Doctors who import and prescribe unapproved medicinal cannabis product are being warned by Medsafe they should be doing so “sparingly” as it investigates multiple complaints about six medical practitioners or medicinal cannabis clinics for breaches of the Medicines Act.
Medsafe said others had been warned about advertising, as the country’s slow-moving Medicinal Cannabis Scheme started to take flight.
For 18 months businesses have spent millions trying to gain manufacturing licences and product approval under the scheme’s stringent rules. But the requirement for products to meet minimum quality standards does not apply to medical practitioners, who can import cannabinoid (CBD) products directly for patients, under section 25 of the Medicines Act, or unapproved THC products with ministerial approval.
The act requires an importer to have available for inspection the specifications for testing of the imported medicine and a certificate of the results of testing of each batch. A certificate verifying that CBD products meet the product definition must also be provided.
* First company gains licence to manufacture medical cannabis
* Tens of millions of dollars… still no local medicinal cannabis industry. What’s gone wrong?
* Pharmacies accused of over-charging patients for medicinal cannabis
Some industry members spoken to by Stuff believe section 25 is ripe for exploitation by practitioners. Many specialised medicinal cannabis clinics have popped up since the scheme was enacted. While it’s illegal to advertise product, Stuff is aware of the sale of white-label or non-approved products by those clinics, alongside some approved products.
Medsafe group manager Chris James said the ministry would be concerned if medical practitioners were importing “large quantities” of unapproved products. There are six approved products in New Zealand.
Asked to clarify what Medsafe would consider “large quantities” James said, “What is important to reiterate is that doctors should be prescribing products that are verified against the minimum quality standards, given the availability of some verified products.
“Section 25 … envisages that authorised prescribers will apply professional judgement in relation to the suitability of a particular product for each individual patient, will weigh up the risks and benefits of prescribing a product that has not been assessed to meet the minimum quality standards and ensure the patient has been informed of this, understands this and gives consent.
“Authorised prescribers have this professional duty. The expectation is that this exemption will be used sparingly.”
Dr Mark Hotu, who runs Green Doctors in Auckland, said the ministry’s warning not to bulk import made little practical sense.
“If you’re a GP, and you’ve got Joe Bloggs, you can import that product just for him. If you’re a clinic like us, and you’ve got 2000 patients, how does that make that different? What if you need to order 2000 bottles? That’s then bulk importing, is that wrong? I don’t know.”
A letter sent by the Ministry of Health to pharmacies and clinics at the end of a transition period, which allowed sales of unapproved product until October 1, ordered that any banned product obtained by wholesalers in New Zealand could not be dispensed and should be destroyed.
Hotu said he had to return about 1500 bottles of Theraleaf CBD oil to his New Zealand wholesaler, but if he wanted to prescribe the product again, he could directly import the same product himself from Spain. “The crazy, crazy, crazy thing is, they’ll probably send us the same bottles back. How ridiculous is that? What’s the difference?”
The price difference between the Theraleaf and an approved Tilray product was about $200 a month, which was significant for patients, Hotu said.
New Zealand Medical Cannabis Council director Sally King said section 25 was intended for doctors to be able to provide specialist drugs for a small market, and that the act was overdue for a refresh.
“I don’t believe that section 25 was ever envisaged to be a way to allow unapproved, or with no quality standard, significant volumes of product to patients; I just don’t believe that was the intent,” King said.
“I question the legitimacy of a business model that depends upon importing products that are below the NZ standards. Having said that, some of the clinics that are specialising have more skills to prescribe medicinal cannabis than a GP. They’ve done training, (but) they should be able to operate with NZ product. It shouldn’t be dependent on them trying to sell unapproved product.”
While King said the patient affordability issue would “in time” be solved as more products come on the market, New Zealand medical cannabis producers have struggled to get product approval.
Just four CBD and THC products, made by Tilray, are approved, while the first two products from a New Zealand supplier, Helius Therapeutics, came on the market this week. Helius and Rua Bioscience are the only two companies granted licences to manufacture. Rua Bioscience is working on getting approval for a CBD product. Helius declined to discuss its pricing.
Medsafe said more products were being assessed with decisions on approval expected in the coming months. This week Health Minister Andrew Little told RNZ he had no sympathy for local businesses who’d been given ample notice to apply for approval for their imported products, or run them down.