108
VOLUME 8 NUMBER 3 • SEPTEMBER 2011
ETHICS FOCUS
SA JOURNAL OF DIABETES & VASCULAR DISEASE
N
o law has changed consumer rights as much as the new
Consumer Protection Act. It has also created new liabilities
for all in the supply chain of medicine and medical devices,
including doctors, nurses and pharmacists.
The way in which one communicates to consumers (patients)
has become critical. The Act necessitates a complete review of all
forms, brochures, notices, etc used in a healthcare facility or practice.
There are also very specific duties relating to misunderstandings,
and this law has changed the way in which informed consent must
be obtained.
What aspects of clinical practice are covered by the
new Act?
All equipment and goods (medicine) that are used in diabetes care
are covered by the Act. The services provided (consultations, advice,
the whole experience when at the doctor, etc) are also covered by
the Act. The Medicines Control Council has asked for exemption for
registered medicines from the Act but the outcome of this process
is not known yet. Also, because medical devices are not registered,
the services and medical devices used when providing healthcare
fall under the act.
The diabetes care team needs to inform patients on the general
performance of the equipment that is being used, e.g. meters,
blood pressure monitors. A note to this effect should be on the
patient’s file: ‘I explained to the patient how to use the glucose
meter and its reliability in common use’.
Everyone in the supply chain is responsible for the delivery of
unsafe goods, a product failure, defect or hazard in any goods,
or inadequate instruction or warnings. One must always issue
instructions and warnings to patients on how to safely and
effectively use health goods. One must draw the patient’s attention
to the brochure or leaflet that comes with a particular product, and
encourage him/her to come back to you if he/she is uncertain about
its purpose or use. Make a note that you have particularly educated
the patient in this regard. If you do this, the buck is returned to the
supplier and does not lie in your hands.
How does this Act strengthen or alter Ethical Rule 23 of the
Health Professions Council of South Africa?
Ethical Rule 23 states that patients must know the treatment
options available to them and understand why these treatments
are indicated. Patients should be offered the best possible care that
is cost-effective, provided that they exercise the choice of treatment
and know what other options they have given up on.
In the diabetes environment where there are expert guidelines
available (such as SEMDSA), neglect to follow these guidelines
could result in a medico-legal challenge and/or challenge under
the Consumer Protection Act. An example is neglect to enforce
An ethical and legal appraisal of the new South African
Consumer Protection Act in terms of diabetes care
S Afr J Diabetes Vasc Dis
2010:
8
: 108
An interview with Ms Elsabé Klinck, consultant in the medico-legal
arena in South Africa
recommendations such as annual evaluation of eyesight,
examination of feet for pathology related to the diabetic condition
and failure to up-titrate medication when HbA
1c
levels are not
under control.
Patients often have an unrealistic expectation of medical
care. How do we deal with this in a way that complies with
the Consumer Protection Act, yet keeps patients committed
to the treatment we are prescribing?
There is a specific requirement to inform patients as to the purpose
and limitations of the treatment. There is also a specific requirement
now to correct misapprehensions, such as if the patient believes in
a particular homeopathic medicine. Prior to this Act, one could just
‘nod at this usage’. Now there is a clear responsibility to correct
a misapprehension by saying and noting that you have warned
the patient that the therapy being followed is not supported by
thorough scientific research.
What about the Consumer Protection Act and formularies?
It is clear that formularies are possible, as cost effectiveness is a valid
reason in terms of medical schemes’ legislation for limiting choice.
However, formularies must be based on evidence. Also, switching
between brands without alerting the consumer/patient to this is not
‘a fair option’. Both the Medicines Act and the Consumer Protection
Act require of a patient to consent to a product substitution. The
medical aid will need to offer the patient a choice to remain on
his/her existing brand, but may require a co-payment if the patient
would have been fine on the formulary treatment.
In the event of failure of the formulary medicine, the non-
formulary medicine required by the patient must then be available
at no extra cost to the patient. The same goes if the patient
experiences an adverse event on a formulary treatment.
How does the process of adjudicating an infringement of the
Consumer Act work?
The consumer has access to the National Consumer Commission
and to a tribunal in the event of a dispute. The Act is being widely
advertised under the byline ‘I know my rights. Do you know yours?’
The Commission can be contacted at share call: 086 026 6786, fax:
086 151 5259, e-mail:
.
J Aalbers, Special Assignments Editor
References
Consumer Protection Act, 2008.
1.
Medical Schemes Act, 1998 and the General Regulations thereto.
2.
Medicines and Related Substances Act, 1965.
3.
