Section 21 Medical Schemes May Only be a Stop-Gap Measure” Until Broader Cannabis Dispensary Framework is in Place
The Section 21 Medical Cannabis Schemes are likely to be replaced by a broader dispensary framework when new regulations come into place. That’s the view of leading law firm Cliff Dekker Hofmeyer, which says until such time new laws are put in place, the domestic medical cannabis market will be challenging.
16 August 2022 at 06:30:00
Reacting to the new Country Investment Strategy, which the Presidency released on 27 May 2022 for public comment, Cliffe Dekker Hofmeyr said that South Africa was optimally placed to take advantage of the expected growth in the worldwide medical cannabis industry.
The legal note was written by CDH's Shaad Vayej and Susan Meyer, who pointed out that although
commercial medical cannabis is already legally possible within the current regulatory framework, it is not without its "pitfalls, costs and shortcomings". Hence the need for a more supportive and streamlined legal framework. Until such time, “navigating the complex regulatory and commercial environment applicable to medical cannabis in South Africa would be challenging”.
In light of this the Section 21 procedures “may be considered a stop-gap measure until registered cannabis medicines become more prevalent locally and are available for prescription by pharmacies across the country”
“Accordingly, more work is required to establish and bolster domestic demand and consumption of medical cannabis, which provides for domestic revenue, scaled operations and a necessary hedge against demand shocks experienced by local, export-oriented medical cannabis businesses. This would include the finalisation and domestic registration of medical cannabis products”.
Domestically, the Medicines Act enables patients to access unregistered, medical cannabis products for therapeutic purposes through the provisions of section 21 of the Medicines Act. In order for patients to access these unregistered medicines, a registered medical practitioner or authorised prescriber needs to apply to the SAHPRA on the patient’s behalf, to allow for the purchase and use of unregistered medicine as a treatment regime. This process has been significantly streamlined and can be completed through online submissions by the registered medical practitioner.
Once the section 21 application is complete, patients can access medical cannabis products through a variety of online and, more recently, physical pharmacies that are authorised to acquire and distribute medical cannabis products.
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