Informed consent is one of the key components of ethical patient care and it is vital that medical practitioners understand the requirements of the law in this regard.
Medical services simply cannot be rendered without obtaining proper informed consent from the patient, or where the patient is unable to provide that consent, from a person who is properly authorised in terms of the legislation or legal authority (such as a power of attorney).
The patient has the ultimate right to choose whether or not to receive health services, what health services are rendered and whether to terminate receiving those health services. In order to exercise this right, the patient must be provided with the relevant and complete information and this is the obligation of the healthcare provider.
Informed consent: treatment
Medical services cannot be rendered to a patient in the absence of informed consent. This is regulated in terms of the National Health Act (NHA), and particularly at sections 6 to 9 of that Act. It is important to note that there is no requirement for this informed consent to be provided in writing, however, it is advisable to have such consent confirmed in writing.
Click on this link to view these portions of the Act in their entirety (National Health Act).
Important aspects of informed consent
Patients have a right to information about their condition and the treatment options available to them. The amount of information that must be given to each patient will vary according to factors such as the nature of the condition, the complexity of the treatment, the risks associated with the treatment or procedure, and the patient’s own wishes.
Patients have a right to information about any condition or disease from which they are suffering. This information should be presented in a language that the patient understands.
When providing information, health care practitioners must do their best to find out about patients’ individual needs and priorities. These would include factors such as the patient’s beliefs, culture, and occupation.
There should be a clear agreement about whether the patient consents to all or only parts of the proposed plan of investigation or treatment, and whether further consent will have to be sought at a later stage.
The South African courts have held that patients must be informed of all “material risks” in order to give a proper informed consent. A risk is ‘material’ if:
- A reasonable person in the position of the patient, if warned of the risk, would attach significance to it
- The healthcare practitioner should reasonably be aware that the patient, if warned of the risk, would attach significance to it.
The NHA provides that healthcare practitioners must provide patients with information about their health status unless ‘there is substantial evidence that the disclosure of the patient’s health status would be contrary to the best interests of the patients’. If healthcare practitioners withhold relevant information from the patient, it should be recorded in the patient’s file.
For proper informed consent the patient must have:
- Knowledge of the nature or extent of the harm or risk
- Appreciated and understood the nature of the harm or risk
- Consented to the harm or assumed the risk
- The consent must have been comprehensive.
In an emergency, where consent cannot be obtained, healthcare practitioners may provide medical treatment to anyone who needs it, provided the treatment is limited to what is immediately necessary to save life or avoid significant deterioration in the patient’s health.
Mentally incapacitated patients and children
The NHA makes provision for certain persons to consent on behalf of mentally incompetent patients to an operation or medical treatment where such patients are unable to give the necessary consent and have not mandated – while still mentally competent – somebody else in writing to give consent on their behalf.
The Act sets out a list of persons who may consent in such circumstances:
- A person authorised by the court, or
- In order of priority, the patient’s spouse, partner, parent, grandparent, major child or brother or sister.
The NHA also permits patients to mandate another person in writing to give consent on their behalf, although they must have given this mandate at a time when they were mentally competent to do so.
Healthcare practitioners must respect any refusal of treatment given when the patient was competent, provided the decision in the advance statement is clearly applicable to the present circumstances, and there is no reason to believe that the patient has changed his or her mind. Where an advance statement of this kind is not available, the patient’s known wishes should be considered.
In terms of the Children’s Act No 38 of 2005, a minor with sufficient maturity over the age of 12 years can be treated as an adult and is legally competent to decide on all forms of treatment and procedures. Where a legally competent child under the age of 18 years refuses life-saving treatment, application may be made to court for it to authorise treatment which is in the child’s best interests.
Where a child is not legally competent to give or withhold informed consent, the parent or guardian may authorise investigations or treatment which are in the child’s best interests. Such parent or guardian may also refuse any intervention, where they consider that refusal to be in the child’s best interests, but healthcare practitioners are not bound by such a refusal and may seek a ruling from the court.
The High Court of South Africa is the ‘upper guardian’ of all minors and therefore has the authority to grant consent on behalf of a minor child, even to the extent that the wishes of the parent/legal guardian, or even the child themselves can be overruled by the High Court.
Fees and costs
In terms of section 53 of the Health Professions Act, a practitioner is required to inform to patient of the fee which is intended to be charged for such services when so requested by the person receiving the services, or where such fee exceeds that usually charged for such services.
Section 6 of the NHA requires the practitioner to, amongst others, inform the patient of the costs of each treatment option available to them.
Therefore, in terms of the NHA, there is a legal obligation on the practitioner to inform the patient of the costs of the health services. If the practitioner does not do this, informed consent has not been obtained.
The Health Professions Act (HPA) and the NHA do not specifically state that a ‘rands and cents’ costs estimate/quotation be provided as part of obtaining informed consent, but it is difficult to imagine how the patient is properly informed of the costs without knowing what those costs are in Rand terms.
The HPCSA Guidelines on informed consent reiterate the obligation to discuss and agree to costs prior to the rendering of services.
The HPCSA issued an e-bulletin in September 2018 which deals with this issue in greater detail and expands upon the legal obligations:
Information about fees and costs for services and treatment should be provided in writing and the patient should acknowledge receipt in writing as acceptance of the fees disclosed. The information about fees should be in Rands and practitioners should refrain from using the terminology such as: private rates, medical aid rates, contacted in, or contracted out as this nomenclature is not recognised by Council. In addition to providing specific information on fees and charges, practitioners should document their fee charging and billing policies which includes the following:
- When payment will be required
- Discounts available for early payment (or charges for late payment)
- Acceptable forms of payment
- Contact for discussion of payment issues and problems.
Council acknowledges that there will be circumstances where it will not be possible to obtain consent related to costs before the treatment is provided (emergency cases or admissions). In these cases, information should be provided to the patient as soon as possible after treatment. Where it is not feasible to provide information directly to the patient either before or after treatment (eg because the patient is not conscious or otherwise incapable of receiving or understanding the information), it may be appropriate to provide the information to a close relative or representative acting in the patient’s interests.
In compliance with the recommendations of the HPCSA in their most recent communique, a costs estimate containing the charges should also be supplied to the patient.
Finally, it is not the responsibility of the practitioner to know what each medical scheme plan covers and to what extent. The obligation to inform the patient of the costs does not include establishing on the patient’s behalf how much the shortfall will be.
The patient still undertakes to pay any shortfall, but they must know up front what the doctor is going to charge and then they will be able to establish how much their own scheme covers and how much they will have to pay-out-of-pocket.
Informed consent: disclosure
In terms of section 14 of the NHA, written informed consent must be obtained from a patient, in order to disclose any information regarding their health status, stay in a health establishment etc.
Unlike the requirements for obtaining informed consent for treatment, the patient must provide the informed consent in writing for the disclosure of their medical information.
It is never safe to assume that a patient has given consent for disclosure of health information in instance such as medical scheme claims or insurance claims. It is therefore recommended that, when in doubt, written confirmation should be obtained from a patient in instances where their health information is to be disclosed to any third party.
There are circumstances where disclosure of the health information of a patient may be disclosed in the absence of written informed consent of that patient. Section 14(2) of the NHA provides for the following circumstances where consent is not required: Where disclosure is required by a law or court order and where non-disclosure represents a serious risk to public health.
The question whether or not to disclose the diagnosis of a patient on a medical certificate is, on the face of it, a fairly simple one to answer, but there are certain considerations that make the question a little more complicated.
Ethical Rule 16 provides a detailed list of requirements for a valid medical certificate. Rule 16(f) state the following:
16(f) a description of the illness, disorder or malady in layman’s terminology with the informed consent of the patient: Provided that if such patient is not prepared to give such consent, the practitioner shall merely specify that, in his or her opinion based on an examination of such patient, such patient is unfit to work.
All the above requirements must be met for the validity of the certificate. It must be remembered that the ethical rules are, in fact, legislation – they are published as regulations to the HPA. Non-compliance with the Ethical Rules is not only unethical conduct, it is unlawful conduct as well.
Effectively this rule means that if the patient does not provide informed consent, the practitioner may not record the diagnosis or nature of illness, disorder or malady on the medical certificate.
Rule 16 does not require the patient to sign or give written confirmation of informed consent to the practitioner to disclose the diagnosis. It does however require the practitioner to obtain such consent.
It is risky to infer that consent has been given when the patient takes the certificate and submits same to the employer – it may be argued, for example, that the patient was unaware that they had the right to insist that their diagnosis is not reflected on the certificate. In addition, consent must be express and implied consent is insufficient for legal and ethical compliance.
To make matters more complicated, according to section 14 of the NHA, all information relating to a ‘user’/patient’s health status, treatment or stay in a health establishment (which by the broad definition contained in that Act would include a private medical practice) is confidential and records/information can only be released or made known to third parties with the written informed consent of the ‘user’/ patient.
Both Ethical Rule 16 and section 14 of the NHA should be read and applied simultaneously – they do not contradict each other (even if they did, section 14 would prevail as the Ethical Rules, as regulations to the HPA are subordinate legislation).
Applying the above legislation to medical certificates in particular, the safest course of action would be that the informed consent of the patient to disclose their diagnosis on the medical certificate must be obtained and recorded in writing.
It is not advisable to have the patient sign the medical certificate itself, as the document leaves the possession of the doctor and there would be no proof on hand in the event that there is a subsequent dispute on whether written informed consent was given or not.
A preferable alternative would be to sign a consent form or add in a clause on the informed consent documents that deal with ICD-10 and National Credit Act matters. Provided there is a written record of the consent which is in the possession of the doctor that can be produced in the event of a dispute, the doctor should be covered.
Informed consent: ICD-10 coding
In terms of the Medical Schemes Act and Regulations, it is a requirement for practitioners to include a diagnostic code on all accounts submitted to medical schemes. If an account is submitted without such diagnostic codes, the medical scheme may, and probably will decline to pay.
The inclusion of the ICD-10 code on accounts submitted to medical scheme is a clear example of the disclosure of a patient’s health status to a third party (being the medical scheme). As such, it is necessary to obtain the written informed consent of the patient to make this disclosure.
As part of obtaining this consent, the patient must be informed that the diagnostic code is required for the medical scheme to pay; that the patient may refuse the inclusion of the ICD-10 code on the account, but that if they refuse to grant consent, they will be personally liable for the doctor’s account.
Informed consent: withdrawal
In line with the principle of patient autonomy, informed consent (whether for medical treatment or for the disclosure of health information) may be withdrawn at any time by the individual who granted it. Such a withdrawal of consent must be express and it is advisable to obtain written confirmation of that withdrawal.
The requirements to obtain informed consent are sometimes regarded as a time-consuming administrative burden. It may be helpful to view the requirements as an opportunity to improve the trust relationship with the patient. Not only does the information supplied to the patient empower that patient to make an informed decision regarding their healthcare, it allows the patient to actively participate in the treatment of their condition and increases the probability that they will co-operate in the subsequent management of their condition.