The legality of cultivating and manufacturing marijuana based medicines

In September 2018, in a land mark judgment, the Constitutional Court declared certain sections of the Drugs and Drug Trafficking Act 140 of 1992 (Drugs Act) and the Medicines and Related Substances Control Act 101 of 1965 (Medicines Act) to be invalid. These particular provisions prohibit the possession and use of cannabis – even for private consumption.

The internet and social media went viral with the news that the South African government had finally freed Sweet Mary-Jane and that soon she would be available in coffee shops and over-the-counter at the local pharmacy. In fact, many have been under the false impression that they may now cultivate and create products incorporating marijuana and its various cannabinoids for the open market.

What the judgment of the Constitutional Court allows you to do is to cultivate, use and possess marijuana and the specific THC cannabinoid - the cannabinoid known for its psychoactive effects - in private. The legislature now carries the burden of regulating the more nitty-gritty aspects of this judgment such as amending the relevant legislation and regulating exactly how much cannabis one can hold in one’s personal possession to constitute private use.

In view of this judgement then, unless registered with the South African Health Products Regulatory Authority (SAHPRA, previously known as the Medicines Control Council) products such as cannabis oils, marijuana infused vitamin tablets, or cannabis shakes to improve appetite, for example, are still illegal on the open market.

Elsewhere in the world, it has long been legal, in certain restricted circumstances, to cultivate marijuana for medicinal purposes and manufacture medicines including cannabinoids. For example, the medication dronibanol, sold under the brand names Marinol and Syndros, is used to treat severe nausea, vomiting and weight loss associated with chemotherapy in several countries including the United States, Canada, Germany and Australia. This drug includes a specific cannabinoid active ingredient called delta-9-tetrahydrocannabinol (delta-9-THC).

In South Africa, the Department of Health along with SAHPRA may approve licences to individual patients and medical professionals to gain access to cannabis containing medicines, which are otherwise unregistered in South Africa. Several such applications have been approved by SAHPRA for use in specific patients. In addition, as the judgement of the Constitutional Court has now decriminalised private use, persons can now grow and use their own cultivated marijuana to aid in their recovery.

Furthermore, the Medicines Act allows SAHPRA to issue licences to members of the public to grow marijuana for medicinal and research purposes. These licenses may be issued for activities such as the cultivation of cannabis or cannabis resin; to extract or test cannabis; and/or to manufacture a medicine which contains cannabinoids.

The issuance of these licences is subject to strict requirements and the growers and their operations are, of necessity, subject to strict regulatory oversight. Part of the reason for these strict requirements for the large scale cultivation of cannabis is to fulfil South Africa’s international obligations to prevent the diversion of cannabis and its derivatives to the illicit market.

When lodging such an application with SAHPRA one has to fulfil certain requirements, such as proving one’s integrity as a fit and proper person. It is therefore not possible that a person with prior convictions for trafficking narcotic drugs will be granted such a license. Further, the personnel employed in this operation must be over 18, must not have prior convictions for a serious offence, must not have an addiction to drugs, or a history of drug use. The operation as a whole must also naturally comply with Good Manufacturing Practice, specifically in relation to medicines.

The most onerous burden when obtaining such a licence are the requirements relating to security. The applicant must prove to SAPHRA, and the Department of Health, that sufficient policies and procedures have been adopted and implemented to comply with the prescribed safety requirements. These security measures must apply equally to all stages of the operation such as the cultivation, harvest, storage, transportation, synthetisation, and destruction of the plant, its derivatives or medicines made therefrom. Importantly, these security measures must be proven to minimise or completely eradicate the risk of diversion to the illicit market. The security measures required are quite extensive and more information can be obtained from the website of SAPHRA (even El Chapo had to have security for his marijuana fields).

After the marijuana is grown, it can then only be resold to a licensed manufacturer of medicines and before the medicine can be made available to the market (being patients who are prescribed such medicines by licensed medical practitioners), the medicine must be evaluated and registered with SAPHRA.

As you can see, we are still a long way off of the euphoric situation where space-cookies and marijuana lip balm are available on the shelves of your corner pharmacy.

This article was first published in Business Day.

Date published: 8 April 2019
Author: Dirk Hanekom and Natalie Slabbert

Tags: medicines marijuana