Legal and regulatory information regarding the growing medical cannabis market in South Africa

Regulatory landscape

South Africa is a signatory to several international treaties, including the 1961 UN Single Convention on Narcotic Drugs, which initially placed cannabis under strict controls. However, changes were made that allowed South Africa to reschedule THC-containing cannabis, opening the door to medical uses and cultivation under strict regulations.

The South African Health Products Regulatory Authority (SAHPRA) is responsible for overseeing the regulation of medical cannabis, ensuring cultivation, processing and distribution comply with strict quality control and safety protocols. SAHPRA audits plants in accordance with the South African Guide to Good Manufacturing Practice (GMP), which requires significant capital expenditure before a section 22C license can be granted.

South Africa’s current regulatory framework, as set out in the National Investment Strategy, recognizes cannabis as a legally traded agricultural commodity. The development of a regulatory structure for the production and export of medicinal cannabis is a priority, with licenses only granted once compliant facilities are built and inspected by SAHPRA.

Approved and unapproved cannabis medicines

Medical cannabis is not yet approved in South Africa, which means local distributors sell their products under Section 21 regulations. Unfortunately, growing cannabis for local sale remains illegal despite obtaining a cultivation license. Barriers to entry are significant, and it can take companies 12 to 24 months to generate revenue due to the extensive capital investment required.

Article 21 of the Medicines Act allows the sale of unregistered cannabis products for medicinal purposes in exceptional circumstances. This regulation is crucial to ensuring patients have access to cannabis when conventional therapies have failed. However, the process remains complex and often misunderstood, causing many local sellers to simplify regulations to stay in business. Simplifying access to medical marijuana could lead to legislative changes, giving patients easier access to this beneficial product.

Medical marijuana approval process

The process of registering and approving medical marijuana in South Africa is both labor-intensive and expensive. Businesses must register under the Companies Act, obtain a business license from SAHPRA and appoint a responsible pharmacist to ensure compliance.

A pharmaceutical company seeking registration must prepare an applicant master dossier for the drug, including detailed information about the company 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 sale of unapproved drugs

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

Section 21 authorization is granted on a case-by-case basis, primarily where conventional therapies have been excluded or failed. While affordability alone is not enough to gain Section 21 approval, each application is reviewed for the safety, effectiveness and quality of available cannabis products.

The role of Bassani Medical in the cultivation of medical cannabis

Bassani Medical is one of the world’s leading medical cannabis companies, exporting high-quality products to international markets. Given that local sales remain illegal, Bassani is focused on complying with local and international regulations to ensure the highest product standards. Regular audits by local and international bodies ensure that Bassani’s growing processes and products comply with rigorous guidelines.

Their primary concern for patients in South Africa is gaining access to safe, high-quality cannabis products. Although cannabis has been used medicinally for centuries, regulatory barriers in South Africa make access difficult. Bassani Medical advocates for greater patient choice in self-care, emphasizing that adults should be able to make informed decisions about their health care.

Safety and effectiveness are at the forefront of their activities. Their highly efficient aeroponic growing technique ensures consistent quality of all products, meeting both local and international standards.

What does the future of medical marijuana 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 licenses 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 businesses to fail. explains Stringer. Bassani Medical predicts that South Africa could follow in the footsteps of countries like Germany, which have transformed the illegal cannabis market into a thriving tax-paying industry. With the right regulatory adjustments, South Africa can see significant growth in the medicinal cannabis sector.

For this to happen, there are many misconceptions about the medical use of cannabis that need to be addressed. Contrary to popular belief, medical marijuana does not always produce a “high” – especially in patients using it for pain relief, because brain receptors process compounds differently than in recreational users. Medical marijuana can be administered in a variety of ways beyond smoking, such as through tinctures, topicals, and edibles. For example, juicing cannabis leaves provides therapeutic benefits without causing a psychoactive effect.

There are exciting advancements on the horizon in the medical marijuana industry, particularly in pharmaceutical research. The largest pharmaceutical companies are currently investing heavily in clinical trials, mergers and acquisitions in the cannabis industry. Pfizer has signed an agreement with clinical-stage company Arena Pharmaceuticals for a total equity value of approximately $6.7 billion. Since 2021, the cannabis pharmaceutical industry has seen several significant deals, including two major multi-billion dollar acquisitions. These landmark deals sparked the pharmaceutical industry’s growing interest in cannabis, and there have been more than a dozen similar deals since then. Bassani Medical envisions participation across the entire value chain, from cultivation to API delivery, supported by innovative delivery systems that enable controlled dosing and precision applications.

The future of medical cannabis in South Africa is extremely promising, provided the regulatory environment evolves to support local sales and patient access. Companies like Bassani Medical are leading the way in this space, ensuring that cannabis grown in South Africa meets the highest standards and reaches the global market. As the industry continues to evolve, both patients and healthcare providers will benefit from a deeper understanding of the therapeutic potential of cannabis.

www.bassanimedical.com

Reference

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