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In recent years, there have been several major innovations in genetics. A striking example is CRISPR-Cas9, a new biotechnology derived from bacteria that could be used to make precise changes at specific locations in the human genome – our DNA.
Scientists could use CRISPR-Cas9 and similar technologies to rule out genetic diseases using germ cells (gametes and embryos). This is known as germline modification; a child born from modified gametes or embryos will have such “changes” in their DNA and can pass them on to their future offspring. Of course, as with anything to do with DNA modification, controversy is rife.
It is possible that the germline edition will be ready for public use within the next decade. Currently, however, many countries do not have rules on the use of this technology. Therefore, it was argued that this situation should be rectified to ensure that germline editing is governed by appropriate legal and ethical rules, although what these rules should be is strongly contested.
In a recent article published by the South African Journal of Science, we investigated the current regulatory framework for germline editing in South Africa. Quite simply, it is lacking and several gaps must be filled. We propose five principles that could guide an appropriate ethical and legal framework for this technology and similar technologies.
The status quo
There is a distinction between the rules for germline editing by scientists for research purposes and germline editing for use in practice by the general public, known as the application clinical.
The regulatory environment in South Africa which covers ethical issues in medicine currently appears to preclude the research and clinical application of human germline editing. This is in line with ethical guidelines published by the Health Professions Council of South Africa and the South African Medical Research Council – although the rationale is unclear.
In contrast, the South African legal regulatory environment allows for a regulatory path that, in principle, would allow research into human germline editing. Indeed, none of the current regulations on research using germ cells prohibit research for germline editing purposes. The legal regulation of the clinical application of human germline editing, by contrast, is uncertain.
As far as research is concerned, there is currently no South African law specifically regulating germline editing. It is believed to adhere to the same laws and ethical requirements as all scientific research relating to human reproduction. . This gap needs to be filled with new regulations.
When it comes to germline modification as a clinical application, new regulations are needed. But the wording will need to be qualified as germline modification has long-term, multigenerational effects that must be taken into account.
The new regulation will also have to deal with loopholes such as the fact that the practice is seen under existing regulations as a hybrid of drug and medical device.
Basically, germline editing can only continue if South African law does not prohibit it. Some may argue that Section 57 of the National Health Act, which prohibits “reproductive cloning of a human,” applies here – and so, they suggest, germline modification is in fact. illegal.
Read more: Why the case against designer babies is collapsing
But we do not agree with this argument. This provision was intended to regulate cloning, and since germline editing is different from cloning, this section should not be interpreted as applying to germline editing.
Having considered all of this, we propose that five guiding principles should guide future regulation of germline editing in South Africa.
Read more: Editing the human gene: who decides the rules?
Principles
Principle 1: Editing of the human germline should be regulated, not prohibited.
Editing the human germline for clinical application has the potential to improve people’s lives. It could, for example, be used to prevent disease. For this reason, it should not be ignored or prohibited; rather, appropriate regulation should be considered that considers the potential long-term implications.
Principle 2: Use the well-established standard of safety and efficacy.
Human germline editing clinical applications should only be made available to the public if they are found to be safe and effective, including for future generations. This will mean that human clinical trials will need to be conducted. These are challenges, but possible.
Principle 3: Non-therapeutic uses of germline editing may be permitted.
Even among those in favor of germline editing, it is often argued that such use should be limited exclusively to “therapy” in the form of prevention of genetic diseases. This, it is said, differentiates it from genetic “improvement” in the form of germline changes that are not made for the purpose of curing people, but to benefit them. An example of genetic improvement would be one that makes a child have a high IQ or greater athletic ability.
These are often seen as morally wrong because they are reminiscent of the state-sponsored eugenics programs of Britain, America, and Nazi Germany from the early 20th century.
It is important to note that the eugenic regimes applied by the state used coercive means that violated the freedom of procreation. But the individual uses of germline editing technologies promote reproductive freedom, leaving their application to individual choice.
Principle 4: Respect the reproductive autonomy of parents.
The choice to use a safe and effective germline modification should be made by the potential parents, as this choice is part of the parents’ right to make decisions about reproduction. The freedom to use new reproductive technologies such as germline editing is one of those that falls under the protection of Article 12 (2) (a) of the South African Constitution.
Principle 5: Promote the achievement of equal access.
New technologies can only be accessed by the rich, which exacerbates existing inequalities in society – especially in societies like South Africa, given the wide gap between rich and poor and the lack of access to health care for the disadvantaged. However, the possibility of inequality cannot be a reason for removing technology. Rather, it should be a reason for measures to be taken to promote access for the most disadvantaged.
Bonginkosi Shozi receives funding from the National Research Foundation and the UKZN African Health Research Flagship.
Marietjie Botes receives funding from UKZN’s flagship Africa health law research program
By Bonginkosi Shozi, Ph.D. researcher, UKZN African Health Research Flagship, University of KwaZulu-Natal
Marietjie Botes, Postdoctoral Fellow, University of KwaZulu-Natal
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