/ 7 January 2020

Ethics of gene editing must be decided by each one of us


Gene editing is an exciting area of scientific research. It allows scientist to use gene-editing tools, such as CRISPR, to alter the genetic sequence of an organism’s cells, with a specific result in mind. This creates the potential to alter crops so that they are more nutritious, or alter a human being’s genetic makeup to remove the potential of an individual to develop a particular disease. The latter has proved controversial, as this new ability that gene editing gives us to alter our genetic characteristics is unprecedented, and many regulatory frameworks do not specifically refer to gene editing and CRISPR.

With respect to the gene editing of a human, there is distinction between somatic gene editing, which will alter specific cells only in an existing person, and germline editing, which is gene editing performed on human eggs, sperm, or embryos. This is the area of heated debate, because while somatic gene editing will only affect a particular patient, germline editing will alter an embryo’s DNA in a manner which is heritable.

In this way, germline editing creates the potential of altering the genetic heritage of future people, an idea which ethicists, philosophers, lawmakers, scientists and others are not comfortable with. For this reason, while there are some somatic gene editing trials under way, there has been consensus that germline editing should not be done until the safety of gene editing has been demonstrated, and the ethical issues can be debated.

In November 2018, the Chinese scientist, He Jiankui, revealed to the world that he had successfully gene-edited human embryos. He spoke of his technological feat at the Second International Summit on Genome Editing in Hong Kong, where he presented his method of gene editing human embryos to attempt to create children who would be resistant to HIV infection. The research presented appeared to show that he had successfully gene-edited the human embryos, which were then implanted into a woman and carried to term.

The resulting children, twin girls referred to only by their pseudonyms — Lulu and Nana — appeared to be healthy and resistant to HIV infection. The gene editing was a success. But the news was met with international outcry, and calls for a moratorium to debate the issues inherent in the gene editing of human beings. Until this time, there had been no clinical application of gene editing to human embryos, because this is largely prohibited by ethics and legal guidelines around the world. He appeared to have had all of his paperwork in order — ethical approval from his research institution to conduct the procedure and informed consent from couples willing to have their embryos genetically edited. But, according to the Human Embryonic Stem Cell Research Ethics Guiding Principles issued by China’s ministry of science and technology and the ministry of health in 2003, human blastocysts that have been used for research cannot be implanted into the reproductive system of humans or any other animal. The “genetic manipulation of human gametes, zygotes, and embryos for the purpose of reproduction” is also prohibited.

So how did this failure of regulatory oversight happen? Whispers of He being placed under house arrest began to circulate. But what would ultimately happen to He, who had clearly broken the rules?

On December 30, a year after his revelation to the gene-editing summit, the world found out. He, together with two co-defendants, were sentenced in the Nanshan district people’s court in Shenzhen for the illegal practice of medicine. Immediately upon release of the news of the birth of the gene edited children in 2018, the Guangdong province immediately set up a “gene editing baby incident” investigation team. On July 31 last year, a public prosecution notice was filed in the Nanshan district people’s court. To protect the privacy of the individuals involved in the case, the court heard the case in private on December 27. The court held that the behaviour of He, together with Zhang Renli and Qin Jinzhou, embryologists who had worked with him, constituted the crime of illegal medical practice. He was sentenced to three years imprisonment and fined three million yuan, Zhang was sentenced to two years’ imprisonment and fined one million yuan and Qin was sentenced to one year and six months imprisonment and two years’ probation. The finding of the court was that the defendants had practiced medicine illegally, under the guise of scientific research and innovation.

The details which have now come to light are arguably more shocking than the news of the birth of the children in 2018.

The court learnt that in 2016, in order to realise his goal of being the first scientist to create the world’s first gene-edited baby, He had formulated a business plan for gene-edited babies and raised funds. In 2017, the defendants arranged for six couples to impersonate people awaiting ordinary assisted reproductive help. He later instructed Zhang and others to falsify the medical ethics approval that would be necessary to conduct the gene editing procedure. He also arranged for necessary reagent materials, which are prohibited for human diagnosis and treatment, to be purchased from outside the country. In August 2017, instructed by He, Zhang began injecting the gene-editing reagents into the fertilized eggs of six couples in violation of the Chinese regulations, and then took samples of the cultured blastocysts (early embryos) for inspection. He selected blastocysts and Zhang transplanted them into patients through an unsuspecting doctor. The result was that two women became pregnant. In 2018, one patient gave birth to twin baby girls, and in 2019, a second patient gave birth to a baby girl. The court also learnt that between May and June 2018, He and Qin had arranged for two more couples to travel to Thailand where he attempted to conduct the gene-editing and implantation procedure again. No pregnancies resulted from this endeavour.

The court held that the defendants had deliberately violated the rules to chase “personal fame and fortune, and had opted deceptive and counterfeiting methods to maliciously evade the supervision of the national competent authority, and applied gene editing technology to assisted reproductive medicine”.

The evidence also showed that when He obtained consent from the couples who underwent the procedure, he had described the technology as “mature”, “safe” and as having “no risk”. From a legal perspective, the consent of these patients was not informed as they had been given false information. The behaviour of the defendants, from the procuring of reagents, counselling of couples, screening and injecting of eggs, implantation and the resulting births also violated the boundaries of scientific experiments and should instead be regarded as medical behaviours. None of the defendants were licenced physicians and yet were still carrying out medical activities, which amount to the crime of illegal medical practice.

But what about the future?

Will this judgment impede innovation in gene editing? It may not necessarily do so. This case will instead help to define the boundaries between what is legal and illegal, at least in China. What will follow now, is stricter oversight and more deliberation on the issues inherent in gene editing. China has already enacted several revisions to its existing laws. More countries will follow. The difficulty with developing a framework is that it will boil down to asking the difficult question: “Who should decide what may be allowed and what should be prohibited?” The prevailing opinion is that since gene editing will affect all of us, because it involves genetic manipulation of the human race, we should all be part of the conversation about its regulation.

Although this is a useful starting point, we must be mindful of cultural and other societal barriers. If the question being debated is what genetic conditions may be edited out of the human population, we must bear in mind that the answer will differ depending on the society to which we pose that question. A recent example is that of the Russian scientist, Denis Rebrikov, who in 2019 announced his intention to genetically edit human embryos to remove the genetic predisposition for deafness. If we are asked to consider whether deafness is a disease or disability, we may receive conflicting opinions.

The knee-jerk response to Rebrikov’s announcement was that deafness is not a disease, not a disability, and that there is a societal structure to assist hearing impaired persons. Further, deafness has assimilated into culture, and to allow gene editing of embryos in a manner which results in deafness being removed from the human population does not speak well to the proponent’s view of persons who are hearing impaired. But Rebrikov has offered an argument in favour of gene editing deafness out of the population. In Russia, deafness is often associated with societal stigmatisation, and the hearing impaired do not necessarily enjoy the support mechanisms of those living in other countries.

This is just one example of one genetic condition, with a set of ethical issues attached to it. A debate on germline gene editing will require us to debate the ethical issues in relation to any disease or genetic condition to which gene editing may be applied.

Asking these questions in different societies, each with values and traditional, religious or cultural norms that may differ is going to create difficulties. Our DNA makes us similar, our traditions and cultures make us different. The regulation of gene editing is going to ask that we find a constructive way to harmonise the two. Lulu and Nana were the world’s first gene-edited babies. More will be born, but by that time the regulatory mechanisms will undoubtedly have changed.

Sheetal Soni is at the School of Law at the University of KwaZulu-Natal


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