The Constitution of the Republic of South Africa, 1996, places an obligation on the State to progressively realise socio-economic rights, including access to healthcare. Section 27 of Chapter 2 of the Bill of Rights of the Constitution states the following concerning healthcare, food, water and social security:
This Act provides a framework for a structured, uniform health system within the Republic, taking into account the obligations imposed by the Constitution and other laws of national, provincial and local governments with regard to health services. The objectives of the National Health Act, as understood alongside other laws and policies that relate to health, are to:
Amended by the Medicines and Related Substances Amendment Act, 72 of 2008, and Medicines and Related Substances Amendment Act, 14 of 2015, and enacted in May 2017, the Act enabled, among others, the establishment of SAHPRA, the licensing of manufacturers and importers of active pharmaceutical ingredients and the regulation of medical devices.
Under the Medicines Act, the Authority’s objects are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration, and control of medicines, scheduled substances, medical devices, radiation control, clinical trials, and other matters related to the public interest.
The Act also provides for the registration and control of veterinary medicines in such a way as to ensure that they are produced, distributed and used without compromising human and animal health. Antimicrobials intended for animal use and registered under the Medicines Act can only be administered or prescribed by a veterinarian.
As per Section 2b (1) of the Medicines Act, the Authority must, in order to achieve its objects, ensure:
That compliance with existing legislation is promoted and achieved through a process of active inspection and investigation; and
That clinical trial or clinical performance study protocols are assessed according to prescribed scientific, ethical and professional criteria and defined standards.
Liaise with any other regulatory authority or institution and may, without limiting the generality of this power, require the necessary information from, exchange information with and receive information from any such authority or institution in respect of:
The Hazardous Substances Act provides for the efficient, effective and ethical evaluation and licensing of radionuclides (Group IV hazardous substances) and listed electronic products (Group III hazardous substances – including but not limited to electronic generators of ionizing or non-ionizing radiation).
SAHPRA is only responsible for regulating Group III and Group IV hazardous substances.
Section 3 of the Act refers to the regulation of Group III hazardous substances, that is, listed electronic products, and Section 3A refers to Group IV hazardous substances, that is, radionuclides.
Due to the complex environment within which SAHPRA operates, it is necessary to list a series of related legislation impacting on and influencing its functioning:
This Act provides for the registration of fertilisers, farm feeds, agricultural remedies, stock remedies, sterilising plants and pest control operators to regulate or prohibit the importation, sale, acquisition, disposal or use of fertilisers, farm feeds, agricultural remedies, and stock remedies. Furthermore, it governs the use of antimicrobials for growth promotion and prophylaxis/metaphylaxis and the purchase of over-the-counter antimicrobials by the lay public (chiefly farmers).
This Act provides for the control of animal diseases and parasites, measures to promote animal health, and related matters.
This Act provides for the establishment, powers, and functions of the South African Veterinary Council, the registration of persons practising veterinary and para-veterinary professions, control over the practising of veterinary and para-veterinary professions, and related matters. It further makes provision for the compounding and/or dispensing of any medicine prescribed by the veterinarian for use in the treatment of an animal under his or her professional care.
Provides for the prohibition of the use or possession of, or the dealing in, drugs and of certain acts relating to the manufacture or supply of certain substances or the acquisition or conversion of the proceeds of certain crimes, the obligation to report certain information to the police, the exercise of the powers of entry, search, seizure and detention in specified circumstances, the recovery of the proceeds of drug trafficking and related matters.
In relation to cannabis, on 18 September 2018, the Constitutional Court declared sections 4(b) and 5(b)
(use and possession) read with Part III of Schedule 2 of the Drugs and Drug Trafficking Act, 1992 (the Drugs Act); and section 22A(9)(a)(i) of the Medicines and Related Substances Act, 1965, read with Schedule 7 of Government Notice No. R. 509 of 2003 is unconstitutional on the premise that they amount to an impermissible limitation of the right to privacy. The Court suspended the order of invalidity for 24 months, from 18 September 2018 to September 2020.
Following consultation with stakeholders, amendments to the Schedules of the Medicines Act aligned with the Constitutional Court judgement were published in Government Notice No. 586, Government Gazette No. 43347, issued on 22 May 2020. The Department of Justice and Constitutional Development responsible for the Drugs Act amendments is in the process of addressing the Constitutional Court judgement.
This legislation regulates foodstuffs, cosmetics, and disinfectants, particularly quality standards that manufacturers must comply with, as well as the importation and exportation of these items.
It provides for cooperative environmental governance by establishing principles for decision-making on matters affecting the environment, institutions that will promote cooperative governance, and procedures for coordinating environmental functions exercised by organs of state and related matters.
Provides for the control over the education, training and registration for practising of health professions registered under the Act and matters incidental thereto.
Provides for consolidation and amending the laws relating to the professions of registered or enrolled
nurses, nursing auxiliaries and midwives and related matters.
The South African Pharmacy Council (SAPC), in terms of Section 35A of the Pharmacy Act,. 53 of 1974, regulates the practice of pharmacy within South Africa. The SAPC ensures that all responsible pharmacists, pharmacy support personnel and pharmacy owners provide pharmaceutical services that comply with good pharmacy practice standards prescribed in the Pharmacy Act and relevant provisions of the Medicines and Related Substances Act. The Medicines Act, in Section 16(d), provides for the possession of medicines or scheduled substances for sale by pharmacists or a person licenced to own a pharmacy in terms of the Pharmacy Act, 1974 or a person who is the holder of a license as completed in section 22C of the Medicines Act. The SAPC has, in terms of Section 38A of the Pharmacy Act, appointed inspection officers to monitor pharmacies for compliance. The provisions of the Pharmacy Act include investigating complaints received alleging misconduct or unprofessional conduct.
Provides for the prohibition and control of the importation, export or manufacture of certain goods and related matters.
A favourable legislative environment is fundamental to the operations of a regulator such as SAHPRA when it comes to supporting the effective execution of its mandate. Notable developments in SAHPRA’s operating environment have necessitated a review of its legislative and policy framework.
In the first instance, SAHPRA enacts its role within an extremely complex legislative context where other players are involved and SAHPRA has only a limited yet important regulatory role. A case in point is a role
SAHPRA should be fulfilling through its representation at key ports of entry where goods that come into the country fall within its legislative obligations for its inspection, as per the Customs and Excise Act, cited above.
One of the key new responsibilities emanating from SAHPRA’s extended mandate relates to radiation control, which has crucial elements within the ambit of the jurisdiction of the Department of Mineral and Petroleum Resources. Another responsibility is cannabis regulation, which involves multiple ministries, such as the Department of Justice and Constitutional Development, the Department of Correctional Services and the Department of Agriculture, to affect the country’s enhancement of access to this medicinal product. As SAHPRA continues to mature into its role, it is becoming increasingly evident that there is a critical need to harmonise roles and responsibilities to avert the risk of an internal leadership vacuum or duplication of efforts and subsequent potential “conflict”.
The court ruling on the recreational use of cannabis has spurred considerable public interest and debate concerning the concomitant implications for medicinal applications of cannabis. In addition, commercial interest is tied to a significant potential economic gain based on the legalisation and the subsequent industrialisation of cannabis. This is evidenced by small-scale growers who seek to play in that space, a vast majority of whom have been growing the cannabis herb illegally for many years. It is imperative that, as an agile regulator, SAHPRA take proactive action by tackling the regulatory framework relating to this area and strengthening collaborative partnerships with various government departments to cause alignment among the various legislations supporting enhanced and broader access to cannabis-based products. The entity, therefore, anticipates that it will participate in national policy discussions that pertain to legislative and policy framework considerations related to cannabis and its industrialisation.