After the birth in China of the first genetically modified humans the result of unregulated experiments, the country has recently introduced a regulation on gene editing in humans. To that end, they have developed a draft of the civil code, by which “experiments on genes in adults or embryos that endanger human health or violate ethical norms can accordingly be seen as a violation of a person’s fundamental rights”, according to the journal Nature.

Governmental control of gene editing in humans including germline regulation

gene editing in humansThus, the aim is to make researchers responsible for the adverse outcomes of these types of experiments. Furthermore, the new regulations of gene editing in humans also require that scientists obtain approval before they can edit the genome of human embryos.

The establishment of regulations with respect to human genome editing is certainly needed, as evidenced recently with the announcement that scientists in Russia are hoping to obtain more genetically modified babies (see HERE).

China’s inclusion of gene editing in the latest draft of the new civil code was a last-minute addition, however — prompted by uproar over gene-editing experiments carried out last November by Chinese biophysicist He Jiankui. He claimed to have done experiments on human embryos that resulted in twin girls whose DNA had been engineered to make them less susceptible to contracting HIV. The controversial experiments drew condemnation in China and internationally, and led to He’s sacking from the Southern University of Science and Technology in Shenzhen in January. He was also censured by Chinese authorities, but it was not clear whether he had broken any of the country’s laws.

The revised civil code places experiments using human genes or embryos under the section of the code that ensures a person’s right to physical well-being, freedom, privacy and dignity. It is the first time that regulations relating to genomes have been included in the civil code, says Zhang.

However, despite the positive aspect of these regulations, it should be remembered that they do not prohibit experimentation with human embryos before editing human embryos. Thus, from an ethical point of view, these measures can be considered inadequate.