A major change to the way we regulate medicines, medical devices and natural health products has recently passed its final hurdle in Parliament. The Detail looks at why it's taken so long to get to this point, and what it means for consumers.
Medicines Photo: 123RF
It's been years in the making, but there's finally a new law to regulate medicines, medical devices and natural health products.
The Therapeutic Products Bill passed its third reading in Parliament late last month.
But it's been controversial – and the debate is far from over.
So what's it all about?
"The intent is to make sure all of the therapeutic products we use are safe," Professor Rhiannon Braund, from Otago University's department of preventive and social medicine, tells The Detail.
"And also that we can have access to technologies where maybe there were barriers in place before."
It'll replace the Medicines Act, which came into force in 1981, and hasn't kept up with the developments in medicine and other health technologies.
The new law will also regulate natural health products for the first time in New Zealand.
"They only come to be considered when there's been a problem identified," Braund says.
"We've had products that are available [with] very little rules and regulations about them, but when they do cause harm to people, that's when the regulator comes in – so this flips it a little bit."
But there were concerns the law would negatively impact people who were importing prescription medicines; things like cancer drugs that aren't available here.
Those people feared they'd become criminals if they continued importing those drugs, but that wasn't the intent of the law changes, Braund says.
"The intent was to stop counterfeit medicines coming in," she explains.
"But what it meant for patients that were importing genuine medicines that were prescribed by a clinician in New Zealand, the appearance was that was actually going to stop that process.
"There was a last minute addition to say actually they need to look at those words much more carefully, because what they want to do is allow people access to safe medicines, while they still maintain the safety around the border."
The regulation - or not - of rongoā Māori has also been controversial. Rongoā is a traditional Māori approach to healing. It uses natural remedies such as tūpākihi, tutu and māmuku.
Rongoā wasn't explicitly mentioned in the original bill, so practitioners were worried their traditional remedies would be subject to the same rules and regulations as other medicines.
Back in June, the government announced that rongoā won't be regulated "in most cases", however any products being sold commercially or being exported will be.
Northland rongoā practitioner Donna Kerridge (Ngāti Tahinga, Ngāti Mahuta) sees this as a breach of treaty rights.
"If I translate [in most cases] that says 'you can continue to use rongoā Māori so as long we say you can'," she tells The Detail.
"I think the only option available to us right now, or the only one I can see, is to make an urgent request to the Waitangi Tribunal to address this matter. It's not OK that the Crown continues to extend its reach into places where it has no authority to do so."
Braund says although it's been signed into law, there's a lot more work to do on the accompanying regulations before it comes into effect.
"We talk about this being passed but really, it's only the start of the journey," she says.
''The regulations now are going to take several years, we won't even see any of this starting to come into play until 2026 and I say at the earliest, because it's going to take a long time – there's so much in that act that has to be unpacked."
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