Acts and Regulations

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).

The 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.

The 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.

The 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;

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.