As has been widely reported, the Government's 100-day plan included "begin work to repeal the Therapeutic Products Act 2023". That Act was set to come into force by 1 September 2026. When it is repealed, the status quo - being the Medicines Act 1981, Dietary Supplements Regulations 1985 and Sunscreen (Product Safety Standard) Act 2022 - will remain in force until any new legislation is passed and takes effect.
We regularly get asked what's next for the regulation of therapeutic products, and, specifically, whether the Government is likely to develop new legislation to replace the Therapeutic Products Act.
Details of the Government's proposed approach have been relatively scarce, however, this is what we know so far:
- Associate Minister of Health Casey Costello is responsible for leading work on the Therapeutic Products Act.
- Ms Costello advised Parliament at the end of February that she was going to seek Cabinet's approval to progress work to repeal the Therapeutic Products Act. There is not yet public advice regarding the outcome of any further Cabinet consideration.
- The Government could introduce new therapeutic products legislation. Ms Costello has commented "The Government has an opportunity to replace the Therapeutic Products Act with legislation that protects consumers without creating unnecessary red tape on industry".
- Ms Costello has indicated that any new regulation of medicines and medical devices will seek to strike a balance between ensuring that "products do what they claim, [and] are high quality", and ensuring that "product approval pathways do not make them inaccessible or unaffordable".
- Any new legislation may have a long lead time. Ms Costello has raised concerns about the proposed commencement date for the Therapeutic Products Act, commenting that the extent of change required to be undertaken by the commencement date "would've been extremely challenging".
- The Government would seek input from relevant stakeholders when developing any new legislation. According to Ms Costello, "We know that communities, health sector, and industry have concerns, and we intend to listen to those concerns as we develop new proposals".
One of the biggest questions about any new legislation is whether it will regulate natural health products. Ms Costello has noted that current regulation of natural health products in New Zealand is "fragmented and outdated", and that this has implications for employment and the economy, which could suggest that some form of regulatory reform is on the cards. However, whether such reform will be acceptable to all of the coalition partners remains to be seen. Interestingly, National introduced the Natural Health and Supplementary Products Bill in 2011, although due to various changes in government, the Bill was never passed and lapsed in 2017.
We will continue to keep a close eye on developments in this space.
