Cannabinoid Drugs and Medicinal Cannabis
Fasken / South Africa
Structured legal guide to cannabinoid drugs, medicinal cannabis and opioid drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
CANNABINOID DRUGS
1. Are Cannabinoid Drugs authorized in your country?
Cannabis use is illegal in most countries and until recently this included South Africa.
In terms of the Drugs and Drug Trafficking Act (“the Drugs Act”) it is illegal to deal in, possess or sell Cannabinoid drugs in South Africa. This stance has however been changed recently by the Constitutional Court of South Africa’s Judgement that now make it legal to make use of or possess Cannabis in private by an adult person for his or her own consumption in private.
Furthermore, certain regulations which specifically govern medicines containing cannabis, cannabis extracts, and cannabis-derived substances such as cannabinoids, which must registered with SAHPRA, has been found to be inconsistent with the right to privacy entrenched in Section 14 of the Constitution.
These substances were rescheduled and listed in Schedule 6 to bring them in line with the scheduling status of other restricted medicines, thus allowing patients to access medicinal cannabis products by prescription at a pharmacy. Any cannabis products not registered by SAHPRA remain in Schedule 7 and were technically still illegal.
However, in August 2017 and prior to the Constitutional Court Judgement of 18 September 2018, SAHPRA released a Communication to Industry document in which they indicated that Cannabidiol specifically was down-scheduled from Schedule 6 to Schedule 4.
The above will however be affected by the Constitutional Court Judgement handed down on 18 September 2018.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating all medicines and medical devices in South Africa by ensuring that they meet standards of efficacy, safety and quality. SAHPRA operates in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) (“the Medicines Act”), the Regulations issued in terms of that Act, and associated Guidelines. The Department of Health is the Government structure responsible for the implementation and management of the Medicines Act.
The Drug Trafficking Act also applies in addition to, and not in substitution for, the provision of the Medicines Act or any regulation made thereunder (Section 2) and is administered by the Department of Justice and Constitutional Development.
The Judgement in the Prince matter has created somewhat of a disruption to the longstanding viewpoint on the matter from a legal and regulatory perspective. The Judgement state that the South African Parliament have the onus to ensure the correction and update of the Constitutional defects in the statutory provisions which it identified.
Parliament has 24 months from the date of Judgement handed down, to cure the constitutional defects, failing which, the reading-in as done in the Judgement, will become final.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
Until the Prince matter had been adjudicated, Cannabinoid Drugs remained illegal in South Africa unless obtained through legal prescription of an authorised medical practitioner. At this time however, there are specific sections in the different Acts and regulations, which will be changed to become operational in line with the Judgement made in this regard.
The regulatory framework should potentially stay with the South African Health Products Regulatory Authority where it concerns Medicinal Cannabis and dealing in Cannabis for non-medicinal purposes, remains regulated under the auspices of the Drugs Act.
4. Which are the cannabinoid drugs that have received market approval to date?
To date, SAHPRA has registered one medicine containing cannabinoids appearing in the plant and has listed the medicine as a schedule 6 product making it illegal to possess the medicine provided that it has been obtained with a prescription from a medical practitioner. In addition, SAHPRA has also issued authorizations for the use of an unregistered medicine containing cannabinoids.
At the time of the Judgement SAHPRA was continuing to work towards implementing a detailed regulatory framework to enable applications for licences and permits for the cultivation, production and manufacture of medical cannabis products. The Prince-judgement however places doubt on the process in its entirety since an adult person is now allowed to cultivate, possess and use Cannabis in private for his or her personal consumption in private or in any other case.
5. Who can prescribe Cannabinoid Drugs?
In terms of Sections 21 and 22A (9) (a) (i) of the medicines Act, authorised practitioners can apply to the SAHPRA for permission to access and prescribe unregistered medicines when intended to treat individual patients7. Section 22A(9)(a)(i) read together with Part III of Schedule 2 of the Drugs Act have been found unconstitutional and as such, will in future not apply to the prescription of Cannabinoid drugs. The changes to the relevant legislation must be implemented by the South African Parliament within 24 months of the date of the Judgement, failing which, the parts read-in with regards to the specific Sections, Schedules and Parts of the Medicines and Drugs Act respectively by the Judges of the Constitutional Court, will become final and automatically part of the legislation.
It is uncertain however, how the latest Judgement regarding Cannabis cultivation, possession and use will affect the regulation of Cannabis for medicinal use.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
Currently the list of medical practitioners who are authorized to prescribe Cannabinoid Drugs is not available to the public.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
Prior to the Judgement, approval from SAHPRA in terms of Sections 21 and 22A (9) (a) (i) of the medicines Act were required for permission to access and prescribe the cannabinoid drugs without it being registered. There may be significant changes to how this process is managed in light of the changes which must be made in line with the Constitutional Court Judgement.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
The cultivation, possession and use of Cannabinoid drugs were illegal in South Africa prior to the Constitutional Court Judgement in the Prince-matter. With this judgement, a person who cultivates, possesses or use Cannabis will not be committing a crime if it is done in private for personal consumption. The cultivation, possession and use of Cannabis have been decriminalised for this pupose.
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?
No.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
Yes, there have been proposals to the SAHPRA, Minister of Health, Department of Health and Parliament – Regulations under the Medicines Act were published on 28 July 2017 in which Cannabidiol is listed as a Schedule 6 medication – this enables a person specifically authorised in terms of Section 22A(5)(f) of the Medicines Act to prescribe or supply, within their scope of practice and subject to indication for use of the substance and in conditions specified by the SAHPRA, Cannabidiol to patients under their care. SAHPRA published a Guideline on the Cultivation of Cannabis and Manufacture of Cannabis-Related Pharmaceutical Products for Medicinal and Research Purposes.
This Guideline indicate that to date, patient access to unregistered Cannabis or cannabinoid-containing medicines has been enabled by SAHPRA through importation of these products under strict control and regulation measures. A framework was developed in consultation with the Department of Agriculture, Forestry and Fisheries (DAFF), the Department of Health and SAHPRA. This framework has the goal to ensure the availability of standardised quality-assured locally grown Cannabis for the manufacture of suitable pharmaceutical products. The intention is to control the cultivation, production and manufacturing of Cannabis-containing products intended for medicinal use in South Africa.
Last mentioned however, will probably be reviewed and updated in light of the Constitutional Court Judgement and the legislative changes that will be following within the next 24 months.
11. When are they likely to come into force?
The above mentioned Regulation came into force on the date of publication in the Government Gazette which is 28 July 2017. They are however subject to change in light of the Constitutional Court Judgement.
MEDICINAL CANNABIS
1. Is Medicinal Cannabis authorized in the country?
The Medicines Act, through the provisions of Section 22A (9) (a) (i), allows for the acquisition, use, possession, manufacture or supply of Cannabis for medicinal use by a medical practitioner, analyst, researcher or veterinarian for the treatment or prevention of a medical condition in a particular patient, or for the purposes of education, analysis or research, provided that a permit is obtained from the Director-General of Health.
Section 22A(9)(i) has however been found to be unconstitutional and as such, will be changed to include wording that indicate in the case of cannabis, should the person be an adult male or female and the Cannabis is used or in their possession in private for personal consumption in private or in any other case. It would not be deemed a criminal act and will carry no punishment. This is in stark contrast to how Cannabis cultivation, possession and use were regulated prior to the Prince-matter. SAHPRA would need to make changes to the guidelines in this regard once changes to this Section in the Medicines Act have been changed in accordance with the requirements and findings as set out in the Constitutional Court Judgement.
2. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The South African Health Products Regulatory Authority (SAHPRA) in conjunction with the Department of Health.
3. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
The current legislative framework to allow for domestic cultivation of medicinal cannabis is currently under development (and has been since 2016) by the Department of Health in consultation with the South African Health Products Regulatory Authority. It will undergo further changes to include the requirements as set out in the recent Constitutional Court Judgement which found that Cannabis cultivation, possession and use in private for personal consumption in private, is not illegal.
In terms of Sections 21 and 22A (9) (a) (i) of the medicines Act, authorised practitioners can apply to the SAHPRA for permission to access and prescribe unregistered medicines when intended to treat individual patients. Section 22A(9)(i) have been found unconstitutional and changes made to how it reads in order to exclude Cannabis cultivation, possession and use from being a criminal activity. How SAHPRA regulates Medicinal Cannabis will depend on the changes to be made to the Medicines Act in this regard.
Cannabis-containing products intended for medicinal purposes may thus be made available, in exceptional circumstances, to specific patients under medical supervision. In addition, the Medicines Act allows SAHPRA to issue a licence to manufacture either a medicine or a Scheduled substance (Active Pharmaceutical Ingredient/API). Section 22(C) (1) (b) of the Medicines Act enables the cultivation and manufacture of the Scheduled substances and ensures the required oversight of SAHPRA in regulating these activities. This provision allows SAHPRA to license cultivators of Cannabis for medicinal use and enables regulatory oversight in a way that is compliant with South Africa’s international obligations.
The legislative framework addresses three regulatory aspects:
- Authorisation of Cannabis cultivation and production domestically, for
medicinal and research purposes. - Satisfying the requirements of South Africa’s international obligations,
under the Single Convention. - Aligning the access of Cannabis-containing products for medicinal purposes
with that of other controlled medicines.
4. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Until now, patient access to unregistered Cannabis or cannabinoid-containing medicines has been enabled by SAHPRA through importation of these products.
In order to ensure the availability of standardised quality-assured locally grown Cannabis for the manufacture of suitable pharmaceutical products, the Department of Health and SAHPRA may permit the cultivation of Cannabis solely for medicinal and research purposes. This process may however undergo changes due to the inevitable changes which will be made to the relevant legislation in this regard.
Access to medicines and Scheduled substances in South Africa are controlled through Scheduling of the substance. Cannabis is a prohibited narcotic substance listed under Schedule 7 of the Schedules to the Medicines Act and cultivation for any purpose other than that explicitly allowed for through the licence and permit system under the medicines Act, is a criminal offence.
Likewise cultivation by non-licensees remains a criminal offense under this and other legislation. SAHPRA currently hasn’t provided any indication as to how they plan to address the required changes proposed in the Constitutional Court Judgement or what timelines would be involved in the process of implementing the new legal requirements into their current Guidelines and Rules.
With the required changes needing to be updated and corrected in National Legislation, this process may take some time before SAHPRA would even be in a position to address the matter from their side and update their documentation accordingly.
5. What approval or notifications are necessary to produce or import Medicinal Cannabis?
In terms of Section 22C (1) (b) of the Medicines Act an applicant may apply to SAHPRA for a licence for any or all of the following activities:
- Cultivate/grow and produce Cannabis and Cannabis resin;
- Extract and test Cannabis, Cannabis resin and/or cannabinoids;
- Manufacture a cannabis-containing or cannabinoid-containing medicine;
- Import a Cannabis-containing medicine;
- Export a Cannabis-containing medicines;
- Distribute a Cannabis-containing medicine.
In addition to the licence application to SAHPRA, applicants are also required to apply to the Director-General of Health for a permit in terms of the provisions of Section 22A(9)(i) of the Medicines Act to acquire, possess, manufacture use or supply Cannabis for medicinal use13. This application process might undergo changes subject to the Constitutional Court Judgement proposed changes to the legislation.
According to the SAHPRA communication dated March 2017, Cannabis is confirmed as a Schedule 7 substance in the Schedules to the Medicines Act, making it illegal to have the plant in your possession. One medicine has been registered to date which contain cannabinoids appearing in the plant and has listed the medicine as a Schedule 6 product, making it illegal to possess the medicine provided that it has been obtained with a prescription from a medical practitioner. In addition to this one registration, authorizations were also issued for the use of an unregistered medicine containing cannabinoids.
Section 22A(9)(a)(i) has been changed to now read in such a manner that, despite cannabis being a Schedule 7 substance, if an adult male or female uses it or is in possession thereof in private for their personal consumption in private or, in any other case, it would not be a criminal offence. There are currently no details available on how SAHPRA intends to manage this change to the Medicines Act which governs how SAHPRA regulates Medicinal Cannabis.
6. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Access to medicines and Scheduled substances in South Africa is controlled through scheduling of the substance. Cannabis used to be a prohibited narcotic substance listed under Schedule 7 of the Schedules to the Medicines Act and cultivation for any purpose other than that explicitly allowed for through the licence and permit system under the Medicines Act, was a criminal offence. In the recent Constitutional Court Judgement, the Court found that the scheduling of Cannabis is inconsistent with the fundamental rights afforded every citizen in so far it relates to Privacy and this part of the legislation will be changed accordingly. Even though Cannabis is a Schedule 7 drug, the manner in which it’s cultivation, possession and use is regulated in Section 22A(9)(a)(i) and the Government Gazette no R509 of 2003 published in terms of this Section, was found to be inconsistent with the constitutional right to privacy.
7. How can patients obtain Medicinal Cannabis?
The only means by which a patient will be able to obtain Medicinal Cannabis in South Africa is through a medical practitioner who holds the relevant licence to prescribe it, which licence is obtained from SAHPRA. A Pharmacist registered accordingly with the relevant Pharmacy Council will be able to provide medicinal cannabis when provided with a legitimate prescription from a medical practitioner as discussed previously. Medicinal Cannabis products may thus be made available to specific patients under medical supervision and through legal channels as confirmed by SAHPRA in the guideline document in this regard.
According to the Constitutional Court Judgement the dealing in cannabis remain illegal and as such, it must be acquired through legal means if not cultivated by the person using it in private for their personal consumption.
8. Who can prescribe Medicinal Cannabis?
Under the Medicines Act, medical practitioners can apply to SAHPRA for permission to access and prescribe unregistered medicines – including cannabis – for their patients in certain exceptional circumstances.
Only registered medical practitioners may apply for authorisation to prescribe a controlled medicine for a specific patient. Authorisation from SAHPRA is dependent on the submission of an appropriate dosage regimen and acceptable justification for the proposed and intended use.
9. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
No list of medical practitioners with authorisation to prescribe Medicinal Cannabis was available at the time of this document being drafted.
10. What approvals or notifications are required to prescribe Medicinal Cannabis?
Approval from SAHPRA after application to become an authorised prescriber of Medicinal Cannabis – this can only be obtained by a medical practitioner registered with the Health Professions Council of South Africa.
11. Where is Medicinal Cannabis available?
At this stage Medicinal Cannabis is only available once prescribed by an authorised medical practitioner with the relevant authority from SAHPRA(through a Section 21 Application which SAHPRA must approve). The dispending is only allowed to be done by an authorised pharmacist in terms of the Medicines Act.
12. Is there a list of retailers authorized to sell Medicinal Cannabis?
This information is not available at this time.
13. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
Yes, there have been proposals to SAHPRA, the Minister of Health, Department of Health and Parliament – Regulations under the Medicines Act were published on 28 July 2017 in which Cannabidiol is listed as a Schedule 6 medication – this enables a person specifically authorised in terms of Section 22A(5) (f) of the Medicines Act to prescribe or supply, within their scope of practice and subject to indication for use of the substance and in conditions specified by the SAHPRA, Cannabidiol to patients under their care.
Related to the above, is the Constitutional challenge which was brought regarding the recreational use of cannabis. The Judgement has been discussed at length in this document and it is uncertain at this stage how the legislation changes will impact the regulation of medicinal cannabis if recreational cultivation, possession and use by adult males and females in private for their personal consumption is no longer considered a crime.
14. When are they likely to come into force?
The Regulations which were proposed to SAHPRA and the Minister of Health and Parliament relating to medicinal cannabis came into force on the date of publication in the Government Gazette which is 28 July 2017. Dealing in cannabis remains illegal, but the personal cultivation, possession and use of cannabis for personal consumption in private, has been legalised.
