Doctors and clinics importing and prescribing unapproved medicinal cannabis products in New Zealand have been warned by Medsafe to do so “sparingly” as the country’s new minimum quality standards start to bite.
Last week, industry leaders stepped up calls for a review into the new standards, with only six products meeting the requirements — four from Tilray verified in March/April and two oils from Helius Therapeutics which got the green light on October 4.
Stuff reports Medsafe is investigating “multiple complaints” about six medical practitioners or cannabis clinics for alleged breaches of the Medicines Act and has warned others about advertising.
While cannabis companies have struggled to get manufacturing licences and product approval under the scheme’s stringent rules, they do not apply to medical practitioners, who can import CBD products directly for patients under section 25 of the Medicines Act, or unapproved THC products with ministerial approval.
Importers must be able to provide the specifications for testing of the imported medicine, a certificate of the test results of each batch and verification that CBD products meet the product definition.
But New Zealand Medical Cannabis Council director Sally King told Stuff section 25 was intended to enable doctors to provide specialist drugs for a small market, and was due for an overhaul.
She added: “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.”
Medsafe group manager Chris James said the ministry would be concerned if medical practitioners were importing “large quantities” of unapproved products.
He added: “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.”
However, Dr Mark Hotu, who runs Green Doctors in Auckland, insisted the ministry’s warning was impractical for clinics.
He said: “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 2,000 patients, how does that make that different? What if you need to order 2,000 bottles? That’s then bulk importing, is that wrong? I don’t know.”