products
- aligning with international regulatory best-practice
- recognising and protecting rongoā Māori traditional healing
- providing for clear definitions, labelling, product, and consumer information
- establishing one regulator that is independent, transparent, accountable and cost effective.
The differences are accounted for in the Bill, along with the different regulations.
See our website for further information (link to updated webpage).
What the health system reforms mean for the Bill
The therapeutic products and natural health products work is integral to New Zealand’s health and disability system. Medicines, medical devices, and natural health products are used every day by New Zealanders and across healthcare settings.
The Bill is well aligned with the Government’s health and disability system reform programme, and it reflects some of the key drivers of these reforms.
As part of the health and disability reforms work, there are strong expectations for the system to reinforce the Tiriti relationship and deliver better health services and support for Māori, Pasifika, disabled peoples and other groups who have not received equitable care in the past.
All parts of New Zealand’s health and disability system need to work together successfully to deliver better outcomes for all New Zealanders and to build a stronger sustainable system.
Key points about the Bill
- We’re developing a modern, comprehensive, cost-effective regulatory system for therapeutic products and NHPs, replacing the outdated Medicines Act.
- The Therapeutic Products Bill takes on board sector feedback, the work underway on the health and disability system reforms, as well as new health technology changes and incorporates lessons from COVID-19.
The new legislation aims to provide New Zealanders with the assurances they would expect about the quality, safety and efficacy of therapeutic products, and the quality and safety of NHPs. It will help deliver better health outcomes for people and ensure consumer safety.
The Bill will regulate how products are manufactured, tested, imported, promoted, supplied, and exported. The new scheme will align with international best practice and will be future proofed with flexibility to ensure effective control over new technologies.
What do therapeutic products include?
- Therapeutic products (medicines and medical devices, including biologics) are used by New Zealanders in their daily lives, and in all parts of the health system. They’re also used to treat and prevent COVID-19.
- The Bill includes regulating medicines from general sale products like paracetamol to gene, cell and tissue therapies, medical devices that range from tongue depressors to implantable pacemakers, as well as NHPs.
What do NHPs include?
NHPs are a broad group of products intended to support health and wellbeing, that are not medicines or foods.
Examples include - garlic capsules, glucosamine capsules, magnesium tablets, herbal products (eg. echinacea and herbal teas), and kawakawa balm.
The Bill will be designed to ensure there is a clear distinction between NHPs, medicines, foods and cosmetics.
When can I provide feedback?
When the Bill reaches Select Committee stage, expected to be at the end of the year or early next year, there will be an opportunity for people to have their say. By this stage you’ll have the updated Bill in its entirety.
There will also be further opportunities during the consultation on the regulations.