The long awaited Therapeutic Products Bill (Bill) was recently introduced to Parliament to replace the Medicines Act 1981 and Dietary Supplements Regulations 1985. The Bill would introduce a new regulatory regime for therapeutic products, including medical devices, medicines, natural health products and active pharmaceutical ingredients. In particular, the Bill would regulate the manufacturing, testing, promotion, supply, import and export of therapeutic products. The Minister of Health, Hon Andrew Little, describes the Bill as, "giving 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".
The most significant changes included in the Bill, compared to the existing regime, include:
Establishing a new Therapeutics Products Regulator (Regulator) to cover a broader scope of therapeutic products, compared to the current medicines' regulator, Medsafe. The Regulator would sit within the Ministry of Health but operate independently from the Director-General of Health and the Minister of Health, being responsible for medicines, medical devices, natural health products, biologics and clinical trials. Specifically, the Regulator would administer a new risk-proportionate market authorisation process (discussed below). The Bill also provides the regulator with a range of compliance and enforcement powers. Additionally, the Regulator would have the power to issue a range of orders that are intended to address safety issues arising after a therapeutic product enters the market, such as recall orders, advertising remediation orders, and direction orders.
Therapeutic products would require a market authorisation before they can be imported into, exported from, or supplied in New Zealand. This is a material change for medical devices, which are currently subject to a notification regime only. Market authorisations for medicines and medical devices would be issued following an evaluation by the Regulator. In conducting this evaluation, the Regulator would take a new risk-proportionate approach, where it would be required to determine whether the medicine's or medical device's safety, quality and efficacy meets its intended authorised indications, and whether the likely benefits of the medicine or medical device outweigh the likely risks associated with it. In limited circumstances, therapeutic products without market authorisation may be imported into, and supplied in, New Zealand (secondary legislation would establish these circumstances). Alternatively, the Regulator may authorise the export of a therapeutic product, despite not meeting New Zealand's requirements, acknowledging contrasting requirements of overseas markets.
A licence would be required to carry on certain activities involving therapeutic products (called "controlled activities"). These controls would work alongside the requirement for market authorisation. For medicines and medical devices, controlled activities would include manufacturing, supply (wholesale and non-wholesale), exports, and product clinical trials. Medicines would have additional controls for prescribing, dispensing, compounding, and administering. Controlled activities for natural health products would be limited to manufacturing and exporting, as well as importing a low concentration natural health product.
Expanding the definition of 'therapeutic purpose' to encompass a broader range of purposes, including supporting human life, providing vitamin, mineral or other human nutritional supplementation, and maintaining or promoting human health. This would mean that products that have general health benefits (such as vitamins), which are not currently regulated under the Medicines Act 1981, would now have a therapeutic purpose, and would be regulated under the new regime (as "natural health products").
Regulating natural health products as a separate category from medicines and medical devices. The Bill includes detailed provisions to determine which products would be classified as a natural health product (and not a medicine). While natural health products still require a market authorisation, this will be through a self-assessment or declaration pathway that is less onerous, reflecting their generally lower risk profile. Additionally, the Bill would regulate 'health benefit claims' made in relation to a natural health product.
- Introducing a range of enforcement tools that include tiered criminal offences, strict liability offences, infringement notices and a civil pecuniary penalty regime. This is intended to allow for graduated and proportionate responses to breaches.
The Bill proposes to maintain the status quo for a few key matters, including:
Pharmacy ownership. The Ministry of Health has stated that due to ongoing health and disability system reforms and the continuing COVID-19 response, loosening pharmacy ownership restrictions would increase uncertainty in the pharmacy sector in the interim.
Direct-to-consumer advertising of prescription medications. However, greater penalties and new provisions on infringement notices would be implemented.
The Bill is expected to have its first reading shortly. Following this, it will be referred to the Health Select Committee, where feedback from the public would be sought on the Bill.
It is expected to take some years before the new regulatory regime comes into full force. The Cabinet paper accompanying the release of the Bill suggests that regulations would be in effect within 12 to 24 months from the Bill's enactment to complete the regulatory scheme. The Bill will not enter into force until an Order in Council is made to bring it into force, with a backstop date of 1 September 2026.
A copy of the Bill is available here, the relevant Cabinet papers are available here, and the Regulatory Impact Statements are available here. If you have any questions, please reach out to one of our experts below.
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