National Health Act (61 of 2003)

Author: Gary Moore

Date: 26 October 2016

The National Health Act, 2003[i] is entitled[ii] an Act to provide a framework for a “uniform health system,” taking in account duties regarding “health services”[iii] imposed by the Constitution[iv] and other laws on national, provincial and local governments; and declares it is enacted: Recognising past imbalances; bearing in mind the State must take “reasonable” legislative and other measures “within its available resources” to achieve “progressive realisation” of the right[v] to have access to health care services; and to unite the elements of the “national health system”[vi] to improve it.[vii]

The Act states that without possessing a “certificate of need” no-one may establish[viii] a “health establishment” [ix] or “health agency;”[x] or increase the number of beds in, or acquire prescribed[xi] “health technology”[xii] at, a health establishment or agency; or provide prescribed health services; or continue to operate a health establishment or agency after expiration of 24 months from the date the Act took effect.[xiii] A person wishing to obtain or renew a certificate of need must apply to the Director-General in the manner and pay the fee prescribed.[xiv]

The Director-General, before issuing or renewing a certificate of need, must take these criteria into account: The need to ensure consistency of health-services development in terms of national, provincial and municipal planning; the needs to promote an equitable distribution and rationalisation of health services and health-care resources, and correct inequities based on racial,[xv] economic and geographical factors; the need to promote an appropriate mix of public and private health services; the potential advantages and disadvantages for existing public and private health services and any affected communities; the quality of health services rendered by the applicant in the past if applicable; and the need to ensure availability and appropriate utilisation of human resources and health technology;[xvi] among other things.[xvii]

The Director-General may issue or renew a certificate of need subject to any condition regarding: the nature, type or quantum of services to be provided by the health establishment or agency; human resources and diagnostic and therapeutic equipment and their deployment or use; public private partnerships; and any of the criteria above.[xviii]

The Director-General may withdraw a certificate of need if the health establishment or agency or a provider or worker in the establishment “obstructs the State in fulfilling its obligations to progressively realise the constitutional right of access to health services,”[xix] inter alia.[xx] If the Director-General refuses an application for a certificate of need[xxi] or withdraws a certificate, he must give the applicant or holder written reasons.[xxii] A certificate is valid for a prescribed period not exceeding 20 years.[xxiii] Anyone aggrieved by the Director-General’s decision may appeal to the Minister, who may confirm, set aside or vary it.[xxiv]

The Minister may[xxv] make regulations relating to: Requirements for issue or renewal of a certificate of need; requirements for a certificate of need for establishments and agencies existing at commencement of the Act; requirements for a certificate for establishments and agencies coming into being after such commencement; and other matters relating to granting a certificate and inspection and administration of establishments and agencies.[xxvi]

Regulations must: Ensure equitable distribution and rationalisation of “health”[xxvii] with special regard to vulnerable groups;[xxviii] ensure and promote access to health services and optimal utilisation of health care resources;[xxix] “ensure” compliance with the Act and national operational norms and standards for delivery of health services;[xxx] seek to avoid or prohibit business practices or perverse incentives which adversely affect the costs or quality of health services or access of “users”[xxxi] to health services;[xxxii] avoid or prohibit practices, schemes or arrangements by health care providers or establishments that conflict with or undermine good ethical and professional practice;[xxxiii] and ensure[xxxiv] that quality of health services provided by health establishments and agencies conforms to prescribed norms and standards.[xxxv]

A person who performs an act which is prohibited without a certificate of need[xxxvi] is guilty of an offence[xxxvii] and liable to a fine or imprisonment for up to five years,[xxxviii] or both.[xxxix]

The Act states it takes effect on a date fixed by the President by proclamation in the Gazette.[xl] Different dates may be fixed for different provisions of the Act.[xli] Several proclamations were gazetted[xlii] bringing most of the Act[xliii] into operation in stages. (Not yet in operation are the provisions for the establishment, objects and functions of the Office of Health Standards Compliance,[xliv] inter alia.[xlv])

The Act’s provisions about certificates of need[xlvi] are not yet in operation.

(The President issued a proclamation in early 2014[xlvii] purporting to bring them into operation on 1 April that year. The President[xlviii] then applied to the Constitutional Court for an order setting aside his proclamation as premature[xlix] in that the Minister had not yet issued regulations for certificates of need, and regulations were required as an essential part of the legislative scheme.[l] The President contended he been led astray by advisors’ mistaken counsel.

The Court—

Accepted that the Act’s provisions[li] brought into force by the proclamation contemplate a legislative scheme that had to be detailed in regulations.[lii]The President’s decision to issue the Proclamation before a mechanism was in place to address applications for certificates of need meant providers were practising without certificates, rendering health-service provision unlawful. It seemed no prosecutions have been brought, but the position was undesirable in that providers might be inhibited from supplying an essential service;

Held that the purpose of the President’s power to bring portions of the Act into operation was to achieve an orderly implementation of a national regulatory scheme for health services. Issuing the proclamation prematurely, thereby rendering service provision an offence, was not rationally connected to that or any other government purpose;

Found his decision irrational and thus invalid. The Court set the proclamation[liii] aside.[liv])

The Act’s provisions about certificates of need[lv] undermine the Rule of Law as follows:

The provisions that a certificate of need may be issued subject to conditions about the nature, type or quantum of services to be provided by the establishment[lvi] and about ensuring consistent health-service development in terms of government planning and promoting an equitable distribution of services,[lvii] mean that each establishment can be subjected to its own specific conditions on grounds unrelated to service quality in general. This breaches the Rule of Law precept that laws should have general application.[lviii] (The precept also appears in the Bill of Rights as the right to equal protection and benefit of the law.[lix])

The provision that a certificate may be subject to conditions regarding the need to promote an “appropriate” mix of public and private services[lx] is vague. The Act gives no guidance about what mix of is “appropriate.” This violates the Rule of Law tenet that laws should indicate with reasonable certainty what is required.[lxi]

The provision that the Director-General may withdraw a certificate if the establishment (or a health-care provider or worker in it) “obstructs” the State in fulfilling its obligations to progressively realise the constitutional right of access to health services[lxii] is also vague, in not give fair warning of what constitutes behaviour that “obstructs” the State in fulfilling those obligations.[lxiii] This likewise violates the Rule of Law principle that laws should indicate what is required with reasonable certainty.[lxiv]

These vague provisions (authorising conditions about an “appropriate” mix of health services, and withdrawal of certificates of establishments that “obstruct” State fulfilment of its duty) in effect confer unfettered discretions. They contravene the Rule of Law precept that one should not to be subject to discretionary powers so broad that the responsible authority is unable to determine their scope, as this may lead to arbitrary exercise of the powers.[lxv]

This unfettered provision authorising withdrawal of a certificate for obstructing the State[lxvi] may thus also violate the right not to be arbitrarily deprived of property (a facet of the Rule of Law embodied in the Bill of Rights[lxvii]).

The provisions about certificates of need[lxviii] may well be invalid in not conforming to the Constitutional stipulation that the State must take “reasonable” legislative and other measures “within its available resources” to achieve progressive realisation of the right of access to health-care services.[lxix] That implies the State must apply its own available financial and human resources to broaden access to services progressively.[lxx] It obliges the government to devise and implement its own programme from State resources[lxxi] and gives rise to budgetary implications for the State.[lxxii] It arguably does not authorise the Act’s prohibition against provision of private health care services without a certificate issued or withheld based on government determination of need.

The provisions[lxxiii] arguably have no proper or rational relationship to the public good the Act ostensibly seeks to achieve, of the right of people to have access to health care services, and the provisions accordingly on that ground fall to be struck down.[lxxiv]

[i] National Health Act 61 of 2003.

[ii] National Health Act, Long title.

[iii] Health care services (including reproductive health care and emergency medical treatment), basic nutrition, and basic health care services, and medical treatment (all as contemplated in specified provisions of the Constitution, see below); and “municipal health services”. National Health Act s 1 sv “health services”. “Municipal health services” include water quality monitoring, food control, waste management, health surveillance of premises, surveillance and prevention of communicable diseases excluding immunisations, vector control, environmental pollution control, disposal of the dead, and chemical safety; and exclude port health, malaria control, control of hazardous substances. National Health Act s 1 sv “municipal health services”.

[iv] Everyone has the right to have access to health care services, including reproductive health care. The state must take “reasonable” legislative and other measures “within its available resources” to achieve the progressive realisation of these rights. No one may be refused emergency medical treatment). Every child has the right to basic health care services. Everyone detained, including a sentenced prisoner, has the right to conditions of detention consistent with human dignity including the provision at state expense of adequate medical treatment. Constitution ss 27(1)(a) and (2), 27(3), 28(1)(c) and 35(2)(e).

[v] Constitution Chap 2 (Bill of Rights) s 27(2) read with s 27(1)(a).

[vi] The system in the Republic, whether in the public or private sector, in which the individual components are concerned with the financing, provision or delivery of health services. National Health Act s 1 sv “national health system.” This presupposes providers are components of a system.

[vii] Among other things. National Health Act, preamble.

[viii] Or construct, modify or acquire.

[ix] A facility, etc., providing outpatient treatment, diagnostic or therapeutic interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services. National Health Act s 1 sv “health establishment.”

[x] A person whose business involves supply of “health care personnel” to users or health establishments, or who employs such personnel for providing health services, or procures health care personnel or health services for benefit of a user, and includes a “temporary employment service” involving “health care providers” or “health workers.” (“Health care personnel” means “health care providers” and “health workers.” A “health care provider” means a person providing health services in terms of any law including the Allied Health Professions Act, 1982, Health Professions Act, 1974, Nursing Act, 1978, Pharmacy Act,1974 and Dental Technicians Act, 1979. A “health worker” means any other person involved in provision of health services to a user. National Health Act s 1 svv “health care personnel,” “health care provider,” “health worker”.

[xi] By regulation. National Health Act s 1 sv “prescribed”.

[xii] Machinery or equipment used in providing health services (other than medicine as defined in the Medicines and Related Substances Control Act 101 of 1965). National Health Act s 1 sv “health technology”.

[xiii] National Health Act s 36(1)(a)–(d).

[xiv] National Health Act s 36(2).

[xv] And gender.

[xvi] National Health Act s 36(3)(a)–(c), (e), (i) and (k).

[xvii] The Director-General must also take in account: The demographics and epidemiological characteristics of the population to be served; the need to protect or advance persons or categories thereof designated under the Employment Equity Act, 1998 in the emerging small, medium and micro-enterprise sector; potential benefits of research and development respecting improvement of health service delivery; the need to ensure ownership of facilities does not create perverse incentives for providers and workers; the probability of financial sustainability of the health establishment or agency; whether a private establishment is for profit or not; and compliance with a non-compliance certificate’s requirements if applicable. National Health Act s 36(3)(d), (f)–(h), (j), (l) and (m).

[xviii] Among others. National Health Act s 36(5)(b)(i)–(iii) and (v).

[xix] National Health Act s 36(6)(d) in part.

[xx] The Director-General may also withdraw a certificate of need: On recommendation of the Office of Standards Compliance; or if continued operation of the health establishment or agency, or activities of a health care provider or health worker working in the establishment, constitute a serious risk to public health; or if the establishment or agency or a provider or health worker in the establishment is unable or unwilling to comply with minimum operational norms and standards necessary for health and safety of users; or if the establishment or agency or a provider or worker in the establishment persistently violates the constitutional rights of users. National Health Act s 36(6)(a) read with s 79(7)(b), and s 36(6)(b) and (c), and (d) in part.

[xxi] Arguably, an application for (by necessary implication) “the issue or renewal of” a certificate of need.

[xxii] National Health Act s 36(7).

[xxiii] National Health Act s 37.

[xxiv] National Health Act s 38.

[xxv] After consultation with the National Health Council.

[xxvi] National Health Act s 39(1)(a)–(d).

[xxvii] Presumably “health services” is intended.

[xxviii] Such as women, older persons, children and people with disabilities. National Health Act s 39(2)(a).

[xxix] With special regard to vulnerable groups. National Health Act s 39(2)(d).

[xxx] National Health Act s 39(2)(e).

[xxxi] A person receiving treatment in a health establishment or using a health service (and if she is below the age of consent to medical treatment or a surgical operation, includes her parent or guardian; if she is incapable of taking decisions, includes her spouse or partner or in his absence her parent, grandparent, adult child or brother or sister; a “user” also includes, in the case of such a below-age or incapable person, another person authorised by law to act on her behalf.) National Health Act s 1 sv “user.”

[xxxii] National Health Act s 39(2)(f). This should more properly be framed to read “seek to avoid perverse incentives and prohibit business practices which adversely affect the costs or quality of health services” etc.

[xxxiii] National Health Act s 39(2)(g). The expression “avoid or” is redundant.

[xxxiv] If taken literally this requires the impossible, in stipulating the regulations must “ensure” compliance and “ensure” service quality conforms to prescribed norms. Legislative measures cannot ensure or guarantee compliance, but merely impose obligations and provide penalties for contravening them.

[xxxv] National Health Act s 39(2)(h).

[xxxvi] National Health Act s 36(1)(a)–(d).

[xxxvii] National Health Act s 40(1).

[xxxviii] The maximum fine corresponding to five years’ imprisonment is currently R200,000.00. Adjustment of Fines Act 101 of 1991 s 1(1)(a) read with Magistrates’ Courts Act 32 of 1944 s 92(1)(a) and (b) and Govt Notice 217 of 27 Mar 2014 (Determination of monetary jurisdiction for causes of action iro district courts). The Adjustment of Fines Act states it does not apply iro an offence “which continues.” Adjustment of Fines Act s 4(a). Presumably this means a maximum fine contemplated by the Act does not apply to continuing offences. Thus a maximum fine would not apply if someone without a certificate of need were to “continue to operate” a health establishment 24 months after the National Health Act took effect. National Health Act s 36(1)(d). But a maximum fine would apply if someone without a certificate of need committed a (non-continuing) act of establishing a health establishment, or increasing the number of beds in or acquiring prescribed technology at a health establishment, or (perhaps) providing prescribed health services. National Health Act s 36(1)(a)–(c).

[xxxix] National Health Act s 40(2).

[xl] National Health Act s 94.

[xli] Interpretation Act s 13(3).

[xlii] Procs R19 of 2005, 22 of 2008, R20 of 2010, 11 of 2012 and (see text accompanying fn 47) 21 of 2014.

[xliii] As amended by National Health Amendment Act 12 of 2013 (in operation: Procs 37 of 2013, 38 of 2014).

[xliv] National Health Act ss 77, 78 and 79 as substituted by the Amendment Act.

[xlv] National Health Act ss 47 and 83, not relevant for present purposes.

[xlvi] National Health Act ss 36–40.

[xlvii] Proc 21 of 2014 (Gazette 37501 of 31 Mar 2014).

[xlviii] With the Minister and Director-General of Health, and Minister and director-general of the Presidency.

[xlix] The South African Dental Association (which had drawn the issue to the President’s attention) and Hospital Association of South Africa were cited as respondents.

[l] President of the Republic and others v South African Dental Association and ano 2015 (4) BCLR 388 (CC).

[li] National Health Act ss 36–40.

[lii] The Court observed that exercise of public power in accordance with the Constitution and Rule of Law was at stake. The court referred to an earlier judgment that the Rule of Law requires that exercise of public power by the Executive and functionaries should not be arbitrary. A decision must be rationally related to the purpose for which the power was given or it is arbitrary and inconsistent with this requirement. Pharmaceutical Mnfrs Assoc and ano: In re Ex parte President and others 2000 (3) BCLR 241 (CC) par[85].

[liii] Proc 21 of 2014

[liv] President of the Republic and others v South African Dental Association and ano (op cit) pars [11]–[18].

[lv] National Health Act ss 36–40.

[lvi] National Health Act s 36(1)(a) and (d).

[lvii] National Health Act s 36(5)(b)(i) and (v) read with s 36(3)(a) and (b).

[lviii] President of the Republic of South Africa and Another vs. Hugo, 1997 (6) BCLR 708 (CC) par [102].

[lix] Constitution, Chap 2 (Bill of Rights), s 9 (Equality): s 9(1).

[lx] National Health Act s 36(5)(b)(v) read with s 36(3)(c).

[lxi] Affordable Medicines Trust and others v Minister of Health and ano 2005 (6) BCLR 529 (CC) par [108].

[lxii] National Health Act s 36(6)(d).

[lxiii] Bertie Van Zyl (Pty) Ltd v Minister for Safety and Security 2009 (10) BCLR 978 (CC) par103. The Law of South Africa vol 5(3) 2 ed repl vol, D W Freeman “Constitutional Law: Structures of Government” par 26.

[lxiv] Affordable Medicines Trust and others v Minister of Health and ano (ibid).

[lxv] Affordable Medicines Trust and others v Minister of Health and ano (ibid) pars [33], [34].

[lxvi] National Health Act s 36(6)(d).

[lxvii] Constitution, Ch 2 (Bill of Rights), s 25 (Property): s 25(1).

[lxviii] National Health Act ss 36–40.

[lxix] Constitution s 27(2) read with s 27(1)(a). What constitutes “reasonable” State measures should be determined by the fact that the Constitution allocates functions among three spheres of government and requires them to assist one another and coordinate their actions. An Act of Parliament must provide for equitable division among the three spheres of government of national revenue and consider the need to ensure provinces and municipalities can perform their functions. Constitution ss 41(1)(h)(ii) and (iv) and 214(2)(d). Health services are a function shared by all three levels of government. (Constitution, Sched 4 Pt A “health services” and Pt B “municipal health services.”)

A reasonable State health-service programme should be a co-ordinated comprehensive one determined by all three spheres of government in consultation, should allocate tasks to the three spheres of government, and ensure appropriate resources are available. It may require (national) framework legislation. Each sphere of government should accept responsibility for implementing parts of the programme, but the national government would ensure laws and policies etc. are adequate to meet the State’s health-service obligations. Any (national) framework legislation should be designed so these obligations can be met.

The content of the measures is for the legislature and executive but must establish a coherent public programme directed to progressive realisation of the right of access to adequate health services within the State’s available means and be capable of facilitating realisation of the right. As to whether such measures are “reasonable”, a court would not enquire if more desirable or favourable measures could have been adopted, or public money better spent. A wide range of possible measures could be adopted by the State to meet the reasonableness requirement.

Legislative measures alone are unlikely to meet Constitutional compliance, and to achieve the intended result should be supported by reasonable State policies and programmes implemented by the executive. The Constitution does not expect more of the State than is achievable “within its available resources,” both as to the rate at which its obligation is achieved and the reasonableness of the measures employed. Govt of the Republic et al v Grootboom et al 2000 (11) BCLR 1169 (CC) pars [34], [39]–[46], [63]–[66], [93]–[95].

[lxx] See Soobramoney v Minister of Health (KwaZulu-Natal) [1998] 1 All SA 268 (CC) at pars [19], [22].

[lxxi] Min of Health and others v Treatment Action Campaign and others (1) 2002 (10) BCLR 1033 (CC) par [135].

[lxxii] In re Certification of the Constitution of the Republic, 1996, 1996 (10) BCLR 1253 (CC) par [78].

[lxxiii] National Health Act ss 36–40.

[lxxiv] Law Society of South Africa and Others v Minister for Transport and Another, ibid, paras [34], [35].

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Gary Moore

Gary Moore BA LL.B. (Witwatersrand) LL.M. (UC London) is a South African lawyer and Senior Researcher at the Free Market Foundation.

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