Legal and regulatory insights into South Africa’s growing medical cannabis market

Regulatory landscape

South Africa is a signatory to several international treaties, including the UN's 1961 Single Convention on Narcotic Drugs, which initially classified cannabis under strict control schedules. However, changes have been made, allowing South Africa to reschedule cannabis containing THC, opening doors to medical use and cultivation under strict regulations.

The South African Health Products Regulatory Authority (SAHPRA) is responsible for overseeing the regulation of medical cannabis, ensuring that cultivation, processing, and distribution adhere to strict quality control and security protocols. SAHPRA audits facilities according to the South African Guide to Good Manufacturing Practice (GMP), which demands significant capital expenditure before a Section 22C license may be granted.

South Africa’s current regulatory framework, as outlined in the Country Investment Strategy, recognises cannabis as a legally traded agricultural commodity. It prioritises the development of a regulatory structure for the production and export of medicinal cannabis, with licenses granted only after compliant facilities are constructed and audited by SAHPRA.

Approved vs. unapproved medical cannabis drugs

Medical cannabis is not yet approved in South Africa, meaning local distributors rely on Section 21 regulations to sell their products. Unfortunately, growing cannabis for local sales remains illegal despite obtaining a cultivation license. The barriers to entry are substantial, and it can take companies 12 to 24 months to generate revenue due to the extensive capital investment required.

Section 21 of the Medicines Act allows for the sale of unregistered cannabis products for medicinal purposes under exceptional circumstances. This regulation is vital for ensuring patient access to cannabis where conventional therapies have failed. However, the process remains complex and often misunderstood, leading many local sellers to simplify regulations to stay afloat. Simplifying access to medical cannabis could drive legislative change, giving patients easier access to this beneficial product.

Approval process for medical cannabis

The process of registering and approving medical cannabis in South Africa is both laborious and expensive. Companies must register under the Companies Act, obtain an operating license from SAHPRA, and appoint a responsible pharmacist to ensure compliance with regulations.

A pharmaceutical company applying for registration must compile an Applicant Drug Master File, detailing the company’s structure, physical address, staff experience, and product testing protocols. Stability studies and extensive analytical test reports are required, and the entire approval process can take up to four years.

Legal sales of unapproved drugs

Despite the regulatory hurdles, patients in South Africa can access unregistered cannabis products for medicinal use through Section 21 and 22 applications. SAHPRA ensures that any cannabis-containing medicines available meet high standards of quality and safety.

Section 21 authorisation is granted on a case-by-case basis, primarily when conventional therapies have been ruled out or failed. While affordability alone isn’t enough to obtain Section 21 approval, each application is reviewed with a focus on the safety, efficacy, and quality of the cannabis products accessed.

Bassani Medical’s role in medical cannabis cultivation

Bassani Medical is one of the leading medical cannabis cultivation companies globally, exporting high-quality products to international markets. Given that local sales remain illegal, Bassani focuses on compliance with local and international regulations to ensure the highest product standards. Regular audits by both local and international bodies guarantee that Bassani’s cultivation processes and products adhere to stringent guidelines.

Their main concern for patients in South Africa is gaining access to safe, high-quality medical cannabis products. Despite cannabis being used medicinally for centuries, the regulatory barriers in South Africa make access difficult. Bassani Medical advocates for greater patient choice in self-medication, emphasising that adults should be able to make informed decisions about their healthcare.

Safety and efficacy are at the forefront of their operations. Their highly efficient aeroponics growing technique ensures consistent quality across all products, meeting both local and international standards.

What does the future of medical cannabis look like?

Mike Stringer, CEO of Bassani Medical suggests that the medical cannabis market in South Africa is still in its infancy. “Of the over 100 cultivation permits in South Africa, only about 20 successfully export medicinal cannabis products. This is slow progress and can be attributed to stringent regulations that prevent local sales, causing many companies to fold” explains Stringer. Bassani Medical predicts that South Africa could follow in the footsteps of countries like Germany, which converted an illicit cannabis market into a thriving, tax-contributing industry. With the right regulatory adjustments, South Africa could see significant growth in its medicinal cannabis sector.

For this to happen, there are many misconceptions about medical cannabis use that need to be addressed. Contrary to popular belief, medical cannabis does not always induce a "high" - especially in patients using it for pain relief, as the brain’s receptors process the compounds differently than those of recreational users. Medical cannabis can be administered in various ways beyond smoking, such as through tinctures, topicals, and edibles. Juicing cannabis leaves, for example, provides therapeutic benefits without inducing a psychoactive effect.

Exciting advancements in the medical cannabis industry are on the horizon, particularly in pharmaceutical research. Major pharmaceutical companies are now investing heavily in clinical trials, mergers, and acquisitions in the cannabis space. Pfizer has signed an agreement with the clinical-stage company Arena Pharmaceuticals for a total equity value of around $6.7bn. Since 2021, the pharmaceutical cannabis industry has seen several significant transactions, including two major multi-billion-dollar acquisitions. These landmark deals marked the start of a growing pharmaceutical interest in the cannabis space, seeing over a dozen similar transactions take place ever since. Bassani Medical envisions participating in the entire value chain, from cultivation to API supply, supported by innovative delivery systems that allow for controlled dosage and precision applications.

The future of medical cannabis in South Africa holds immense promise, provided the regulatory environment evolves to support local sales and patient access. Companies like Bassani Medical are leading the charge in this space, ensuring that South African-grown cannabis meets the highest standards and reaches the global market. As the industry continues to grow, patients and healthcare providers alike will benefit from a deeper understanding of cannabis’s therapeutic potential.

www.bassanimedical.com

References

https://www.cliffedekkerhofmeyr.com/en/news/publications/2022/Sector/Healthcare/healthcare-and-pharmaceutical-alert-15-june-2022-medicinal-cannabis-in-south-africa-licensing-quality-control-and-access-to-market.html