New Zealand's Therapeutic Products Act 2023: Transformative Changes

Tuesday 12 September, 2023

The new Therapeutic Products Act 2023 is a transformative overhaul of New Zealand's medicines, medical devices, and natural health products regulatory regime. The new Act aims to support continued innovation while ensuring the controlled use of therapeutic products across their life cycle.

Two critical changes are outlined below.

Categories now requiring market authorisation

Central to the Act is the requirement for market authorisation. For a therapeutic product to be imported into, supplied in, or exported from New Zealand, the product sponsor must hold a market authorisation for that product.

Several product categories that previously did not require market approval under the existing Medicines Act 1981 will now require market authorisation. These include:

• Medical Devices: Defined as therapeutic products achieving their primary function not through pharmacological or similar means.
• Software as a Medical Device: Software that stands alone as a therapeutic product or augments another non-therapeutic product to create a combined therapeutic entity.
• Natural Health Products (NHPs): Comprising of specific ingredients, these will have a special exemption process if they are of low concentration or supplied on a small scale.

While the requirement for market authorisation for medical devices is new for New Zealand, we do not anticipate this to be a significant change for industry as the Act is aligning New Zealand’s medical devices regime with the rest of the world.

Direct-to-consumer advertising of prescription medicines

The new Act preserves the ability for pharmaceutical sponsors to directly promote prescription medicines to patients. The Act broadens the scope of what constitutes a medical advertisement by removing the requirement for there to be any direct or indirect commercial driver behind the “promotion” of a therapeutic product. This means that any form of communication that “promotes” a therapeutic product will be considered an “advertisement” for the purpose of the Act.

The new Act contains a number of defences against a breach of an advertising requirement, which are not present in the existing Medicines Act. The defences apply if:

(a) the conduct that constituted the breach was undertaken in good faith for any of the following purpose:

• reporting of news or a matter of public concern:
• research, study, or education:
• criticism or review of a therapeutic product or information about a therapeutic product:
• fundraising to enable the acquisition of a specified therapeutic product by or for a specified individual or individuals:
• advocating for a change to Government policy about therapeutic products (including about public funding for therapeutic products (either generally or specifically)); and

(b) engaging in that conduct for that purpose was reasonable in all the circumstances.

The availability of the defences:

• reinforces the broad meaning and scope of “promotion”; and
• means that the emphasis under the new therapeutic advertising regime will be on the application of the defences, rather than the (extremely broad) meaning of “promotion”.

Implementation Timeline

The provisions of the new Therapeutic Products Act will be implemented gradually, and the entire regime will be in forced by 1 September 2026. This phased implementation allows for the establishment of the new regulator, the drafting of regulations to support the Act, and the development of rules for specific matters.

Preparing for the Change

The life sciences industry should take proactive measures to familiarise themselves with the Act’s requirements. Steps include:

• Evaluating Implications: Understand the temporary market authorisations and/or licences that will apply during the transition period, and what licences and permits will now be required to undertake certain supply chain activities in relation to a therapeutic product.
• Planning Compliance: Review existing compliance measures and consider whether updated measures are required.
• Stay Updated: As the regime unfolds, keep informed about the new regulations, rules, and details about the new regulator.

Our View

The Therapeutic Products Act aligns New Zealand with global best practices, while ensuring the safety and efficacy of medicines, medical devices, and natural health products. Early engagement, proactive compliance planning, and staying updated as the new regime unfolds are crucial during the transition period.

If you would like specific advice about how the legislative changes will affect your business, please contact one of our life sciences and health law experts.