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CRISPR Cas-9 genome editing: A legal and ethical overview


We are on the verge of the next revolution, one that will happen within us.

The tool that will enable that revolution is CRISPR Cas-9 (CRISPR is the acronym for Clustered Regularly Interspaced Short Palindromic Repeats). 

To put it simply, CRISPR is a system that makes it possible to cut a cell’s genome at a desired location, allowing existing genes to be removed and new ones to be added.

The technique was discovered in the 1960s, but it was not until 2018 when a Chinese scientist modified a human embryo for the first time. Although genetic engineering in microorganisms, plants and animals is fairly ethically acceptable nowadays, the ethics of the application of the CRISPR-Cas-9 are often questioned. The potential consequences of the technology might be so irreversible that it has become surrounded by big ethical and legal issues. 

So the question is, is the use of CRISPR interference with nature or a cure for all diseases?

He Jiankui, the scientist who made the first genome-edited babies in order to reduce the risk of HIV infection, faced widespread criticism. His research was suspended by the Chinese authorities. He was found guilty of forging documents and unethical conduct and sentenced to three years in prison. He also faced a fine of 3 million yuan (approximately £330,000).

On the other hand, we must confront the ‘industrial revolution of the genome’. The opportunities are as significant as the ethical uncertainties. Biohackers around the world even experiment at home. The former NASA biochemist Josiah Zayner was the first to use the technology and injected the DIY gene therapy into his left arm, live-streaming the procedure on the internet. He even published a free guide for enthusiasts who want to undertake the experiment themselves. Zayner argues that being able to control what genes we have is a human right. 

Sceptics, however, have concerns over the use of CRISPR, including the implications of creating “designer babies” or “super humans”.  They argue it might create greater societal inequalities – The technology might not be distributed equally and only the rich will gain access to it.

The legal and regulatory issues surrounding CRISPR are also significant.To date, there is no internationally valid regulatory framework for CRISPR; currently each country decides for itself how to regulate and control the new technology.

The European Union has developed a legal framework based on Directive 2001/18/EC, which regulates the use of genetic engineering technology. However, there is a debate questioning whether an organism manipulated by CRISPR is really a genetically modified one because there is no insertion of foreign DNA, but only altering of the existing genome.  There is still little clarity on the topic.

Other countries like Canada prohibit human germline editing. The 2004 Assisted Human Reproduction Act criminalises the use of the technology and it is punishable by fines of 500,000 Canadian dollars and the possibility of up to 10 years in jail. The Act has come into force following the public’s negative reaction when researchers produced a cloned sheep named Dolly in 1996.

The situation in Germany is similar under the 1990 Embryo Protection Act. It bans the use of embryos for research and experiments. By contrast, France The country has ratified the Oviedo Convention, which states that “An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic, or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants”.

China has revised its Civil Code which will include the following clause: ‘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’. This version of the Code is expected to be adopted in March 2020.

The issues around CRISPR are controversial, challenging, thought-provoking and philosophical. The technology could be  revolutionary, but also an ethical minefield. And as Arthur Caplan, a bioethicist at New York University, puts it:“For one of the most important experiments you could do in the history of eugenics, we’re stepping off the ethical cliff with no ropes or safeguards or protections.

Slavina Petrova