Informed Consent Requirements in South Africa: The Legal Rules

Updated 2026-07-06 · Written for South African healthcare practitioners by Sphygmos.

Informed consent in South Africa is a statutory requirement, not a courtesy. Sections 6 to 9 of the National Health Act 61 of 2003 set out what a patient must be told, when a health service may proceed without the patient's own consent, and who decides in the patient's place. For children, section 129 of the Children's Act 38 of 2005 fixes the ages and the substitutes. This guide sets out the requirements as the statutes state them, and what a defective consent costs.

The rule: no health service without informed consent

Section 7(1) of the National Health Act states the rule: subject to section 8, a health service may not be provided to a user without the user's informed consent. The Act's term for a patient is a user, and the rule applies across public and private care.

The Act defines the term it uses. Under section 7(3), informed consent means consent for the provision of a specified health service, given by a person with legal capacity to do so who has been informed as contemplated in section 6. Both legs matter: capacity and information. A signature from a patient who was never properly informed is not informed consent as the Act defines it, and consent to one specified service is not consent to another.

Section 7(2) adds a duty of effort: a health care provider must take all reasonable steps to obtain the user's informed consent.

What the patient must be told: section 6

Section 6(1) lists the information every health care provider must give a user:

The user's health status, except where there is substantial evidence that disclosure would be contrary to the user's best interests
The range of diagnostic procedures and treatment options generally available to the user
The benefits, risks, costs and consequences generally associated with each option
The user's right to refuse health services, with an explanation of the implications, risks and obligations of such refusal

Language and literacy: section 6(2)

The section governs the manner of informing as well as the content. Where possible, the provider must inform the user in a language the user understands and in a manner that takes the user's level of literacy into account. A form in English handed to a patient who reads little English does not, on its own, satisfy the section.

This is the piece most often missed in practice, and it is why the information conversation, not the signature, is the legal centre of consent. The signature only records that the conversation happened.

When treatment without the patient's own consent is lawful

Section 7(1) lists the only exceptions to the rule. A health service may be provided without the user's own informed consent where:

The user cannot consent, and consent is given by a person mandated by the user in writing, or authorised by law or a court order, to consent on the user's behalf
The user cannot consent and no one is mandated or authorised, in which case consent may be given by the user's spouse or partner, and in their absence a parent, a grandparent, an adult child, or a brother or sister of the user, in that specific order
Provision of the service without informed consent is authorised by law or a court order
Failure to treat the user, or a group of people that includes the user, will result in a serious risk to public health
Any delay might result in the user's death or irreversible damage to the user's health, and the user has not expressly, impliedly or by conduct refused the service

Participation in decisions and admission without consent

Consent is the gate; participation is the wider right. Under section 8(1), a user has the right to participate in any decision affecting their personal health and treatment. Where the informed consent required by section 7 is given by someone other than the user, that person must, if possible, consult the user before consenting. A user who is capable of understanding must still be informed under section 6 even if they lack the legal capacity to consent, and a user who could not participate in a decision must be informed afterwards, unless disclosure would be contrary to the user's best interests.

Two neighbouring provisions complete the framework. Section 5 provides that a health care provider, health worker or health establishment may not refuse a person emergency medical treatment. Section 9 deals with admission without consent: where a user is admitted to a health establishment without consenting, the establishment must notify the head of the relevant provincial health department within 48 hours, unless the user consents to a health service there within 24 hours of admission.

Who can consent for a child: Children's Act section 129

Section 129 of the Children's Act 38 of 2005 fixes the ages. A child may consent to their own medical treatment, or to the medical treatment of their own child, if the child is over the age of 12 years and is of sufficient maturity and has the mental capacity to understand the benefits, risks, social and other implications of the treatment.

Surgery is treated differently. A child over 12 with that same maturity and mental capacity may consent to a surgical operation only if duly assisted by a parent or guardian. For a child under 12, or over 12 but without sufficient maturity, the Act distinguishes between the adults: the parent, guardian or care-giver may consent to medical treatment, but only the parent or guardian, not a care-giver, may consent to a surgical operation.

Where the usual consent cannot be obtained, section 129 provides fallbacks:

The superintendent of a hospital, or the person in charge in the superintendent's absence, may consent where the treatment or operation is necessary to preserve the child's life or save the child from serious or lasting physical injury or disability, and the need is so urgent that consent cannot first be obtained
The Minister may consent where the parent or guardian unreasonably refuses to consent or to assist the child, is incapable of consenting, cannot readily be traced, or is deceased
The Minister may also consent where the child unreasonably refuses to consent
A High Court or children's court may consent in all instances where another person who may give consent refuses or is unable to do so
No parent, guardian or care-giver may refuse to assist a child or withhold consent by reason only of religious or other beliefs, unless they can show a medically accepted alternative to the treatment or operation concerned

The HPCSA layer and consent in specific settings

For HPCSA-registered practitioners, the statutory floor is built on by Booklet 4 of the ethical guidelines, Seeking Patients' Informed Consent: The Ethical Considerations, revised in December 2021. Booklet 4 requires consent to be sought before treatment or care is provided, including history taking and examination, and treats obtaining consent as a continuing process rather than an isolated event.

Some settings carry their own consent rules. A telehealth consultation requires informed consent both for the treatment and for the use of the telehealth technology, given in writing or recorded orally, under Booklet 10 of the HPCSA guidelines. Under section 11 of the National Health Act, a health service for experimental or research purposes requires prior written authorisation from the user, the provider primarily responsible for the treatment, the head of the health establishment and the relevant health research ethics committee.

Section 7 itself does not prescribe a form for routine treatment: the Act requires informed consent, not a particular document. What the form or recording does is prove the consent afterwards, which is why the consent record belongs on the patient record rather than in a drawer.

What getting it wrong costs

Treatment without valid consent exposes a practitioner on three fronts at once. In South African law, consent is what makes physical treatment lawful, so a procedure performed without a valid consent can ground a civil claim for damages even where the procedure itself was competently done, and in serious cases a criminal charge of assault.

Before the HPCSA, failure to obtain proper informed consent is a professional conduct matter. The penalties available after a conduct inquiry under the Health Professions Act range from a caution or reprimand and fines to suspension from practice or removal from the register.

For children, the fallbacks have teeth. Where a parent or guardian withholds consent on religious grounds alone, the Minister or a court can consent in their place, and South African hospitals have obtained urgent court orders to proceed with treatment. Whichever way such a dispute runs, it is decided afterwards on the record of who was told what and who agreed to what. Sphygmos logs that record on the patient file at the moment it is made.

How Sphygmos helps

Consent capture is built into Sphygmos's recording flow. Before a consultation is recorded, consent is requested and the patient's response is logged on the patient record alongside the consultation itself, so the practice can show afterwards what was agreed and when. Every generated document stays a draft until the doctor reviews and signs it; the doctor is always the final gate.

See Sphygmos, the clinical operating system for South African doctors

Frequently asked questions

What are the informed consent requirements in South Africa?

Under section 7 of the National Health Act 61 of 2003, a health service may not be provided without the user's informed consent, meaning consent to a specified service given by a person with legal capacity who has been informed as section 6 requires: their health status, the available diagnostic and treatment options, the benefits, risks, costs and consequences of each, and the right to refuse. Where possible this must happen in a language the patient understands, taking their literacy into account, and the provider must take all reasonable steps to obtain the consent.

At what age can a child consent to medical treatment in South Africa?

From over the age of 12, provided the child is of sufficient maturity and has the mental capacity to understand the benefits, risks, social and other implications of the treatment, under section 129 of the Children's Act 38 of 2005. A child under 12, or over 12 but without that maturity, is treated with the consent of a parent, guardian or care-giver.

Who can consent to a surgical operation on a child?

A child over 12 with sufficient maturity and mental capacity may consent to their own operation, but only if duly assisted by a parent or guardian. Where the child cannot consent, only a parent or guardian may consent to surgery; a care-giver may consent to medical treatment but not to an operation. In urgent cases needed to preserve life or prevent serious lasting harm, the hospital superintendent may consent, and the Minister or a court may consent where a parent unreasonably refuses.

Who can consent when a patient is unconscious or lacks capacity?

Section 7(1) of the National Health Act sets the order: first a person mandated by the patient in writing or authorised by law or court order, then the spouse or partner, and in their absence a parent, grandparent, adult child, or brother or sister, in that specific order. Where no one is available and delay might result in death or irreversible harm, treatment may proceed without consent provided the patient has not expressly, impliedly or by conduct refused it.

Does informed consent have to be in writing in South Africa?

Not for routine treatment: section 7 of the National Health Act requires informed consent but does not prescribe a written form. Writing is required in specific settings, such as the prior written authorisation needed for experimental or research services under section 11, while HPCSA guidance allows telehealth consent to be given in writing or recorded orally. A written or recorded consent is what proves the consent if it is later disputed.

Can a parent refuse medical treatment for a child on religious grounds in South Africa?

Not on beliefs alone. Section 129(10) of the Children's Act provides that no parent, guardian or care-giver may withhold consent by reason only of religious or other beliefs unless they can show a medically accepted alternative to the treatment or operation. Where consent is unreasonably refused, the Minister or a High Court or children's court may consent instead, and a hospital superintendent may consent in urgent life-threatening cases.

Can a patient refuse treatment in South Africa?

Yes. Section 6(1) of the National Health Act obliges providers to inform patients of the right to refuse health services and to explain the implications, risks and obligations of refusal. The emergency exception in section 7(1) applies only where the patient has not expressly, impliedly or by conduct refused the service, so a capable adult's refusal stands. A child's unreasonable refusal is different: under the Children's Act the Minister may consent in the child's place.

Sources

This guide is general information for healthcare practitioners, not legal advice. Verify current legislation and HPCSA guidance before relying on any detail.