The head of New Zealand’s first medicinal cannabis company agrees with a University of Otago academic who claims cannabis is unable to be considered a medicine because it contains multiple active ingredients.
Professor Michelle Glass published an opinion piece in the New Zealand Medical Journal today suggesting there is no need for the Ministry of Health to develop new regulations governing cannabis as medicine because the Medicines Act already outlines the standards a product needs to reach in order to be considered a medicine.
“Recognition of cannabis as a medicine is challenging when whole plant extracts contain active ingredients in addition to THC and CBD” said Manu Caddie, CEO of Hikurangi Cannabis Company based in Ruatoria.
“So I agree with Professor Glass that in some ways it is problematic to consider cannabis as a conventional medicine, but the efficacy of cannabis-derived products is well established for a range of conditions and the safety profile for the two main cannabinoids is better than the active ingredients in aspirin and toothpaste.”
“There is a global debate raging on what makes something a medicine and we see that debate reflected in the Therapeutics Products Bill currently being consulted on which is designed, in part, to replace the archaic wording used in the Medicines Act 1981.”
The wording in the draft Therapeutic Products Bill suggests any product may be considered a therapeutic product “if it is intended for use in, on, or in relation to humans for a therapeutic purpose”… and “a naturally occurring thing that might not otherwise be considered to be a product may become a [therapeutic] product if it is changed from its naturally occurring state.”
“Professor Glass’ article raises an important issue relating to product consistency, this is a critical consideration for the regulatory requirements of our fledgling medicinal cannabis industry. Without quality standards it will be difficult for patients and prescribers to have confidence in cannabinoid-based products whether they are made locally or imported. The aim of new legislation was to ensure patients have better access to high quality medicinal cannabis products – that means controlled processes across cultivation, manufacturing and distribution.”
Mr Caddie says that while plant-based medicines are still rare in the pharmaceutical industry which prefers to make synthetic versions of particular compounds once they are proven, herbal medicines are recognised in most pharmacopeia and in Appendix 7 of the global Pharmaceutical Inspection Co-operation Scheme established in 1995 as an extension to the Pharmaceutical Inspection Convention from 1970.
“Professor Glass is right in the sense that we don’t need a whole new regime to enable cannabis to recognise as medicinal or therapeutic, but given the stigma and concerns associated with the plant it seems that specific regulations to cover the security and licensing provisions would be helpful to provide clarity to industry and peace of mind to the public that production will be managed carefully.”
Two products made from cannabis, Sativex® and Epidiolex® contain plant-derived cannabinoids in a defined concentration and have approval for specific medical conditions, with Epidiolex® having been approved last year by the FDA and Sativex® is approved by Medsafe on prescription in New Zealand.
“Our focus at Hikurangi is to ensure the safety of patients and efficacy of medicinal cannabis products by working with prescribers and medical researchers to undertake clinical trials in New Zealand. We are building strong alliances with local medical professionals and international research institutions to align our plant genetics programme and clinical research with the most recent scientific knowledge on cannabinoids.”
Hikurangi Cannabis Company was the first New Zealand company to be granted a medical cannabis cultivation licence, and in April 2019 established the first legal medicinal cannabis breeding programme in New Zealand. The company is currently negotiating supply agreements with buyers in Europe, Asia and North America and has plans to supply New Zealand pharmacies and export a range of medicinal cannabis products once commercial licenses are issued in early 2020.