It is trite that Healthcare in South Africa is highly regulated by a number of statutes. These statutes are primarily designed to be consumer orientated. The Medical Schemes Act No. 131 of 1998, as amended ("the MSA") and the Medicines and Related Substances Act No. 101 of 1965, as amended ("the Medicines Act") are good examples. In both of these statutes, the issue of consumer rights stands at the forefront of what these statutes are designed to achieve. This is evident from their objectives. The MSA provides in sections 7(a) and (d) that the functions of the Council for Medical Schemes shall be to "protect the interest of the beneficiaries at all times ... investigate complaints and settle disputes in relation to the affairs of medical schemes as provided for in this Act". The Medicines Act states that "[i]n determining whether or not the registration or the availability of a medicine is in the public interest, regard shall be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on the health of man or any animal, as the case may be."
Objectives of the CPA
The consumeristic nature of both the MSA and the Medicines Act is now to be tested against the provisions of the CPA. This is because the CPA is designed exclusively to promote the rights of South African consumers. The CPA's objectives deal with various types and classes of consumers. Therefore, the CPA is arguably designed to protect the rights of the consumer in all instances where there is a transaction as this term is defined in the CPA.
The objectives of the CPA are set out in section 3(1):
"The purposes of this Act are to promote and advance the social and economic welfare of consumers in South Africa by –
(a) establishing a legal framework for the achievement and maintenance of a consumer market that is fair, accessible, efficient, sustainable and responsible for the benefits of consumers generally;
(b) reducing and ameliorating any disadvantages experienced in accessing any supply of goods or services by consumers –
- who are low-income persons or persons comprising low-income communities;
- who live in remote, isolated or low-density population areas or communities;
- who are minors, seniors or other similarly vulnerable consumers; or
- whose ability to read and comprehend any advertisement, agreement, mark, instruction, label, warning, notice or other visual representations limit by reason of low literacy, vision impairment or limited fluency in a language in which the representation is produced, published or presented;
(c) promoting fair business practices;
(d) protecting consumers from –
- unconscionable, unfair, unreasonable, unjust or otherwise improper trade practices; and
- deceptive, misleading, unfair or fraudulent conduct;
(e) improving consumer awareness and information and encouraging responsible and informed consumer choice and behaviour;
(f) promoting consumer confidence, empowerment, and the development of a culture of consumer responsibility, through individual and group education, vigilance, advocacy and activism;
(g) providing for a consistent, accessible and efficient system of consensual resolution of disputes arising from consumer transactions; and
(h) providing for an accessible, consistent, harmonise, effective and efficient system of redress for consumers."
The provision of a healthcare service to a patient in exchange for remuneration and an expected positive outcome would fall within this scope and ambit of the definition of the term "transaction" in the CPA. Therefore, on the face of it, the CPA applies to healthcarerelated transactions. Accordingly, this brings into sharp focus the manner in which one would apply the CPA in instances where a healthcare related transaction occurs.
Healthcare related transactions
For purposes of this paper, a healthcare related transaction includes the provision of a hospital service, an emergency service, and an ambulance service or a consultation or a related healthcare service that has as its desired outcome the improvement of the health of the patient. In each of these instances, the transactions are primarily controlled by healthcare legislation on the basis that:
- the healthcare service is to be provided by a duly qualified healthcare provider and in accordance with the obligations imposed upon the healthcare provider, both ethically and legally, to provide the service correctly and without harming the patient. Provisions of such legislation as the Allied Health Professions Act No. 63 of 1982, as amended and the Health Professions Act No. 56 of 1974 as amended or the HPA, all find relevance to the transaction that occurs;
- the sale of medicines equally is controlled by the Pharmacy Act No. 53 of 1974, as amended and the Medicines Act, which require that medicines be sold in a particular manner by a person duly authorised in law to dispense such medicines;
- the provision of private medical scheme cover is also dealt with exclusively in the MSA and the transaction that occurs is required to comply with the provisions of this Act, which would include the rules of a particular medical scheme;
- other pieces of healthcare-related legislation deal with the manner in which hospital services are provided and how healthcare services in general are to be provided including such issues as informed consent, the consent of minors and the consent of vulnerable persons – all dealt with in the National Health Act No. 61 of 2003 ("the NHA").
In so far as healthcare services have been provided to date in terms of the existing statutory matrix of applicable healthcare legislation, the question is whether or not the provision of those services is, in accordance with that healthcare matrix, sufficient to promote and protect consumer rights. This question arises primarily due to the directive contained in section 2(9) of the CPA about how one is to interpret the CPA when it is interacting with an existing piece of legislation. The general principle is that the CPA will apply in circumstances where it does a better job, through its application, of advancing and protecting consumer rights than the piece of legislation with which it is being compared. This is not a self-evident comparison as one needs carefully to understand not only the provisions of the CPA in so far as they protect consumer rights, but whether or not arguably they do so in a better way than older pieces of legislation including existing provisions of healthcare legislation.
Consumer rights, statutory tribunal and alternative dispute resolution
On the face of it, the CPA contains a number of consumer rights that are not expressly found in other pieces of healthcare legislation. I say "expressly" as the healthcare legislation to which I have referred is not necessarily as dedicated and as focused on consumer rights as the CPA. Therefore, the more pronounced and clearer rights contained in the CPA may very well trump the manner in which existing healthcare legislation endeavours to promote, advance and provide for consumer rights. The comparison that must occur would conceivably have to determine the substantive nature of the consumer right that is being advanced and protected. Therefore, one would be required to draw comparisons between, for example, the National Patients' Rights Charter, which appears as part of the publications published by the Health Professions Council of South Africa (HPCSA), and the consumer rights contained in the CPA.
Therefore, a consumer's right to information about a product, service or information that is provided in a clear, plain and understandable way would need to be compared to rights contained in the NHA concerning the manner in which informed consent must be provided to a patient prior to that patient receiving treatment. In so far as the informed consent provisions of the NHA fall short of the consumer rights contained in the CPA, then conceivably, the CPA would apply. In such circumstances the CPA would impose consumer rights into the healthcare transaction and require a new evaluation of that transaction on that basis - healthcare legislation aside.
The provisions contained in healthcare legislation that create statutory tribunals for the resolution of disputes between consumers and healthcare providers, most notably, those contained in section 47 of the MSA and the dispute resolution mechanisms contained in the HPA, which allow consumers to refer disputes about healthcare practitioners to the HPCSA, would also need to be evaluated on the basis of whether or not those tribunals are effective for purposes of enforcing consumer rights. The CPA, as part of its dispute resolution mechanism processes, recognises the ability of accredited institutions to resolve consumer complaints with reference to the provisions contained in the CPA. However, in order to resolve such disputes, with reference to the provisions of the CPA, the dispute resolution tribunal in question must be accredited by the Minister of Trade and Industry in terms of the CPA. I am not aware of any such accreditations having occurred to date for any of the tribunals that are currently functioning within the healthcare arena.
The provision of alternative dispute resolution mechanisms is an important part of the CPA. The CPA is designed to be accessible to the ordinary man and woman in the street. Therefore, its provisions allow for complaints to be lodged, without the intervention necessarily of the legal fraternity, directly by the consumer with such bodies as the National Consumer Commission or an accredited Ombudsperson who is authorised to deal with such disputes. Therefore, existing dispute resolution mechanisms also need to be evaluated in relation to their effectiveness to resolve consumer disputes between patients and healthcare providers with reference to the provisions contained in the CPA.
The power and influence of the CPA should thus not be underestimated. In accordance with the provisions of South African law, conflicts between pieces of legislation are resolved in accordance with the principles of the interpretation of statutes. One of these principles states that more recent legislation trumps the provisions of older legislation where there may be a conflict. The fact that the CPA was enacted in 2010 and its citation refers to the fact that it was proposed in 2008, indicates that it will trump the majority of existing healthcare legislation – in so far as I am not aware of any healthcare legislation that was enacted after the CPA came into effect, even in circumstances where the CPA was brought into force gradually and then finally on 1 April 2010.
Interaction in the UK
These are uncertain times in relation to the interaction between the CPA and its creation of consumer rights and interaction with existing healthcare legislation. The interaction between healthcare legislation and consumer protection legislation has already received attention in the United Kingdom which possesses similar legislation to that of the CPA. This interaction is examined in a publication by Margaret Brazier entitled Medicine, Patients and the Law (third edition) at page 198.
The examination occurs most usefully in relation to the imposition of product liability principles in respect of the sale of medicines and medical devices. Currently, in South African law, medicines are controlled in our marketplace – in respect of their distribution, manufacture, sale and dispensing – in terms of the Medicines Act and the Pharmacy Act. Medical devices have, to date, received less attention but regulations are pending for purposes of controlling medical devices.
In relation to the imposition of consumer protection principles in ordinary product liability law, with reference to a special commodity such as medicines and medical devices, Brazier argues that there is a complex interaction between the sale of medicines that cause injury to the person taking them and consumer protection legislation.
The interaction is complex to a point of deciding whether or not medicines fall within the scope and ambit of the English consumer protection legislation but nevertheless there is uncertainty on whether or not medicines would fall outside of such legislation. The prevailing view being that the legislation, in the form of the English Consumer Protection Act, applies to such goods. In this regard, Brazier cites the decision of Abouzaid v Mothercare Ltd in which a 12 year old boy had his eye damaged as a result of a strap slipping from his grasp and hitting him in the left eye after endeavouring to clip a sleeping bag to a push chair by passing elasticised straps around the back of the chair with a metal buckle. Brazier states "[t]he Court of Appeal found that the product was defective. There was a failure to provide instructions and the design of the product was unsafe because it could not be secured without risk. Consumers would properly expect that such a product could be used without that degree of risk. Relatively minor alterations in the design would eliminate that risk. The Mothercare judgment can be applied to make two key points about liability for drugs. (1) Instructions about the use of, and warnings concerning possible adverse effects of, drugs are crucial. Failure to warn of a known risk will, as argued earlier, render a drug defective. (2) Common sense will play its part in determining what 'people generally' may expect from a product." (at pages 209 to 210).
This point was then enforced in a further judgment in Richardson v LRC Products Ltd in which the plaintiff sued due to a defect in a condom, which caused her to become pregnant. Usefully, Brazier states the problem in the following assessment of the interaction primarily between the sale of medicines and consumer protection legislation: "Returning to drug-induced harm, consider the following examples in the light of the... cases. You purchase Ibuprofen in a supermarket. The packet clearly warns you not to take the medicine if you suffer from asthma. You ignore that warning and, despite your asthma, take several tablets. An acute attack of asthma lands you in hospital. Is that pack of Ibuprofen defective? You are prescribed a cream to cure acne. No warning accompanies the product. The cream causes the eruption of a rash all over your body. Evidence emerges that the product will produce just such an allergic reaction in about 2% of female users if they use the cream during pregnancy. Neither you nor your GP was aware you were pregnant at the time. Is the product defective?" (at page 210).
hat remains evident is there is a complex interaction between product liability and medicines and medical devices in South African law. The CPA also contains strict liability provisions for products that are unsafe or cause harm to consumers. Therefore, manufacturers, distributors, dispensers and anyone within the healthcare profession who recommends the use of a product, which ultimately causes the patient harm, may very well find themselves on the end of a product liability claim. A complex legal debate will then occur not only on the basis of who knew about what, but whether or not there was in fact a causal link between the harm suffered by the patient and the use and sale of the medicine in question. The twist in the introduction of the CPA is that the causal connection is something that must be approved by the defendant as opposed to the plaintiff along with other aspects concerning negligence. This is the effect of strict liability, which shifts the burden of proving that there was no negligence to the defendant as opposed to, as is traditionally the case, the plaintiff who is required to prove his or her case in court.
The effect of a comparison between legislation such as the MSA or the NHA and the CPA does reveal an interesting correlation between the rights contained in the CPA and those already contained in existing legislation. Such a comparison, albeit on very broad principles, is provided.
The difficulty remains, however, whether or not a patient will pursue his or her rights under existing healthcare legislation and nevertheless enjoy additional rights to pursue claims, on a far easier litigation basis, due to the effects of strict liability in the CPA: in terms of his or her rights under the CPA. This is enhanced by directions in the CPA that require a judge or a court, when dealing with the application of the CPA for purposes of deciding a consumer complaint, to interpret the legislation before him or her or the contractual terms of the transaction, as the case may be, in such a way as to favour the consumer.
The actual interaction between the CPA and existing healthcare legislation may be resolved in so far as statutory bodies, which are primarily responsible for the control and application of their various statutes, such as the Council for Medical Schemes or the HPCSA, obtain an exemption from the CPA for them to conduct their affairs in accordance with provisions contained in their existing legislation and of which they are the wardens. Applications for such exemptions will have to be made directly to the Minister of Trade and Industry and a careful analysis undertaken in order to show that consumers are equally protected under the existing healthcare legislation as they are under the CPA. Whether or not such exemptions will in fact be provided, remains a matter of speculation. Currently, however, consumers are king in so far as they enjoy rights under the CPA and, conceivably, under existing healthcare legislation.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.