China set to impose regulations on gene-editing following controversial trial with human embryos

After global backlash involving the use of gene-editing tool CRISPR on human embryos, China will further tighten regulation on manipulating the human genome.

According to a report in Nature, a draft of new code in the country’s civil law explicitly lists human genes and embryos as protected personal rights for the first time ever.

Lawyers interviewed by Nature say that the law would make any doctor or scientist engaging in the editing of the human genome liable for the outcome of their experiments. 

China continues to tighten restrictions on editing human genomes after a controversial trial by one of the country’s scientists last year

‘The law makes clear that those who do research with human genes and embryos cannot endanger human health or violate ethics,’ said Zhang Peng, a criminal-law scholar at Beijing Wuzi University to Nature. 

Nature reports that the draft of the code was submitted to China’s top legislative body last month and will likely be ratified next year.

The country’s decision to codify rules surrounding the use of CRISPR to ‘edit’ humans’ genes follows an incident last year in which a Chinese scientist claims to have edited the genomes of two twin babies to make the resistant to HIV.

Researcher He Jiankui’s announcement marked a precedent in science and medicine that many doctors around the world called unethical, citing the lack of peer-reviewed literature regarding the ultimate effects of such manipulation in humans.

‘Unconscionable … an experiment on human beings that is not morally or ethically defensible,’ said Dr. Kiran Musunuru, a University of Pennsylvania gene editing expert and editor of a genetics journal told the Associated Press following the news.

CRISPR is both simple an effective in editing genomes of humans and more. The tool effectively allows scientists to ‘copy’ and ‘paste’ within genes.

This month, a group of bioethicists from China also called on the country to dramatically alter its approach to the field of human genomic experimentation.

‘China is at a crossroads,’ wrote researchers. ‘The government must make substantial changes to protect others from the potential effects of reckless human experimentation.’ 

While the law tighten’s the country’s grip on medical research involving the use of CRISPR to edit human genomes, the country’s position on the practice stops well short of an outright moratorium. 

He Jiankui shocked the scientific world when he announced that, using a tool called CRISPR, he has genetically altered two human embryos to make them HIV-resistant. 

In March, China’s legislature introduced regulations that would require scientists to receive approval from the country’s top health agency before carrying out experiments that involve editing cells in the human body. 

The law would impose fines and penalties relating to eligibility of grant applications and reaffirms that unsanctioned use of gene-editing tools may criminally break national law.

As both technologies like CRISPR and the research behind how the human genome functions expand, the prospects of being able to selectively edit human genes to achieve an outcome has become more and more of a reality.  

In an ideal scenario, technology could be used to guard against genetic diseases and benefit humans across the globe. 

Conversely, skeptics say the tool may also open the door to a host of other consequences including ‘genetic inequality‘ where only those who can afford to enhance their genes are able to.

Unknown ripple effects of editing just a single gene in someone’s body have also been recorded. Babies altered during He Jiankui’s genetic test may have inadvertently had genes relating to human cognition and memory unlocked according to MIT.

WHAT IS CRISPR-CAS9?

CRISPR-Cas9 is a tool for making precise edits in DNA, discovered in bacteria.

The acronym stands for ‘Clustered Regularly Inter-Spaced Palindromic Repeats’.

The technique involves a DNA cutting enzyme and a small tag which tells the enzyme where to cut.

The CRISPR/Cas9 technique uses tags which identify the location of the mutation, and an enzyme, which acts as tiny scissors, to cut DNA in a precise place, allowing small portions of a gene to be removed

By editing this tag, scientists are able to target the enzyme to specific regions of DNA and make precise cuts, wherever they like.

It has been used to ‘silence’ genes – effectively switching them off.

When cellular machinery repairs the DNA break, it removes a small snip of DNA.

In this way, researchers can precisely turn off specific genes in the genome.

The approach has been used previously to edit the HBB gene responsible for a condition called β-thalassaemia.