Kia Ora

Welcome to the latest edition of our newsletter. It’s still a really busy time for the Therapeutics team and this year is flying past!

Drafting of the Bill is ongoing, and we’re looking forward to seeing the Bill introduced to Parliament later this year.

There continues to be considerable work underway in the natural health products (NHPs) space, as well as analysing how best to embed Te Tiriti in the Bill, and working with Te Kāhui Rongoā Trust on how best to recognise and protect rongoā Māori.

We’ve had a number of key engagements with a range of groups which are highlighted below. We’re looking at further engagement with specific organisations/stakeholders to ensure people have a chance to have their say and help finetune the Bill and subsequent regulations.

We’ll be continuing to engage with key groups over the coming months, with our focus over the next few weeks on the NHP sector, pharmacy sector, and on rongoā Māori. 

Please forward our newsletter to any of your colleagues who would be interested. Look out for our next update in late July.  If you want to get in touch with the team, you can email us at: therapeuticproducts@health.govt.nz

Ngā mihi
Therapeutics Policy Team

Engagement with the sector

Getting feedback from the sector is invaluable to our work. We’ve continued to hold regular catch ups and engagement opportunities with a range of organisations over the last couple of months. This includes:

Medicines New Zealand (MNZ) – we had a good discussion on the progress of the draft Bill and we addressed some of the issues raised by MNZ in its submission on the exposure draft Bill (such as transparency of approval timeframes and international harmonisation).

Te Kāhui Rongoā Trust – we’re grateful to Donna Kerridge for dedicating her time to introduce us to rongoā Māori. We had a really interesting day at Zealandia in Wellington and it was followed up with another wānanga in the Botanical Gardens. We learnt a lot over the two days. See pic below.

Pharmacy sector – we met with several pharmacy groups recently and gave an update on the draft Bill. 

Medical Technology Association of New Zealand (MTANZ) – the team has been asked to speak at MTANZ’s Healthtech conference next month.

Natural Health Products New Zealand (NHPNZ) – we met recently with NHPNZ and discussed a number of issues, including health benefit claims and ways to facilitate safe dietary supplements exports.

Consumer New Zealand – we had a good discussion with Consumer NZ about how the Bill is developing.

Therapeutic Advertising Pre-vetting Service (TAPS) – the team joined one of the TAPS group’s meetings and gave an update on the draft Bill.  

Embedding Te Tiriti in the Bill

Another big area of work for the team is ensuring Te Tiriti o Waitangi and its principles are reflected appropriately in the Bill for medicines, medical devices and NHPs. They are a central part of our health system, and embedding Te Tiriti will support equity of health outcomes for Māori and all New Zealanders.

This work includes aligning the Bill with the wider health system changes, including the Pae Ora Bill and the recommendations of the Health and Disability System Review.

We are currently developing advice on how best to incorporate Te Tiriti in the Bill, how the new regulator can give effect to Māori-Crown relationships, and ensuring the development and administration of the wider therapeutic products regulatory regime has an appropriate equity lens.

We expect to provide a further update in our next edition, particularly on how we will be engaging with our partners and stakeholders to get their input.

Lifecycle for regulating therapeutic products

Some of you will already know this, but we wanted to run through the lifecycle for therapeutic products regulation.

As you know, therapeutic products are a diverse group of products that everyone is likely to need at some point in their lives. While they are an essential component to the delivery of high quality health and disability support services, they can potentially cause harm if they are not regulated appropriately.

The Bill defines three types of therapeutic products:

• medicines (including cell and tissue therapies, vaccines and biological medicines)
• active ingredients of medicines (called active medicinal ingredients or AMIs)
• medical devices (including in-vitro tests and software).

We need to ensure that therapeutic products in New Zealand meet acceptable safety, quality and efficacy or performance requirements across their lifecycle - from design, manufacturing to post-market surveillance.

The therapeutic products regulatory framework is based around two broad components:

• product approval requirements - products will need to be approved before they can be imported or supplied. Approval holders will need to comply with requirements around monitoring for post-market safety.
• controlled activity requirements - these vary across product types and include conducting a clinical trial, manufacturing, wholesale supply, prescribing, and pharmacy activities. Appropriate authorisation will be required to perform a controlled activity. Authorisation will be given through licences or permits.

While the medicines sector is familiar with the lifecycle regulation, the new regime under the Bill will require product approval to be in place before importation, compared to before distribution under the Medicines Act 1981. 

Radiopharmaceuticals and most cell and tissue products will be regulated under the umbrella term of medicines. The regulatory requirements for different kinds of medicines will be tailored to accommodate the different characteristics and risk profiles.

Medical devices - for the medical devices’ sector, this means the new regime will bring in a full suite of pre- and post-market controls throughout the lifecycle regulation. This will bring New Zealand in line with the international best practice promoted and implemented by the International Medical Device Regulators Forum and the World Health Organization.

Moving to the new regime will be a big leap for the medical industry. For example, under the new regime, medical devices will be assigned to a risk class using agreed classification rules, and manufacturers will be required to demonstrate that the devices they produce meet requirements for safety and performance as part of the pre-market approval process.

As a principle based legislative framework, the Bill sets high level guiding principles for the development of regulations and other secondary legislative such as rules and notices. Technical requirements such as classification rules and general safety and performance standards will be developed after the Bill is introduced to Parliament, and there will be an opportunity for the sector to have their say in developing these requirements during the public consultation.

The diagram below shows how the regulatory controls would be applied across the lifecycle of a product. Note that not all controls are applied to all product types.

Q&A

Is the Bill based on the previous draft exposure Bill?

The fundamental structure and framework of the Bill remains largely the same as the 2019 exposure draft Bill.

A significant difference is obviously the inclusion of NHPs, but it will be based on and developed from the draft Natural Health and Supplementary Products Bill that lapsed in 2017.

Revisions are being made to certain areas of the Bill, including to:

• strengthen the role and independence of the regulator
• better reflect principles of risk management
• provide the regulator with a full suite of modern regulatory and enforcement tools
• respond to advancements in medical technologies and treatments, including advanced gene and cell therapies, as well as lessons from COVID-19
• align with wider health system changes, including the Pae Ora Bill and the recommendations of the Health and Disability System Review, and to better recognise the principles of Te Tiriti o Waitangi.

Why has it taken so long to get to this stage?

This is a complex policy area. The Bill covers a diverse and large range of products, and is also technically and legally complex to draft.

The nature of the sector and its practitioners, the history of use of NHPs, the Crown’s obligations under Te Tiriti and the evolution of international best practice, makes it important to ensure any legislation is future-looking, flexible and sensitive to the needs and aspirations of all New Zealanders, including Māori, Pacific groups and the disabled community. 

Natural Health Products (NHPs)

Health benefit claims

We’re doing further work on health benefit claims for NHPs, and how it will interface with the definition of a ‘therapeutic purpose’ for therapeutic products.

We’ve consulted with our colleagues in Australia and Canada to better understand how their regimes work and the issues they’re facing. This forms part of our wider work to ensure we align with international best practice.

Both countries provided valuable insights which we’re considering to ensure we have the range of claims that are suitable under a self-declaration pathway and are appropriate in the context of the therapeutic products regime.

It’s worth noting the Bill will just set out the high level principles. There is still considerable work to occur, most of which will be in subsequent regulations, including evidence to substantiate a health benefit claim. 

Rongoā Māori

We’re working in partnership with Te Kāhui Rongoā Trust to better understand rongoā Māori, and we‘ll research together to develop what is needed in the Bill to recognise and protect rongoā Māori.

When can I provide feedback?

When the Bill reaches Select Committee stage, expected to be 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.