Point of Order: Modernising our medicines regulatory regimen.....

.....Medsafe is being replaced but traditional Māori healing will be exempted

When the Therapeutic Products Bill was introduced in Parliament in November last year, Health Minister Andrew Little said it was intended “to modernise the way medicines, medical devices and natural health products are regulated”.

The result of more than a decade of policy work, the Bill replaces the Medicines Act 1981 and Dietary Supplements Regulations 1985 with “a comprehensive regulatory regime that is fit for the future”, Little said.

It replaces Medsafe with a new regulator.

And – as things are turning out – it is establishing a separate regimen for Māori.

Consumer safety sat at the heart of the Bill, which would better protect the community “from goods and gadgets that make unfounded or misleading therapeutic claims”, Andrew Little said in his press statement on November 30.

This suggested snake oil would come under the critical eye of the new regulator, although – on second thoughts – New Zealand has no snakes and hence we have no snake oil or peddlers of snake oil.

Do we?

A modern set of laws and regulations that lined up with international practices would help the country’s manufacturers of medicines and natural health products to export to the world, Little said.

It established a new regulator within the Ministry of Health, headed by an independent statutory officer, with a wider remit than the medicines regulator Medsafe.

The new regulator will be responsible for ensuring the safety, quality and efficacy of regulated products across their lifecycle.

The Bill includes a range of modern enforcement tools allowing for a graduated and proportionate response to breaches, including tiered criminal offences, strict liability offences, improved infringement notices and a civil pecuniary penalty regime.

But the Treaty of Waitangi could not be ignored and special consideration would be needed to deal with rongoā Māori.

Rongoā, a traditional Māori healing system, involves the use of native plant-based remedies (rongoā rākau), massage (mirimiri) and spiritual healing through prayer (karakia).

Accommodating this healing system within legislation aimed at modernising the regulation of medicines and health treatments was bound to be challenging.

Henare, the Associate Minister for Health (Māori), acknowledged this in a separate press statement on November 30 which said the Crown had an obligation under the treaty to actively protect rongoā Māori.

The conflicting considerations were made plain when Henare said:

• “We … have a responsibility to provide all New Zealanders with health products and services that are safe, high-quality, and effective. That is why we have introduced the Therapeutic Products Bill to Parliament today.”

And:

• “We recognise the importance of rongoā, and we have been carefully considering how to recognise and protect it. This has included consulting with Te Kāhui Rongoā, a governance body for rongoā practitioners, Māori clinicians and health providers.”

Accordingly a “new rongoā work stream” which was being established “will explore the interface of the Therapeutic Products Bill and rongoā”.

The group involved in this work would also explore whether rongoā matters are being addressed through other government work programmes.

Officials would analyse the Therapeutic Products Bill “to identify any gaps and opportunities to protect rongoā Māori, assure whānau safety, and ensure access to the export market for practitioners”.

This was far from enough to satisfy the Māori Party.

Speaking during the first reading debate in December, co-leader Debbie Ngarewa-Packer said her party had concerns

“… that the regulation of the rongoā poses huge risk to the protection and restoration of mātauranga Māori and would remove the powerful decisions relating to rongoā from whānau, hapū, and iwi perspectives to the State.”

The Treaty of Waitangi makes no mention of rongoā.

She invoked it anyway:

“Rongoā Māori is a Tiriti-protected taonga. Despite this, aside from requiring the regulator to have the capacity and capability to give effect to the principles of the Treaty, there are no other Tiriti protections in this legislation.

“If Māori rights under the Tiriti were being acknowledged and reflected in this process, then engagement with tangata whenua could have and should have occurred before the bill was introduced to Parliament, and this would be reflected by Treaty-based protections in the bill.”

Ngarewa-Packer seized on the two ministerial press statements that had been released a fortnight earlier:

• Andrew Little’s press release suggested the bill was the result of 10 years of work and a work programme in Government, she noted,

“… and yet they’ve failed to work with tangata whenua on rongoā regulations.

 

• ”Peeni Henare had announced a process to consult with Māori during the summer,

“… while people won’t even be paying attention, and told people to submit at select committee.

“This only shows that the Government failed to do anything about rongoā until right before this bill being introduced.

“While we are open to discussions about protecting rongoā through regulation, this needs to be driven by tangata whenua, including rongoā practitioners, kaimahi, or those who have the active consent of our people, at the very least.”

Rather than protect rongoā, Ngarewa-Packer said, the Bill brought civil and criminal penalties into practice.

She called for changes to protect rongoā Māori, and its tohunga and practitioners.

The latest development as the Bill is nudged towards enactment is a press statement released yesterday by Health Minister Ayesha Verrall (Andrew Little’s successor in the portfolio) and Peeni Henare.

Many small-scale Natural Health Product (NHP) manufacturers and rongoā practitioners would be exempted from regulation, they said.

Verrall thanked the thousands of submitters on the Bill and said the feedback received by the Select Committee had shaped the proposed changes.

Small-scale producers of natural health products are being spared the need to obtain a product authorisation or manufacturing licence from the new Regulator when their wares are made and supplied in-person to customers in New Zealand.

Product authorisation will still be required for imported products.

The changes further propose that – in most cases – the Government will not regulate rongoā in the new regulatory system.

It will establish an advisory committee of rongoā experts and Māori health leaders to implement the new provisions in the Bill.

Members will be appointed by the Minister of Health, Associate Minister of Health (Māori) and Minister for Māori Development, in consultation with other Ministers and health agencies.

Henare said:

“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.

“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.

Point of Order is a blog focused on politics and the economy run by veteran newspaper reporters Bob Edlin and Ian Templeton