South Africa’s new research guidelines are not a green light for heritable human genome editing microbiologystudy

The recently updated South African Ethics in Health Research Guidelines have been a recent cause of concern, with some researchers and bioethicists interpreting them as allowing what’s known as heritable human genome editing.

Heritable human genome editing involves editing the DNA of sex cells (eggs, sperm) or early embryos in a manner that may be inherited by offspring. Because the impacts on future offspring and society are unknown, there is vigorous and active ongoing debate on the ethics of such interventions.

Rather than allowing heritable human genome editing, the guidelines acknowledge the reality that South African law already allows human genome editing. The only change lies in how the guidelines provide a framework on oversight into heritable human genome editing. This guidance should not be interpreted as a green light for heritable human genome editing.

From this perspective, the guidelines provide much-needed clarity on how research ethics committees can go about ensuring that research and clinical applications of genome editing in humans are carried out safely.

The law in South Africa

The current controversy relates to one particular statutory provision: Section 57(1) of the South African National Health Act. The provision reads as follows:

A person may not—

(a) manipulate any genetic material, including genetic material of human gametes, zygotes or embryos; or

(b) engage in any activity, including nuclear transfer or embryo splitting,

for the purpose of the reproductive cloning of a human being.

What stands out from this provision is that it prohibits a number of acts, including the manipulation of genetic material, zygotes and embryos. One might interpret this provision as including heritable human genome editing. Viewed in this way, the guidelines are problematic in that they allow something the law prohibits.

However, such an interpretation of Section 57(1) conflicts with the rules of statutory interpretation in South Africa.

Statutory interpretation

Statutes in South Africa must be interpreted purposively. How to interpret Section 57(1) does not depend on whether the text can be read as applying to heritable human genome editing, but rather whether the apparent purpose of the provision was to prohibit heritable human genome editing, considering the context within which the words appear.

There is no mystery around why Section 57(1) exists, which is to prohibit human reproductive cloning. That this was the purpose is evidenced by the language of the provision itself, which prohibits “manipulation of genetic material” only “for the purposes of the reproductive cloning of a human being.”

Other principles of statutory in South African law point to the conclusion that Section 57(1) does not apply to heritable human genome editing. Where a provision in a statute features the word “include,” the words after it define the general class of things that fall within the scope of that provision.

Section 57(1) prohibits “reproductive cloning,” which it defines as “the manipulation of genetic material in order to achieve the reproduction of a human being and includes nuclear transfer or embryo splitting for such purpose.” The general class of things this section applies to are clarified to be “nuclear transfer or embryo splitting,” which are both cloning techniques.

Therefore, the rules of statutory interpretation require that the definition of what Section 57(1) prohibits (reproductive cloning) not be read as including heritable human genome editing.

Another feature of statutory interpretation in South Africa that is relevant here is the presumption that where a provision is linked with a criminal sanction—as is the case with Section 57(1)—the narrowest possible interpretation of that statutory provision is to be preferred. So if Section 57(1) can reasonably be interpreted as limited only to human reproductive cloning and not heritable human genome editing, such an interpretation is the one our law gives effect to.

The guidelines reflect an accurate understanding of South African law by its drafters. South African law may prohibit genetic manipulation, but this only applies for the purposes of human reproductive cloning.

Genetic manipulation for other purposes, including heritable human genome editing, is not prohibited; there is nothing in the law preventing heritable human genome editing.

Not a green light

It is important to note that the guidelines should not be taken as endorsing the use of heritable human genome editing technology. South Africa’s health research ethics guidelines serve as a “minimum benchmark of norms and standards for conducting responsible and ethical research in South Africa.” They are a tool meant to inform, guide and empower research ethics committees (RECs).

RECs ultimately decide whether or not to approve research. The guidelines simply provide guidance on how RECs should analyze research protocols including heritable human genome editing, but ultimately such research will not occur unless the relevant committee is convinced that doing so is safe and effective.

The inclusion of a form of research in the guidelines should not be understood as a green light for that kind of research or its clinical applications. There is no reason to believe that South African RECs will permit heritable human genome editing in South Africa before there is compelling evidence that doing so is safe.

Looking towards the future

Concerns have been expressed about the extent to which South Africa may be pushing the envelope with the new guidelines, given that other countries have not explicitly permitted heritable human genome editing. It is worth noting, however, that research on policies relating to heritable human genome editing reveals that most of the countries with restrictive policies are in the West, and are predominantly in Europe.

An important factor to consider in why South Africa—or any other country—may seek to plot a path forward when it comes to heritable human genome editing has to do with how those countries perceive the ethical considerations in question.

There is hardly consensus on the ethics of heritable human genome editing, and we have relatively little insight into non-western perspectives on editing the human genome editing. What research does exist suggests there may be material differences on what aspects, if any, of heritable human genome editing people consider ethically problematic and a cause for concern.

In the context of South Africa, a deliberative public engagement study found that an overwhelming majority of participants supported allowing the use of heritable human genome editing to prevent genetic health conditions or provide immunity against tuberculosis and HIV/AIDS, provided it was conducted in a safe and effective manner.

The guidelines do well to adopt an open-ended approach to the future of heritable human genome editing, by remaining open to the possibility that there may come a time where at least some applications are found to be both safe and ethically acceptable in South Africa.

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