The introduction of a new regime, principally to replace the 40-year old Medicines Act 1981, was first signalled some years ago. In June, we examined the possible content of a new therapeutic products regime in New Zealand in The Big Picture: Health.
We now have visibility over the intended overhaul of the regulation of therapeutic products in New Zealand with the introduction of the Therapeutic Products Bill (the Bill) to Parliament on 30 November 2022. The Bill is intended to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985.
What changes under the Therapeutic Products Bill?
The Bill will regulate how specified products are manufactured, tested, imported, promoted, supplied, and exported. Products covered by the proposed legislation that have not previously been fully regulated include:
- treatments involving biological components, gene therapies, and advanced cell and tissue therapies;
- medical devices; and
- natural health products including vitamin and mineral supplements.
Considerable changes can be expected for manufacturers and retailers of these types of products. In particular, market authorisation will now be required before such products are supplied, either through an evaluation process by the new regulator following a risk-proportionate approach, or self-assessment/declaration in the case of lower-risk natural health products.
By replacing the Medicines Act and the Dietary Supplements Regulations, the Bill aims to establish a single and comprehensive regime that covers all products that have a therapeutic purpose. The Bill seeks to deliver better health outcomes for people, ensure consumer safety, provide a flexible and future-proof approach in order to ensure effective control over new technologies, and align New Zealand with international best practices.
The Bill’s principles include that the likely benefits of products should outweigh the likely risks, and their regulation should be proportionate to those benefits and risks. These are seen as critical factors for regulating medicines, medical devices and natural health remedies alike.
Some key aspects of the Bill are:
- a risk proportionate approach to the manufacture of natural health products;
- an expanded definition of “therapeutic purpose”, to include supporting human life, providing vitamin, mineral or other human nutritional supplementation, and maintaining or promoting human health;
- requirements that support exports, taking relevant international standards and practice into account, and meeting New Zealand’s international obligations;
- a definition for natural health products that differentiates such products from food and therapeutic products;
- a licensing regime for controlled activities;
- the ability to make health benefit claims that can be substantiated by robust scientific or traditional evidence;
- recognition and protection of rongoā Māori (traditional Māori healing);
- labelling to support consumers to make informed choices about their own health and wellbeing;
- expanded provisions to deal with problematic products (there are a range of orders available); and
- significantly increased penalty provisions.
Importantly, the Bill also establishes the Therapeutic Products Regulator (the Regulator), which will replace Medsafe. The Regulator will be responsible for ensuring the safety, quality and efficacy of regulated products across their lifecycle. It is intended that the Regulator will design and implement proportionate, risk-based market authorisation pathways to support the timely availability of therapeutic products. The functions of the Regulator will include, in addition to market authorisation, licensing controlled activities, post-market surveillance, compliance and enforcement. Most of these functions were previously undertaken by Medsafe.
Some of these new enforcement tools include tiered criminal offences, strict liability offences, improved infringement notices and a civil pecuniary penalty regime, allowing for a gradual and proportionate response to any breaches should they occur.
What will stay the same?
Some things are likely to remain largely the same under the proposed legislation:
- Direct to consumer advertising will still be permitted, but with stricter penalties for non-compliance.
- Supplemented food will not fall within this scheme, but will instead still be regulated by the Ministry for Primary Industries.
- Provisions in the Medicines Act relating to the ownership of pharmacies will be retained.
- The proposed legislation does not affect the current regulatory arrangement relating to medicinal cannabis or controlled drugs.
- Products that are currently consented under the Medicines Act 1981 will automatically receive a market authorisation under the proposed legislation. Other products that were lawfully supplied in New Zealand before any new legislation commences will have a transition period of 2 to 5 years in which to seek market authorisation.
The Bill is expected to have its first reading in Parliament in December, after which it will be referred to the Health Select Committee for detailed examination including public and industry submissions. It is likely to be several years before the legislation and associated regulations are finalised and fully come into force. The proposed legislation has a backstop commencement date of 1 September 2026.
Organisations within the therapeutic products sector, including those that produce or sell medicines, vitamins, supplements or natural remedies, and other associated stakeholders should remain attuned to these changes and take any opportunities that may arise within the coming months to engage with the process.
If you have any questions about the matters raised in this article, please get in touch with the contacts listed, or your usual Bell Gully adviser.