Medicinal cannabis guidelines being put together

Author: Tamar Kahn

Source: Business Day

PARLIAMENT has heard that the Medicines Control Council (MCC) is simplifying the legal framework for medicinal cannabis to make it easier for patients to use these products. It has already re-classified medicinal cannabis from a tightly-restricted schedule 7 product to a permitted schedule 6 or schedule 4 product, depending on its composition, and next week is expected to approve the final guidelines governing the cultivation of cannabis for medical purposes.

Little will immediately change for patients, but these developments mean that doctors will be able to prescribe cannabis-containing medicines once they have been registered by the MCC. And the door is about to open for individuals or companies that wish to cultivate the plant to make a medicinal product. The regulatory push to ease access to medicinal cannabis is taking place independently of the legal challenge launched by two Johannesburg residents who have asked the High Court in Pretoria to find the ban on adult dagga use unconstitutional and to instruct Parliament to make new laws reflecting this.

The two key compounds of interest in cannabis are THC (delta-9-tetrahydrocannabinol) and cannabidiol: products containing THC, which has psychoactive properties, are now schedule 6, while those that contain only cannabidiol are schedule 4. No such products have been registered by the MCC, nor have any companies applied for approval, the MCC’s deputy director for law enforcement Griffith Molewa told parliament’s portfolio committee on health. This means doctors still need to apply to the MCC on a patient-by-patient basis for permission to prescribe unregistered medicinal cannabis products, which can be imported under what is known as a section 21 exemption to the Medicines Act. Scientists can also apply for section 21 exemptions for medical research.

The MCC recently approved two section 21 applications from universities doing medical cannabis research on mice, and one for a patient using dried cannabis flowers. It was currently considering 31 section 21 applications for Tilray medical cannabis extracts. Molewa said the MCC had received almost 400 comments in response to the draft guidelines for cultivating cannabis it published in March. Industry concerns centred on the distribution of medical cannabis products, which he said would be governed by the same regulatory framework as other medicines.