Yes We Need Regulations

YES, WE NEED REGULATIONS

Declan Burger
Regulatory Director, Greenhouse Project

Ensuring the regulatory compliance of cannabis enables the global trade to operate with a common expectation of quality from cultivators to manufacturers and distributors from around the world.

Consider a world without the standardised USB, where tech companies annually redevelop and recreate their own proprietary charging and data exchange cables. The consumer is obligated to purchase more cables as each supplier updates their products periodically. Suppliers would need to accommodate the relatively higher cost of smaller batch production relative to their portion of the market and forego the economies of scale that would come with larger production quantities. Ultimately, a clear solution is to require all such manufacturers to construct their products using a standardised design, resulting in what we have today known as the USB.

By creating an internationally observed standard, there is inherent harmonisation in procedure, record keeping, competitive pricing and outcome quality, safety and efficacy. When it comes to the costs and benefits of having an international standard, ultimately, the end-user would bare the higher output cost, however, the consumer would also be able to purchase confidently knowing the international standard is designed to ensure a high-quality, safe and effective product and, on the supply side, a competitive market would be formed amongst suppliers as the output quality would be substantially similar.

Now, consider a world where the quality of product is the competitive edge, while you are protected from harmful production methods, cultivators are able to expand their market globally by complying with the regulations in foreign importing countries. As a result, the consumer is provided with a wider range of products originating from around the world, and cultivators are able to compete fairly with the potential to expand their operations through the increase in revenue from the global trade.

Cannabis is currently controlled by the Drugs and Drugs Trafficking Act as a “undesirable dependent producing substance”, where the only exemption from the restrictions of the act are enabled through the Medicines and Related Substances Act. Globally, cannabis is classified as a medicine based on the risks of its psychoactive characteristic with medicinal claims.

As long as cannabis is a medicine based on its medicinal claims, it will remain a regulated substance.

“Yes, we need regulations, but it doesn’t necessarily need to be pharmaceutical”

Right now in South Africa, cannabis can only be traded as a medicine as this is the only route of exception of the Drugs Act. Only once cannabis is classified under a regulating Act and an exemption from the Drugs Act is implemented will this change, but to be involved with the global industry it will never be a free-for-all, cannabis will always remain subject to regulatory conformity to an international standard to ensure its quality. Regulations are enforced through a careful consideration of the balance between what is commercially practical whilst protecting the consumer.

The international standard for pharmaceutical production is Good Manufacturing Practices (GMP), created, implemented and maintained by PIC/s (Pharmaceutical Inspection Co-operation Scheme). In addition, the WHO has created, implemented and maintained the Good Agricultural and Collection Practices for products cultivated and harvested, such as cannabis. GMP and GACP are connected through Annexure 7 to the GMP which specifically deals with Manufacture of Herbal Medicinal Products.

Countries have adopted these standards through becoming observing or member states, SAHPRA (the South African Health Products Regulatory Authority) is the mandated local regulatory authorities to enforce this standard in South Africa.

Understanding the complexities of a regulated industry, the Greenhouse Project has been formed with legal, regulatory and commercial as our core activities.

Greenhouse Project
info@greenhouseproject.co.za

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