The Bill was introduced to Parliament at the end of November by Health Minister Andrew Little, who said the legislation would modernise the way medicines, medical devices and natural health products were regulated.
The Therapeutic Products Bill replaces the Medicines Act 1981 and Dietary Supplements Regulations 1985.
Minister Little said the new legislation would give New Zealanders “peace of mind” about the safety, quality and efficacy of the medicines, medical devices such as Covid-19 test kits and natural health products they are using.
At the same time, Associate Health Minister Peeni Henare announced a new “work stream” established within Government to consider how rongoā might be protected in legislation.
Minister Henare said that under Te Tiriti o Waitangi, the Crown has an obligation to actively protect rongoā Māori.
“We also 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.
“We recognise the importance of rongoā, and we have been carefully considering how to recognise and protect it. This has included consulting with Te Kahui Rongoā, a governance body for rongoā practitioners, Māori clinicians and health providers,” Minister Henare said.
This new rongoā work stream will explore the interface of the Therapeutic Products Bill and rongoā. The group will also explore whether rongoā matters are being addressed through other Government work programmes.
“Officials within the work stream will 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 will present a whole new world of opportunities for both rongoā practitioners and whānau living abroad who have been wanting to access rongoā and other natural health products from Aotearoa,” Minister Henare said.
Te Pati Māori (The Māori Party) has called on the Prime Minister and the Labour Party to withdraw the bill, which they say “brings rongoā Māori into Pākehā law without active consent of Māori, a breach of Te Tiriti o Waitangi.”
The draft Bill has no mention of rongoā Māori.
Indigenous biotechnology entrepreneur Manu Caddie (Ngāti Pūkenga, Ngāti Hauā) says he has been waiting on the Therapeutic Products Bill for more than five years.
He has founded three companies developing products and ingredients derived from indigenous organisms and has been working at local, national and international levels on issues around intellectual property (IP), indigenous rights and the commercialisation of IP derived from indigenous species.
Mr Caddie believes there is a lot of misinformation and disinformation being circulated about the Therapeutic Products Bill , including by political parties.
“Those responsible for preparing the Bill are very aware of the issues around rongoā and after consultation with rongoā practitioners, intentionally left rongoā out of the draft legislation. Some people are claiming the Crown is trying to control, steal or commercialise rongoā, when the opposite is the case.”
Some practitioners seem keen to see some protection for rongoā and rongoā practitioners in the regulatory framework, so that there is clarity on what rongoā is and is not, and who can and can't call themselves a rongoā practitioner.
Others are opposed to any reference to rongoā being in legislation and want it kept well away from any Government processes.
“I can see both sides of the argument and so can the Ministry, which is why they're encouraging Māori to wānanga the issues and see if consensus can be found or suggestions on how the different perspectives can be accommodated.”
Mr Caddie says when organisations connected to him started doing research for proven natural health products, it became clear that the Medicines Act (1981) was not fit for purpose.
“We have undertaken clinical studies and pre-clinical research to prove the safety and efficacy of our products so that we can make claims about them, but the Medicines Act meant we couldn't make any claims even when we had robust evidence backing the claims.”
Mr Caddie organised a national hui for Māori at the University of Auckland School of Medicine in November where iwi and hapū representatives, Māori medical experts and researchers came together to discuss the development of medicines by and for Māori.
“A number of initiatives came out of that event but one of the most important is a project focusing on developing a new lexicon for the biotechnology and life sciences sector as it pertains to Māori. Participants agree that ‘rongoā' is not a kupu (word) that is appropriate for all medicines — it should be retained for traditional formulations and practices. We need new words in te reo for modern medicines, including those with active ingredients derived from indigenous plants, fungi and shellfish, for various aspects of genomics; like how do you say ‘nucleotide polymorphism' in te reo Māori?”
Botanical drugs have a long tradition in cultures around the world. In Europe, the Americas, Asia, Africa and Australia, regulators have made provision for herbal remedies to be recognised and accommodated in national regulations to ensure patients can have confidence in products and ingredients that have low risks, without the compliance required of full medicines.
The Therapeutic Products Bill aims to provide a similar regulatory pathway for “natural health products”, including traditional medicines from overseas that are made and used in Aotearoa.
“This Bill is overdue and it is long and complex. But it will bring Aotearoa New Zealand in line with other jurisdictions that have created pathways for natural health products, botanical drugs and herbal remedies to make claims based not only on clinical evidence, but also evidence from traditional use, which is really exciting to have other evidence bases recognised as the basis for therapeutic claims,” Mr Caddie said.
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