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CBD Oil (Cannabidiol) declared a Schedule 6 Prescription Drug

By: Anthony Rees (National Chairman – TNHA)

On the 28th of July, and just four days preceding the Trial of the Cannabis Plant by the Dagga Couple, the Medicines Control Council, after consultation with the Minister of Health spuriously gazetted a list of substances to be included in the schedules in terms of section 22A(2) of the Medicines and Related Substances Act (Act No. 101 of 1965).

One of the substances hidden on the bottom page 27 of the gazette is Cannabidiol, or more commonly known as CBD Oil.

Cannabidiol is one of the most exciting cannabinoids — natural compounds found in cannabis — that we are aware of today. Also known as CBD, cannabidiol is transforming from a little-known molecule, to a potential breakthrough nutritional component and treatment.

Cannabidiol (CBD) is found throughout the seeds, stalk and flowers of cannabis plants — including hemp and marijuana. Unlike many of the 103 currently identified cannabinoids that we are aware of, cannabidiol occurs naturally in significant quantities in cannabis, so it is relatively easily extracted from the plant.

Thousands of studies have shown the wide array of potential benefits that cannabidiol may have. As regulators and lawmakers around the world begin to finally take notice of and grapple with new cannabis reforms brought on by challenges by civil society, cannabidiol will become a mainstream ingredient in all kinds of common dietary supplements and pharmaceutical products.

In terms of Section 22A(5)(f) of the Medicines Control Act, only medical practitioners registered under the Health Professions Act, whom within their limited scope of practice, and subject to the indications for use of such substances, may prescribe Schedule 6 substances.

This means that as of the 28th of July, the open sale of cannabidiol with any therapeutic health claims (either on the product label or associated marketing materials), and without a prescription by a registered medical doctor is illegal. 

It also means that possession of an unregistered cannabidiol containing product, labelled with therapeutic claims, and without a script from a registered medical doctor is illegal, and can land the seller or one in possession of it being criminally charged and having to pay a hefty fine, and/or for being imprisoned for up to 10 years.

The definition of the word ‘sell; in Section 1 the Medicines Control Act is exceptionally broad, meaning that even possession, storage, bartering or gifting someone with a medicine for free is considered selling.

“sell” means sell by wholesale or retail and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to any person whether for a consideration or otherwise; and “sale” and “sold” have corresponding meanings.
According to substance’s listing in the scheduling notice, it states Cannabidiol, when intended for therapeutic purposes“.

This technically means that only cannabidiol containing products sold with therapeutic claims on their labels or supportive marketing materials fall under Schedule 6, and therefore must first be registered by the Medicines Control Council as a Category A (pharmaceutical) medicine.

Cannabidiol as a substance, or in a mixture of other substances sold without any health claims on the product label or associated marketing materials remains unscheduled and can be sold without registration or be solely prescribed by a medical doctor.

If you are currently an importer, manufacturer or distributor of a cannabidiol containing product you have two choices to continue trading.

  1. THE REGISTRATION ROUTE – You can market your cannabidiol containing product with approved therapeutic claims by registering it as a Category A (pharmaceutical) medicine with the Medicines Control Council. Applications for new medicines currently take between 3 and 5 years to be assessed and approved if all the required paperwork is in order.. To apply to register a medicine in terms of the Medicines Control Act you will first have to posses a pharmaceutical manufacturing licence and/or import licence. You will then have to submit an application for the product and satisfy the high safety, quality and efficacy standards demanded for the registration of a Category A (pharmaceutical) medicine. In your application you will have to submit a Common Technical Document (CTD), with all the scientific and technical evidence required to register your medicine. You will need an expert regulatory pharmacist or pharmaceutical registration consultant to do this on your company’s behalf. You will also have to employ a full-time pharmacist to be the responsible person to supervise and sign off on all your import, manufacture and distribution procedures. Once your product has been registered (licensed) you will be confined to distributing your medicine through registered pharmacies, and your product will only be able to be prescribed by a medical doctor. You will only be allowed to market your medicine with the heath claims expressly approved. The cost of research and development, manufacturing compliance and licensing can easily cost tens of millions of Rand to get off the starting blocks. Because your product can not be patented, due to cannabidiol being a naturally occurring substance, cost recovery after passing the regulatory hurdles will potentially take decades. In essence, only large multinational drug companies will be able to jump the hurdles. Whether they will, or not, considering the delays in registration and the non-patentability of cannabidiol still remains to be seen.
  2. THE UNREGISTERED ROUTE – You can sell the product without any therapeutic claims whatsoever. Your product label may only state the percentage of cannabidiol by volume and the same for any other ingredients found in it. note the Medicines Act’s definition of advertise below.
“advertisement”, in relation to any medicine, Scheduled substances , medical device or IVD, means any written, pictorial, visual or other descriptive matter or verbal statement or reference — (a) appearing in any newspaper, magazine, pamphlet, electronic media (including radio or television) or other publication; (b)distributed to members of the public; or (c)brought to the notice of members of the public in any manner whatsoever, which is intended to promote the sale of that medicine, Scheduled substance, medical device or IVD, and ‘advertise’ has a corresponding meaning.

THE NEW SCHEDULING STATUS CAN BE APPEALED

Section 25(a) of the Medicines Control Act makes provision for any decisions made by Council or any of its expert committees to be taken up on appeal. In this case the Scheduling Committee was responsible for this listing. All decisions of the Council and its expert committees must be rational and weigh up risk vs. benefit based on the latest scientific evidence. As far as we can ascertain, there is no overwhelming evidence of risk related to cannabidiol which necessitates it being placed into the second highest schedule under the Act. In fact, cannabidiol has a demonstrably high safety profile compared with thousands of other registered pharmaceutical drugs in the lower schedules.

WHAT’S NEXT FOR THE PURVEYORS OF CBD OIL?

  • The cannabidiol industry role players could consider launching an appeal against the Scheduling Committee’s decision to have the substance scheduled.
  • They should immediately strip any therapeutic claims (whether stated directly or indirectly) from their product labels and associated marketing materials in order not to be in violation of the Medicines Control Act. Any products currently on retail shelves with therapeutic claims should also be recalled and replaced with products without therapeutic claims immediately.
  • They could attempt to register their products as Category A (pharmaceutical) medicines, however this isn’t advised.

Download the 28 July Scheduling Notice (13.4Mb)