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New rules for regulating medicines and rongoā Māori – Expert Reaction

On Wednesday, the Therapeutic Products Bill was introduced to Parliament, and the establishment of a new rongoā workstream was announced. 

The Therapeutics Products Bill aims to modernise the way medicines, medical devices and natural health products are regulated in New Zealand.

Associate Minister for Health (Māori) Hon Peeni Henare said the workstream will explore the interface of the Therapeutics Products Bill and rongoā, and identify any gaps and opportunities to protect rongoā Māori within the Bill. The group will also explore whether rongoā matters are being addressed through other government work programmes.

The Science Media Centre asked pharmaceutical experts and rongoā researchers to comment on how the Therapeutic Products Bill will change the medical landscape in Aotearoa, and the potential benefits and challenges of protecting and regulating rongoā Māori.

Professor Rhiannon Braund, New Zealand Pharmacovigilance Centre, University of Otago, President of the Pharmaceutical Society of New Zealand, comments:

“The Therapeutics Products Bill (TPB) will supersede the current governing document, the Medicines Act 1981. A new “rule book” needs to be written to accommodate new technologies, ensure consistent safety  valuation and monitoring, and to meet the needs of the public in terms of how medicines and other therapeutic products can be accessed.

“Within the wider pharmaceutical sector, the TPB is expected to be “enabling” and future-focused, and additionally more flexible in response to the way that medicines, devices and natural health products are made available, assessed and monitored.

“While this document was already in preparation, COVID-19 has highlighted some of the limitations in the current Act, such as electronic prescribing, how medicines can be accessed (i.e. some prescription medications being available without a prescription from a pharmacist), increased use of natural health products and how timely and safe access to therapeutic products can meet the needs of consumers, whānau and communities.

“Controversially, this Bill has incorporated natural health products, which will include Rongoā. While the details of how this will be considered has not been worked through, the intent should not be to ‘limit’ access, but to ensure that accessing products is safe and importantly, to protect this unique taonga. Many natural health products are available in Aotearoa New Zealand, and there is limited quality control of these products. The TPB will provide confidence to the consumers of these products that minimum standards have been met.

“At this time, much attention has been given to the regulation of ‘products’ but this Bill will also include how medicines are supplied and even who can own a pharmacy.

“Currently, equitable access to medicines in a timely manner is a genuine concern. It is anticipated that Bill will provide both increased access to therapeutic products and confidence of the safety and efficacy of these products. This increased access may occur via classification of particular products, wider consideration of who can initiate treatments and modifications to both the period of supply and continuation of supply to ensure appropriate access.

“This Bill will have a significant impact on public health through a balanced approach to the evaluation and access of therapeutic products that are used across all medical specialities.

“It is also important to note that the tabling of this Bill is only the start of the kōrero, and that the upcoming debate and wide consultation will be crucial to ensure that this Bill not only meets the needs of Aotearoa currently, but well into an unknown future.”

No conflicts of interest

Dr Annabel Ahuriri-Driscoll (Ngāti Porou, Ngāti Raukawa, Ngāti Kahungunu) Senior Lecturer above the Bar, Faculty of Health, University of Canterbury, comments:  

“Recognition of the validity and legitimacy of rongoā Māori has long been sought by traditional healers and rongoā practitioners. The Tohunga Suppression Act 1907 prohibited rongoā practice, forcing it underground. Although rongoā has continued to exist within Māori communities, healers have expressed concern about the future and sustainability of rongoā if there is not some level of institutional support. In 2011 the Waitangi Tribunal reported that, as a taonga under Article 2 of the Treaty of Waitangi, rongoā should be actively protected by the Crown. It was found that despite measures such as public funding of rongoā services, the Crown had failed considerably in meeting its Treaty obligations with respect to rongoā.

“For healers and practitioners, an ideal scenario would involve realising the benefits of rongoā integration as a health service or product, while maintaining its integrity as a customary practice. Given the history of suppression and prohibition, healers are understandably concerned that the Therapeutic Products Bill will not strike this balance; rather, that it will again subject rongoā to inappropriate scrutiny and enforcement, undermine healer and Māori community tino rangatiratanga, and restrict Māori community access to rongoā healing.

“Whether legislation can ever adequately accommodate tikanga remains an overarching question. However, a truism in te ao Māori is that if the process is right or good, right and good outcomes will follow. In this regard the involvement of healer collective Te Kāhui Rongoā in the Bill consultation and a proposed rongoā workstream is a critical mechanism.”

No conflict of interest

Glennis Mark (Ngapuhi, Tainui, Ngai Tahu, Ngati Koata), Independent Researcher (currently working in collaboration with Whakauae on a Rongoā research project), comments:

“It would be ideal if Rongoā were considered enough of a significant Maori cultural taonga to warrant its own bill, to protect and maintain the Maori cultural rights of Rongoā under the Treaty of Waitangi, rather than under an umbrella title of all therapeutic products.  Any government workstream that considers how Rongoā might be protected in legislation, must be led by Rongoā practitioners who are well experienced in Rongoā practice and tikanga Māori for it to be an authentic and equitable endeavour to ensure Māori culturally appropriate protection of Rongoā healing, practice and theory.”

No conflict of interest declared.

Donna Kerridge, (Ngāti Tahinga / Ngāti Mahuta) Independent Researcher (currently working in collaboration with Whakauae on a Rongoā research project), comments:

“There is urgent need for the reform of the Medicines Act (1981) and a need for a therapeutic products regime that recognizes, protects and enables the current practice of rongoā Māori in this country, alongside other important priorities.

“The new Therapeutic Products regime is an opportunity to directly address inequity in health legislation and recognise rongoā Māori (as understood and practiced by Māori) as an equal to other Crown supported health care products and services in Aotearoa. It is also an opportunity to better support a health system that is currently struggling to meet demand and help to equitably provide for Māori.

“It was our concern that the Therapeutic Products regime proposed to regulate the mode of administration of some rongoā remedies, what ingredients can and can’t be used in some rongoā products, who and how rongoā manufacturers can sell their products to, here and abroad. Nothing in the text of the Bill introduced to Parliament today eases our concerns.

“It is disappointing to note that the Bill does not recognise or even mention Rongoā in its entire text. In its current form, the Bill requires producers of rongoā to obtain ‘market authorisation’ before their rongoā can be supplied in New Zealand or exported commercially. It also requires that rongoā only contain recognised natural health product ingredients. It is not for Crown or any one national body to decide whether or not rongoā products and devices have been produced according to local tikanga, or whether they are more akin to rongoā than modern day pharmacy.

“Rongoā Māori is safe. More than 65,000 rongoā treatments delivered over past 2 years, did not generate a single safety related complaint. Despite past attempts to outlaw rongoā Māori, its continued use for 700 years by Māori suggests that rongoā is safe or our tūpuna would have put a stop to it as soon as it was superseded by something better.

“History has proven Māori have adequately managed the safety of rongoā for hundreds of years. And recent data collected by ACC regarding its own rongoā services demonstrates its safety, efficacy and growing consumer demand for the service (38% of which is by non-Māori).

“This legislation is extremely important. Continued Crown intervention in the way rongoā is produced in any way will have intergenerational repercussions for Māori and mātauranga will be lost. It is extremely disappointing that the protection of rongoā will not be included in the first reading of the Bill in Parliament.

“What is required is for the Crown to include a clear and explicit statement in the Therapeutic Products Bill recognising rongoā and its intention to protect and enable rongoā Māori practice in its current form (including the preparation and trading of remedies). It must not prioritise the needs of western models of care and growing commercial interests in the natural health products industry ahead of the rights of its Treaty Partner. The findings and recommendations of the proposed Government rongoā workstream, in partnership with Māori, must be incorporated into the Bill prior to it being passed into legislation. The Crown, through this piece of legislation, must ensure that rongoā Māori (as understood by Māori) receives, the same, long overdue, privilege that Western Medicine enjoys in the current NZ Eurocentric Healthcare system from the first day this Bill is passed into legislation. It is not just a Treaty right, it is a health equity imperative.”

Conflict of interest statement: “This was a personal statement supported by Whakauae Research Services who I contract to.  It is NOT as a representative of any other organisation I have affiliations with ie. Te Kāhui Rongoā or ACC Rongoā Advisory Panel etc”