Stevenson National Health Act Guide 2019 1

THE
National
Health
Act
GUIDE
THIRD EDITION
Edited by
SASHA STEVENSON
Acknowledging editors of previous editions of the

National Health Act Guide
Jonathan Berger Adila Hassim
Mark Heywood Brian Honermann
Mieke Krynauw Umunyana Rugege
2019
First published in 2008
Second edition 2013
Third edition 2019
by
Siber Ink CC
PO Box 30702, Tokai 7966, Cape Town, South Africa
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for
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Foreword
The National Health Act Guide, now in its third edition, is an inval-
uable resource for government, health care workers, health service
users, academics, students and civil society. The Guide contains
not only the Act itself but also detailed analysis and commentary,
including links to and explanations of related legislation, regu-
lations and policy. The Guide also contains an up-to-date list of
contact details for all health departments in the country.
The National Health Act Guide focuses on what all of us can do
to improve health in South Africa: from participation in clinic
committees and hospital boards, to becoming organ donors, to
taking part in the budget- and policy-making process.
Government has a huge responsibility to provide health care
services and to regulate the private sector, but it cannot operate
alone. Civil society and individuals must speak up and govern-
ment must listen, to ensure that we have a health care system
that serves all the people of South Africa.
At a time of great policy shifts and a struggling health care
system, which is both public and private, I welcome the pub-
lication of the third edition of The National Health Act Guide.
I encourage everyone with an interest in health to use the Guide
and to become an activist for positive change in our health care
system. This publication must be on every policy maker’s table,
on every manager’s desk, in every health worker’s pocket, and in
every student’s bag.
Malebona Precious Matsoso

Director-General of the National Department of Health
March 2019
iii
Acknowledgements
SECTION27 acknowledges the partnership of the Swedish

International Development Cooperation Agency and the AIDS
Foundation South Africa in funding this edition of The National
Health Act Guide.
Thanks to Zaziwe Hendricks, Mark Heywood, Tendai Mafuma,

Thuthukile Mbatha, Daniel McLaren, Sibongile Mtshelu, and
Thokozile Mtsolongo for their writing, editing and administra-
tive assistance.
v
Contents
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . .v
List of Acronyms . . . . . . . . . . . . . . . . . . . . . . . . xiii
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . 1
NATIONAL HEALTH ACT 61 OF 2003 . . . . . . . . . . . . 33
1. Definitions . . . . . . . . . . . . . . . . . . . . . . . 41
1. Objects of Act, responsibility for health and eligibility
for free health services . . . . . . . . . . . . . . . . . 52
2. Objects of Act . . . . . . . . . . . . . . . . . . . . . . 52
3. Responsibility for health . . . . . . . . . . . . . . . . 53
4. Eligibility for free health services in public health
establishments . . . . . . . . . . . . . . . . . . . . . 55
2. Rights and duties of users and health care personnel . 56
5. Emergency treatment . . . . . . . . . . . . . . . . . . 56
6. User to have full knowledge . . . . . . . . . . . . . . 57
7. Consent of user . . . . . . . . . . . . . . . . . . . . . 58
8. Participation in decisions . . . . . . . . . . . . . . . . 59
9. Health service without consent . . . . . . . . . . . . . 60
10. Discharge reports . . . . . . . . . . . . . . . . . . . . 60
11. Health services for experimental or research purposes . 61
12. Duty to disseminate information . . . . . . . . . . . . 61
13. Obligation to keep record . . . . . . . . . . . . . . . . 62
14. Confidentiality . . . . . . . . . . . . . . . . . . . . . 62
15. Access to health records . . . . . . . . . . . . . . . . 63
16. Access to health records by health care provider . . . . 64
17. Protection of health records . . . . . . . . . . . . . . 64
18. Laying of complaints . . . . . . . . . . . . . . . . . . 66
vii
The National Health Act Guide
19. Duties of users . . . . . . . . . . . . . . . . . . . . . .67

20. Rights of health care personnel . . . . . . . . . . . . . 67
3. National health . . . . . . . . . . . . . . . . . . . . . 68
21. General functions of national department . . . . . . . 68
22. Establishment and composition of National Health
Council . . . . . . . . . . . . . . . . . . . . . . . . . 70
23. Functions of National Health Council . . . . . . . . . 71
24. National Consultative Health Forum . . . . . . . . . . 73
4. Provincial health . . . . . . . . . . . . . . . . . . . . 74
25. Provincial health services, and general functions of
provincial departments . . . . . . . . . . . . . . . . . 74
26. Establishment and composition of Provincial Health
Council . . . . . . . . . . . . . . . . . . . . . . . . . 77
27. Functions of Provincial Health Council . . . . . . . . 78
28. Provincial consultative bodies . . . . . . . . . . . . . 80
5. District health system . . . . . . . . . . . . . . . . . . 81
29. Establishment of district health system . . . . . . . . 81
30. Division of health districts into subdistricts . . . . . . 81
31. Establishment of district health councils . . . . . . . . 83
32. Health services to be provided by municipalities . . . 85
33. Preparation of district health plans . . . . . . . . . . . 86
34. Transitional arrangements concerning municipal
health services . . . . . . . . . . . . . . . . . . . . . 87
6. Health establishments . . . . . . . . . . . . . . . . . . 87
35. Classification of health establishments . . . . . . . . . 87
36. Certificate of need . . . . . . . . . . . . . . . . . . . 88
37. Duration of certificate of need . . . . . . . . . . . . . 91
38. Appeal to Minister against Director-General’s
decision . . . . . . . . . . . . . . . . . . . . . . . . . 91
39. Regulations relating to certificates of need . . . . . . . 92
viii
Contents
40. Offences and penalties in respect of certificate

of need . . . . . . . . . . . . . . . . . . . . . . . . . 93
41. Provision of health services at public health
establishments . . . . . . . . . . . . . . . . . . . . . 93
42. Clinics and community health centre committees . . 96
43. Health services at non-health establishments and at
public health establishments other than hospitals . . . 96
44. Referral from one public health establishment to
another . . . . . . . . . . . . . . . . . . . . . . . . . 97
45. Relationship between public and private health
establishments . . . . . . . . . . . . . . . . . . . . . 98
46. Obligations of private health establishments . . . . . 98
47. Evaluating services of health establishments . . . . . . 99
7. Human resources planning and academic health
complexes . . . . . . . . . . . . . . . . . . . . . . . . 99
48. Development and provision of human resources in
national health system . . . . . . . . . . . . . . . . . 99
49. Maximising services of health care providers . . . . . 100
50. Forum of Statutory Health Professional Councils . . . 100
51. Establishment of academic health complexes . . . . 104
52. Regulations relating to human resources . . . . . . . 105
8. Control of use of blood, blood products, tissue and
gametes in humans . . . . . . . . . . . . . . . . . . . 106
53. Establishment of national blood transfusion service . 106
54. Designation of authorised institution . . . . . . . . . 107
55. Removal of tissue, blood, blood products or gametes
from living persons . . . . . . . . . . . . . . . . . . 108
56. Use of tissue, blood, blood products or gametes
removed or withdrawn from living persons . . . . . 108
57. Prohibition of reproductive cloning of human
beings . . . . . . . . . . . . . . . . . . . . . . . . . 109
ix
58. Removal and transplantation of human tissue in

hospital or authorised institution . . . . . . . . . . . 110
59. Removal, use or transplantation of tissue, and
administering of blood and blood products by
medical practitioner or dentist . . . . . . . . . . . . .111
60. Payment in connection with the importation,
acquisition or supply of tissue, blood, blood
products or gametes . . . . . . . . . . . . . . . . . . .111
61. Allocation and use of human organs . . . . . . . . . 112
62. Donation of human bodies and tissue of deceased
persons . . . . . . . . . . . . . . . . . . . . . . . . . 113
63. Human bodies, tissue, blood, blood products or
gametes may be donated to prescribed institution
or person . . . . . . . . . . . . . . . . . . . . . . . . 114
64. Purposes of donation of body, tissue, blood or
blood products of deceased persons . . . . . . . . . . 114
65. Revocation of donation . . . . . . . . . . . . . . . . 115
66. Post mortem examination of bodies . . . . . . . . . 115
67. Removal of tissue at post-mortem examinations and
obtaining of tissue by institutions and persons . . . . 116
68. Regulations relating to tissue, cells, organs, blood,
blood products and gametes . . . . . . . . . . . . . 118
9. National health research and information . . . . . . 120
69. National Health Research Committee . . . . . . . . . 120
70. Identification of health research priorities . . . . . . 121
71. Research on or experimentation with human
subjects . . . . . . . . . . . . . . . . . . . . . . . . 122
72. National Health Research Ethics Council . . . . . . . 123
73. Health research ethics committees . . . . . . . . . . 125
74. Co-ordination of national health information
system . . . . . . . . . . . . . . . . . . . . . . . . . 125
75. Provincial duties in relation to health information . . 126
x
Contents
76. Duties of district health councils and

municipalities . . . . . . . . . . . . . . . . . . . . . 126
10. Office of health standards compliance, board,
inspections and environmental health investigations,
health officers and inspectors, complaints and appeal
procedure . . . . . . . . . . . . . . . . . . . . . . . 126
77. Establishment of Office of Health Standards
Compliance . . . . . . . . . . . . . . . . . . . . . . 126
78. Objects of Office . . . . . . . . . . . . . . . . . . . . 128
79. Functions of Office . . . . . . . . . . . . . . . . . . 128
79A. Establishment of Board . . . . . . . . . . . . . . . . 129
79B. Composition of Board . . . . . . . . . . . . . . . . . 130
79C. Appointment of members of Board . . . . . . . . . . 130
79D. Chairperson and vice-chairperson of Board . . . . . . 131
79E. Disqualification from membership of Board and
vacation of office . . . . . . . . . . . . . . . . . . . 132
79F. Meetings of Board . . . . . . . . . . . . . . . . . . . 133
79G. Committees of Board . . . . . . . . . . . . . . . . . 134
79H. Appointment of Chief Executive Officer . . . . . . . 134
79I. Functions of Chief Executive Officer . . . . . . . . . 135
79J. Delegation of powers and assignment of duties
by Chief Executive Officer . . . . . . . . . . . . . . . 136
79K. Accountability of and reporting by Chief Executive
Officer . . . . . . . . . . . . . . . . . . . . . . . . . 136
80. Appointment of health officers and inspectors . . . . 137
81. Appointment of Ombud . . . . . . . . . . . . . . . . 138
81A. Functions of Ombud . . . . . . . . . . . . . . . . . 139
81B. Independence, impartiality and accountability of
Ombud . . . . . . . . . . . . . . . . . . . . . . . . . 141
82. Inspections . . . . . . . . . . . . . . . . . . . . . . . 142
82A. Non-compliance with prescribed norms and
standards . . . . . . . . . . . . . . . . . . . . . . . . 143
xi
83. Environmental health investigations . . . . . . . . . 144

84. Entry and search of premises or health establishment
with warrant by health officer or inspector . . . . . . 145
85. Identification prior to entry, and resistance
against entry, by health officer or inspector . . . . . 147
without warrant by health officer or inspector . . . . 148
86A. Constitutional right to privacy . . . . . . . . . . . . 149
87. Disposal of items seized by health officer or
inspector . . . . . . . . . . . . . . . . . . . . . . . . 149
88. Miscellaneous provisions relating to health officers,
inspectors and compliance procedures . . . . . . . . 149
88A. Appeals against decisions of Office or Ombud . . . . 150
89. Offences and penalties . . . . . . . . . . . . . . . . 150
11. Regulations . . . . . . . . . . . . . . . . . . . . . . 152
90. Regulations . . . . . . . . . . . . . . . . . . . . . . 152
12. General provisions . . . . . . . . . . . . . . . . . . . 156
91. Minister may appoint committees . . . . . . . . . . 156
92. Assignment of duties and delegation of powers . . . 156
93. Repeal of laws, and savings . . . . . . . . . . . . . . 157
94. Short title and commencement . . . . . . . . . . . . 158
APPENDICES
A Regulations under the National Health Act . . . . . 159
B Other Health Legislation . . . . . . . . . . . . . . . 164
C Policy Documents and Guidelines . . . . . . . . . . . 177
D Contact Details . . . . . . . . . . . . . . . . . . . . 184
xii
List of Acronyms
AGYW Adolescent Girls and Young Women

AIDS Acquired Immune Deficiency Syndrome
AHPCSA Allied Health Professions Council of South Africa
ANC Antenatal care
ART Antiretroviral Therapy
CEO Chief Executive Officer
CMS Council for Medical Schemes
DHB District Health Barometer
DHMIS District Health Management Information System
DR-TB Drug Resistant Tuberculosis
GBV Gender-based violence
HCT HIV Counselling and Testing
HIV Human Immunodeficiency Virus
HPCSA Health Professions Council of South Africa
HPV Human Papilloma Virus
HRH Human Resources for Health
KP Key population
LGBTQIA+ Lesbian, Gay, Bisexual, Transgender, Queer, Intersex,
Asexual and Others
MCC Medicines Control Council (now South African
Health Products Regulatory Authority)
MDR-TB Multi-Drug-Resistant Tuberculosis
MEC Member of the Executive Committee
MRC Medical Research Council
MSM Men who have sex with men
NAPHISA National Public Health Institute of South Africa
NHREC National Health Research Ethics Council
NHA National Health Act
xiii
NHI National Health Insurance

NHLS National Health Laboratory Service
NHRC National Health Research Committee
OHSC Office of Health Standards Compliance
PEP Post-exposure Prophylaxis
PEPFAR President’s Emergency Plan for AIDS Relief
PFMA Public Finance Management Act 1 of 1999
PMB Prescribed Minimum Benefit
PMTCT Prevention of Mother to Child Transmission
PrEP Pre-exposure Prophylaxis
SAMA South African Medical Association
SANC South African Nursing Council
SRHR Sexual and Reproductive Health and Rights
STI Sexually Transmitted Infections
TAC Treatment Action Campaign
TB Tuberculosis
ToP Termination of Pregnancy
VMMC Voluntary Medical Male Circumcision
WHO World Health Organisation
XDR-TB Extensively Drug-Resistant Tuberculosis
xiv
Introduction
This third edition of The National Health Act Guide comes at a time
of great flux in the health care system and the health policy land-
scape. Since the first edition (2008) and second edition (2013) of
this Guide, new strategies, legislation and regulations have been
produced to govern matters of health care in South Africa. Some
important examples include the National Development Plan:
Vision 2030, with its chapter on health;1 the Ward-Based Primary
Health Care Outreach Team Policy 2018/19 to 2023/24,2 which
standardises the employment of and conditions relating to com-
munity health workers; and the promulgation of the National
Health Amendment Act in 2013, which brought the Office of
Health Standards and the Health Ombud into existence. Perhaps
even more significantly, the draft National Health Insurance
Bill and the Medical Schemes Amendment Bill have both been
approved by the South African Cabinet, and the Provisional
Report of the Competition Commission Market Inquiry into the
Private Health Sector has been published, paving the way for fun-
damental change to the structure and funding of health care in
South Africa.
This health legislation and policy change is located in the
context of the continued and deepening weakness of a divided
health care system. The public health sector is overburdened by
patients with a limited choice of health care options, and crip-
pled by severe mismanagement fault lines, deep-seated corrup-
tion, historic underdevelopment, and instances of poor policy
choices, including the poor implementation of sound policies.
1
https://www.nationalplanningcommission.org.za/Documents/devplan_ch10_0.pdf
2
https://rhap.org.za/wp-content/uploads/2018/04/Policy-WBPHCOT-4-April-2018-1.pdf
1
The private health sector is increasingly expensive, unafforda-

ble for most, insufficiently regulated, and is not measured to
ensure that its services are of a high quality and also meet other
standards.
This edition of the Guide comes at an appropriate time, allow-
ing us to reflect on the legal landscape in health care provision,
and the overall health care system in South Africa.
Users of health facilities, health care providers and health
activists must have a clear understanding of the legal framework
that guides South Africa’s health care system. This knowledge
empowers us to take advantage of opportunities for input, activ-
ism and change.
We hope that this third edition of The National Health Act
Guide not only serves as an update, but also makes the National
Health Act (NHA) more accessible to a wide range of actors,
including activists, health care users and providers, government
and the private sector.
Big changes on the health care system horizon

2019, the year of publication of the third edition of this Guide,
could be a year of significant change for the South African health
system.
National Health Insurance (NHI) has been discussed and
debated for a long time but, in late 2018, a draft Bill was approved
by Cabinet and was the subject of a public consultation pro-
cess. The National Health Insurance Bill envisages wide-ranging
changes to the health care system, including the development
of an NHI Fund that will pay for the health care services of all
South Africans (excluding most non-nationals). In terms of the
Bill, health care users will access services from accredited provid-
ers, either in the public sector or the private sector, and will be
entitled to receive services from a package of services that is yet
2
Introduction
to be defined. The Bill envisages the establishment of a number

of institutional structures, including District Health Management
Offices and Contracting Units for Primary Care, both of which
are responsible for the organisation of services.
Unfortunately, there are some serious problems with the Bill
as it is currently drafted, and with the health care system that it
seeks to establish. Insufficient attention is paid to governance,
particularly of the NHI Fund and the various structures estab-
lished. The Minister of Health has governance, management
and decision-making functions in respect of too many of the
structures and institutions, and this leads to over-centralisa-
tion. Quality control is not given sufficient consideration, and
the majority of non-nationals are excluded from any coverage,
which constitutes an unacceptable regression in access to health
care services. We await further developments with regard to the
Bill and the changes that it may effect.
The Medical Schemes Amendment Bill was approved by
Cabinet at the same time as the NHI Bill was approved. This Bill
seeks to make changes to medical schemes and the regulation
thereof. This Bill is however no longer a priority as the findings
of the Competition Commission’s Health Market Inquiry are
still awaited. The Commission has been investigating the private
health sector since January 2014. The Preliminary Report of the
Health Market Inquiry made a series of far-reaching recommen-
dations for quality monitoring and improved regulation of the
private health care sector, among other recommendations. On
23 January 2019, the Competition Commission announced that
the work of the Inquiry would be postponed until April 2019, due
to budgetary constraints. This apparent deficit of political will is
of great concern as a failure to implement the recommendations,
which are the result of years of evidence assessment and data
analysis, will disadvantage health services users.
3
Finally, the National Public Health Institute of South Africa

(NAPHISA) is a public entity that will be created by the National
Public Health Institute of South Africa Bill, first published in
2017. NAPHISA will perform health surveillance functions and
strengthen the epidemiology of communicable diseases, non-com-
municable diseases, occupational health and safety, cancer, injury
and violence prevention, and environmental health, among other
functions. At the time of publication, the Bill is being considered
by the National Council of Provinces, which is the final step before
signature by the President. If the Bill is passed, NAPHISA should
strengthen South Africa’s surveillance of and ability to mitigate the
effects of a range of public health risks.
The inter-relationship of rights and laws

The National Health Act 61 of 2003 was passed by Parliament
to give effect to the right of everyone to have access to health
care services. This right is guaranteed by section 27 of the
Constitution of the Republic of South Africa, 1996, which places
express obligations on the state to progressively realise socio-eco-
nomic rights, including access to health care.
Section 27 of the Constitution provides as follows:
Health care, food, water, and social security
(1) Everyone has the right to have access to —
(a) health care services, including reproductive health care;
(b) sufficient food and water; and
(c) social security, including, if they are unable to support
themselves and their dependents, appropriate social
assistance.
(2) The state must take reasonable legislative and other meas-
ures, within its available resources, to achieve the progres-
sive realisation of each of these rights; and
(3) No one may be refused emergency medical treatment.
4
Introduction
Section 27 obviously refers, in part, to health. But all the rights

in our Constitution are indivisible, interrelated and mutually sup-
porting, which means that it is necessary to achieve the realisation
of some rights in order to fully enjoy other rights. For example:
• ‌An inability to access nutritious food affects health and access
to health care services: children whose growth is stunted due
to undernutrition and people who are obese due to over- or
poor nutrition will experience health problems and this places
a strain on the health care system.
• ‌If patients who access health services are examined or phys-
ically exposed in front of others in a health facility or have
their personal medical information shared improperly, then
their rights to privacy and to dignity are infringed.
• ‌The right to equality requires equal access to health care ser-
vices, which means that all individuals, including people
who are not citizens of South Africa, should be provided with
health care services.
• ‌Enjoying the right to health, and the right to exercise auton-
omy in decisions related to one’s own health (in line with
the rights to bodily integrity and security of the person), may
mean that one requires access to one’s own medical records
from a health facility or elsewhere in order to lodge a com-
plaint or to give consent for medical treatment.
In short, the right to health is not fully realisable without other
constitutional rights being realised.
Section 27 is also not the only section of the Constitution that
deals with health. Section 28 provides that every child has the
right to ‘basic nutrition, shelter, basic health care services and
social services’. This right is not subject to progressive realisa-
tion or available resources, which means that the right is imme-
diately realisable. The health needs of people who are arrested
or detained are specifically provided for in section 35(2), which
5
provides for medical treatment at state expense and the detain-

ee’s right to be visited by his or her chosen medical practitioner.
In other words, the imperatives of section 27 should not be
seen in isolation but as a necessary part of the achievement of all
the rights in the Bill of Rights.
The National Health Act as the foundational law on

health
The National Health Act (NHA) sets out the structure of the health
care system, delineating power and responsibility at national
level, provincial level and district level, and providing for public
and private components to the system. The Act is designed to
create the framework for delivering health care services, includ-
ing the duty on the Minister under section 3 to ‘promote the
inclusion of health services in the socio-economic development
plan of the Republic’, and providing for the rights and duties
of health care personnel, the governance of health facilities, the
quality of health care services, and human resources planning,
among others.
As with every piece of legislation, the NHA cannot contain
everything. Section 90 of the NHA provides for the Minister to
make regulations on a long list of issues. Other Acts and policies
deal with specific aspects of health law and the health system,
including health care workers, medicine registration, mental
health, traditional health practitioners, and abortion, among
others. Health-related legislation is listed in Appendix B.
The full promulgation of the NHA has taken a long time
with, for example, the provisions relating to the Office of Health
Standards Compliance being promulgated only in 2015. With
the intended reorganisation of the health care system under the
National Health Insurance Act, it is unclear what the future is for
the NHA.
6
Introduction
Rights within the health care system

The NHA includes a large set of patient rights. We highlight and
explain some of these rights in the diagram and commentary
below:
1. Emergency
Treatment
2. Full user
7. Complain
knowledge
3. Informed
6. Confidentiality
consent
4. Participation 5. Dissemination
in decisions of information
Emergency medical treatment

In line with section 27(3) of the Constitution, section 5 of the
NHA provides that no one may be refused emergency medical
treatment by a health care provider, health worker or health
establishment.
People may need emergency medical treatment for many dif-
ferent reasons, for example, when they sustain injuries due to
7
motor accidents, are victims of violence, or sustain burns in fires.

In such situations ,they will require urgent attention from the
nearest health facility, public or private. The right not to be refused
emergency medical treatment means that there is an obligation
on all health facilities, including private facilities or providers, to
stabilise a person in need of emergency medical treatment before
requiring them to pay. This is important to note, because it means
that in an emergency you cannot be turned away from a private
health facility simply because you are unable to pay.
On 1 December 2017, the Regulations relating to Emergency
Medical Services (http://section27.org.za/wp-content/uploads/2018/02/EMS-Regulations-
2017.pdf) were published by the National Department of Health
(NDoH). Emergency medical services providers (including
ambulances) in the public and private sectors are required to be
licensed from December 2018, which entails compliance with
certain standards. This is a welcome development in policy but
will not address all the problems in accessing emergency medical
services, such as provinces having insufficient vehicles and insuf-
ficient human resources to run the service. Such problems require
better planning and budgeting from provincial departments of
health, in line with the obligation not to refuse emergency med-
ical treatment.
Full user knowledge, informed consent and participation in

decisions
The right to full user knowledge includes knowledge about your
health status, the range of procedures available to you, the risks,
costs and benefits of those procedures, and the right to refuse
treatment. This right recognises the autonomy of the patient and
the power imbalances between patients and health providers.
The patient must be able to choose what is best for him or her,
having been provided with the information needed to make such
8
Introduction
a choice, rather than the doctor making choices for an unwitting

or uninformed patient.
The right to informed consent is linked to the right to full
user knowledge, and is important to prevent medical procedures
being performed on people without their knowledge and consid-
ered agreement.
Section 6 of the NHA gives you the right — before you are
given any medical treatment — to be told what treatment options
are available to you, the benefits and risks of each treatment, and
the cost of each treatment. Sections 7 and 8 state that you have
the right to participate in making any decisions regarding what
treatment you want, and that you must consent before you are
treated, unless it is an emergency and you are unable to con-
sent — for example, if you are unconscious. Section 9 recognises
that there are times when people can be forcibly admitted to a
health establishment, whether they consent or not. In these cases
there is an obligation on the provincial department of health to
monitor the person’s treatment to ensure that his or her rights
are respected.
A person can be forcibly admitted to a health establishment
or forced to receive treatment only in exceptional circumstances,
such as when that person is a danger to him- or herself, or to the
public generally. For example, if a person is very depressed and
threatens to commit suicide, his or her family may try to have
that person admitted at a health facility without his or her con-
sent. Likewise, if a person has a dangerous communicable disease
that could pose a public health risk — such as Ebola — that person
may have to be isolated and treated without his or her consent
in order to protect public health. In these rare circumstances, it
is the provincial department of health’s responsibility to ensure
that the infringement of the person’s right to refuse medical
treatment is justified and is the least restrictive method possible.
9
In addition, a person may be forced to undergo medical test-

ing without consent if he or she is accused of committing sexual
assault. The Criminal Law (Sexual Offences and Related Matters)
Amendment Act 32 of 2007 (Sexual Offences Act) allows a sexual
assault survivor, an interested person, or an investigating officer to
seek a court order compelling the alleged offender to take an HIV
test and disclose the results to the survivor, the interested person,
the investigating officer, or the prosecutor. The procedures for
compulsory testing in these circumstances are contained in the
Sexual Offences Act and its regulations, not in the NHA.
Dissemination of information
Appropriate, adequate and comprehensive information must
be distributed by provincial departments, districts and munici-
palities about all aspects of health services that would be useful
to the public. This includes information about your rights and
duties, timetables for access to services, types of services available
at facilities, and complaints procedures. Such information should
be available at health facilities and more generally. Further infor-
mation can be found in section 12 of the NHA. The kind of
information described in this section is frequently unavailable,
making use of the health care system difficult.
Laying of complaints
The right to complain and to have a complaints procedure through
which to do so is at the very core of our legal system, as is the right
to advocate for rights generally. Effective complaints mechanisms
are central to the functioning of health care facilities and are there-
fore part of everyone’s right to access health care services.
Section 18 of the NHA gives people the right to complain
about how they have been treated by a health facility. The pro-
cedures to follow in laying a formal complaint should be clearly
displayed in all health facilities and must be provided to a person
10
Introduction
who asks for them. You must follow these procedures in order for
your complaint to be investigated. Private health care facilities
must allow you to complain to the head of the facility.
Since 2013, an additional avenue for complaints about health
facilities has been available in the Office of Health Standards
Compliance (OHSC) and the Health Ombud, provided for in
Chapter 10 of the NHA. The work of the OHSC focuses specifi-
cally on resolving matters related to health establishments, and
not matters relating to individual health professionals. The pro-
cedures for the referral of complaints to the OHSC or the Health
Ombud can be found at http://healthombud.org.za/submit-complaint/.
Where a complaint concerns the conduct of or treatment by a
particular health professional, a patient can lay a complaint with
the Health Professions Council of South Africa (HPCSA), using
the procedure that can be found here: http://www.hpcsa.co.za/Complaints.
The HPCSA is required to investigate the complaint and may
hold a hearing about the complaint, at which the complainant
will have to testify.
In addition to health-specific complaints channels, there are
other opportunities to complain, either to institutions support-
ing democracy or to independent human rights organisations.
Chapter 9 of the Constitution establishes the Public Protector
(section 182) and the South African Human Rights Commission
(section 184). These bodies have a number of functions, which
include receiving and investigating complaints about the func-
tionality of and conduct of public servants at state institutions.
The details about laying a complaint can be found here: http://www.
pprotect.org/?q=content/complaint-process and here: https://www.sahrc.org.za/index.php/
what-we-do/lodge-complaints.
Organisations such as SECTION27, the Treatment Action
Campaign and the Rural Health Advocacy Project, among others,
are independent human rights-based organisations that work on
11
realising the right of access to health care services and can be

contacted for assistance or advice. Further information and con-
tact details can be found here:
• SECTION27 — 011 356 4100; www.section27.org.za
• Treatment Action Campaign — 011 100 4721; www.tac.org.za
• Rural Health Advocacy Project — 010 601 7427; www.rhap.org.za
Community involvement in the health care system

The Constitution requires that government proactively attempts
to involve us all in not only voting for the government, but in
the daily running of the government. The Constitutional Court
has described our country as a ‘participatory democracy’, that is,
one in which we do not simply hand over control of our coun-
try and the use of public resources to our elected representa-
tives between elections. Instead, we can participate in processes,
which include making public services work efficiently every day.
Section 195 of the Constitution requires that all public servants,
including health care professionals, must ensure that ‘people’s
needs must be responded to, and the public must be encouraged
to participate in policy-making.’ The importance of community
participation in the running of health care facilities should be
understood in this context. The NHA sets up several bodies that
allow for the public to be involved in the governance of health
care facilities and the system as a whole.
Clinic and community health centre committees

Section 42 of the NHA provides that clinic and community health
centre committees should be created and must include members
of the community. The powers and responsibilities of these com-
mittees are unclear in the NHA. However, the Act requires that
provincial legislation should outline the functions of a committee.
Many provinces still do not have provincial health laws dealing
12
Introduction
with clinic and community health centre committees. Only four

provinces (Kwa-Zulu Natal, the Eastern Cape, the Western Cape
and the Free State) have passed provincial legislation or have
adopted policies on the regulation of these committees, but not
all these documents deal with the powers and responsibilities of
the structures. Clinic and community health centre committees
therefore remain insufficiently governed and have various weak-
nesses, including political interference, lack of knowledge of roles
(among committee members, community members and health
facility management), lack of empowerment and lack of funding.
The much-needed user participation in health facilities will not
occur without the development of proper processes for the elec-
tion and functioning of these committees.
The provincial legislation that currently exists and the provi-
sions relating to health committees are set out below.
Eastern Cape Provincial Health Act 10 of 1999
The Act was promulgated before the NHA but deals briefly with
health committees. Section 35 states that the MEC shall appoint
a community health committee for each community health facil-
ity within the Province.
The Act does not set out the duties and powers of clinic com-
mittees. However, it states that the MEC must set out the terms
of reference for the committees. The terms of reference must be
published in a gazette.
Free State Provincial Health Act 3 of 2009
Section 39(1) states that the MEC must consult with the district
health council to establish a clinic committee for a ward in which
the clinic is located.
The duties of a clinic committee are set out in section 39(3),
and include:
• ‌advising the management of a health facility;
13
• i‌nvestigating administrative complaints in respect of a health

facility and making recommendations regarding the resolving
of complaints;
• ‌assisting users in following the complaints procedures; and
• ‌investigating health service delivery problems at the facility
and making recommendations to the district health council.
Gauteng District Health Services Act 8 of 2000
The Act is not yet in effect and, in any case, does not provide
for the establishment of clinic and/or community health centre
committees.
KwaZulu Natal Health Act 1 of 2009
Section 42(1) states that the MEC must establish committees
within 12 months of the Act coming into effect.
The powers and functions of the committees are set out in
section 43(1), and include:
• ‌overseeing the administration of human resources, financial
resources, assets, facilities and the general affairs of a facility;
• ‌reporting any maladministration of a facility to the MEC;
• ‌providing the MEC with biannual reports on the performance
of a facility; and
• ‌acting as a link to ensure collaboration with stakeholders in all
provincial and national health-related initiatives.
Limpopo Province Health Services Act 5 of 1998
The Act was promulgated before the NHA and does not provide
for the establishment of clinic and/or community health centre
committees.
Western Cape Health Facility Boards and Committees Act 4 of 2016
Section 4(4) states that the MEC must establish a committee for
each primary health care facility or for a group of primary health
care facilities.
14
Introduction
The duties of a clinic committee are set out in section 12, and
include:
• ‌requesting feedback on measures taken by the management
of the facility to improve the quality of service at the facility;
• ‌assisting the community to effectively communicate its needs,
concerns and complaints to the management of the facility;
• ‌conducting scheduled visits to the facility, without impeding
its functioning, and providing constructive written feedback
on such visits to the management; and
• ‌providing constructive feedback to the management of the pri-
mary health care facility in order to enhance service delivery.
In terms of section 13, the committee has the power to:
• ‌conduct surveys, meetings and consultative workshops in the
community or communities concerned;
• ‌disseminate information to the community on various issues,
including the performance standards and policies of the
facility;
• ‌advise and make recommendations to the MEC, the manage-
ment of the primary health care facility, the head of depart-
ment or the municipality concerned, on any matter relating
to the performance of the committee’s functions; and
• ‌obtain information from the facility if the information does
not violate the rights of a patient or staff member to privacy
and confidentiality.
Hospital boards
Section 41 of the NHA requires the Minister to appoint hospi-
tal boards for each central hospital or group of hospitals. These
boards must include up to three representatives of the commu-
nities served by the hospitals. Membership of hospital boards
provides community members with the opportunity to provide
input into the governing of the hospitals that serve them.
15
National, provincial and district health councils

The National Health Council is established by section 23 of the
NHA and includes the Minister, the Deputy Minister, the Director-
General and Deputy Directors-General at national level, and all
MECs and heads of department at provincial level, among others.
Its role is to advise the Minister of Health on policy, legislation,
proposed norms and standards for the establishment of health
establishments, guidelines for the management of health dis-
tricts, the implementation of national health policy, the national
and provincial integrated health plans contemplated in section
21(5), and an integrated national strategy for health research, and
to perform any other function determined by the Minister.
Section 26 of the NHA establishes similar structures at the pro-
vincial level. Like the National Health Council, provincial health
councils are responsible for advising the provincial department
on health policy, among other functions.
Section 31 of the NHA instructs the MEC for Health in each
province to create a district health council in each health district.
Although there is no official role for members of the commu-
nity in national, provincial or district health councils, the coun-
cils may consider representations from any person, organisation,
institution or authority. Therefore, health activists must monitor
these bodies since they help to establish national, provincial and
district health policy, and may be a useful target for advocacy.
Consultative health forums

Sections 24 and 28 of the NHA establish consultative health
forums at the national and provincial levels respectively. The
main function of these bodies is to promote and facilitate the
sharing of information on health issues. Provincial consulta-
tive health forums must include relevant stakeholders, such as
community-based organisations, and must meet at least every 12
16
Introduction
months. The consultative health forums are important targets for

mobilisation and advocacy. Health care advocates should enquire
about the meetings of consultative health forums and make sure
that they attend, to ensure that the agendas include issues that
are important to users of the health care system, and to ensure
that critical voices are heard when necessary.
National, provincial and district health plans

Section 33 of the NHA requires each district health manager to
create annual district health and human resource plans and to
present them to the MEC and the district health council. Section
25 of the NHA contains the same obligation in respect of prov-
inces and requires that provincial plans be submitted to the
Director-General. The district and provincial health plans must
be developed according to guidelines published by the NDoH. At
a national level, section 21(3) to (5) of the NHA requires that the
Director-General produces an annual national health plan, and
that he or she should ‘integrate the health plans of the national
department and provincial departments annually and submit the
integrated plans to the National Health Council.’
Knowing the contents of these plans is very important, as this
knowledge gives advocates the ability to monitor what those
responsible for health at the national, provincial and district
levels are meant to accomplish, and to hold them accountable for
any failure to meet their mandates. If individuals, communities
and organisations are more aware of health plans and budgets,
they can measure these plans against a needs-based health assess-
ment of a community or district.
Budgeting for health

While the NHA establishes the structure of the health system, it
does not state how that system will be funded. Instead, the public
17
health system is funded and financially managed in terms of

national and provincial legislation, which is framed by the rights,
duties and principles of governance and financial management
established by the Constitution. Key legislation includes the
Public Finance Management Act 1 of 1999, the Intergovernmental
Fiscal Relations Act 97 of 1997, the Money Bills Amendment
Procedure and Related Matters Act 9 of 2009, the Division of
Revenue Act (enacted annually) and the Appropriations Act
(enacted annually).
How public health services are funded

National government raises revenue (money) through a vari-
ety of means, including taxes. Section 213 of the Constitution
states that all revenue raised nationally must be deposited into a
National Revenue Fund. In addition, government borrows money
to close the gap between planned expenditure and expected reve-
nue. The total government budget is ‘vertically’ divided between
the three spheres of government: national, provincial and local.
The national share of revenue goes to national departments and
agencies, the provincial share goes to provincial governments
and agencies, and the local share goes to local municipalities.
Schedule 4 of the Constitution and the NHA establish that
health services are a concurrent function of national government
and provincial government. This means that there are national
and provincial departments of health, which have distinctive but
interdependent and interrelated responsibilities.
The National Department of Health is responsible for overall
priority setting and the development of national laws and poli-
cies, which provincial governments must implement. Provincial
departments of health are responsible for the day-to-day manage-
ment and functioning of health care facilities and programmes,
18
Introduction
including the management of hospitals and clinics. The bulk of

the health care budget is therefore spent at the provincial level.
In the 2019/20 financial year, the NDoH received R51.5 billion
out of a total health budget of R208.8 billion. However, R45 bil-
lion of this allocation was transferred directly to provincial health
departments in the form of conditional grants. Conditional
grants must be spent on specific national priorities by the prov-
inces. For the past decade, the largest conditional grant has been
the comprehensive HIV, AIDS and TB grant, which received R20
billion in 2019/20, reflecting the high priority status given to
combating these epidemics. The other direct grants are given for
national tertiary services (R13.2 billion), health facility revitalisa-
tion (R6.0 billion) and health professions training and develop-
ment (R2.9 billion).
However, provinces’ main source of funding is their equitable
share allocation. This is a share of revenue raised nationally that
is allocated (‘horizontally’) to each province, based on a formula
that takes account of a number of factors, including the demand
for health services.
Provinces have the discretion to decide how to allocate their
equitable share allocation. On average, provincial governments
allocate 32% of their total budget (including conditional grants)
to health care, with Gauteng and the Western Cape allocating the
highest proportion at 36%, and Mpumalanga and the North West
allocating the lowest proportion, at 26% and 27% respectively in
2017/18.
User fees (such as those fees charged at hospitals) make up a
very small proportion of provincial health funding, at only 1%
on average.
With conditional grants, equitable share and provincial own
revenue (user fees) included, provinces have approximately
R202.3 billion of the R208.8 billion health budget available to
19
spend on delivering quality health services to all. This is equal to

97% of the total spend on public health.
The programmes funded and implemented by the NDoH in
2018/19 were: Administration; National Health Insurance, Health
Planning and Systems Enablement; HIV/AIDS, Tuberculosis, and
Maternal and Child Health; Primary Health Services; Hospitals,
Tertiary Health Services and Human Resource Development; and
Health Regulation and Compliance Management.
At the provincial level, programmes can vary, but in 2018/19
they generally included: Administration, District Health Services,
Emergency Medical Services, Provincial Hospital Services, Central
Hospital Services, Health Sciences and Training, Health Care
Support Services, and Health Facilities Management.
Participating in the budgeting process

The budgeting process refers to the process of raising, allocat-
ing and evaluating the expenditure of public money. Overall,
this process is managed by the National Treasury, but it involves
all government departme nts and agencies at the national and
provincial level, as well as the 278 local municipalities. The pro-
cess results in budget proposals that are tabled in the national
and provincial legislatures. When voted for and adopted by
the legislatures, these proposals are captured in legislation (the
Appropriations Act and the Division of Revenue Act), in which
the budgets of every government department and agency are
contained.
The budgeting process, as well as the use and accounting of
public funds, is governed by the Public Finance Management Act
1 of 1999 (PFMA). The object of the PFMA is ‘to secure trans-
parency, accountability, and sound management of the rev-
enue, assets and liabilities of [public/state] institutions.’ The
Constitution and the PFMA require that public participation in
20
Introduction
the budgeting process is encouraged and facilitated. As a result

of a number of transparency reforms intended to give effect to
these principles, South Africa has one of the most transparent
budgeting processes in the world.
Any member of the public can access a comprehensive range
of national and provincial budget information by visiting vulekamali.
gov.za. In relation to health, one can access the main and adjusted
budgets of all national and provincial health departments, as
well as additional information, such as information about health
infrastructure projects. Users of the portal can compare what was
budgeted to what was actually spent and see whether budgets are
increasing in real terms or whether cuts have been applied. The
performance and audit information contained in annual reports
and Auditor-General reports is also accessible.
Unfortunately, despite the availability of budget information,
public participation in the budgeting process remains low. It
is especially poor at the planning and prioritising stages of the
budgeting process, compared to the budget review and evalua-
tion stages. Opportunities for public participation do exist, how-
ever, especially in the national and provincial legislatures.
Opportunities for public participation in the budgeting process

Any member of the public can:
• ‌Make written or oral submissions or petitions in any of the
official languages of South Africa to the parliamentary com-
mittees of the National Assembly, the National Council of
Provinces and the provincial legislatures.
–– The key committees involved in the health budgeting
process are Finance, Appropriations, Public Accounts and
Health.
–– You can find more information about these committees,
including when they meet, at www.pmg.org.za.
21
• R‌ equest MPs to ask questions on your behalf in the parliamen-

tary committees and in monthly sessions with the executive.
• ‌Participate in public hearings on the budget organised by the
national and provincial treasuries.
• ‌Lobby national and provincial health departments on their
budget submissions as well as on their performance and
spending of their budgets.
• ‌Keep up with key national budget events by visiting
https://vulekamali.gov.za/events
• ‌Submit ‘Budget Tips’ to the Minister of Finance by visiting
www.treasury.gov.za.
• ‌Tweet the National Treasury @TreasuryRSA or the National
Department of Health @HealthZA
Trends in health funding

After about a decade of positive growth in the public health care
budget between 2000 and 2010, health care funding has recently
slowed to a crawl as a result of austerity3 and sluggish economic
growth. This has put severe strain on health services and delayed
the implementation of NHI, which requires a doubling of spend-
ing on public health. Other policies delayed as a result of a lack
of funds in recent years include palliative care, health infrastruc-
ture improvements and the formalisation (and remuneration) of
community health workers. Perhaps the biggest impact, how-
ever, has been on posts in provincial health departments, which
have been frozen at times in order to meet austere expenditure
ceilings. Vacant doctor, nursing and other posts — estimated by
the National Director-General of Health at more than 40 000
nationally in 2017 — have undoubtedly affected the quality of
care available at public health facilities and have contributed to
3
The policy of government since 2012 to cut public expenditure in order
to reduce the budget deficit.
22
Introduction
an exponential rise in medico-legal claims4 in recent years. These

posts urgenly need to be filled.
NHI proposals for health funding revolve around the intro-
duction of an NHI Fund that will pay for all health care services.
How the fund will be funded (ie whether through existing or new
taxation measures) and how it will be managed and governed
are still to be decided. The evolution of public health funding
in South Africa over the next decade will largely depend on how
these two questions are resolved.
Sexual and reproductive health and rights

The Constitution specifically includes the right to reproduc-
tive health care services in section 27. The Constitution thus
appropriately prioritises this fundamental component of the
right to health, and its intersection with the rights to dignity,
bodily integrity, freedom and security of the person, privacy and
equality.
What are sexual and reproductive health rights? It is helpful
to start with the definition of sexual and reproductive health.
In May 2018, a report published by the Guttmacher-Lancet
Commission5 provided a helpful combined definition of sexual
and reproductive health: ‘sexual and reproductive health is a
state of physical, mental and social wellbeing in relation to all
aspects of sexuality and reproduction, not merely the absence of
disease, dysfunction, or infirmity.’
4
Medico-legal claims against provincial health departments have grown
from R28.6 billion in March 2015 to R804 billion in March 2018
(National Treasury, 2019 Budget Review).
5
Guttmacher-Lancet Commission Accelerate Progress: Sexual and Reproduc
tive Health and Rights for All (May 2018).
Available at https://www.thelancet.com/commissions/sexual-and-reproductive-health-and-rights.
23
The attainment of sexual and reproductive health requires

the realisation of sexual and reproductive health rights, which
include everyone’s right to:
• ‌have their bodily integrity, privacy and personal autonomy
respected;
• ‌freely define their own sexuality, including sexual orientation
and gender identity and expression;
• ‌decide whether and when to be sexually active;
• ‌choose their sexual partners;
• ‌have safe and pleasurable sexual experiences;
• ‌decide whether and when, and whom to marry;
• ‌decide whether, when, and by what means to have a child or
children, and how many.
The realisation of sexual and reproductive health rights therefore
goes far beyond a health care system, requiring societal and atti-
tudinal change, as well as cooperation between many different
stakeholders, including those in government (the health sector,
the education sector and the police service) and civil society.
Included in the requirements for the realisation of sexual and
reproductive health rights are the health services required for the
realisation of these rights. The Guttmacher-Lancet Commission
report notes the following services are needed for the realisation
of the rights:
• ‌Counselling and care related to sexuality, sexual identity and
sexual relationships;
• ‌ Services for the prevention and management of sexually
transmitted infections, including HIV;
• ‌Prevention and management of cancers of the reproductive
system;
• ‌Access to all forms of affordable, safe, effective and acceptable
methods of contraception of one’s choice;
24
Introduction
• A‌ ccess to appropriate health care services to ensure safe and

healthy pregnancies and childbirth, and healthy infants;
• ‌Access to safe abortion services, including post-abortion care.
Many of the services listed in the Guttmacher-Lancet report form
part of the service package that is meant to be available within
the public health sector in South Africa. The reproductive health
services offered by the state include access to contraception,
ante-natal care, abortion, ante-retroviral treatment (ART) for the
management of HIV, HIV prevention, screening and manage-
ment of reproductive cancers, screening and treatment of sex-
ually transmitted infections (STIs), and psycho-social support.
These services should be accessed at public clinics, hospitals,
schools and community health centres. Services at public health
facilities should be free for pregnant and lactating women.
However, access to such services is still limited for many
people. A number of issues hinder access to such critical services,
including:
• ‌Stock-outs of vital medicines and supplies such as ART, con-
traceptives, abortion pills and female condoms. As a result of
these stock-outs, we see continuing high levels of unwanted
pregnancies, HIV and STIs.
• ‌While the Choice on Termination of Pregnancy Act 92 of 1996
(CToP Act) has existed for over two decades, access to safe abor-
tion services remains a problem. According to the CTOP Act, a
woman or girl can terminate a pregnancy upon request during
the first 12 weeks of gestation. Termination of pregnancy can
still be offered to women and girls after 12 weeks under certain
conditions. However, women still find it difficult to access
abortions due to the insufficiency of designated facilities that
offer abortion, conscientious objection by health providers,
staffing shortages, abortion medication stock-outs and others.
This has led to an increase in complicated and incomplete
25
abortions occurring outside of the designated facilities at

illegal centres, sometimes affecting the life and health of the
woman concerned.
• ‌The public health system is faced with a huge and increasing
shortage of skilled health personnel. As health care workers
leave the public sector, the system is weakened and access to
services, including sexual and reproductive health services,
decreases.
• ‌The problems in access to emergency medical services, par-
ticularly in rural areas, have a real impact on the realisation of
sexual and reproductive health rights. Pregnant women some-
times give birth at home when the ambulance they called fails
to arrive, posing risks to the mother and the baby.
• ‌The public health sector offers multiple options for HIV pre-
vention. However, access to most options is limited, and focus
has mostly been on the expansion of the male condoms roll-
out programme. There is lack of social marketing of other
methods, such as the female condom, post-exposure proph-
ylaxis (PEP) and pre-exposure prophylaxis (PrEP). The use of
PrEP as an HIV prevention tool started in 2016, when it was
provided to sex workers in a number of demonstration sites.
The programme of PrEP roll-out has been gradually increasing
to include men who have sex with men (MSM) and young
people. At the time of publication, there are only 72 sites that
provide PrEP, however, and so the majority of people at sub-
stantial risk of acquiring HIV are unaware of the option or lack
access to PrEP.
• ‌South Africa has a large family planning programme, but in
many instances women are not informed about the different
forms of contraception available and are given whatever the
nurse decides to give them. The right to participate in deci-
sions is therefore denied.
26
Introduction
• I‌n trying to ensure that everyone’s sexual and reproductive

health and rights are accommodated, the South African
National LGBTI HIV Plan 2017 to 2022 offers a guide to health
care providers and communities on how to provide services to
LGBTQIA+ people. The plan notes the importance of sensitisa-
tion of health care providers to providing population-specific
services. It provides for a core package of health services. The
plan also entails the provision of dental dams, finger cots and
rectal swab examinations to test for rectal cancer. However,
these services are not currently being offered to LGBTQIA+
people, and many still face discrimination and prejudice
when seeking sexual and reproductive health care services.
• ‌The Department of Basic Education National HIV, STI and TB
Policy specifies the services that should be provide to adoles-
cents of school-going age in order to prevent, treat and manage
the three epidemics. These services include access to modern
methods of contraception, referral to abortion services, con-
doms, HPV vaccinations and comprehensive sexuality educa-
tion. Progress has been made by the state in providing HPV
vaccinations, which are critical for the prevention of cervical
cancer, to nine-year-old girls in schools. Between 2014 and
2016, 1 093 880 Grade 4 learners (nine-year-old girls) received
vaccinations. More recent numbers are not available at the
time of publication. However the continued lack of access
to other required services has hindered progress in trying to
curb the rates of teenage pregnancy and untreated STIs among
learners in schools.
Selected SRHR policy documents and guidelines

A very brief summary of various SRHR-related policy documents
and guidelines follows, together with links to allow the reader to
access the relevant documents. Policy documents and guidelines
27
related to the health system in general and to HIV and TB can be

found in Appendix C.
National Condoms Policy and Management Guidelines (2011)

The policy aims to ensure that condoms are readily available and
easily accessible to all communities and individuals in South
Africa. It provides a plan for the procurement and distribution
of male condoms to every sexually active individual to protect
against unwanted pregnancies, STIs and HIV.
https://www.medbox.org/za-policies-others/
south-africa-national-condoms-policy-and-management-guidelines/preview?
National Contraception and Fertility Planning Policy and Service

Delivery Guidelines and National Contraception Clinical Guidelines
(2012)
These documents seek to promote (to health care providers and
health service users) the use of the different types of contracep-
tives available in the public health sector, and to integrate HIV
and sexual and reproductive health services.
https://www.health-e.org.za/wp-content/uploads/2014/05/National-contraception-clinical-
guidelines.pdf
www.health-e.org.za/2014/05/06/guidelines-national-contraception-fertility-planning-policy/
South African National Guidelines for Medical Male Circumcision

(2016)
This document provides comprehensive guidance for organising
and ensuring the quality of voluntary male medical circumcision
service delivery, both in the public sector and the private sector.
https://www.usaidassist.org/toolkits/vmmc-cqi-and-eqa-toolkit/
south-african-national-guidelines- medical-male-circumcision
28
Introduction
PrEP Implementation Pack (2017)

This document comprises the PrEP draft policy, guidelines and
roll-out plans. It is a guide for the provision of PrEP to individuals
who are identified as being at substantial risk of contracting HIV.
https://www.prepwatch.org/wp-content/uploads/2017/07/SA_ImplementationPack.pdf
National Cancer Strategic Framework 2017–2022

The National Cancer Strategic Framework is the basis of the other
policies on cancer, described below. It is important to read the
Strategic Framework in conjunction with the following policies on
cancers of the reproductive health system:
1. Cervical cancer prevention and control policy (2017)
http://www.health.gov.za/index.
php/2014-08-15-12-53-24?download=1393:cervical-cancer-policy-pdf
2. Breast cancer prevention and control policy (2017)
http://www.health.gov.za/index.
php/2014-08-15-12-53-24?download=2533:breast-cancer-policy
3. Prostate cancer diagnostic and treatment guidelines (2013)
http://prostate.acitravel.co.za/cake/app/webroot/uploads/files/Prostate_Cancer_
Guidelines_2013.pdf
Department of Basic Education National Policy on HIV, STIs and TB

(2017)
This policy is intended to assist the Department of Basic
Education in the management of HIV, STIs and TB in schools,
by mainstreaming a response to HIV, STIs and TB, improving
sex and sexuality education, improving access to services, and
increasing the retention of learners, educators, school support
staff and officials.
https://serve.mg.co.za/content/documents/2017/06/14/dbehivtbpolicyfinaljune2017
cabinetapproved.pdf
29
Guidelines for Maternity Care in South Africa: A manual for clinics,

community health centres and district hospitals (2015)
These guidelines include the basic information that all profes-
sional nurses and doctors need to have in relation to maternity
care. These guidelines seek to decrease high maternal and perina-
tal morbidity and mortality rates and improve the quality of care
of mothers and their babies.
https://www.health-e.org.za/wp-content/uploads/2015/11/Maternal-Care-Guidelines-2015_
FINAL-21.7.15.pdf
The Tshwane Declaration of Support for Breastfeeding in South

Africa, 2012
The NDoH convened the National Breastfeeding Consultative
Meeting in 2012, which adopted a policy to actively promote,
protect and support exclusive breastfeeding as a health interven-
tion to optimise child survival, irrespective of the mother’s HIV
status.
http://www.sajcn.co.za/index.php/SAJCN/article/viewFile/586/820
Draft Department of Basic Education National Policy on the

Prevention and Management of Learner Pregnancy (2018)
The draft policy seeks to ensure the provision of accessible infor-
mation on prevention, choice of termination of pregnancy, care,
counselling and support, frameworks for impact mitigation, and
guidelines for systemic management and implementation in
schools.
http://www.governmentpublications.lib.uct.ac.za/news/
draft-dbe-national-policy-prevention-and-management-learner-pregnancy
Conclusion
Since the last edition of this Guide, significant progress has
been made in promulgating sections of the NHA and in
30
Introduction
legislative interventions to improve access to health care services.

Unfortunately, the legislative interventions have not translated
into substantial improvements in access to high quality health
care services. It is hoped that, by putting the text of the NHA into
the hands of people in communities and organisations, they can
start to mobilise to demand full implementation of their rights
under the NHA and the Constitution.
31
National Health Act
61 of 20031
(English text signed by the President)
ACT
To provide a framework for a structured uniform health system
within the Republic, taking into account the obligations imposed
by the Constitution and other laws on the national, provincial
and local governments with regard to health services; and to
provide for matters connected therewith.
PREAMBLE RECOGNISING —
• ‌the socio-economic injustices, imbalances and inequities of health
services of the past;
• ‌the need to heal the divisions of the past and to establish a soci-
ety based on democratic values, social justice and fundamental
human rights;
• ‌the need to improve the quality of life of all citizens and to free
the potential of each person;
1
Most provisions of the NHA were brought into effect on 2 May 2005.
In subsequent years, provisions that had not been initially promulgated
(meaning brought into effect) were promulgated and should, therefore,
be implemented. Notably, the National Health Amendment Act 12 of
2013 brought into effect (and amended) the provisions relating to the
Office of Health Standards Compliance and the Health Ombud as of 2
September 2013. Sections 36, 37, 38, 39 and 40 relating to the require-
ment for certificates of need were promulgated on 21 March 2014, but
the promulgation was subsequently set aside by the Constitutional
Court on 27 January 2015, in case CCT 201/14. These sections of the
NHA are therefore not currently in effect. The only other provision that
is not yet in effect is section 47(2) of the NHA.
33
BEARING IN MIND THAT —

• ‌the State must, in compliance with section 7(2) of the Constitution,
respect, protect, promote and fulfil the rights enshrined in the Bill
of Rights, which is a cornerstone of democracy in South Africa;
• ‌in terms of section 27(2) of the Constitution the State must take
reasonable legislative and other measures within its available
resources to achieve the progressive realisation of the right of
the people of South Africa to have access to health care services,
including reproductive health care;
• ‌section 27(3) of the Constitution provides that no one may be
refused emergency medical treatment;
• ‌in terms of section 28(1)(c) of the Constitution every child has the
right to basic health care services;
• ‌in terms of section 24(a) of the Constitution everyone has the
right to an environment that is not harmful to their health or
well-being;
AND IN ORDER 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 manage-
ment of health services, within national guidelines, norms and
standards, in which each province, municipality and health dis-
trict must address questions of health policy and delivery of qual-
ity 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 advo-
cacy which encourages participation;
• ‌promote a spirit of co-operation and shared responsibility among
public and private health professionals and providers and other
34
National Health Act 61 of 2003
relevant sectors within the context of national, provincial and dis-

trict health plans,
BE IT ENACTED by the Parliament of the Republic of South Africa,
as follows: —
ARRANGEMENT OF SECTIONS
Sections
1. Definitions
CHAPTER 1
OBJECTS OF ACT, RESPONSIBILITY FOR HEALTH AND
ELIGIBILITY FOR FREE HEALTH SERVICES
2. Objects of Act
3. Responsibility for health
4. Eligibility for free health services in public health establishments
CHAPTER 2
RIGHTS AND DUTIES OF USERS AND HEALTH CARE PERSONNEL
5. Emergency treatment
6. User to have full knowledge
7. Consent of user
8. Participation in decisions
9. Health service without consent
10. Discharge reports
11. Health services for experimental or research purposes
12. Duty to disseminate information
13. Obligation to keep record
14. Confidentiality
15. Access to health records
16. Access to health records by health care provider
17. Protection of health records
18. Laying of complaints
19. Duties of users
20. Rights of health care personnel
35
CHAPTER 3
NATIONAL HEALTH
21. General functions of national department
22. Establishment and composition of National Health Council
23. Functions of National Health Council
24. National Consultative Health Forum
CHAPTER 4
PROVINCIAL HEALTH
25. Provincial health services, and general functions of provincial
departments
26. Establishment and composition of Provincial Health Council
27. Functions of Provincial Health Council
28. Provincial consultative bodies
CHAPTER 5
DISTRICT HEALTH SYSTEM FOR REPUBLIC
29. Establishment of district health system
30. Division of health districts into subdistricts
31. Establishment of district health councils
32. Health services to be provided by municipalities
33. Preparation of district health plans
34. Transitional arrangements concerning municipal health
services
CHAPTER 6
HEALTH ESTABLISHMENTS
35. Classification of health establishments
36. Certificate of need
37. Duration of certificate of need
38. Appeal to Minister against Director-General’s decision
39. Regulations relating to certificates of need
40. Offences and penalties in respect of certificate of need
36
41. Provision of health services at public health establishments

42. Clinics and community health centre committees
43. Health services at non-health establishments and at public
health establishments other than hospitals
44. Referral from one public health establishment to another
45. Relationship between public and private health establishments
46. Obligations of private health establishments
47. Evaluating services of health establishments
CHAPTER 7
HUMAN RESOURCES PLANNING AND ACADEMIC HEALTH
COMPLEXES
48. Development and provision of human resources in national
health system
49. Maximising services of health care providers
50. Forum of Statutory Health Professional Councils
51. Establishment of academic health complexes
52. Regulations relation to human resources
CHAPTER 8
CONTROL OF USE OF BLOOD, BLOOD PRODUCTS, TISSUE AND
GAMETES IN HUMANS
53. Establishment of national blood transfusion service
54. Designation of authorised institution
55. Removal of tissue, blood, blood products or gametes from
living persons
56. Use of tissue, blood, blood products or gametes removed or
withdrawn from living persons
57. Prohibition of reproductive cloning of human beings
58. Removal and transplantation of human tissue in hospital or
authorised institution
59. Removal, use or transplantation of tissue, and administering of
blood and blood products by medical practitioner or dentist
37
60. Payment in connection with the importation, acquisition or

supply of tissue, blood, blood products or gametes
61. Allocation and use of human organs
62. Donation of human bodies and tissue of deceased persons
63. Human bodies, tissue, blood, blood products or gametes may
be donated to prescribed institution or person
64. Purposes of donation of body, tissue, blood or blood products
of deceased persons
65. Revocation of donation
66. Post-mortem examination of bodies
67. Removal of tissue at post-mortem examinations and obtaining
of tissue by institutions and persons
68. Regulations relating to tissue, cells, organs, blood, blood prod-
ucts and gametes
CHAPTER 9
NATIONAL HEALTH RESEARCH AND INFORMATION
69. National Health Research Committee
70. Identification of health research priorities
71. Research on or experimentation with human subjects
72. National Health Research Ethics Council
73. Health research ethics committees
74. Co-ordination of national health information system
75. Provincial duties in relation to health information
76. Duties of district health councils and municipalities
CHAPTER 10
OFFICE OF HEALTH STANDARDS COMPLIANCE,
BOARD, INSPECTIONS AND ENVIRONMENTAL HEALTH
INVESTIGATIONS, HEALTH OFFICERS AND INSPECTORS,
COMPLAINTS AND APPEAL PROCEDURE
77. Establishment of Office of Health Standards Compliance
78. Objects of Office
38
79. Functions of Office

79A. Establishment of Board
79B. Composition of Board
79C. Appointment of members of Board
79D. Chairperson and vice-chairperson of Board
79E. Disqualification from membership of Board and vacation of
office
79F. Meetings of Board
79G. Committees of Board
79H. Appointment of Chief Executive Officer
79I. Functions of Chief Executive Officer
79J. Delegation of powers and assignment of duties by Chief
Executive Officer
79K. Accountability of and reporting by Chief Executive Officer
80. Appointment of health officers and inspectors
81. Appointment of Ombud
81A. Functions of Ombud
81B. Independence, impartiality and accountability of Ombud
82. Inspections
82A. Non-compliance with prescribed norms and standards
83. Environmental health investigations
84. Entry and search of premises or health establishment with war-
rant by health officer or inspector
85. Identification prior to entry, and resistance against entry, by
health officer or inspector
86. Entry and search of premises or health establishment without
warrant by health officer or inspector
86A. Constitutional right to privacy
87. Disposal of items seized by health officer or inspector
88. Miscellaneous provisions relating to health officers, inspectors
and compliance procedures
88A. Appeals against decisions of Office or Ombud
39
89. Offences and penalties
CHAPTER 11
REGULATIONS
90. Regulations
CHAPTER 12
GENERAL PROVISIONS
91. Minister may appoint committees
92. Assignment of duties and delegation of powers
93. Repeal of laws, and savings
94. Short title and commencement
SCHEDULE
40
Section 1 National Health Act 61 of 2003
1. Definitions
In this Act, unless the context indicates otherwise —
“authorised institution” means any institution designated as an
authorized institution in terms of section 54;
“blood product” means any product derived or produced from
blood, including circulating progenitor cells, bone marrow pro-
genitor cells and umbilical cord progenitor cells;
“Board” means the Office of Health Standard Compliance Board
established in terms of section 79A;
“central hospital” means a public hospital designated by the
Minister to provide health services to users from more than one
province;
“certificate of need” means a certificate contemplated in section 36;
“Chief Executive Officer” means the person appointed as Chief
Executive Officer in terms of section 79H(1);
“communicable disease” means a disease resulting from an infec-
tion due to pathogenic agents or toxins generated by the infec-
tion, following the direct or indirect transmission of the agents
from the source to the host;
“Constitution” means the Constitution of the Republic of South
Africa, 1996 (Act No. 108 of 1996);
“death” means brain death;
“Director-General” means the head of the national department;
“district health council” means a council established in terms of
section 31;
“essential health services” means those health services prescribed
by the Minister to be essential health services after consultation
with the National Health Council;2
2
As of April 2019, the Minister had not yet promulgated regulations
defining ‘essential health services’. For more information on the signifi-
cance of a definition of ‘essential health service’ see note 25 on page 54
below.
41
The National Health Act Guide Section 1
“embryo” means a human offspring in the first eight weeks from

conception;
“Forum of Statutory Health Professional Councils” means the
Forum established by section 50;
“gamete” means either of the two generative cells essential for
human reproduction;
“gonad” means a human testis or human ovary;
“health agency” means any person other than a health
establishment —
(a) whose business involves the supply of health care personnel
to users or health establishments;
(b) who employs health care personnel for the purpose of pro-
viding health services; or
(c) who procures health care personnel or health services for
the benefit of a user, and includes a temporary employment
service as defined in the Basic Conditions of Employment
Act, 1997 (Act No. 75 of 1997), involving health workers or
health care providers;3
“health care personnel” means health care providers and health
workers;
“health care provider” means a person providing health services in
terms of any law, including in terms of the —
(a) Allied Health Professions Act, 1982 (Act No. 63 of 1982);
(b) Health Professions Act, 1974 (Act No. 56 of 1974);
3
According to section 1 of the Basic Conditions of Employment Act 75 of
1997, a ‘temporary employment service’ means:
any person who, for reward, procures for, or provides to, a client, other
persons —
(a) who render services to, or perform work for, the client and
(b) who are remunerated by the temporary employment service.
42
(c) Nursing Act, 1978 (Act No. 50 of 1978);4

(d) Pharmacy Act, 1974 (Act No. 53 of 1974); and
(e) Dental Technicians Act, 1979 (Act No. 19 of 1979);
“health district” means a district contemplated in section 29;
“health establishment” means the whole or part of a public or
private institution, facility, building or place, whether for profit
or not, that is operated or designed to provide inpatient or out-
patient treatment, diagnostic or therapeutic interventions, nurs-
ing, rehabilitative, palliative, convalescent, preventative or other
health services;
“health nuisance” means a situation, or state of affairs, that endan-
gers life or health or adversely affects the well-being of a person
or community;
“health officer” means the person appointed as health officer in
terms of section 80(1);
“health research” includes any research which contributes to
knowledge of —
(a) the biological, clinical, psychological or social processes in
human beings;
(b) improved methods for the provision of health services;
(c) human pathology;
(d) the causes of disease;
(e) the effects of the environment on the human body;
(f) the development or new application of pharmaceuticals,
medicines and related substances; and
(g) the development of new applications of health technology;
“health research ethics committee” means any committee regis-
tered in terms of section 73;
4
The Nursing Act of 1978 has been repealed and replaced by the Nursing
Act 33 of 2005.
43
“health services” means —

(a) health care services, including reproductive health care and
emergency medical treatment, contemplated in section 27
of the Constitution;5
(b) basic nutrition and basic health care services contemplated
in section 28(1)(c) of the Constitution;6
5
Section 27 of the Constitution provides as follows:
Health care, food, water and social security
(1) Everyone has the right to have access to —
(a) Health care services, including reproductive health care;
(b) Sufficient food and water; and
(c) Social security, including, if they are unable to support them-
selves and their dependants, appropriate social assistance.
(2) The state must take reasonable legislative and other measures,
within its available resources, to achieve the progressive realisation
of each of these rights.
(3) No one may be refused emergency medical treatment.
6
According to section 28(1)(c) of the Constitution, every child has the
right to basic nutrition, shelter, basic health care services and social ser-
vices. There is no definition of ‘basic health care services’. Importantly,
however, there is no provision in section 28(1)(c) for these rights of chil-
dren to be realised progressively. This means that a child’s right to basic
health care services is immediately realisable. In Governing Body of the
Juma Musjid Primary School and others v Essay NO and others (Centre for
Child Law and another, amici curiae) 2011 (8) BCLR 761 (CC) at para 37
the Constitutional Court referred to the immediately realisable nature
of the right to basic education — another right that is not limited by
the internal limitation of ‘progressive realisation’. What ‘immediately
realisable’ means in practice has not yet been defined by the courts.
Dr Faranaaz Veriava has written that ‘where there is a violation of the
right to basic education, government will be required to provide a par-
ticular educational input immediately, unless and to the extent that it
is impossible under the circumstances.’ F Veriava ‘The Contribution of
the Courts and of Civil Society to the Development of a Transformative
Constitutionalist Narrative for the Right to Basic Education’ LLD thesis,
University of Pretoria, 2018.
44
(c) medical treatment contemplated in section 35(2)(e) of the

Constitution;7 and
(d) municipal health services;8
“health technology” means machinery or equipment that is used
in the provision of health services, but does not include medicine
as defined in section 1 of the Medicines and Related Substances
Control Act, 1965 (Act No. 101 of 1965);9
7
According to section 35(2) of the Constitution, everyone who is detained
by the state, such as an inmate in a correctional centre, must be held
in a way that respects their dignity and provides them with legal rep-
resentation, adequate nutrition and medical treatment at state expense.
In Minister of Health of the Province of the Western Cape v Goliath and
Others (13741/07) [2008] ZAWCHC 41; 2009 (2) SA 248 (C) (Goliath) the
Western Cape High Court accepted the argument made by the respond-
ents that persons detained in terms of the NHA (in order to be treated
for drug-resistant TB against their will) are also entitled to the protec-
tions contained in section 35(2) of the Constitution. However, the court
did not consider this point from a legal perspective and another court
may make a different decision. In addition, in Dudley Lee v Minister for
Correctional Services (CCT 20/12) [2012] ZACC 30; 2013 (2) BCLR 129
(CC); 2013 (2) SA 144 (CC); 2013 (1) SACR 213 (CC), the Constitutional
Court considered certain legal questions around Mr Lee’s contracting TB
while he was an awaiting-trial prisoner at Pollsmoor for six years. Mr Lee
sued the Minister for damages on the basis that poor prison health man-
agement resulted in his being infected with TB. Although the judgment
does not rely on the NHA, this is an important health-related judgment
because it affirmed that there is a legal duty on the responsible author-
ities to provide adequate health services as part of the constitutional
right of all prisoners to conditions of detention that are consistent with
human dignity, and that there was, in this case, a probable chain of
causation between the negligent omissions by the responsible authori-
ties and Mr Lee’s infection with TB.
8
See the definition of ‘municipal health services’ below.
9
According to section 1 of the Medicines and Related Substances Act 101
of 1965, a ‘medicine’ means any substance that is claimed to be able
to diagnose, treat, mitigate, modify or prevent a disease. A medicine,
however, is not a machine. For example, even though a device such as a
45
“health worker” means any person who is involved in the provision

of health services to a user, but does not include a health care
provider;
“hospital” means a health establishment which is classified as a hos-
pital by the Minister in terms of section 35;10
“inspector” means any person appointed as an inspector in terms
of section 80(2);
“military health establishment” means a health establishment
which is, in terms of the Constitution and the Defence Act, 2002
(Act No. 42 of 2002), the responsibility of and under the direct or
indirect authority and control of the President, as Commander in
Chief, and the Minister of Defence, and includes —
(a) the Institutes for Aviation and Maritime Medicine;
(b) the Military Psychological Institute;
(c) military laboratory services; and
(d) military training and educational centres;
“Minister” means the Cabinet member responsible for health;
“municipal council” means a municipal council contemplated in
section 157(1) of the Constitution;11
“municipal health services”, for the purposes of this Act, includes —
(a) water quality monitoring;
(b) food control;
pace maker does help prevent heart attacks, it would not be considered
a medicine, while a tablet that reduces the risk of heart disease would be
a medicine. A pace maker would be a ‘health technology’, according to
the NHA’s definition.
10
The Minister, in consultation with the National Health Council, prom-
ulgated regulations on 2 March 2012 that classify categories of hospital
and list all public hospitals. The regulations specify which services dif-
ferent categories of hospital must provide.
11
According to the Constitution, a municipal council is the elected body
that is given both administrative and legislative powers in respect of a
particular municipality. Section 157(1) of the Constitution sets out the
requirements for the composition and election of municipal councils.
46
(c) waste management;

(d) health surveillance of premises;
(e) surveillance and prevention of communicable diseases,
excluding immunisations;
(f) vector control;
(g) environmental pollution control;
(h) disposal of the dead; and
(i) chemical safety, but excludes port health, malaria control
and control of hazardous substances;
“municipality” means a municipality as defined in section 1 of the
Local Government: Municipal Systems Act, 2000 (Act No. 32 of
2000);12
“national department” means the national Department of Health;
“National Health Council” means the Council established by sec-
tion 22(1);
“national health policy” means all policies relating to issues of
national health as approved by the Minister;
“National Health Research Committee” means the Committee
established in terms of section 69(1);
“National Health Research Ethics Council” means the Council
established by section 72(1);
“national health system” means the system within the Republic,
whether within the public or private sector, in which the individ-
ual components are concerned with the financing, provision or
delivery of health services;
12
According to section 1 of the Local Government: Municipal Systems
Act, the definition of ‘municipality’ depends on how the word is used.
Municipality refers either to the municipal government (ie the munic-
ipal council itself) or to the physical geographic area of a municipality.
Throughout the text, the NHA ordinarily uses the word ‘municipality’
on its own to refer to a municipal government. When the NHA intends
to refer to a geographic area, it uses the term ‘metropolitan or district
municipality’.
47
“non-communicable disease” means a disease or health condition

that cannot be contracted from another person, an animal or
directly from the environment;
“norm” means a statistical normative rate of provision or measurable
target outcome over a specified period of time;
“Office” means the Office of Health Standards Compliance estab-
lished by section 77(1);
“Ombud” means the person appointed as Ombud in terms of sec-
tion 81(1);
“oocyte” means a developing human egg cell;
“organ” means any part of the human body adapted by its structure
to perform any particular vital function, including the eye and
its accessories, but does not include skin and appendages, flesh,
bone, bone marrow, body fluid, blood or a gamete;
“organ of state” means an organ of state as defined in section 239
of the Constitution;13
“pollution” means pollution as defined in section 1 of the National
Environmental Management Act, 1998 (Act No. 107 of 1998);14
“premises” means any building, structure or tent together with the
land on which it is situated and the adjoining land used in con-
nection with it and includes any land without any building, struc-
ture or tent and any vehicle, conveyance or ship;
13
According to section 239 of the Constitution, an organ of state includes
all government departments at the national, provincial or local levels.
This includes, for example, the NDoH, provincial departments of health
and local government health departments. Statutory institutions, such
as the National Health Council or the Forum for Statutory Health
Professionals, are also regarded as organs of state. Administrators of
public facilities, such as public hospitals, are also organs of state.
14
Section 1 of the National Environmental Management Act defines pollu-
tion as anything, including things like noises and smells, that changes
the environment in a way that has a negative effect on human health,
the ecosystem in the area, or on the ability of people to use the land.
48
“prescribed” means prescribed by regulation made under section

90;15
“primary health care services” means such health services as may
be prescribed by the Minister to be primary health care services;16
“private health establishment” means a health establishment that
is not owned or controlled by an organ of state;
“provincial department” means any provincial department respon-
sible for health;
“Provincial Health Council” means a Council established by section
26(1);
“public health establishment” means a health establishment that is
owned or controlled by an organ of state;17
15
See Appendix A for a list of regulations prescribed under the NHA.
16
The Minister has not prescribed which services constitute primary
health care services. See note 25 on page 54 below for more on the sig-
nificance of a definition for ‘primary health care services’. A number of
policies that relate to primary health care services have, however, been
developed. See Appendix C for a list of a selection of the policies.
17
All public health establishments are bound by the provisions of section
195 of the Constitution. Because of its importance, section 195 is repro-
duced here in full:
Basic values and principles governing public administration
(1) Public administration must be governed by the democratic values
and principles enshrined in the Constitution, including the follow-
ing principles:
(a) A high standard of professional ethics must be promoted and
maintained.
(b) Efficient, economic and effective use of resources must be
promoted.
(c) Public administration must be development-oriented.
(d) Services must be provided impartially, fairly, equitably and
without bias.
(e) People’s needs must be responded to, and the public must be
encouraged to participate in policy-making.
(f) Public administration must be accountable.
49
“rehabilitation” means a goal-orientated and time-limited process

aimed at enabling impaired persons to reach an optimum mental,
physical or social functional level;
“relevant member of the Executive Council” means the member
of the Executive Council of a province responsible for health;
“statutory health professional council” means —
(a) the Health Professions Council of South Africa established
by section 2 of the Health Professions Act, 1974 (Act No. 56
of 1974);18
(g) Transparency must be fostered by providing the public with

timely, accessible and accurate information.
(h) Good human-resource management and career-development
practices, to maximise human potential, must be cultivated.
(i) Public administration must be broadly representative of the
South African people, with employment and personnel man-
agement practices based on ability, objectivity, fairness, and
the need to redress the imbalances of the past to achieve broad
representation.
(2) The above principles apply to —
(a) administration in every sphere of government;
(b) organs of state; and
(c) public enterprises.
(3) National legislation must ensure the promotion of the values and
principles listed in subsection (1). The appointment in public
administration of a number of persons on policy considerations is
not precluded, but national legislation must regulate these appoint-
ments in the public service.
(4) Legislation regulating public administration may differentiate
between different sectors, administrations or institutions.
(5) The nature and functions of different sectors, administrations or
institutions of public administration are relevant factors to be taken
into account in legislation regulating public administration.
18
The functions of the HPCSA include a duty to ‘uphold and maintain
professional and ethical standards within health professions in order to
protect the interest of the public’. Section 53 of the Health Professions
Act requires health professionals to disclose to patients the fee that will
be charged prior to rendering a service on request or if the fee exceeds
50
(b) the South African Nursing Council established by section 2

of the Nursing Act, 1978 (Act No. 50 of 1978);19
(c) the South African Pharmacy Council established by section
2 of the Pharmacy Act, 1974 (Act No. 53 of 1974);
(d) the Allied Health Professions Council of South Africa estab-
lished by section 2 of the Allied Health Professions Act, 1982
(Act No. 63 of 1982);
(e) the South African Dental Technicians Council contemplated
in section 2 of the Dental Technicians Act, 1979 (Act No. 19
of 1979); and
(f) such other statutory health professional council as the
Minister may prescribe;
“this Act” includes any regulation made thereunder;
“tissue” means human tissue, and includes flesh, bone, a gland, an
organ, skin, bone marrow or body fluid, but excludes blood or a
gamete;
“use”, in relation to tissue, includes preserve or dissect;
“user” means the person receiving treatment in a health establish-
ment, including receiving blood or blood products, or using a
health service, and if the person receiving treatment or using a
health service is —
(a) below the age contemplated in section 39(4) of the Child
Care Act, 1983 (Act No. 74 of 1983), “user” includes the
person’s parent or guardian or another person authorised
by law to act on the first mentioned person’s behalf;20 or
what is usually charged for such services. This is an important way to

ensure that patients are not over-charged for health care services, par-
ticularly in the private sector.
19
See note 4 on page 43 above.
20
The Child Care Act was repealed by the Children’s Act 38 of 2005.
Section 129 of the Children’s Act sets out the rules for when a child is
able to consent to medical treatment. For normal medical procedures,
a child can consent if they are over 12 years and have the ability to
51
(b) incapable of taking decisions, “user” includes the person’s

spouse or partner or, in the absence of such spouse or part-
ner, the person’s parent, grandparent, adult child or brother
or sister, or another person authorised by law to act on the
first mentioned person’s behalf;
“zygote” means the product of the union of a male and a female
gamete.
Chapter 1
OBJECTS OF ACT, RESPONSIBILITY FOR HEALTH AND
ELIGIBILITY FOR FREE HEALTH SERVICES
2. Objects of Act
The objects of this Act are to regulate national health and to provide
uniformity in respect of health services across the nation by —
(a) establishing a national health system which —
(i) encompasses public and private providers of health services;
and
understand the benefits, risks, and consequences of the treatment.

Consent for surgical treatment is the same, except the child must also
be assisted by a parent or guardian when making a decision. The Act
also governs the HIV testing of children (see section 130). Children can
consent to HIV tests at age 12 or younger if of sufficient maturity to
understand the benefits, risk and social implications of the HIV test.
Section 133 prohibits anyone from disclosing a child’s HIV status with-
out consent, and section 134 governs children’s access to contracep-
tives. Consent for the termination of pregnancy is different. Section 5
of the Choice of Termination of Pregnancy Act 92 of 1996 says that a
minor must be advised by a medical practitioner, registered midwife or
registered nurse to speak to a parent, guardian, family member or friend
before terminating a pregnancy. Importantly, however, a child cannot
be denied a termination if — after being so advised — she chooses not
to talk to anyone else. The UCT Children’s Institute has published a
series of helpful guides to the Children’s Act for health professionals and
others in the health sector. The guides can be found here: http://www.ci.uct.
ac.za/ci/law-reform/childrens-act/guides.
52
(ii) provides in an equitable manner the population of the

Republic with the best possible health services that available
resources can afford;
(b) setting out the rights and duties of health care providers, health
workers, health establishments and users; and
(c) protecting, respecting, promoting and fulfilling the rights of —
(i) the people of South Africa to the progressive realisation
of the constitutional right of access to health care ser-
vices, including reproductive health care;
(ii) the people of South Africa to an environment that is not
harmful to their health or well-being;
(iii) children to basic nutrition and basic health care services
contemplated in section 28(1)(c) of the Constitution;21
and
(iv) vulnerable groups such as women, children, older per-
sons and persons with disabilities.
3. Responsibility for health22
(1) The Minister must, within the limits of available resources —
(a) endeavour to protect, promote, improve and maintain the
health of the population;23
21
According to section 28(1) of the Constitution, every child has the right
to basic nutrition, shelter, basic health care services and social services.
22
The Minister has promulgated the Policy Guidelines for the Licensing
of Residential and/or Day Care Facilities for Persons with Mental Illness
and/or severe or Profound Intellectual Disabilities in terms of this
section of the NHA. A link to the Policy Guidelines can be found in
Appendix A.
23
In Treatment Action Campaign and Another v Rath and Others (12156/05)
[2008] ZAWCHC [2008]; 4 All SA 360 (C) (13 June 2008), the Western
Cape High Court held that the Minister of Health’s obligation to pro-
tect, promote, improve and maintain the health of the population cre-
ated obligations on the Minister to implement national health policy,
including policies established in other legislation, such as the Medicines
53
(b) promote the inclusion of health services in the socio-eco-

nomic development plan of the Republic;
(c) determine the policies and measures necessary to protect,
promote, improve and maintain the health and well-being
of the population;24
(d) ensure the provision of such essential health services, which
must at least include primary health care services, to the
population of the Republic as may be prescribed after con-
sultation with the National Health Council;25 and
(e) equitably prioritise the health services that the State can
provide.26
(2) The national department, every provincial department and
every municipality must establish such health services as are
required in terms of this Act, and all health establishments and
health care providers in the public sector must equitably pro-
vide health services within the limits of available resources.
and Related Substances Act (Medicines Act). For more information, see
Appendix B relating to the Medicines Act.
24
The Minister promulgated the Policy on the Management of Public
Hospitals in terms of this section. A link to the Policy can be found in
Appendix C.
25
Even though section 3 requires the Minister of Health to ensure that
essential health services — which must include but are not limited to
primary health care services — are provided, it leaves it to the Minister
to determine the content of both ‘essential health services’ and ‘primary
health care services’. As of April 2019, the Minister had not yet promul-
gated a definition for either.
26
The use of the concept of equity here is important. As opposed to ‘equal-
ity’, which requires equal treatment, ‘equity’ requires just treatment
according to the circumstances of different people. This means that
different interventions will be required for different people or commu-
nities. In a rural area, for example, access to health services may require
the provision of staff accommodation or transport for health service
users coming from far away, which may not be required in urban areas.
54
4. Eligibility for free health services in public health

establishments
(1) The Minister, after consultation with the Minister of Finance,
may prescribe conditions subject to which categories of persons
are eligible for such free health services at public health estab-
lishments as may be prescribed.27
(2) In prescribing any condition contemplated in subsection (1),
the Minister must have regard to —
(a) the range of free health services currently available;
(b) the categories of persons already receiving free health
services;
(c) the impact of any such condition on access to health ser-
vices; and
(d) the needs of vulnerable groups such as women, children,
older persons and persons with disabilities.
(3) Subject to any condition prescribed by the Minister, the State
and clinics and community health centres funded by the State
must provide —
(a) pregnant and lactating women and children below the age
of six years, who are not members or beneficiaries of medi-
cal aid schemes, with free health services;28
27
As of April 2019, the Minister had not yet determined any conditions
regarding eligibility for free health services. That means there are no
restrictions on the list of people eligible for free health services or free
primary health services set out in subsection (3), and these categories
of people must be provided with the relevant free services, regardless
of nationality or any other characteristics. The Minister could expand
the range of free services currently available, in consultation with the
Minister of Finance. These may be subject to conditions as determined
by the Ministers.
28
It is important to note here that there is nothing limiting the care avail-
able to pregnant and lactating women and children under the age of
six years to primary health care services. The right is to all health care
services. It is also important that the right of the pregnant and lactating
55
(b) all persons, except members of medical aid schemes and

their dependants and persons receiving compensation
for compensable occupational diseases, with free primary
health care services; and
(c) women, subject to the Choice on Termination of Pregnancy
Act, 1996 (Act No. 92 of 1996), free termination of preg-
nancy services.
CHAPTER 2
RIGHTS AND DUTIES OF USERS AND HEALTH CARE
PERSONNEL
5. Emergency treatment29
A health care provider, health worker or health establishment may
not refuse a person emergency medical treatment.30
woman is not limited to her health needs as they relate to her preg-
nancy or lactation.
29
See pages 7–8 in the Introduction to this Guide for further information
on access to emergency treatment.
30
There is no definition of ‘emergency medical treatment’ but provi-
sion of such treatment has been dealt with in two Constitutional
Court cases. In Soobramoney v Minister of Health (Kwazulu-Natal),
(CCT32/97) [1997] ZACC 17; 1998 (1) SA 765 (CC); [1998] 1 All SA 268
(CC) (Soobramoney) the Constitutional Court helped to define what
emergency medical treatment means in terms of section 27(3) of the
Constitution. In Soobramoney, the applicant was suffering from renal
failure which required ongoing dialysis treatment in order to keep him
alive. Mr Soobramoney claimed that because the treatment was life-sav-
ing, it should be considered ‘emergency medical treatment’ that cannot
be refused. The court, however, said that ‘emergency medical treatment’
refers to treatment that is necessary because of a ‘sudden catastrophe
which calls for immediate medical attention’. A person suffering from
a treatable but incurable condition, such as renal failure, does not fall
within the protection of section 27(3) of the Constitution, but is instead
protected by the obligations imposed on the state by section 27(2),
which requires the state to take all reasonable measures to ensure that
access to health care services is progressively realised. The Constitutional
56
6. User to have full knowledge31

(1) Every health care provider must inform a user of —
(a) the user’s health status except in circumstances where
there is substantial evidence that the disclosure of the user’s
health status would be contrary to the best interests of the
user;
(b) the range of diagnostic procedures and treatment options
generally available to the user;
(c) the benefits, risks, costs and consequences generally associ-
ated with each option; and
(d) the user’s right to refuse health services and explain the
implications, risks, obligations of such refusal.
(2) The health care provider concerned must, where possible,
inform the user as contemplated in subsection (1) in a language
that the user understands and in a manner which takes into
account the user’s level of literacy.
Court’s ruling allowed Mr Soobramoney to be refused any further dial-

ysis treatment in the public health care sector. Mr Soobramoney died
from his condition a week after the Constitutional Court’s judgment.
In Oppelt v Head: Health, Department of Health Provincial Administration:
Western Cape (CCT185/14) [2015] ZACC 33; 2016 (1) SA 325 (CC); 2015
(12) BCLR 1471 (CC), the majority found that an unreasonable delay in
transferring a young man with a spinal cord injury to specialised care
that could have prevented his permanent paralysis constituted a ‘con-
structive’ refusal of emergency medical treatment in violation of section
27(3) of the Constitution.
Two regulations relating to emergency medical treatment have
been promulgated: the Regulations Relating to Emergency Care at Mass
Gathering Events, and the Emergency Medical Services Regulations.
Links to both sets of regulations can be found in Appendix A.
31
on full user knowledge.
57
7. Consent of user32
(1) Subject to section 8, a health service may not be provided to a
user without the user’s informed consent, unless —
(a) the user is unable to give informed consent and such con-
sent is given by a person —
(i) mandated by the user in writing to grant consent on his
or her behalf; or
(ii) authorised to give such consent in terms of any law or
court order;
(b) the user is unable to give informed consent and no person
is mandated or authorised to give such consent, and the
consent is given by the spouse or partner of the user or, in
the absence of such spouse or partner, a parent, grandpar-
ent, an adult child or a brother or a sister of the user, in the
specific order as listed;
(c) the provision of a health service without informed consent
is authorised in terms of any law or a court order;33
(d) failure to treat the user, or group of people which includes
the user, will result in a serious risk to public health; or
(e) any delay in the provision of the health service to the user
might result in his or her death or irreversible damage to his
32
on user consent.
33
After many years of development, the Regulations Relating to the
Surveillance and the Control of Notifiable Medical Conditions were
promulgated on 15 December 2017. A link to the regulations can be
found in Appendix A. Regulation 15 deals with mandatory medical
examination, prophylaxis, treatment, isolation and quarantine, and
provides that the head of a provincial department of health must apply
to a High Court for a court order if a person who is a clinical or labora-
tory confirmed case, carrier or contact of a notifiable medical condition
refuses consent for medical examination, prophylaxis, treatment, iso-
lation and quarantine. Various protections are put in place to prevent
court orders under this section being sought unnecessarily.
58
or her health and the user has not expressly, impliedly or by

conduct refused that service.
(2) A health care provider must take all reasonable steps to obtain
the user’s informed consent.34
(3) For the purposes of this section “informed consent” means con-
sent for the provision of a specified health service given by a
person with legal capacity to do so and who has been informed
as contemplated in section 6.
8. Participation in decisions35
(1) A user has the right to participate in any decision affecting his or
her personal health and treatment.
(2) (a) If the informed consent required by section 7 is given by a
person other than the user, such person must, if possible,
consult the user before giving the required consent.
(b) A user who is capable of understanding must be informed
as contemplated in section 6 even if he or she lacks the legal
capacity to give the informed consent required by section 7.
(3) If a user is unable to participate in a decision affecting his or
her personal health and treatment, he or she must be informed
as contemplated in section 6 after the provision of the health
34
For a patient in a hospital or clinic to give informed consent, he or
she must know about and understand which health service is going
to be given to him or her. They must also know about and understand
the risks of that service. This well-recognised principle of our law was
first set out in Stoffberg v Elliott 1923 CPD 12 and was confirmed by
the Supreme Court of Appeal in Louwrens v Oldwage (181/2004) [2005]
ZASCA 81; 2006 (2) SA 161 (SCA); [2006] 1 All SA (SCA). However, even
though patients must know about and understand the risks before
giving consent, their doctor does not have to warn them of every possi-
ble risk (such as the risk of minor harm that is unlikely to occur).
35
on user participation in decisions.
59
service in question unless the disclosure of such information

would be contrary to the user’s best interest.
9. Health service without consent36
(1) Subject to any applicable law, where a user is admitted to a
health establishment without his or her consent, the health
establishment must notify the head of the provincial depart-
ment in the province in which that health establishment is sit-
uated within 48 hours after the user was admitted of the user’s
admission and must submit such other information as may be
prescribed.
(2) If the 48-hour-period contemplated in subsection (1) expires
on a Saturday, Sunday or public holiday, the health establish-
ment must notify the head of the provincial department of the
user’s admission and must submit the other information con-
templated in subsection (1) at any time before noon of the next
day that is not a Saturday, Sunday or public holiday.
(3) Subsection (1) does not apply if the user consents to the provi-
sion of any health service in that health establishment within 24
hours of admission.
10. Discharge reports
(1) A health care provider must provide a user with a discharge
report at the time of the discharge of the user from a health
establishment containing such information as may be
prescribed.
(2) In prescribing the information contemplated in subsection (1),
the Minister must have regard to —
(a) the nature of the health service rendered;
(b) the prognosis for the user; and
(c) the need for follow-up treatment.
36
on the provision of health services without consent.
60
(3) A discharge report provided to a user may be verbal in the

case of an outpatient, but must be in writing in the case of an
inpatient.
11. Health services for experimental or research purposes
(1) Before a health establishment provides a health service for
experimental or research purposes to any user and subject to
subsection (2), the health establishment must inform the user in
the prescribed manner that the health service is for experimen-
tal or research purposes or part of an experimental or research
project.37
(2) A health establishment may not provide any health service to
a user for a purpose contemplated in subsection (1) unless the
user, the health care provider primarily responsible for the user’s
treatment, the head of the health establishment in question
and the relevant health research ethics committee, or any other
person to whom that authority has been delegated, has given
prior written authorisation for the provision of the health service
in question.
12. Duty to disseminate information38
The national department and every provincial department, district
health council and municipality must ensure that appropriate, ade-
quate and comprehensive information is disseminated on the health
services for which they are responsible, which must include —
(a) the types and availability of health services;
(b) the organisation of health services;
(c) operating schedules and timetables of visits;
37
The Regulations relating to Research on Human Participants prescribes
in regulation 5 how users must be informed of the nature of the service.
The regulations were promulgated on 19 September 2014. A link to the
regulation can be found in Appendix A.
38
See page 10 in the Introduction to this Guide for further information on
the duty to disseminate information.
61
(d) procedures for access to the health services;

(e) other aspects of health services which may be of use to the
public;
(f) procedures for laying complaints; and
(g) the rights and duties of users and health care providers.
13. Obligation to keep record
Subject to National Archives of South Africa Act, 1996 (Act No. 43
of 1996), and the Promotion of Access to Information Act, 2000 (Act
No. 2 of 2000), the person in charge of a health establishment must
ensure that a health record containing such information as may be
prescribed is created and maintained at that health establishment for
every user of health services.
14. Confidentiality39
(1) All information concerning a user, including information relat-
ing to his or her health status, treatment or stay in a health
establishment, is confidential.
39
In Tshabalala-Msimang and Another v Makhanya and Others (18656/07)
[2007] ZAGPHC 161; 2008 (6) SA 102 (W); [2008] 1 All SA 509 (W),
then Minister of Health Dr Tshabalala-Msimang sued the editor, two
journalists and the publisher of the Sunday Times for allegedly violating
her right to privacy under the Constitution and infringing the NHA’s
protections against obtaining or disclosing the contents of a person’s
medical records without his or her consent. The High Court said that
details of a public figure’s private medical records may be published if
publication is in the public interest. However, possession of the medical
records by the media may still be a crime under section 17 of the NHA.
While the court allowed the continued publication of articles regarding
the Minister, it also ordered that the records be returned to the health
establishment. In most circumstances, a non-public figure’s medical
records are not a matter of public interest and the media would not be
allowed to promulgate them, even if a reporter was able to get access to
them. Additionally, health care workers are not ordinarily allowed to
discuss a person’s health status with anyone other than the patient. In
this way, for example, the NHA attempts to protect people against being
62
(2) Subject to section 15, no person may disclose any information

contemplated in subsection (1) unless —
(a) the user consents to that disclosure in writing;
(b) a court order or any law requires that disclosure; or
(c) non-disclosure of the information represents a serious threat
to public health.
15. Access to health records
(1) A health worker or any health care provider that has access to
the health records of a user may disclose such personal informa-
tion to any other person, health care provider or health estab-
lishment as is necessary for any legitimate purpose within the
ordinary course and scope of his or her duties where such access
or disclosure is in the interests of the user.
(2) For the purpose of this section, “personal information” means
personal information as defined in section 1 of the Promotion of
Access to Information Act, 2000 (Act No. 2 of 2000).40
stigmatised when they go to a health facility for a medical assessment

or treatment for a cause of illness such as infection with HIV.
40
According to section 1 of the Promotion of Access to Information Act,
‘personal information’ means information about an identifiable indi-
vidual, including, but not limited to —
(a) information relating to the race, gender, sex, pregnancy, marital
status, national, ethnic or social origin, colour, sexual orientation,
age, physical or mental health well-being, disability, religion, con-
science, belief, culture, language and birth of the individual;
(b) information relating to the education or the medical, criminal or
employment history of the individual or information relating to
financial transactions in which the individual has been involved;
(c) any identifying number, symbol or other particular assigned to the
individual;
(d) the address, fingerprints or blood type of the individual;
(e) the personal opinions, views or preferences of the individual,
except where they are about another individual or about a proposal
for a grant, an award or a prize to be made to another individual;
63
16. Access to health records by health care provider

(1) A health care provider may examine a user’s health records for
the purposes of —
(a) treatment with the authorisation of the user; and
(b) study, teaching or research with the authorisation of the
user, head of the health establishment concerned and the
relevant health research ethics committee.
(2) If the study, teaching or research contemplated in subsection
(1)(b) reflects or obtains no information as to the identity of the
user concerned, it is not necessary to obtain the authorisations
contemplated in that subsection.
17. Protection of health records
(1) The person in charge of a health establishment in possession of
a user’s health records must set up control measures to prevent
unauthorised access to those records and to the storage facility
in which, or system by which, records are kept.
(2) Any person who —41
(a) fails to perform a duty imposed on them in terms of subsec-
tion (1);
(f) correspondence sent by the individual that is implicitly or explic-

itly of a private or confidential nature or further correspondence
that would reveal the contents of the original correspondence;
(g) the views or opinions of another individual about the individual;
(h) the views or opinions of another individual about a proposal for a
grant, an awarder a prize to be made to the individual, but exclud-
ing the name of the other individual where it appears with the
views or opinions of the other individual; and
(i) the name of the individual where it appears with other personal
information relating to the individual or where the disclosure of
the name itself would reveal information about the individual,
but excludes information about an individual who has been dead for
more than 20 years.
41
See note 39 on page 62 above.
64
(b) falsifies any record by adding to or deleting or changing any

information contained in that record;
(c) creates, changes or destroys a record without authority to
do so;
(d) fails to create or change a record when properly required to
do so;
(e) provides false information with the intent that it be included
in a record;
(f) without authority, copies any part of a record;
(g) without authority, connects the personal identification ele-
ments of a user’s record with any element of that record
that concerns the user’s condition, treatment or history;
(h) gains unauthorised access to a record or record-keeping
system, including intercepting information being trans-
mitted from one person, or one part of a record-keeping
system, to another;
(i) without authority, connects any part of a computer or other
electronic system on which records are kept to —
(i) any other computer or other electronic system; or
(ii) any terminal or other installation connected to or form-
ing part of any other computer or other electronic
system; or
(j) without authority, modifies or impairs the operation of —
(i) any part of the operating system of a computer or other
electronic system on which a user’s records are kept; or
(ii) any part of the programme used to record, store,
retrieve or display information on a computer or other
electronic system on which a user’s records are kept,
commits an offence and is liable on conviction to a fine or to impris-
onment for a period not exceeding one year or to both a fine and
such imprisonment.
65
18. Laying of complaints42

(1) Any person may lay a complaint about the manner in which
he or she was treated at a health establishment and have the
complaint investigated.
(2) The relevant member of the Executive Council and every
municipal council must establish a procedure for the laying of
complaints within those areas of the national health system for
which they are responsible.
(3) The procedures for laying complaints must —
(a) be displayed by all health establishments in a manner that
is visible for any person entering the establishment and the
procedure must be communicated to users on a regular
basis;
(b) in the case of a private health establishment, allow for
the laying of complaints with the head of the relevant
establishment;
(c) include provisions for the acceptance and acknowledg-
ment of every complaint directed to a health establishment,
whether or not it falls within the jurisdiction or authority of
that establishment; and
(d) allow for the referral of any complaint that is not within the
jurisdiction or authority of the health establishment to the
appropriate body or authority.
(4) In laying a complaint, the person contemplated in subsection (1)
must follow the procedure established by the relevant member
of the Executive Council or the relevant municipal council, as
the case may be.
19. Duties of users
A user must —
42
See the relevant section in the Introduction to this Guide for further
information on the laying of complaints.
66
(a) adhere to the rules of the health establishment when

receiving treatment or using health services at the health
establishment;
(b) subject to section 14 provide the health care provider with
accurate information pertaining to his or her health status
and co-operate with health care providers when using
health services;
(c) treat health care providers and health workers with dignity
and respect; and
(d) sign a discharge certificate or release of liability if he or she
refuses to accept recommended treatment.
20. Rights of health care personnel
(1) Health care personnel may not be unfairly discriminated against
on account of their health status.
(2) Despite subsection (1) but subject to any applicable law, the
head of the health establishment concerned may in accordance
with any guidelines determined by the Minister impose con-
ditions on the service that may be rendered by a health care
provider or health worker on the basis of his or her health status.
(3) Subject to any applicable law, every health establishment must
implement measures to minimise —
(a) injury or damage to the person and property of health care
personnel working at that establishment; and
(b) disease transmission.
(4) A health care provider may refuse to treat a user who is physi-
cally or verbally abusive or who sexually harasses him or her.
Chapter 3
NATIONAL HEALTH
21. General functions of national department
(1) The Director-General must —
67
(a) ensure the implementation of national health policy in so far

as it relates to the national department; and
(b) issue guidelines for the implementation of national health
policy.
(2) The Director-General must, in accordance with national health
policy —
(a) liaise with national health departments in other countries
and with international agencies;
(b) issue, and promote adherence to, norms and standards on
health matters, including —
(i) nutritional intervention;
(ii) environmental conditions that constitute a health
hazard;43
(iii) the use, donation and procurement of human tissue,
blood, blood products and gametes;
(iv) sterilisation and termination of pregnancy;
(v) the provision of health services, including social, physi-
cal and mental health care;
(vi) health services for convicted persons and persons await-
ing trial;
(vii) genetic services; and
(viii) any other matter that affects the health status of people
in more than one province;
(c) promote adherence to norms and standards for the training
of human resources for health;
(d) identify national health goals and priorities and monitor the
progress of their implementation;
43
The National Environmental Health Norms and Standards for Premises
and Acceptable Monitoring Standards for Environmental Health
Practitioners have been promulgated in terms of this section. A link to
the Norms and Standards can be found in Appendix A.
68
(e) co-ordinate health and medical services during national

disasters;
(f) facilitate and promote the provision of port health service
and participate in intersectoral and interdepartmental
collaboration;
(g) promote health and healthy lifestyles;
(h) promote community participation in the planning, provi-
sion and evaluation of health services;
(i) conduct and facilitate health systems research in the plan-
ning, evaluation and management of health services;
(j) facilitate the provision of indoor and outdoor environmental
pollution control services;
(k) facilitate and promote the provision of health services for
the management, prevention and control of communicable
and non-communicable diseases; and
(l) co-ordinate health services rendered by the national depart-
ment with the health services rendered by provinces and
provide such additional health services as may be necessary
to establish a comprehensive national health system.44
(3) (a) The Director-General must prepare strategic, medium term
health and human resources plans annually for the exercise
of the powers and the performance of the duties of the
national department.45
44
This is an important section but co-ordination is a weakness in the
health system. The NDoH complains of a failure by provincial depart-
ments to implement policies, while provincial departments complain
that ‘unfunded mandates’ (orders to do certain things or implement
certain policies without being given the necessary funding to do so) are
handed down by the NDoH. This section places a clear obligation on
the NDoH, and its accounting officer, the Director-General, to provide
services not provided by provincial departments to ensure the establish-
ment of a comprehensive national health system.
45
The National Department of Health: Strategic Plan 2015–2020 is
available at http://www.health.gov.za/index.php/2014-03-17-09-09-38/strategic-documents/
69
(b) The national health plans referred to in paragraph (a) must

form the basis of —
(i) the annual budget as required by the national depart-
ment responsible for finance and state expenditure; and
(ii) any other governmental planning exercise as may be
required by any other law.
(4) The national health plans must comply with national health
policy.
(5) The Director-General must integrate the health plans of the
national department and provincial departments annually
and submit the integrated health plans to the National Health
Council.46
22. Establishment and composition of National Health Council47
(1) A council to be known as the National Health Council is hereby
established.
(2) The National Health Council consists of —
(a) the Minister, or his or her nominee, who acts as chairperson;
(b) the Deputy Minister of Health, if there is one;
(c) the relevant members of the Executive Councils;
category/229-2015str?download=1057:strategic-plan-2015. The National Department of

Health Annual Performance Plan 2018/19–2020/21 can be found here:
http://www.health.gov.za/index.php/2014-03-17-09-09-38/strategic-documents/category/442-2018-stra-
tegic-documents?download=2680:annual-performance-plan-2018. There is no publicly avail-
able strategic, medium-term human resources plan.
46
It is unclear whether the integrated health plans required by this section
have been produced. They are not publicly available.
47
The most recent meeting of the National Health Council at the time of
publishing was reported to have been in December 2018, but the details
of the meetings are not publicly available. See the relevant section in the
Introduction to this Guide for further information on the importance of
monitoring proceedings in the National Health Council.
70
(d) one municipal councillor, representing organised local gov-

ernment and appointed by the national organisation con-
templated in section 163(a) of the Constitution;
(e) the Director-General and the Deputy Directors-General of
the national department;
(f) the head of each provincial department;
(g) one person employed and appointed by the national organ-
isation contemplated in section 163(a) of the Constitution;48
and
(h) the head of the South African Military Health Service.
23. Functions of National Health Council
(1) The National Health Council must advise the Minister on —
(a) policy concerning any matter that will protect, promote,
improve and maintain the health of the population,
including —
(i) responsibilities for health by individuals and the public
and private sector;
(ii) targets, priorities, norms and standards relating to the
equitable provision and financing of health services;
(iii) efficient co-ordination of health services;
(iv) human resources planning, production, management
and development;
(v) development, procurement and use of health
technology;
(vi) equitable financial mechanisms for the funding of
health services;
48
Section 163 the Constitution requires that legislation be enacted by
Parliament to ‘provide for the recognition of national and provincial
organisations representing municipalities’. The national organisation
referred to in section 163(a) is the South African Local Government
Association (SALGA), established in accordance with the provisions of
the Organised Local Government Act 52 of 1997.
71
(vii) the design and implementation of programmes to pro-

vide for effective referral of users between health estab-
lishments or health care providers, or to enable integra-
tion of public and private health establishments;
(viii) financial and other assistance received from foreign
governments and intergovernmental or nongovern-
mental organisations, the conditions applicable to
receiving such assistance and the mechanisms to ensure
compliance with these conditions;
(ix) epidemiological surveillance and monitoring of national
and provincial trends with regard to major diseases and
risk factors for disease; and
(x) obtaining, processing and use of statistical returns;
(b) proposed legislation pertaining to health matters prior to
such legislation being introduced into Parliament or a pro-
vincial legislature;
(c) norms and standards for the establishment of health
establishments;
(d) guidelines for the management of health districts;
(e) the implementation of national health policy;
(f) the national and provincial integrated health plans contem-
plated in section 21(5);
(g) an integrated national strategy for health research; and
(h) the performance of any other function determined by the
Minister.
(2) The National Health Council may determine the time frames,
guidelines and the format for the preparation of national and
provincial health plans.
(3) The National Health Council must strive to reach its decisions by
consensus but where a decision cannot be reached by consen-
sus, the decision of the majority of the members of the National
Health Council is the decision of the National Health Council.
72
(4) The National Health Council may consult with or receive rep-
resentations from any person, organisation, institution or
authority.
(5) The National Health Council may create one or more commit-
tees to advise it on any matter.
(6) The National Health Council determines the procedures for its
meetings.
(7) A quorum for the National Health Council is at least half of the
members plus one.
(8) The Minister or his or her nominee contemplated in section
22(2)(a) must convene the first meeting of the National Health
Council within 60 days of the commencement of this Act.
24. National Consultative Health Forum49
(1) The Minister must establish a body to be known as the National
Consultative Health Forum.
(2) The National Consultative Health Forum must promote and
facilitate interaction, communication and the sharing of infor-
mation on national health issues between representatives of the
national department, national organisations identified by the
Minister and provincial consultative bodies contemplated in
section 28.
(3) (a) Subject to paragraphs (b) and (c), the Minister must deter-
mine the composition and the place, date and time of any
meeting of the National Consultative Health Forum.
(b) The National Consultative Health Forum must include rele-
vant stakeholders.
(c) The National Consultative Health Forum must meet at least
once every 12 months.
49
The Presidency held a National Health Consultative meeting on 24
August 2018 on National Health Insurance. It is unclear whether this
was a National Consultative Health Forum meeting.
73
Chapter 4
PROVINCIAL HEALTH50
50
Health services is a functional area in which national government and
provincial government share legislative competence, while the only
health-related functional area that is the exclusive domain of provincial
government is ambulance services. Concurrent legislative competence
means that both provincial government and national government may
pass legislation that fits into the functional area of health services. If
there is a conflict between the provincial health services legislation and
the national health services legislation, section 146 of the Constitution
governs the resolution of these conflicts. In order for the national legis-
lation to prevail, certain requirements must be met, such as the national
legislation providing uniformity by establishing norms and standards,
frameworks and policies. There have not yet been any cases dealing with
conflicts between the NHA and provincial health legislation. It should
be reiterated that concurrent legislative competence allows provinces to
enact health services-related legislation, and it does not mean that the
provinces must rely exclusively on the NHA.
Another important provincial consideration is the power of the
national executive to intervene when a province cannot or does not
fulfil an executive obligation in terms of legislation or the Constitution.
The terms for such interventions are in section 100 of the Constitution.
In December 2011, Limpopo’s Department of Health was placed under
section 100(1)(b) national executive administration. The department
was returned to the control of the provincial administration in 2015.
The financial position of the department improved during the time of
intervention, although there has been subsequent deterioration, lead-
ing to calls for the Limpopo Department of Health to be placed under
administration again, because of its failure to pay the salaries of medical
personnel. On 26 April 2018 the North West Department of Health was
placed under the administration of the national government under sec-
tion 100(1)(b) of the Constitution.
There is no case law relating to interventions in provincial depart-
ments of health, but in Centre for Child Law and Others v Minister of Basic
Education and Others (1749/02) [2012] ZAECGHC 60; [2012] 4 All SA 35
(ECG) the Eastern Cape Department of Basic Education had been placed
under the administration of the national government in terms of sec-
tion 100(1)(b) of the Constitution. The court reiterated Constitutional
Court jurisprudence that, by intervening in terms of section 100(1)(b),
74
25. Provincial health services, and general functions of

provincial departments
(1) The relevant member of the Executive Council must ensure the
implementation of national health policy, norms and standards
in his or her province.
(2) The head of a provincial department must, in accordance with
national health policy and the relevant provincial health policy
in respect of or within the relevant province —51
(a) provide specialised hospital services;
(b) plan and manage the provincial health information system;
(c) participate in interprovincial and intersectoral co-ordination
and collaboration;
(d) co-ordinate the funding and financial management of dis-
trict health councils;
(e) provide technical and logistical support to district health
councils;
the national government takes on the powers of the provincial admin-

istration as well as its obligations. The case dealt with the Minister’s
obligation to fill certain non-teaching staff posts at schools. The court
held that the Minister is obliged to both declare post establishments and
fill those posts.
The South African Local Government Association published a posi-
tion paper on the provincialisation of personal primary health care ser-
vices in 2009. This document includes useful information on health
care services at a provincial level. It is available at
https://www.salga.org.za/Documents/Knowledge%20Hub/SALGA%20Position%20Papers/SALGA-Position-
Paper-on-Provincialisation-of-Primary-Health-Care.pdf.
51
The extensive powers and responsibilities of the head of department
in a provincial department of health are laid out here. While MECs for
Health hold political power, the HoDs bear significant legal responsi-
bility for the provision of health care services in the province. Political
interference in health can, therefore, put HoDs in the position of having
to decide whether to comply with political instructions from a superior
or with their obligations under the NHA. On paper, this may seem an
easy decision to make but, in reality, many HoDs have found it difficult.
75
(f) plan, co-ordinate and monitor health services and must

evaluate the rendering of health services;
(g) co-ordinate health and medical services during provincial
disasters;
(h) conduct or facilitate research on health and health services;
(i) plan, manage and develop human resources for the render-
ing of health services;
(j) plan the development of public and private hospitals, other
health establishments and health agencies;
(k) control and manage the cost and financing of public health
establishments and public health agencies;
(l) facilitate and promote the provision of comprehensive pri-
mary health services and community hospital services;
(m) provide and co-ordinate emergency medical services and
forensic pathology, forensic clinical medicines and related
services, including the provision of medico-legal mortuaries
and medico-legal services;
(n) control the quality of all health services and facilities;
(o) provide health services contemplated by specific provincial
health service programmes;
(p) provide and maintain equipment, vehicles and health care
facilities in the public sector;
(q) consult with communities regarding health matters;
(r) provide occupational health services;
(s) promote health and healthy lifestyles;
(t) promote community participation in the planning, provi-
sion and evaluation of health services;
(u) provide environmental pollution control services;
(v) ensure health systems research; and
(w) provide services for the management, prevention and con-
trol of communicable and non communicable diseases.
(3) The head of a provincial department must —
76
(a) prepare strategic, medium term health and human

resources plans annually for the exercise of the powers of,
the performance of the duties of and the provision of health
services in the province by the provincial department; and
(b) submit such plans to the Director-General within the time
frames and in accordance with the guidelines determined
by the National Health Council.
(4) Provincial health plans must conform with national health
policy.
26. Establishment and composition of Provincial Health
Council52
(1) A council to be known as the Provincial Health Council is hereby
established in each province.
(2) Every Provincial Health Council consists of —
(a) the relevant member of the Executive Council, or his or her
nominee, who acts as chairperson;
(b) one Councillor from each of the metropolitan municipalities
in the province if there are such municipalities in the prov-
ince in question;
(c) one Councillor from each of the district municipalities in the
province;
(d) the head of the provincial department;
52
KwaZulu-Natal Health Department inaugurated a provincial health
council in 2011. On 9 November 2012, the regulation for the council
was drafted (http://www.kznhealth.gov.za/mediarelease/2011/phc11.8.2011.htmf). However,
it is unclear whether the council is still functioning. Chapter 4 of the
Free State Health Act 2009 established a provincial health council
(http://www.fshealth.gov.za/portal/pls/portal/PORTAL.wwsbr_imt_services.GenericView?p_doc-
name=3136978.PDF&p_type=DOC&p_viewservice=VAH&p_searchstring). However, it is unclear
whether the council is still functioning. It is also unclear whether other
provinces have established and maintained the functioning of provin-
cial health councils. See the Introduction to this Guide for further infor-
mation on participation in provincial health councils.
77
(e) not more than three representatives involved in the man-

agement of local government; and
(f) such number of other persons as the relevant member of
the Executive Council may consider appropriate.
(3) The persons contemplated in subsection (2)(e) must be
appointed by the national and relevant provincial organisation
contemplated in section 163(a) of the Constitution.53
27. Functions of Provincial Health Council
(1) A Provincial Health Council must advise the relevant member of
the Executive Council on —
(a) policy concerning any matter that will protect, promote,
improve and maintain the health of the population within
the province, including —
(i) responsibilities for health within the province by individ-
uals and the public and private sector;
(ii) targets, priorities, norms and standards within the prov-
ince relating to the equitable provision and financing of
health services;
(iii) efficient co-ordination of health services within the
province and between neighbouring provinces;
(iv) human resources planning, production, management
and development;
(v) development, procurement and use of health technol-
ogy within the province;
(vi) equitable financial mechanisms for the funding of
health services within the province;
(vii) the design and implementation of programmes within
the province to provide for effective referral of users
between health establishments or health care providers
53
For more on section 163 of the Constitution, see note 48 on page 71
above.
78
or to enable integration of public and private health

establishments;
(viii) financial and other assistance received by the province
from foreign governments and intergovernmental or
nongovernmental organisations, the conditions appli-
cable to receiving such assistance and the mechanisms
to ensure compliance with these conditions;
(ix) epidemiological surveillance and monitoring of provin-
cial trends with regard to major diseases and risk factors
for disease; and
(x) obtaining, processing and use of statistical returns;
(b) proposed legislation relating to health matters before it is
introduced in the relevant provincial legislature;
(c) norms and standards for the establishment of health
establishments;
(d) guidelines for the management of health districts;
(e) the implementation of national and provincial health policy;
and
(f) the performance of any other function determined by the
relevant member of the Executive Council.
(2) A Provincial Health Council may determine the time frames,
guidelines and the format for the preparation of district health
plans within its jurisdiction.
(3) A Provincial Health Council may consult with or receive rep-
resentations from any person, organisation, institution or
authority.
(4) A Provincial Health Council determines the procedures for its
meetings.
(5) The Provincial Health Council may create one or more commit-
tees to advise it on any matter.
(6) A quorum of a Provincial Health Council is at least half of the
members plus one.
79
(7) The relevant member of the Executive Council or his or her

nominee contemplated in section 26(2)(a) must convene the
first meeting of the Provincial Health Council within 90 days of
commencement of this Act.54
28. Provincial consultative bodies55
(1) The relevant member of the Executive Council must establish a
consultative body for his or her province.
(2) A provincial consultative body must promote and facilitate
interaction, communication and the sharing of information on
provincial health issues between representatives of the provin-
cial department and provincial and municipal organisations
identified by the relevant member of the Executive Council.
(3) (a) Subject to paragraphs (b) and (c) the relevant member of
the Executive Council must determine the composition and
the place, date and time of any meeting of the provincial
consultative body in his or her province.
54
Given the apparent failure to establish provincial health councils in 7
out of 9 provinces, section 27(7) of the NHA appears not to have been
complied with.
55
The KwaZulu-Natal Health Department established a provincial health
consultative forum in Chapter 5 of the KwaZulu-Natal Health Act 2009
(http://www.rhap.org.za/wp-content/uploads/2014/05/KZN-Health-Act-1-20091.pdf).

The Act refers to section 28 of the NHA, stating that it applies to the
forum’s establishment and composition. The most recent meeting of
the forum appears to have taken place on 21 November 2017 (http://www.
kznhealth.gov.za/mediarelease/2017/Media-invite-Health-matters-to-fall-under-spotlight.htm).

The Free State Health Department established a provincial health con-
sultative forum in Chapter 4 of the Free State Health Act 2009
(http://www.fshealth.gov.za/portal/pls/portal/PORTAL.wwsbr_imt_services.GenericView?p_doc-
name=3136978.PDF&p_type=DOC&p_viewservice=VAH&p_searchstring=).
The forum’s most recent meeting appears to have been held in 2015
(https://www.ofm.co.za/article/local-news/161747/beleaguered-free-state-health-mec-holds-health-fo-
rum). See the Introduction to this Guide for further information on par-
ticipation in provincial health consultative forums.
80
(b) A provincial consultative body must include relevant

stakeholders.
(c) A provincial consultative body must meet at least once
every 12 months.
Chapter 5
DISTRICT HEALTH SYSTEM56
29. Establishment of district health system
(1) A district health system is hereby established.
(2) The system consists of various health districts, and the bound-
aries of health districts coincide with district and metropolitan
municipal boundaries.
30. Division of health districts into subdistricts
(1) (a) The relevant member of the Executive Council may, with
the concurrence of the member of the Executive Council
responsible for local government in the province in ques-
tion and subject to subsection (2), divide any health district
in the province into subdistricts and may determine and
change the boundaries of such subdistricts.
(b) Where a health district falls within more than one province,
the members of the Executive Council of all the relevant
provinces must agree to any division, determination or
change contemplated in paragraph (a).
(c) Details of any division, determination or change must be
published in the Gazette.
56
The Health Systems Trust publishes an annual District Health Barometer
(DHB), which is a tool designed to assist in making functional infor-
mation available for monitoring progress in health services delivery
at the district level. The DHB is available at: www.hst.org.za/publications/Pages/
HSTDistrictHealthBarometer.aspx
81
(2) The members contemplated in subsection (1) must have due

regard to the principles laid down in sections 2757 and 19558 of
the Constitution and the criteria laid down in section 25 of the
Local Government: Municipal Demarcation Act, 1998 (Act No.
27 of 1998),59 particularly in so far as they relate to —
(a) equity;
(b) access to services;
(c) quality;
(d) overcoming fragmentation;
(e) comprehensive services;
(f) effectiveness;
(g) efficiency;
(h) local accountability;
(i) community participation;
(j) developmental and intersectoral approach; and
(k) sustainability.
31. Establishment of district health councils
(1) The relevant member of the Executive Council, after consulta-
tion with the member of the Executive Council responsible for
local government in the province in question and the munici-
pal council of the relevant metropolitan or district municipality,
57
Section 27 of the Constitution covers the right to have access to health
care, food, water and social security. The text of section 27 is set out in
note 5 on page 44 above.
58
Section 195 of the Constitution sets out the basic principles governing
public administration. The entire text of section 195 is set out in note 17
on page 49 above.
59
Section 25 of the Local Government: Municipal Demarcation Act 27 of
1998 sets out a list of factors that must be considered when determining
a municipal boundary. The factors include things such as how different
boundaries will affect the economy, delivery of services (such as health
care), people’s employment, and whether the boundary will help to
integrate the area, rather than divide it.
82
must establish a district health council for every health district in

his or her province.
(2) (a) A district health council consists of —
(i) a member of the metropolitan or district municipal
council situated in the health district in question, nomi-
nated by the relevant council;
(ii) a person appointed by the relevant member of the
Executive Council to represent him or her;
(iii) a member of the council of each local municipality
within the health district, nominated by the members
of the relevant council; and
(iv) not more than five other persons, appointed by the rel-
evant member of the Executive Council after consulta-
tion with the municipal council of the metropolitan or
district municipality, as the case may be.
(b) The member contemplated in paragraph (a)(i) is the chair-
person of the district health council.
(c) In the case of a cross-boundary district, the relevant mem-
bers of the Executive Council may each appoint a member
to represent them and the persons contemplated in para-
graph (a)(iv) must be appointed by the relevant members
of the Executive Council in consultation with each other.
(3) A district health council must —
(a) promote co-operative governance;
(b) ensure co-ordination of planning, budgeting, provisioning
and monitoring of all health services that affect residents
of the health district for which the council was established;
and
(c) advise the relevant members of the Executive Council,
through the Provincial Health Councils, and the municipal
council of the relevant metropolitan or district municipality,
83
on any matter regarding health or health services in the

health district for which the council was established.
(4) A district health council may create one or more committees to
advise it on any matter.
(5) Provincial legislation must at least provide for —60
(a) the functioning of district health councils;
(b) the approval, after consultation with the relevant district
health council, by the relevant member of the Executive
Council and the municipal council of the metropolitan or
district municipality, as the case may be, of the detailed
budget and performance targets for health services in the
health district to which both the provincial and municipal
spheres of government must contribute; and
60
Most provinces have not complied with the obligation to promulgate
provincial legislation on health that covers the various matters referred
to in the NHA, including the functioning of district health councils
under section 31, the establishment and functioning of clinic and com-
munity health centre committees under section 42, and the provision
of health services at public health establishments other than hospitals
under section 43. Provincial health legislation dealing with these mat-
ters exists in the Free State, KwaZulu-Natal and the Western Cape in the
form of the Free State Provincial Health Act 3 of 2009 (came into effect
on 30 March 2009), the KwaZulu-Natal Health Act 1 of 2009 (came into
effect on 6 September 2012), the Western Cape District Health Councils
of Act 5 of 2010 (came into effect on 24 August 2011) and the Western
Cape Health Facility Boards and Committees Act 4 of 2016 (came
into effect on 7 December 2017). Provincial health legislation prom-
ulgated before the NHA, which is therefore not in line with the Act,
exists in Limpopo, the Eastern Cape and Gauteng in the form of the
Limpopo Province Health Services Act 5 of 1998 (came into effect on
30 September 1999), the Eastern Cape Provincial Health Act 10 of 1999
(came into effect on 1 March 2000) and the Gauteng District Health
Services Act 8 of 2000 (not in effect). Mpumalanga, the Northern Cape
and the North West have no relevant provincial legislation on health at
the time of publication.
84
(c) (i) deadlock-breaking mechanisms for cases where agree-

ment between the relevant member of the Executive
Council and the municipal council on the budget or
performance targets contemplated in paragraph (b)
cannot be reached within a period specified in the leg-
islation; and
(ii) corrective action to be taken if the agreement contem-
plated in subparagraph (i) is breached.
(6) The relevant member of the Executive Council must ensure that
each health district and each health subdistrict is effectively
managed.
32. Health services to be provided by municipalities
(1) Every metropolitan and district municipality must ensure that
appropriate municipal health services are effectively and equita-
bly provided in their respective areas.
(2) The relevant member of the Executive Council must assign such
health services to a municipality in his or her province as are
contemplated in section 156(4) of the Constitution.61
(3) An agreement contemplated in section 156(4) of the
Constitution is known as a service level agreement and must
provide for —
(a) the services to be rendered by the municipality;
(b) the resources that the relevant member of the Executive
Council must make available;
(c) performance standards which must be used to monitor ser-
vices rendered by the municipality; and
(d) conditions under which the agreement may be terminated.
61
Section 156(4) of the Constitution provides that both the national gov-
ernment and the provincial government must allow local governments
to administer certain functions, including health services, if the local
government is able to do so and can administer the services more effec-
tively than the provincial government or the national government.
85
33. Preparation of district health plans62

(1) Each district and metropolitan health manager must within
the national budget cycle develop and present to the district
health council in question and the relevant member of the
Executive Council a district health plan drawn up in accordance
with national guidelines issued by the Director-General with
due regard to national and provincial health policies and the
requirements of the relevant integrated development plan pre-
pared in terms of section 25 of the Local Government: Municipal
Systems Act, 2000 (Act No. 32 of 2000).63
(2) The relevant member of the Executive Council must ensure that
each health district develops and implements a district human
resource plan in accordance with national guidelines issued by
the Director-General.
34. Transitional arrangements concerning municipal health
services
Until a service level agreement contemplated in section 32(3) is con-
cluded, municipalities must continue to provide, within the resources
available to them, the health services that they were providing in the
year before this Act took effect.
62
The local health district office must provide you with a copy of the
district health plan upon request. The contact information for each
health district is available in Appendix D. Additionally, the NDoH has
issued Guidelines for District Health Planning and Reporting, which is
included within the 2018/2019 District Health Planning and Monitoring
Framework.

See http://www.health.gov.za/DHP/docs/DHP_and_M_Framework_and_Guidelines_25Aug_DG.pdf.
63
Section 25 of the Local Government: Municipal Systems Act 32 of 2000
requires all newly elected municipal councils to adopt a strategic plan
for the development of the municipality. The plan must link all the rel-
evant areas (such as health, infrastructure and transportation) and must
be compatible with both national and provincial development plans for
the municipality. Copies of these plans must be made available upon
request by your local municipal council.
86
Chapter 6
HEALTH ESTABLISHMENTS
35. Classification of health establishments64
The Minister may by regulation —
(a) classify all health establishments into such categories as may be
appropriate, based on —
(i) their role and function within the national health system;
(ii) the size and location of the communities they serve;
(iii) the nature and level of health services they are able to
provide;
(iv) their geographical location and demographic reach;
(v) the need to structure the delivery of health services in
accordance with national norms and standards within an
integrated and co-ordinated national framework; and
(vi) in the case of private health establishments, whether or not
the establishment is for profit or not; and
(b) in the case of a central hospital, determine the establishment of
the hospital board and the management system of such central
hospital.
36. Certificate of need65
(1) A person may not —
(a) establish, construct, modify or acquire a health establish-
ment or health agency;
64
Through the Regulations: Categories of Public Hospitals, promulgated in
2012, the Minister has categorised public hospitals as district, regional,
tertiary, central and specialised. Each category has a certain maximum
number of beds, and the regulations set out which services must and
may be provided at each category of hospital. A link to the regulations
can be found in Appendix A.
65
Sections 36, 37, 38, 39 and 40 of the NHA relating to certificates of need
are not in effect. For more detail, see note 1 on page 33 above.
87
(b) increase the number of beds in, or acquire prescribed health

technology at, a health establishment or health agency;
(c) provide prescribed health services; or
(d) continue to operate a health establishment or health agency
after the expiration of 24 months from the date this Act
took effect,
without being in possession of a certificate of need.
(2) A person who wishes to obtain or renew a certificate of need
must apply to the Director General in the prescribed manner
and must pay the prescribed application fee.
(3) Before the Director-General issues or renews a certificate of
need, he or she must take into account —
(a) the need to ensure consistency of health services devel-
opment in terms of national, provincial and municipal
planning;
(b) the need to promote an equitable distribution and ration-
alisation of health services and health care resources, and
the need to correct inequities based on racial, gender, eco-
nomic and geographical factors;
(c) the need to promote an appropriate mix of public and pri-
vate health services;
(d) the demographics and epidemiological characteristics of
the population to be served;
(e) the potential advantages and disadvantages for existing
public and private health services and for any affected
communities;
(f) the need to protect or advance persons or categories of
persons designated in terms of the Employment Equity
Act, 1998 (Act No. 55 of 1998), within the emerging small,
medium and micro-enterprise sector;
(g) the potential benefits of research and development with
respect to the improvement of health service delivery;
88
(h) the need to ensure that ownership of facilities does not

create perverse incentives for health service providers and
health workers;
(i) if applicable, the quality of health services rendered by the
applicant in the past;
(j) the probability of the financial sustainability of the health
establishment or health agency;
(k) the need to ensure the availability and appropriate utilisa-
tion of human resources and health technology;
(l) whether the private health establishment is for profit or not;
and
(m) if applicable, compliance with the requirements of a certifi-
cate of non-compliance.
(4) The Director-General may investigate any issue relating to an
application for the issue or renewal of a certificate of need and
may call for such further information as may be necessary in
order to make a decision upon a particular application.
(5) The Director-General may issue or renew a certificate of need
subject to —
(a) compliance by the holder with national operational norms
and standards for health establishments and health agen-
cies, as the case may be; and
(b) any condition regarding —
(i) the nature, type or quantum of services to be provided
by the health establishment or health agency;
(ii) human resources and diagnostic and therapeutic equip-
ment and the deployment of human resources or the
use of such equipment;
(iii) public private partnerships;
(iv) types of training to be provided by the health establish-
ment or health agency; and
(v) any criterion contemplated in subsection (3).
89
(6) The Director-General may withdraw a certificate of need —

(a) on the recommendation of the Office of Standards
Compliance in terms of section 79(7)(b);
(b) if the continued operation of the health establishment or
the health agency, as the case may be, or the activities of
a health care provider or health worker working within the
health establishment, constitute a serious risk to public
health;
(c) if the health establishment or the health agency, as the case
may be, or a health care provider or health worker working
within the health establishment, is unable or unwilling to
comply with minimum operational norms and standards
necessary for the health and safety of users; or
(d) if the health establishment or the health agency, as the case
may be, or a health care provider or health worker working
within the health establishment, persistently violates the
constitutional rights of users or obstructs the State in fulfill-
ing its obligations to progressively realise the constitutional
right of access to health services.
(7) If the Director-General refuses an application for a certificate
of need or withdraws a certificate of need the Director-General
must within a reasonable time give the applicant or holder, as
the case may be, written reasons for such refusal or withdrawal.
37. Duration of certificate of need66
A certificate of need is valid for a prescribed period, but such pre-
scribed period may not exceed 20 years.
66
90
38. Appeal to Minister against Director-General’s decision67

(1) Any person aggrieved by a decision of the Director-General
in terms of section 36 may appeal in writing to the Minister
against such decision.
(2) Such appeal must —
(a) be lodged within 60 days from the date on which written
reasons for the decision were given by the Director-General
or such later date as the Minister permits; and
(b) set out the grounds of appeal.
(3) After considering the grounds of appeal and the Director-
General’s reasons for the decision, the Minister must as soon as
practicable —
(a) confirm, set aside or vary the decision; or
(b) substitute any other decision for the decision of the
Director-General.
(4) The Minister must within a reasonable time after reaching a
decision give the appellant written reasons for such decision.
39. Regulations relating to certificates of need68
(1) The Minister may, after consultation with the National Health
Council, make regulations relating to —
(a) the requirements for the issuing or renewal of a certificate of
need;
(b) the requirements for a certificate of need for health estab-
lishments and health agencies existing at the time of com-
mencement of this Act;
(c) the requirements for a certificate of need for health estab-
lishments and health agencies coming into being after the
commencement of this Act; and
67
68
91
(d) any other matter relating to the granting of a certificate of

need and the inspection and administration of health estab-
lishments and health agencies.
(2) Regulations made under subsection (1) —
(a) must ensure the equitable distribution and rationalisation
of health, with special regard to vulnerable groups such as
woman, older persons, children and people with disabilities;
(b) may prescribe the fees payable in respect of applications for
the issuing and renewal of certificates of need;
(c) must prescribe the formats and procedures to be used in
applications for the issuing and renewal of certificates of
need, and the information that must be submitted with
such applications;
(d) must ensure and promote access to health services and the
optimal utilisation of health care resources, with special
regard to vulnerable groups such as woman, older persons,
children and people with disabilities;
(e) must ensure compliance with the provisions of this Act and
national operational norms and standards for the delivery of
health services;
(f) must seek to avoid or prohibit business practices or per-
verse incentives which adversely affect the costs or quality
of health services or the access of users to health services;
(g) must avoid or prohibit practices, schemes or arrangements
by health care providers or health establishments that
directly or indirectly conflict with, violate or undermine
good ethical and professional practice; and
(h) must ensure that the quality of health services provided by
health establishments and health agencies conforms to the
prescribed norms and standards.
92
40. Offences and penalties in respect of certificate of need69

(1) Any person who performs any act contemplated in section
36(1) without a certificate of need required in terms of that sec-
tion is guilty of an offence.
(2) Any person convicted of an offence in terms of subsection (1) is
liable on conviction to a fine or to imprisonment for a period not
exceeding five years or to both a fine and such imprisonment.
41. Provision of health services at public health establishments
(1) The Minister, in respect of a central hospital, and the relevant
member of the Executive Council, in respect of all other public
health establishments within the province in question, may —
(a) determine the range of health services that may be pro-
vided at the relevant public health establishment;
(b) prescribe the procedures and criteria for admission to and
referral from a public health establishment or group of
public health establishments;
(c) subject to subsection (2), prescribe schedules of fees,
including penalties for not following the procedures con-
templated in paragraph (b), for —
(i) different categories of users;
(ii) various forms of treatment; and
(iii) various categories of public health establishments; and
(d) in consultation with the relevant Treasury, determine the pro-
portion of revenue generated by a particular public health
establishment classified as a hospital that may be retained by
that hospital, and how those funds may be used.
(2) When determining a schedule of fees, the fee for a particular
service may not be varied in respect of users who are not ordi-
narily resident in a province.
69
93
(3) Despite subsection (2), a province whose residents make use of

another province’s services must compensate that province for
health services provided to such residents in the manner and to
the extent prescribed by the Minister in consultation with, in the
case of a central hospital, the National Treasury and, in the case
of any other hospital, the relevant Treasury.
(4) The Minister must appoint a representative hospital board for
each central hospital or group of central hospitals.70
(5) The functions of a central hospital board must be prescribed by
the Minister.71
(6) (a) The relevant member of the Executive Council must —72
(i) appoint a representative board for each public health
establishment classified as a hospital or for each group
of such public health establishments within the relevant
province;
(ii) prescribe the functions of such boards; and
(iii) prescribe procedures for meetings of the board.
(b) A hospital contemplated in paragraph (a) does not include
a central hospital.
70
Once hospital boards are appointed in terms of this section, contact
information for them must be made available upon request at a central
hospital or from the local health district office. See Appendix D for con-
tact information for each local health district.
71
In March 2012 the NDoH promulgated its Policy on the Management
of Public Hospitals, which deals in part with the functions of hospital
boards. The core function of hospital boards is to advise on policy and
processes. The policy states that the hospital boards are largely advisory
governance structures that have a mandate to act honestly in the best
interests of the public and the users. In addition, hospital boards must
develop a working knowledge of the hospital and must be cognisant of
the economic, social, and political milieu in which the hospital oper-
ates. A link to the policy can be found in Appendix C.
72
See page 16 in the Introduction to this Guide for further information on
hospital boards.
94
(7) The boards contemplated in subsections (4) and (6) must be

composed of —
(a) one representative from each university associated with the
hospital;
(b) in the case of a board contemplated in subsection (4), one
representative from the national department;
(c) in the case of boards contemplated in subsections (4) and
(6), one representative from the provincial department in
the province in which the relevant hospital is situated;
(d) not more than three representatives of the communities
served by the hospital, including special interest groups
representing users; and
(e) not more than five representatives of staff and management
of the hospital but such representatives may not vote at a
meeting of the board.
(8) The boards contemplated in subsections (4) and (6) may
include not more than five persons with expertise in areas such
as accounting, financial management, human resources man-
agement, information management and legal matters.
(9) Members of a hospital board are appointed for a period of three
years at a time and the Minister, in the case of central hospi-
tals, or the relevant member of the Executive Council, in the
case of other hospitals, may replace any member on good cause
shown.
42. Clinics and community health centre committees73
(1) Provincial legislation must at least provide for the establishment
in the province in question of a committee for —74
73
See the Introduction to this Guide for further information on clinic and
community health centre committees.
74
For further information on provincial legislation, see note 60 on page
84 above. Unfortunately, because many provinces have not finalised
legislation, these committees — which are meant to include community
95
(a) a clinic or a group of clinics;

(b) a community health centre; or
(c) a clinic and a community health centre or a group of clinics
and community health centres.
(2) Any committee contemplated in subsection (1) must at least
include —
(a) one or more local government councillors;
(b) one or more members of the community served by the
health facility; and
(c) the head of the clinic or health centre in question.
(3) The functions of a committee must be prescribed in the provin-
cial legislation in question.
43. Health services at non-health establishments and at public
health establishments other than hospitals
(1) The Minister may prescribe —75
(a) minimum standards and requirements for the provision
of health services in locations other than health establish-
ments, including schools and other public places; and
(b) penalties for any contravention of or failure to comply with
any such standards or requirements.
(2) Provincial legislation must provide for the provision of health
services at health establishments in the province in question
other than hospitals.
representatives — have not yet been established in the manner intended.

There are, however, some clinic committees operating in facilities across
the country.
75
The Minister has prescribed regulations relating to the provision of
emergency medical services — in general and at mass gatherings — in
terms of this section. Links to the regulations can be found in Appendix
A. In addition, while the Integrated School Health Programme is not
published in terms of this section, it provides for health service provi-
sion at schools. A link to the policy can be found in Appendix C.
96
(3) (a) The Minister may, in the interests of the health and well-be-
ing of persons attending an initiation school and subject to
the provisions of any other law, prescribe conditions under
which the circumcision of a person as part of an initiation
ceremony may be carried out.
(b) For the purposes of this subsection —
(i) “initiation school” means any place at which one or
more persons are circumcised as part of an initiation
ceremony; and
(ii) “initiation ceremony” means a traditional ritual or prac-
tice in terms of which a person is inducted into an order
or accorded a certain status or recognition within a
community.
(4) The Minister may, subject to the provisions of any other law,
prescribe conditions relating to traditional health practices to
ensure the health and well-being of persons who are subject to
such health practices.
44. Referral from one public health establishment to another
(1) Subject to this Act, a user may attend any public health estab-
lishment for the purposes of receiving health services.
(2) If a public health establishment is not capable of providing the
necessary treatment or care, the public health establishment in
question must transfer the user concerned to an appropriate
public health establishment which is capable of providing the
necessary treatment or care in such manner and on such terms
as may be determined by the Minister or the relevant member
of the Executive Council, as the case may be.
97
45. Relationship between public and private health

establishments
(1) The Minister must prescribe mechanisms to enable a co-ordi-
nated relationship between private and public health establish-
ments in the delivery of health services.76
(2) The national department, any provincial department or any
municipality may enter into an agreement with any private
practitioner, private health establishment or non-governmental
organisation in order to achieve any object of this Act.
(3) An agreement contemplated in subsection (2) must comply
with the Public Finance Management Act, 1999 (Act No. 1 of
1999), or any municipal finance management legislation, as the
case may be.
46. Obligations of private health establishments
Every private health establishment must maintain insurance cover
sufficient to indemnify a user for damages that he or she might suffer
as a consequence of a wrongful act by any member of its staff or by
any of its employees.
47. Evaluating services of health establishments77
(1) All health establishments must comply with the quality require-
ments and standards prescribed by the Minister after consulta-
tion with the Office.
76
The coordination of public and private health establishments is weak.
One of the aims of National Health Insurance is to improve this coordi-
nation by integrating licensed and accredited health establishments (be
they public or private) into a single health care system and by allowing
health services to be purchased from any health establishment within
that system.
77
The Office of Health Standards Compliance is responsible for the evalu-
ation of health facilities in terms of the promulgated norms and stand-
ards. However, the quality of the services provided in the public sector
or private sector is not evaluated in accordance with set standards. This
weakness should be addressed as part of reforms in line with National
98
(2) The quality requirements and standards contemplated in sub-

section (1) may relate to human resources, health technology,
equipment, hygiene, premises, the delivery of health services,
business practices, safety and the manner in which users are
accommodated and treated.
(3) The Office must monitor and enforce compliance with the qual-
ity requirements and standards contemplated in subsection (1).
Chapter 7
HUMAN RESOURCES PLANNING AND ACADEMIC HEALTH
COMPLEXES
48. Development and provision of human resources in national
health system78
(1) The National Health Council must develop policy and guidelines
for, and monitor the provision, distribution, development, man-
agement and utilisation of, human resources within the national
health system.
(2) The policy and guidelines contemplated in subsection (1) must
amongst other things facilitate and advance —
(a) the adequate distribution of human resources;
(b) the provision of appropriately trained staff at all levels of the
national health system to meet the population’s health care
needs; and
Health Insurance. Section 47(2) of the Act is one of the few provisions
of the NHA whose commencement date has not been proclaimed.
78
The NDoH published a Human Resources for Health South Africa: HRH
Strategy for the Health Sector 2012/13–2016/17. The strategy was not
accompanied by a plan and was largely unimplemented. There has been
no publicly available strategy or plan since 2016/17, and insufficient
human resources for health remains a significant impediment to access
to health care services.
99
(c) the effective and efficient utilisation, functioning, manage-

ment and support of human resources within the national
health system.
49. Maximising services of health care providers
The Minister, with the concurrence of the National Health Council,
must determine guidelines to enable the provincial departments and
district health councils to implement programmes for the appropri-
ate distribution of health care providers and health workers.
50. Forum of Statutory Health Professional Councils79
(1) A forum to be known as the Forum of Statutory Health
Professional Councils is hereby established on which all the stat-
utory health professional councils must be represented.
(2) The Forum of Statutory Health Professional Councils consists of
the chairpersons of the statutory health professional councils
and the registrars or chief executive officers, as the case may be,
of the statutory health professional councils.
(3) (a) In addition to the representatives contemplated in subsec-
tion (2), the Minister must appoint —
(i) two representatives of the national department;
(ii) three community representatives who have been
appointed to any of the statutory health professional
councils contemplated in subsection (1); and
(iii) two representatives of tertiary education institutions,
to the Forum of Statutory Health Professional Councils.
(b) (i) The Minister must appoint a suitable person as chair-
person of the Forum of Statutory Health Professional
Councils.
(ii) The chairperson holds office for such period, but not
exceeding two years, as the Minister may determine at
79
We understand that this forum exists and is functioning, but there is no
information available online about the forum.
100
the time of his or her appointment, and may be reap-

pointed at the expiry of his or her term of office.
(c) Any member of the Forum of Statutory Health Professional
Councils, including the chairperson, must vacate his or her
office if —
(i) his or her estate is sequestrated;
(ii) he or she becomes disqualified from practising his or
her profession in terms of any law;
(iii) he or she becomes mentally ill to such a degree that it
is necessary that he or she be detained, supervised or
controlled;
(iv) he or she is convicted in the Republic or elsewhere of
an offence involving dishonesty or an offence in respect
whereof he or she is sentenced to imprisonment with-
out the option of a fine;
(v) he or she ceases to be a South African citizen;
(vi) he or she has been absent from more than two consecu-
tive ordinary meetings of the Forum without leave from
the Forum;
(vii) he or she tenders his or her resignation in writing and
the Minister accepts the resignation;
(viii) he or she ceases to hold any qualification necessary for
his or her appointment; or
(ix) the Minister, in the public interest, terminates his or her
membership.
(4) The Forum of Statutory Health Professional Councils must —
(a) protect the interests of the public and users;
(b) ensure communication and liaison between the statutory
health professional councils upon matters affecting more
than one of the registered professions;
(c) in the interests of the public, promote inter-professional liai-
son and communication between registered professions;
101
(d) promote good practice in health services and sharing of

information between the statutory health professional
councils;
(e) ensure consistency in the actions and decisions of the statu-
tory health professional councils;
(f) consult and liaise with any relevant authority on matters col-
lectively affecting all registered health professions;
(g) investigate and report on, of its own accord, at the request
of one or more of the statutory health professional councils
or at the request of the Minister, any matter of relevance to
more than one statutory health professional council;
(h) in the prescribed manner, act as ombudsperson in respect
of complaints by members of the public and other persons
concerning the councils referred to in subsection (1);
(i) advise the Minister on the development of coherent policies
relating to the education and training and optimal utilisa-
tion and distribution of health care providers;
(j) monitor and advise the Minister on the implementation of
health policy in so far as it impacts on health care providers
and the registered professions;
(k) hold the statutory health professional councils explicitly
to account for their performance as competent public
authorities;
(l) publish an annual report on the performance of the statu-
tory health professional councils;
(m) set performance improvement targets with the statutory
health professional councils and monitor their progress; and
(n) advise the Minister and the individual statutory health pro-
fessional councils concerning —
(i) the scopes of practice of the registered professions;
(ii) common educational and training requirements of
health care providers;
102
(iii) new professions to be regulated;

(iv) targets, priorities, norms and standards relating to the
equitable distribution of health care providers;
(v) development, procurement and use of health service
technology;
(vi) perverse incentives within the registered professions;
(vii) the recruitment, evaluation and registration of foreign
health care professionals;
(viii) effective co-ordination of the objectives and respon-
sibilities of the various statutory health professional
councils;
(ix) responsibilities of health care providers in promoting
and maintaining public health;
(x) inter-professional communication and relationships;
and
(xi) any other matter that may be prescribed.
(5) (a) In performing its duties the Forum of Statutory Health
Professional Councils may —
(i) consult or hear representations by any person, body or
authority; and
(ii) establish a committee to advise it on any matter.
(b) A committee contemplated in paragraph (a)(ii) may consist
of not more than seven persons who must have the relevant
knowledge, expertise, skills and experience to enable the
committee to give the required advice.
(c) The chairperson of the Forum must be a member of the
committee.
(6) (a) A decision of the Forum of Statutory Health Professional
Councils must be taken by the votes of a majority of at
least two thirds of the members of the Forum present at the
meeting of the Forum.
103
(b) A quorum for any meeting of the Forum is at least half of the
members of the Forum plus one.
(c) In the event of an equality of votes, the chairperson of the
Forum has a casting vote in addition to his or her delibera-
tive vote.
(7) The Forum of Statutory Health Professional Councils may deter-
mine the procedure for its meetings.
(8) The Forum of Statutory Health Professional Councils must meet
at least three times a year.
(9) The Forum of Statutory Health Professional Councils is funded
through prescribed membership fees paid by the statutory
health professional councils.
(10) The members of the Forum of Statutory Health Professional
Councils may agree that a person employed by one of the stat-
utory health professional councils represented on the Forum
must act as secretary at a meeting of the Forum.
51. Establishment of academic health complexes
The Minister may, in consultation with the Minister of Education,
establish —
(a) academic health complexes, which may consist of one or more
health establishments at all levels of the national health system,
including peripheral facilities, and one or more educational
institutions working together to educate and train health care
personnel and to conduct research in health services;80 and
(b) any co-ordinating committees that may be necessary in order to
perform such functions as may be prescribed.
80
As of April 2019 the academic health complexes that exist do so only at
the ten central hospitals and do not, as intended in this section, con-
sist of facilities throughout the health care system, providing a training
platform at the various levels of health service provision.
104
52. Regulations relating to human resources81

The Minister may make regulations regarding human resources
within the national health system in order to —
(a) ensure that adequate resources are available for the educa-
tion and training of health care personnel to meet the human
resources requirements of the national health system;
(b) ensure the education and training of health care personnel to
meet the requirements of the national health system;
(c) create new categories of health care personnel to be educated
or trained;
(d) identify shortages of key skills, expertise and competencies
within the national health system and to prescribe strategies
which are not in conflict with the Higher Education Act, 1997
(Act No. 101 of 1997), for the —
(i) recruitment of health care personnel from other countries;
and
(ii) education and training of health care providers or health
workers in the Republic, to make up the deficit in respect of
scarce skills, expertise and competencies;
(e) prescribe strategies for the recruitment and retention of health
care personnel within the national health system;
(f) ensure the existence of adequate human resources planning,
development and management structures at national, provin-
cial and district levels of the national health system;
(g) ensure the availability of institutional capacity at national, pro-
vincial and district levels of the national health system to plan
for, develop and manage human resources;
(h) ensure the definition and clarification of the roles and func-
tions of the national department, provincial departments and
81
As of April 2019, no regulations under this section have been released
for public comment or passed.
105
municipalities with regard to the planning, production and

management of human resources; and
(i) prescribe circumstances under which health care personnel
may be recruited from other countries to provide health ser-
vices in the Republic.
Chapter 8
CONTROL OF USE OF BLOOD, BLOOD PRODUCTS, TISSUE
AND GAMETES IN HUMANS82
53. Establishment of national blood transfusion service
(1) The Minister must establish a blood transfusion service for the
Republic by granting a licence to a non-profit organisation,
which is able to provide a blood transfusion service throughout
the territory of the Republic.
(2) The holder of the licence granted in terms of subsection (1) —
(a) must comply with prescribed norms and standards and
must provide the prescribed blood transfusion and related
services;
(b) may establish regional units, for the delivery of blood trans-
fusion services, which must function under the control of
the licence holder; and
(c) has the sole right to provide a blood transfusion service in
the Republic.
(3) Any person other than the holder of the licence granted in terms
of subsection (1) who provides a blood transfusion service in the
Republic, is guilty of an offence and liable on conviction to a fine
82
The majority of sections in Chapter 8 came into effect on 1 March 2012.
In conjunction with this, the Minister promulgated a number of regula-
tions regulating the control of the use of human blood, blood products,
tissue and gametes, primarily in terms of section 68. These regulations
106
or to imprisonment for a period not exceeding five years or to

both a fine and such imprisonment.83
54. Designation of authorised institution
(1) The Minister may, by notice in the Gazette, designate any insti-
tution other than an institution contemplated in section 63 as
an authorised institution.84
(2) An authorised institution may —
(a) acquire, use or supply the body of a deceased person for
any of the purposes referred to in section 64;
(b) acquire or use any tissue lawfully imported or removed from
the body of a living or deceased person for any of the pur-
poses referred to in section 56 or 64, as the case may be;
(c) supply any tissue preserved by it to an institution or person
contemplated in section 63 for any of the purposes referred
to in section 58 or 64; and
(d) acquire, use and supply blood products for any of the pur-
poses referred to in section 56 or 64.
(3) The Minister may, in the notice contemplated in subsection (1),
impose conditions in respect of the exercise of a power referred
to in subsection (2).
55. Removal of tissue, blood, blood products or gametes from
living persons
A person may not remove tissue, blood, a blood product or gametes
from the body of another living person for the purpose referred to in
section 56 unless it is done —
83
This section imposes criminal liability on anyone found guilty of pro-
viding a blood transfusion service without the correct licence.
84
Although section 54 came into effect on 1 March 2012, as of April 2019,
the Minister has not designated any institutions in terms of this section.
107
(a) with the written consent of the person from whom the tissue,
blood, blood product or gametes are removed granted in the
prescribed manner; and
(b) in accordance with prescribed conditions.
56. Use of tissue, blood, blood products or gametes removed or
withdrawn from living persons
(1) A person may use tissue or gametes removed or blood or a
blood product withdrawn from a living person only for such
medical or dental purposes as may be prescribed.
(2) (a) Subject to paragraph (b), the following tissue, blood, blood
products or gametes may not be removed or withdrawn
from a living person for any purpose contemplated in sub-
section (1):
(i) Tissue, blood, a blood product or a gamete from a
person who is mentally ill within the meaning of the
Mental Health Care Act, 2002 (Act No. 17 of 2002);
(ii) tissue which is not replaceable by natural processes
from a person younger than 18 years;
(iii) a gamete from a person younger than 18 years; or
(iv) placenta, embryonic or foetal tissue, stem cells and
umbilical cord, excluding umbilical cord progenitor
cells.
(b) The Minister may authorise the removal or withdrawal of
tissue, blood, a blood product or gametes contemplated in
paragraph (a) and may impose any condition which may be
necessary in respect of such removal or withdrawal.
57. Prohibition of reproductive cloning of human beings
(1) A person may not —
(a) manipulate any genetic material, including genetic material
of human gametes, zygotes or embryos; or
108
(b) engage in any activity, including nuclear transfer or embryo

splitting, for the purpose of the reproductive cloning of a
human being.
(2) The Minister may, under such conditions as may be prescribed,
permit therapeutic cloning utilising adult or umbilical cord stem
cells.
(3) No person may import or export human zygotes or embryos
without the prior written approval of the Minister.
(4) The Minister may permit research on stem cells and zygotes
which are not more than 14 days old on a written application
and if —
(a) the applicant undertakes to document the research for
record purposes; and
(b) prior consent is obtained from the donor of such stem cells
or zygotes.
(5) Any person who contravenes a provision of this section or who
fails to comply therewith is guilty of an offence and is liable on
conviction to a fine or to imprisonment for a period not exceed-
ing five years or to both a fine and such imprisonment.
(6) For the purpose of this section —
(a) “reproductive cloning of a human being” means the manip-
ulation of genetic material in order to achieve the repro-
duction of a human being and includes nuclear transfer or
embryo splitting for such purpose; and
(b) “therapeutic cloning” means the manipulation of genetic
material from either adult, zygotic or embryonic cells in
order to alter, for therapeutic purposes, the function of cells
or tissues.
109
58. Removal and transplantation of human tissue in hospital or

authorised institution85
(1) A person may not remove tissue from a living person for trans-
plantation in another living person or carry out the transplanta-
tion of such tissue except —
(a) in a hospital or an authorised institution; and
(b) on the written authority of —
(i) the medical practitioner in charge of clinical services
in that hospital or authorised institution, or any other
medical practitioner authorised by him or her; or
(ii) in the case where there is no medical practitioner
in charge of the clinical services at that hospital or
authorised institution, a medical practitioner author-
ised thereto by the person in charge of the hospital or
authorised institution.
(2) The medical practitioner contemplated in subsection (1)(b) may
not participate in a transplant for which he or she has granted
authorisation in terms of that subsection.
85
In 2016, Peter Frederiksen was tried in the High Court, Free State Division
in S v Frederiksen 2018 (1) SACR 29 (FB) on 58 counts, including rape,
child pornography, and transgressions of the NHA. The transgressions
of the NHA that he was alleged to have committed concerned the surgi-
cal removal of the clitorises of various women in his bedroom, which he
used as a surgical theatre, in Bloemfontein. Mr Frederiksen was charged
with having committed offences under sections 55 and 58 of the NHA.
While non-compliance with the provisions of equivalent sections under
the Human Tissues Act 65 of 1983 had been offences, no offences are
listed under section 55 and 58 of the NHA, which repealed the Human
Tissues Act. In the circumstances, Mr Frederiksen was acquitted on these
counts. He was put to his defence on the other counts. The judgment
can be found here: https://juta.co.za/media/filestore/2017/12/S_v_Frederiksen.pdf.
110
59. Removal, use or transplantation of tissue, and administering

of blood and blood products by medical practitioner or
dentist
(1) For the purposes of this Chapter, only a registered medical prac-
titioner or dentist may remove any tissue from a living person,
use tissue so removed for any of the purposes contemplated in
section 56 or transplant tissue so removed into another living
person.
(2) Subject to the Medicines and Related Substances Control Act,
1965 (Act No. 101 of 1965), only a registered medical practi-
tioner or dentist, or a person acting under the supervision or on
the instructions of a medical practitioner or dentist, may for the
purposes of this Chapter administer blood or a blood product
to, or prescribe blood or a blood product for, a living person.
60. Payment in connection with the importation, acquisition or
supply of tissue, blood, blood products or gametes
(1) No person, except —
(a) a hospital or an institution contemplated in section 58(1)(a),
a person or an institution contemplated in section 63 and
an authorised institution or, in the case of tissue or gametes
imported or exported in the manner provided for in the reg-
ulations, the importer or exporter concerned, may receive
payment in respect of the acquisition, supply, importation
or export of any tissue or gamete for or to another person
for any of the purposes contemplated in section 56 or 64;
(b) a person or an institution contemplated in section 63 or an
authorised institution, may receive any payment in respect
of the importation, export or acquisition for the supply to
another person of blood or a blood product.
(2) The amount of payment contemplated in subsection (1) may
not exceed an amount which is reasonably required to cover the
111
costs involved in the importation, export, acquisition or supply

of the tissue, gamete, blood or blood product in question.
(3) This section does not prevent a health care provider registered
with a statutory health professional council from receiving
remuneration for any professional service rendered by him or
her.
(4) It is an offence for a person —
(a) who has donated tissue, a gamete, blood or a blood prod-
uct to receive any form of financial or other reward for such
donation, except for the reimbursement of reasonable costs
incurred by him or her to provide such donation; and
(b) to sell or trade in tissue, gametes, blood or blood products,
except as provided for in this Chapter.
exceeding five years or to both a fine and such imprisonment.
61. Allocation and use of human organs
(1) Human organs obtained from deceased persons for the purpose
of transplantation or treatment, or medical or dental training or
research, may only be used in the prescribed manner.
(2) Human organs obtained in terms of subsection (1) must be allo-
cated in accordance with the prescribed procedures.
(3) An organ may not be transplanted into a person who is not a
South African citizen or a permanent resident of the Republic
without the Minister’s authorisation in writing.
(4) The Minister must prescribe —
(a) criteria for the approval of organ transplant facilities; and
(b) procedural measures to be applied for such approval.
(5) (a) A person who contravenes a provision of this section or
fails to comply therewith or who charges a fee for a human
organ is guilty of an offence.
112
(b) Any person convicted of an offence in terms of paragraph

(a) is liable on conviction to a fine or to imprisonment for a
period not exceeding five years or to both a fine and such
imprisonment.
62. Donation of human bodies and tissue of deceased persons86
(1) (a) A person who is competent to make a will may —
(i) in the will;
(ii) in a document signed by him or her and at least two
competent witnesses; or
(iii) in an oral statement made in the presence of at least
two competent witnesses,
donate his or her body or any specified tissue thereof to
be used after his or her death, or give consent to the post
mortem examination of his or her body, for any purpose
provided for in this Act.
(b) A person who makes a donation as contemplated in para-
graph (a) must nominate an institution or a person contem-
plated in section 63 as done.
(c) If no done is nominated in terms of paragraph (b), the
donation is null and void.
(d) Paragraph (b) does not apply in respect of an organ
donated for the purposes contemplated in section 61(1)
and the donee of such organ must be determined in terms
of section 61(2).
(2) In the absence of a donation under subsection (1)(a) or of a
contrary direction given by a person whilst alive, the spouse,
partner, major child, parent, guardian, major brother or major
sister of that person, in the specific order mentioned, may, after
86
Donations of the body, tissue, blood or blood products of a deceased
person is governed by Regulations: General Control of Human Bodies,
Tissue, Blood, Blood Products and Gametes, which came into effect on
2 March 2012. A link to the regulations can be found in Appendix A.
113
that person’s death, donate the body or any specific tissue of

that person to an institution or a person contemplated in sec-
tion 63.
(3) (a) The Director-General may, after the death of a person and
if none of the persons contemplated in subsection (2) can
be located, donate any specific tissue of that person to an
institution or a person contemplated in section 63.
(b) The Director-General may only donate the specific tissue if
all the prescribed steps have been taken to locate the per-
sons contemplated in subsection (2).
63. Human bodies, tissue, blood, blood products or gametes
may be donated to prescribed institution or person
A human body, tissue, blood, blood products or gametes may be
donated by any person contemplated in section 55(a) or 62 to any
prescribed institution or person for any purpose contemplated in
section 56 or 64(1).
64. Purposes of donation of body, tissue, blood or blood
products of deceased persons
(1) A donation in terms of section 62 may only be made for —
(a) the purposes of the training of students in health sciences;
(b) the purposes of health research;
(c) the purposes of the advancement of health sciences;
(d) therapeutic purposes, including the use of tissue in any
living person;87 or
87
One of the purposes of donation of organs and tissue is for transplan-
tation. The Southern African Transplantation Society provides useful
information regarding transplantation. Its website is https://www.sats.org.za.
There are not enough people registered as organ donors in South Africa.
If you would like to be an organ donor, register at the Organ Donor
Foundation and tell your family about your wishes. The Organ Donor
Foundation website is https://www.odf.org.za/.
114
(e) the production of a therapeutic, diagnostic or prophylactic

substance.
(2) This Act does not apply to the preparation of the body of a
deceased person for the purposes of embalming it, whether or
not such preparation involves the —
(a) making of incisions in the body for the withdrawal of blood
and the replacement thereof by a preservative; or
(b) restoration of any disfigurement or mutilation of the body
before its burial.
65. Revocation of donation88
A donor may, prior to the transplantation of the relevant organ into
the donee, revoke a donation in the same way in which it was made
or, in the case of a donation by way of a will or other document, also
by the intentional destruction of that will or document.
66. Post mortem examination of bodies89
(1) Subject to subsection (2), a post mortem examination of the
body of a deceased person may be conducted if —
(a) the person, while alive, gave consent thereto;
(b) the spouse, partner, major child, parent, guardian, major
brother or major sister of the deceased, in the specific order
mentioned, gave consent thereto; or
88
The Regulations: General Control of Human Bodies, Tissue, Blood,
Blood Products and Gametes of 2012 also provides the process to be
followed if a person has made conflicting donations. In these circum-
stances, the donation that was last made is the one that will be given
effect to. If a person first donated her entire body to one donee and
afterwards donated specific tissue to another donee, the donation of her
entire body will take precedence.
89
Although not made in terms of this section, the Regulations Regarding
the Rendering of Forensic Pathology Service of 2018 are relevant to this
section as they lay out clearly the requirements for the rendering of
such service and the conducting of post-mortem examinations. A link
to the regulations can be found in Appendix A.
115
(c) such an examination is necessary for determining the cause

of death.
(2) A post mortem examination may not take place unless —
(a) the medical practitioner in charge of clinical services in the
hospital or authorised institution or of the mortuary in ques-
tion, or any other medical practitioner authorised by such
practitioner, has authorised the post mortem examination
in writing and in the prescribed manner; or
(b) in the case where there is no medical practitioner in charge
of clinical services, a medical practitioner authorised by the
person in charge of such hospital or authorised institution,
has authorised the post mortem examination in writing and
in the prescribed manner.
67. Removal of tissue at post-mortem examinations and
obtaining of tissue by institutions and persons
(1) (a) The Minister may, on the written application of an institu-
tion or person requiring tissue for a purpose contemplated
in section 64(1), authorise that institution or person, in
writing, to obtain such tissue from a medical practitioner
contemplated in subsection (3) or a person or an institution
contemplated in section 63.
(b) The Minister may impose any condition on the institution
or person to which or to whom he or she has granted an
authorisation in terms of paragraph (a).
(c) This Act does not prevent persons or institutions from
acquiring tissue in terms of the National Heritage Resources
Act, 1999 (Act No. 25 of 1999), for the purposes of that
Act.90
90
The National Heritage Resources Act recognises human remains as being
included in the national estate, which are heritage resources that are of
cultural significance or other special value for the present community
and future generations.
116
(2) The medical practitioner in charge of clinical services in the hos-

pital or authorised institution or of the mortuary in question, or
any other medical practitioner authorised by such practitioner,
or, in the case where there is no medical practitioner in charge
of clinical services, a medical practitioner authorised by the
person in charge of such hospital or authorised institution, may,
in writing and in the prescribed manner, authorise —
(a) a prescribed institution or person contemplated in section
63; or
(b) an authorised institution making application therefor in
writing, to remove any specified tissue from the body con-
cerned before burial thereof.
(3) Despite anything to the contrary in any other law, a medical
practitioner who conducts a post mortem examination in terms
of —
(a) section 3 of the Inquests Act, 1959 (Act No. 58 of 1959);91
or
(b) section 71(1)(a) or (b), must remove or cause to be removed
from a body such tissue as may be specified in an author-
isation under subsection (1) and must hand it over to the
institution or person in possession of the authorisation.
(4) The removal contemplated in subsection (3) may not be
effected if —
(a) the removal of the tissue is likely to affect the outcome of
the examination; or
91
Section 3 of the Inquests Act allows a police officer who believes that
a person has died from something other than natural causes (such as
poison or an accident) to investigate the cause of death and to have
the district surgeon or other medical practitioner examine the body to
determine the cause of death.
117
(b) the body or tissue in question has been donated or if the

removal would be contrary to a direction given by the
deceased before his or her death.
68. Regulations relating to tissue, cells, organs, blood, blood
products and gametes92
(1) The Minister may make regulations regarding —
(a) the post mortem examination of bodies of deceased
persons;
(b) the preservation, use and disposal of bodies, including
unclaimed bodies;
(c) the removal of donated tissue or cells from persons, tissue
or cells obtained from post mortem examinations and the
procurement, processing, storage, supply and allocation of
tissue or human cells by institutions and persons;
(d) tissue transplants;
(e) the production, packaging, sealing, labelling, storage and
supplying of therapeutic, diagnostic and prophylactic sub-
stances from tissue;
(f) the supply of tissue, organs, oocytes, human stem cells and
other human cells, blood, blood products or gametes;
(g) the importation and exportation of tissue, human cells,
blood, blood products or gametes;
(h) the withdrawal of blood from living persons and the preser-
vation, testing, processing, supply or disposal of withdrawn
or imported blood;
(i) the administering of blood and any blood product to living
persons;
(j) the production, packaging, sealing, labelling and supplying
of blood and blood products;
92
There are 11 sets of regulations made in terms of this section, made in
2012 and 2013. Links to the regulations can be found in Appendix A.
118
(k) the bringing together outside the human body of male and
female gametes, and research with regard to the product of
the union of those gametes;
(l) the artificial fertilisation of persons;
(m) the appointment and functions of inspectors of anatomy
and investigating officers;
(n) the records and registers to be kept by persons and
institutions;
(o) the returns and reports, including extracts from registers, to
be submitted to specified persons and institutions;
(p) the acquisition, storage, harvesting, utilisation or manipu-
lation of tissue, blood, blood products, organs, gametes,
oocytes or human stem cells for any purpose;
(q) the appointment and functions of inspectors of the national
blood transfusion service and progenitor cell transplant
institutions; and
(r) any other matter relating to regulating the control and the
use of human bodies, tissue, organs, gametes, blood and
blood products in humans.
(2) The Minister, with the concurrence of the Cabinet member
responsible for finance, may make regulations concerning the
payment of persons or institutions in connection with pro-
curement, storage, supply, import or export of human bodies,
tissue, blood, blood products or gametes.93
(3) The Minister may, if it is consistent with the objects of this Act
and upon such conditions as the Minister may deem fit, by
93
In terms of the Regulations: Tissue Banks, promulgated in 2012, an
authorised tissue bank, organisation or person may receive payment
only for the activities listed in section 60 of the NHA, and any payment
must be recorded, including the amount paid, to whom the payment
was made, the reason for the payment and who made the payment. A
link to the regulations can be found in Appendix A.
119
notice in the Gazette exempt any person or category of persons

from any or all of the regulations made under this section.94
Chapter 9
NATIONAL HEALTH RESEARCH AND INFORMATION
69. National Health Research Committee95
(1) The Minister must establish a committee to be known as the
National Health Research Committee.
(2) (a) The National Health Research Committee consists of not
more than 15 persons, appointed by the Minister after con-
sultation with the National Health Council.
(b) A person appointed in terms of paragraph (a) —
(i) serves for a term of not more than three years and may
be reappointed for one or more terms; and
(ii) ceases to be a member on resignation or if requested by
the Minister for good cause to resign.
(c) A vacancy in the National Health Research Committee must
be filled by the appointment of a person for the unexpired
portion of the term of office of the member in whose place
the person is appointed, and in the same manner in which
the member was appointed in terms of paragraph (a).
(3) The National Health Research Committee must —
(a) determine the health research to be carried out by public
health authorities;
(b) ensure that health research agendas and research resources
focus on priority health problems;
94
As of April 2019, no exceptions have been published.
95
The Regulations Governing the Establishment and Constitution of the
National Health Research Committee (NHRC) were passed in 2010. A
link to the regulations can be found in Appendix A. Other than the reg-
ulations and the advertisement for the appointment of members of the
committee, there is little evidence of the functioning of the committee
and we understand that as at April 2019 it is not functional.
120
(c) develop and advise the Minister on the application and

implementation of an integrated national strategy for
health research; and
(d) coordinate the research activities of public health authorities.
(4) The Minister must prescribe the manner in which the National
Health Research Committee must conduct its affairs and the
procedure to be followed at meetings of the Committee, includ-
ing the manner in which decisions must be taken.
(5) A member of the National Health Research Committee who is
not in the full-time employment of the State must in respect of
his or her service as a member be paid such remuneration as the
Minister may determine with the concurrence of the Minister of
Finance.
70. Identification of health research priorities
(1) The National Health Research Committee must identify and
advise the Minister on health research priorities.
(2) In identifying health research priorities, the National Health
Research Committee must have regard to —
(a) the burden of disease;
(b) the cost-effectiveness of interventions aimed at reducing
the burden of disease;
(c) the availability of human and institutional resources for the
implementation of an intervention at the level closest to the
affected communities;
(d) the health needs of vulnerable groups such as woman, older
persons, children and people with disabilities; and
(e) the health needs of communities.
121
71. Research on or experimentation with human subjects96

(1) Notwithstanding anything to the contrary in any other law,
research or experimentation on a living person may only be
conducted —
(a) in the prescribed manner; and
(b) with the written consent of the person after he or she has
been informed of the objects of the research or experimen-
tation and any possible positive or negative consequences
on his or her health.
(2) Where research or experimentation is to be conducted on a
minor for a therapeutic purpose, the research or experimenta-
tion may only be conducted —
(a) if it is in the best interests of the minor;
(b) in such manner and on such conditions as may be
prescribed;
(c) with the consent of the parent or guardian of the child; and
(d) if the minor is capable of understanding, with the consent
of the minor.
(3) a) Where research or experimentation is to be conducted on a
minor for a non-therapeutic purpose, the research or exper-
imentation may only be conducted —
(i) in such manner and on such conditions as may be
prescribed;
(ii) with the consent of the Minister;
(iii) with the consent of the parent or guardian of the minor;
and
(iv) if the minor is capable of understanding, the consent of
the minor.
96
The Regulations Relating to Research with Human Participants were
promulgated in 2014 in terms of this section. A link to the regulations
122
(b) The Minister may not give consent in circumstances

where —
(i) the objects of the research or experimentation can also
be achieved if it is conducted on an adult;
(ii) the research or experimentation is not likely to signifi-
cantly improve scientific understanding of the minor’s
condition, disease or disorder to such an extent that it
will result in significant benefit to the minor or other
minors;
(iii) the reasons for the consent to the research or experi-
mentation by the parent or guardian and, if applicable,
the minor are contrary to public policy;
(iv) the research or experimentation poses a significant risk
to the health of the minor; or
(v) there is some risk to the health or well-being of the
minor and the potential benefit of the research or
experimentation does not significantly outweigh that
risk.
72. National Health Research Ethics Council97
(1) A council to be known as the National Health Research Ethics
Council is hereby established.
(2) The Minister must —
(a) after consultation with the National Health Council, appoint
as members of the National Health Research Ethics Council
not more than 15 persons nominated by interested parties
at the invitation of the Minister by notice in the Gazette;
and
(b) publish the list of appointees in the Gazette.
97
The National Health Research Ethics Council (NHREC) is governed by
regulations that were gazetted on 23 September 2010. A link to the
Regulations Relating to the National Health Research Ethics Council can
be found in Appendix A. The Council’s website is at: http://www.nhrec.org.za/.
123
(3) A member of the National Health Research Ethics Council is

appointed for three years but may be reappointed for one or
more further terms.
(4) A member of the National Health Research Ethics Council must
vacate his or her office if he or she resigns or if requested by the
Minister for good cause to resign.
(5) If a member of the National Health Research Ethics Council
vacates office or dies, the Minister may fill the vacancy by
appointing a person in accordance with subsection (2) for the
unexpired portion of the term of office of his or her predecessor.
(6) The National Health Research Ethics Council must —
(a) determine guidelines for the functioning of health research
ethics committees;
(b) register and audit health research ethics committees;
(c) set norms and standards for conducting research on humans
and animals, including norms and standards for conducting
clinical trials;
(d) adjudicate complaints about the functioning of health
research ethics committees and hear any complaint by a
researcher who believes that he or she has been discrimi-
nated against by a health research ethics committee;
(e) refer to the relevant statutory health professional council
matters involving the violation or potential violation of an
ethical or professional rule by a health care provider;
(f) institute such disciplinary action as may be prescribed
against any person found to be in violation of any norms
and standards, or guidelines, set for the conducting of
research in terms of this Act; and
(g) advise the national department and provincial departments
on any ethical issues concerning research.
(7) For the purposes of subsection (6)(c), “clinical trials” means a
systematic study, involving human subjects that aims to answer
124
specific questions about the safety or efficacy of a medicine or

method of treatment.
73. Health research ethics committees
(1) Every institution, health agency and health establishment at
which health research is conducted, must establish or have
access to a health research ethics committee, which is registered
with the National Health Research Ethics Council.
(2) A health research ethics committee must —
(a) review research proposals and protocols in order to ensure
that research conducted by the relevant institution, agency
or establishment will promote health, contribute to the pre-
vention of communicable or non-communicable diseases or
disability or result in cures for communicable or non-com-
municable diseases; and
(b) grant approval for research by the relevant institution,
agency or establishment in instances where research pro-
posals and protocol meet the ethical standards of that
health research ethics committee.
74. Co-ordination of national health information system98
(1) The national department must facilitate and co-ordinate the
establishment, implementation and maintenance by provincial
departments, district health councils, municipalities and the
private health sector of health information systems at national,
provincial and local levels in order to create a comprehensive
national health information system.
98
In line with the NDoH’s obligations under this section, it has published
the District Health Management Information System (DHMIS) Policy
2011, which is available at
http://policyresearch.limpopo.gov.za/bitstream/handle/123456789/903/District%20Health%20
management%20Information%20System%20Policy.pdf?sequence=1.
Information management remains a huge problem within the health
system.
125
(2) The Minister may, for the purpose of creating, maintaining

or adapting databases within the national health information
system contemplated in subsection (1), prescribe categories or
kinds of data for submission and collection and the manner and
format in which and by whom the data must be compiled or
collated and must be submitted to the national department.
75. Provincial duties in relation to health information
The relevant member of the Executive Council must establish a com-
mittee for his or her province to establish, maintain, facilitate and
implement the health information systems contemplated in section
74 at provincial and local level.
76. Duties of district health councils and municipalities
Every district health council and every municipality which provides
a health service must establish and maintain a health information
system as part of the national health information system contem-
plated in section 74.
Chapter 10
OFFICE OF HEALTH STANDARDS COMPLIANCE,
BOARD, INSPECTIONS AND ENVIRONMENTAL HEALTH
INVESTIGATIONS, HEALTH OFFICERS AND INSPECTORS,
COMPLAINTS AND APPEAL PROCEDURE99
77. Establishment of Office of Health Standards Compliance
(1) The Office of Health Standards Compliance is hereby estab-
lished as a juristic person.
99
Chapter 10 was amended and brought into effect in September 2013
through the National Health Amendment Act 12 of 2013. The Office of
Health Standards Compliance (OHSC) is a separate juristic entity and is
funded by money appropriated by Parliament directly. The OHSC is sub-
ject to the Public Finance Management Act 1 of 1999. The main object
of the OHSC is to protect and promote the health and safety of people
using health services. The OHSC does this by monitoring compliance
126
(2) The Office is funded by —

(a) money appropriated by Parliament; and
by health establishments with the norms and standards prescribed by

the Minister in relation to the national health care system. In addition,
the OHSC acts as a mechanism for complaints to be investigated and
handled. The OHSC advises the Minister, as well as inspecting and cer-
tifying health establishments. The OHSC is run by a CEO appointed by
the Minister. The chapter sets out in a fair amount of detail the way in
which the health officers from the OHSC must perform their duties,
including a requirement that although the officers and inspectors have
the power to enter and search premises, this must be done with strict
regard to decency and good order and in line with all their constitu-
tional obligations, such as respecting the right to privacy and dignity.
In addition, the Minister must appoint a suitably qualified and
experienced person as Ombud. The Ombud — who is independent and
impartial — may, after receiving a written or verbal complaint, investi-
gate that complaint. The Ombud can also initiate an investigation itself.
The Ombud must submit a report to the CEO recommending a course
of action to resolve the complaint. If the CEO does not take the recom-
mended steps, the Ombud may request that the Minister intervenes.
The Ombud has conducted a number of important and high pro-
file investigations, including an investigation into the deaths of mental
health care users who were moved out of Life Esidimeni and into Tower
Hospital in the Eastern Cape. The recommendations in the Life Esidimeni
investigation report formed the basis for mental health system reform
efforts and led to the initiation of the Life Esidimeni arbitration, which
culminated in an arbitration award providing for apologies, counsel-
ling, the development of a monument, and financial compensation,
including constitutional damages. The Life Esidimeni investigation
report can be found here: http://ohsc.org.za/wp-content/uploads/2017/09/FINALREPORT.
pdf and the arbitration award can be found here: http://www.saflii.org/images/
LifeEsidimeniArbitrationAward.pdf. The Tower Hospital Report can be found here:
http://ohsc.org.za/wp-content/uploads/OHO-Report-Final.pdf
Regulations relating to the Office of Health Standards and Com
pliance procedures and the Norms and Standards, according to which
the OHSC monitors health facilities, were promulgated in 2016 and 2018
respectively, although they were not promulgated explicitly in terms of
this chapter. Links to the regulations can be found in Appendix A.
127
(b) fees received for services rendered.

(3) The Office is subject to the Public Finance Management Act,
1999 (Act No. 1 of 1999).
78. Objects of Office
The objects of the Office are to protect and promote the health and
safety of users of health services by —
(a) monitoring and enforcing compliance by health establishments
with norms and standards prescribed by the Minister in relation
to the national health system; and
(b) ensuring consideration, investigation and disposal of complaints
relating to non-compliance with prescribed norms and stand-
ards in a procedurally fair, economical and expeditious manner.
79. Functions of Office
(1) The Office must —
(a) advise the Minister on matters relating to the determination
of norms and standards to be prescribed for the national
health system and the review of such norms and standards;
(b) inspect and certify health establishments as compliant
or non-compliant with prescribed norms and stand-
ards or, where appropriate and necessary, withdraw such
certification;
(c) investigate complaints relating to breaches of prescribed
norms and standards;
(d) monitor indicators of risk as an early warning system relat-
ing to serious breaches of norms and standards and report
any breaches to the Minister without delay;
(e) identify areas and make recommendations for intervention
by a national or provincial department of health, a health
department of a municipality or health establishment,
where it is necessary, to ensure compliance with prescribed
norms and standards;
128
Section 79A National Health Act 61 of 2003
(f) publish information relating to prescribed norms and stand-

ards through the media and, where appropriate, to specific
communities;
(g) recommend quality assurance and management systems
for the national health system to the Minister for approval;
(h) keep records of all its activities; and
(i) advise the Minister on any matter referred to it by the
Minister.
(2) The Office may —
(a) issue guidelines for the benefit of health establishments on
the implementation of prescribed norms and standards;
(b) collect or request any information relating to prescribed
norms and standards from health establishments and users;
(c) liaise with any other regulatory authority and may, without
limiting the generality of this power, require the necessary
information from, exchange information with and receive
information from any such authority in respect of —
(i) matters of common interest; or
(ii) a specific complaint or investigation; and
(d) negotiate cooperative agreements with any regulatory
authority in order to —
(i) coordinate and harmonise the exercise of jurisdiction
over health norms and standards; and
(ii) ensure the consistent application of the principles of
this Act.
79A. Establishment of Board
(1) The Office of Health Standards Compliance Board is hereby
established.
(2) The Office functions under the control of the Board.
(3) The Board is the accounting authority of the Office and must —
(a) determine the policy of the Office;
129
The National Health Act Guide Section 79B
(b) do the necessary planning in connection with the functions

of the Office; and
(c) perform such other functions as may be assigned to it by
this Act.
79B. Composition of Board
(1) The Board consists of no less than 7 members and no more than
12 members appointed by the Minister, as follows:
(a) five members who have expertise in, among others, med-
icine, pharmacy, reproductive and maternal health, nurs-
ing, paediatrics, surgery, clinical governance and clinical
risk management, occupational health and safety, infection
control, and public health, nominated by institutions of
higher learning or any other institution;
(b) one member appointed on account of his or her knowledge
of the law;
(c) one member appointed on account of his or her knowledge
of economics and financial matters or accounting;
(d) one member appointed on account of his or her knowledge
of private healthcare sector;
(e) one member appointed on account of his or her knowledge
of public healthcare and public administration;
(f) one member appointed on account of his or her knowledge
of quality assurance;
(g) one representative from organised labour; and
(h) one representative from civil society or the community.
(2) The Chief Executive Officer and the Chief Financial Officer of the
Office are ex officio members of the Board.
79C. Appointment of members of Board
(1) The Minister must appoint the members contemplated in sec-
tion 79B(1)(a) after consultation with the relevant bodies and
institutions.
130
Section 79D National Health Act 61 of 2003
(2) The Minister must, before appointing the members contem-

plated in section 79B(1)(b) to (h), by notice in the Gazette
and in two or more nationally circulating newspapers in the
Republic, invite all interested persons to nominate, within the
period specified in the notice, persons who in the opinion of
such interested persons are fit to be so appointed, stating the
grounds upon which such opinion is based.
(3) If a suitable person or the required number of persons is not
nominated in terms of subsection (2), the Minister must appoint
an appropriate person or persons who qualify to be appointed
in terms of this Act.
(4) The members of the Board hold office for a term of at least three
years, as the Minister may determine at the time of appoint-
ment, but are eligible for re-appointment for one additional
term.
(5) A member of the Board, excluding a member who is in the full-
time employment of the State or the Service, must be appointed
on such conditions as the Minister may, with the concurrence of
the Minister of Finance, determine.
(6) If the number of members of the Board is reduced to such an
extent that a quorum cannot be obtained, the Minister may
appoint any suitably qualified persons on a temporary basis to
serve on the Board until new members are appointed in terms
of this section.
79D. Chairperson and vice-chairperson of Board
(1) The Minister must appoint a chairperson and vice-chairper-
son of the Board from the members contemplated in section
79B(1).
(2) Whenever the chairperson of the Board is absent or unable to
perform his or her functions as chairperson, the vice-chairperson
must act as chairperson and, if the vice-chairperson is absent
or unable to act as chairperson the Minister must designate
131
The National Health Act Guide Section 79E
another member of the Board to act as chairperson until the

chairperson or vice-chairperson is available.
(3) Any person acting as chairperson of the Board in terms of sub-
section (2), must exercise all the powers and perform all the
duties of the chairperson.
79E. Disqualification from membership of Board and vacation
of office
(1) A person may not be appointed as a member of the Board if that
person —
(a) is not a South African citizen and ordinarily resident in the
Republic;
(b) is an unrehabilitated insolvent;
(c) has at any time been convicted of an offence involving
dishonesty, whether in the Republic or elsewhere, and sen-
tenced to imprisonment without the option of a fine; or
(d) has been removed from an office of trust.
(2) A member of the Board must vacate his or her office if —
(a) he or she becomes disqualified in terms of subsection (1)
from being appointed as a member of the Board;
(b) he or she submits his or her resignation to the Minister in
writing;
(c) he or she is declared by the High Court to be of unsound
mind or mentally disordered or is detained under the
Mental Health Act, 1973 (Act No. 18 of 1973);
(d) he or she has, without the leave of the Board, been absent
from more than two consecutive meetings of the Board;
(e) the Minister withdraws the appointment because in the
opinion of the Minister, and after consultation with the
Board, the member is incompetent or unfit to fulfil his or
her duties; or
(f) he or she ceases to be ordinarily resident in the Republic.
132
Section 79F National Health Act 61 of 2003
(3) If a member of the Board dies or vacates his or her office in

terms of subsection (2), the Minister may, subject to section
79C, appoint a person to fill the vacancy for the unexpired por-
tion of the period for which that member was appointed.
79F. Meetings of Board
(1) The meetings of the Board and the conduct of business at meet-
ings must be prescribed by the rules.
(2) A quorum for a meeting of the Board is the majority of its
members.
(3) A decision of the majority of the members of the Board pres-
ent at any meeting constitutes a decision of the Board and, in
the event of an equality of votes, the member presiding at the
meeting has a casting vote in addition to his or her deliberative
vote.
(4) A decision taken by the Board or an act performed under the
authority of the Board is not invalid by reason only of a vacancy
on the Board, or that a person who is not entitled to sit as a
member of the Board sat as a member at the time when the
decision was taken or the act was authorised, if the decision
was taken or the act was authorised by the requisite majority
of the members of the Board who were present at the time and
entitled to sit as members.
(5) Minutes of the proceedings of every meeting of the Board must
be prepared and entered in a book kept for that purpose.
(6) Minutes of the proceedings of each meeting must be submit-
ted at the next meeting of the Board and, if passed as correct,
must be confirmed by the signature of the chairperson or other
member presiding thereat and may, when so confirmed, be
evidence in a court of law of the proceedings of the first-men-
tioned meeting.
(7) In the absence of the chairperson or the person acting as
the chairperson from a particular meeting of the Board, the
133
The National Health Act Guide Section 79G
members present at that meeting may elect one of their number

to preside at that meeting.
79G. Committees of Board
(1) The Board may appoint one or more committees from among
its members to assist it with the performance of its functions
and exercise of its powers.
(2) The Board may appoint one or more specialist advisory commit-
tees consisting of members other than members of the Board,
to assist it with the performance of its functions and exercise of
its powers.
79H. Appointment of Chief Executive Officer
(1) The Board must, in consultation with the Minister, subject to the
laws governing the public service, appoint a fit and proper and
suitably qualified South African citizen as the Chief Executive
Officer of the Office.
(2) The Chief Executive Officer holds office for a term of five years
and may be reappointed for one additional term of five years.
(3) (a) The appointment of a person as the Chief Executive Officer
is subject to the conclusion of a written performance agree-
ment entered into between that person and the Board, in
consultation with the Minister.
(b) The Board, in consultation with the Minister, and the Chief
Executive Officer may, in writing and by agreement, amend
the performance agreement.
(4) The Board may, in consultation with the Minister, remove the
Chief Executive Officer from office on account of serious mis-
conduct, incapacity or incompetence, after affording him or her
reasonable opportunity to be heard and subject to applicable
legislation.
(5) If the Chief Executive Officer is unable to perform the functions
of the Office, or during a vacancy in the office of Chief Executive
134
Section 79I National Health Act 61 of 2003
Officer, the Board may, after consultation with the Minister, des-
ignate another employee of the Office to act as Chief Executive
Officer.
(6) No person may be designated as acting Chief Executive Officer
for longer than 90 days at a time.
(7) The Chief Executive Officer is entitled to the pension and retire-
ment benefits calculated on the same basis as those of a head of
a department in the public service.
79I. Functions of Chief Executive Officer
(1) The Chief Executive Officer —
(a) is the head of the Office;
(b) is responsible for the proper and diligent implementation
of the Public Finance Management Act, 1999 (Act No. 1 of
1999); and
(c) must appoint suitably qualified persons as employees of
the Office in accordance with an organisational structure
approved by the Board in consultation with the Minister.
(2) As head of the Office, the Chief Executive Officer is responsible
for —
(a) the formation and development of an efficient
administration;
(b) the organisation and control of staff;
(c) the maintenance of discipline; and
(d) the effective deployment and utilisation of staff to achieve
maximum operational results.
(3) The Chief Executive Officer may, after consultation with the
Board, enter into contracts with any person or organisation or
appoint expert or technical committees to assist the Office in
the performance of its functions, including the conducting of
inspections.
135
The National Health Act Guide Section 79J
(4) The Chief Executive Officer must take appropriate action to

ensure the implementation of the findings of the report and the
recommendations of the Ombud referred to in section 81A(9).
(5) The Chief Executive Officer may, subject to subsection (4),
request the intervention of the Minister, a member of the exec-
utive council responsible for health in the province or a member
of the municipal council responsible for health if the complaint
relates to a matter falling under the national department or that
particular province or municipality, as the case may be.
79J. Delegation of powers and assignment of duties by Chief
Executive Officer
(1) The Chief Executive Officer may —
(a) delegate to an employee of the Office any of his or her
powers in terms of this Act; or
(b) assign to an employee of the Office any of his or her duties
in terms of this Act.
(2) The delegation in terms of subsection (1) —
(a) must be in writing;
(b) may be subject to such terms and conditions the Chief
Executive Officer may determine or impose;
(c) may at any time be amended or revoked by the Chief
Executive Officer; and
(d) does not divest the Chief Executive Officer of the responsi-
bility concerning the exercise of the power.
79K. Accountability of and reporting by Chief Executive Officer
(1) The Chief Executive Officer must, subject to the Public Finance
Management Act, 1999 (Act No. 1 of 1999) —
(a) cause the necessary accounting and other records to be
kept;
136
(b) in consultation with the Board, prepare and submit to

the Minister an annual report for approval by the Minister
within five months after the end of the financial year.
(2) The annual report referred to in subsection (1) must include —
(a) audited annual financial statements by the Auditor-General;
(b) the Auditor-General’s report; and
(c) a detailed report of the activities of the Office undertaken
during the year to which the audit relates.
(3) The Minister must table in Parliament a copy of the annual
report, financial statements and the audit report on those state-
ments within one month after receipt thereof if Parliament is in
session or, if Parliament is not in session, within one month after
the commencement of its next ensuing session.
(4) The Chief Executive Officer must, once the annual report, finan-
cial statements and audit report have been tabled in Parliament,
make the annual report, financial statements and audit report
on those statements accessible to the public.
(5) Notwithstanding subsections (1) and (2), the Board or Chief
Executive Officer, as the case may be, must, upon request by the
Minister —
(a) furnish the Minister with information or a report in respect
of any case, matter or subject dealt with by the Office; and
(b) provide the Minister with reasons for any decision taken by
the Board, Chief Executive Officer, an inspector or any other
employee of the Office.
80. Appointment of health officers and inspectors
(1) The Minister, relevant member of the Executive Council or
mayor of a municipal council may designate any person in the
employ of the national department, province or municipality, as
the case may be, as a health officer.
137
(2) The Chief Executive Officer must, subject to section 79I(1)(c),

appoint any suitably qualified person with appropriate pre-
scribed expertise and skill as an inspector.
(3) A health officer designated or an inspector appointed in terms
of this section must be issued with a certificate stating that he or
she has been designated or appointed, as the case may be, as a
health officer or as an inspector in terms of this Act.
(4) When a health officer or an inspector performs any function in
terms of this Act, he or she —
(a) must be in possession of a certificate of designation or cer-
tificate of appointment, as the case may be, issued in terms
of subsection (3);
(b) must show that certificate to any person who is affected by
the action of the health officer or inspector in terms of this
Act; and
(c) has the powers of a peace officer, as defined in section 1 of
the Criminal Procedure Act, 1977 (Act No. 51 of 1977), and
may exercise any of the powers conferred on a peace officer
by law.
81. Appointment of Ombud
(1) The Minister must, after consultation with the Board, appoint
a suitably qualified and experienced South African citizen as
Ombud.
(2) The Minister must, before appointing the Ombud in terms of
subsection (1), by notice in the Gazette and in two or more
nationally circulating newspapers in the Republic, invite appli-
cations from suitable persons.
(3) The Ombud —
(a) holds office for a non-renewable term of seven years;
(b) is located within the Office;
(c) is assisted by persons designated and seconded by the
Office with the concurrence of the Ombud; and
138
(d) reports to and is accountable to the Minister.

(4) The Minister, with the concurrence of the Minister of Finance,
must determine the remuneration and other terms and condi-
tions of service of the Ombud.
(5) The Ombud may at any time resign by submitting a written
notice to the Minister at least 90 days prior to the intended
date of vacation of office, unless the Minister allows for a shorter
period.
(6) The Minister may terminate the employment of the Ombud on
account of serious misconduct, incapacity or incompetence,
after affording him or her reasonable opportunity to be heard
and subject to applicable legislation.
(7) The Minister must, during a vacancy or when the Ombud is
unable to fulfil any of his or her functions, appoint a person on a
temporary basis in accordance with subsection (1) to act in the
position until a permanent person is appointed.
81A. Functions of Ombud100
(1) The Ombud may, on receipt of a written or verbal complaint
relating to norms and standards, or on his or her own initiative,
consider, investigate and dispose of the complaint in a fair, eco-
nomical and expeditious manner.
(2) A complaint referred to in subsection (1) may involve an act
or omission by a person in charge of or employed by a health
establishment or any facility or place providing a health service.
(3) In conducting an investigation, the Ombud may, subject to sub-
section (8) —
(a) be assisted by any person contemplated in section 81(2)(c);
(b) (i) obtain an affidavit or a declaration from any person;
(ii) direct any person to appear before him or her;
100
See note 99 on page 126 above for further information on the work of
the Ombud.
139
The National Health Act Guide Section 81A
(iii) direct any person to give evidence or produce any doc-

ument in his or her possession or under his or her con-
trol which has a bearing on the matter under consider-
ation or being investigated; and
(iv) interrogate such person;
(c) request an explanation from any person whom he or she
reasonably suspects of having information which has a bear-
ing on a matter under consideration or which is being or to
be investigated; and
(d) require any person appearing as a witness to give evidence
under oath or after having made an affirmation.
(4) A direction contemplated in subsection (3)(b) may be by way of
a subpoena containing particulars of the matter in connection
with which the person subpoenaed is required to appear before
the Ombud and served on the person subpoenaed either by
a registered letter sent through the post or by delivery by a
person authorised thereto by the Ombud.
(5) If it appears to the Ombud that any person is being implicated
in the matter being investigated, the Ombud must afford such
person an opportunity to be heard in connection therewith
by way of the giving of evidence, and such person is entitled,
through the Ombud, to question other witnesses, determined
by the Ombud, who have appeared before the Ombud in terms
of this section.
(6) The Ombud may, when considering or investigating a com-
plaint in terms of this section, require the assistance of or refer
the complaint to any other authority established in terms of leg-
islation or any other appropriate and suitable body or entity to
investigate similar complaints.
(7) The authority, body or entity, as the case may be, contemplated
in subsection (6) must provide —
(a) the Ombud with the assistance required; and
140
Section 81B National Health Act 61 of 2003
(b) report to the Ombud on the progress made in relation to

complaints referred to it.
(8) No self-incriminating answer given or statement made by any
person to the Ombud exercising powers in terms of this Act,
is admissible as evidence against that person in criminal pro-
ceedings against that person instituted in any court, except in
criminal proceedings for perjury or in which that person is tried
for an offence contemplated in this Act, and then only to the
extent that the answer or statement is relevant to prove the
offence charged.
(9) After each investigation, the Ombud must submit a report
together with his or her recommendations on appropriate
action to the Chief Executive Officer.
(10) Where the Chief Executive Officer fails to act in accordance with
the findings and recommendations of the Ombud, the Ombud
may request the intervention of the Minister.
(11) The Ombud must, after the conclusion of an investigation,
inform the complainant or the respondent or both, as the case
may be, of his or her findings and recommendations.
81B. Independence, impartiality and accountability of Ombud
(1) The expenditure connected with the appointment and functions
of the Ombud is paid out of funds appropriated by Parliament
for that purpose, as part of the budget of the Office.
(2) When dealing with any complaint in terms of this Act, the
Ombud, including any person rendering assistance and support
to the Ombud —
(a) is independent and impartial; and
(b) must perform his or her functions in good faith and without
fear, favour, bias or prejudice.
(3) The Minister, national department and Office must afford the
Ombud such assistance and support as may be reasonably
141
necessary for the Ombud to perform his or her functions effec-

tively and efficiently.
(4) The Ombud must, within one month after the end of the finan-
cial year, prepare a report on the affairs and functions of the
Ombud during the financial year in question, and submit such
report to the Minister for tabling in Parliament.
82. Inspections
(1) A health officer may enter any premises, excluding a private
dwelling, whereas an inspector may enter any health establish-
ment, at any reasonable time, and —
(a) inspect such premises or health establishment, as the case
may be, in order to ensure compliance with this Act;
(b) question any person who he or she believes may have infor-
mation relevant to the inspection;
(c) require the person in charge of such premises or health
establishment to produce, for inspection or for the purpose
of obtaining copies or extracts thereof or therefrom, any
document, including any health record contemplated in
section 15, which such person is required to maintain in
terms of any law; and
(d) take samples of any substance or photographs relevant to
the inspection.
(2) A health officer or an inspector may be accompanied by an
interpreter and any other person reasonably required to assist
him or her in conducting the inspection.
(3) A health officer or an inspector may issue a compliance notice
to the person in charge of the premises or health establishment,
as the case may be, if any norm and standard or a provision of
this Act has not been complied with.
(4) A compliance notice remains in force until the relevant provision
of the Act has been complied with and a compliance certificate
has been issued by the relevant authority.
142
(5) A health officer or an inspector who removes any item other

than that contemplated in subsection (1)(d) must —
(a) issue a receipt for it to the person in charge of the premises
or health establishment, as the case may be; and
(b) subject to the Criminal Procedure Act, 1977 (Act No. 51 of
1977), return it as soon as practicable after achieving the
purpose for which it was removed.
(6) The provisions of section 86A apply with the necessary changes
required by the context to inspections conducted in terms of
this section.
(7) A compliance certificate issued by the Office shall be valid for a
period of no more than four years and must be renewed before
or on the expiry date in a manner prescribed.
82A. Non-compliance with prescribed norms and standards
(1) An inspector may issue a compliance notice to a person in
charge of any health establishment if such establishment does
not comply with any prescribed norm and standard.
(2) The notice contemplated in subsection (1) must set out —
(a) the health establishment to which the notice applies;
(b) any prescribed norm and standard that have not been com-
plied with;
(c) details of the nature and extent of non-compliance;
(d) any steps that are required to be taken and the period over
which such steps must be taken; and
(e) the penalties that may be imposed in the event of contin-
ued non-compliance.
(3) A compliance notice issued in terms of this section remains
in force until the Office, on the basis of information furnished
by the inspector, issues a certificate of compliance or until it
is appealed against and set aside by the tribunal appointed in
terms of section 88A(2)(a).
143
(4) If a person in charge of a health establishment to whom a com-

pliance notice has been issued, fails to comply with the notice,
the Office may as appropriate and taking into account the
nature, extent, gravity and severity of the contravention —
(a) issue a written warning to achieve compliance within a set
period of time in a manner prescribed;
(b) require a written response from the health establishment
regarding the continued non-compliance;
(c) recommend to the relevant authority any appropriate and
suitable action to be undertaken, including the institution of
disciplinary proceedings against persons responsible for the
non-compliance or continued non-compliance;
(d) revoke the compliance certificate and recommend to the
Minister the temporary or permanent closure of the health
establishment or part thereof that constitutes a serious risk
to public health or to health service users;
(e) impose upon that person or health establishment a fine
as determined by the Minister in the Gazette from time to
time; or
(f) refer the matter to the National Prosecuting Authority for
prosecution.
(5) The Chief Executive Officer must inform the head of a national
or provincial department, the municipal manager or the head of
a health establishment of any persistent non-compliance.
83. Environmental health investigations
(1) If a health officer has reasonable grounds to believe that any
condition exists which —
(a) constitutes a violation of the right contained in section
24(a) of the Constitution;101
(b) constitutes pollution detrimental to health;
101
Section 24(a) of the Constitution states that everyone has the right to
an environment that is not harmful to their health or well-being.
144
(c) is likely to cause a health nuisance; or

(d) constitutes a health nuisance,
the health officer must investigate such condition.
(2) If the investigation reveals that a condition contemplated in sub-
section (1) exists, the health officer must endeavour to deter-
mine the identity of the person responsible for such condition.
(3) The health officer must issue a compliance notice to the person
determined to be responsible for any condition contemplated in
subsection (1) to take appropriate corrective action in order to
minimise, remove or rectify such condition.
(4) Any person aggrieved by a determination or instruction in terms
of subsection (2) or (3) may, within a period of 14 days from the
date on which he or she became aware of the determination or
instruction, lodge an appeal with the person who appointed a
health officer in terms of section 80(1).
(5) Only a health officer who is registered as an environmental
health practitioner in terms of the Health Professions Act, 1974
(Act No. 56 of 1974), may exercise any of the powers conferred
under this section.
84. Entry and search of premises or health establishment with
warrant by health officer or inspector
(1) A health officer or inspector may, where necessary, be accompa-
nied by a police official and may, on the authority of a warrant
issued in terms of subsection (5) and subject to sections 85 and
86A, enter any premises, including a private dwelling, or health
establishment, as the case may be, specified in the warrant,
and —
(a) inspect, photograph, copy, test and examine any docu-
ment, record, object or material, or cause it to be inspected,
photographed, copied, tested and examined;
145
(b) seize any document, record, object or material if he or she

has reason to suspect that it might be used as evidence in a
criminal trial; and
(c) examine any activity, operation or process carried out on
the premises or health establishment.
(2) A health officer or an inspector who removes anything from the
premises or health establishment being searched, as the case
may be, must —
(a) issue a receipt for it to the owner or person in control of the
premises or health establishment; and
(b) unless it is an item prohibited in terms of this Act, return it
as soon as practicable after achieving the purpose for which
it was removed.
(3) Upon the request of a health officer or an inspector acting in
terms of a warrant issued in terms of subsection (5), the occu-
pant and any other person present on the premises or health
establishment, as the case may be, must —
(a) make available or accessible or deliver to the health officer
or inspector any document, record, object or material which
pertains to an investigation or inspection contemplated in
subsection (1) and which is in the possession or under the
control of the occupant or other person;
(b) furnish such information as he or she has with regard to the
matter under investigation or inspection; and
(c) render such reasonable assistance as the health officer or
inspector may require to perform his or her functions effi-
ciently in terms of this Act.
(4) Before questioning any person at the premises or health estab-
lishment in question, the health officer, inspector or police offi-
cial must advise that person of his or her right to be assisted at
the time by an advocate or attorney, and allow that person to
exercise that right.
146
(5) A warrant contemplated in subsection (1) may be issued by a

judge or a magistrate —
(a) in relation to the premises or health establishment on or
from which there is reason to believe an act has been or is
being committed in contravention of this Act; and
(b) if it appears from information on oath or affirmation that
there are reasonable grounds to believe that there is evi-
dence available in or upon such premises or health estab-
lishment of a contravention of this Act.
(6) The warrant may impose restrictions on the powers of the
health officer or inspector.
(7) A warrant issued in terms of this section —
(a) remains in force until —
(i) it is executed;
(ii) it is cancelled by the person who issued it or, if such
person is not available, by any person with like authority;
(iii) the expiry of one month from the day of its issue; or
(iv) the purpose for the issuing of the warrant has lapsed,
whichever occurs first; and
(b) must be executed by day unless the person who issues the
warrant authorises the execution thereof by night.
(8) No person is entitled to compensation for any loss or damage
arising out of any bona fide action by a police official, a health
officer or an inspector under this section.
85. Identification prior to entry, and resistance against entry, by
health officer or inspector
(1) A health officer or an inspector who has obtained a warrant in
terms of section 84(5) or the police official accompanying him
or her, must immediately before entering the premises or health
establishment in question, as the case may be —
147
(a) audibly announce that he or she is authorised to enter the

premises or health establishment and demand admission to
the premises or establishment; and
(b) notify the person in control of the premises or health estab-
lishment of the purpose of the entry, unless there are rea-
sonable grounds to believe that such announcement or
notification might defeat the purpose of the search.
(2) The health officer or inspector, as the case may be, must —
(a) hand to the person in control of the premises or health
establishment a copy of the warrant or, if such person is
not present, affix such a copy to a prominent place on the
premises; and
(b) on request of the person in charge of such premises or
health establishment, show his or her certificate of appoint-
ment as health officer or inspector to that person.
(3) A health officer or an inspector, as the case may be, or a police
official contemplated in subsection (1), may overcome resist-
ance to the entry and search by using such force as is reasonably
required, including the breaking of a door or window of the
premises or health establishment.
(4) Before using force, the health officer or inspector, as the case
may be, or police official must audibly demand admission and
must announce the purpose of the entry, unless there are rea-
sonable grounds to believe that doing so might defeat the pur-
pose of the search.
without warrant by health officer or inspector
A health officer or an inspector may, subject to section 86A, without
a warrant exercise any power referred to in section 84(1) if —
(a) the person who is competent to do so consents to such
exercise; or
148
(b) there are reasonable grounds to believe that a warrant

would be issued in terms of section 84(5) and that the delay
in obtaining the warrant would defeat the object of the
warrant.
86A. Constitutional right to privacy
Any entry upon or search of any premises or health establishment in
terms of this Act must be conducted with strict regard to decency
and good order, including —
(a) the right of a person to dignity;
(b) the right of a person to freedom and security; and
(c) the right of a person to privacy.
87. Disposal of items seized by health officer or inspector
A health officer or an inspector may dispose of anything seized in
terms of section 84 or 86 in the manner provided for in Chapter
2 of the Criminal Procedure Act, 1977 (Act No. 51 of 1977).
88. Miscellaneous provisions relating to health officers,
inspectors and compliance procedures
For the purposes of this Act, the head of a national or provincial
department, the municipal manager or the head of a health estab-
lishment must be regarded as being —
(a) the owner and occupier of any premises or health estab-
lishment that the national or provincial department or the
municipality occupies or uses; and
(b) the employer of persons in the service of that national or
provincial department or municipality if, as an employer,
the national or provincial department or municipality —
(i) performs any duty imposed upon an employer by or
under this Act; or
(ii) exercises any power conferred upon an employer by or
under this Act.
149
The National Health Act Guide Section 88A
88A. Appeals against decisions of Office or Ombud

(1) Any person aggrieved by any decision of the Office or any find-
ing and recommendation of the Ombud in relation to a matter
regulated by this Act, or a person acting on his or her behalf,
may within 30 days of him or her gaining knowledge of that
decision, lodge a written appeal with the Minister.
(2) The Minister must, upon receipt of the appellant’s written
appeal contemplated in subsection (1) —
(a) appoint an independent ad hoc tribunal in terms of subsec-
tion (3);
(b) submit the appeal to the tribunal for adjudication in the
prescribed manner.
(3) A tribunal contemplated in subsection (2) must consist of not
more than three persons, of whom —
(a) one must be a person who is a retired judge of a High Court
or a retired magistrate, who must be the chairperson; and
(b) two must be persons appointed on account of their knowl-
edge of the health care industry.
(4) A tribunal contemplated in subsection (2) —
(a) may confirm, set aside or vary the decision of the Office or
Ombud; and
(b) must notify the parties of its decision.
89. Offences and penalties
(1) A person is guilty of an offence if he or she —
(a) obstructs or hinders a health officer or an inspector who is
performing a function or any other person rendering assis-
tance or support to a health officer or an inspector under
this Act;
(b) refuses to provide a health officer or an inspector with such
information as that person is required to provide under this
Act;
150
(c) knowingly gives false or misleading information to a health

officer or an inspector;
(d) unlawfully prevents the owner of any premises or health
establishment, or a person working for the owner, from
entering the premises or health establishment in order to
comply with a requirement of this Act;
(e) impersonates a health officer or an inspector;
(f) fails to comply with a compliance notice issued to him or
her by a health officer or an inspector in terms of this Act;
(g) discloses any information acquired in the performance of
any function in terms of this Act which relates to the finan-
cial or business affairs of any person, to any other person,
except if —
(i) such other person requires that information in order to
perform any function in terms of this Act;
(ii) the disclosure is ordered by a court of law; or
(iii) the disclosure is in compliance with the provisions of
any law; or
(h) interferes with, hinders or obstructs the Ombud or any
other person rendering assistance or support to the Ombud
when he or she is performing or exercising a function or
power under this Act.
exceeding 10 years or to both a fine and such imprisonment.
151
Chapter 11
REGULATIONS
90. Regulations102
(1) The Minister, after consultation with the National Health
Council or the Office, as the case may be, may make regulations
regarding —
(a) anything which may or must be prescribed in terms of this
Act;
(b) (i) the fees to be paid to public health establishments for
health services rendered; or
(ii) the fees to be paid to the Office for services rendered;
(c) the norms and standards for —
(i) the national health systems; or
(ii) specified types of protective clothing and the use,
cleaning and disposal of such clothing;
(d) the performance of the functions of the Board and the
Office;
(e) the development of an essential drugs list and medical and
other assistive devices list;
(f) human resource development;
(g) co-operation and interaction between private health care
providers and private health establishments on the one
hand and public health care providers and public health
establishments on the other;
(h) returns, registers, reports, records, documents and forms to
be completed and kept by the national department, pro-
vincial departments, district health councils, health care
providers, private health establishments and public health
establishments;
102
For a list of all regulations that have been promulgated as of April 2019,
see Appendix A.
152
(h) the functions of persons who render voluntary, charita-

ble or similar services in connection with a public health
establishment;
(i) the rendering of forensic pathology, forensic medicine and
related laboratory services, including the provision of medi-
co-legal mortuaries and medico-legal services;103
(j) communicable diseases;104
(k) notifiable medical conditions;
(l) rehabilitation;
(m) emergency medical services and emergency medical treat-
ment, both within and outside of health establishments;105
(n) environmental health, including health nuisances and med-
ical waste;
(o) the import and export of pathogenic micro-organisms;
(p) health laboratory services, including —
(i) the classification, accreditation and licensing of health
laboratories; and
(ii) setting, monitoring and enforcing quality control stand-
ards applicable to health laboratories;
(q) non-communicable diseases;106
103
The Regulations Regarding the Rendering of Forensic Pathology Service
were promulgated in 2018 in terms of this section. A link to the regula-
tions can be found in Appendix A.
104
The Regulations Relating to the Surveillance and the Control of
Notifiable Medical Conditions were finally promulgated in 2017 in line
with this section and with section 90(1)(k) below. See note 33 on page
58 above for more information.
105
The Regulations Relating to Emergency Care at Mass Gathering Events
and the Emergency Medical Services Regulations were both promul-
gated in 2017 in terms of this section. Links to the regulations can be
found in Appendix A.
106
The Regulations Relating to Cancer Registration were promulgated in
2011 in terms of this section. A link to the regulations can be found in
Appendix A.
153
(r) health technology;

(s) health research;107
(t) the national health information system contemplated in
section 74;
(u) the processes and procedures to be implemented by the
Director-General in order to obtain prescribed information
from stakeholders relating to health financing, the pricing of
health services, business practices within or involving health
establishments, health agencies, health workers and health
care providers, and the formats and extent of publication of
various types of information in the public interest and for
the purpose of improving access to and the effective and
efficient utilisation of health services;108
(v) the processes of determination and publication by the
Director-General of one or more reference price lists for ser-
vices rendered, procedures performed and consumable and
disposable items utilised by categories of health establish-
ments, health care providers or health workers in the private
health sector which may be used —
(i) by a medical scheme as a reference to determine its
own benefits; and
107
The Regulations Relating to the National Health Research Ethics Council
and the Regulations Relating to the Establishment of the National
Health Research Committee were both promulgated in 2010 in terms of
this section. Links to the regulations can be found in Appendix A.
108
The Regulations Relating to the Obtainment of Information and the
Processes of Determination and Publication of Reference Price List were
can be found in Appendix A. The regulations were promulgated in terms
of section 90(1)(u) and (v). In Hospital Association of South Africa and
Others v Minister of Health and Others [2010] ZAGPPHC 69 (28 July 2010),
the court found that the regulations were invalid on both procedural
and substantial grounds. The Minister has not yet promulgated new
regulations in this regard.
154
(ii) by health establishments, health care providers or

health workers in the private health sector as a refer-
ence to determine their own fees, but which are not
mandatory; and
(w) generally, any other matter which it is necessary or expe-
dient to prescribe in order to implement or administer this
Act.
(1A) The Minister may, after consultation with relevant regulatory
authorities, prescribe different norms and standards for different
types of health establishments.
(2) The Minister, subject to the Medicines and Related Substances
Control Act, 1965 (Act No. 101 of 1965), and after consultation
with the National Health Research Ethics Council, may make
regulations regarding research on human subjects.
(3) The Minister may, in any regulation made under this Act —
(a) designate as authoritative any methodology, procedure,
practice or standard that is recognised as authoritative by
internationally recognised health bodies within the relevant
profession; and
(b) require any person or body to comply with the designated
methodology, procedure, practice or standard.
(4) (a) The Minister must publish all regulations proposed to be
made under this Act in the Gazette for comment at least
three months before the date contemplated for their
commencement.
(b) If the Minister alters the draft regulations, as a result of any
comment, he or she need not publish those alterations
before making the regulations.
155
(c) The Minister may, if circumstances necessitate the immedi-

ate publication of a regulation, publish that regulation with-
out the consultation contemplated in paragraph (a).109
Chapter 12
GENERAL PROVISIONS
91. Minister may appoint committees
(1) The Minister may, after consultation with the National Health
Council, establish such number of advisory and technical com-
mittees as may be necessary to achieve the objects of this Act.110
(2) When establishing an advisory or technical committee, the
Minister may determine by notice in the Gazette —
(a) its composition, functions and working procedure;
(b) in consultation with the Minister of Finance, the terms,
conditions, remuneration and allowances applicable to its
members; and
(c) any incidental matters relating to that advisory or technical
committee.
92. Assignment of duties and delegation of powers
Subject to the Public Finance Management Act (Act No. 1 of 1999) —
109
The Regulations Relating to the Management of Human Remains were
110
Seven committees have been established under this section: the National
Committee on Confidential Enquiries into Maternal Deaths, the NHI
Advisory Committee, the Advisory Committee on the Prevention and
Control of Cancer, the National Forensic Pathology Services Committee,
the Ministerial Committee on e-Health, the Advisory Committee on
Health Technology Assessment, and the Advisory Committee on Organ
Transplants. Links to the notices to this effect, other than in relation
to the National Committee on Confidential Enquiries into Maternal
Deaths and and the Advisory Committee on Organ Transplant, about
which we were unable to trace the relevant notices, can be found in
Appendix A.
156
(a) the Minister may assign any duty and delegate any power
imposed or conferred upon him or her by this Act, except the
power to make regulations, to —
(i) any person in the employ of the State; or
(ii) any council, board or committee established in terms of this
Act;
(b) the relevant member of the Executive Council may assign any
duty and delegate any power imposed or conferred upon him
or her by this Act, except the power to make regulations, or
assigned or delegated to him or her by the Minister, to any
officer in the relevant provincial department or any council,
board or committee established in terms of this Act;
(c) the Director-General may assign any duty and delegate any
power imposed or conferred upon him or her by this Act to any
official in the national department; and
(d) the head of a provincial department may assign any duty and
delegate any power imposed or conferred upon him or her in
terms of this Act to any official of that provincial department.
93. Repeal of laws, and savings
(1) Subject to this section, the laws mentioned in the second
column of the Schedule are hereby repealed to the extent set
out in the third column of the Schedule.
(2) Anything done before the commencement of this Act under a
provision of a law repealed by subsection (1) and which could
have been done under a provision of this Act must be regarded
as having been done under the corresponding provision of this
Act.
(3) The Minister may prescribe such further transitional arrange-
ments as may be necessary to effect a smooth transition
between the laws referred to in the Schedule and this Act.
157
94. Short title and commencement

This Act is called the National Health Act, 2003, and takes effect on a
date fixed by the President by proclamation in the Gazette.
SCHEDULE
LAWS REPEALED111
(Section 93)
No. and year of Short title Extent of
Act repeal
Act No. 63 of 1977 Health Act, 1977 The whole
Act No. 18 of 1979 Health Amendment Act, 1979 The whole
Act No. 65 of 1983 Human Tissue Act, 1983 The whole
Act No. 106 of 1984 Human Tissue Amendment Act, 1984 The whole
Act No. 51 of 1989 Human Tissue Amendment Act, 1989 The whole
Act No. 116 of 1990 National Policy for Health Act, 1990 The whole
Act No. 86 of 1993 Academic Health Centres Act, 1993 The whole
Act No. 118 of 1993 Health and Welfare Matters Amendment Sections 1,
Act, 1993 2, 4, 5, 6, 7,
8, 9 and 10
111
Despite the repeal of these Acts or sections, the savings clause in sec-
tion 93 does allow any conduct done before the commencement of the
NHA, which could have been done under a corresponding provision of
the NHA, to be considered as having been done under the NHA. Thus,
certain regulations under these Acts, despite their repeal, may remain in
effect if the NHA allows for similar regulations to be created.
158
Appendix A
Regulations under the National Health Act
• 18 January 201 — Procedural Regulations Pertaining to the

Functioning of the Office of Health Standards Compliance
and Handling of Complaints by the Ombud: Code of Conduct
for Inspectors (Gazette 42162, Notice 11)
–– https://www.gov.za/sites/default/files/gcis_document/201901/42162gon11.pdf
• 23 March 2018 — Regulations Regarding the Rendering of
Forensic Pathology Services (Gazette 41524, Notice 359)
–– ‌http://www.gpwonline.co.za/Gazettes/Gazettes/41524_23-3_Health.pdf
• ‌16 March 2018 — Policy Guidelines for the Licensing of
Residential Authority and/or Day Care Facilities for Persons
with Mental Illness and/or Severe or Profound Intellectual
Disability (Gazette 41498, Notice 218)
–– ‌https://www.gov.za/sites/default/files/41498_gon218b.pdf
• ‌2 February 2018 — Norms and Standards Regulations
Applicable to Different Categories of Health Establishments
(Gazette 41419, Notice 267)
–– ‌http://us-cdn.creamermedia.co.za/assets/articles/attachments/72969_41419_gon67.
pdf
• ‌15 December 2017 — Regulations Relating to the Surveillance
and Control of Notifiable Medical Conditions (Gazette 41330,
Notice 1434)
–– ‌http://www.gpwonline.co.za/Gazettes/Gazettes/41330_15-12_Health.pdf
• ‌1 December 2017 — Emergency Medical Services Regulation,
2017 (Gazette 41287, Notice 1320)
–– ‌http://section27.org.za/wp-content/uploads/2018/02/EMS-Regulations-2017.pdf
• ‌July 2017 — National Health Insurance White Paper (which
establishes the Advisory Committee on Health Technology
159
Assessment, although it is not clear if the committee has in

fact been established) (Gazette 40969, Notice 625)
–– ‌http://www.health.gov.za/index.php/nhi?download=2257:white-paper-nhi-2017
• 15 June 2017 —
‌ Regulations Relating to Emergency Care at
Mass Gatherings (Gazette 4019, Notice 566)
–– ‌https://www.gov.za/sites/default/files/40919_gon566s.pdf
• ‌2 November 2016 — Procedural Regulations Pertaining to the
Functioning of the Office of Health Standards Compliance
and Handling of Complaints by the Ombud (Gazette 40396,
Notice 1365)
–– ‌http://www.polity.org.za/attachment.php?aa_id=65754
• ‌24 December 2015 — National Environmental Health Norms
and Standards for Premises and Acceptable Monitoring
Standards for Environmental Health Practitioners (Gazette
39561, Notice 1229)
• 10 July 2015 —
‌ Establishment of the National Advisory
Committee on e-Health (Gazette 38981, Notice 595)
• ‌19 September 2014 — Regulations Relating to Research with
Human Participants (Gazette 38000, Notice 719)
–– ‌https://www.gov.za/sites/www.gov.za/files/38000_rg10268_gon719.pdf
• 11 March 2014 —
‌ Establishment of the National Forensic
Pathology Services Committee (Gazette 37430, Notice 178)
• 4 December 2013 —
‌ National Environmental Health Policy
• ‌22 May 2013 — Regulations Relating to the Management of
Human Remains (Gazette 36473, Notice 363)
160
Appendix A
• 1‌ 5 June 2012 — Call for Establishment of a National Advisory

Committee on the Prevention and Control of Cancer (Gazette
35447, Notice 462)
–– ‌Link not available without subscription to a database
• ‌2 March 2012 — Regulations Relating to Categories of
Hospitals (Gazette 35101, Notice 185)
–– ‌http://www.health.gov.za/index.php/2014-03-17-09-09-38/legislation/joomla-split-
menu/category/84-2012r?download=138:regulations-relating-to-categories-of-
hospitals-r185-2012
• ‌2 March 2012 — Regulations Relating to Stem Cell Banks
–– ‌h ttp://www.health.gov.za/index.php/2014-03-17-09-09-38/legislation/
joomla-split-menu/category/84-2012r?download=134
• ‌2 March 2012 — Regulations Relating to Tissue Banks (Gazette
35099, Notice 182)
–– ‌h ttp://www.health.gov.za/index.php/2014-03-17-09-09-38/legislation/joom-
la-split-menu/category/84-2012r?download=139:regulations-relating-to-tis-
sue-banks-r182-2012
• ‌2 March 2012 — Regulations Relating to the Import and Export
of Human Tissue, Blood, Blood Products, Cultured Cells, Stem
Cells, Embryos, Foetal Tissue, Zygotes and Gametes (Gazette
35099, Notice 181)
joomla-split-menu/category/84-2012r?download=243:regulations-relating-
to-the-import-and-export-of-human-tissue-blood-blood-products-cultured-
cells-stem-cells-embryos-foetal-tissue-zygotes-and-gametes-r181-2012&usg=AFQjCNF-
WfP_1DhhKVIFoo-FxVY-ssJCKMQ&sig2=rk4pPsvACg1ujADyIg9c9g
• ‌2 March 2012 — Regulations Regarding the General Control
of Human Bodies, Tissue, Blood, Blood Products and Gametes
–– ‌https://www.gov.za/documents/national-health-act-regulations-general-control-hu-
man-bodies-tissue-blood-blood-products-0
161
• 2‌ March 2012 — Regulations Relating to Blood and Blood

Products (Gazette 35099, Notice 179)
joomla-split-menu/category/84-2012r?download=241:regulations-relat-
ing-to-blood-and-blood-products-r179-2012
• ‌2 March 2012 — Regulations Relating to the Registration of
Microbiological Laboratories and the Acquisition, Import
ation, Handling, Maintenance and Supply of Human Patho
gens (Gazette 35099, Notice 178)
menu/category/84-2012r?download=137:regulations-relating-to-the-registration-of-
microbiological-laboratories-and-the-acquisition-importation-handling-maintenance-an
d-supply-of-human-pathogens-r178-2012
• ‌2 March 2012 — Regulations Relating to the Use of Human
Biological Material (Gazette 35099, Notice 177)
–– ‌https://www.gov.za/sites/www.gov.za/files/35099_rg9699_gon177.pdf
• ‌2 March 2012 — Regulations Regarding the Rendering of
Clinical Forensic Medicine Services (Gazette 35099, Notice 176)
–– ‌https://www.gov.za/sites/default/files/gcis_document/201409/35099rg9699gon176.
pdf
• ‌2 March 2012 — Regulations Relating to Artifical Fertilisation
of Persons (Gazette 35099, Notice 175)
menu/category/84-2012r?download=135:regulations-relating-to-artificial-fertilisa-
tion-of-persons-r175-2012
• ‌11 November 2011 — Regulations Relating to the Taking of
Buccal Sample or Withdrawal of Blood from a Living Person
for Testing: Amendment (Gazette 34750, Notice 944)
• ‌26 April 2011 — Regulations Relating to Cancer Registration
162
Appendix A
–– h‌ ttps://www.gov.za/sites/default/files/gcis_document/201409/34248rg9527gon380.
pdf
• 23 September 2010 —
‌ Regulations Relating to the
Establishment of the National Health Research Committee
–– ‌https://www.gov.za/sites/default/files/gcis_document/201409/33575840.pdf
‌ Regulations Relating to the National
Health Research Ethics Council (Gazette 33574, Notice 839)
–– ‌http://us-cdn.creamermedia.co.za/assets/articles/attachments/30051_r_839.pdf
‌ Establishment of the National Health
Insurance Advisory Committee (Gazette 32564, Notice 903)
–– ‌http://us-cdn.creamermedia.co.za/assets/articles/attachments/23668_not_903.pdf
• 23 July 2007 —
‌ Regulations Relating to the Obtainment
of Information and the Processes of Determination and
Publication of Reference Price List (Gazette 30110, Notice 681)
menu/category/119-reg2007?download=246:regulations-relating-to-the-obtain-
ment-of-information-and-the-processes-of-determination-and-publication-of-reference-
price-list-part-1
163
Appendix B
Other Health Legislation
Allied Health Professions Act 63 of 1982

The Allied Health Professions Act provides for the control
of the practice of allied health professions, and for that pur-
pose establishes an Allied Health Professions Council of South
Africa (AHPCSA). Allied health professions include the practice
of Ayurveda, Chinese medicine and acupuncture, chiropractic,
homeopathy, naturopathy, osteopathy, phytotherapy, therapeu-
tic aromatherapy, therapeutic massage therapy or therapeutic
reflexology.
As in the Health Professions Act, professional boards may be
established to regulate the conduct of the various professions.
The Council receives complaints from members of the public but
can delegate any inquiries or disciplinary proceedings to the rel-
evant professional board.
Choice on Termination of Pregnancy Act 92 of 1996

The Choice on Termination of Pregnancy Act sets the conditions
and procedures to be followed for a woman to obtain a termina-
tion of pregnancy. In terms of section 2 of the Act, a pregnancy
may be terminated:
(a) upon the request of a woman during the first 12 weeks of …
pregnancy;
(b) from the 13th up to and including the 20th week [of preg-
nancy] if a medical practitioner, after consultation with the
pregnant woman, is of the opinion that —
(i) the continued pregnancy would pose a risk of injury to
the woman’s physical or mental health; or
164
Appendix B
(ii) there exists a substantial risk that the foetus would suffer
from a severe physical or mental abnormality; or
(iii) the pregnancy is the result of rape or incest; or
(iv) the continued pregnancy would significantly affect the
social or economic circumstances of the woman;
(c) after the 20th week [of pregnancy] if a medical practitioner,
after consultation with another medical practitioner or
a registered midwife, is of the opinion that the continued
pregnancy —
(i) would endanger the woman’s life;
(ii) would result in a severe malformation of the foetus; or
(iii) would pose a risk of injury to the foetus.
For information on access to and consent for a termination of
pregnancy for a minor, see note 20 on page 51 above.
Criminal Law (Sexual Offences and Related Matters) Amendment

Act 32 of 2007
The Criminal Law (Sexual Offences and Related Matters)
Amendment Act reviewed and amended all aspects of the laws
relating to sexual offences. The Act includes the right to access
post-exposure prophylaxis (PEP) if a person has been the victim
of a sexual offence and may have been exposed to HIV. PEP is
a treatment regimen of anti-retroviral drugs that prevents the
transmission of HIV if it is administered within 72 hours of the
incident. The service is free at designated public health facilities.
While the law requires a person to report a case of sexual assault
to the police, failure to do so does not prevent such a person from
accessing PEP at a designated health facility first. The regulations
promulgated under this Act include provisions relating to the
HIV testing of alleged sex offenders.
165
Provisions of the Amendment Act that criminalised consen-

sual sex and sexual acts between teenagers were declared uncon-
stitutional by the High Court on 15 January 2013,
and the declaration of unconstitutionality was confirmed by
the Constitutional Court on 3 October 2013.
The provisions required any health care worker or other
person who became aware of such activity to report it to the
police. The judgment ensures that children can seek sexual and
reproductive information and services without fear of criminal
sanction. Sexual violence perpetrated by or against children will
still be prosecuted according to existing law.
Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972

The Foodstuffs, Cosmetics and Disinfectants Act (Foodstuffs Act)
governs the advertising, labelling, safety standards and selling
of foodstuffs and other products that have the potential to neg-
atively impact the health of people consuming them. The Act
grants the Minister of Health the authority to regulate processes
such as the testing of foodstuffs to ensure that there are no dan-
gerous toxins, or to require warning labels to be included on dis-
infectants that may be dangerous if used incorrectly.
In late 2017 and early 2018, there was an outbreak of listeriosis
in South Africa, which was traced back to the consumption of
processed meats produced at a plant in Polokwane. The outbreak
resulted in the deaths of 200 people and exposed the lack of ade-
quate regulation of cold meat production. Attempts to regulate
hygiene standards for processed meat products had been stalled,
partly due to industry pressure.
It is important to note that the Foodstuffs Act and the
Medicines Act do not cover the same products. Anything that
falls within the definition of a medicine in the Medicines Act is
exclusively governed by the Medicines Act. For instance, while
166
Appendix B
a multivitamin can be sold as a nutritional supplement under

the Foodstuffs Act, if the same multivitamin is advertised as
preventing heart disease, it must meet all the requirements of
the Medicines Act, even if it still claims to only be a nutritional
supplement.
Health Professions Act 56 of 1974

The Health Professions Act regulates the registration and prac-
tice of most health professionals in the country, with the excep-
tion of nurses, traditional health practitioners and allied health
practitioners. The Health Professions Act establishes the Health
Professions Council of South Africa, which oversees the conduct
of different categories of professionals through its professional
boards. Each professional board represents and regulates a dif-
ferent field of health practitioners. The professional boards are
responsible for receiving complaints and investigating those
practising in their field. Practising in any of these fields without
a licence is a criminal offence under the Act. The professional
boards that have been established in terms of the Act are:
• ‌ Professional Board for Medical and Dental (and Medical
Science)
• ‌Professional Board for Dental Assisting, Dental Therapy and
Oral Hygiene
• ‌Professional Board for Dietetics and Nutrition
• ‌Professional Board for Emergency Care
• ‌Professional Board for Environmental Health
• ‌Professional Board for Medical Technology
• ‌ Professional Board for Occupational Therapy, Medical
Orthotics, Prosthetics and Arts Therapy
• ‌Professional Board for Optometry and Dispensing Opticians
• ‌Professional Board for Physiotherapy, Podiatry and Biokinetics
• ‌Professional Board for Psychology
167
• P
‌ rofessional Board for Radiography and Clinical Technology
• ‌
Professional Board for Speech, Language and Hearing
Professions
Medical Schemes Act 131 of 1998

The Medical Schemes Act governs the terms of regulation and reg-
istration of medical schemes in the country. All medical schemes
must be registered with the Council for Medical Schemes in terms
of this Act prior to selling any medical aid products to the public.
The Medical Schemes Act is likely to be substantially amended as
the Department of Health seeks to move towards a NHI system.
In June 2018 a draft Bill to this effect was published for public
comment. At the time of publishing the Department of Health
is reported to be awaiting the final report of the Competition
Commissions Market Inquiry into the Private Healthcare Sector
so that the findings can inform the final Bill and the subsequent
Act.
The Medical Schemes Act currently provides that all registered
medical schemes must pay in full for the costs of diagnosis and
treatment of specified medical conditions and chronic conditions
called prescribed minimum benefits (PMBs). The PMBs are set out
in the Regulations under Medical Schemes Act, and include HIV/
AIDS and other chronic conditions.1
1
In Board of Health Care Funders of the Southern Africa (Association
Incorporated under section 21 of the Companies Act 61 of 1973) & another v
Council for Medical Schemes & others [2012] JOL 28806 (GNP), the Board of
Health Care Funders (BHCF) brought an application against the Council
for Medical Schemes (CMS) and a range of medical schemes, arguing that
payment for PMBs should be done on the basis of the scheme’s own tar-
iffs and not the full invoice of the health care provider. The CMS argued
that schemes are required to pay the full invoice of the health care pro-
vider and that patients should not have to pay. However, the case was not
decided on the merits and so there was no pronouncement on this issue.
In Council for Medical Schemes v Genesis Medical Scheme (CCT139/16) [2017]
168
Appendix B
Medicines and Related Substances Act 101 of 1965

The Medicines and Related Substances Act (Medicines Act) creates
the regulatory structure that oversees all registration of medicines
and medical devices in the country. Under the Medicines Act, any-
thing that falls within the definition of a medicine2 may not be
sold or advertised in South Africa unless it has been proven to be
ZACC 16; 2017 (9) BCLR 1164 (CC); 2017 (6) SA 1 (CC), the dependent
daughter of a member of a registered medical scheme (‘Genesis’), who
was entitled to coverage under her mother’s plan, suffered a compound
fracture to her leg and was surgically fitted with an external fixator, which
was subsequently twice replaced. All three procedures were performed
at private hospitals. In terms of the Medical Schemes Act, Genesis was
obliged to pay in for the treatment of any ‘prescribed minimum bene-
fit condition’, one of which was listed as an ‘open fracture/dislocation
of bones or joints’. Genesis disputed its liability to pay for the fixators,
claiming they were fitted at a private hospital. It argued that since its
rules provided that it would pay ‘100% of actual cost in respect of [PMBs]
. . . when obtained from a Public or State Hospital or designated service
provider [DSP]’, and it had not appointed any DSPs, it was only obliged
to pay for the costs of treating a PMB condition if it were ‘obtained from a
Public or State Hospital’. The Supreme Court of Appeal held that Genesis
was liable to pay for all three prostheses even though they had been fitted
at a private hospital. The Supreme Court of Appeal held that the rules
of a medical scheme cannot be viewed in isolation and that, as the pro-
visions of the Act have as their goal the obligation of a medical scheme
to provide a prescribed level of treatment to all its members suffering
from certain conditions, whether obtained from the private sector or
public sector, Genesis could not be permitted to contract out of those
provisions. Consequently, as the member’s dependant suffered from a
prescribed medical benefit condition, Genesis was obliged to pay for the
treatment administered in respect thereof, including all three prostheses.
Genesis had had the opportunity under the Act of ameliorating this by
appointing designated service providers with whom it could have agreed
beneficial rates, but it had failed to do so.
2
‘Medicine’, in terms of the Act, means any substance or mixture of sub-
stances used or purporting to be suitable for use or manufactured or sold
for use in —
169
safe for use in humans and effective at treating a stated condition,

and the manufacturer is able to consistently deliver a good quality
product. Criminal penalties may be enforced against anyone who
sells or advertises a medicine in contravention of the Act.
Unfortunately, the government has been reluctant to prose-
cute violations of the Act. The Treatment Action Campaign (TAC)
and the South African Medical Association (SAMA) successfully
sued Mathias Rath in Treatment Action Campaign and Another v
Rath and Others (12156/05) [2008] ZAWCHC 34; [2008] 4 All SA
360 (C); 2007 (4) SA 563 (C) (13 June 2008). The court held that
the products being distributed by Mathias Rath as treatments for
HIV were being distributed unlawfully. Additionally, the TAC and
SAMA filed suit against the Minister of Health and the Director-
General of the NDoH to compel them to ensure the enforcement
of the Medicines Act against those distributing products in con-
travention of the Act. The court clearly held that the Minister of
Health and the Director-General have a duty to take reasonable
measures to prevent unauthorised clinical trials and the distribu-
tion of such unauthorised products.
The Medicines Act has been amended to replace the Medicines
Control Council (MCC) — the body that was responsible for reg-
ulating the performance of clinical trials and the registration of
medicines — with the South African Health Products Regulatory
Authority (SAHPRA).3 SAHPRA has a broader authority to regulate
medical products — such as medical devices — than the MCC. The
first Board and an Acting CEO of SAHPRA have been appointed
and SAHPRA has commenced its work.
(a) the diagnosis, treatment, mitigation, modification or prevention of
disease, abnormal physical or mental state or the symptoms thereof
in man; or
(b) restoring, correcting or modifying any somatic or psychic or
organic function in man, and includes any veterinary medicine.
3
SAHPRA’s website is https://www.sahpra.org.za/
170
Appendix B
The Regulations Relating to Transparent Pricing System for

Medicines and Scheduled Substances are promulgated under the
Medicines Act and set the dispensing fees that pharmacists may
charge.4 These regulations are intended to make medicines more
affordable for everyone.
The most recent case involving the Medicines Act is Minister
of Justice and Constitutional Development and Others v Prince (Clarke
and Others Intervening); National Director of Public Prosecutions and
Others v Rubin; National Director of Public Prosecutions and Others
v Acton (CCT108/17) [2018] ZACC 30; 2018 (10) BCLR 1220 (CC);
2018 (6) SA 393 (CC) (18 September 2018), a case concerning the
cultivation and use of cannabis. The case was the most recent in a
series of cases involving Mr Garreth Prince, who first approached
the Constitutional Court in relation to the use of cannabis for
religious purposes in 2002. In the 2018 matter, the Constitutional
Court found that section 22A(9)(a)(i) read with Schedule 7 of the
Medicines Act was inconsistent with the Constitution in so far as
it prohibits the possession, cultivation and use of cannabis by an
adult in private or for his or her personal consumption. This, the
court found, is a limitation on the right to privacy, which limita-
tion is not reasonable and justifiable. The court suspended the dec-
laration of unconstitutionality for a period of 24 months to allow
the legislature to make the required changes to the Act, but in the
interim read the following into the Act: an adult may use or be in
possession of cannabis in private for their own personal consump-
tion in private, the use of cannabis in public or in the presence of
children or non-consenting adults is not permitted, and the culti-
vation of cannabis by an adult in a private place for their personal
consumption in private is no longer a criminal offence.5
4
Government Notice R1090 in Government Gazette 33775 of 19 November
2010.
5
The full decision can be found here: http://www.saflii.org/za/cases/ZACC/2018/30.html.
171
Mental Health Care Act 17 of 2002

The Mental Health Care Act provides for the care, treatment and
rehabilitation of persons who are mentally ill. The Act sets out
procedures for admission to mental health facilities and estab-
lishes Mental Health Review Boards to review admissions and to
which complaints can be directed.
The Life Esidimeni disaster highlighted the severe problems
in the mental health care system in South Africa. Following the
move of mental health care users from chronic mental health
facilities to ill-equipped NGOs, 144 people died. The ensuing
Health Ombud’s investigation and the Life Esidimeni arbitration
has led to efforts at mental health system reform.
National Health Laboratory Service Act 37 of 2000

The National Health Laboratory Services Act establishes the
National Health Laboratory Service (NHLS),6 which is the con-
solidation of a number of previous institutes and centres. The
NHLS is the backbone of health laboratory testing in the public
sector, including testing required for diagnosing HIV and TB,
such as CD4 count tests, viral load tests, and TB sputum micros-
copy and culture. Unfortunately, the NHLS has faced continuous
severe funding shortfalls, partly due to non-payment by provin-
cial health departments for NHLS services, affecting its ability to
perform its functions and resulting in frequent crises.
Nursing Act 33 of 20057

The Nursing Act, like the Health Professions Act, regulates the
registration and practice of nurses in the country. All practis-
ing nurses must be registered with the South African Nursing
6
The NHLS website is available at http://www.nhls.ac.za.
7
The Nursing Act 33 of 2005 repealed and replaced the Nursing Act 50 of
1978 that is referenced in the NHA.
172
Appendix B
Council (SANC). Practising without a licence is a criminal

offence under the Act.8 Draft Regulations Relating to the Keeping,
Supply, Administering, Prescribing or Dispensing of Medicine by
Registered Nurses were published on 14 December 2011. The reg-
ulations were intended to make it easier for nurses to dispense
ARVs in line with the policy allowing nurses to initiate and
managed antiretroviral treatment (Nurse-Initiated Management
of Antiretroviral Treatment). The regulations have not yet been
passed.
Pharmacy Act 53 of 1974

The Pharmacy Act regulates the registration, training, and prac-
tice of pharmacists in South Africa. All practising pharmacists,
including pharmacy students, interns, technicians and assistants,
must be registered in terms of the Act in order to practise in South
Africa. The Act also establishes the South African Pharmacy
Council9 which, much like the South African Nursing Council
and the professional boards established in the Health Professions
Act, is responsible for registering and investigating complaints
regarding pharmacists, and, if necessary, taking appropriate
actions against a pharmacist if there has been a violation of the
Act. Practising as a pharmacist without a licence is a criminal
offence under the Act.
Prevention of and Treatment for Substance Abuse Act 70 of 2008

The Prevention of and Treatment for Substance Abuse Act pro-
vides for mechanisms aimed at reducing demand and harm in
relation to substance abuse through prevention, early interven-
tion, treatment and reintegration programmes. The Act provides
for the registration and establishment of treatment centres and
8
The SANC’s website is available at: http://www.sanc.co.za.
9
The Council’s website is available at: http://www.pharmcouncil.co.za.
173
halfway houses. Finally, it provides for the committal of persons

to and from treatment centres and for their treatment, rehabilita-
tion and skills development in such treatment centres.
Refugees Act 130 of 1998

The Refugees Act has been amended by the Refugees Amendment
Act 33 of 2008, which provides that a refugee is entitled to
full legal protection, including the rights set out in Chapter 2
of the Constitution — including the right to access to health
care — apart from those rights that apply only to citizens (such
as voting). The Amendment Act also provides that the rights in
the Constitution apply in so far as they are applicable to asylum
seekers. The Amendment Act has, however, not come into effect
as at April 2019. Therefore the earlier version of the Act applies,
providing that refugees are entitled to ‘basic health services’. This
term remains undefined.
A National Directive was issued by the NDoH in 2007, which
clarified that refugees and asylum seekers — with or without iden-
tity documents — are able to access certain public health services,
including ARVs, without payment.10 This is subject to the person
not being a member of a medical aid scheme. Despite this direc-
tive and section 4 of the NHA, refugees and asylum seekers still
struggle to access health care services at public health facilities.
Sterilisation Act 44 of 1998

The Sterilisation Act provides for the right to access sterilisation
services in a health facility. The Act sets out the circumstances in
which sterilisation may be performed, either with or without con-
sent. The age of consent for sterilisation is 18 years. Sterilisation
may be performed on a person younger than 18 years only if a
10
A copy of this directive can be found here:https://sahivsoc.org/Files/2008-Circular-
Access-to-ART-for-Pts-without-SA-Identity-Documents.pdf.
174
Appendix B
failure to do so would jeopardise that person’s life or seriously

impair his or her health. The Act also covers the sterilisation of
people who are incapable of consenting or are incompetent to
consent due to mental disability. There is no provision for ster-
ilisation if a person is HIV-positive. In reported cases, outside
South Africa, health care workers either forced or coerced HIV-
positive mothers to undergo sterilisation, based on a moral judg-
ment about their lack of suitability as parents. No similar cases
have occurred in South Africa; however, such conduct would be
unlawful not only in terms of the Sterilisation Act, but on the
basis of every person’s right to make autonomous decisions about
his or her reproductive health care. Any contravention of the Act
is a criminal offence and may be prosecuted.
Tobacco Products Control Act 83 of 1993

The Tobacco Products Control Act prohibits and restricts smoking
in public places, and regulates the sale and advertising of tobacco
products. This includes regulating what information must appear
on the packaging of tobacco products. The most recent amend-
ment to the Act occurred in 2008, when designated indoor smok-
ing areas were introduced. In British American Tobacco South Africa
(Pty) Ltd v Minister of Health (National Council Against Smoking as
amicus curiae) [2012] JOL 29239 (SCA), British American Tobacco
(BAT) alleged that the Act unconstitutionally limited its right to
communicate information concerning its tobacco products. The
court held that BAT’s constitutional freedom of expression was
justifiably limited, because the hazards of smoking far outweigh
the interests of smokers as a group. The 2018 Draft Control of
Tobacco Products and Electronic Delivery Systems Bill introduces
a number of changes to the existing legislation, including 100%
smoke-free indoor and outdoor public places, the regulation of
e-cigarettes, plain packaging of all tobacco products, a ban on the
175
sale of tobacco products in vending machines, and the removal

of all advertising at point-of-sale. The Bill is subject to significant
push back from tobacco companies, among others.
Traditional Health Practitioners Act 22 of 2007

The Traditional Health Practitioners Act creates a regulatory
framework similar to that of the Health Professions Act. The
Act seeks to ensure the efficacy, safety and quality of traditional
health care services. In terms of the Act, no person is permit-
ted to practise as a traditional healer without being registered
with the Interim Traditional Health Practitioners Council. To do
so — even as a student — is criminally punishable. The Council
has the authority and responsibility to register and investigate
the practices of traditional healers and to receive and investigate
complaints of misconduct by a traditional healer.11
11
Regulations Relating to the Appointment by the Minister as Members
of the Interim Traditional Health Practitioners Council of South Africa
were promulgated on 22 August 2011. A copy of the 2011 regulations is
available at: http://www.lawsofsouthafrica.up.ac.za/index.php/browse/medical-and-health/tradition-
al-health-practitioners-act-22-of-2007/regulations-and-notices/22-of-2007-traditional-health-practitioners-
act-regs-gnr-685-2011-08-22-to-date-pdf/download. The Interim Traditional Health
Practitioners Council was inaugurated in February 2013, and in May
2014 the sections of the Traditional Health Practitioners Act that give
it full powers came into effect. However, the Council is reported to be
having difficulties performing its functions. For more information, see B
Tshela ‘Traditional health practitioners and the authority to issue medi-
cal certificates’ (April 2015) 105(4) SAMJ.
176
Appendix C
Policy Documents and Guidelines
The Department of Health has developed policies and guide-

lines covering many aspects of health care and disease manage-
ment. There is no complete list of policies and guidelines but the
list on the Department of Health’s website can be found here:
http://www.health.gov.za/index.php/2014-03-17-09-09-38/policies-and-guidelines. Below
we provide links to some of the most important policies and
guidelines. Links to and descriptions of policies and guidelines
relating specifically to sexual and reproductive health rights can
be found in the Introduction to this Guide.
Health system planning

National Development Plan, 2030: Promoting Health
‘Promoting Health’ is a chapter in the National Planning
Commission Department’s National Development Plan. The key
points of this chapter are that greater intersectoral and intermin-
isterial collaboration is central to the Commission’s proposals
to promote health in South Africa. The Commission identified
reducing the disease burden to a manageable level as a major goal.
Furthermore, the Commission noted that human capacity is key
and that appropriate training and management are needed, and
that health care professionals need to be produced in adequate
numbers and deployed where most needed. Importantly, the
Commission noted that governance must be improved and infra-
structure backlogs must be eliminated in order to strengthen the
national health care system as a whole. Lastly, the Commission
was of the view that a NHI system should be implemented in
phases, complemented by a reduction in the relative costs of
177
private medical care and supported by better human capacity and

systems in the public health sector.
https://www.gov.za/sites/www.gov.za/files/ndp2030_chap10.pdf
National Department of Health: Strategic Plan 2015–2020

The National Department of Health Strategic Plan 2015–2020
outlines the strategic goals of the Department over the medium
term.
http://www.health.gov.za/index.php/2014-03-17-09-09-38/strategic-documents/
category/229-2015str?download=1057:strategic-plan-2015
District Health Management Information System (DHMIS) Policy,

2012
This policy was developed to meet the requirement in the NHA
for the NDoH to facilitate and coordinate the establishment,
implementation and maintenance of information systems by
provincial departments, district health councils, municipalities
and the private health sector at all levels to create a comprehen-
sive national health information system. To ensure uniformity in
the implementation and use of the DHMIS, the NDoH identified
a need to develop an overarching national policy with associ-
ated processes, standard operating procedures (SOPs), and norms
and standards. This is the overarching policy for the DHMIS and
should be read in conjunction with the SOPs once these have
been published by the NDoH.
https://www.idealhealthfacility.org.za/docs/policies/District%20Health%20
Management%20Information%20System%20Policy_2011.pdf
Policy on the Management of Public Hospitals, 2012

This policy was published by the Minister of Health after consul-
tation with the National Health Council and is in line with the
Ten-Point Plan’s strategy of overhauling the health care system
178
Appendix C
and improving its management. The classification of hospitals is

an important part of this policy.
https://www.gov.za/sites/default/files/35101_rg9701_gon186.pdf
The National Infection Prevention and Control Policy and Strategy,

2007
This policy aims to establish a framework for improving the man-
agement of health care associated infections at all levels of health
care, from national through to district level.
https://www.idealclinic.org.za/docs/policies/IPC%20Policy.pdf
National Health Promotion Policy and Strategy, 2015

The National Health Promotion Policy and Strategy acknowl-
edges health promotion as a strategy to reduce disease by address-
ing the social, behavioural and structural determinants of health.
For example, the policy commits the NDoH to supporting health
workers within ward-based outreach teams implementing com-
munity mobilisation efforts and to creating health promotion
norms and standards. It also proposes the creation of a national
obesity strategy and the development of a health promotion
curriculum.
https://www.health-e.org.za/wp-content/uploads/2015/09/The-National-Health-Promotion-
Policy-and-Strategy.pdf
Strategy for the Prevention and Control of Obesity in South Africa

2015–2020
This strategy focuses on six broad goals, including preventing
childhood obesity, enabling access to healthy food and promot-
ing physical activity.
https://www.health-e.org.za/wp-content/uploads/2015/12/National-Strategy-for-
prevention-and-Control-of-Obesity-4-August-latest.pdf
179
Youth and child health

National Adolescent and Youth Health Policy, 2017
The National Adolescent and Youth Health Policy aims to pro-
mote the health and wellbeing of young people, aged from 10 to
24 years, by providing guidance to departments and organisa-
tions working with the Department of Health on how to respond
to the health needs of young people. The approach of the policy
is to focus on the promotion of healthy lifestyles, the mitigation
of risk factors, and the development of ‘safety nets’ for preven-
tion, early detection and intervention.
https://www.idealhealthfacility.org.za/docs/policies/National%20Adolescent%20and%20
Youth%20Health%20Policy%202017.pdf
Integrated School Health Policy, 2012
The objective of the Integrated School Health Policy is to
guide the provision of a comprehensive package of health care
services at schools, which will be provided as part of the Primary
Health Care package at a district level. This policy envisages each
district establishing a team that will be responsible for overseeing
school health services.
https://www.health-e.org.za/wp-content/uploads/2013/10/Integrated_School_Health_
Policy.pdf
HIV, STIs and TB

There are many policies and guidelines related to HIV, STIs
and TB. We have provided descriptions of and links to a selec-
tion of these documents. For a complete list see https://sahivsoc.org/
SubHeader?slug=ndoh-and-who-guidelines. There are also useful apps available
in the App Store or Google Play, entitled ‘HIV Clinical Guidelines’,
‘TB Clinical Guidelines’ and ‘EML Clinical Guidelines’.
180
Appendix C
National Strategic Plan on HIV, STIs and TB, 2017–2022

NSP 2017–2022 is the latest of four national strategic plans, devel-
oped as part of a comprehensive response to HIV and expanded
to include TB. This iteration has the theme ‘focus for impact’,
providing that ‘[w]hile comprehensive prevention and care will
be provided countrywide, intensified, concentrated efforts will be
made in the 27 districts that account for 82% of all people living
with HIV and for the majority of new infections and in the 19
districts with the highest TB burden.’ Each province should have
a provincial implementation plan although the level of imple-
mentation of these plans is questionable.
http://sanac.org.za/wp-content/uploads/2017/05/NSP_FullDocument_FINAL.pdf
National HIV Testing Services Policy, 2016

The National HIV Testing Services Policy provides a guideline for
the different types of HIV Testing Services that should be pro-
vided in the country to accelerate universal access to HIV pre-
vention, treatment, care and support services for people living
with HIV and AIDS. The goal of the policy is to identify people
living with HIV timeously, by providing quality testing services
for all and effectively linking them to appropriate prevention,
care, treatment and support services.
https://sahivsoc.org/Files/HTS%20Policy%2028%20July%20final%20copy.pdf
National Consolidated Guidelines for the Prevention of Mother-to-

Child Transmission of HIV (PMTCT) and the Management of HIV in
Children, Adolescents and Adults, 2015
The consolidated guidelines provide standardised drug combina-
tions for managing Prevention of Mother to Child Transmission
(PMTCT), and for managing children, adolescents and adults
with HIV/AIDS, TB and other common opportunistic infec-
tions. The guidelines are used to provide guidance for clinicians,
181
managers and trainers on the use of available regimens within

the context of the continuum of HIV comprehensive care for pre-
vention, treatment and support.
https://sahivsoc.org/Files/ART%20Guidelines%2015052015.pdf
Code of Good Practice on HIV and AIDS and the World of Work,
2012
The Minister of Labour published this Code on the advice of the
Commission for Employment Equity in terms of the Employment
Equity Act 55 of 1998. The focus of the Code is broad, and includes
counselling and testing, disclosure, and management of HIV and
AIDS in the workplace. It also includes measures to address dis-
crimination on the basis of HIV status in the workplace.
http://www.labour.gov.za/DOL/downloads/legislation/acts/employment-equity/hivaidstech-
nicalguide.pdf
Interim Clinical Guidance for the Implementation of Injectable-

free Regimens for Rifampicin-resistant Tuberculosis in Adults,
Adolescents and Children, 2018
This document provides interim clinical guidance on the imple-
mentation of the modified short- and long-treatment regimens
for people with Rifampicin Resistant Tuberculosis (RR-TB) in
South Africa. National guidelines are scheduled to be revised
in 2019 following the publication of the updated WHO policy
guidelines on MDR-TB treatment.
http://www.tbonline.info/media/uploads/documents/dr_tb_clinical_guidelines_for_rsa_sep-
tember_2018.pdf
The National Infection Prevention and Control Guidelines for TB,

MDR-TB and XDR-TB, 2015
The goal of this policy is to help health care facility management
and staff minimise the risk of TB transmission in their facilities
and other facilities where the risk of transmission of TB may be
182
Appendix C
high due to the high prevalence of both diagnosed and undiag-

nosed TB, such as prisons.
https://www.idealclinic.org.za/docs/National-Priority-Health-Conditions/Nationl%20IPC%20
Guideline%20for%20TB%20MDR%20and%20XDR%202015.pdf
Multi-Drug Resistant Tuberculosis: A Policy Framework on

Decentralised and Deinstitutionalised Management for South
Africa, 2011
Decentralised DR-TB treatment offers more effective treatment
for the patient by taking social and family pressures into consid-
eration. It also avoids the need for a person to spend an extremely
lengthy period in hospital. The policy explains the rationale and
protocols for such an approach.
https://www.tbfacts.org/wp-content/uploads/2015/08/SA-MDR-TB-Policy.pdf
Health policies passed by other departments

Other government departments have also developed policies that
impact on access to health care services. For example, in 2018,
the Department of Trade and Industry finalised the Intellectual
Property Policy of the Republic of South Africa. The policy will
be implemented in phases, and aims to strike a balance between
intellectual property rights and the state’s duty to promote the
realisation of fundamental rights. Phase I of the policy covers
issues relating to intellectual property and public health. It pro-
poses several interventions that will improve access to medicines.
http://www.thedti.gov.za/news2018/IP_Policy2018-Phase_I.pdf
183
Appendix D
Contact Details
NATIONAL STRUCTURES
National Department of Health
Tel: (012) 395 8000
Physical Address: Civitas Building, Cnr Thabo Sehume and
Struben Streets, Pretoria
Postal Address: Private Bag X828, Pretoria, 0001
Email: [email protected]
Website: http//www.health.gov.za
Allied Health Professions Council of South Africa (AHPCSA)
Tel: (012) 349 2331
Physical Address: Persequor Technopark, 5 De Havilland Cres,
Persequor, Pretoria, 0084
Postal Address: Private Bag X025, Lynnwood Ridge, 0040
E-mail: [email protected] (account and general enquiries)
E-mail: [email protected] (complaints)
Website: http://www.ahpcsa.co.za
Council for Medical Schemes (CMS)
Tel: (012) 431 0500
Physical Address: Block A Eco Glades 2 Office Park 0157, 420
Witch-Hazel Ave, Centurion, 0144
Postal Address: Private Bag X34, Hatfield, 0028
E-mail: [email protected]
General Enquiries: [email protected]
Complaints: [email protected]
Website: http://www.medicalschemes.com
184
Appendix D
Health Professions Council of South Africa (HPCSA)

Tel: (012) 338 9300/9301
Physical Address: 553 Madiba St, Arcadia, Pretoria, 0083
Postal Address: P O Box 205, Pretoria, 0001
Website: http://www.hpcsa.co.za
Medical Research Council (MRC)
Tel: (021) 938 0911
Physical Address: Francie van Zijl Drive Parowvallei, Cape Town
Postal Address: PO Box 19070, Tygerberg, 7505
Website: http://www.mrc.ac.za
National Health Research Ethics Council (NHREC)
Tel: (012) 395- 8125 / 8119
Email: [email protected]; [email protected]; nhrec@
health.gov.za
South African Health Products Regulatory Authority (SAHPRA)
Tel: (012) 842 7596/7
Physical Address: CSIR Reception Building 38a, Meiring Naude
Road, Brummeria, Pretoria
Postal Address: Private Bag X828, Pretoria, 0001
Website: www.sahpra.org.za
South African National AIDS Council (SANAC)
Tel: (012) 7481000
Physical Address: 333 Grosvenor Street, Hatfield, Pretoria, 0028
Website: http://sanac.org.za/contact/
South African Nursing Council (SANC)
Tel: (012) 420 1000; Fax: (012) 343 5400
185
Physical Address:
Postal Address: P O Box 1123, Pretoria, 0001
Website: https://sanac.org.za
South African Pharmacy Council
Tel: (086) 172 7200/ (012) 319 8500
Physical Address: 591 Belvedere Street Arcadia Pretoria
Postal address: Private Bag X40040, Arcadia, 0007
Website: https://www.pharmcouncil.co.za
PROVINCIAL STRUCTURES
Eastern Cape
Eastern Cape Department of Health
Tel: 08000 32364
Physical Address: Dukumbana Building, Independence Building,
Bisho, 5605
Postal Address: Private Bag X0038, Bisho, 5605
Website: http://www.echealth.gov.za
Alfred Nzo Health District
Tel: (039) 727 4462
Amathole Health District
Tel: (043) 707 6766
Cacadu Health District
Tel: (041) 408 8152
186
Appendix D
Chris Hani Health District

Tel: (045) 807 1100
Nelson Mandela Bay Metro Health District
Tel: (041) 391 8150
Email: [email protected]; [email protected]
O.R. Tambo Health District
Tel: (047) 531 1344
Ukhahlamba Health District
Tel: (051) 634 1899
Free State
Free State Department of Health
Tel: (051) 408 1200
Physical Address: Cnr Harvey & Charlotte Maxeke Streets,
Bloemfontein, 9300
Postal Address: PO Box 277, Bloemfontein, 9300
Website: http://www.fshealth.gov.za
Fezile Dabi Health District
Tel: (016) 970 9300
Lejweleputswa Health District
Tel: (057) 352 9277/1453
Motheo Health District
Tel: (051) 447 2194/ 083 395 2285
E-mail: [email protected]; [email protected]
187
Thabo Mofutsanyane Health District

Tel: (058) 713 2154/ 7130135
Xhariep Health District
Tel: (051) 447 2777
Gauteng
Gauteng Department of Health
Tel: (011) 355 3000 / 2222 / 7633 / 7650 / 7636 / 7633
Physical Address: 37 Albertina Sisulu Rd, Ferreirasdorp,
Johannesburg, 2107
Postal Address: Private Bag X35, Johannesburg, 2000
Website: http://www.gauteng.gov.za
Ekurhuleni Health District
Tel: (011) 876 1700 / 1800
Johannesburg Metro Health District
Tel: (011) 407 7513
Email: [email protected]; [email protected]; khotokh@
joburg.org.za
Sedibeng Health District
Tel: (016) 950 6000
Tshwane-Metsweding Health District
Tel: (012) 303 9012 / 393 9600
West Rand Health District
Tel: (011) 953 4515
188
Appendix D
KwaZulu-Natal
KwaZulu-Natal Department of Health
Tel: (033) 395 2111
Physical Address: Natalia 330 Langalibalele (Longmarket) Street
Pietermaritzburg 3201
Postal Address: Private Bag X9051, Pietermaritzburg, 3200
Email: [email protected]; thabani.mnyandu@
kznhealth.gov.za
Website: http://www.kznhealth.gov.za
Amajuba Health District
Tel: (034) 328 7000
E-mail: [email protected]; Silindo.
[email protected]
eThekwini (Durban) Health District
Tel: (031) 240 5300
Email: [email protected]; karen.moodley@
kznhealth.gov.za
Ilembe Health District
Tel: (032) 437 3500
Sisonke Health District
Tel: (039) 834 8200 / 8300
Ugu Health District
Tel: (039) 688 3000
Email: [email protected]; Samkelisiwe.Nqoko@
kznhealth.gov.za
189
uMgungundlovu Health District

Tel: (033) 897 1000
Email: [email protected]; thule.kunene@kznhealth.
gov.za
Umkhanyakude Health District
Tel: (035) 572 1327
Email: [email protected]; secretary.
[email protected]
Umzinyathi Health District
Tel: (034) 299 9100
Email: [email protected]; charlotte.vanross@
kznhealth.gov.za
Uthukela Health District
Tel: (036) 631 2202
Email: [email protected]; secretary.uthukela@
kznhealth.gov.za
Uthungulu Health District
Tel: (035) 787 0633
Zululand Health District
Tel: (035) 874 2381
Email: [email protected]; nokuphila.mtshali@
kznhealth.gov.za
Limpopo
Limpopo Department of Health and Social Development
Tel: (015) 293 6000
Physical Address: 18 College Street, Polokwane, 0700
Postal Address: Private Bag X9302, Polokwane, 0700
190
Appendix D
Website: http://www.doh.limpopo.gov.za
Capricorn Health District
Tel: (015) 290 9000
Greater Sekhukhune Health District
Tel: (015) 633 2300
Mopani Health District
Tel: (015) 811 6500
Vhembe Health District
Tel: (015) 960 2000
Waterberg Health District
Tel: (014) 717 8356
Mpumalanga
Mpumalanga Department of Health and Social Development
Tel: (013) 766 3527 /29/30
Physical Address: Government Boulevard, Riverside Park,
Nelspruit, Mpumalanga
Postal Address: Private Bag X11285, Nelspruit, 1200
Website: http://www.mpumalanga.gov.za/dept/health_social_
developmen htm
Ehlanzeni Health District
Tel: (013) 755 5186
191
Gert Sibande Health District

Tel: (017) 811 1642
Nkangala Health District
Tel: (013 249 2017
North West Province

North West Province Department of Health
Tel: (018) 391 4000/1
Physical Address: Cnr 1st Street &, Sekame St, Mahikeng, 2745
Postal Address: Private Bag x2068, Mmabatho, 2735
Website: http://health.nwpg.gov.za/
Bojanala Health District
Tel: (014) 591 9700
Dr Ruth Sekgomotsi Mompati Health District
Tel: (053) 927 0456/7/8
Ngaka Modiri Molema Health District
Tel: (018) 384 0240
Dr Kenneth Kaunda Health District
Tel: (018) 462 7722
Northern Cape
Northern Cape Department of Health
Tel: (053) 830 2000
192
Appendix D
Physical Address: James Exum Building, Du Toit Span Road,

Kimberley
Postal Address: Private Bag X5049, Kimberley, 8300
Website: http://www.northern-cape.gov.za/health/
Frances Baard Health District
Tel: (053) 831 4695
JT Gaetsewe Health District
Tel: (053) 712 0775
Namakwa Health District
Tel: (027) 712 1601
Pixley ka Seme Health District
Tel: (053) 631 1575
Siyanda Health District
Tel: (054) 337 0600
Western Cape
Western Cape Department of Health
Tel: (053) 631 1575
Physical Address: Room T20-06, 4 Dorp Street, Cape Town
Postal Address: 9 Wale Street, Cape Town, 8001
Website: https://www.westerncape.gov.za/dept/health
Boland/Overberg Health District
Tel: (023) 348 8101
193
Cape Town Metro Health District
Tel: (021) 483 2518
Central Karoo Health District
Tel: (044) 803 2707
Eden Health District
Tel: (044) 803 2700
West Coast Winelands Health District
Tel: (022) 487 9210
194
2019
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THE

Acknowledging editors of previous editions of the

ISBN (print format) 978-1-928309-26-0

Original materials copyright © SECTION27

Distributed under Creative Commons

You are free to

Cover design by Nic Jooste, Comet Design

Malebona Precious Matsoso

SECTION27 acknowledges the partnership of the Swedish

Thanks to Zaziwe Hendricks, Mark Heywood, Tendai Mafuma,

19. Duties of users . . . . . . . . . . . . . . . . . . . . . .67

40. Offences and penalties in respect of certificate

58. Removal and transplantation of human tissue in

76. Duties of district health councils and

83. Environmental health investigations . . . . . . . . . 144

AGYW Adolescent Girls and Young Women

NHI National Health Insurance

The private health sector is increasingly expensive, unafforda-

Big changes on the health care system horizon

to be defined. The Bill envisages the establishment of a number

Finally, the National Public Health Institute of South Africa

The inter-relationship of rights and laws

Section 27 obviously refers, in part, to health. But all the rights

provides for medical treatment at state expense and the detain-

The National Health Act as the foundational law on

Rights within the health care system

Emergency medical treatment

motor accidents, are victims of violence, or sustain burns in fires.

Full user knowledge, informed consent and participation in

a choice, rather than the doctor making choices for an unwitting

In addition, a person may be forced to undergo medical test-

realising the right of access to health care services and can be

Community involvement in the health care system

Clinic and community health centre committees

with clinic and community health centre committees. Only four

• i‌nvestigating administrative complaints in respect of a health

National, provincial and district health councils

Consultative health forums

months. The consultative health forums are important targets for

National, provincial and district health plans

Budgeting for health

health system is funded and financially managed in terms of

How public health services are funded

including the management of hospitals and clinics. The bulk of

spend on delivering quality health services to all. This is equal to

Participating in the budgeting process

the budgeting process is encouraged and facilitated. As a result

Opportunities for public participation in the budgeting process

• R‌ equest MPs to ask questions on your behalf in the parliamen-

Trends in health funding

an exponential rise in medico-legal claims4 in recent years. These

Sexual and reproductive health and rights

The attainment of sexual and reproductive health requires

• A‌ ccess to appropriate health care services to ensure safe and

abortions occurring outside of the designated facilities at

• I‌n trying to ensure that everyone’s sexual and reproductive

Selected SRHR policy documents and guidelines

related to the health system in general and to HIV and TB can be

National Condoms Policy and Management Guidelines (2011)

National Contraception and Fertility Planning Policy and Service

ISBN (print format) 978-1-928309-26-0

4. Eligibility for free health services in public health

6. User to have full knowledge31

16. Access to health records by health care provider

18. Laying of complaints42

25. Provincial health services, and general functions of

33. Preparation of district health plans62

38. Appeal to Minister against Director-General’s decision67

40. Offences and penalties in respect of certificate of need69