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National Health Act [South Africa]

In South Africa, human genetic modification technologies are regulated by the National Health Act and the ethics research guidelines issued by the Minister of Health. Under the Act, “the manipulation of any genetic material, including human gametes, zygotes or embryos” is explicitly prohibited. Violation of the ban is punishable with imprisonment for up to five years and/or the imposition of fines (Art. 62).

With regard to somatic gene therapy, the general provisions pertaining to research on human subjects are applicable (National Health Act, Chapter 9). The National Health Research Ethics Council is responsible for the drafting of guidelines for the functioning of research ethics committees and for the setting of norms and standards for conducting research and clinical trials on humans.

Finally, the Minister of Health’s “Ethics in Health Research” guidelines contain South Africa’s national policy on the ethical practice of research. They establish mechanisms for the ethical review of studies conducted on human subjects and draw attention to the ethical implications of professional actions, particularly human genetic research.

Other normative measures

The Medical Research Council (MRC) of South Africa, in its 2002 Guidelines on Ethics for Medical Research, adopted recommendations for the regulation of human genetic modification techniques. The MRC is of the opinion that human germline modification should not be attempted at this time due to the insufficient knowledge about possible risks to future generations.

Relating to somatic cell gene therapy, the MRC is of the opinion that it should be governed initially by the same requirements that already apply in South Africa to other research involving human subjects. Given the uncertainty about its safety and efficacy, the MRC recommends that somatic gene therapy be limited to patients in whom the potential for benefit is greatest in relation to possible inadvertent harm (i.e. patients whose disorders are life threatening or cause serious handicap and/or those for which other treatment is unavailable or unsatisfactory).

Finally, the MRC recommends that a new expert supervisory body be established with the responsibility for:
a) advising on the content of proposals, including the details of protocols, for therapeutic research in somatic cell gene modification;
b) advising on the design and conduct of the research;
c) advising on the facilities and service arrangements necessary for the proper conduct of the research;
d) advising on the arrangements necessary for the long-term surveillance and follow-up of treated patients; and,
e) receiving proposals from clinicians who wish to conduct gene therapy in individual patients, and making an assessment of:

  • the clinical status of the patient;
  • the scientific quality of the proposal, with particular regard to the technical competence and scientific requirements for achieving therapy effectively and safely;
  • whether the clinical course of the particular disorder is known sufficiently well for sound information, counseling and advice to be given to the patient (or those acting on behalf of the patient) so that informed consent may be obtained (see 5.3 Book 1) - for the outcomes of therapy to be assessable;
  • the potential benefits and risks to the patient of the proposal; and,
  • the ethical acceptability of the proposal.

In the light of this assessment, the expert supervisory body should recommend whether or not the proposal should be approved. Where applicable, conditions should be stated. The supervisory body should also have responsibility for:
f) acting in collaboration with existing Research Ethics Committees;
g) acting as a repository of up-to-date information on research in gene therapy internationally;
h) setting up and maintaining a confidential register of patients who have been the subjects of gene therapy;
i) oversight and monitoring of the research; and,
j) providing advice to Health Ministers on scientific and medical developments that bear on the safety and efficacy of human gene modification.

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