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Published by tasch, 2018-05-03 05:04:34

Medical Ethics Handbook 2018

Keywords: medical magazine,online magazine,mims,mims magazine,medical ethics,medical ethics handbook,medical journal

Medical Ethics

2018 CPD ProgramME

In proud association with

Reference: DOH Pricing Database. Accessed 1 February 2018.

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Mispel Street, Bellville, 7530, RSA. Website: Customer Care: 080 222 6662.

Credits 1


Editor: Ulundi Behrtel,
BLC LLB, Cert Med Law, Cert Leg Drafting,
PG Dip Int Res Ethics
Publishing editor:
Designer: Lynette Snyman
Cover design:
Sales executive: Tanya Pretorius
Production manager:
Business manager: Eona Smit
GM: Magazines:
Loren Chimes

Mercy Baloyi

Silke Friedrich

Jocelyne Bayer

Copyright 2018 MIMS – a division of Tiso Blackstar Group (Pty) Ltd. All rights
reserved. Apart from any fair dealings for the purposes of private study,
research, criticism and review as permitted under the Copyright Act, no part
may be reproduced by any process without permission, nor stored in a
retrieval system. MIMS – a division of Tiso Blackstar Group (Pty) Ltd – is an
independent company and not affiliated to any pharmaceutical manufac-
turer or professional association. The opinions expressed by the authors of
the various articles and advertisements within this publication are not neces-
sarily the opinions of the Publisher. Although every effort has been made in
compiling and checking the information to ensure that it is accurate, the
Publisher, authors and editors shall not be responsible for the continued
accuracy and currency of the information, or for any errors, omissions and
inaccuracies in this publication, whether arising from negligence or other-
wise, or for any consequence therefrom.



Medical Ethics and Their Historical Context............................................................................. 4

Prof Annelize Nienaber

Ethical Rules Applicable to Practitioners Registered with

the HPCSA.................................................................................................................................... 6

Ulundi Behrtel

Ethics in Pharmacy Practice.................................................................................................... 10

Lorraine Osman

Ethical Responsibilities and Challenges of Health-Care

Professionals within the NHI...................................................................................................... 14

Elizabeth Parker and Elsabé Klinck

The Council for Medical Schemes and Ethical Conduct

in Practice.................................................................................................................................. 17

Dr Elsabé Conradie

The South African Nursing Council and Ethics in Nursing Practice...................................... 20

Dr Sue Armstrong and Nelouise Geyer

Protecting the Information of Your Patients........................................................................... 24

Esmé Prins-van den Berg

The Medicines Control Council and its Applicability to

Health-Care Professionals........................................................................................................ 28

Shakira Ramlakhan and Elsabé Klinck

Generic/Therapeutic Substitution and Off-Label Prescribing.............................................. 31

Val Beaumont

Biosimilars: Should We Embrace the New Biotechnology

Medicines? ............................................................................................................................... 36

Prof Jacques Snyman

Understanding Informed Consent in Health Care in

South Africa............................................................................................................................... 40

Wendy Massaingaie

Medical Negligence and Malpractice in South Africa........................................................ 43

Sarah Sithole

Suspected Patient Malingering and Fraudulent

Practitioner Claims.................................................................................................................... 48

Prof Morgan Chetty

Medical Treatment and Consent in Vulnerable Populations.............................................. 51

Dr Jillian Gardner

Legal Aspects Relating to Euthanasia, the Moment of Death, Living Wills and

Resuscitation Orders in South African Medical Law: Some Reflections.............................. 55

Prof Pieter Carstens


Contents 3

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S4 Reg. No. 44/34/1014 S5 Reg. No. 42/5.3/0490, 0491
CIPLA MEDPRO (PTY) LTD. Co. Reg. No. 1995/004182/07. Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA.
Website: Customer Care: 080 222 6662. [13404]


Medical Ethics and Their
Historical Context

Prof Annelize Nienaber self-regulating discipline among those
BHons, LLD sharing craft knowledge and committed
 Professor: Department of Public Law, to serving others”. The Hippocratic Oath,
Faculty of Law, University of Pretoria therefore, was the beginning of aware-
ness of ethics in medical practice. Further,
Ill health and death have always been the idea of medical practice as a profes-
part of society, so too the health practi- sion was introduced in the Oath, “whereby
tioners who tried in various ways to physicians make a public promise that
alleviate the burdens upon society of such they will place the interests of their patients
ill health and death: in ancient times above their own interests”.
through concoctions, magic potions and
herbal remedies; and in more recent The foremost American writers on
history through the products of scientific biomedical and medical ethics,
discovery. Indications are that even Beauchamp and Childress, define the
ancient health practitioners were aware term “ethics” as “a generic term for
of a “moral” dimension to their relationship various ways of understanding and exam-
with the recipients of their art and science. ining the moral life”. “Ethics” is most
commonly used to denote the academic
Among the oldest writings about this study of moral concepts and theories. In
awareness of the physician’s moral role in departments of philosophy, “ethics” is
society are the Law Code of Hammurabi termed “moral philosophy” or “moral
in Mesopotamia by the king of Babylon theory”. Other writers, such as Beauchamp
(about 1750 BCE); Egyptian papyri; and and Steinbock, use the terms “ethics” and
the writings of ancient Indian, Japanese “morality” interchangeably.
and Chinese societies. The roots of modern
medical ethics are traced to ancient The term “morality” requires further eluci-
Greece and, specifically, to the teachings dation. Beauchamp and Childress define
of the Hippocratics on the island of Cos. morality as being those norms about right
Porter writes as follows about the and wrong human conduct that are so
Hippocratic physicians: “The significance widely shared that they form a stable social
of Hippocratic medicine was twofold: it consensus. Morality, thus, includes stand-
carved out a lofty role for the selfless physi- ards of conduct, such as moral principles,
cian which would serve as a lasting model rules, rights and virtues. A set of norms
for professional integrity and conduct, shared by all “morally serious” persons is
and it taught that understanding of sick- referred to as the “common morality”.
ness required understanding of nature”. Further, morality includes moral ideals (that
The emphasis in the quotation on a “self- a group readily accepts), communal
less physician” shows the beginnings of a norms (that bind members of a certain
contemplation of the role of medical community), and virtues, and so on.
practitioners in society; similarly, the
emphasis on an “understanding of A distinction is made in the literature
nature” demonstrates an awareness of between universal morality and commu-
science as the foundation of medical nity-specific morality, in which universal
practice. morality refers to the norms in common
morality, whereas community-specific
As their name indicates, the Hippocratic morality indicates moral norms that are
physicians were also originators of the specific to a particular cultural, religious or
Hippocratic Oath, “foreshadow[ing] the institutional setting. Professional morality –
western paradigm of a profession (one of which medical ethics is part – is the set
which professes an oath) as a morally of norms or a standard of conduct that is


Medical Ethics 5

generally acknowledged by members of concepts, and methods of reasoning in
a profession who acknowledge the moral ethical discourse; they investigate the
duties and responsibilities of that profes- meaning of ethical terms such as “duty”,
sion. As Beauchamp and Childress point “good” and “obligation”.
out, professional morality in the medical
and related professions stems from the Applied (also practical) ethics aim to
“institutions, practices and traditions of “implement general norms and theories
medicine”. Codes of medical, nursing and for particular problems and contexts”. The
research ethics attempt to formalise these term “applied” is an indication of the use
moral duties and responsibilities. The of theory and analysis to examine moral
earliest code of medical ethics written by problems in professions, institutions and
a medical organisation is the ethics code public policy. In applied ethics, theory and
of the American Medical Association, principles are starting points and a general
published in May 1847. The World Health guide to the development of norms of
Organization issued the first worldwide appropriate conduct. Medical ethics
ethical code in the Declaration of Geneva constitute a relatively recent discipline
in 1948. which is a sub-field of applied ethics.
Modern medical ethics have their begin-
Government agencies sometimes nings in the late 1960s and early 1970s,
formulate codes that contain normative and, partly, were born from student
ethical guidelines, and these guidelines demands at Anglo-Saxon universities in
may be legislated. Such guidelines reflect the 1960s for an education that was “rele-
public policy, for example, guidelines vant”, and, partly, as a result of advances
regulating biomedical research carried in medical science and the novel ethical
out on foetal tissue. Public policies are a questions they raised. The concern of
reflection of moral and ethical considera- medical ethics is with ethics that should
tions, and exist within “social disagree- guide physicians and scientists. Medical
ments, uncertainties, and different inter- ethics, therefore, refer to the application
pretations of history”. of general and fundamental ethical prin-
ciples to clinical medical practice
Approaches to ethics are either norma- situations. The aim of medical ethics is the
tive or nonnormative. “Normative ethics” protection of patients in their relationship
signify an attempt to identify the general with medical practitioners.
moral norms to be used for deciding
conduct that is ethically acceptable. In A broad range of literature on topics in
other words, normative ethics attempt to medical ethics has developed to include
provide a theoretical or foundational the doctor-patient relationship, informed
basis for how people ought to behave. consent, clinical research, euthanasia,
Various ethical theories provide ways to genetic testing, and reproductive choices.
identify and justify these moral norms. In recent years, the term “medical ethics”
has in some instances been supplanted by
“Nonnormative ethics”, on the other the term “biomedical ethics”. “Biomedical
hand, consist of two broad categories – ethics” is preferred by some authors as it
descriptive ethics and meta-ethics. includes ethical principles relating to all
Descriptive ethics involve the factual branches of the life and health sciences.
investigation of moral conduct and beliefs
with the purpose of finding out how References available on request.
people reason and act. Meta-ethics refer
to a theoretical analysis of the language,


Ethical Rules Applicable to Practitioners
Registered with the HPCSA

Ulundi Behrtel The Ethical Rules deal with various
BLC LLB, Cert Med Law, Cert Leg Drafting, aspects of professional practice, includ-
PG Dip Int Res Ethics  ing provisions pertaining to practice in
 Health Law and Ethics Consultant general, dealing with colleagues and
other health-care practitioners, business
All practitioners registered with the Health (employment)/financial interests, inter-
Professions Council of South Africa acting with patients and other provisions.
(HPCSA) are expected to practise their In the interest of brevity, only rules that
professions in accordance with the Ethical have been found to be most challenging
Rules of Conduct for Practitioners Regis- or problematic for practitioners will be
tered under the Health Professions Act, discussed in this article. However, it
1974 (Ethical Rules) as applicable from remains every practitioner’s obligation to
time to time. The professional governing be familiar with all the Ethical Rules and
body, the HPCSA, has a statutory duty to the way it may impact his/her profes-
uphold and maintain professional and sional practice.
ethical standards within the health-care
professions. These standards are published Provisions pertaining
as the Ethical Rules and failure to adhere to professional practice
to these rules may lead to disciplinary Advertising
action being instituted against the practi-
tioner by the relevant professional board Ethical Rule 3 states that a practitioner may
of the HPCSA. Practitioners must also advertise his/her services or permit, sanc-
remember to read the Ethical Rules tion or acquiesce to such advertisement,
together with other HPCSA publications, provided that the advertisement is not
e.g., Guidelines on Ethical Rules, Regu- unprofessional, untruthful, deceptive or
lations and Policy Guidelines. misleading, or causes consumers unwar-
ranted anxiety that a person(s) may be
Overview of the Ethical Rules suffering from any health condition. The
rule, however, strictly forbids canvassing or
The Ethical Rules consist of 28 general rules touting or any canvassing or touting to be
that apply to all practitioners registered in done for a patient on his/her behalf.
the different professions governed by the Practitioners must note the new definitions
professional boards of the HPCSA. This of “canvassing” and “touting” that were
means that the same rules apply to all introduced on 1 March 2013. This is particu-
registered health-care professionals. larly relevant to medical and dental
Additional rules by the different profes- practitioners in the field of aesthetic medi-
sional boards are provided for and cine and cosmetic dentistry.
included as annexures to the Ethical Rules,
e.g., Annexure 6, setting out Rules of Professional stationery
Conduct Pertaining Specifically to the Ethical Rule 4, also amended in 1 March
Medical and Dental Professions, as 2013, sets out the information that must
compiled by the Medical and Dental appear on a practitioner’s professional
Board. In total, there are 12 annexures to stationery. The rule reads as follows:
the general Ethical Rules. It is beyond the
ambit of this article to discuss the rules in “(1) A practitioner shall print or have
these annexures. printed on letterheads, account forms,


Ethical Rules Applicable to Practitioners Registered with the HPCSA 7

and electronic stationery, information another practitioner who has not taken a
pertaining to such practitioner’s – commensurate part in the services for
(a) name which such fees are charged. A practi-
(b) profession tioner is only allowed to charge or receive
(c) registered category fees for services personally rendered,
(d) speciality or sub-speciality or field except when the services were rendered
by another practitioner in his/her employ-
of professional practice (if any) ment or with whom he or she is associated
(e) registered qualifications or other as a partner, shareholder or locum tenens.
Booklet 5 published by the HPCSA specifi-
academic qualifications or cally deals with perverse incentives, and
honorary degrees in abbreviated practitioners are strongly advised to famil-
form iarise themselves with the guidelines.
(f) registration number
(g) a d d r e s s e s ( i n c l u d i n g e m a i l Practising with other
address) health-care professionals
(h) telephone and fax numbers and sharing of rooms
(i) practice or consultation hours In terms of Rule 8 of the Ethical Rules, a
(j) practice code number practitioner may only practise in the
(k) dispensing licence number following business models and only within
(if any).” the scope of the profession in respect of
which he/she is registered under the Act:
Naming of a practice solo practice, partnership, association with
In terms of Ethical Rule 5, a practitioner another practitioner who is registered under
must use his/her own name or the name of the Act, and in or as a juristic person who is
a registered practitioner or practitioners exempted from registration in terms of
with whom he/she is in partnership or with section 54A of the Act only if such juristic
whom he/she practises as a juristic person, person complies with the conditions of such
as a name for his/her private practice. A exemption. The rule further prescribes that a
practitioner is not allowed to use, in the practitioner may only employ another
name of his/her private practice, the person if that person is registered under the
expression “hospital”, “clinic” or “institute” Act and renders a supportive health-care
or any other expression which may give service. Practitioners must also note the
the impression that such private practice HPCSA Policy Document on Business
forms part of, or is in association with, a Practices (as at 29 September 2015).
hospital, clinic or institute.
Ethical Rule 8A states that a practitioner is
Fees and commission not allowed to share his/her rooms with a
Many practitioners often fall foul of the person or entity not registered in terms of the
provisions of Ethical Rule 7 in respect of Act, i.e., the Health Professions act, 1974. In
fees and commission. The rule prohibits a terms of the definitions clause of the Ethical
practitioner from accepting commission Rules, “rooms” means “a physical structure,
or any material consideration (monetary with an exclusive entrance and walled all
or otherwise) from a person or from round for the privacy of patients, the preser-
another practitioner or institution in return vation of their confidentiality and the
for the purchase, sale or supply of any safe-keeping of records, where a practi-
goods, substances or materials used by tioner conducts his or her practice”.
him/her in the conduct of his/her profes-
sional practice. A practitioner must not Scope of profession
pay commission or offer any material and performance
consideration (monetary or otherwise) to of professional acts
any person for recommending patients. On 6 March 2006, two sets of regulations
Furthermore, a practitioner is not allowed were promulgated defining the scope of
to share fees with any person or with


the profession of medicine and the scope provide consent for treatment himself or
of the profession of dentistry. herself, from his or her next of kin; and
(h) keep accurate patient records".
These regulations are of utmost impor-
tance in respect of performance of Other important ethical rules
professional acts and must be read with for practitioners
the provisions of Ethical Rule 21 which
stipulate that: Practitioners must take note of other
“A practitioner shall perform, except in an ethical rules dealing with practice- and
emergency, only a professional act - patient-related issues such as itinerant
(a) for which he or she is adequately practice; professional confidentiality;
signing of official documents; certificates
educated, trained and sufficiently and reports; issuing of prescriptions; finan-
experienced; and cial interests in hospitals; and referral of
(b) under proper conditions and in appro- patients to hospitals. Practitioners must
priate surroundings.” also be aware of their obligation to report
the impairment and unprofessional, illegal
Main responsibilities or unethical conduct of colleagues.
of health practitioners
The February 2009 amendment of the Recent HPCSA judgements
Ethical Rules introduced a very important An analysis of the convictions and judge-
rule for practitioners regarding their ments imposed by the HPCSA against
professional responsibilities. Rule 27A practitioners for unprofessional conduct
serves as a summary of the main responsi- for the period February to May 2016 shows
bilities of health practitioners. that the most common transgressions by
practitioners are the submission of fraudu-
Rule 27A reads as follows: lent claims to medical schemes for
"27A. Main responsibilities of health services not rendered, failure to obtain
practitioners proper informed consent before
A practitioner shall at all times - performing procedures, failure to ensure
(a) act in the best interests of his or her continuity of care for the patient, and
failure to adhere to Rule 20 of the Ethical
patients; Rules. Penalties and sanctions imposed
(b) r e s p e c t p a t i e n t c o n f i d e n t i a l i t y , ranged from various fines (the highest for
the period being R125 000), reprimands,
privacy, choices and dignity; and various periods of suspension from the
(c) maintain the highest standards of register which were wholly suspended on
conditions (the longest being five years’
personal conduct and integrity; suspension from the register, the imposi-
(d) provide adequate information about tion of penalty conditionally suspended
for five years). Failure by practitioners to
the patient’s diagnosis, treatment respond to correspondence from the
options and alternatives, costs associ- HPCSA as stipulated in Ethical Rule 20
ated with each such alternative and resulted in fines of R20 000.
any other pertinent information to
enable the patient to exercise a Conclusion
choice in terms of treatment and
informed decision-making pertaining The Health Professions Act mandates the
to his or her health and that of others; HPCSA to uphold and maintain profes-
(e) keep his or her professional knowl- sional and ethical standards within the
edge and skills up to date; health professions registered with the
(f) m a i n t a i n p r o p e r a n d e f f e c t i v e Council. These standards are set out in the
communication with his or her patients Ethical Rules as well as other HPCSA publi-
and other professionals; cations, e.g., policy documents and
(g) except in an emergency, obtain
informed consent from a patient or, in
the event that the patient is unable to


Ethical Rules Applicable to Practitioners Registered with the HPCSA 9

guidelines. Practitioners must ensure that action being taken against the practi-
they are familiar with these rules and tioner by the relevant professional board
that they at all times comply with their of the HPCSA.
provisions. Failure to adhere to the
Ethical Rules may result in disciplinary References available on request.


Ethics in Pharmacy Practice

Lorraine Osman on the other hand, how many pharmacists
 Head: Public Affairs, Pharmaceutical would be prepared to stand up in court
Society of South Africa and explain why they felt it to be critical to
the patient’s wellbeing, and possibly his/
Pharmacists and pharmacy support staff her life, to give an emergency supply of
know that they are bound by numerous medicine? For example, a holidaymaker
rules. These include the so-called “Ethical has run out of chronic medicine, such as
Rules”, which relate to acts or omissions in that for diabetes or epilepsy. If you are
respect of which the South African convinced that the prescriber intended
Pharmacy Council (SAPC) may take disci- the patient to remain on treatment, you
plinary steps. There is also the Code of are permitted to give it to the patient in an
Conduct, which takes into account the emergency, provided that it is in accord-
legal and ethical responsibilities of phar- ance with the original prescription. What if
macists. The Good Pharmacy Practice you have only the patient’s word for it?
(GPP) Rules set standards for everything, What if it is after hours and you cannot
ranging from what material to use for check? Would you run the risk of a medical
pharmacy fittings and fixtures to how phar- emergency, or would you consider it safe
macy staff should interact with clients. to give it to the patient, and to explain
later, if necessary?
So surely that means that if we abide by
all the rules and act within the law, we are ETHiCAL PRiNCiPLES
practising ethically? It may surprise you to
hear that the answer is “not necessarily”. Since 1978, it has generally been
accepted that there are four medical
Ethics recognise the application of ethical principles: beneficence, nonma-
moral beliefs and values to all human leficence, respect for autonomy, and
activities that affect the societies in which justice. There has been some discussion
we live. our decision-making as well as our that depending on cultural and commu-
understanding of what is right and wrong, nity circumstances, these may be inter-
arise within ourselves. preted differently.


Laws are a way of enforcing behaviour The Code of Conduct is a profession-
that is perceived to be in the interests of specific code that takes into account the
the citizens of the country. There are legal legal and ethical responsibilities of phar-
consequences to breaking the law. Does macists, but does not replace either.
this mean that if one sticks to the law, Compliance to the Code of Conduct
one’s behaviour is always ethical? cannot guarantee ethical conduct, but it
does suggest a list of principles by which
Consider the sale of complementary to live our professional lives. As with all
medicines in South Africa prior to 2013. The human values and rights, there will some-
market was flooded with “natural” prod- times be limitations, and the pharmacist
ucts promoting weight loss. The products will need to make a judgement call,
were not illegal, but was it ethical for taking into consideration all factors that
pharmacists to sell them? After tests were influence the decision.
conducted, it was discovered that some
products contained unlawful scheduled PRiNCiPLE Of BENEfiCENCE
substances, while others were very unlikely Beneficence encompasses acting in
to be effective. In november 2013, the law the best interests of the patient, as well
changed to require submission for registra-
tion. This is an example of how laws are
guided by ethical principles.


Ethics in Pharmacy Practice 11

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CIPLA MEDPRO (PTY) LTD. Co. Reg. No. 1995/004182/07. Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA.
Website: Customer Care: 080 222 6662. [13404]


as commitment to the wellbeing of information must also be controlled. In
the public. cases such as this, however, the pharma-
cist must balance the risk associated with
This is arguably the primary principle nondisclosure with the right of the patient
applicable to all health-care professionals. to confidentiality.
Not every pharmacist has direct contact
with patients, but all pharmacists work Continuing professional development
towards improving the health of the (CPD) is an ethical as well as a legal
people of this country. Both direct patient responsibility, in the interests of both
care and promotion of public health care beneficence and nonmaleficence. It
must result in optimal therapeutic would be highly detrimental to the
outcomes in both health and quality of life. patient, for example, if the pharmacist
was unaware of new information which
Nonmaleficence would assist in rational medicine use.
Nonmaleficence means not doing harm,
and as medicines become increasingly The autonomy of a patient
complex, there are times when benefi- A competent and rational patient has a
cence and nonmaleficence must be right to participate in decision-making
balanced. Is the therapeutic effect of the regarding his/her health. This is another
medicine good enough to justify potential reason why it is important to ensure that
risks such as side effects? Or are the side the patient has all the necessary informa-
effects and potential adverse effects so tion about the medicine. There may be a
serious and the beneficial effects so conflict between the intended benefi-
minimal that it just isn’t in the patient’s cence of the pharmacist and the
interest to administer any medicine. autonomy of the patient – the ultimate
decision about whether or not to take the
The pharmacist must ensure that the medicine is made by the patient.
patient understands how to use the medi-
cine so that it will be effective and safe. Justice in the supply of medicines
This in itself can be a challenge if the In this context, justice means that there
patient is vulnerable because he/she is should be fair and equitable distribution
deaf or blind or illiterate or disabled in any and use of medicine, which is a scarce
way. Ethically, the pharmacist must take health resource. While there are very
responsibility for the patient’s under- expensive medicines that would rapidly
standing of the medicine leaflet. deplete a limited budget if used for one or
two patients, there are also literally millions
Another potential conflict between of people who suffer from conditions that
beneficence and nonmaleficence could can be managed by relatively inexpen-
arise when the pharmacist believes that it sive medicines. How then can we apply
is in the best interest of the patient to justice’s demand that scarce health
communicate confidential information to resources should be distributed fairly?
someone else, such as the patient’s
doctor or health official. The patient has a Other principles in the Code
right to privacy, making it imperative that of Conduct
information acquired in the course of Pharmacists are expected to uphold the
professional practice may not be honour and dignity of the profession. Is this
disclosed except under certain prescribed a form of cronyism where everyone
circumstances. This extends to privacy in protects the other’s back? Not at all. It is
the dispensary, where other consumers recognition that like Caesar’s wife, the
should not be able to overhear confiden- health-care profession must be beyond
tial discussions between the pharmacist reproach. While this may not appear
and the patient, or the disclosure of confi- directly related to the principles of health
dential information in documents, such as ethics, it impacts on matters of trust and
product information leaflets or copies of
prescriptions. Access to computer


Ethics in Pharmacy Practice 13

confidence in care. A pharmacist engag- or may not be a pharmacist, requires him/
ed in nefarious practices, whether in his/ her to put business considerations first.
her professional or personal life, is consid-
ered to be unethical and unprofession- Conclusion
al. For example, fraud is completely
unacceptable. Are ethics important in pharmacy prac-
tice? Acting in the interest of the patient’s
An interesting principle is that of profes- wellbeing, causing no harm, respecting
sional independence. A pharmacist will the patient’s autonomy and ensuring
be held fully accountable and responsible justice in the use of scarce resources – I
for his/her actions. No matter whether the think the question answers itself. With
pharmacist is an employer or an emplo- quality pharmaceutical care taking into
yee, each individual is accountable for account the safety of the patient, trust
compliance with all norms and standards and professional respect will follow natu-
that pertain to pharmacy practice, rally, together with the knowledge that
including legislation and the Code of you have made a positive difference in
Conduct. Clearly, there is the concern someone’s life.
that an employee may feel obliged to
engage in unethical or unprofessional References available on request.
behaviour when the employer, who may


Ethical Responsibilities
and Challenges of Health-Care
Professionals within the NHI

Elizabeth Parker and Elsabé Klinck population is entitled to the benefits,
B Iuris, LLB, BA Hons (German), including those who do not contribute.
BA Applied Psych The aim of the NHI is universal coverage of
 Elsabé Klinck Consulting CC the population with adequate health
care at an affordable cost. NHI promotes
The National Health Insurance (NHI) White health-risk cross-subsidisation across the
Paper was released in December 2015, whole population.
and at the time of writing this article it is up
for comment. Although it is still in draft In Section 27(1)(a) of the South African
form, many aspects, such as the Office of Constitution, access to health-care
Health Standards Compliance, have services, including reproductive health
already been put in place. The NHI pilot care, is listed as a right. Section 27(2)
sites have also revealed the challenges makes it clear that the state must take
facing a fledgling NHI as relating as much, reasonable measures within its available
if not more, to capacity as budget. resources to ensure that this right is
progressively realised. The poor and unin-
The definition of National Health sured may not be deprived of health care
Insurance is given as follows in the White due to lack of money, but herein lies the
Paper of 11 December 2015: challenge for practitioners in private
practice – to what extent should they
“NHI is a health financing system that is contribute to making this right a reality, or
designed to pool funds to provide does the obligation only rest with govern-
universal access to quality, affordable ment, to take reasonable legislative and
personal health services for all South other measures to effect this? Should
Africans based on their health needs, irre- practitioners only fulfil this right towards
spective of their socio-economic status. patients who can afford their fees? In the
NHI will be implemented through the NHI, would there be an ethical, or a legal
creation of a single fund that is publicly duty, placed on the practitioner to serve
financed and publicly administered. The NHI patients, and to serve them at the fees
health services covered by NHI will be offered by the NHI Fund? When would the
provided free at the point of care. NHI will NHI legislative and policy measures
provide a mechanism for improving cross- possibly become “unreasonable” towards
subsidisation in the overall health system. practitioners? Or should the rights of prac-
Funding will be linked to an individual’s titioners give way to the rights of patients?
ability to pay and benefits from health
services will be in line with an individual’s How the NHI will affect the primary health-
need for health care. Implementation of care professional is stipulated in section 6.1.4
NHI is based on the need to address of the White Paper, wherein it states:
structural imbalances in the health system
and to reduce the burden of disease.” “176. An essential step in strengthening
Primary Health Care (“PHC”) and ensuring
The above definition is the aim of the NHI integrated services is the contracting of
at its core. The introduction of the National private health practitioners to render
Health Insurance (NHI) Scheme in South services. Contracting will be undertaken
Africa will push the health-care system to address the health needs of the popu-
towards a socialised model. NHI is a lation and will be aimed not only at
system of health-care funding in which all improving access but also at reducing the
taxpayers or income earners make burden of disease. With regard to children,
mandatory contributions, but the whole to address early childhood development


Ethical Responsibilities and Challenges of Health-Care Professionals within the NHI 15

as well as physical bearers to learning, in health facilities. It is unclear what sub-
addition to general practitioner services, optimal results would mean for public
the services of nutritionists, dental thera- facilities, and whether this would mean
pists, audiologists, speech and hearing that a facility would not be able to render
therapists, psychologists, optometrists, oral services under the NHI, until an inspection
hygienists and other relevant allied health is passed.
professionals will be prioritised."
Details as to the content of the con-
It goes on further to state: tracts are set out in paragraph 334 of the
“181. In the next phases of implementa- White Paper:
tion, private providers at the Primary
Health Care level will be contracted and “Providers who satisfy accreditation
reimbursed through a capitation model requirements will be considered for
where appropriate, instead of a Fee For contracting with the NHI Fund. The
Service as it is happening currently.” contracts will contain a clear statement of
This means that contracting would be performance expectations in respect of:
essential in order to serve NHI patients. patient management; patient volumes;
Remuneration will not be based on a fee for quality of services delivered; adherence to
service, but on being responsible for certain clinical protocols and treatment guidelines;
patients at a flat fee. It is not yet clear how and improved access to health services.”
this fee will be determined, or whether it will
be pre-payment, or only past-payment, as One of the aspects still under considera-
the White Paper does refer to “reimburse- tion is the role of medical schemes in the
ment” by the NHI Fund. The level of NHI. This will definitely impact on the way in
reimbursement will be set as follows which practitioners run their practices in
(although elsewhere in the White Paper the future, especially if a large number of
reference is made to a sub-structure of the patients move from being medical scheme
NHI responsible for “price determination): patients to NHI patients. Accordingly,
“335. The NHI Fund in consultation with practitioners will have very little option but
the Minister will determine its own pricing to contract to the NHI so as to maintain
and reimbursement mechanisms. their patient base. The White Paper also
Providers who wish to contract with the envisages a withdrawal of state subsidies to
NHI Fund must comply with the stipulated government employee medical schemes,
pricing and reimbursement mechanisms.” such as GEMS and Polmed, which could
If in order to become a health-care also have an impact on patients. Given
professional who is part of the NHI, one that NHI guidelines and protocols would
would also require accreditation: have to be followed, this could also impact
“331. Health-service benefits to which on the care provided, and treatment
the population is entitled will be delivered options available to patients.
by public and private providers that have
been accredited and contracted by the There is a currently a definite shift to a
NHI Fund. The accreditation process will more consumer-based approach to
require providers to firstly meet the health care, with an emphasis on patients
minimum quality norms and standards (consumers) having choices and options,
and be certified by the Office of Health and doctors being intermediaries in the
Standards Compliance (“OHSC”), and supply of medicines and devices. Patients
where relevant by the appropriate sta- are taking greater responsibility and
tutory professional council, which having an important say in their health-
will continue to register and license care journey. Therefore the NHI is bound to
professionals in line with national place limitations on this approach to
health legislation.” health care. Both practitioner and patient
The OHSC has already been set up and would be bound to limited options and
has undertaken inspections of public choices, which would place pressure on
the practitioner from an ethics- and legal
compliance perspective. Details as to
how a patient and/or provider could opt


out of prescribed conditions set on the medicines, those medicines would have
delivery of care are not stated. It is not also to be kept separate from the NHI stock.
clear how patients who need exceptional This also raises the question as to whether
care, e.g., off-protocol care, would be a contracted-in practitioner will be able
handled. This raises issues in terms of how to benefit from national tenders for
practitioners will manage patient expecta- consumables and the likes, when servicing
tions, consumer rights, and ethics, in the NHI. NHI patients. This would mean tapping into
public sector supply-chain systems, which
Currently, in the private sector, doctor has, traditionally, come with issues relating
and patient autonomy is limited by factors to stock-outs or shortages at depots.
such as the protocols and formularies of a
medical scheme, and the patient’s plan In summary, this means that although
option at the scheme. There are, however, the system is undergoing an overhaul,
options such as appeals to the scheme medical practitioners will be expected to
and the Council for Medical Schemes, adhere to all the ethical rules and guide-
co-payments and total out-of-pocket lines set out by the Health Professions
payments if the patient is not satisfied with Council of South Africa. Along with that,
the service that the scheme provides, or there will have to be an understanding
where the patient clinically needs an amongst health-care professionals
alternative. It is clear that the practitioner, accredited by the NHI that they are
being contracted to the NHI and paid on working for the common good of the
a capitated basis, would be expected to country and not for their own pockets, as
consider his or her obligations to society, such. They would be remunerated and
and not necessarily take an individual guaranteed business, as the NHI would
viewpoint, when it comes to a specific allocate patients to them, but they would
patient and his or her wishes. It also is not be required to work on a capitation basis,
clear whether and how exceptional and within strict rules relating to medicines,
processes (appeals, exceptions, etc.) will protocols and other supplies. This could
be handled under the NHI. result in challenges to doctors, both finan-
cially and ethically.
For dispensing doctors, the NHI might
also bring an added dynamic relating to References available on request.
medicines stock-holding – e.g., as long as
there is a single exit price for private-sector


The Council for Medical Schemes and Ethical Conduct in Practice 17

The Council for Medical Schemes
and Ethical Conduct in Practice

Dr Elsabé Conradie The Institute of Directors (IoD) remarked
PhD (Marketing Management, PhD that sustainability is the primary moral and
(Communication Management), MBL economic imperative of this century and
 General Manager: Stakeholder, the current, incremental changes being
Council for Medical Schemes made to comply with this principle are
insufficient. It has become necessary for
“The time is always right to do what organisations to devise a new set of values
is right.” and behaviour – for instance, that govern-
Martin Luther King: 1929-1968 ance, leadership, strategy and sustaina-
American leader of civil rights movement bility are inseparable and that the legiti-
and Nobel Peace Prize winner mate expectations of stakeholders are
considered to be in the best interest of
Good corporate governance is receiving organisations.
attention, in that new ways are being
sought to conceptualise the responsibili- Preble defines an organisation’s stake-
ties of organisations in all sectors of the holders as persons or groups that have or
economy, i.e., the business world, govern- claim ownership rights or interests in an
ment and the nonprofit sector, including organisation. Freeman’s most commonly
health care. Corporate scandals such as used definition states that the term stake-
Enron, WorldCom, and Tyco created a holder means any group or individual who
need for organisations to regain the can affect or is affected by the achieve-
public’s trust by rethinking traditional ment of the organisation’s objectives. He
concepts of responsibility. further suggests that stakeholders have
diverse needs and a vested interest in the
The King Report on Governance for operations of the organisation.
South Africa (King III) emphasises that a
fundamental shift is needed in the way Freeman’s analysis of stakeholders
organisations act and organise them- provides a link to corporate citizenship.
selves to achieve good governance. Investopedia describes corporate citizen-
Good governance is essentially about ship as: “The extent to which businesses
effective leadership. Leadership is char- are socially responsible for meeting legal,
acterised by ethical values underpinning ethical and economic responsibilities
good governance, namely responsibility, placed on them by shareholders. The aim
accountability, fairness and transparency, is for businesses to create higher standards
which are based on moral duties, of living and quality of life in the communi-
including conscience, care, compe- ties in which they operate, while still
tence, commitment and courage. preserving profitability for stakeholders”.

By implication, ethics and good govern- King III’s description of corporate citizen-
ance are inseparable. The Concise Oxford ship is echoing Investopedia’s description,
Dictionary defines ethics as a set of princi- but focuses strongly on organisations that
ples or morals, the science thereof, and should protect, enhance and invest in the
rules of conduct. Business ethics are thus a wellbeing of society. A holistic approach
set of principles designed to help profes- to economic, social, and environmental
sionals conduct business honestly and with issues is required by organisations in formu-
integrity. Organisations use a code of lating their core business strategies in order
ethics, i.e., a set of principles, to govern to achieve effective management of
their decision-making in choosing business opportunities and risks.
between right and wrong.
King III was probably the first to view
stakeholder relationships as a key tenet to
ensure good corporate governance.


Chapter 8 of the Report proposes 10 Development (CPD) provider and offers
stakeholder-relationship management two introductory and two accredited skills
principles that the boards of organisations training programme sessions per annum to
should include in their corporate govern- BoT members. The principal outcome is
ance practices. “improved governance and decision-
making in medical schemes”.
To summarise:
1. The board should include the legitimate One of the duties of the BoT is to appoint
interests of stakeholders in its decisions. a principal officer (PO) who is also fit and
2. The organisation should proactively proper to hold such office. The legislature
manage stakeholder relationships. anticipated that, despite the provision of
3. & 4. The organisation should promote training, the BoT may in some instances
and enhance stakeholder engagement to lack sufficient expertise to perform its func-
achieve the appropriate balance tions and therefore Section 57(4)(g)
between its various stakeholder groupings. provides that members may obtain expert
5. Organisations should ensure the equi- advice on legal, accounting, business or
table treatment of shareholders. any other relevant matter as required.
6. & 7. Transparent and effective com- Subsection (6) provides for the BoT to: a)
munication with stakeholders is essential take all reasonable steps to ensure that
for building and maintaining their respect, the interests of beneficiaries are protected
trust and confidence. at all times; b) act with due care, dili-
8., 9. & 10. The board should ensure gence, skill and good faith; c) take all
disputes are resolved as effectively, effi- reasonable steps to avoid conflicts of
ciently and expeditiously as possible. interest; and d) act with impartiality with
respect to beneficiaries.
These principles are also applicable to
medical schemes, which are nonprofit Section 46 of the MSA states that the
trust funds governed by a Board of CMS may remove a BoT member from
Trustees (BoT). Section 57 of the Medical office if there is sufficient reason to believe
Schemes Act 131 of 1998 (MSA) contains that the relevant person is not fit and
the general provisions on governance proper to hold the office concerned. In
and requires that every medical scheme terms of Section 29(1)(c), a medical
shall have a BoT, which is fit and proper to scheme should also provide in its regis-
manage the scheme. Although the terms tered rules for removal from office of
“fit” and “proper” are not defined in the officers of the scheme.
MSA, King III advises that when considering
the skills and suitability of a proposed The purpose of the CMS, as stipulated in
trustee, magnitudes requiring considera- the MSA, is to protect beneficiaries of
tion are the knowledge and experience medical schemes, maximise access to
required to fill the gap on the BoT; the coverage and protect the public interest.
apparent integrity of the individual; and Without regulation, only private interests
the skills and capacity of the individual to would prevail, reducing access and
discharge his/her duties to the BoT. accountability.
Trustees should be individuals with cour-
age to contribute effectively to the busi- It cannot be stressed enough, however,
ness of the scheme. that medical scheme members should
actively participate in Annual General
Induction, mentoring and support Meetings where BoT members are elect-
programmes should be implemented to ed. They should ensure that adequate
address any lack of experience of trus- policies are in place and that appropriate,
tees. The Council for Medical Schemes fit and proper persons are appointed as
(CMS), the regulator of medical schemes, BoT members.
is an approved Continuous Professional
Good governance and ethical behav-
Handbook of MEDICAL ETHICS iour are imperative for the sustainability of
any medical scheme, but health-care
providers also have a responsibility,

The Council for Medical Schemes and Ethical Conduct in Practice 19

especially regarding prescribed minimum will ensure definite payment of claims,
benefits (PMB). since PMBs enjoy guaranteed medical aid
cover. Providers should also consider to
PMBs are a set of defined benefits to which option patients belong and what
ensure that all medical scheme members can realistically be covered before
have access to certain minimum health recommending a drug or treatment. They
services, regardless of the benefit option should alert patients to the fact that their
they have selected. The aim is to provide condition is a PMB and encourage them
people with continuous care to improve to engage their medical scheme on the
their health and wellbeing and to make matter, should the need arise.
health care more affordable.
Designated Service Providers (DSP) are
PMBs are a feature of the MSA, in terms of medical schemes’ first choice when their
which medical schemes have to cover the members require diagnosis of, or treat-
costs related to the diagnosis, treatment ment/care for, a PMB condition. Hence,
and care of any emergency medical providers are encouraged to allow their
condition, a limited set of 270 medical practices to be listed as a DSP. The
conditions (defined in the Diagnosis “payment in full” concept was introduced
Treatment Pairs), and 25 chronic conditions to ensure accessibility of health-care
(defined in the Chronic Disease List). services for medical scheme beneficiaries
if the DSP is not available; it is not a reim-
The two main reasons why PMBs were bursement model.
created are to ensure that medical
scheme beneficiaries have continuous In 2010 a Code of Conduct with regard
health care; even if a member’s benefits to PMB benefits was published to assist
in a particular year are depleted, the medical schemes, administrators and
medical scheme still has to pay for the health-care providers in offering PMBs to
treatment of PMB conditions. Secondly, members in compliance with current
they ensure that health care is paid for by legislation. The Code is still applicable,
the correct parties. Medical scheme although a revision is pertinent.
members with PMB conditions are entitled
to the specified treatments and these Not adhering to the PMB Code of
have to be covered by their medical Conduct and abuse of PMBs will result in an
scheme, even if the patients were treated unsustainable private health-care system
at a state hospital. with unaffordable contribution increases. In
line with King III, all involved in health care,
Usually health-care providers do not should provide effective leadership based
have a direct contractual relationship on an ethical foundation.
with medical schemes. Most merely
submit their claims to the medical scheme. “It is easy to dodge our responsibilities,
This, however, does not mean that PMBs but we cannot dodge the consequences
are not important to healthcare providers, of dodging our responsibilities.”
nor that they do not have a role to play in Josiah Charles Stamp: 1880-1941
its successful functioning. English Economist and President of the
Bank of England
It is critical for health-care providers to
familiarise themselves with ICD-10 References available on request.
codes and how these correspond with
PMB codes. Using the correct ICD-10 code


The South African Nursing Council
and Ethics in Nursing Practice

Dr Sue Armstrong in nursing. The ethical foundation of the
D Cur, MSc Nursing, B Ed (Hons) South African nursing/midwifery profession
 Senior Lecturer: Faculty of Health consists of various versions of the Nurses’
Sciences, University of the Witwatersrand Pledge which has been derived from the
Nightingale Pledge.
Nelouise Geyer
MCur Nursing Practitioners who take the pledge enter
 Nursing Education Association into a verbal agreement with society that
they will act in the best interest of their
South Africa has a nurse-based health patients. While ethical codes guide deci-
system, meaning that the bulk of health sion-making and behaviour, these codes
care is delivered by nurses. The South cannot avoid ethical dilemmas or provide
African health system is challenged by an complete rules for ethical decision-making
extensive and changing quadruple and action in every possible situation.
burden of disease, exacerbated by a
shortage of health-care practitioners. For Here the ethical rules related to scope
this reason, the Nursing Strategy proposes of practice and acts and omissions can
strategies to strengthen the nursing profes- assist, but primarily ethical decision-
sion to address the many challenges in the making requires professionals who act
health sector. In addition to well-known morally. The SANC also provides oversight
ethical dilemmas, the shortage of nurses of the ethical practice of nurses and
and midwives also present ethical chal- through its professional conduct oversight,
lenges in practice. should provide direction to the profession
on what constitutes ethical behaviour.
Regulation of the profession
Ethics and values
Nurses and midwives are autonomous
practitioners accountable for their own We usually accept the ethical rules of a
acts and omissions. Their practice is profession without question until things go
authorised by a legal-ethical framework wrong, but someone had to have made
and oversight of such practice is those rules at some stage and in the case
executed by the South African Nursing of the Code of Ethics and the Nurses’
Council (SANC). The ability of the nursing Pledge, this occurred some time ago.
profession to regulate its own profes- Ethical rules are based on what the
sional-ethical affairs is based on a social people devising those rules valued – what
agreement with society grounded in the was important to them and their
trust that the profession will act in the best profession.
interests of society in the way it controls its
own affairs. Values determine what, in our opinion, is
right and what is wrong, whereas doing
Ethics in nursing what is right or wrong (based on values) is
and midwifery practice what ethical behaviour is all about. If we
value human life, it is necessary to have a
Ethical rules play an important role in law to protect unborn babies; if we value
shaping ethical behaviour of profes- impartiality and confidentiality as a profes-
sionals. The International Council of Nurses sion we need those principles to be
(ICN) Code of Ethics and the Nurses’ embedded in our pledge, as they are.
Pledge of Service are the most prominent
examples of the ethical codes referred to We live in a multifaith and multicultural
society so do we, or can we, value the
same things? Can we all agree on ethical
rules and, if not, where does that leave us?


The South African Nursing Council and Ethics in Nursing Practice 21


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Ethical dilemmas in nursing process, and damages the doctor-
and midwifery patient relationship.

Ethical dilemmas are situations where right, Dual loyalties probably constitute the
wrong or satisfactory solutions are not most prominent ethical challenge in
possible. Ethical decision-making therefore modern-day health care. The most serious
entails making the best choice of the avail- example of dual loyalties is where health-
able options, a process in which doing care practitioners support the State’s
good and avoiding harm become the agenda to the detriment of the patient,
most important guiding principles. such as in the Steve Biko and the Carol
Ann Meyers cases. The latter case
Ethical dilemmas generally concern the concerns the death of a prisoner placed
same issues over time, but sometimes in a straitjacket as a disciplinary measure.
there is a shift of emphasis. An example is The prison nurse failed to respond to the
pregnancy termination. While the choice distress of the prisoner, who developed
to terminate pregnancy has been sanc- dangerously low blood pressure when the
tioned through legislation , it has created straitjacket was applied too tightly. In her
other dilemmas. Nurses’ religious beliefs defence, the nurse said that she was “not
may prohibit them from participating in allowed to remove the straitjacket as it
the termination of pregnancies, but they was correctional regulations”.
may not refuse to provide general
nursing/midwifery care to women who Dual loyalties come into play in less
have terminated their pregnancy. The controversial ways in daily practice. How
Constitution of the country makes provi- should limited health-care resources,
sion for religious objection as a basic particularly those affecting the public
human right, but nurses/midwives are sector, be distributed?
expected to advise their employer time-
ously if they are not prepared to The Constitution dictates that public
participate in pregnancy termination services should provide health care to the
procedures. Another dilemma that has population, but as the court decision in
arisen following the legalisation of preg- the Soobramoney vs KZN Minister of Health
nancy termination, is that it has in many (CCT32/97) case indicated, health
cases become a form of family planning, services can only be provided within the
which was not the original objective of resources available for the services at the
the legislation. time. To guide decision-making, practi-
tioners are often provided with workplace
Evidence-based practice versus policies.
personal beliefs can give rise to thorny
dilemmas in other disciplines of nursing/ However, once again, this does not
midwifery – for example, religious beliefs eliminate the ethical dilemma for practi-
denying the administration of blood or tioners; while Mr Soobramoney did not
blood products to save a life, or personal qualify for haemodialysis according to
beliefs preventing parents from immu- policy guidelines, he died as a result of not
nising their children, can jeopardise the accessing this service in the public health-
health of communities. These types of care sector after his medical aid ran out.
situations can prove very difficult for Similarly, nurses and midwives may have
health-care practitioners in that their to deal with situations where a live prema-
professional judgement is at odds with ture baby under a certain weight cannot
their patients’ right to make health-care be resuscitated because of policy states.
decisions relating to themselves and
their dependents. While court orders can Dual loyalties can be subtler, too. The
assist practitioners to oblige parents to shortage of nurses and resources to
allow the administration of blood or provide quality care, creates a dilemma
vaccines to their children, obtaining for nurses. While nurses must do the best
such permission is a lengthy and costly they can with the means available, they
should also continually lobby the authori-
Handbook of MEDICAL ETHICS ties to remind them that they are working in

The South African Nursing Council and Ethics in Nursing Practice 23

high-risk environments. Not doing so would not possible to make a well-considered
mean that they are being loyal to the decision prior to an adverse event occur-
authorities at the expense of safe working ring. In such a case, it is important to
environments for nurses and patients. review the dilemma after the event, to
determine what could have been done
Conclusion differently – this will shape the future
behaviour of practitioners.
Ethical decision-making requires multipro-
fessional group work which should include References available on request.
patients and/or their loved ones. Often it is


Protecting the Information
of Your Patients

Esmé Prins-van den Berg gender, physical or mental health,
BLC, LLB, LLM medical history, identity numbers, medical
 Consultant: Healthcare Navigator scheme information, as well as practi-
tioners’ opinions about the patients – and
The Protection of Personal Information Act could include patients’ names depending
4 of 2013 (“POPI” or “the Act”) gives effect on the context and circumstances.
to the Constitutional right to privacy and
contains, amongst others, conditions for “Processing” of personal information
the lawful processing of personal informa- includes all the activities that could be
tion. Only a few provisions of POPI have performed with information such as
been implemented at the time of writing collection, receipt, recording, organisa-
this article and it is as such not yet appli- tion, storage, retrieval, usage, dissemi-
cable to health-care practices and nation, merging and erasure.
pharmacies. Once fully implemented,
practitioners would have at least another The data subject is the person to whom
12 months to become compliant with the the personal information relates and
provisions. It is expected that the Infor- includes natural and juristic persons. From
mation Regulator would be established a practitioner’s perspective, data subjects
soon after which the Act should be fully would include patients, suppliers, vendors
implemented. Health-care practitioners in and even medical schemes. Furthermore,
private practice will generally be respon- the practice, pharmacy and the practi-
sible for compliance with the Act. tioners could be data subjects, depending
Practitioners should therefore take note of on the context.
the implications of POPI for their practices
and pharmacies. When personal information
may be processed
Application of POPI
In terms of POPI, personal information
The processing of personal information of may, in general, be processed in the
patients by or on behalf of health-care following circumstances:
practices and pharmacies in the Republic n With the consent of the data subject
of SA (“RSA”) will in general be subject to
the provisions of POPI. In certain instances (the patient or a competent person in
POPI will, however, not be applicable – for the case of a child) which could be
example when personal information is withdrawn at any time. Consent must
processed, which has been de-identified be voluntary, specific and informed
and cannot be re-identified (truly anony- n To conclude or perform a contract to
mous information). POPI will also not apply which the data subject is a party
to the processing of personal information n To comply with an obligation imposed
that has been exempted by the Infor- by law on the responsible party, i.e.,
mation Regulator. the practitioner, practice or pharmacy
n To protect a legitimate interest of the
Processing of personal data subject
information n For the proper performance of a
public law duty by a public body
“Personal information” includes in essence n To pursue the legitimate interests of
all the information about patients that a the responsible party or a third party
health-care practitioner or pharmacy to whom the information was supplied
processes such as contact details, age,
In the latter three instances, a data subject
Handbook of MEDICAL ETHICS may object on reasonable grounds to the

Protecting the Information of Your Patients 25

processing of the information, in which not legally competent, without the assis-
event the information may only be tance of a competent person, to take any
processed if permitted by legislation. action or decision in respect of any matter
concerning him- or herself.”
POPI also identifies certain categories of
personal information as “special personal Information of children may only be
information”, which is subject to special processed in the following circumstances:
requirements. “Special personal informa- n With the consent of a competent
tion” is personal information concerning a
data subject’s: person
n Religious or philosophical beliefs n To establish, exercise or defend a right
n Race or ethnic origin
n Trade union membership or obligation in law
n Political persuasion n To comply with an obligation of
n Health or sex life
n Biometric information and international public law
n Criminal behaviour to the extent that n For historical, statistical or research

such information relates to the alleged purposes subject to the conditions
commission by a data subject of any specified
offence or any proceedings related to n When the information has deliberately
such an offence. been made public by the child with
the consent of a competent person
Special personal information may only be n The Regulator has authorised the
processed in accordance with the provi- processing.
sions of sections 27 to 33 of POPI. The
processing of health information by The Information Regulator must be notified
health-care practitioners, institutions or of, and provide authorisation for, certain
facilities is, for example, only permissible in processing activities. Depending on the
the following circumstances: circumstances, authorisation could be
n With the consent of the data subject implicit. Examples of these activities are:
n To establish, exercise or defend a right n When information is processed for the

or an obligation in law purposes of credit reporting; and
n To comply with an obligation of n When special personal information

international public law or the personal information of
n For historical, statistical or research children is transferred to a third party
in a foreign country where there is
purposes subject to the conditions not adequate protection for the
specified processing of this information. It
n The information has deliberately been should be noted that the transfer
made public by the data subject of personal information across the
n For the proper treatment and care of borders of the RSA may only occur on
the data subject the grounds specified in POPI.
n For the administration of the
professional practice or health-care Conditions for the lawful
institution/facility; or processing of personal
n The Regulator has authorised the information
There are eight conditions for the lawful
The processing of the personal information processing of personal information, which
of children is also subject to special provi- must all be met whenever personal infor-
sions and therefore requires special care. mation is processed. These conditions are
A “child” for purposes of POPI is “a natural briefly listed in Table 1.
person under the age of 18 years who is
Direct marketing

When practitioners, practices or pharma-
cies engage in direct marketing, which


Table 1. Conditions for the lawful processing of personal information

Condition Subject Brief explanation
1 Accountability
2 The responsible party is accountable and must ensure
Processing compliance with the conditions for the lawful processing
3 limitation of personal information.
5 Purpose Personal information must be processed lawfully and in a
6 specification reasonable manner so as not to infringe the privacy of
the data subject. This condition also stipulates when
7 Further personal information may be processed and from whom
processing it may be collected.
8 limitation
Information Personal information must be collected for a specific,
quality explicitly defined and lawful purpose related to a function
Openness or activity of the responsible party. This condition also
deals with record-keeping requirements.
safeguards Further processing of personal information must be
compatible with the purpose for which it was collected.
Data subject
participation The responsible party must take the necessary steps to
ensure that the personal information is complete,
accurate, not misleading and updated.

The responsible party must maintain the documentation
relating to all its processing operations as required by the
Promotion of Access to Information Act 2 of 2000. The
responsible party must also ensure that the data subject is
aware of certain specified information such as the
purpose and source of collection subject to exceptions.

This condition prescribes the security safeguards, which
entail technical and organisational measures, that
responsible parties (and persons processing information
on their behalf) must employ related to their processing
activities. Unlawful access to personal information must
be reported to the Information Regulator and the
relevant data subjects subject to certain conditions.

A data subject may gain access to records or
descriptions of personal information held by responsible
parties as well as other information subject to certain
conditions. A data subject may also request corrections
to and deletions of the information subject to certain

includes approaching persons personally, manner and form for obtaining consent
by mail or electronic communication, to will be prescribed by regulation. It should
promote or offer to supply services or goods be borne in mind that consumers are also
to them, they must have the consent of entitled to restrict unwanted direct
those persons to use their personal informa- marketing in terms of the Consumer
tion for purposes of the marketing. Protection Act 68 of 2009.

A responsible party may request a data Direct marketing should be distinguished
subject, who has not previously withheld from, for example, newsletters that are
consent, only once for such consent. The sent to bona fide patients and which


Protecting the Information of Your Patients 27

contain practice/pharmacy-related infor- Conclusion
mation. Should the newsletters, however,
contain marketing information, the provi- Information is essential for the delivery of
sions of POPI and the CPA would apply. appropriate treatment and care to patients
The rules, rulings and policies of the Health by health-care practitioners and for the
Professions Council of SA and the SA administration of their practices and phar-
Pharmacy Council also need to be macies. POPI will impose strict conditions on
considered by practitioners when the handling of this information in the future.
engaging in marketing initiatives. It is therefore recommended that practi-
tioners should commence with the
Penalties for noncompliance enhancement of processes, procedures
and documentation, where necessary, to
Noncompliance with POPI could, in addi- ensure that they would be compliant once
tion to attracting significant fines (of up to POPI was fully implemented. Legal advice
R10 million), also result in claims for damages, should be obtained where necessary to
including aggravated damages, and ensure accurate interpretation and appli-
consequently reputational risk for noncom- cation of the provisions of this Act.
pliant practices or pharmacies.


The Medicines Control Council
and its Applicability to Health-Care

Shakira Ramlakhan and Elsabé Klinck the HPCSA, is limited by legislation such as
B Iuris, LLB, BA Hons (German) BA Applied the Medicines Act. Issues such as actions
Psych associated with certain scheduled medi-
 Elsabé Klinck Consulting CC cines, the number of repeat prescriptions,
duration of validity of a prescription, etc.
Medicines are registered and regulated are governed by section 22A of the
for use and sale by the Medicines Control Medicines Act. Any entity may sell a
Council (MCC) in terms of the Medicines Schedule 0 substance.
and Related Substances Act, 1965 (“the
Medicines Act”). The National Depart Pharmacists may sell Schedule 1
ment of Health has embarked upon a substances, while dentists may only
process to replace the MCC with the dispense them if they have a dispensing
South African Health Products Regulatory licence. Other practitioners, e.g., nurses,
Authority (SAHPRA). SAHPRA will continue emergency-care providers or other
as the country’s Health Products Regu- HPCSA-empowered professionals, can
latory Authority and fulfil the same only prescribe Schedule 1s within their
mandate as the MCC with certain addi- scope of practice. To exactly delineate
tional features, such as including medical what specific substances may be
devices and in vitro diagnostics (IVDs) in prescribed by the aforementioned health-
its regulatory scope. care professionals, Schedule 1 in the
Medicines Act refers to Annexures 1A and
Due to this regulatory role, any health- 1B for paramedics and emergency-care
care professional who prescribes and/or practitioners, Annexure 2 for dental thera-
uses medicines (and in future medical pists and Annexure 3 for optometrists.
devices and IVDs) is by virtue of such Similar annexures exist only for emergency
prescription and/or use subject to the staff for Schedules 2 to 6, whereas dental
provisions of the Medicines Act. The MCC therapists have prescription rights in rela-
and in some respects the National tion to Schedule 2 medicines listed in
Department of Health through the office Annexure 2 to that schedule.
of the Director-General (DG), by virtue of
this legal mandate, regulate various Schedules 2 to 6 medicines can only be
related aspects pertaining to health prescribed by medical practitioners and
professional practice. There is an interre- dentists, and by any other health-care
latedness between the Health Professions professionals identified in the schedules.
Council of South Africa (HPCSA) and (An optometrist would have no prescribing
other statutory bodies, insofar as rights with regard to these schedules, but
prescribing rights and licensing are a dental therapist would have prescribing
concerned, and these aspects will be rights with regard only to Schedule 2
discussed in this article. products.) Further rules in this regard relate
to the period of validity of a prescription,
Important provisions i.e., it must be filled within 30 days, and a
in the Medicines Act verbal instruction to dispense can be only
Prescription rights be for 7 days of treatment. Repeat
prescriptions for Schedule 2 to 4 medicines
The right to prescribe, which principally can be issued for up to six months at a
originates from the professional activities time, but with Schedule 5 medicines a
as authorised by a statutory body, such as repeat after six months is possible for
longer than six months.


The Medicines Control Council and its Applicability to Health-Care Professionals 29

Repeat prescriptions for Schedule 5 medi- licences are not issued on the authority of
cines that are anxiolytic, antidepressant, the MCC, but on that of the Director-
tranquillising or analgesic in nature, can General, i.e., the National Department of
only be continued after six months if the Health. Further details are set out in the
prescriber has consulted with another “General” regulations in the Act.
psychiatrist (in the case of medicines used Regulation 18, for example, states that
in mental health) or with another medical dispensing shall only take place within the
practitioner, in the case of analgesics. scope of practice of the specific profes-
These requirements are widely regarded sional. It makes it mandatory for the
as impractical, and hampering access to licence-holder to keep sales records of all
health care, given the shortage of psychia- medicines, ensure appropriate premises,
trists, and the practical difficulty to “consult” appropriate labelling and that any
with another practitioner on a substantial prescription is preceded by a proper
number of prescriptions in a day. diagnosis for a patient.

No repeats of Schedule 6 medicines are Advertising
possible, which poses not only an access Health professional prescribers are not
barrier, but an additional financial hurdle – allowed to advertise medicines as such
very few, if any, medical schemes will pay advertisements could be seen as a viola-
for 12 consultations with a medical practi- tion of the ethical rules on touting and
tioner (and in particular specialists) per canvassing, as well as of the rule that
year. It is also very difficult, and sometimes prohibits endorsement of medicines in
impossible, to secure a monthly appoint- contravention of Ethical Rule 23. Even
ment with a practitioner, due to the vast where a practitioner has a dispensing
number of patients they have to serve. licence, and dispenses medicines that
Schedule 6 medicines may be provided could be advertised to the public in terms
without a prescription in an emergency, of section 18 of the Medicines Act,
but then only in the smallest pack avail- the HPCSA rules would prohibit such
able, and a written prescription must advertisement.
follow within seven days.
The SEP and commercial deals
Section 22A (15) contains an override Section 22G compels practitioners who
provision, under which the DG of Health, sell medicines, to do so at the Single Exit
after consultation with Pharmacy Council, Price, and at no other price. A dispensing
issues a permit to “any person or organisa- fee, as stipulated in the 2005 Pricing
tion performing a health service”, Regulations, can be charged, but no
authorising such person or organisation to mark-ups or other fees may be levied, or
acquire, possess, use or supply any speci- paid by, for example, manufacturers or
fied medicines containing Schedule 1, wholesalers to prescribers and dispensers.
Schedule 2, Schedule 3, Schedule 4 or
Schedule 5 substances. This means A health professional may not partici-
prescribing rights, and dispensing rights, pate in a bonus, rebate or incentive
may be afforded by the sole discretion of scheme pertaining to the sale of health
the DG of Health. products as this is prohibited by section
18A of the Act. Similarly, no medicine
Licensing may be received or provided as a
sample in SA. The amendments to the
Section 22C is the dispensing licence, Medicines Act, which are not yet in force,
which may be issued to a medical practi- make provision for regulations to be
tioner, or any other person registered by made on acceptable, and unaccep-
the HPCSA, after completion of a table business practices, as well as the
Pharmacy Council-accredited course provision of samples for so-called
(which must be set in conjunction with the “appraisal purposes”.
HPCSA or another statutory body, such as,
for example, the Nursing Council). These


Section 18C of the Medicines Act provides Generic substitution
for the recognition of an industry code The substitution of generic medicines is
relating to the regulation of advertising of mandatory under South African law,
health products to consumers and health unless, amongst other exceptions, the
professionals. A self-regulatory Code has prescribing practitioner has written, in his/
been established by the industry together her own hand, “no substitution” on the
with a self-regulatory body known as the prescription.
Marketing Code Authority (MCA) of South
Africa. The Code regulates the manner in Other issues
which the industry engages with health Other matters governed under the
professionals and details such aspects such Medicines Act, and which affect health-
as the provision of educational information, care professionals, relate to recalls,
gifts, sponsorships, etc. to prevent any adverse-event reporting and so-called
perversities and unethical solicitation of “dear health-care professional” letters
health professionals to endorse or prescribe (which update professionals on the latest
health products. The MCA may refer a warnings or precautions to be taken in
matter, e.g., where a health-care profes- relation to medicines).
sional solicits a gift or sponsorship in return
for a promise of support to a product, or Offences and penalties
where payment is expected from a repre- Not complying with the provisions on
sentative to see a practitioner, to the advertising (section 18), commercial deals
HPCSA, or another appropriate body. (sections 18A to 18C and section 22G),
prescribing and dispensing rights (section
Research- and named patient 22A), licensing (section 22C) and generic
medicines substitution, is an offence. This means being
liable for prosecution in the criminal system,
Only registered medicines may be sold by and possibly attracting a fine or imprison-
authorised prescribers, but one exception ment of up to 10 years, as a penalty.
pertains to health products recognised
under section 21 of the Act. Unregistered Conclusion
medicines (which can include medicines
used in clinical trials, medicines that have It is clear that no health-care professional,
been de-registered and which are no and specifically no medical practitioner,
longer available on the market, or medi- can afford not to be familiar with the
cines required in emergency situations), various provisions of the Medicines Act as
can all be imported in the name of a it applies to them. Not only is there close
medical practitioner, under his/her instruc- collaboration on prescribing rights; provi-
tions and oversight, for use within these sions under the HPCSA Ethical Rules place
settings. Detailed records have to be kept, further limitations on how practitioners
and each product has to be linked to a can deal with medicines in their profes-
named patient for whom the product has sional capacity.
been prescribed.


Generic/Therapeutic Substitution and Off-Label Prescribing 31

Generic/Therapeutic Substitution
and Off-Label Prescribing

Val Beaumont The reference below to a pharmacist
M Pharm (Industrial Pharmacy) refers to a licensed dispenser.
 Independent Consultant
Generic substitution
Our National Drug Policy, 1996 (NDP), is a
generic-friendly framework for the pre- The Drug Policy encourages generic
scribing and dispensing of medicines in prescribing using the international
South Africa, promoting the availability of nonproprietary name (INN) of products.
safe and effective medicines at the lowest In the private sector where prescribing is
possible cost. The drug policy and health typically by brand name, provision is
legislation encourage generic substitution made in legislation for generic substitu-
of medicines, however, therapeutic medi- tion at pharmacist level, with provision for
cine substitution by dispensers is prohibited. patients to exercise choice on substitu-
tion of generic drugs.
Generics typically come on the market
some eight to 10 years after the new A pharmacist must inform all concerned
chemical entity (NCE), and the generic (when presented with a prescription for
package insert is based on that of the dispensing) of the benefits of generic
originator. The responsibility of adjudi- substitution, and substitute with a cheaper
cating on the equivalence between a generic unless expressly forbidden by the
generic and the originator rests with the patient to do so or if the prescriber has
medicines regulator. written by hand on the prescription the
words ”no substitution”. Where substitution
Pharmaceutical equivalence is generally takes place, the manufacturer’s name or
used to demonstrate equivalence between brand must be noted on the prescription
the new generic and the originator medi- and reasonable steps taken to inform the
cine. The exception to this standard is in the prescriber. If substitution is forbidden by
case of biological medicines where biosimi- the patient it must be noted on the
lars are not equivalent to the originator and prescription by the dispenser.
are not interchangeable.
The pharmaceutical science
The package insert of a medicine (PI) is behind generic substitution
the blueprint for the prescribing and
dispensing of medicines and the power to Generic medicines, or “interchangeable
make substitutions is found in two statutes; multisource medicines” (IMSM), are regis-
the Medicines and Related Substances tered on the basis that they are medicines
Act (Act 101) lists the conditions and that contain the same active substances
categories of persons who may prescribe and which are identical in:
scheduled medicines and the Pharmacy n strength or concentration
Act controls the various aspects related to n dosage form and route of
the dispensing of medicines.
This overview of the legal and scientific n meet the same or comparable
framework for generic substitution also
provides background on why a drug, standards for therapeutic equivalence
which is not a true generic, cannot be
considered as a legal substitute for a Therapeutic equivalence can also be
prescribed medicine. demonstrated for the purposes of registra-
tion of medicines, between
Third-party pressure, at the point of n two medicines containing different
dispensing, to change a prescription based
on a formulary, creates an ethical dilemma forms of the same chemical moiety or
for the health-care professional (HCP). between


n two different dosage forms with the make therapeutic decisions for patients,
same chemical moiety. intervene in the health practitioner-
patient relationship and in decisions
A pharmacist may substitute one generic regarding treatment choice.
for another.
Where a funder seeks to enforce a change
Importantly, the concept of thera- in a prescription, which is not generic
peutic equivalence only applies to the substitution, the following ethical issues
same chemical moiety. Therapeutic related to professional independence
equivalence between drugs that are not should be considered and ethical
generics, even though they may be in reasoning applied to determine the action
the same therapeutic category, cannot in the best interest of the patient:
be claimed. Substitution for each other is n A pharmacist should not enter into
not allowed.
arrangements which impact negatively
The original policy document with a list on professional independence or the
of “nonsubstitutable” medicines has been ethics of the profession. In particular,
retracted. These medicines typically had he/she should not agree to practice
a low therapeutic index, significant inter- under terms or conditions that interfere,
and intra-patient variability or long-acting amongst other things, with the proper
or complex sustained-release formula- exercising of professional judgement or
tions. It is incumbent on the pharmacist to skill. The receipt of financial incentives
consider these scientific factors when from funders for participation in
making decisions on generic substitution a scheme to effect or facilitate
for patients. The clinical relevance of therapeutic substitution, could amount
switching between a nCE and generic or to breach in the Pharmacy Code
between different brands of a generic of Conduct (Code), especially if it is
medicine, will depend on these factors as not considered to be in the patient’s
well as on the quality and batch-to-batch best interest when all aspects are
consistency in manufacture. The responsi- considered.
bility for making this substitution choice n Patients may be incentivised by
rests with the pharmacist, particularly with funders to receive pharmaceutical
repeat prescriptions. and medical services from providers
that have contracted to adhere to
DiSPENSiNG: OBLiGATiONS funders’ formularies. Such incentives
TO ASSESS A PRESCRiPTiON AND may lead to a Code breach.
CONSULT ON iDENTifiED PROBLEMS n Patients may be unaware that
pharmacists may not make a
The pharmacist must independently assess formulary-based substitution of
a doctor’s prescription to ensure the optimal prescribed medicines without prior
use of the medicine. Where problems are engagement with the prescriber on
identified, the dispenser must contact the a care plan. These steps should be
prescriber to determine a care plan. relayed to patients.
Therapeutic aspects and socio-, legal- and n The pharmacist in consultation with
economic aspects are to be considered. the doctor may, in the patient’s
The pharmacist should use professional interest, refuse to swap an item as
judgement in deciding the course of action directed by a funder. This has cost
that would be in the patient’s best interest; implications for the patient that must
the pharmacist has the right not to dispense be explained. The patient cannot
the prescription if he/she is concerned force a pharmacist to dispense such a
about a risk to a patient. prescription.
n An sms received by a patient from
ETHiCAL DiLEMMA a funder querying a decision of the

An ethical dilemma occurs where third-
party funders (funders), not mandated to


Generic/Therapeutic Substitution and off-Label Prescribing 33



For further prescribing information refer to the package insert.

A 21.5.1 S2 Reg. No. A38/21.5.1/0341

CIPLA MEDPRO (PTY) LTD. Co. Reg. No. 1995/004182/07. Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA.
Website: Customer Care: 080 222 6662. [13404]


Figure 1. Flow chart of dispensing decisions

Prescription as per Act 101. HCP or Prescription as per Act 101. HCP or
licensed prescriber and complies with licensed prescriber, off-label prescribing,
registered package insert. evidence-based

Pharmacist assesses prescription – Pharmacist assesses prescription –
ensures optimal use of medicine/s. ensures optimal use of medicine/s and
Refers back to prescriber if problems checks/notes off-label prescribing.
identified for discussion and care plan. Refers back to prescriber if problems
identified, highlights off-label
prescribing. Care plan.

Dispenser must Inform patient of generic substitution requirements, substitute with
contact prescriber a generic unless forbidden by patient or doctor.
for authorisation
to change

Funder seeks Agreement on care plan. Pharmacist may refuse to
change in item to Prescription or changed dispense prescription in
comply with prescription dispensed patient’s interests
formulary for cost
savings No authorisation on item change – original item
dispensed. Patient informed of cost implications.

HCP team not to alter the prescription by the research company in support of
can undermine the relationship the registration application. It contains
between patient and HCP and the information about the use, indications and
independence of such practitioners. safety profile of a medicine when used
n Practitioners contracting with funders correctly. No advertisement for a medi-
to implement formularies should cine may make claims that go beyond
satisfy themselves that the process the registered PI.
is transparent, that the formulary
is scientifically substantiated and, A need can arise where a doctor
most importantly, that no financial prescribes medicines outside of the PI
considerations or payments pass from parameters for “off-label” use. Although a
parties with vested interests, e.g., medicine lacks a specific paediatric indi-
medicine manufacturers, influencing cation, formulation or registered dosage,
the formulary listings. an assumption could be made on the
n The prescriber has to ensure proper adjustment of dose for the potential
patient care in revaluating a benefit to the child. Other examples
prescription. In the case of chronic include the use of a medicine for an indi-
conditions recent health information cation not in the PI or where a dose other
may be needed to confirm a than that approved in the PI is prescribed
prescription change. (see Figure 1).

Off-label use of medicines Such practices, while not mandated by
law, are not necessarily ethically wrong. In
The PI of a medicine is compiled from the prescribing “off-label”, the practitioner is
pharmaceutical, pharmacological and obliged to ensure the decision is evidence-
clinical research conducted and submitted based and justifiable and the details
recorded. A pharmacist presented with a

Generic/Therapeutic Substitution and Off-Label Prescribing 35

prescription that does not comply with the Index of abbreviations and key words
PI should evaluate the prescription and if
not satisfied, confirm the details with the HCPs Health care practitioners
prescriber in the context that the prescrip- ISMS Interchangeable multisource
tion is beyond the PI and record this on the
prescription and dispensing record. medicines
NDP National Drug Policy
The doctor is responsible for the PI Package insert
outcomes of prescribing a medicine for Moeity molecule
off-label use.


Biosimilars: Should We Embrace
the New Biotechnology Medicines?

Prof Jacques Snyman lead to neutralising antibodies which
MD render the medicine inactive, or – even
 CEO: ISIMO Health, Durbanville, more devastating – to anaphylactic shock
Cape Town or target organ damage due to an
immune mechanism triggered by the now
“Biologicals” is a term coined to describe foreign protein or peptides. In order for
medicines made by replicating endoge- patients to gain broader access to these
nous peptides or proteins or targeting these biologicals they had to wait for patent
by manufacturing antibodies against the expiry and for other manufacturers to start
receptor sites. There currently exist a myriad producing the same or similar medical
examples of these so-called biologicals as entities at a cheaper price. The develop-
they constitute the current trend away ment of these products was rapid, as
from simpler, small chemical entities for the copying the manufacturing processes
treatment of many so-called orphan and was not that difficult. However, a stum-
often previously untreatable conditions, bling block was safety and efficacy, both
such enzyme storage diseases and cancer. of which are key to the licencing and
However, exciting as this may sound, only a regulation of products for use. For
privileged few are able to afford these example, the European and US regulatory
rather expensive new entities for the treat- bodies only recently (namely March and
ment of their diseases. November 2015 respectively) finalised
their respective regulations for insulin
An example of an older biological copies of the original.
medicine is insulin. Insulin has revolution-
ised the treatment of diabetes mellitus, The main question relating to this
becoming an affordable and sustainable process of copying original biologicals is:
therapy option for any diabetic patient “Are they the same as the originator?” The
requiring a significant reduction of blood answer to this is not easy as these mole-
glucose levels and for the prevention of cules vary significantly in size and structure –
typical diabetic complications associated e.g., insulin is a c 6 000 Dalton protein
with an uncontrolled disease. Insulin is consisting mainly of two side chains with
therefore an essential medicine, accord- rather simple interconnecting disulphide
ing to the WHO list. However, not all insulins bonds, whereas a monoclonal antibody
are on this list, e.g., insulin analogues. This (e.g., trastuzumab [Herceptin®] used for
immediately prompts the question as to the treatment of Her2 breast cancer
why other more expensive drugs, some patients) is a 160 000 Dalton molecule with
even considered to be life-saving, are not complex folding and very specific
listed. The answer is simple: price and receptor target sites. This is in stark contrast
affordability. The cost to develop these to the typical small chemical entity, e.g.,
newer agents far outweighs that of the aspirin which is 180 Dalton in size. With this
smaller molecules, most of which were complexity and size, replicating these
developed during the past 30 years. entities has very specific challenges, i.e.,
Development costs and risks are high as the more modern manufacturing since
many of the target medicines fail clinical the initial molecule was patented 20 years
scrutiny during early-phase clinical ago, as well as the challenge that the
research. The main reasons for failure are factory of these proteins essentially
adverse effects due to the mode of consists of other living cells. Recombinant
action or unintended side effects because DNA technology has allowed the transfer
of the peptide type or the undesired anti- of specific DNA segments from the human
genicity of the new entity. The latter may host to a bacterial or yeast cell, with the


Biosimilars: Should We Embrace the new Biotechnology Medicines? 37

Figure 1. Most biological medicines are proteins coded in human genome


Each gene can Most biological
be translated into medicines are
a specific protein proteins

A code Proteins are large
organised into and complex and
genes >30 000 carry out the
in each of us body’s functions

aim of allowing the latter to manufacture and complexity, one has only to look at the
the protein coded by the transferred example of the erythropoietin originator
human DnA (see Figure 1). The fermenta- manufacturer who just changed the
tion process was then followed by rubber stopper on the multidose vial of the
purification of the desired protein in order same active moiety and instead of stimu-
to obtain the final active moiety. The latter lating red cell replication in the bone
is then used to make the pharmaceutical marrow it resulted, in some susceptible
product for human use (see Figure 2). This patients, in total red cell aplasia. This
clearly represent multiple processes, all happened because the rubber stopper
which can be different in different and the contents of the vial introduced a
processing plants (see Figure 1). hapten, resulting in an immune destruction
of the red cell precursors (see Figure 2).
Insulin, for instance, can be manufac-
tured in E. coli or yeast cells to start off So where does this leave the patient
with, meaning the cell making the same requiring access to these more expensive
insulin may be different. This complexity and at times life-saving or life-prolonging
leads to minor differences in the protein medicines? Producing so-called generics,
structures of the new “copied” entities i.e., biosimilars will bring the price down
and hence the terms “biosimilars” and but not to the same level as when the
“follow-on biologics” were coined as they patents of smaller molecules, that were
are not exact copies, as was the case with originally generically manufactured,
small chemical entities such as aspirin. The expired. Regulatory oversight is complex
reality, therefore, is that they may differ in and safety parameters can only be
pharmacokinetic, pharmacodynamic appreciated over time as not all safety
and safety properties from the originator. aspects are immediately evident, e.g., it
To claim similarity, these new biosimilars took 8.6 years before rituximab was caus-
need extensive testing that entails ally linked to fatal infusion reactions,
repeating the same clinical phases in the tumour lyses syndrome and mucocuta-
development of the original, and only neous reactions. A new biosimilar may be
when they pass the test of sameness, are relatively easy to manufacture with newer
they registered as biosimilars. Develop- techniques but the issue of safety remains
ment, therefore, requires significant risk owing to the complexity of the large
capital from investors, which translates protein. Folding and sequencing differ-
into rather large price tags as there is also ences may lead to the exposure of foreign
the uncertainty of market take-up and receptor sites to the treated patient’s
penetration due to predictably smaller immune system which may then lead to it
patient numbers. To illustrate this difficulty being recognised as foreign. This unknown


Figure 2. Schematic diagram of the production of a recombinant protein medicine
Cloning and Protein Expression

Protein Production, Purification and Validation

antigenicity of the biosimilar can be tested more robust economies such as the
in preclinical and clinical research, but when United States of America to cope with the
rare may only manifest years after being high price of biosimilars. Is the significant
used in uniquely susceptible individuals. This rise in individual bankruptcies of late a
places an additional pharmacovigilance direct result of patients trying to pay for
requirement on the manufacturer, which these medicines?
again increases costs.
There has even been some suggestion
The originator companies have now of relooking the patent process, i.e.,
started to “clone” their own products by prolongation to allow longer periods over
selling them at a cheaper price (e.g., 20% which to recover development costs.
less) and under new branding. This is to Other specific access programmes are
stave off the threat of biosimilars entering under consideration globally to ensure
the market at more or less the same price sustained development of these new enti-
reduction. The issue of access is, there- ties but with greater market guarantees to
fore, only partially addressed in that reduce cost in order to enhance access.
when treatment costs reach millions of In some developed markets, risk-sharing
rands to prolong the life of one patient, agreements are in place whereby the
the societal impact may be of such a funder of the product gets a payback if
nature that it remains inaccessible even the product fails for a particular patient.
at the reduced price. It may be neces- These schemes are well described and, as
sary to re-assess the regulatory framework they also allow data gathering and insight
for these entities within poorer countries into the response to the new biological
such as South Africa in order to address when used freely in the medical commu-
the specific issue of access to expensive nity, this may lead to future price
biological medicines. It is even difficult for reductions based on volumes and


Biosimilars: Should We Embrace the New Biotechnology Medicines? 39

response. This, however, does not immedi- Only when more players enter the market
ately address the needs of the poor who and regulatory authorities come to under-
will, despite the efforts of making biosimi- stand the challenges of access and safety
lars or coming up with ingenious access and the trade-offs inherent in these, will the
programmes, still not be able to afford price of biosimilars come down signifi-
these new technologies. cantly. A country that currently has greater
access to biosimilars in Africa is Kenya and
In conclusion, biosimilars will reduce the should perhaps be looked at for a model to
price of biological medicines. However, implement locally.
access will remain restricted in the near
future due to the cost of development and References available on request.
future pharmacovigilance programmes.


Understanding Informed Consent
in Health Care in South Africa

Wendy Massaingaie (2) The health-care provider concerned
LLB must, where possible, inform the user as
 Legal Advisor: Governance and Legal contemplated in subsection (1) in a
Department, South African Medical language that the user understands
Association NPC and in a manner which takes into
account the user’s level of literacy.”
Informed consent means that a patient
confirms his/her willingness to undergo Health Professions Act Section
medical treatment. In order to ensure that 53(1) of the Health Professions
the patient has willingly agreed, the Act states:
medical practitioner is required to provide “[E]very person registered under this Act
the patient with sufficient information to shall, unless circumstances render it
allow him/her to make an informed deci- impossible for him or her to do so, before
sion regarding health care. The patient- rendering any professional services inform
doctor relationship is based on trust; with- the person whom the services are to be
holding information from the patient rendered or any person responsible for
would tarnish that trust. the maintenance of such person, of the
fee which he or she intends to charge for
Legislation such services.”

There are various laws in place to ensure Ethical rules of conduct for
that medical practitioners are well practitioners registered under
informed of their duty to obtain informed the Health Professions Act Rule
consent from a patient. 27(A)(d) of the Ethical Rules of
Conduct for Practitioners
National Health Act Section 6 Registered under the Health
of the National Health Act sets Professions Act, states:
out the requirements for “A practitioner shall at all times provide
informed consent as follows: adequate information about the patient’s
“(1) E very health-care provider must diagnosis, treatment options and alterna-
tives, costs associated with each such
inform a user of - alternative and any other pertinent infor-
(a) the user’s health status except in mation to enable the patient to exercise a
choice in terms of treatment and informed
circumstances where there is decision-making pertaining to his or her
substantial evidence that the health and that of others.”
disclosure of the user’s health
status would be contrary to the Methods of obtaining
best interests of the user; informed consent
(b) the range of diagnostic proce-
dures and treatment options There are a few ways in which a patient
generally available to the user; may give informed consent. At the onset,
( c) the benefits, risks, costs and con- to determine whether informed consent
sequences generally associated has been obtained, the medical practi-
with each option; and tioner should ensure that the patient
(d) the user’s right to refuse health understands the nature of his/her ailment,
services and explain the implica- the treatment to be performed, any side
tions, risks, obligations of such


Understanding Informed Consent in Health Care in South Africa 41

effects, as well as any other implications. (b) the user is unable to give in-
The patient may provide express verbal formed consent and no person is
informed consent, without having same mandated or authorised to give
reduced to writing. Obtaining written such consent, and the consent is
informed consent may be crucial in cases given by the spouse or partner of
where the treatment to be provided is the user or, in the absence of
complicated or the risks of the procedure such spouse or partner, a parent,
are great. Another form of informed grandparent, an adult child or a
consent is implied consent. This usually brother or a sister of the user, in
occurs where consent was obtained by a the specific order as listed;
third party and there is no written informed
consent. Medical practitioners should be (c) the provision of a health service
wary of this situation as the patient may without informed consent is
not fully comprehend the nature of the authorised in terms of any law or
treatment to be performed. In this case, a court order;
the practitioner should endeavour to
obtain express consent from the patient. (d) failure to treat the user, or group
What is imperative is that the patient of people which includes the
understands what he/she is consenting to. user, will result in a serious risk to
public health; or
It is important to note that there is no
requirement for the informed consent (e) any delay in the provision of the
to be in writing, however, ensuring that health service to the user might
the informed consent is reduced to result in his or her death or irre-
writing is a good way of safe-guarding versible damage to his or her
medical practitioners against any health and the user has not ex-
unforeseen blame. pressly, impliedly or by conduct
refused that service.
When the patient cannot
provide consent (2) A health-care provider must take all
reasonable steps to obtain the user’s
In instances where the patient is not able informed consent.
to give informed consent, the medical
practitioner should obtain the informed (3) F o r t h e p u r p o s e s o f t h i s s e c t i o n
consent of a legally authorised represent- “informed consent” means consent for
ative. Alternatively, the practitioner should the provision of a specified health
have the patient provide verbal consent service given by a person with legal
in the presence of a witness who would capacity to do so and who has been
then sign the informed consent form. informed as contemplated in section 6.”

In support of this, section 7 of the National In addition to the above, section 8(2) of
Health Act provides as follows: the National Health Act reads:
“(1) S ubject to section 8, a health service “(2) (a) If the informed consent required

may not be provided to a user without by section 7 is given by a person
the user’s informed consent, unless - other than the user, such person
(a) the user is unable to give inform- must, if possible, consult the user
before giving the required con-
ed consent and such consent is sent.
given by a person - (b) A user who is capable of under-
(i) mandated by the user in standing must be informed as
contemplated in section 6 even
writing to grant consent on if he or she lacks the legal ca-
his or her behalf; or pacity to give the informed
(ii) a u t h o r i s e d t o g i v e s u c h consent required by section 7.”
consent in terms of any law The National Health Act further
or court order; stipulates the steps to be taken
by the medical practitioner,


should treatment be conducted Conclusion
without the required informed
consent. Essentially, section 9 of In light of the above, it is clear that
the Act provides that should informed consent comprises more than
such a situation occur, the prac- completing a form, but that a dialogue
titioner should, within 48 hours, needs to take place between the patient
advise the Head of the Provincial and the medical practitioner. This allows
Department in which the health the patient to decide on whether or not
establishment is located. he/she wishes to receive the treatment. In
order for the informed consent to be valid,
Should a medical emergency occur, it must be given willingly by a competent
where informed consent cannot be person. As discussed above, should the
obtained from the patient, the medical patient be unable to provide the informed
practitioner still has a duty to provide the consent, same may be given by someone
emergency treatment which is necessary in their stead.
to save the patient’s life. Section 5 of the
National Health Act stipulates that “[a] Furthermore, medical practitioners must
health-care provider, health worker or be able to respond honestly to any ques-
health establishment may not refuse a tions that the patients may have regarding
person emergency medical treatment”. their care. It is evident from the above that
Following the emergency treatment, the informed consent is vital when providing
medical practitioner should explain to care to a patient, unless the abovemen-
the patient what treatment was provided tioned exceptions exist. It would be
and the reasons therefore. Should any correct to state that the medical practi-
other treatment be required, the medical tioner has an ethical duty to ensure the
practitioner should guarantee that he/ wellbeing of his or her patients – this
she obtains informed consent from the includes obtaining informed consent from
patient, prior to any other treatment the patient.
being provided.
References available on request.


Medical Negligence and Malpractice in South Africa 43

Medical Negligence and Malpractice
in South Africa

Sandra Sithole rendering medical treatment to him, the
LLB physician was negligent in the perfor-
 Director: Norton Rose Fulbright South mance of his professional duties, and
Africa Inc. claimed damages. The court made the
following rule with regard to medical
There has been a significant increase in negligence:
medical malpractice litigation involving
both the public and private sector over “There can be no doubt that a medical
the past few years. practitioner, like any professional man, is
called upon to bring to bear a reason-
Whilst the general principles of liability able amount of skill and care in any case
have not changed, health-service pro- in which he has to attend; and that
viders in South Africa – particularly where it is shown that he has not exer-
health-care practitioners and specia- cised such skill and care, he will be liable
lists – have seen an increase in the for damages”.
number and size of medical malpractice
claims. These are driven by an increasing Thirty years later in Kovalsky v Krige
awareness by claimants of their rights to (1910), the physician treated a baby of
claim, the growth of the sophisticated nine months for complications arising from
plaintiffs’ medical malpractice legal a circumcision performed at a religious
profession acting on a contingency ceremony. In assessing the physician’s
basis, and the re-invention of many negligence, the court held that:
plaintiffs’ attorneys who previously liti-
gated Road Accident Fund matters as “… [E]very person who enters into a
medical malpractice attorneys. learned profession undertakes to bring to
it the exercise of reasonable care and
The problematic discipline areas of clin- skill. A surgeon does not undertake that
ical management leading to medical he will perform a cure, nor does he under-
malpractice claims are obstetrics and take to use the highest possible degree of
gynaecology cases, paediatric cases, skill… he undertakes to bring a fair,
orthopaedic surgery, trauma-related reasonable and competent degree of
cases and, more recently, treatment with skill to his case”.
defective products.
Thus the general principle that a physi-
The aim of this article is to provide a cian’s negligence should be assessed with
synopsis of medical malpractice law in reference to the benchmark of a reason-
South Africa, setting out the health-care able expert was established.
practitioner’s exposure to liability, the
basic principles of liability as they apply Basic principles of liability
under common law, the current trends in
medical malpractice claims and recent Liability arises from the negligence or
legislation creating additional exposure intentional causing of harm. In our law
for medical practitioners. there is no strict (also known as “no
fault”) liability in medical malpractice
Medical negligence cases. A medical negligence claim
in South Africa against a health-care practitioner would
be based either in contract or in delict
The first South African case to deal with arising from the health-care practitioner-
professional medical negligence was patient relationship.
decided in 1877 in Lee v Schonnberg. The
patient, a double-amputee alleged that in Under our law, the health-care practi-
tioner has two main duties to the patient:


n An obligation not to breach the “A medical practitioner is not expected to
implied term of contract between bring to bear upon the case entrusted to
the patient and the health-care him the highest possible degree of profes-
practitioner to care for the patient sional skill, but he is bound to employ
without negligence; and reasonable skill and care, and in deciding
what is reasonable the court will have
n A duty of care under the law of regard to the general level of skill and dili-
negligence not to cause harm to the gence possessed and exercised at the time
patient. by members of the branch of the profession
to which the practitioner belongs…”.
Thus in Coppen v Impey, a 1961 misdiag-
nosis and X-ray burn case, it was said: A court determining whether proper skill
“While on the one hand a medical man and care has been used will look at:
does not undertake to perform a cure, or n The circumstances in which the
to treat his patient with the utmost skill and
competency, he will, on the other hand, negligence occurred.
be liable for negligence or unskilfulness in n What the reasonable practitioner
his treatment; for, holding himself out as a
professional man, he undertakes to in the same position as the treating
perform a service required of him with medical practitioner would have
reasonable skill and ability”. done in the circumstances.
n Whether the practitioner performed
NEGLiGENCE TESTS the operation or embarked on
treatment of a patient while knowingly
In an action against the health-care not having the necessary knowledge
practitioner, the test of liability will usually or experience to do so, and the
be based on whether there has been patient is prejudiced.
negligence on the part of the health-care n The existence of different schools
practitioner or his/her staff. of opinion regarding methods of
The test of negligence will be whether a n Existing knowledge, methods of
reasonable health-care practitioner or treatment and custom.
employee under the circumstances in n Health-care practitioners must not be
question would have: held liable just because something
n foreseen the reasonable possibility of goes wrong – if the error is one which
a reasonable, competent practitioner
their conduct, which may be by way might have made, it will not amount
of act or omission, injuring the patient to negligence.
and causing loss, and
n taken reasonable steps to guard The elements set out above do not form
against the occurrence. The health- part of an exclusive test for negligence.
care practitioner or employee will What will be negligent will also depend on
be liable if they fail to take such the particular circumstances of a par-
reasonable measures to avoid harm ticular case and particularly the error
to the patient. made. The test of a reasonable practitioner
should not be reduced to a test of the
our courts have held that the health-care average practitioner and the patient must
practitioner must exercise the general prove the health-care practitioner was
level of skill and diligence possessed and negligent. If there are conflicting opinions
exercised at the time by members of the from experts, a claimant may not succeed.
branch of the profession to which that
person belongs. EXPOSURE TO LiABiLiTy

In the famous 1924 “swab case” of Van Liability arises in circumstances where the
Wyk v Lewis, our highest court held: health-care practitioner’s negligence


Medical negligence and Malpractice in South Africa 45

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corticosteroid for the treatment of
asthma in both the large
and small airways.1,2,3,4

Ciclovent is priced at a significant

cost saving compared to the

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Respiratory Medicine (2006) 100, 375–384 4. Chapman KR et al (2005): Maintenance of asthma control by once-daily inhaled ciclesonide in
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causes injuries resulting in damages being is an increasing need for the use of over-
suffered by a patient. seas statistical data on issues such as life
expectancy and a decreasing reliance
There is also liability where there is failure to: on conditions either specific to an indi-
n exercise care in maintaining safe vidual or to local conditions (see the Singh
v Ebrahim case). Furthermore, medical
premises technology has advanced enormously
n appoint competent or trained staff with a commensurate increase in costs,
and the quantum of claims has increased
or where the health-care practitioner substantially.
allows incompetent health-care
practitioners or staff to use the facilities The effect of all this, of course, is that
(where the health-care practitioner insurance claims reserves are increasing,
is aware or ought to be aware of with a major effect on premiums paid by
incompetency) health-care practitioners and health-care
n take reasonable steps to supply facilities.
sufficient and safe implanted devices,
prostheses and medication Recent legislation
n take reasonable steps to implement Consumer Protection Act, 2008
safety measures to protect patients,
for example from infection, injury or Should a health-care practitioner’s
assault by fellow patients contracts make use of or include
n take reasonable steps to supply disclaimers or indemnity clauses, these
sufficient and safe equipment, clauses would need to be revised under
including the maintenance of that the plain language and disclaimer clauses
equipment and indemnity provisions of the Consumer
n take reasonable steps to ensure that Protection Act (CPA). This is because the
prompt and suitable treatment of a Act requires that contracts be written in
patient is given. plain and understandable language.

Another scenario where liability may arise is Likewise, where disclaimer or indemnity
where a patient is discharged simply for notices are used at a health-care practi-
financial reasons at a time when it is medi- tioner’s premises, the contents would
cally unsafe for the patient to be discharged. need to be considered and the manner of
display and appropriate protocols drawn
Current trends up to ensure that proper notice to the
patient is achieved.
Our courts are adopting a far more equi-
table and sympathetic approach towards There is also liability exposure under the
medical malpractice cases. product liability provisions of the CPA
should medical instruments or equipment
There is a shift in favour of the patient be defective during medical treatment of
from a strictly legal approach to one of a patient, resulting in negligent injury or
equity and fairness and very often death. In those instances, the manufac-
sympathy. Judges seem to give them- turer or supplier of the medical device or
selves more discretion than they did equipment may also incur legal liability on
historically, with an increase in subjectivity the basis of product liability.
when making judicial decisions. This is
exacerbated by attorneys and expert Protection of Personal
witnesses who are aggressively quanti- Information Act, 2009
fying and litigating claims. The Protection of Personal Information
(POPI) Act is expected to become opera-
Whilst we have an adequate pool of tional soon to give effect to the rights to
properly qualified experts in the various privacy by safeguarding personal infor-
fields, there is still inadequate research in mation of individuals (called data
relation to the applicability of international subjects) processed by public and private
trends in South Africa. For example, there


Medical Negligence and Malpractice in South Africa 47

bodies (called responsible parties). The purpose of avoiding adverse outcomes.
provisions and impact of POPI on health- Alternatively, health-care practitioners are
care professionals and practices are moving away from compassion-centred
discussed in greater detail elsewhere in care towards the practice of defensive
this publication. medicine which drives up the cost of
health care and exposes patients to
Conclusion unnecessary risk.

The effect of the increased medical negli- Increased malpractice litigation results
gence liability on the health-care system in higher premiums for the health-care
and insurance premiums is exponential. practitioner and health-care facility;
consequently patient fees escalate so
An increase in medical malpractice that health-care practitioners are able to
claims has both direct and indirect effects afford their insurance premiums.
on the cost of health care.
In recognition of the seriousness and
There is a greater risk and greater finan- unsustainable nature of the current trend
cial exposure for health-care practitioners in medical malpractice claims, the
who either react by performing additional Minister of Health has requested an inves-
and often unnecessary diagnostic and tigation by the South African Law Reform
screening tests, which leads to the Commission, with a view to preparing
rendering of medical services to patients possible legislation to govern malpractice
of limited or questionable value for the claims and litigation in future.


Suspected Patient Malingering
and Fraudulent Practitioner Claims

Prof Morgan Chetty symptoms generation and is similar in
MBChB, FCFP (SA), M Fam Med, terms of external incentive.
MPH (USA), DTM&H, DHSM n Malingering is similar to factitious
 Specialist Family Physician, disorders in its symptom production,
Chairman: IPA Foundation of SA but differs in that factitious disorder
is not associated with a palpable
Medicine is not a trade to be learned, but external reward.
a profession to be entered. A profession is n Malingering is a diagnosis of exclusion.
characterised by a specialised body of The patient must be thoroughly
knowledge that its members must teach evaluated by taking a detailed history,
and expand, by a code of ethics and a mental status examinations, relevant
duty of service that put patient care laboratory investigations and, if
above self-interest and by the privilege of necessary, psychometric evaluations.
self-regulation granted by society. n Malingering may co-exist with genuine
Physicians must individually and collec- psychosocial problems.
tively fulfil the duties of the profession. n When a patient is found to be a
While outside influences on medicine and malingerer, clinicians should keep
the patient-physician relationship are proper notes in medical records.
many, the ethical foundation of the
profession must remain in sharp focus. Clinical features

Malingering in clinical setup Clinicians should be strongly suspicious of
malingering whenever there is a marked
Malingering is the deliberate production or discrepancy or symptom inconsistency
exaggeration of false, physical or physiolog- between subjective complaints and
ical symptoms for a known external reward. objective findings. For example, a
It is not considered a form of mental illness or depressed patient who complains of poor
psychopathy, although it can occur in the appetite and sleep may be discreetly
context of other mental illness. observed to always finish his meal, sleep
soundly and interact appropriately with
Even though it is easy to define, malin- others. Clinicians must also look for bizarre
gering presents special challenges to the presentation in the presence of external
clinician, including diagnostic uncertainty, incentives like seeking prescription drugs.
the confrontation of potentially criminal
conduct and countertransference and Malingering may present as a mental fog
personal reactions. It is important to main- during the commitment of a crime, and a
tain a traditional, clinical approach to the vigilant clinician may notice inconsistency
patient suspected of malingering. This will between the patient’s verbal complaint and
enable the professional to draw analogies physical observations. Just as in hysteria,
to other disorders and utilise customary malingering may reflect that patient’s
diagnostic and therapeutic skills. perception of psychopathology. Malingerers
also volunteer more visual hallucinations
Important focus points than genuinely psychiatric patients.
with malingering
Making a diagnoses
n Malingering is the intentional
production of false or exaggerated No studies have given context results.
physical or psychological symptoms Clinicians should mostly use open-ended
questions. Inquiries should be phrased
n Malingering differs from somatisation without giving clues and the more
disorder in its intentionality of


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