Firm asks organisations doing business in health sector to stay vigilant
The two authors of a new report from Bell Gully – Kirsty Dobbs, partner, and Dr Laura Hardcastle, senior associate – have raised the question of whether to expect the retirement of the outdated Medicines Act 1981 next year, following multiple replacement attempts.
“We have largely been working with rules developed in 1981 for the past 44 years,” Dobbs said in an insight from the firm. “There have been a number of prior attempts at reform but these haven’t gone anywhere.”
In its report titled “The Big Picture: Health,” Bell Gully called on organisations to remain vigilant and stay on top of reforms affecting significant pieces of legislation that will impact business within New Zealand’s health sector.
“For businesses it’s a question of staying on top of everything that’s happening,” Dobbs 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.”
The firm explained that the report seeks to inform organisations currently doing business in the country’s health sector, as well as those planning to do so, regarding:
In its report, Bell Gully noted that recent or contemplated changes include:
“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,” Dobbs said in the insight. “There’s a lot going on.”
Regarding the Medical Products Bill, the firm expects reforms to address software, which the specific requirements of the current Medicines Act regime do not currently cover.
Hardcastle, whose 2022 PhD focused on the future regulation of medical devices, stated that the Medical Products Bill would have a substantial impact on medical device regulation.
“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,” Hardcastle said in the insight.
