Last week the Department of Health published an update on regulations surrounding cannabis in South Africa, effectively deregulating certain components of the plant.
The cannabis plant comprises two main compounds – Tetrahydrocannabinol (THC) and Cannabidiol (CBD).
THC is considered to be the psychoactive component of cannabis, whereas CBD is not associated with psychoactive outcomes.
According to Helen Michael – a director in the Healthcare & Life Sciences practice at Werksmans – before the publication of the gazette THC and CBD (which are not intended for therapeutic purposes) were all listed as Schedule 7substances in term of the Medicines Act.
Schedule 7 substances – which also include substances such as heroin – are considered highly regulated drugs, which may only be supplied or used pursuant to a permit issued by the director-general of Health and under specific circumscribed circumstances.
“The effect of the government notice is to remove CBD (that is not intended for therapeutic purposes) from Schedule 7 and to include it under Schedule 4 of the Medicines Act,” said Michael.
“Schedule 4 substances are, in turn, those substances that may be sold by pharmacists when presented with a written prescription.”
Michael said that the government notice goes further in that entirely excludes certain preparations containing CBD from the schedules to the Medicines Act.
- CBD preparations that contain a maximum daily dose of 20 milligrams and which do not claim to treat or cure any medical condition – but instead, contain a ‘low risk claim or health claim’, including reference to ‘general health enhancement without any reference to specific diseases’, ‘health maintenance’ or ‘relief of minor symptoms’ which are not related to a disease or disorder;
- Products ‘made from raw plant material and processed products’ which contain a very small amount of THC (not more than 0.0001%) and CBD (not more than 0.0075%).
“Notably, the exception contained in the exclusion notice is only valid for a period of 12 months from the date of signature of the notice (15 May 2019),” said Michael.
“The exception will, therefore, expire on 15 May 2020 unless the notice is renewed by the Minister of Health.”
What does this mean for South Africa’s broader cannabis industry?
The notices considerably alter the regulatory framework applicable to the sale and purchase of CBD (or cannabis) related products in South Africa, said Michael.
“The changes have the potential to give rise to a significant expansion in the sphere of commercialisation of CBD related products – which commercialisation has, to date, been severely curtailed by the strict requirements applicable to schedule 7 substances.
“Whilst cannabis itself, as well as THC related products, continue to be strictly regulated, the notices arguably represent a shift in the perception on the role of cannabis-based substances in South Africa, particularly with reference to the medical relevance of such substances,” she said.