A bill making its way through parliament has caused controversy over potential ramifications for rongoā practitioners. So what’s the deal and how is it being addressed?
Since the Therapeutic Products Bill was introduced to parliament on November 30, 2022, it’s been hailed as an important step in modernising our regulating system around medicines and natural products. But it’s also faced scrutiny from small-scale producers, patient advocates and, notably, many Māori who say the bill oversteps the line when it comes to rongoā or traditional Māori medicine practices.
The bill would regulate how therapeutic products are manufactured, tested, imported, promoted, supplied and exported “in a way that is comprehensive and balances the risks and benefits of the products”, according to wording on the parliament website.
The health select committee called for submissions on December 15, 2022 and these closed on March 5, and more than 16,500 written submissions were received during that time. Oral hearings were held in March, when 210 organisations and 127 individual submitters were heard. An announcement from the government on Tuesday that rongoā would now be excluded from the bill was prompted by this feedback and has seen mixed responses.
Before we go on, what are therapeutic products?
Therapeutic products include medicines, medical devices, natural health products and pharmaceutical ingredients. This could include anything from plasters to herbal remedies to paracetamol to Covid-19 tests and beyond.
And what’s currently in place for regulations?
At the moment, the Medicines Act 1981 is the main legislation covering access to safe medicines and medical devices, whereas natural health products are regulated by the Dietary Supplements Regulations 1985 under the Food Act 2014. This new bill aims to replace both the Medicines Act and the Dietary Supplements Regulations.
Changes the bill proposes include a requirement that therapeutic products receive authorisation before they can be imported into, exported from, or supplied in New Zealand and establishing a regulator to do this.
So what exactly does this have to do with rongoā?
The definition of products regulated within the bill includes plant-based medicines and dietary supplements under the category of natural health products (also called NHPs). The bill acknowledges the lower risk that natural health products tend to pose, and therefore it’s intended that they will be evaluated against different standards than higher-risk pharmaceutical drugs and medical devices.
Rongoā isn’t explicitly mentioned in the bill so you’d be forgiven for thinking it wasn’t relevant. However, because the regulation of products operates through a permitted ingredients list – including plants and animals that are likely used in the practice of rongoā – it’s likely that products made by rongoā practitioners, or used in the practice of rongoā, will be captured by the bill in its current form.
Wait, can you give an example of rongoā?
Rongoā includes things like plant-based remedies (rongoā rākau), massage (mirimiri) and healing through karakia.
What was the response to rongoā initially being included in the bill?
It was heated.
Since the bill was announced, concerns have been raised by rongoā practitioners, iwi, academics, Te Aka Whai Ora (the Māori Health Authority), members of the health select committee and more that the bill posed a risk of overreach into rongoā Māori, making it difficult to practise and access traditional forms of medicine. The National Party, Te Pāti Māori and independent MP Elizabeth Kerekere (formerly of the Greens) have all cited the potential ramifications on rongoā in their opposition to the bill, and more than 12,000 people signed a petition against the bill.
What issues have been raised in terms of how rongoā is dealt with in the bill?
Beyond a general frustration at inadequate consultation with Māori before the bill’s introduction, concerns have been raised since that it runs the risk of creating a Crown regime with the power to determine what can be used in rongoā Māori, who is allowed to make and administer it, who can use it, and how its benefits can be described – something Māori have always had control of. Some have compared the bill to historic legislation like the Tohunga Suppression Act, which outlawed traditional practices like rongoā between 1907 and 1962.
Others have raised concerns that there is no recognition of kaitiakitanga and rangatiratanga over rongoā and an absence of Te Tiriti principles within the bill. Waitangi Tribunal’s Wai 262 Report He Aotearoa Tenei reaffirmed that rongoā is a taonga under te Tiriti, yet there was no explicit reference to te Tiriti o Waitangi protection clauses in the draft bill.
In December last year, Te Pāti Māori called for the bill to be withdrawn, saying that it “brings rongoā Māori into Pākehā law without the active consent of Māori, a breach of Te Tiriti”.
“This is a dangerous bill. The regulation of rongoā poses huge risks to the protection and restoration of mātauranga Māori and would remove the power for decisions relating to rongoā from whānau, hapū and iwi to the state,” Te Pāti Māori co-leader Debbie Ngarewa-Packer said on Facebook at the time.
How did this mess happen?
Good question. In 2021, when the proposal was under consideration by ministers, a cabinet committee agreed there needed to be protection and recognition of rongoā Māori in the bill.
According to Stuff, advice provided by officials from Te Aka Whai Ora and Te Puni Kōkiri even recommended rongoā be specifically excluded from the bill, and that the bill should include a strong te Tiriti provision. But when the bill was introduced last year there was no mention of rongoā.
What has the government done in response?
On November, 2022, Peeni Henare, associate minister of health (Māori), announced a new rongoā workstream to look into the implications of the bill on rongoā. Still, this was criticised by the Mental Health and Wellbeing Commission in its March submission: “This additional workstream and late engagement do not appear to reflect the partnership principle in te Tiriti. The order of this process needs to be reversed, with meaningful engagement with Māori shaping the bill.”
Ouch. So now it’s… been taken out of the bill?
On Tuesday, health minister Ayesha Verrall announced that, prompted by the feedback received by the committee during submissions, rongoā practitioners would be exempt from regulation under the bill. “The changes announced today recognise that the bill as originally drafted went too far,” Verall said.
In the same statement, Peeni Henare said, “we have listened to what Māori have told us. It is now proposed that in most cases, government will not regulate rongoā in the new regulatory system. That means whānau will continue to use and manage rongoā just as they have for generations.”
Proposed changes to the bill would ensure rongoā activities and services operating from marae continued as usual, he added. The regulation will apply when products are made for commercial wholesale or commercial export.
How will these changes be made?
The government will establish an advisory committee of rongoā experts and Māori health leaders to implement the new provisions in the bill, with members appointed by Henare and the minister for Māori development Willie Jackson, in consultation with other ministers and health agencies.
“We recognise Māori have their own systems in place to regulate rongoā, and these will continue to be used to ensure the oranga of whānau and Māori communities,” said Henare.
“We also acknowledge government doesn’t have the expertise to protect rongoā in a way that upholds mātauranga Māori. That’s why we’re establishing a committee to take on that protection role and guide the implementation of the bill.”
The government will introduce a Supplementary Order Paper (SOP) amending the bill to remove many of its obligations in relation to small-scale NHP producers and rongoā practitioners. The details of the small-scale NHP producers’ exemption will be set out in secondary legislation, to be made after the bill passes.
What’s the response been like?
Te Pāti Māori co-leader Debbie Ngarewa-Packer welcomed the announcement in a press release, saying, “It’s good to see the minister has finally caved to the demands of our people, exempting our rongoā practitioners from the act.”
In an email to The Spinoff, National Party MP Dr Shane Reti noted issues with the select committee process but said, “National is pleased with these two changes made to the Therapeutics Products Bill. However, more changes still need to be made.”
But independent MP Elizabeth Kerekere told The Spinoff she remained unconvinced and couldn’t support the bill till rongoā was explicitly excluded. “Since the exemptions are not stipulated in the bill, we must rely on secondary regulation which has not yet been written,” Kerekere said via email. “We are forced to trust government officials and the regulator to get it right for the natural health sector, for tangata whenua, and for people who rely on imported medicine not funded by Pharmac. This has not always gone well for us.”
Rongoā Māori practitioner Donna Kerridge told The Spinoff the press release about the changes being made to the bill offered little to ease her concerns about the implications of the proposed legislation on rongoā, particularly around the forming of an advisory committee. “Māori are not advisers to the Crown on rongoā – Māori are the authority on rongoā and we have a kaitiaki responsibility to this precious taonga.”
“The Crown and the Ministry of Health know nothing of rongoā and I for one am not handing over the mana of rongoā to the Crown to decide what we can and can’t do in that space,” she said. “The bill must recognise rongoā as a taonga, not collectively as a natural health product, and that authority over rongoā sits with those who are experts in the field, not the Crown or Crown-appointed Māori.”
Kerridge took particular issue with the lack of acknowledgement of te Tiriti or rangatiratanga within the reasoning given in the press release. As well, she felt the reference to “most cases” – “it is also proposed that in most cases the government will not regulate rongoā in the new regulatory system” – was ambiguous.
“Exemption with exceptions is not exemption and it sure as hell is not rangatiratanga,” she said. “The Crown have deliberately missed the point – rongoā is a taonga and the Crown has no place in interfering with it on any level.” Rather than a promise of secondary legislation, she wants to see the matter addressed in proposed supplementary order papers.