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Regarding Cannabidiol (CBD) – Minutes of the April 2016 Meeting of the EACD

Cannabidiol (CBD)

[redacted] (Senior Policy Analyst, MoH) and [redacted] (Principal Advisor, Medicines control) attended the meeting at 10.21am.


Dr Stewart Jessamine chaired the discussion as Assoc. Prof. Cynthia Darlington had declared a conflict of interest due to her involvement in preclinical research into cannabinoid pharmacology. The Committee had no issues with Assoc. Prof. Cynthia Darlington being present for the discussion given her expertise in the area but she would be excluded from the decision making process due to the outcome potentially impacting the regulatory environment for research.


[redacted] gave a brief contextual overview within the Ministry of Health (MoH). [redacted] has been involved in therapeutic uses of controlled drugs for the last few years, with her main area of interest recently being around medicinal cannabis. The MoH policy unit are of the understanding that Minister Dunne is comfortable around the current legal framework regarding access and use of controlled drugs, but he is interested to see if the policies and processes are as streamlined as they can be regarding patient safety and access.


The policy unit are currently doing work around medicinal cannabis classification in line with the EACD meetings consideration. [redacted] gave a brief overview of the function of Medicines Control. Medicines Control is a regulatory unit that regulate the medicines supply chain, which includes controlled drugs. The classification of medicinal cannabis has been quite topical in the last year and whatever final recommendations are made by the Committee will affect Medicines Control as they administer licences, approvals, permissions etc.


[redacted] advised that currently, if a practitioner wishes to prescribe a cannabinoid or products that contain cannabinoids, they have to make an application to the Minister. Currently there are no products containing only CBD that are approved medicines both domestically and internationally. There are however, a number of non-pharmaceutical products available. It was noted that there was a difference of opinion between ESR and MoH regarding whether or not CBD should be considered a controlled drug or not. The Therapeutic Goods Administration (TGA) in Australia have recently down-scheduled CBD to a prescription only medicine with less than two percent of other cannabinoids as most CBD extracts contain small amounts of tetrahydrocannabinol (THC) due to the difficulty and associated cost to separate the two substances. The Misuse of Drugs Act (MoDA) only requires one molecule of a controlled substance to be present in a preparation for it to be captured as a controlled drug.


There is an entry in the Medicines Regulations for CBD as a prescription medicine, however, if it is also considered a controlled drug, then MoDA acts as the dominant piece of legislation.


The technical paper looked at the potential therapeutic effects of CBD in comparison to the abuse potential. The Committee had been asked to determine whether or not there was sufficient evidence to make a recommendation for de-scheduling CBD from being captured under MoDA so that it is classified as a prescription medicine only. The Committee was also asked to consider an amendment allowing CBD preparations to contatin THC and other cannabinoids found in cannabis up to a certain threshold to enable the de-scheduling of CBD to take effect. The Committee considered the options for streamlining medical access to CBD as a controlled drug.


[redacted] advised that there were some controlled drugs that had been exempted from the ministerial approval requirements process as they had been specifically named as exempt as medicines under the Misuse of Drugs Regulations. Blanket or general approvals, permissible under Regulation 22 of the Misuse of Drugs Regulations, have also been issued to supply prescribe and administer certain controlled substances . There are multiple avenues that could be considered with regard to what mechanisms are available to streamline the process to access CBD based medicines, however, the main driver for the reclassification of CBD is the TGA decision because they have set a new approach to cannabinoid based medicines.


[redacted] spoke to the notes submitted by [redacted] which covered a few issues with the current legislation. [redacted] also advised that although CBD does have the same molecular formula, ESR do not consider CBD as an isomer of THC within the specific chemical designation under MoDA as CBD is significantly different in structure from THC and is not explicitly named under the legislation. ESR also do a lot of testing for hemp growers who have expressed interest in information regarding CBD content of hemp plants and hemp fibre for therapeutic use. Another point of consideration is that more clarification around what is considered the definition of medicinal cannabis is needed.


Research in this area can be difficult due to the bureaucratic layers to obtain permission. Moving CBD out of MoDA would remove those controls but would still need to address the THC component of the argument as THC is specifically named as a controlled drug under MoDA. More research is required regarding the potential associated risks, however, the risk of CBD causing psychoactive harm is very low as CBD on its own does not produce psychoactive effects. It was also noted that approved prescription medicines have to meet quite stringent requirements regarding controls around dosage, concentration and stability among other testing criteria.


Currently, under section 29 of the Medicines Act 1981*, there is an exemption for medical practitioners to prescribe unapproved medicines. Non-pharmaceutical forms do not need to meet the same requirements as approved prescription medicines.


MoH considers that CBD, even in the absence of THC, is a controlled drug under the isomer provisions of MoDA and it has administered the Medicines and Misuse of Drugs Acts in accordance with this view. If CBD is de-scheduled from MoDA to be a prescription medicine only, prescriptions will still be required to be in possession of CBD. There was a discussion around what the potential implications would be for de-scheduling CBD regarding over prescribing and abuse. Though CBD can be converted to THC, abuse and conversion of CBD to THC is considered unlikely as CBD based medicines would most likely cost much more than buying cannabis off the street as well as having to go through the process of gaining a prescription to access the CBD medicine. Currently, individuals can carry on their person up to a month’s supply of controlled drugs into NZ with appropriate overseas prescriptions and proof that it was lawfully supplied overseas for the purpose of treating a medical condition..


To address the issue around THC content in CBD medicines, it was suggested that a THC content threshold be set, similar to the allowable threshold of THC in hemp. It was discussed if the limit should be two percent, in line with Australia, or 0.35 percent in line with the threshold for THC in hemp.


The Committee queried whether there was enough evidence presented to make a recommendation for an allowable THC threshold in CBD preparations. They were particularly interested in the processes that led to the 0.35 percent threshold of THC allowed in hemp in NZ and the two percent threshold of other cannabinoids allowed in CBD medicines in Australia. The question was also raised of what the THC content of cannabis generally is.


Outcome: The Committee deferred the decision to the next meeting as more information is needed regarding the process that lead to the 0.35 percent of THC content threshold being allowed in hemp and the two percent threshold of other cannabinoids allowed in CBD medicines in Australia. Research around the effects of consumption of two percent of additional cannabinoids in a CBD product also needs to be looked at by the Secretariat and brought to the Committee.


Action: Secretariat to find out the process that lead to the 0.35 percent threshold of THC content allowed in hemp and report back to the Committee.


Action: Secretariat to find out what the process was for the TGA reaching the two percent threshold of other cannabinoids allowed in CBD medicines.


Action: Secretariat to find out more information around concentration levels of THC in the average cannabis that is circulating in the NZ market.


Action: Secretariat to find out more information regarding effects of consumption of products containing different concentrations of THC.


Action: Secretariat to add CBD to the next agenda.


[redacted] and [redacted] left the meeting at 12.04pm


Section 29 Medicines Act 1981

29Exemption for medicine required by medical practitioner


Neither section 20 nor section 24 shall prevent—


the supply by any person to any medical practitioner, on the medical practitioner’s request, of any medicine required by that medical practitioner for the treatment of a particular patient currently under that medical practitioner’s care; or


the administration by any medical practitioner of any such medicine to any such patient.


Every person who, for the purposes of subsection (1), sells or supplies to any practitioner any medicine that is a new medicine by virtue of paragraph (a) of the definition of the term new medicine in section 3(3) before the consent of the Minister to the distribution of that medicine has been notified in the Gazette shall, as soon as practicable after the end of every month in which he has so sold or supplied any such medicine, report that sale or supply to the Director-General in writing, naming the practitioner and patient, describing the medicine, and identifying the occasion when and the place where the medicine was so sold or supplied.


Without limiting section 48, if any person fails to comply with subsection (2), the Minister may, in the manner prescribed in that section but without complying with subsection (2) of that section, prohibit that person from selling and supplying any new medicine to which subsection (2) applies before the consent of the Minister to the distribution of that medicine has been notified in the Gazette.