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BOARD OF HEALTHCARE FUNDERS' CONFERENCE, DURBAN, 9 July 2006 - HEALTHY
PEOPLE: THE COSTS AND COMPLEXITIES
Cutting Through Complexities: A Review of Current Health Legislation in the light of its
contribution to the controlling of costs in healthcare
I ABSTRACT
Healthcare legislation in South Africa has been overhauled in the wake of the final
Constitution.1 The political agenda and socio-economic climate in South Africa have
necessitated that the focus of government initiatives in healthcare remain fixed on the
displacement of primary healthcare services from the exclusive purview of the wealthier
sectors of society to the poorer majority of South Africans.
The effect of the amendments to healthcare legislation in South Africa have been marked and
drastic; ranging from the elimination of risk rating in respect of the provision of private medical
funding, the liberalisation of pharmacy ownership; the introduction of price regulation in
respect of the provision and sale of medicines and Scheduled substances. As an African
economic powerhouse, South Africa determines the pace and the trends that are followed in
Africa. As such, the attitude to and the present legal system governing the provision of
healthcare services and the pricing of medicines in South Africa will, in all likelihood, constitute
a trend that will be followed throughout sub-Saharan Africa.2 It is therefore important, as an
instrumental economic and social component in Africa, for trends in South African healthcare
law to be monitored closely. This is especially so in the context of HIV and AIDS where,
unfortunately, South Africa and other members of the South African Development Community
have the most infected populations on the planet.
Medicine regulation and the imposition of restrictions concerning the practice of various
medical professions in South Africa bring into conflict the present matrix of healthcare
legislation with the provisions of the Constitution, which, inter alia, provides that reasonable
1
Act No. 108 of 1996
2
For the purposes of regulating the registration of medicines within the South African Development
Community, the SADC Harmonisation process is expected to be approved in June 2004 and adopted in August
2004. In terms of the harmonisation process each member state will retain its own medicines control authority but
these authorities will follow a uniform (SADC approved) process, which is dependant on quality assurance and
uniform forms and guidelines for the registration of medicines. This harmonisation process is designed to expedite
the registration of medicines by the sharing of information between SADC members. In terms of section 13 of the
amended Medicines and Related Substances Control Act No. 101 of 1965 in Namibia, a deeming provision has
been inserted that deems all medicines registered by South Africa‟s Medicines Control Council as having registered
for the purposes of Namibian Legislation. It should be noted that this section applies only to medicines that were
registered as such in South Africa prior to Namibia‟s independence in 1990.
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access to healthcare services should be provided to everyone in the country. The potential
conflict between healthcare legislation and constitutional prerogatives and directives, make for
interesting debate. This conflict places South Africa ironically amongst more developed
nations in so far as the provision of healthcare services to the general population is
concerned.
The present legal healthcare regime in South Africa has been revolutionised. The debates
continue as to its effectiveness and whether or not it will withstand constitutional muster. As a
trendsetter in Africa, South Africa's present attitude toward the pricing of medicines, patent
and intellectual property rights in respect of medicines and the provision of primary healthcare
services constitute not only a potential trend for sub-Saharan Africa but an attitude that may
be adopted generally by the Third World, especially in countries like Brazil and India, which
are currently South Africa's newly acquired economic allies.3
This paper explores the current healthcare system in South Africa, the revolution in trends,
their impact internationally and the manner in which South Africa, as a society straddling the
Third and First Worlds, will ultimately give content to a constitutional directive to provide
reasonable access to healthcare services for all.
II INTRODUCTION
Disease has proliferated and the challenges with which we are faced are becoming
exponentially complex. It is therefore not surprising, that armed with the powers of scientific
investigation, human kind has discovered (and is discovering) new ways and means of
addressing the challenges presented by the affects of twenty-first century living on the human
body and mind. Medical science has diversified into numerous fields, drawing on philosophies
from Western conventional medicine and eastern and western traditional philosophy and
mysticism. It is no wonder therefore that our understanding of the term "medicine" has
changed. In fact, due to the revolution that is occurring in genetics and generics, we have had
to amend our views of what medicine is and what it does.
3
“Although South Africa is probably one of only a handful of lower-to-middle income countries to introduce
such legislation, countries like Australia, France, Germany, Canada, Belguim and the United Kingdom have used
difference models (depending on their particular and social needs) to achieve the same outcome “A Thom (a dose
of strong medicine)” Mail and Guardian February 2 20 to 26, 2004. See A Stevens “Pharmaceutical Pricing and
Reimbursement Policies in Australia” http://www.pharmacos.eudra.org/f3:g10/docs/tse/austriala.pdf and A Wall
Healthcare Systems in Liberal Democracies (1996)
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In South Africa, the term "medicine" has, of late, become a dirty word as a result of the recent
publication of regulations by the Ministry of Health concerning pricing regulation of
pharmaceuticals for the first time in South Africa.4 However, notwithstanding its current
controversies, medicine, as a concept as opposed to a regulatory regime, has been around in
Africa for quite some time.5 It is ironically this state of affairs: a western regulatory system in a
traditional context that has caused much of the friction between the objectives of the
government and those of the private sector. In fact, it is a conflict that arises elsewhere in
Africa.6 Therefore, notwithstanding a traditional western approach to medicine and medicine
regulation, South Africa is changing its focus and embracing a broader range of treatment
options.7
The motivation for the paradigm shifts in South African medicine regulations is the "optional
use of limited resources".8 In addition, section 27(1)(a) of the Constitution mandates the
government to provide reasonable access to healthcare services.9 The end is therefore
cheaper medicine but better quality care. The means include broadening the number of
people who can provide legal primary care, relieving the country of patent obligations in
respect of medicines and regulating medicine prices from manufacturer to consumer. It is the
stuff of high drama and the South African High Court has already dealt with two
applications; the first in respect of licences that doctors who dispense medicine must obtain in
4
Regulations Relating to a Transparent Pricing System for Medicines and Schedule Substances, GNR 553,
dated 30 April 2004, which came into effect on 2 May 2004.
5
See Bisseker “Herbal Medicine : a potent brew” Financial Mail
6
Y A Vawda “Current Developments : From Doha to Cancun : Request to Increase Access to Medicines
Under the WTO Rules” (2003) 19 South African Journal of Human Rights 679 and the South African Development
Community : Protocol on Health, more particularly, article 19 read together with read article 2
7
The Traditional Health Practitioners Act No. 66 of 2003 was forwarded, on 7 June 2004, by the Portfolio
Committee on Health to Parliament for adoption.
8
National Drug Policy for South Africa, January 1996 at paragraph 1.3, page 2. The National Drug Policy
has as its economic objectives, at paragraph 2.2, “to lower the costs of drugs in both the private and public
sectors”, “to promote the cost – effective and rational use of drugs”, “to establish a complementary partnership
between Government bodies and private providers in the pharmaceutical sector” and “to optimism the use of
scarce resources to co-operation with international and regional agencies.”
9
“(1) Everyone has the right to have access to -
(a) healthcare services, including reproductive healthcare;
(b) sufficient food and water; and
(c) social security, including, if they are unable to support themselves 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.”
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terms of the Medicines and Related Substances Act10 and the second in respect of the
medicine pricing regulations to which reference shall be made later in greater detail.11 Issues
concerning so-called complementary medicines are, as yet, a forthcoming attraction in South
African law as formal regulation of these medicines remains outstanding.
Currently, South African health care legislation deals with allopathic and generic medicines,
which are properly defined as "medicine", and substances that make health-related claims
but are not registered medicines and are referred to as complementary medicines. To
regimes: one problem.
The role of the allied health professions in society is best illustrated by reference to
publications that deal with issues pertaining to the allied health professions and the manner in
which these particular philosophies deal with the human condition. The Complete Guide to
Health and Well-being states that "[t]he so-called 'alternative' health practices tend to differ
from modern medicine in one basic way: they take a holistic perspective. That is, they
consider the whole body, not just the obvious symptoms of the illness and not just a physical
body with all its interconnected systems and functions but also your mind, emotions and spirit,
your lifestyle and the way you are affected by the world around you."12
Associated with natural processes and alternative healing methods, is the philosophy of
Christian Science. This too supports an alternative means of healing. The philosophy of
Christian Science recognises the strength of a person's belief in the ability of a particular
course of healing action to assist him or her with the treatment of a medical condition. It is this
belief in the ability of a system of medicine to cure one, which accords to it the power to do so.
This ideology and philosophy is based on the successful marriage of certain elementary
principles, which include truth. Christian Science, which straddles both the domains of religion
and medicine, is an important example of a system of medicine that is underscored and
supported by religious beliefs. The same may be said of Chinese medicine and the origins of
Western medicine. Therefore, it is not always possible to reduce a particular allied health
10
No. 101 of 1965, as amended. In terms of section 22C(1)(a), medical practitioners who dispense
medicines, which is normally the exclusive reserve of pharmacists, must obtain a licence in terms of this Act to
continue to dispense medicines after 2 July 2004.
11
An order was granted by the Cape of Good Hope Provincial Division of the High Court of South Africa on
1 June 2004 suspending the effects of the medicine pricing regulations pending the outcome of argument by the
parties in the High Court on 16 June 2004. Also see T Kahn “Prescriptions Before Policy?” Business Day
6 May 2004 and T Kahn “u – turn on Licenses for Dispensing Doctors” Business Day 6 May 2004 and W de Bruin
“Bad Side Effects : Pharmacists see no future for themselves in SA” Finance Week 12 May 2004.
12
See T Eatts The Complete Guide to Health and Well-being at the introduction
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profession to basic constituencies of the manner in which it treats the human condition or the
medicines that it uses to do so.13
To this end, the allied health professions and the particular manner in which they treat the
human condition, disable there professions and the substances and manner used to treat
medical conditions from being regulated properly or at all in terms of the existing legal
infrastructure, to which we refer below, in South Africa.
What is apparent from the passages referred to above, is that there is a significant change in
the manner in which medicine is being used in the world today. What is, however, clear is that
there is more than one particular system of healing the human body, which relies not only on
allopathic medicines to do so. The rise of alternative remedies has necessitated that South
African law responds adequately and accurately to ensure the integrity of the practice of the
allied health professions. It is submitted that it will not be adequate for the law to presume that
the allied health professions, and the manner in which they are practised, will be capable of
regulation in the same manner or under the same medicinal regime as has been applied for
decades to conventional medical professions and allopathic Western medicines.
III THE ALLIED HEALTH PROFESSIONS
The Chiropractors, Homeopaths and Allied Health Service Professions Act14 (“the Allied
Health Professions Act”) now formally, by amendment, regulates, endorses and includes by
law the professions of a chiropractor, homeopath, African and Chinese traditional medicine
practitioner, anthroposophist, aromatherapist, ayurevidic specialist, acupuncturist, naturopath,
osteopath, phytotherapist, reflexologist, Unani-tibb specialist and therapeutic massage
therapist, collectively referred to as “the allied health professions”.15
13
"Vegetarianism, homeopathy, and hydropathy have diminished drugging; but if acts are an antidote to
disease, why lessen the antidote? If drugs are good things, is it safe to say that the less in quantity you have of
them the better? If drugs possess intrinsic virtues or intelligent curative qualities, these qualities must be mental.
Who named drugs, and what made them good or bad for mortals, beneficial or injurious? …It is recorded that the
profession of medicine originated in idolatry with Pagan priests, who besought the gods to heal the sick and
designated Apollo as 'the god of medicine'. He was supposed to have dictated the first prescription, according to
the 'History of 4 000 years of Medicine'. It is here noticeable that Apollo was also regarded as the sender of
disease, 'the god of pestilence'. Hippocrates turned from image-gods to vegetable and mineral drugs for healing.
This was deemed progress in medicine; but what we need is the truth which heals both mind and body. The future
history of material medicine may correspond with that of its material god, Apollo, who was banished from heaven
and endured great sufferings upon earth … Drug systems are quitting their hold on matter and so letting in matters
high stratum, mortal mind. Homeopathy, a step in advance of allopathy, is doing this. Matter is going out of
medicine; and mortal mind, of a higher attenuation than the drug, is governing the pellet." M B Eddy Science and
Health 155 at line 28 to 156 at line 4 and 158 at line 1 and 158 at line 25.
14
No. 63 of 1982
15
Section 1 read together with section 16 of the Allied Health Professions Act.
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The Allied Health Professions Act also establishes the Allied Health Professions Council,
makes provision for professional boards and “[provides] for matters relating to the
responsibility, accountability, democratisation and transparency of the Council and
professional boards.”16 The Allied Health Professions Act arguably attempts to regulate the
allied health professions in the same way that the Health Professions Act regulates the health
professions of medical practitioners, dentists, psychologists and veterinarians.17
There is therefore an attempt by our legislature to equalise the traditional health professions
with the emerging allied health professions.18 It is interesting to note that South Africa has
elected not to regulate the allied health professions within the parameters of the Health
Professions Act but in a separate piece of legislation. The Traditional Health Practitioners Act
perpetuates this trend. It may be argued that this distinction, in the legislative regime
16
The preamble to the Amendment Act No. 50 of 2000. The amending Act came into force with effect from
12 February 2001, see Government Gazette 22025, dated 12 February 2001.
17
No. 56 of 1974
18
In terms of the memorandum on the objects of the Traditional Health Practitioners Bill, 2003, it is stated
that "[t]he Bill aims to -
(a) control and regulate traditional health practice in the Republic;
(b) assist in the promotion of the health of the population of the Republic;
(c) ensure quality of healthcare and traditional health practice;
(d) protect and serve the interest of members of the public who use or are affected by the services of
traditional health practitioners;
(e) determine policy with regard to traditional health practitioners in matters of education, fees,
insurance, registration, professional conduct, ethics, disciplinary procedure, scope of traditional
health practice, inter-professional matters and the maintenance of professional competence;
(f) ensure the maintenance and observation of ethical and professional standards by traditional
health practitioners;
(g) promote and develop the traditional health profession by encouraging research, education and
training in traditional health practice;
(h) promote communication between the various fields of training and traditional health practice in
the Republic and to promote the standard of such training in the Republic;
(e) maintain and enhance the dignity of the profession and the integrity of traditional health
practitioners;
(j) promote a traditional health practice which complies with the universally accepted healthcare
norms and values with a view to improving the quality of life of the general public;
(k) create a registry for persons who engage in traditional health practice in accordance with the
prescribed requirements for registration;
(l) guide the profession;
(m) create a consultative process with the relevant authorities in matters affecting traditional health
practitioners and matters which involve traditional health practice;
(n) promote and regulate, in the interest of the public, liaison between traditional health practitioners
and other health professionals registered in terms of any other law;
(o) give effect to health policies set by the Minister concerning the traditional health practice;
(p) communicate with the Minister information the public importance acquired by the Council in terms
of the performance of the functions under this Act.”
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governing the health and allied health professions, is specifically intended to grant recognition
to the differences that exist between the two fields; not in form but in substance, not in the
objects of professions concerned but the ideologies that support the respective fields. At the
heart of this distinction, it may be argued, is the emphasis that is placed on the manner in
which the human condition is considered and consequently treated.
The ideological distinction that I am attempting to draw between the health professions and
the allied health professions are arguably illustrated with reference to the provisions of the
legislation concerned. This distinction is best illustrated in section 16 of the Allied Health
Professions Act and Chapter III of the Health Professions Act. Section 16 provides that:
“The Minister may, at the request of the council, by notice in the Gazette declare the
provisions of this Act to be applicable to any profession which has its object the
promotion of health, or the treatment, prevention or relief of physical or mental defects,
illnesses or deficiencies in humans, excluding any profession referred to in subsection
(1A) or any profession to which the provisions of the Pharmacy Act … Health
Professions Act … the Nursing Act … or the Dental Technicians Act … apply.”
In contrast to section 16, Chapter III of the Health Professions Act states that this Act is
concerned with the “act[s] of diagnosing, treating or preventing any physical defect, illness or
deficiency in respect of any person.”19 The ideology underlying the Allied Health Professions
Act is arguably broader than that underlying the Health Professions Act.
In so far as the Allied Health Professions Act is concerned, the ideology of this Act is arguably
based upon the promotion of health and the relief of physical or mental defects, illnesses or
deficiencies in humans. The Health Professions Act, in stark contrast, is based upon the
diagnosis, treatment and prevention of any mental defect, illness or deficiency in respect of
any person. Clearly, both fields focus on the end, being the treatment of physical or mental
defects, illnesses or deficiencies in humans but the means are different. The difference
between the two fields, as endorsed and recognised by the legislation, is found arguably in the
manner in which the two fields approach ideologically the physical or mental defects, illnesses
or deficiencies in humans. The promotion of health implies a more holistic approach to the
health of the human condition (both physical and mental) than the diagnostic and preventative
regime by which the health professions are governed in terms of the Health Professions Act.
19
See sections 36(1)(b)(ii) (in respect of medical practitioners) and 37(1)(b)(ii) (in respect of psychologists).
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In effect, the allied health professions and the health professions are based on different
ideologies. If this so, why then should they lend the same meaning to the term “medicine”?
We have two sources from which to derive the meaning that South Africa law ascribes to the
term “medicine”. The first is the common law and the second is legislation.
IV THE MEANING OF THE TERM "MEDICINE"
In the decision by his Lordship Mr Justice De Villiers in the Pretoria High Court in the matter of
Reitzer Pharmaceuticals (Pty) Ltd v Registrar of Medicines and Another in 1998,20 the
meaning of the term “medicine” is judicially considered.
The court in the Reitzer case was charged with deciding whether or not Florex, “a dried yeast
product prescribed by doctors and used by patients as an anti-diarrhoeal to be used as an
adjunct to antibiotic therapy”,21 could be considered to be a medicine and thus subject to
registration in terms of the then Medicines and Related Substances Control Act (“the old
Medicines Act”).22 Reitzer Pharmaceuticals argued that the definition of “medicine”, in the old
Medicines Act, was overbroad and consequently restricted its rights enshrined in section 26(1)
of the interim Constitution23 to engage freely in economic activity.24 This argument was based
on the premise that Florex was not a medicine for the purposes of definition contained in the
old Medicines Act.
The definition of “medicine” in section 1 of the old Medicines Act provides that “medicine”
means:
“any substance or mixture of substances used or purporting to be suitable for use or
manufactured or sold for use in –
(a) the diagnosis, treatment, mitigation, modification or prevention of disease,
abnormal physical or mental state or the symptoms thereof in man; or
20
1998 (4) SA 660 (T)
21
See the headnote to the Reitzer case at page 660.
22
Act No. 101 of 1965 (unamended)
23
Act No. 200 of 1993
24
Section 26 provided for “every person … [to] … have the right freely to engage in economic activity.” This
section was replaced in the final Constitution (Act No. 108 of 1996) by section 22, which provides that “[e]very
citizen has the right to choose their trade, occupation or profession freely. The practice of a trade, occupation or
profession may be regulated by law.” See the Reitzer case at page 667.
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(b) restoring, correcting or modifying any somatic or psychic or organic function in
man,
and includes any veterinary medicine.”
It should be noted that the definition of "medicine" has remained unamended by the Medicines
and Related Substances Control Amendment Act No. 90 of 1997. Therefore, the
subsequently amended Medicines and Related Substances Act contains and relies upon the
same definition of "medicine". Consequently, the common law, in the form of the Reitzer
case, remains applicable.
The court in the Reitzer case found that, inter alia, “even assuming that the [old Medicines] Act
prima facie exceeded the limits imposed by Chapter 3 of the [interim] Constitution … although
the „therapeutic purpose‟ of the substance was more strongly pronounced in para[graph] (a) of
the definition of „medicine‟ than in para[graph] (b), both paragraphs were intended to refer to
substances used for therapeutic or medicinal purposes. In that case, the, water used merely
to quench thirst, although it might prima facie be included under para[graph] (b), would not be
used for a therapeutic or medicinal purpose and would therefore not fall within the definition of
„medicine‟.”25
In coming to his decision, Mr Justice De Villiers, was of the view that in “para[graph] (a) of the
definition of „medicine‟, a so-called „therapeutic purpose‟, if one may call it that, comes to the
fore. When a substance is used in the diagnosis, treatment, mitigation, modification or
prevention of disease, abnormal physical or mental state or the symptoms thereof in man, one
can hardly envisage that the substance is being used other than for a therapeutic or medicinal
purpose. The words in para[graph] (a) of the definition all suggest this.”26
On the face of it, and with respect, Mr Justice De Villiers makes a compelling argument.
However, it is important to note that this judgement, together with it's reasoning, preceded the
amendments effected to the Allied Professions Health Act in 2000. The recognition finally
accorded to the allied health professions has, it is submitted, changed the context in which
one is now required to evaluate the definition of “medicine” in both the old and amended
25
See the headnote at pages 661 to 662 and the judgement at pages 685G to 686F.
26
At page 685
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Medicines Acts. In this regard, Mr Justice De Villiers poses the following question in his
judgment:
“The question arises whether the Legislature attempted in some way to draw a
distinction between the contents of the two paragraphs of the definition by wording
them differently. Could it have been intended that para[graph] (a) would refer to
substances used for therapeutic or medicinal purposes, whereas para[graph] (b) would
refer to substances not so used, or at least would include substances not so used?”27
In 1998, the judge‟s answer was, with respect, correct; no such distinction was intended by the
legislature; “[b]oth para[graphs] (a) and (b) were … intended [only] to refer to substances used
for therapeutic or medicinal purposes.”28 However, for the purposes of the twenty-first
century, his answer is now, with respect, suitably outdated.
It is submitted that the traditional definition of “medicine”, in the old and amended Medicines
Acts and in the Reitzer case, is just that, traditional. The regime established by the Allied
Health Professions Act and the proposed Traditional Health Practitioners Act29 requires a re-
evaluation of the definition of medicine; this regime is a square peg and arguably cannot be
fitted into the traditional round hole of medicine in terms of the old and amended Medicines
Act and the common law. This fact is arguably now formally recognised by in the Allied Health
Professions Act in section 16(3). Section 16(3) provides that:
“Subject to the Medicines and Related Substances Control Act, 1965 … and subject to
the approval of the Medicines Control Council, the Minister may, on the
recommendation of the council, by regulation prescribe access to and availability of
medicines relative to the professions registered in terms of this Act.” (emphasis added)
Section 16(3) appears to subjugate the Allied Health Professions Act to the old Medicines Act.
However, the old Medicines Act may not be interpreted in order to create conflicts with or
ambiguities in the Allied Health Professions Act. The two pieces of legislation must be
27
At page 686A
28
Ibid
29
The term "traditional medicine" is defined in section 1 of the Bill as "an object or substance used in
traditional health practice for -
(a) the diagnosis, treatment or prevention of physical or mental illness; or
(b) any curative or therapeutic purpose, including the maintenance or restoration of physical or
mental health-being in human beings,
but does not include a dependence-producing or dangerous substance or drug".
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interpreted so as to promote certainty and consistency within the law.30 These principles of
interpretation accord with the rule of law and the right of administrative justice enshrined in
section 33 of the Constitution and subsequently in terms of the Promotion of Administrative
Justice Act ("the AJA").31
This section also requires that “the access and availability of medicines relative to the
professions registered in terms of this Act” will be regulated. This section must be read
together with sections 61(1)(j) and (k) of the Allied Health Professions Act. These sections
provide that “the Minister may, in consultation, with the council, make regulations relating to
… any matter which in terms of this Act is required to be prescribed by regulation” and
“generally, all matters which the Minister considers necessary or expedient prescribe in order
that the purposes of this Act may be achieved…, respectively.” Section 16(3) arguably
requires that the Minister must promulgate regulations dealing with the access to and
availability of medicines relative to the allied health professions with which the Allied Health
Professions Act is concerned.
If one accepts the arguments set out above, then the regulation of medicines, relative to the
allied health professions, must be performed in terms of the Allied Health Professions Act.
This argument arguably accords with the legislative intent underlying the amendments in Act
No. 50 of 2000 and the acceptance of alternative and complementary medicines by South
African law.
If one recognises that medicines, relative to the allied health professions, are used differently
(and in some instances are markedly different) to those allopathic medicines used by the
health professions, then one must accept that the intention of the legislature is to deal with
such medicines in terms of the Allied Health Professions Act.
V THE REGISTRATION REQUIREMENTS OF MEDICINES IN TERMS OF THE OLD AND
AMENDED MEDICINES ACTS
Both the old and the amended Medicines Acts make provision for the registration of
medicines.32 Section 14(2) of the old and the amended Medicines Acts requires the
Medicines Control Council or the MCC to follow a particular procedure in order to register
30
“What is vital is that the ordinary citizen is bound to construe correctly the law of the land.” See E A
Kellaway Principles of Interpretation: Statutes, Contracts and Wills (1995) at pages 3 to 4.
31
No. 3 of 2000
32
See section 14, 19 and 36 of the old and amended Medicines Acts.
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certain medicines. In this regard, a resolution is required to be published in terms of
section 14(2) that requires a particular category of medicines to be registered. In terms of
section 14(2)(a), the MCC has a discretion to call for the registration of medicines by
resolution. However, in light of the provisions of section 14(1), whilst there is discretionary
power in section 14(2)(a), due to the use of the word "may", the discretionary power exists in
so far as the determination of the class or category of medicines or part of any class or
category of medicines that are to be the subject matter of the resolution are concerned. The
discretion does not therefore attach to the procedure that the Medicines Control Council must
follow in order to call those medicines up for registration.
Fundamentally, the registration of medicines in South African law is an administrative
procedure. With the advent of the final Constitution, section 33 of the Constitution enshrines
everyone's right to procedurally fair and just administrative action by the State.33 Pursuant to
certain constitutional directives, the State enacted the AJA. The AJA makes provision for
procedurally fair administrative action. Therefore, any person who wishes to deal with
medicines in South Africa becomes subject to the provisions of the Medicines Act and an
administrative procedure. There is therefore greater flexibility in South African law in order to
deal with administrative procedures and ensure that they are procedurally fair. This is an
important integration of constitutional and administrative law with an area of the law that
affects a number of people directly especially in so far as the provision of medicines is
concerned.
Constitutional rights are brought into conflict in so far as the reasonable access to medicine
and everyone's right to a procedurally fair administrative action require that the state ensure
expeditious registration of medicine but not at the expense of the rights of manufacturers,
distributors or wholesalers to receive procedurally fair administrative action during the
registration process.
VI THE PRICING OF MEDICINE
If one accepts the arguments set out above, then it may be argued that the pricing regulations
apply only to those medicines that had been registered in terms of the old Medicines Act. The
bases upon which this argument is premised are set out below in detail.
33
Section 33 provides that:
"(1) everyone has the right to administrative action that is reasonable and procedurally fair.
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The pricing regulations flow from section 22G of the amended Medicines Act. Section 22G
makes provision for the existence of a transparent pricing system and a single exit price in
respect of medicines.34 The old and amended Medicines Acts, however, refer to medicines as
defined in section 1 and Scheduled substances that are set out in detail in the Act.
The provisions of the old and amended Medicines Acts apply to those substances registered
as medicines in terms of those Acts. The application of the provisions of either one of the
aforementioned Acts is arguably ultra vires should such provisions be applied to substances
that have not been summoned for registration in terms of section 14(1) and thus do not fall
within the scope and ambit of the provisions concerned.
In so far as complementary medicines, it is argued that such substances are not subject to
these Acts and therefore fall beyond the scope and ambit of the pricing regulations. However,
if one accepts these arguments then it would not be necessary to call-up for registration any
complementary medicine as the provisions of both the old and amended Medicines Acts
would be equally applicable to such substances.
The very act of registering a substance as a medicine and scheduling it accordingly, requires
the MCC to process that application and substance in accordance with a prescribed
procedure. In the absence of the application of the prescribed procedure, there is no basis
upon which that substance may be subjected to the provisions of either the old or amended
Medicines Act.
It is arguably not for the MCC to apply arbitrarily the amended Medicines Act to substances
that are not registered in accordance with its provisions. This would have the effect of
avoiding the registration procedures contemplated in the amended Medicines Act and that are
required to be followed by the MCC. This would constitute an egregious departure from the
provisions of the amended Medicines Act and detract materially from the principles of
administrative justice set out in both the common law, the Constitution and the AJA.
34
Section 2G(2) provides that: "The Minister may, on the recommendation of the Pricing Committee, make
regulations -
(a) on the instruction of a transparent pricing system for all medicines and Scheduled substances
sold in the Republic;
(b) on an appropriate dispensing fee to be charged by a pharmacist or by a person licensed in terms
of section 2C(1)(a);
(c) on an appropriate fee to be charged by wholesalers or distributors or any other person selling
Schedule 0 medicines."
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In order therefore properly to apply the provisions of the pricing regulations to complementary
medicines, those substances must be registered in accordance with the provisions of the
amended Medicines Act. Once these substances are registered and scheduled, the General
Regulations35 that are promulgated in terms of the old Medicines Act and those that come into
existence in accordance with the amended Medicines Act would then be applicable to those
substances. Alternatively, the Minister of Health is required to promulgate regulations in
accordance with the Allied Health Professions Act in order to deal with complementary
medicines in terms of that Act. It would then be open to the Minister to amend the Allied
Health Professions Act so as to include within its provisions the pricing regulations by
reference or in any other manner that she deems fit.
Even if one were to accept an argument that complementary medicines are subject to the
provisions of the amended Medicines Act and the pricing regulations, it is not possible to apply
the pricing regulations to complementary medicines. The pricing regulations are dependant
upon the existence of a Scheduled status in respect of the medicines that it purports to
regulate. Without a reference to the particular Scheduled status of a medicine, it would be
difficult to apply the provisions of the pricing regulations properly or at all. One cannot
assume, for the purposes of applying the pricing regulations to complementary medicines, that
these substances are all Schedule 0 substances. This is the rationale, presumably, behind
the notice; allowing the MCC to determine the registerability and Scheduled status of the
complementary medicines concerned. The uncertainty that exists in respect of the manner in
which the pricing regulations should be applied, if at all, to complementary medicines,
arguably contravenes the provisions of the AJA, more particularly, those relating to the
certainty of administrative law as contained in section 3(2)(b).36
The pricing regulations are therefore arguably applicable only to those substances already
registered as medicines and scheduled accordingly. This is evident from the provisions of the
pricing regulations, more particularly, those contained in Regulations 10 and 11, which rely
exclusively upon the Scheduled status of medicines in order to determine, inter alia, the
35
GNR510, dated 10 April 2003
36
"In order to give effect to the right to procedurally fair administrative action, an administrator, subject to
subsection (4), must give a person, referred to in subsection (1) -
(i) adequate notice of the nature and purpose of the proposed administrative action;
(ii) a reasonable opportunity to make representations;
(iii) a clear statement of the administrative action;
(iv) adequate notice of any right of review or internal appeal, where applicable; and
(v) adequate notice of the right to request reasons in terms of section 5."
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appropriate dispensing fee to be charged by pharmacists.37 This regulatory disparity is
controversial and legally difficult to manage, which may frustrate the provision of primary
health care services in South Africa.
As a result of the fact that complementary medicines are not, as yet, dealt with as medicines
or Scheduled substances in terms of either the old or amended Medicines Act, the remaining
regulations, promulgated in terms of both the old and amended Medicines Acts have not been
applied to those substances. In the absence of the application of other regulations, there is no
basis upon which the pricing regulations should be applied to such substances.
Therefore, the General Regulations promulgated in terms of the old Medicines Act and
amended in accordance with the amendments to the amended Medicines Act, do not apply to
complementary medicines. The basis for such a discriminatory regime, as between the
general regulations and the pricing regulations, remains unsubstantiated by arguments that
complementary medicines should fall within the scope and ambit of the pricing regulations as
they are fundamentally medicines as contemplated in the definition in section 1 of the
amended Medicines Act.
VII THE CONSTITUENTS OF THE PRIMARY HEALTHCARE SYSTEM
South Africa presents a stark contrast between the desperation of a third world population in
search of homes, food, security and medicine and a world-class private healthcare system.
In this regard, attempts by the Department of Health to ensure that healthcare is provided to
all have been met with enthusiasm or embraced by the private sector. However, the
37
"The appropriate dispensing fee as contemplated in section 22G(2)(b) of the Act to be charged by
pharmacists must be calculated as follows:
(1) With regard to medicines and Scheduled substances falling into Schedules 1 and 2 of the Act, in
the absence of a prescription, the dispensing fee, inclusive of Act, must not exceed -
(a) 16% of the single exit price of a medicine or Scheduled substance where the single
exist price of that medicine or Scheduled substance is less than R100.00;
(b) R16.00 in respect of a medicine or Scheduled substance where the single exit price of
that medicine or Scheduled substance is greater than or equal to R100.00.
(2) With regard to medicines and Scheduled substances falling into Schedules 3, 4, 5, 6, 7, and 8 of
the Act, and medicines and Scheduled substances falling into Schedules 1 and 2 of the Act in
respect of which a prescription has been written, the dispensing fee, exclusive of VAT, must not
exceed -
(a) 26% of the single exit price in respect of a medicine or Scheduled substance where the
single exit price of that medicine or Scheduled substance is less than R100.00;
(b) R26.00 in respect of a medicine or Scheduled substance where the single exit price of
that medicine or Scheduled substance is greater than or equal to R100.00"
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Government continues to pursue its National Drug Policy.38 The constitutional prerogatives
and directions contained in the constitution and various pieces of legislation emanating from
the Constitution, do allow for a certain amount of flexibility in so far as the private sector is
able to protect traditionally held rights, however; the future of medicine in South Africa is not in
the hands of the private sector.
People are too desperate, too poor and too sick to afford private healthcare funding or rely
upon a system of healthcare that is governed by a traditional Western approach to
pharmaceutical and professional regulation. Other more inventive means are required and it
is submitted that South African law has responded with a great deal of flexibility by introducing
a number of legislative amendments –
(1) traditional primary healthcare providers in terms of the Allied Health Professions Act
and the Traditional Health Practitioners Act;39
(2) eliminating risk rating for the purposes of private healthcare funding by amending the
Medical Schemes Act40 to afford access to private healthcare funding;
(3) regulating the pricing of medicines;
(4) requiring licences for the practising of any aspect of medicine in a particular area with
reference to prescribed criteria in terms of the National Health Act;41
(5) the suspension of patent and intellectual property rights in those circumstances
described in section 15C of the amended Medicines Act;42
38
“Although South Africa spends 6,66% of its GNP on healthcare 1992/93 a breakdown of this figure
between private and public expenditure shows that public sector expenditure are counted for only 3,44% of GNP,
with a private sector taking up 3,22%. Put differently, the private sector was responsible for 48,5% of the total
healthcare expenditure 1992/93. Differences between the public and private sectors are further illustrated by the
fact that in 1990 the private sector was responsible for 80% of the country‟s total expenditure on drugs, although 60
to 70% of the total volume of pharmaceuticals was consumed on the public sector.”
39
Act No. 35 of 2004
40
Act No. 131 of 1998, as amended
41
See section 36 of the National Health Act, which provides for the so-called Certificate of Need. This
certificate is based upon the application of certain criteria by the Department of Health including, inter alia, the
nature of the population served by a health practice, its geographical location and the need for the services in that
area.
42
This section provides that “[t]he Minister may prescribe conditions for the supply of more affordable
medicines in certain circumstances so as to protect the health of the public, and in particular may -
(a) notwithstanding any thing to the contrary contained in the Patents Act, 1978 (Act No. 57 of
1978), determine that the rights with regard to any medicine under a patent granted in the
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(6) the prohibition of perverse incentives and in respect of the sale of medicines and
Scheduled substances;43
(7) introducing therapeutically equivalent medicines and generic medicine substitution as
a prerequisite during the dispensing process;44
(8) liberating pharmacy ownership so as to allow non-pharmacists to own pharmacies;45
(9) provision for an expedited registration for medicines and Scheduled substances
obtained by the State in terms of an international tendering process;46 and
(10) expanding the prescribed minimum benefits that must be provided by private health
care funders;47
(11) ensuring that all South Africans may receive emergency medical care;48 and
(12) the policy-making powers that are set out in the National Health Act.
The South African government is already under a directive from the Constitutional Court in so
far as the provision of reasonable access to healthcare services is concerned. "[t]he much
criticised case of Soobramoney is positive in establishing, for the first time, that it "should not
Republic shall not extend to acts in respect of such medicine which is being put on to the market
by the owner of the medicine, or with his or her consent;
(b) prescribe the conditions on which any medicine which is identical in composition, meets the
same quality standard and is intended to have the same proprietary name as that of another
medicine already registered in the Republic, but which is imported by a person other than the
person who is the holder of the registration certificate of the medicine already registered and
which originates from any site or manufacture of the original manufacturer as approved by the
counsel in the prescribed manner, may be imported;
(c) prescribe the registration procedure for, as well as the use of, the medicine referred to in (b)”
43
See sections 18A and 18B of the amended Medicines Act.
44
See section 22F of the amended Medicines Act read together with Regulation 2 of the General
Regulations promulgated in terms of the amended Medicines Act.
45
See section 22A of the Pharmacy Act No. 56 of 1974 read together with the Regulations Relating to the
Ownership and Licensing of Pharmacies GNR553, dated 25 April 2003.
46
See regulations 3 and 5 of the General Regulations promulgated in terms of the amended Medicines Act.
47
See regulation8 of the General Regulations promulgated in terms of the Medical Schemes Act, as
amended, more particularly, regulation 8(1), which provides that: “[s]ubject to the provisions of this regulation, any
benefit option that is offered by medical scheme must pay in full, without co-payment or the use of deductibles, the
diagnosis, treatment and care costs of the prescribed benefit conditions.”
48
See section 7(3) of the Constitution read together with Chapter 3 of the General Regulations promulgated
in terms of the Medical Schemes Act and section 5 of the National Health Act.
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be enough for the state merely to assert or plead lack of resources without providing coach
and justificatory evidence." Such evidence is considered against the background of available
resources."49
VIII THE ORIGINS OF POLICY: THE NATIONAL HEALTH ACT
The national health policy, according to section 1 of the National Health Act, is "all policies
relating to issues of national health as approved by the Minister [of Health]". This appears to
be a relatively simple concept – a number of policies may, at any one time, exist and only
those that are approved by the Minister constitute our national health policy.
Health policy is an important component of the manner in which both the public and private
sectors allocate resources in this country for the purposes of addressing concerns of a
healthcare nature. Policy is, in fact, becoming an important element of the provision of health
care services in this country. This trend is reflected primarily in the increasing number of
sections in legislation dealing with the policy-making powers of a various number of bodies.
This trend is primarily evident from the provisions of section 2 of the National Health Act,
which sets out the objects of the Act so as to include the tenets of a national health policy in
this country:
"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
(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
49
G van Bueren Chapter on Health in M H Cheadle, D M Davis and N R L Haysom (eds) South African
Constitutional Law: The Bill of Rights (2002 at 493). The Soobramoney decision is cited as
Soobramoney v Minister of Health, KwaZulu-Natal 1997 (12 BCLR 1696) CC
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(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 services, including
reproductive health care;
(ii) the people of South Africa to an environment that is not harmful
to their health or wellbeing;
(iii) children to basic nutrition and basic health care services
contemplated in section 28(1)(c) of the Constitution; and
(iv) vulnerable groups such as women, children, older persons and
persons with disabilities."
Chapter 3 of the National Health Act sets out the various functions of the bodies that are
created by the Act and that are responsible for the provision of health care services in South
Africa. The duty of establishing and co-ordinating policy decisions rests, however, with the
National Health Council.50
Other bodies that play a role either in the enforcement of the national health policy or advising
the National Health Council on issues pertaining to national health policy, include the
Director-General of Health and the National Consultative Health Forum.51
The National Consultative Health Forum, in terms of section 24(3)(b) of the National Health
Act, includes all relevant stakeholders, which it is presumed would therefore include
representatives from the private sector. All bodies that are created by the National Health Act,
which include provincial health bodies, are bound by the policy that is created by the National
Health Council. The National Health Council therefore becomes an exceptionally important
and influential body for the purposes of determining health policy in this country.
Currently, in terms of the National Health Act, the National Health Council consists of the
Minister of Health, the Deputy Minister of Health, the relevant members of the executive
50
Established in terms of section 22 of the National Health Act.
51
Established in terms of section 24 of the National Health Act.
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councils, one municipal councillor, the Director-General and Deputy Director-Generals of the
National Health Department, the head of each provincial health department, a person
employed and appointed by a national organisation representing municipalities and the head
of the South African Military Health Services.52 Therefore, only members of the government
constitute the National Health Council. In turn, the Director General of Health and the
provincial health service departments are required to implement the national health policy
determined by the National Health Council.53 Therefore the heart of policy-making, for the
purposes of the provision of health care services in South Africa, rests with the National
Health Council, which, in turn is the government of the day.
IX BUT SO WHAT OF HEALTH POLICY?
In so far as the health policy that will prevail in South Africa is concerned, how is one to
determine, as a member of the private sector, what this policy is in order to tailor one's cloth
accordingly. Policy is to play an important role in the formulation of the content of the rights
and nature of the obligations of both health care service providers and health care users. It is
ultimately the policy that will determine how resources are allocated and priorities determined.
However, with a diminished or non-existent participation by the private sector in the
determination of health policy, this policy may fall short in so far as it becomes entirely
irrelevant to concerns and realities faced by the private sector and the provision of health care
services to an increasingly demanding public.
The future for health care policy in this country, which has been governed, to a large degree,
by the National Drug Policy of 1996, will be based on the reform of the sector. The National
Drug Policy is concerned with the reform of the health care sector following the skewed
provision of health services under the Nationalist Party government along racial lines.
Politically, health care is a difficult policy area to handle in so far as "[h]ealth reform is
inherently multi-dimensional. Reform can be defined to the public in terms of new benefits,
effects on existing benefits, coverage expansions, cost reductions, access to new medical
treatments, balance between government role and market-based approaches, effects on small
businesses, and so forth. Because of the many dimensions to health reform issues, shifts in
definition can create unexpected swings in the direction of policymaking."54
52
See sections 22(2)(a) to (h) of the National Health Act.
53
See sections 21(1)(a) and 25(1), respectively, of the National Health Act.
54
See T Skocpol and P S Keenan "Cross Pressures: The Contemporary Politics of Health Reform" in
D Mechanic, L B Rogut, D C Colby and J R Knickman (eds) Policy Challenges in Modern Health Care (2005) at 27.
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South Africa is engaged, to a degree, in a process of health reform – in so far as the provision
of health services was once skewed on racial lines, it now has to be adjusted so as to be
accessible to all South Africans irrespective of their race. Within the context of the American
model, public opinion plays an important role in relation to the formulation of health policy.
This is not the case in South Africa: clear political majorities in parliament and the make-up of
the National Health Council, mean that policy will, in all likelihood, be formulated by one party
for the balance of the country to follow. Public opinion will therefore have a diminished role in
relation to the formulation of that policy. The agenda for policy-making by the National Health
Council is set out in section 23 of the National Health Act and consists primarily of ten issues:
"(i) responsibilities for health by individuals in 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;
(vii) the design and implementation of programmes to provide for effective referral
of users between health establishments or health care providers, or to enable
the integration of public and private health establishments;
(viii) financial and other assistance received from foreign governments in
inter-governmental or non-governmental 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".
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The overarching policy, which is described in the National Health Act is, however, "policy
concerning any matter that will protect, promote, improve and maintain the health of the
population". The nuts and bolts of the policy, that will probably follow the agenda contained in
section 21(1)(a) of the National Health Act, is yet to be determined. However, there may still
be room for the National Drug Policy to play a role in so far as it sets out perhaps the nuts and
bolts that provide us with a degree of insight into what future health care related policy in this
country will look like. Whilst a number of the issues, contained in the National Drug Policy,
have already been dealt with, a number of issues remain outstanding: licensing of premises
from which health care services may be provided, medicines quality control laboratories,
quality assurance of medicines, the formulation of a basic health care package with reference
to the essential drugs list, the development of a system of joint responsibility between the
government and the patient for the financing of medicines, best possible procurement
strategies, the local manufacture of drugs, the formulation of hospital therapeutic committees
in order to ensure the rational, efficient and cost effective supply and use of medicines, human
resources development, expanding the role of traditional medicines and the providers of such
medicines, and technical co-operation with other countries and international agencies.
The formulation of health care policies for the purposes of securing the progressive realisation
of every South African's right to reasonable access to health care services, as contemplated in
the Constitution, will be an arduous task, made all the more difficult by the political
configurations and considerations that may otherwise frustrate the realisation of these policies.
However, in so far as the future of policy in the health care sector is concerned, its extent and
parameters remain unknown. However, it may be that one is able to determine what this
policy will look like with reference to the provisions of the National Health Act as read together
with the National Drug Policy of 1996.
X POLICY AND COST
The one prevailing issue that has characterised all of the policy decisions by Government to
date is the issue of the costs of health care services.
The cost of health care has, to a degree, been dealt with by Government in so far as one
considers the introduction of the prescribed minimum benefits in terms of the Medical
Schemes Act55 and the introduction of the single exit pricing in respect of registered medicines
55
Quoted above
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and scheduled substances.56 However, there are a number of areas of health care that have
been left unregulated from a costs point of view. These areas include the cost of so-called
hospital "bed and breakfast" costs, the cost of medical devices and certain unsecured benefits
that are available in terms of medical scheme benefits. The debate in respect of the last-
mentioned of these areas has been dealt with, to a degree, by the Council for Medical
Schemes in its circular number eight.
There is already a discrepancy in the private health care market place between various rates
at which services that are not prescribed minimum benefits are available to the public. The
costs of these services may be determined with reference to a number of tariff structures
including those published by the South African Medical Association and the National Health
Price Reference List or NHPRL. There are significant differences between the two applicable
tariffs. Therefore, there is wide spread uncertainty in the private health care arena as to what
benefits should cost, which are otherwise not described as prescribed minimum benefits.
The most controversial proposal is that private health care benefits should be controlled, from
a price and cost point of view, as registered medicines and Scheduled substances are
currently controlled: in terms of a single exit price model that is set out in regulations.
Certainly, this would have the effect of controlling, to a large degree, the costs of private
health care and shifting significantly the emphasis, in respect of health care, from cost to
quality of care. It would very much be like the current petroleum pricing model in this country:
everyone must charge a prescribed rate for the sale of petroleum and the only way one is able
to compete is on the basis of one's service and the goods stocked in one's garage shop. A
similar model in the health care sector would obviously cater quite neatly for the overburdened
consumer in so far as costs would then be fixed, ascertainable and certain and I would be in a
position then to know how much it would cost me to have flu or measles or break my leg.
Controversial programmes and recommendations are a foot and certainly with the introduction
of the Government Employee Medical Scheme and the Low Income Medical Scheme models,
the issue of costs remains at the forefront of policymaking and the motivations behind policy
making both now and into the future. Certainly, pricing models will continue to remain the
focus of any policy relating to the provision and access of health care in this country. This is
conceivably why the equity, access and quality elements were included in the Health Charter
alongside the requirements relating to black economic empowerment. It is therefore important
56
Regulations Relating to the Transparent Pricing of Medicines and Scheduled Substances GNR1102,
dated 11 November 2005, as amended
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and vital, in the context of both the provisions of the National Health Act, the National Drug
Policy and the Constitution, that the private sector applies its mind to the manner in which
costs, in respect of the provision of health care services, across the board, are to be
determined into the future.
Pricing models, not only in respect of registered medicines and Scheduled substances, need
to be considered for the provision of all health care services. Basic packages of medicines or
health care benefits or even prescribed minimum benefits are simply not sufficient to counter
the effects of the costs of medicines and health care services generally so as to make these
elements more accessible to a greater number of South Africans. It is therefore imperative
that, at a conference of this nature at which there is a meeting of some great minds from both
the public and private sectors, that recommendations should be made to the National Health
Council in respect of the way in which, at least, the private sector foresees the pricing of
health care services generally in this country: not just at the level of basic packages of care
but across the board and not just in respect of prescribed minimum benefits or particular
algorithms but in respect of the health care services that every South African is entitled to
whether or not we are talking about complex neuro-surgery or vaccinations for childhood
diseases. The costs of these services remain at the forefront of debates surround the
provision of and access to health care in this country and have formed the basis of the most
destructive debate and confrontations between the public and private sectors.
The removal of the obstacles, relating specifically to the cost of health care services, may
allow both the public and private sectors to focus rather their efforts and considerable
resources on providing better quality health care services to more people whether you live in
Sandton, Mafikeng, Uppington or Craddock.
Some degree of clarity in respect of the issue of the costs of health care services is required
from the private sector. In so far as the private sector does not use an opportunity such as
this conference to apply itself to making at lease some movement on the way forward, in
respect of a comprehensive and collective proposal relating to the pricing of health care
services, then, in light of the provisions of the National Health Act and the make up of the
National Health Council, that policy will, in all likelihood, be prescribed to the private sector
whether it likes it or not.
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XI CONCLUSION
It is merely reasonable access to healthcare services. The formula sounds so simple but
within its folds are complex issues relating to professional skills, access to medicine, the cost
of healthcare generally and ethical considerations concerning the provision of care, treatment
and medicine.
I submit South Africa that sits as a microcosm of what the issues are at a global level. The
interaction between the wealthier North and the poorer South will, on the issues of healthcare,
become concerned with precisely those issues with which the South African Department of
Health is concerned at present.
The trend is established and the solutions may, on a global scale, be based upon a national
approach. However, all is not necessarily well with the South African healthcare system. It is
certainly not without fault and legal challenge haunts its every step. Notwithstanding this, the
South African approach to a number of issues has found favour with its contemporaries within
the South African Development Community and in Africa at large through South Africa's
prominent role in the African Union. The issues therefore that are currently being debated in
South Africa may form the subject matter of legislation in the Africa Union in general and
possibly the basis of a Third World protocol for problems at large.
