37-year-old laws surrounding therapeutic products may finally be catching up with the times, in light of a recent announcement from the country’s Minister of Health, David Clark.
On December 14, Minister of Health David Clark announced that consultation was now open for the first stage of a new regulatory scheme for therapeutic products.
A draft of the new Therapeutic Product Bill, along with a consultation paper, is now available on the Ministry of Health’s website; the ministry is welcoming submissions from both industry and consumers.
Due to the complexity of the Bill, as well as the Christmas and New Year holiday period, the consultation will be open for four months, until 18 April 2019.
The Therapeutic Products Bill will replace the Medicines Act 1981, and will cover therapeutic products, including medicines and medical devices.
Clark said, “The Medicines Act is old, hard to use, and doesn’t cover products adequately. There is a long history of reform attempts and it is time to finally get a new scheme in place.
“The Bill sets up the main controls on things like clinical trials, product approvals, and prescribing. Importantly, it also defines what we mean by ‘therapeutic product’.
“While that is obvious for many products, for others such as sunscreen, it’s not so clear and people may want to comment on those kinds of details as well.”
He added that the ministry would also be consulting on a series of details to be settled before the scheme could be properly implemented, such as medicine labelling and product standards.
Additionally, the ministry is seeking feedback on topics such as ownership rules for pharmacies and direct-to-consumer advertising of ‘named prescription medicines’.
However, the new regulatory scheme will exclude natural health products, as the New Zealand government plans to regulate such products separately and is still in the midst of establishing a suitable system for this purpose.
The draft Bill defines a therapeutic product as one that is “intended for use in, on, or in relation to humans for a therapeutic purpose, specified in the regulations to be a therapeutic product or intended for use as an active ingredient of a medicine”.
Naturally occurring ingredients can only be considered therapeutic products if they are converted from their natural state for therapeutic purposes.
The draft states: “The government is considering options for the regulation of natural health products and intends to exclude them from the Bill. However, the definition of natural health product(s) and the exact mechanism by which they will be excluded from the Bill are yet to be determined.”
Industry in limbo?
This exclusion may well affect industry players specialising in natural health products, especially since organisations such as Natural Health Products New Zealand (NHPNZ) and the New Zealand Wellness Association (NZWA) have long been pushing for an update to the existing Dietary Supplements Regulations 1985.
The regulations, which were set to expire in March 2019, were extended in February 2018 to March 2021. Before that, the proposed Natural Health Products Bill was removed from the parliamentary timetable after the 2017 election, much to the NHPNZ’s disappointment.
In July 2018, MP Mark Patterson — a member of Kiwi political party New Zealand First — proposed a new Members’ Bill in Parliament, with the support of the NZWA.
However, the Bill was withdrawn not long after its proposal.
In light of the new Bill and an impending separate regulatory scheme for natural health products, NHPNZ’s public affairs director Alison Quesnel told NutraIngredients-Asia: “The Therapeutic Products Bill will affect the small number of our members who have products regulated as medical devices.
“We have always advocated for a separate regulatory regime for dietary supplements because they are different from pharmaceutical medicines.
“A separate regulatory regime will benefit the industry by having our products well defined as dietary supplements, with all the associated benefits of separating them from pharmaceutical medicines.
“We are therefore very pleased with the announcement that there will be legislation specific to natural health products. This is the best solution for the sector, exporters and consumers.
“We are hoping for a new regulatory regime that benefits consumers, the natural health products sector and New Zealand as a whole by providing consumers with a higher level of assurance that products are safe, approved, effective and true-to-label, and enabling them to retain access and choice for the vast majority of products.”
She added that the NHPNZ also hoped that the new system would help to maintain “New Zealand’s control over setting the regulatory rules for natural health products sold here and overseas under Brand NZ, and boost our exports by better aligning with key markets’ regulatory regimes and therefore, providing our overseas markets with greater reassurance of product quality”.