New Zealand's aspiring cannabis export industry is calling for the removal of an export ban to foster domestic suppliers of medicinal cannabis for the terminally ill, Thomas Coughlan reports.
Two industry players argued before the select committee considering a bill to decriminalise the use of medicinal cannabis that the local industry would not be able to supply New Zealanders as the bill stands currently.
The bill needed to ensure local products could reach the market quickly, and the removal of the ban would encourage the development of products here, the select committee was told.
One submitter said it could take up to a decade to produce pharmaceutical grade medicinal cannabis locally, if the Government uses an Australian-style pharmaceutical approach once the bill is passed.
The legislation as currently drafted acknowledges that most cannabis products do not meet “quality and efficacy requirements” of therapeutic product regulators like Medsafe. It gives the Health Minister the ability to establish minimum standards for therapeutic cannabis products.
Chris Fowlie, the founder and CEO of medicinal cannabis company Pharma Cann, says New Zealand’s regulation should not take the “pharmaceutical” approach.
Fowlie’s submission to the committee urged members to consider following the route of Canada and some European countries and regulate medicinal cannabis products to the level of things like food and health supplements rather than a ‘pharmaceutical’ grade.
This would mean medicinal cannabis products would be regulated to the same standards as health supplements, but not be required to go through the lengthy clinical trials that other pharmaceuticals are required to go through.
“Our standard pharmaceutical medicine approach assumes it’s a novel synthetic compound and requires extensive research and clinical trials that can cost millions of dollars,” Fowlie told Newsroom.
He argued that as cannabis is a naturally occurring plant, which is already in common use, it could be regulated along the lines of other naturally occurring products, avoiding the clinical trial process.
Fowlie said that adopting the pharmaceutical approach, as Australia had done, would lead to expensive clinical trials, which inflated the stock prices of drug companies without bringing products to market in time to help patients.
“Australia has been going three years now and they don’t have any products to market,” he said.
Fowlie said that it would still be possible to hold the products to a high standard, like GMP, or Good Manufacturing Practice. This standard is used in the pharmaceutical industry as well as the food, beverage and cosmetics industry to denote that a product is made in reliable and safe way.
Cost is another factor. Clinical trials are expensive. Although pharmaceutical companies keep secret the cost of shepherding products from conception, to trials and on to patients, estimates range into the billions of dollars.
That is significant for New Zealand’s law, as it restricts medicinal cannabis use to only terminally ill patients, meaning domestic manufacturers may struggle to find a significant market for their products here. The law currently prohibits exporting cannabis products for commercial purposes, meaning producers would be confined to the tiny New Zealand market.
The Ministry of Health has estimated from a survey that 235,000 New Zealanders currently used cannabis for medicinal purposes, but the proportion of these people who are terminally ill and would be exempted under this new legislation would be much smaller. A US study in 2016 found 86 percent of those who said they used cannabis medicinally also used it recreationally.
Other submitters from the nascent industry also submitted on the bill.
'Let us start growing and manufacturing'
Helius Therapeutics, a New Zealand company founded just last year, aims to bring products to market soon after the law is passed. It is currently waiting on a license to manufacture cannabis products in New Zealand. The company has made a $15 million investment to cultivate, research and eventually manufacture cannabis products.
Matthew Rhoden, who has founded several medicinal cannabis businesses in the United States, is a partner in Helius and the company already owns IP for several cannabis products from the North American market.
“We have IP for a dozen product lines already,” Paul Manning, the company’s director told the committee.
Helius also raised concerns with the number of people who could access medicinal cannabis products, saying that accessibility was a key concern. They also took issue with the restrictions on exporting the product.
Not roots and all
Another issue raised by Helius is the legislation’s restriction of non-cannabidiol cannabinoids. The legislation will only permit cannabidiol or CBD cannabis products and prohibits products which contain more than 2 percent of other cannabinoids like THC.
Manning said that this would prohibit “whole plant” products, known as “full spectrum” products, which he said were more effective.
But not everyone is convinced.
Dr Giles Newton-Howes, a senior lecturer at the University of Otago told Newsroom in February that he questioned the suitability of current cannabis products as medicine.
Cannabis contains over 400 distinct compounds, including 100 different phyto-cannabinoid compounds. Creating a product that filtered the therapeutic would be difficult, Newton-Howes said.
He added that while there was a prospect of new strains of medical-grade cannabis becoming available in the future, getting it to the level of medical approval would be difficult.
"It is highly likely a whole dried cannabis plant will reach a sufficient level of consistency to gain Medsafe approval.”