7.2 Legislative Mandate
SAHPRA’s objective is to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, in vitro diagnostics and further matters related to the public interest.
Since its establishment in February 2018, as a schedule 3A entity of the National Department of Health (NDoH), there has been no updates to its legislative and policy mandates. The cornerstone legislative mandates of SAHPRA are derived from the national Constitution (1996), the National Health Act, 2003 (Act No. 61 of 2003) and the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended (herein after referred to as “the Medicines Act”).
Pursuant to the expansion of SAHPRA’s mandate which, inter alia, includes the regulation and control of radiation emitting devices and radioactive materials, it is important to consider that the following pieces of legislation define the legislative framework within which SAHPRA executes its mandate:
7.2.1 The National Health Act, 2003 (Act No. 61 of 2003)
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 government with regard to health services. The objectives of the National Health Act (2003), as understood alongside other laws and policies that relate to health, are to:
- Unite the various elements of the national health system into a common goal so as to actively promote and improve the national health system in South Africa.
- Provide a system of co-operative governance and management of health services within national guidelines, norms and standards, in which each province, municipality and health district must address questions of health policy and delivery of quality health care services.
- Establish a health system based on decentralised management, principles of equity, efficiency, sound governance, internationally recognised standards of research and a spirit of enquiry and advocacy which encourage participation.
- Promote a spirit of co-operation and shared responsibility among public and private health professionals and providers and other relevant sectors within the context of national, provincial and district health plans.
- Create the foundations of the health care system.
7.2.2 The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965, as Amended)
Amended by the Amendment Act, 2008 (Act No. 72 of 2008) and Amendment Act, 2015 (Act No. 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.
In terms of the Medicines Act (1965, as amended), the objectives of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, medical devices, radiation control, clinical trials and further matters related to the public interest.
The Medicines Act (1965, as amended) also provides for 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 use in animals and registered under the Medicines Act (1965, as amended) can only be administered or prescribed by a veterinarian.
As per section 2b (1) of the Medicines Act (1965, as amended), the Authority must, in order to achieve its objectives, ensure:
- The efficient, effective and ethical evaluation or assessment and regulation of medicines, medical devices, radiation-emitting devices and radioactive nuclides that meet the defined standards of quality, safety, efficacy and performance, where applicable.
- That the process of evaluating or assessing and registering of medicines, medical devices, radiation emitting devices and radioactive nuclides is transparent, fair, objective and concluded timeously.
- The periodic re-evaluation or re-assessment and ongoing monitoring of medicines, medical devices, radiation-emitting devices and radionuclides.
- The investigation, monitoring and analysis of evidence of existing and new adverse events as well as reactions, interactions and signals emerging from post-marketing surveillance and vigilance activities, while ensuring that these are acted upon.
- That compliance with existing legislation is promoted and achieved through a process of active inspection and investigation.
- That clinical trial or clinical performance study protocols are assessed according to prescribed scientific, ethical, and professional criteria and defined standards.
In executing its functions, the Authority may:
- 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:
– Matters of common interest.
– A specific investigation.
– Entering into agreements to co-operate with any regulatory authority in order to achieve the objects of the Medicines Act (1965, as amended).
7.2.3 Hazardous Substances Act, 1973 (Act No. 15 of 1973)
The Hazardous Substances Act (1973) 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 ionising or non-ionising radiation).
SAHPRA is only responsible for the regulation of Group III and Group IV hazardous substances.
Section 3 of the Act refers to regulation of Group III hazardous substances, that is, listed electronic products, and section 3A refers to Group IV hazardous substances, that is, radionuclides.
7.2.4 Other Related Legislations
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:
- Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947)
This Act provides for the registration of fertilisers, farm feeds, agricultural remedies, stock remedies, sterilising plants, and pest control operators with the aim of regulating or prohibiting 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).
- Animal Diseases Act, 1984 (Act No. 35 of 1984)
Provides for the control of animal diseases and parasites, for measures to promote animal health and for related matters.
- Veterinary and Para-Veterinary Professions Act, 1982 (Act No. 19 of 1982)
Provides for the establishment, powers and functions of the South African Veterinary Council, the registration of persons practising veterinary professions and para-veterinary professions, control over the practising of veterinary professions and para-veterinary profession 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.
- Drugs and Drug Trafficking Act, 1992 (Act No. 140 of 1992)
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); 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 unconstitutional on the premises 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 (1965) 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 and Drug Trafficking Act (1992) amendments is in the process of addressing the Constitutional Court judgement.
- Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972, as Amended)
Provides for the regulation of foodstuffs, cosmetics and disinfectants and, in particular, quality standards that must be complied with by manufacturers as well as the importation and exportation of these items.
- Environmental Management Act: Waste Management Act, 1998 (Act No. 107 of 1998)
Provides for co-operative, 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.
- Health Professions Act, 1974 (Act No. 56 of 1974)
Provides for the control over the education, training and registration for practising of health professions registered under the Act and matters incidental thereto.
- Nursing Act, 1978 (Act No. 50 of 1978)
Provides for consolidation and amending of the laws relating to the professions of registered or enrolled nurses, nursing auxiliaries and midwives and related matters.
- Pharmacy Act, 1974 (Act No. 53 of 1974)
The South African Pharmacy Council (SAPC) in terms of section 35A of the Pharmacy Act (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 (1974) and relevant provisions of the Medicines and Related Substances Act (1965, as amended). The Medicines and Related Substances Act (1965, as amended), in section 16(d), provides for possession of medicines or scheduled substances for sale by the 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 licence as completed in section 22C of the Medicines and Related Substances Act (1965, as amended). The SAPC has, in terms of section 38A of the Pharmacy Act (1974), appointed inspection officers with a view to monitoring pharmacies for compliance. The provisions of the Pharmacy Act (1974) include investigation of complaints received alleging misconduct or unprofessional conduct.
- Customs and Excise Act, 1964 (Act No. 91 of 1964)
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 an effective execution of its mandate. There have been notable developments in SAHPRA’s operating environment that 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 a series of other players are involved and where 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 there are goods that come into the country that fall within its legislative obligations, for its inspection, as per the Customs and Excise Act (1964), 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 Resources and Energy. Another responsibility is cannabis regulation, which involves multiple ministries such as the Department of Justice and Correctional Services and the Department of Agriculture and Rural Development, 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.”.