The Legal Framework for Preimplantation Genetic Testing in South Africa

By Sheetal Soni 2 months ago
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The Legal Framework for Preimplantation Genetic Testing in South Africa

Introduction

Reproductive genetic testing can broadly be divided into three categories: Carrier testing, which are genetic tests performed on adults where there is a family history of a genetic condition or high incidence of a specific condition in the relevant population; prenatal testing, which is genetic testing done during a pregnancy and preimplantation genetic testing (PGT) which is the diagnosis of genetic disorders in gametes or early embryos. Reproductive genetic testing aims to provide information about the risk of passing on a genetic condition to the next generation. This article focusses on PGT which is genetic testing that is performed after fertilization of an ovum in vitro but prior to the implantation of the fertilized ovum in the womb.

PGT is further described as taking the following forms:

  • Testing for aneuploidy (PGT-A): this test determines the number of chromosomes possessed by an embryo. An embryo will be classified as ‘aneuploid’ if it has a number of chromosomes which deviates from the normal 46.
  • Testing for structural rearrangements (PGT-SR): tests embryos for specific structural rearrangements and is usually advised for individuals who are known to be carriers of a balanced translocation. This test determines the size of chromosomes and their arrangement in relation to each other.
  • Testing for monogenetic disorders (PGT-M): Monogenetic disorders are disorders which result from a single mutated gene. This testing aims to determine if a known gene alteration has been inherited by the embryo. This testing can only be offered if there is a confirmed genetic diagnosis in the family.

Combined with IVF, these tests allow people the opportunity to maximise their chances of having healthy children.

The South African Legal Framework

Therapeutic PGT is permitted in terms of section 12 of the Constitution of South Africa, 1996. Broadly referred to as the ‘right to reproductive autonomy’, the section identifies reproductive decision-making as an important element of the right and states that “Everyone has the right to bodily and psychological integrity, which includes the right to make decisions concerning reproduction.” It includes the right to make decisions regarding when to reproduce, the spacing of one’s children, and the use of assisted reproductive technology.

The National Health Act 61 of 2003 does not specifically refer to PGT. Chapter 8 regulates the use of blood, blood products, tissue and gametes in humans, and prohibits the removal of this human biological material from living persons for medical or dental use without the procurement of proper written consent of such person. It also contains important prohibitions on the removal of biological material in certain instances (such as removal from individuals under the age of 18 or the mentally ill), but it is the Regulations issued by the Minister of Health in terms of the Chapter which are directly applicable. The Regulations Relating to Artificial Fertilisation of Persons (R175 of GG 35099, 2012) allow individuals to reproduce via artificial fertilisation using their own, or alternatively, donor gametes. It regulates the withdrawal of gametes, the management of donor files, and establishes a Central Data Bank where information regarding gamete and embryo donations are housed. It also regulates who has authority to remove gametes as well as where such activity may take place, as well as the purposes for which gametes and embryos may be used. In addition to legal principles, professional guidelines issued by professional bodies such as the HPCSA and SASREG are also relevant.

The current legal framework permits therapeutic PGT, which is testing carried out for the purposes of identifying serious genetic condition. Using PGT for purposes of enhancement, such as identifying genetic traits such as height, hair or eye colour, is prohibited. An example of the distinction between therapeutic and non-therapeutic PGT is its use for sex selection of the embryo. The Regulations expressly state that PGT for selecting the sex of a child is prohibited except in the case of a serious sex-linked or sex limited genetic condition.  It is interesting to note that until 2012, there was no legal prohibition of non-therapeutic sex-selection in South African law, and no justification for the prohibition has been given. However, many jurisdictions base the prohibition on the opinion that it reinforces cultural preference for a male child, as well as discrimination against the female sex.

Although non-therapeutic sex selection of embryos may be requested by patients who desire a child of a specific sex, or those who simply want to balance their family by having a child of the absent sex (known as ‘family balancing’), it would be prudent for practitioners to ensure that they act within the parameters of the law and professional guidelines. While breach of professional guidelines may result in suspension or revocation of a practice licence, breach of the Regulations is identified as an offence which is punishable by conviction and imposition of a fine or imprisonment of up to ten years (or a combination of both).

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 Sheetal Soni

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