3 years from law change to market: Industry's first NZ-made cannabis medicines available from Thursday

Helius Therapeutics has two new CBD medicines that are the first locally-made cannabis medicines to get over the line under new regulations. Photo / Jason Oxenham

Two new Kiwi-made cannabidiol medicines will be available on prescription from Thursday - 18 months after new regulations came into force, and almost three years after a law change triggering a new industry.

And they're expected to be cheaper than imported medicines on the market, with pricing comparable to the CBD products that have been harder to access since the end of a grace period last week.

It's considered a historic landmark, given how long it has taken to get to this point, which had prompted some finger-pointing from Health Minister Andrew Little about why it had taken so long.

It's also somewhat of a surprise, given that the New Zealand Medicinal Cannabis Council (NZMCC) recently said that locally-made medicines were not expected to be available until the end of the year.

"This is only the start of the journey, with Kiwi patients our priority," said Carmen Doran, chief executive of Helius Therapeutics, the company making the new CBD medicines.

"They've waited a really long time for this day."

Hopes were high for a new industry when a new law to make medicinal cannabis more widely available for those who needed it was passed at the end of 2018.

It took another year for the industry's new regulations to be passed, and they only came into force in April 2020.

A grace period started at the same time to allow patients access to products while local companies built up the new industry.

The period was extended to 12 months and then to 18 months because there were still no locally-made products available, but Little refused to extend it again, saying companies had had enough time to "get with the programme".

The period ended last week, at the end of September, prompting concerns that thousands of patients would be left in the lurch because the 13 CBD products they were using during the period were no longer legal.

On Monday the Medicinal Cannabis Agency said that two CBD medicines from Helius - one of only two companies to have gained GMP (Good manufacturing Practice) certification - had met the minimum safety standards.

Health Minister Andrew Little caused a stir when he said any patient suffering from the end of the grace period was because of those companies that "didn't get off their asses". Photo / Mark Mitchell

The Herald understands the Helius products will be available on prescription from Thursday.

Some cannabis clinics will have them in stock, while pharmacies will be able to order them overnight.

They are both CBD sublingual solutions - to be dropped under the tongue - and they differ in concentration; one is 100 mg/mL, and one is 25 mg/mL.

They are expected to cost considerably less than the four other products that also meet the minimum standards, which are all made by Canadian pharmaceutical company Tilray.

There is still little quality clinical evidence about the efficacy of medicinal cannabis, which is why such medicines are not subsidised by Pharmac, and why Medsafe haven't approved any since 2010.

But there is abundant anecdotal evidence they can improve people's quality of life by treating chronic pain and anxiety.

They've also been used to treat sleeplessness and seizures, and have been used as alternatives to other medicines that patients had an adverse reaction to.

NZMCC executive director Sally King said the new medicines will go some way to address patients' concerns about limited choices after the end of the grace period.

"It is the dawn of a new era for medicinal cannabis in New Zealand," King said.

"This should give prescribers and patients confidence that Ministry of Health-approved medicinal cannabis products made in New Zealand are reliable, high-quality medicine that can be trusted and supplied locally."

The NZ Drug Foundation welcomed the new products, adding that many more were needed for "a functioning and accessible system".

King also welcomed new testing requirements that would make it easier for companies to make medicines without compromising safety.

The change means that some of the tests can be done by an ISO-accredited lab (International Organisation for Standardisation) instead of a GMP lab.

The previous rules meant that some of the testing couldn't be done in New Zealand, which had led to lengthy delays.