Most Complete Ever! Uncovering the Fast-Growing and Unique South African Medical Marijuana Market！

Implementation of New Laws

On May 28th of this year, South African President Cyril Ramaphosa approved and signed the Cannabis for Private Purpose Act (CfPPA), legalizing the possession and cultivation of cannabis by adults.

The regulatory reforms enabled by the Private Use of Marijuana Act (CfPPA) will completely remove marijuana from the Drugs and Drug Trafficking Act. This will further facilitate amendments to the scheduling of the Drugs and Related Substances Act and provide targeted regulatory reforms to the Plant Breeder's Bill of Rights and the Plant Improvement Act, as well as other legislation that needs to be amended to allow industrialization of the cannabis industry.”

The bill also provides further guidance on how to prescribe medical marijuana to children and protects children from overexposure to marijuana. Also, the bill explicitly prohibits marijuana transactions. Lawmakers emphasized that the bill does not allow marijuana sales, legal or otherwise. Adults would need to grow their own marijuana and use it only in private homes. The bill also provides for the expungement of prior convictions for marijuana possession and cultivation.

The 2024 legislation provides a comprehensive framework to address these ambiguities. The following key provisions are outlined in the Private Use of Marijuana Act:

1. Personal Use and Cultivation: Adults 18 years of age and older are allowed to possess up to 600 grams of dried cannabis flower per person and grow up to eight plants per household for personal use. The sale of cannabis products is strictly prohibited.

2. Consumption in public places: Consumption of cannabis in public places remains prohibited, similar to the rules for alcohol use. This measure is intended to balance personal freedom with public health and safety concerns.

3. Commercialization: While personal use of cannabis has been legalized, the commercial sale of cannabis requires strict licensing. This regulatory approach is designed to ensure quality control, prevent underage access to marijuana, and curb the illicit market.

4. Medical Marijuana: The bill expands the use of medical marijuana by allowing healthcare professionals to prescribe marijuana-based treatments for a variety of conditions. The bill also promotes research into the therapeutic benefits of marijuana.

5. Social Justice Programs: Recognizing the historical injustice of marijuana offenses, the legislation includes provisions for social justice programs.
Indeed, South Africa is at a pivotal moment as global interest in medical marijuana grows. Thanks to favorable agricultural conditions, stringent quality control measures, and an evolving regulatory framework, South Africa has the potential to become a major player in the global medical cannabis market. We look at the opportunities and challenges ahead by delving into the current legal environment, including regulatory developments, approval processes and patient access.

Regulatory Landscape

South Africa was a signatory to a number of international treaties, including the United Nations Single Convention on Narcotic Drugs of 1961, which had initially classified cannabis under strict control. However, that has now changed in South Africa, which has reclassified the control of medical marijuana containing THC, opening the door to medical use and cultivation under strict regulation.

The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating medical cannabis to ensure that cultivation, processing and distribution meet strict quality control and safety protocols.SAHPRA audits facilities against South African Good Manufacturing Practices (GMP) guidelines, which require medical cannabis businesses to make the required amount of capital investment before being granted a Section 22C license.

Under South Africa's current regulatory framework, it recognizes cannabis as a legally traded agricultural product. However, the framework prioritizes the development of a regulatory structure for the production and export of medical cannabis, whereby licenses can only be granted once a compliant facility has been built and audited by SAHPRA.

Approved and Unapproved Cannabis Drugs

To date, no registered cannabis medicines have been approved in South Africa, but according to section 21 of the Medicines Act, people can obtain, use and possess medical cannabis if they have a license from a licensed medical practitioner. Local distributors can also sell their medical marijuana products under this section. The Medicines Act also allows licensed physicians to apply for a license to import and distribute marijuana medicines.

It is worth noting that despite obtaining a cultivation license, South African law makes it illegal to cultivate cannabis for local sale. This indicates a high barrier to entry, and due to the large capital investment required, businesses may typically take 12 to 24 months to generate revenue.

Section 21 of the Medicines Act also allows access to unregistered medical cannabis products in exceptional circumstances. This statute is critical to ensuring that patients have access to marijuana when traditional therapies have not worked.

For patients to access these unregistered medicines, a registered practitioner or authorized prescriber needs to apply to SAHPRA on behalf of the patient; however, this process is complex and often misunderstood, leading many sellers to simplify the regulations to stay afloat. Simplifying access to medical marijuana may further drive legislative change and make this beneficial product more accessible to patients.

Under South African law, THC was amended to Schedule 6, except for the personal use of the plant or its derivatives by adults who do not have/claim to have no pharmacological effect or medical use. Schedules 6 and 7 are narcotics and other controlled substances and product categories such as morphine and heroin. These substances are not readily available and, according to the Medical Association of South Africa, are “used only in extreme cases”.

Medical Marijuana Approval Process

The process of registering and approving medical marijuana in South Africa is laborious and expensive. Companies must register under the Companies Act and then obtain a license to operate from SAHPRA and appoint a responsible pharmacist to ensure that they can comply with the regulations.

In the case of a pharmaceutical company, the application for registration must produce an Applicant Drug Master File detailing the company's structure, physical address, staff experience and product testing procedures. Undoubtedly, stability studies and extensive analytical test reports of the drug product are required, and the entire approval process can take up to four years.

Legal marketing of unapproved drugs

Despite regulatory barriers, patients in South Africa can apply for access to unregistered medical cannabis products through sections 21 and 22 of the Medicines Act.SAHPRA must ensure that any medicines containing cannabis meet high quality and safety standards.

Section 21 authorizations under the South African Medicines Act are granted on a case-by-case basis and can be applied primarily only when conventional therapies have been ruled out or failed. While affordability alone is not sufficient to obtain a section 21 authorization, each application is scrutinized with a focus on the safety, efficacy and quality of the cannabis-containing medicinal product used.

The future of medical marijuana in South Africa

The medical cannabis market in South Africa is still in its infancy. There are more than 100 cultivation licenses in South Africa, but only about 20 have succeeded in exporting medical cannabis products. This is a slow process that can be attributed to strict regulations that hinder local sales.

It is also possible that South Africa will follow the lead of other countries, such as Germany, in transforming the illegal cannabis market into a thriving tax-contributing industry. We believe that the future outlook for the medical cannabis industry in South Africa is bright through appropriate regulatory adjustments that support local sales and patient access in an evolving regulatory environment that maximizes the use of the region's unique geographic and climatic resources.