Regulatory update: Repeal of the Therapeutic Product Act
Topics covered in this article: Business Owners, Other
The new coalition government’s commitment to repeal the Therapeutic Products Act 2023 and what this could mean for you and your business.
The Therapeutic Products Act 2023 (Act) would have bought about the most significant change to the regulation of medicines, medical devices and natural health products in New Zealand in nearly 40 years. The Act received royal assent on 26 July 2023 with most of its provisions due to come into effect by mid-2026.
The new legislation aimed to provide fit-for-purpose regulation of medical devices, as well as cell, gene and tissue therapies not regulated previously. It also imposed significant new regulation on natural health products (NHPs). NHPs include an extensive range of consumer health products produced in New Zealand for both local and export markets including herbal remedies, vitamin and mineral supplements, fish oil capsules and products used to support health and wellness. The new regime was meant to be flexible enough to allow for innovation within the sector while also ensuring effective control over, what are, quickly evolving technologies within the health and well-being space.
Nevertheless, the regulation of these products would have had a substantial and wide reaching impact on New Zealand’s consumer healthcare businesses which critics say was not well thought through. With over 400 submissions received from a variety of stakeholders during the consultation process concerns were raised in numerous areas including the ability for practitioners to prescribe, dispense and supply medicines under the new regime, the direct to consumer advertising of prescription medicines, the ambiguity regarding the process for obtaining product approval and the regime not being fit for purpose in regard to the tailored way medicines are handled within hospital settings. Submitters were not asked to provide feedback on the proposed regulation of NHPs however the proposed regulation of these products has been targeted by vocal critics such as the Natural Health Alliance.
Impact of the repeal
If the proposed repeal goes ahead then the legislation that the Act intended to replace (such as the Medicines Regulations Act 1984, Food Act 2014, Sunscreen (Product Safety Standard) Act 2022 and Dietary Supplements Regulations 1985) will likely remain in force for the time being.
We will provide updates as developments occur. In the meantime if you have any questions about this article or how this repeal may affect you or your business, please feel free to contact one of our team.
Latest Update: 20 December2023
