Legislation to modernise the way medicines, medical devices and natural health products are regulated has been introduced in Parliament this week.

The Therapeutic Products Bill replaces the Medicines Act 1981 and Dietary Supplements Regulations 1985 with a comprehensive regulatory regime that is fit for the future.

Health Minister Andrew Little said the Bill will give New Zealanders peace-of-mind about the safety, quality and efficacy of the medicines, medical devices (such as COVID-19 test kits) and natural health products they are using.

'Quality medicines and medical devices are essential for a well-functioning health system, and consumers need to know the natural health products they're buying off the shelf are safe,” Andrew Little said.

'The Therapeutic Products Bill is a flexible regulatory framework for how therapeutic products are manufactured, prescribed, imported, advertised, supplied and exported, and makes the regulation of clinical trials more robust.

'It enables New Zealand to take advantage of advances in medicine, such as cell and tissue therapies, emerging gene therapies, and the use of artificial intelligence and machine learning software. Having risk-proportionate approval systems will improve access to necessary and life-saving medicines, such as vaccines in a pandemic.

'Consumer safety sits at the heart of the Bill, so the community will be better protected from goods and gadgets that make unfounded or misleading therapeutic claims.

'Having a modern set of laws and regulations that line up with international practices will also help our medicines and natural health products industries to export to the world.

'The Therapeutic Products Bill has been more than a decade in the making and, alongside the Pae Ora (Health Futures) Act, will contribute to building a health system New Zealanders expect and deserve,” Andrew Little said.

New rongoā workstream announced alongside Therapeutic Products Bill

A new workstream has been established within government to consider how rongoā might be protected in legislation. This comes as the Therapeutic Products Bill is introduced in Parliament today, Associate Minister for Health (Māori) Hon Peeni Henare said.

'Under Te Tiriti o Waitangi, the Crown has an obligation to actively protect rongoā Māori. We also have a responsibility to provide all New Zealanders with health products and services that are safe, high-quality, and effective. That is why we have introduced the Therapeutic Products Bill to Parliament today.

"We recognise the importance of rongoā, and we have been carefully considering how to recognise and protect it. This has included consulting with Te Kāhui Rongoā, a governance body for rongoā practitioners, Māori clinicians and health providers.

This new rongoā work stream will explore the interface of the Therapeutic Products Bill and rongoā. The group will also explore whether rongoā matters are being addressed through other government work programmes.

'Officials within the workstream will analyse the Therapeutic Products Bill to identify any gaps and opportunities to protect rongoā Māori, assure whānau safety, and ensure access to the export market for practitioners.

'This will present a whole new world of opportunities for both rongoā practitioners and whānau living abroad who have been wanting to access rongoā and other natural health products from Aotearoa,” Peeni Henare said.

Now the Bill has been introduced to Parliament, there will be an opportunity for people to have their say at Select Committee. As part of the rongoā workstream, Manatū Hauora are currently planning to engage between February and March 2023 with Māori partners and stakeholders to capture their views.

'Rongoā practitioners, whānau and expert groups will have the opportunity to share their whakaaro through targeted engagement that will be led by Manatū Hauora. This will ensure their thoughts, experiences and aspirations for rongoā are appropriately reflected in legislation,” Peeni Henare said.

Manatū Hauora will provide advice to the Minister in April 2023, following targeted engagement with key stakeholders, Māori partners and expert groups over the next few months.

In parallel, Te Aka Whai Ora intend to lead a programme of work to build on investments made to date and to support the future sustainability of rongoā Māori.

To this end, Te Aka Whai Ora will be engaging with the rongoā sector through variety of channels, including their whānau voice programme, to:

• surface Māori priorities and aspirations for preserving, protecting and supporting rongoā Māori
• understand the mechanisms that are needed within the health system to support those Māori priorities and aspirations for the sustainability and viability of these important services
• identify the funding paths and other resources needed for a sustainable rongoā Māori sector.