07 October 2019 - NW972
Chirwa, Ms NN to ask the Minister of Health
Which criteria did the SA Health Products Regulatory Authority use to approve five of the 80 medicinal cannabis licence applications and/or reject the other 75, despite the fact that there has not been amendments and/or legislation passed to accommodate the anticipated legislation to allow for the manufacturing of medicinal cannabis and hemp?
The Constitutional Court found Section 22A(9)(a)(i) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) (“the Medicines Act”) to be unconstitutional, as it renders the use or possession of cannabis by an adult in private for that adult’s personal consumption in private a criminal offence. In terms of this ruling, it is no longer an offence for an adult person to use or be in possession of cannabis in private for his or her personal consumption in private, and to grow cannabis in a private place for his or her personal consumption in private. Furthermore, the Constitutional Court has required that the relevant provisions of the Medicines Act, as well as that of other applicable legislation, be amended accordingly.
The Medicines Act allows the South African Health Products Regulatory Authority (SAHPRA) to regulate cultivation of cannabis for research purposes and the cultivation, production and manufacture of cannabis containing products for medicinal use. Thus enables effective control, and facilitates patient access to safe, effective and quality products. Cannabis grown for medicinal purposes, as well as any resulting products prepared form the plant material, are subject to stringent security and quality control measures. In this regard, SAHPRA has published guidelines on the cultivation of cannabis and manufacture of cannabis-containing medicines intended for therapeutic and research purposes.
The five applicants whose applications were compliant and were recommended by the SAHPRA Licensing Unit to be issued with licences, were as a result of site inspections and subsequent corrections of inspection findings found to be deficient.
To date no applications have been rejected. There is ongoing review of these applications by SAHPRA and correspondences have been sent to applicants to address deficiencies identified in the original licence applications. A few applicants communicated withdrawal of their licence applications, however, they did not indicate whether the withdrawal was temporary or permanent.