Almost all of New Zealand’s economy is based upon plants, and how prolifically they grow here. Even after much of the native bush was felled to make way for sheep, cows and pine trees, it’s the grass and plants that replaced this, that feed milk or meat producing animals. Agricultural products continue to make up a huge percentage of our exports and GDP contribution, even more so now that Covid-19 has seen plummeting earnings from industries such as tourism and foreign student education provision.
The success of NZ’s Food and Beverage industries derives not only from our reputation for producing high quality products, but also establishment of and maintenance of world class regulations. Nobody in Shanghai or Tokyo or New York wants to buy NZ organic milk from grass fed cows, unless they are sure that what they are paying a premium for, is exactly as stated on the label, and that it is safe. Regulations are there to make sure expected quality parameters are upheld, ensure safety, and in many industry sectors, help facilitate exports.
As with quality food and beverage products, herbal medicines are growing in popularity and global demand, and the current Covid 19 pandemic has reminded us that drugs are not always a solution to rely upon to save us from nature’s dominance over our plight.
Demand for various herbal medicines has long surpassed the point where demand exceeds supply. As with the global food supply chain, changing consumer preferences and climate change stressors, are also contributing to this supply shortfall.
As I’ve written previously, this provides huge opportunities for New Zealand. We have a rich diversity of natural resources, fertile soils, great farmers, and an enviable track record of research and development in biological and agricultural sciences, and pharmaceutical company development.
Why then have successive governments since the last Labour one, not taken the need to regulate and enable the absolutely huge growth potential of a local natural health product industry seriously?
The recent decision by the Ministry of Health to reclassify ‘Artemisia annua extract’ as a prescription only medicine, is symptomatic of these serious regulatory deficits for natural health products.
On 18 May the Ministry of Health issued a Gazette notice to reclassify ‘Artemisia annua extract’ as a Prescription-Only Medicine, following receipt by the New Zealand Pharmacovigilance Centre of 29 reports of hepatic adverse reactions occurring in patients taking two specific products purchased ‘over-the-counter’, and made in NZ from a supercritical CO2 extract of Artemisia annua in grapeseed oil.
What this effectively means, is that all Artemisia annua containing products in addition to those containing the particular extract involved in these adverse event reports, have now become ‘prescription only’. In other words, medical herbalists and naturopaths, most of whom have undertaken at least 3 years study to obtain a degree qualification in natural medicine, are no longer able to treat patients with traditional and GMP manufactured preparations of this herb. But somehow, doctors and other registered medical practitioners who have had no training at all in herbal or natural medicine, are suddenly deemed adequately qualified to prescribe ‘Artemisia annua extract’.
In fact no other regulator in the world has restricted access to all ‘Artemisia annua extracts’, because evidence implicating the herb Artemisia annua itself in liver adverse events, is basically zilch. There is a lack of adverse event reports involving Artemisia annua-containing products reported to pharmacovigilance agencies in other countries, and no previous association of Artemisia annua with liver adverse events exists in its extensive scientific literature.
Such a cluster of cases in New Zealand only, all apart from 1 relating to one particular product manufactured and sold direct to consumers as a ‘dietary supplement’, reeks of a product quality problem. The supercritical CO2 extract used, is also very different to more traditionally used forms of Artemisia annua. As is low alcohol beer from Schnapps.
Why then has the NZ regulator taken this course of action?
Lack of any definition of a ‘natural health product’ in any New Zealand legislation, should raise a large red flag, in terms of how ridiculously outdated our regulations for natural health products are. This is the case despite the NZ Natural Health Products Industry trying for more than 20 years to get successive governments to introduce regulations to replace the completely outdated 1981 Medicines Act, and inadequate Dietary Supplements Regulations.
In 2003, the NZ and Australian governments signed a treaty to establish a joint scheme for the regulation of Therapeutic Products (ANZTPA), which would have included regulations also for natural health products. These are known as and regulated as ‘complementary medicines’, by the Australian regulator, the TGA.
Government officials, industry representatives, academics and lawyers from both countries then spent 11 years consulting, developing and preparing these regulations for implementation, but opposition from the National, NZ First and Green Parties, and a Labour government majority of 1 at the time, lead to this legislation only passing its first reading in the house, and then being canned by the new National government in 2014.
National and the Greens then spent some years developing a new NZ-only draft Bill, the Natural Health and Supplementary Products Bill. This proposed a much lighter regulatory agency than ANZTPA, but as with ANZTPA, involved a large amount of work and consultation by government officials, industry representatives and academics, who evaluated and prepared a list of several thousand permitted ingredients able to be included in natural health products without any need to apply for a Medicines licence. However, National dragged their heels on this despite being in power for 3 terms of government and the Bill was never passed, even though it was supported by National, the Greens, Labour and NZ First, with only the ACT party opposing it.
Upon coming to power in 2017, the current Labour-NZ First coalition government removed the Natural Health Products Bill from the order paper while it was awaiting its third reading, soon after talks with its coalition partner NZ First.
Various communications and workshops with industry have since taken place, with the apparent objective of reinventing the wheel and finding out how to appropriately regulate natural health products and draft a new Bill, although no timeline for this has been provided. The recent extension of the ‘Dietary Supplement Regulations’ (under which most natural health products are currently ‘regulated’) to 2026, suggests that the government still has no sense of urgency about the need for a drastically different regulatory environment.
Meanwhile this regulatory void means committed New Zealand companies trying to build export markets for locally produced natural health products are struggling to assure customers in offshore markets of their product quality and safety parameters. To make it even harder for them, for several years we’ve had a situation where many products are being imported and sold into New Zealand with illegal label statements and therapeutic claims, but nothing is being done to stop these imported brands competing with more law abiding local companies.
Industry and Ministry of Health officials share some of the responsibility for this debacle, and it is time we stopped pretending that these products are all ‘dietary supplements’. Plant medicines are true medicines, and when good quality products are taken in optimal doses, they can be as effective as drugs for many health conditions. The Australian view of natural health products as ‘complementary medicines’, is much more appropriate, their regulatory system acknowledges their ability to sometimes have therapeutic effects, and also permits such claims to be made on their packaging, where scientific or traditional evidence exists. It also recognises that natural health practitioners after training at least 3 years to obtain degree level qualifications, have particular skills that enable them to use certain forms of herbal medicines that may not necessarily be appropriate or safe as ingredients in ‘over the counter’ products.
The dairy, beef, wine, kiwifruit and so many other vibrant export industries have all been established not only through being lucky enough to have perfect growing conditions here, but also a regulatory system in place that fulfils the needs of any premium quality and premium priced product, to be sold into offshore markets.
Natural health products are challenging to regulate appropriately, but isn’t everything? It’s time for elements of the industry to stop pretending all products are ‘dietary supplements’ rather than medicines, and for New Zealand politicians from all parties to stop messing around with the Natural Health Product Industry like a game of political football, before the next 3 year election cycle.
The long game as we reflect on the post-Covid world, has to seriously leverage New Zealand’s many unique strengths and quality attributes, to create a sustainable portfolio of industries which can boost export revenue, have high margins, look after the environment, and respect the principles of Kaitiakitanga. The local Natural Health Products industry tick all these boxes, but is now in urgent need of world class regulations to support its export lead growth.