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Posted on January 15, 2020 at 11:19 AM

by Vera Lúcia Raposo, Ph.D.

Last December it was made public that He Jiankui was sentenced to 3 years in prison and a fine of 3M yuan due to the genetic modification of two twin babies. This story is an epic science-fiction drama that might dictate the future of gene editing in China.

Let’s go back in time, however, to late November 2018, when He Jiankui announced the birth of the first genetically modified babies in the entire world. The twin girls, Nana and Luna, were born in the aftermath of a scientific experiment (this is the proper designation for what happened) involving several couples in which the male was an HIV carrier. He Jiankui and his team (two of which were also convicted) managed to disable the CCR5 genes of the babies in order to make them HIV immune, using the CRISPR-Cas9 technique.

This was not the first Chinese experiment with CRISPR-Cas9. In the last couple of years, Chinese researchers have published several studies involving this genetic technique, either with animals or with non-viable human embryos. Nonetheless, this was the first time (at least, the first publicly disclosed time) viable human embryos were used and, more than that, allowed to be born.

The incident raised huge outcry worldwide and the criticism is justified. First, this conduct cannot find legal basis in the existing Chinese regulations, including the Implementation Measures for Administration of Assisted Reproductive Technology (人类辅助生殖技术管理办法) from 2001, the Human Assisted Reproductive Technology Specification (人类辅助生殖技术规范) from 2003, and the Ethics Rules of Human-assisted Reproductive Technology and Sperm Bank (人類輔助生殖技術和人類精子庫倫理規則) also from 2003. The problem is that these regulations belong to the lower level of the Chinese legal system, and so they are rarely used to solve a case in a court of law.

Up until now China has had scarce and ambiguous norms in relation to these practices. One can only hope that the Chinese government takes this incident as an incentive to create more accurate regulation that is able to establish which kind of genetic interventions are allowed. This ought to include considerations regarding the effects (only somatic interventions? Both somatic and germinal? None of them?) and regarding the aims (only therapeutic interventions? Any health-related intervention, including health-related enhancements?), and under which conditions (informed consent, approval by ethics committees) genetic editing ought to be allowed. Some developments can already be seen in the draft of the new Civil Code, in the personality rights chapter. The most appropriate norm relevant to gene editing, Article 1009 in the latest version available, states ‘Those engaged in medical and scientific research activities related to human genes, human embryos, etc. shall abide by laws, administrative regulations and relevant state regulations, and shall not endanger human health, violate ethics and morals, or damage public interests’ (author’s translation). Article 1009 demands that researchers comply with the existing regulations, but as already explained those are insufficient, unclear and unfit to be used to solve individual cases. Clearly a detailed legal framework is necessary, especially for a country that aims to be the leading player in biotechnology, as it is the case with China.

Besides the lack of legal grounds, He Jiankui’s genetic intervention was reproachable at several different levels. Though CRISPR-Cas9 is a very promising technique, it is still in an experimental stage. We lack scientific evidence to predict all the consequences of using this procedure. Eventually, some risky interventions will be considered when patients are in a life or death situation and there is no other alternative treatment, however, this was not the case with the Chinese experiment. Nowadays HIV is not a life-threatening condition. Moreover, there are other procedures able to fight the risk of transmission of HIV to progeny, in particular, a procedure called sperm washing, a widely used technique around the world (and arguably used by He Jiankui). Therefore, the use of gene editing was not necessary and it can only be considered a mechanism aimed to satisfy scientific curiosity. To reinforce its qualification as pure experimentation is the fact that the girls were diversely edited: in one of them, both copies of the virus were disabled, while in the other only one copy was (thus, the latter can still be infected, though she has additional protection when compared with a person who maintains its CCR5 genes unedited). This seems to indicate that the purpose of the experiment was to compare the development of both girls while they grow. From the perspective of informed consent, it is not clear how informed were the babies’ parents (the ones entitled to consent in representation of their unborn children) about the experimental nature of the procedure and the unpredictability of the outcome.

Last, but not least, there is the suspicion that the genetic modification envisaged a more obscure purpose—to create more intelligent human beings. According to some animal studies, rats in which the CCR5 gene had been disabled show better memory and higher cognitive capacities. If that is the case, than, people with the CCR5 genes modified might end up having better learning capabilities and better memory, which obviously are very seducing features, not only for individuals, but also for governments.

In sum, the Chinese incident is extremely concerning. Having said that, it is also extremely promising regarding the potential benefits that CRISPR-Cas9, and gene editing in general can bring to humankind in the near future. Gene editing can become a very useful tool to combat diseases that up until now have not had significant chances of cure, or currently have no cure at all using other medical interventions. This is the case of cancer, Tay-Sachs disease, and Huntington disease in which gene editing may prove to be useful. Gene editing can be used, not only to cure exiting pathologies, but also to prevent their transmission to offspring (in case of hereditary diseases) or their contagion (in case of infectious diseases).

The condemnation of He Jiankui should not be seen as the condemnation of genetic interventions. Many good things involving gene editing are still to come and China might aspire to have a leading role in this domain, as long as it invests in a proper legal framework.

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