Kia Ora

On 26 July 2023 the Therapeutic Products Bill received Royal assent, becoming the Therapeutic Products Act (2023). The passing of the Act marks the most significant change to the regulation of medicines, medical devices and natural health products in nearly 40 years.

Most provisions in the Act will not come into effect until mid-2026. Until then, Manatū Hauora (the Ministry) will be busy developing the necessary rules and regulations to support the new therapeutic products regulatory regime. The Ministry will also be establishing the Regulator to administer the Act, and a digital platform and services that will be needed to support it.

This issue includes an overview of the work the Ministry will undertake over the next couple of years and provides an update on our engagement strategy.  For those interested in past decisions by Government, this newsletter also includes links to some recently pro-actively released documents.

Programme of work

Implementing the Act is a large-scale and complex programme of work. It currently includes three major workstreams:

1. Secondary legislation 
2. Digital platform 
3. The Regulator 

Secondary Legislation

While the Act is a lengthy piece of legislation, a functional therapeutics regime will also need a large and comprehensive body of secondary legislation. This includes new regulations, rules and Regulator’s notices. In addition, we’ll also need to develop guidelines and policies to support industry, practitioners and applicants.

It is anticipated that it will take approximately three years to deliver due to the scale, complexity and broad coverage of products and activities that are affected.  Because of the size of the task, our team is prioritising those instruments that are essential for Day 1 of the new regime.

These include the regulations and rules necessary to enable product authorisations (including self-assessment and declaration pathways) and licensing of controlled activities. Regulations will also need to be in place to ensure essential healthcare services can be delivered.

Many of the issues raised by the sector during the Act’s development must be addressed in secondary legislation. The Ministry will work closely with the sector in its development.

Digital Platform

A new digital platform will be critical for the operations of the new regulator and regime from 2026. This will provide the new regulator and regime with a digitally enabled operating model that is customer centric, fit for purpose, and stable and scalable. Scoping work for this platform is underway.

The Regulator

Given the range of products to be regulated under the new regime, the Ministry anticipates the new regulator may be two to three times larger than Medsafe. Work is now underway to scope and develop a high-level strategy, operating model, organisational design and implementation plan for the new regulator.  

Proactive release of documents

The Government recently agreed to proactively release several documents that were developed as part of its consideration of the Supplementary Order Paper (SOP) on the exemption of many small-scale Natural Health Product (NHP) manufacturers and rongoā practitioners from regulation under the Bill.

There are three sets of documents. The first are Cabinet documents and papers which have Cabinet approval to release. The second includes briefings related to the SOP.  These provide useful context for people seeking to understand decisions around the regulation of rongoā, small-scale NHP manufacturers and direct-to-consumer advertising of prescription medicines. The third responds to feedback from Crown organisations, including Te Aka Whai Ora, on the SOP. 

The documents convey advice regarding how to reflect Te Tiriti o Waitangi including rongoā in the Act, the establishment of the rongoā workstream, engagement with Māori to inform the workstream and other related matters. The documents can be found on the Ministry website (www.health.govt.nz).

Engagement

We are developing an engagement approach which will enable both general and specific engagement with stakeholders over the months and years ahead. It will include the establishment of formal and informal technical working groups, and consultation on regulations, size, scale, approach and international alignment of the new regulator, and sector funding for the cost recovery model.  

You will hear more about this over the coming months.

Contact Us

Please monitor the Therapeutic Products Act page of the Ministry of Health website which will be regularly updated with new information.

If you, or people you know, would like updates on progress with the therapeutic products regulatory regime, we encourage you to subscribe to the newsletter and read previous editions of the newsletter.

If you would like more information or to contact the team, please contact us at therapeuticproducts@health.govt.nz