What’s the status of cannabis-containing products (including oils) and the cultivation of cannabis for medicinal use since the Constitutional Court declared existing legislation criminalising the use, possession and cultivation of cannabis unconstitutional?

According to SAHPRA, the cultivation of cannabis for medicinal use and the manufacturing of cannabis-containing pharmaceutical products will be subject to strict monitoring.

Last September the Constitutional Court declared existing legislation criminalising the use, possession and cultivation of cannabis unconstitutional. The ruling made it legal for an adult to use or be in the possession of cannabis for use in private. It is also now legal for an adult to cultivate cannabis in a private place for his/her personal consumption.

The Court further ruled the section of the Medicine and Related Substances Act, 1965 (Act 101 of 1965) to be unconstitutional, in that it prohibits the actions mentioned above, and suggested amended wording, which will be in effect until reviewed by Parliament.

But what does this mean with regard to the cultivation of cannabis for medicinal use, as well as the production and sale of cannabis-containing products for medicinal use?

CULTIVATION OF CANNABIS FOR MEDICINAL USE

According to South African Health Products Regulatory Authority (SAHPRA) chairman Professor Helen Rees, “Currently the only reason SAHPRA and the Department of Health may permit the cultivation of cannabis is for medicinal and research purposes. This is to ensure the availability of standardised, quality-assured, locally grown cannabis.”

“Developed in consultation with the Department of Agriculture, Forestry, and Fisheries, this framework is intended to control the cultivation, production and manufacturing of cannabis-containing products intended for medicinal use in SA,” said Prof Rees. “Licensed domestic cultivation of cannabis for medicinal use is aimed at ensuring sufficient local supply for medical, scientific and clinical research purposes and the implementation of control measures necessary to prevent diversion and misuse, as well as to ensure patient safety. The cultivation of cannabis for medicinal use and the manufacturing of cannabis-containing pharmaceutical products shall be subject to strict monitoring to avoid any diversion for unapproved purposes,” Prof Rees said.

To date, SAHPRA has received 21 licence applications for the cultivation of cannabis for medicinal use. Of these, one application has subsequently been withdrawn. Of the remaining applicants, 16 applicants have been inspected and four applicants are scheduled for inspection. “No licences have yet been issued, but a developmental approach to the approval of suitable licences is being pursued,” said Prof Rees.

CANNABIS-CONTAINING PRODUCTS (INCLUDING OILS)

Although the Constitutional Court’s ruling may be the first step towards it, currently the production of cannabis-containing products (including extract cannabis oils) from cannabis cultivated in a private place, and then sold to the public is still illegal.

Despite this, there are currently several outlets and individuals selling cannabis-containing products (including oils) for medicinal use. “Products not registered or approved by SAHPRA are illegal,” said Prof Rees. “Suppliers and users of such illegal products are exposing themselves and others to legal and health risks as the safety, efficacy, and quality of these products cannot be assured.”

Over and above lodging an application for registration of a cannabis-containing product with SAHPRA, an application to licence the manufacturer, importer and distributor of the product must be submitted. Only after SAHPRA finds the product safe, effective, and of good quality, and the manufacturer is deemed GMP compliant, will the product be registered and legalised for the market.

“There are however certain instances where it is possible to apply for individual patient access to unregistered medicines containing cannabis, or specific cannabinoids (tetrahydrocannabinol and/or cannabidiol),” said Prof Rees. Because no quality-assured products are available in SA, approval needs to be sought for the importation thereof from other countries like Canada or the Netherlands.

“To date, 56 such applications have been approved by SAHPRA, based on motivation for use in specific patients by an authorised prescriber,” said Prof Rees.