Leading law firm Bell Gully urges businesses to “stay on top” of a wave of legislative changes that will impact how business is done within the New Zealand health sector.
With several key pieces of legislation governing the sector undergoing major reforms, a Bell Gully report emphasises that businesses who currently, or are planning to, do business in this area need to understand how these updates may affect them.
The Big Picture: Health highlights multiple areas of uncertainty for the sector and aims to inform businesses on the current position and potential for further change. The report’s authors, Bell Gully partner, Kirsty Dobbs and senior associate Dr Laura Hardcastle, explore the layers of change underway and ask the question: will 2026 finally see the outdated Medicines Act 1981 retired, after many attempts at replacement?
“We have largely been working with rules developed in 1981 for the past 44 years. There have been a number of prior attempts at reform but these haven’t gone anywhere. Now we have a further Bill coming hot on the heels of amendments to the medicines approval process and against the backdrop of changes to the Healthy Futures legislation and potentially natural health products. There’s a lot going on,” said Dobbs.
“For businesses it’s a question of staying on top of everything that’s happening,” she said. “There will also be opportunities for consultation: if you want to have a say, you will want to understand what to expect in order to stay ahead of the curve.”
Senior associate Dr Hardcastle, whose 2022 PhD thesis was focused on the future regulation of medical devices, said based on what we already know the Medical Products Bill expected in 2026 would represent wholesale reform. “This will change regulation of medical devices significantly,” she said.
One key area that is expected to be included will be software, which is not currently covered by any specific requirements in the current Medicines Act regime. “Software issues have been a common cause of medical device recalls in Australia, so businesses involved with software as a medical device will want to keep a keen eye on reforms to see how it is proposed to be regulated,” she said.
The report explores recent changes as well as those expected to progress in 2026, highlighting further opportunities to engage with the reforms. These changes include:
- The Medicines Amendment Act 2025, which passed in November.
- The Healthy Futures (Pae Ora) Amendment Bill, expected to proceed in late 2025/early 2026.
- A new Medical Products Bill expected to be released next year.
- Potential for engagement on a Natural Health Products Bill.
For further details see here
Disclaimer: This publication is necessarily brief and general in nature. You should seek professional advice before taking any action in relation to the matters dealt with in this publication.
