Medical Innovation Bill and cannabis
Dr Narend Singh who took over the tabling of the Private Members’ Medical Innovation Bill from the late Dr Mario Ambrosini, said that he was so impressed by the progress of the Department of Health (DHA) in their support of the use of cannabis for medical purposes that he could see the possibility arising where he could withdraw his Members’ Bill in favour of broader legislation tabled by the Minister of Health.
He said “there was light at the end of the tunnel” and he himself was on a “high” to learn from Dr Joey Gouws, in charge of regulatory and legislative enforcement at DHA, that regulations on the growing of cannabis, manufacture, dispensing and medical use for medicinal purposes could be in place by the end of 2017 including registration processes and classification systems.
Dr Gouws was briefing the Parliamentary Portfolio on Health on progress towards the commencement of such a programme and which not only covered the medical use of cannabis as proposed in the Medical Innovation Bill but covered research, registration, manufacture and the scheduling of substances. Separate legislation would be in parallel amending such Acts as the Drugs and Drugs Trafficking Act.
Regulations were a draft form stage in authorising permits for use by practitioners, analysts, researchers or veterinarians. In fact, said the DHA team presenting the update to parliamentarians, it might be possible to see certain herbal products with limited THC levels available within three months.
Dr Gouws said that in the United Kingdom similar legislation, to be enacted, provided for innovation in medical treatment and allowed medical doctors to depart from medical treatments for a condition but the UK Bill did not specially address the use of cannabis. In South Africa, it will be allowed for under specific prescribed conditions for the treatment of certain medical conditions and for education, research and analysis. Similar legislation in Australia and Canada had been studied.
Patients that are proposed for eligibility are those with severe pain, nausea, vomiting or wasting arising from cancer and HIV/AIDS, including treatment. Muscle spasms and severe pain associated with multiple sclerosis and seizures from epilepsy where other treatment options have failed or have intolerable side effects. Severe chronic pain is included as part of the proposals for indications.
Crop trials completed
The Department of Agriculture, the DHA team said, has justMedicines Control South Africa forwarded the outcome of cultivation trials at four agricultural research facilities jointly overseen by both departments. This would now be disseminated and assessed, which results would form part of the ongoing research by the Medical Research Council and other academic research centres involved in the future clinical use of cannabis.
Currently, cannabis is listed as a Schedule 7 prohibited substance but regulations will shift this towards Schedules 3-6 which are prescription-only medicines with authorised prescribers. Scheduling decisions involve levels of toxicity and safety; the proposed indication for a substance; the need for medical diagnosis before prescribing; the potential for dependence, abuse and misuse and access disciplines.
Certain cannabis products are prescribed at present but unregulated illegal herbal cannabis, Dr Gouws said, which is grown incorrectly and bought from the black market will have unknown concentrations of THC’s and cannabinoid concentrations combined with potentially harmful ingredients. Cannabinoid drugs currently used are Dronabinal for loss of appetite during severe illnesses, Nabilone for nausea under similar conditions and Sativex for spasticity.
Conditions of use
If legalised, it will be proposed that objective evidence to support the proposed use of cannabinoids in whatever regulated form must be provided; the manner and duration of treatment provided; a patient must be monitored to ensure efficacy; the treatment outcome reported upon; the physician involved must be a specialist and informed consent by the patient or legal representative obtained.
In questioning the DHA, parliamentarians were particularly concerned that appropriate measures amending the Drugs and Drugs Trafficking Act, the criminal Procedure Act and the Medicines and Related Substances Act were undertaken. One MP remarked that there must be no question of unintended consequences with law enforcement processes in order that criminal procedures under certain circumstances involving cultivation, marketing, administering and research can be clearly separated and easily understood by the South African Police Service.
Dr Joey Gouws said that this matter had already been investigated and the issues involved were with the State Law Advisor at this very moment. It appeared that they were satisfied. The framework for medical use and research had also been submitted, which also included the licensing of growers using controlled cultivation methods for medical, scientific and research purposes. There were various cultivars of cannabis which had different medicinal properties, she said.
The framework being worked to by DHA also includes reaching a standardised, quality assured product for medical use indications, bearing in mind that clinical decision-making in terms of Section 22A(9)(ii) and Section 21 of the Medicines Act must be made to the scheduling of products, Dr Gouws said.
For a while, Dr Joey Gouws said, cannabis as a medicinal drug for pain may remain as a Section 21 drug as things exist until all regulations were in place and registration and classification complete, so that the use could have a controlled start. Herbal classifications may be allowed far earlier.