General Overview

The Therapeutic Products Bill ('Bill'), which is destined to replace the Medicines Act 1981 and Dietary Supplements Regulations 1985 with a comprehensive new regulatory regime, had its first reading in Parliament on the 14th of December 2022. The Bill has now been referred to the Health Select Committee. The Chair of the Health Committee has called for public submissions, the closing date for submissions is 11.59pm Thursday 9 February 2023.

It will still be some time before the Bill receives Royal Assent, after which there will be another two to three years before the scheme commences and the regulations are set. 

Natural health products will be regulated in a separate category to medicines. A separate workstream will accompany the Bill to protect rongoā (Māori medicine and healing) led by Te Aka Whai Ora and Manatū Hauora, the Ministry of Health, and guided by rongoā practitioners and Māori.

Product Classification

Principles-based

The Bill is a principles-based framework. There will be less detail in legislation and more in the regulations and regulator-made instruments. At this stage, the regulations, rules and notices have not been developed and there is still no indication of what these will include.

Categories

The Bill introduces a four category system in relation to therapeutic products:

1. medicines;
2. AMIs;
3. medical devices; and
4. NHP (natural health products).

Controlled Activities

Under the Bill, ‘controlled activities’ in relation to medicines and medical devices include:

1. manufacturing;
2. wholesale supply;
3. non-wholesale supply;
4. prescribing and administering;
5. possession; and
6. conducting clinical trials.

A person will not be permitted to carry out a controlled activity unless they are authorised to do so by a licence, permit, or provision similar authorisation requirements to those necessitated under the Act.

Permits and Licenses

Under the new regime, temporary licences will automatically be granted to those parties holding equivalent product or activity licences under the Act. Consultation materials from 2018 suggest that parties will then have six months to apply for product approval under the Bill. Licences remain in force for no longer than five years. Permits remain in force for no longer than two years.

Market Authorisation

Overview

Therapeutic products (other than active medical ingredients) will be regulated by means of market authorisations. In broad terms, the process for obtaining market authorisation requires an applicant to satisfy the Regulator about the quality, safety, and efficacy or performance of the product. This effectively means that there will be more regulation of medical devices and NHP’s across their lifecycle.

The market authorisation regime replaces the consent regime in relation to new medicines. Existing consents granted under the Act will generally become market authorisation under the Bill. The market authorisation regime replaces the consent regime in relation to new medicines. Existing consents granted under the Act will generally become market authorisation under the Bill.

Low concentration NHP’s do not require market authorisation. A person may also be authorised by licence, permit, or provision of the Bill to import or supply a product without an authorisation. The authorised person may only act within the terms and conditions of the authorisation.

Authorisation Process

A person may apply to the Regulator for authorisation of a medicine, medical device, or NHP. When evaluating an application, the Regulator must have regard to:

1. criteria for market authorisation under the Bill;
2. compliance with the relevant product standards; and
3. whether the person named in the application as the proposed sponsor meets the necessary criteria.

The sponsor is responsible for ensuring that the product conforms to its authorisation and meets the applicable product standards. The sponsor also has ongoing obligations in relation to such things as post-market surveillance , record-keeping, and reporting.

Promotion and Distribution

Advertising of Medicines

The Bill retains much of the existing regulations in relation to the advertising of medicines and medical products, although  the definition of “advertisement” is wider. 

The Bill continues to permit the advertising of prescription medicines and other medical products directly to consumers. However, the Bill introduces a specific offence in relation to misrepresentation about a therapeutic product. This new offence addresses the issue of misleading branding, which is no longer a separate offence under the Bill.

There are increased penalties, with wider enforcement options available to the Regulator. There is a new provision in the Bill which prohibits improper inducements to health practitioners. 

Distribution 

The Bill does not specifically require medicine importers or manufacturers to possess quality testing details and certificates in relation to therapeutic products. However, product sponsors are obliged to conduct quality testing where necessary to comply with their post-market surveillance obligations.

The Bill retains much of the existing regime in  relation to the supply of therapeutic products.  However,  the Bill introduces a distinction  between 'wholesale' and 'non-wholesale' supply, which was not previously accounted  for under the Act.

New Technology

General

Gene, cell and tissue therapies are currently not fully regulated in New Zealand. The Bill intends to enable 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.

Cell and Gene Therapy

Under the Bill, ‘medicines’ can include medicines made from biological components, gene therapies, and advanced cell and tissue therapies.

The Bill contains a provision in relation to the Human Tissue Act 2008 ('HTA'). The Bill modifies the HTA so that ‘use’ of tissue does not include the use of human tissue that is lawful under the Bill or the use of human tissue to manufacture a therapeutic product.

Software as a Medical Device

Currently, software is not strictly regulated as a medical device and does not require pre-market approval. The Bill will introduce a specific provision incorporating software under the new regime for medical devices.

This means that software as a medical device must receive approval before it can be supplied. The Bill also preserves the offence for contravening these approval provisions, which will now extend to software as a medical device.