Constitution of the Republic of South Africa, 1996
In terms of the constitutional provisions, the Authority is, amongst others, guided by the following sections and schedules: The Constitution of the Republic of South Africa, 1996, places obligations 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 with regard to healthcare, food, water and social security:
- Everyone has the right to have access to healthcare services, including reproductive healthcare; sufficient food and water; and social security, including appropriate social assistance if they are unable to support themselves and their dependents.
- The state must take reasonable legislative and other measures within its available resources to achieve the progressive realisation of each of these rights, and no one may be refused emergency medical treatment.
Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as amended
The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), which was amended by Amendment Act, 2008 (Act No. 72 of 2008) and Amendment Act, 2015 (Act No. 14 of 2015) and enacted in May 2017, enabled, amongst 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, 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 related matters in the public interest. It 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 may 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 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;
- Ensure 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;
- Ensure the periodic re-evaluation or re-assessment and ongoing monitoring of medicines, medical devices, radiation emitting devices and radioactive nuclides;
General Regulations
The General Regulations of the above Act include the arrangement of regulations for supply of medicines, registration of medicines, permits, licencing and authorisation, management of medicines, the Authority, appeals, investigations, offences, and penalties.
Hazardous Substances Act (Act No. 15 of 1973)
Within the Medicines Act, “medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and IV Hazardous Substances contemplated in the Hazardous Substances Act, 1973 (Act No. 15 of 1973) (hereinafter referred to as “the Hazardous Substances Act”).
The Hazardous Substances Act provides for the efficient, effective and ethical evaluation and registration of non-ionizing radiation emitting devices and radioactive nuclides. It also prohibits and controls the importation, manufacture, sale, use, operation, application, modification, disposal or dumping of substances and (electronic) products that may cause injury or death due to their detrimental direct or indirect effects. The Hazardous Substances Act classifies such substances and products in groups according to the risk associated with them.
A Group I, Group II, Group Ill or Group IV hazardous substance means a substance, mixture of substances, product or material declared in terms of section 2 (1) of the Hazardous Substances Act to be a Group I, Group II, Group III or Group IV hazardous substance, including:
- Any substance or mixture of substances which, in the course of customary or reasonable handling or use, including ingestion, might, by reason of its toxic, corrosive, irritant, strongly sensitising or flammable nature or because it generates pressure through decomposition, heat or other means, cause injury, ill-health or death to human beings, declared to be a Group I or a Group II hazardous substance;
- Any electronic product, declared to be a Group III hazardous substance; and
- Subject to the approval of the Minister of Mines, any radio-active material, declared to be a Group IV hazardous substance.
National Health Act, 2003 (Act No. 61 of 2003)
The 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 on national, provincial and local government with regard to health services. The objectives of the National Health Act (NHA) are to:
- Unite the various elements of the national health system in a common goal to actively promote and improve the national health system in South Africa;
- Provide for 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 healthcare 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.
Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947)
The Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies 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 (OTC) antimicrobials by the lay public (chiefly farmers).
Animal Diseases Act, 1984 (Act No. 35 of 1984)
The Animal Diseases Act 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)
The Veterinary and Para-Veterinary Professions Act 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)
The Drugs and Drug Trafficking Act 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 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.
Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) as amended
The Foodstuffs, Cosmetics, and Disinfectants Act provide 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)
The Environmental Management Act: Waste Management Act provides for co-operative, environmental governance by establishing principles for decision-making on matters affecting the environment, institutions that will promote co-operative governance, and procedures for coordinating environmental functions exercised by organs of state and related matters.
Health Professions Act, 1974 (Act No. 56 of 1974)
The Health Professions Act 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)
The Nursing Act 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 (Act No. 53 of 1974) regulates the practice of pharmacy within South Africa. 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 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 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 with a view to monitoring pharmacies for compliance. The provisions of the Pharmacy Act include investigation of complaints received alleging misconduct or unprofessional conduct.
Customs And Excise Act, 1964 (Act No. 91 of 1964)
The Customs and Excise Act 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.
Basic Conditions of Employment Act, 75 of 1997
The Basic Conditions of Employment Act, 75 of 1997 provides for the right to fair labour practices referred to in section 23(1) of the Constitution by establishing and making provisions for the regulation of basic conditions of employment; and thereby comply with the obligations of the Republic as a member state of the International Labour Organisation.
Promotion Of Access To Information Act 2 of 2000
The purpose of the PAIA Act is to actively promote a society in which the people of South Africa have effective access to information to enable them to more fully exercise and protect all of their rights.
Promotion of Administrative Justice Act 3 of 2000
The Promotion of Administrative Justice Act 3 of 2000 intends:
- To give effect to the right to administrative action that is lawful, reasonable and procedurally fair and to the right to written reasons for administrative action as contemplated in section 33 of the Constitution of the Republic of South Africa, 1996; and
- to provide for matters incidental thereto.
Broad-Based Black Economic Empowerment Act 2003
The Broad-Based Black Economic Empowerment Act provides a legislative framework for the promotion of black economic empowerment; to empower the Minister to issue codes of good practice and to publish transformation charters; to establish the Black Economic Empowerment Advisory Council; and to provide for matters connected therewith.
Mandated obligations and functions of SAHPRA
The South African Health Products Authority (SAHPRA) is the regulatory authority of South Africa responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nuclides; and the conduct of clinical trials.
The legislative mandates of SAHPRA are derived from the Constitution; the National Health Act, 2003 (Act No. 61 of 2003); the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended (hereinafter referred to as “the Medicines Act”); and other relevant legislation, regulations and policies.
Further, SAHPRA’s mandate has expanded to include the regulation and control of radiation emitting devices and radioactive nuclides under the Medicines Act and the Hazardous Substances Act, 1973 (Act No. 15 of 1973).