Department of Health

National Policy for Health Act, 1990 (Act No. 116 of 1990)

I, ME TSHABALALA-MSIMANG, Minister of Health, intends in terms of section 2 of the National Policy for Health Act, 1990 (Act 116 of 1990), to determine national policy to be applied in respect of testing for HIV as set out in the schedule hereto.

SCHEDULE

DRAFT NATIONAL POLICY ON TESTING FOR HIV

Testing for HIV infection presents serious medical, legal, ethical, economic and psychological implications in the health care setting. Because HIV infection is a life-threatening condition, reasonable persons and health care workers will attach significance to the outcome of an HIV test, especially a positive diagnosis. For these reasons, and in accordance with the constitutional guarantees of freedom and security of the person, and the right to privacy and dignity, the following HIV testing policy shall constitute national policy. This policy applies to all HIV testing conducted within private and public facilities.

  1. Definitions

"Acquired Immune-Deficiency Syndrome (AIDS)" - the late and most advanced stage of HIV disease and is characterised by signs and symptoms of severe immune-deficiency, where the body loses the ability to fight against infections because the immune system is weakened.

"Epidemiology" - the study of the distribution of diseases in society, and the application of this information for the prevention and control of disease.

"Epidemiological purposes" - the testing for HIV in order to obtain information regarding the distribution of HIV infection within society.

"Human Immuno-Deficiency Virus (HIV)" - the virus that causes AIDS.

"HIV Testing" - the obtaining of a bodily sample for the specific purpose of performing a medical test or a number of medical tests to determine the HIV status of a person.

"Informed consent" - means that the individual has been provided with information, they have understood it and based on this they agree to undergo the HIV test. It implies that the individual understands what the test is, what the object and purpose of the test is, why it is necessary and the benefits, risks, alternatives and possible social implications of the outcome.

"Post-test counselling" - the counselling provided when an individual receives his or her HIV test result. Post-test counselling involves one or more sessions (ideally at least two) and should include discussions on:

"Pre-test counselling" - counselling given to an individual before an HIV test, to make sure that the individual has sufficient information to make an informed decision about having an HIV test. During the session the individual should be given an opportunity to make a decision on whether he or she wishes to undergo the HIV test. Pre-test counselling should include discussions on:

"Proxy consent" - consent by a person legally entitled to grant consent on behalf of another individual. For example, in terms of the Child Care Act no. 74 of 1983 a parent or guardian of a child below the age of consent to medical treatment (14 years) may give proxy consent to HIV testing of the child. Similarly, in accordance with the Mental Health Act no. 18 of 1973 certain designated persons may consent to the medical treatment undertaken on a mentally ill person.

"Risk-bearing accident" - an occupational accident which accident that carries the risk of exposure to HIV.

"Trained HIV counsellor" - a person trained in HIV counselling skills, preferably on a course which meeting the standards of the Department of Health’s National Minimum Standards for Training of HIV Counsellors.

  1. Circumstances under which HIV testing may be conducted with informed consent

Testing for the human immuno-deficiency virus (HIV) may only be done in the following circumstances:

  1. Upon individual request;

  2. On the recommendation of a medical doctor provided this is done in consultation with the patients that such testing is clinically indicated;

  3. As part of HIV testing for research purposes in accordance with national legal and ethical provisions regarding clinical research in human subjects;

  4. As part of the screening of blood products and donations, in accordance with statutory provisions regarding blood donations;

  1. Circumstances under which HIV testing may be conducted without informed consent

Testing for HIV may only be conducted in the following circumstances:

  1. on an existing blood or tissue sample as part of unlinked and anonymous testing for epidemiological purposes, provided that such testing is carried out in accordance with national legal and ethical guidelines regarding such testing;

  2. where an existing blood sample of a source patient is available, and an emergency situation necessitates testing the source patient's blood (e.g. when a health care worker has sustained a risk-bearing accident such as a needle-stick injury when a health care worker has been accidentally exposed to the source person’s blood in the course of medical procedures ), HIV testing may be undertaken without informed consent but only after informing the source patient that the result may be disclosed the source person has declined to give his/her informed consent or is unable to do so, and he/she has been informed that the result may be disclosed to the health care worker concerned but will otherwise remain confidential; or

  3. where statutory provision or other legal authorisation exists for testing without informed consent.

  1. Other specific circumstances where HIV testing may not be undertaken

  1. Testing of a person for HIV infection for the perceived purpose of protecting a health care worker from infection is impermissible.

  2. Testing of an employee or job applicant to determine that employee’s HIV status is prohibited unless authorised by an order of the Labour Court, in accordance with the Employment Equity Act No. 55 of 1998, section 7(2). HIV testing conducted in compliance with an order of the Labour Court must comply with this policy.

  1. Informed consent, pre-test counselling and post-test counselling

  1. Testing for HIV infection at all health care facilities will be carried out with informed consent, which includes pre and post-test counselling. The information regarding the result of the test must remain fully confidential, and may only be disclosed in the absence of an overriding legal or ethical duty with the individual's fully informed consent.

  2. In the context of HIV/AIDS, testing with informed consent implies that the individual understands what the test is, why it is necessary and the benefits, risks, alternatives and possible social implications of the outcome.

  3. Informed consent further implies the giving of express agreement to HIV testing in a situation devoid of coercion, in which the individual should feel equally free to grant or withhold consent. Written consent should be obtained where possible.

  4. Where a person is unable to consent to an HIV test due to their incapacity or age another person may consent to the test on their behalf. In such circumstances proxy consent must be given in accordance with common law and legislative provisions.

  5. Pre-test counselling should occur before an HIV test is undertaken. It should be a confidential dialogue with a suitably qualified person, for example a doctor, nurse, pharmacist, social worker, psychologist or trained HIV counsellor, undertaken as a means of passing on information and gaining consent.

  6. Posters, pamphlets and other media (including videos) may be used in making information on HIV/AIDS available, but cannot be regarded as a general substitute for pre-test counselling.

  7. A doctor, nurse, pharmacist, psychologist or trained HIV counsellor should also ensure that post-test counselling takes place as part of the process of informing an individual of the results of an HIV test, regardless of whether it is negative or positive.

  8. The person administering the HIV test and its results should accept, after personal consultation, an individual's decision to refuse counselling (pre or post-test). Such a decision by the patient should be recorded in writing.

  9. Where a patient presents with recognisable HIV/AIDS specific symptoms but no facilities exist for pre-test counselling, then treatment for the specific symptom or illness should proceed without an HIV test. Referral for pre-test counselling with a view to a possible HIV test must occur at the earliest opportunity.

  1. Interpretation of policy

In all instances, this policy shall be interpreted to ensure respect for rights to privacy, dignity, bodily integrity and autonomy.

  1. Enforcement of this Policy

Where infringements of this policy occur the procedures for patient complaints set out in the draft National Health Act may be followed. This does not detract from a patient’s rights in terms of any other law.

Signed: ME Tshabalala-Msimang
Minister of Health