Reported by Sophia Ismail

On 5th June 2021, RWC Community Series organised a Webinar titled “Introduction to Genome Editing and The Law” via Facebook live. It was part of RWC’s new webinar series related to Regulation Technology. The speaker was Dr Lau Pin Lean, a lecturer in Bio-Law at Brunel Law School in London. It was moderated by Richard Wee. 

In the introduction, Dr Lau established the concept of the topic by reference to Captain America, the famous superhero character. “What if we had real life Captain Americas?”, a question enough to grab anyone’s attention. Based on the Captain America plot, he was given a special serum that gave him special powers. Dr Lau made the distinction that with genome editing, it is not a serum but simplistically, it is technology that can modify DNA and lead to genetic enhancement.

Genome Editing: an overview

Genome editing has the ability to modify, insert, and make corrections to DNA. It is not a new form of technology and has been in use since the 1990s. However, developments such as CRISPR-Cas9 which was created in 2012 has changed the game. The creators even won the Nobel Prize in Chemistry for it in 2020. Some of the benefits of the technology include providing cheaper, easier and efficient techniques for human gene editing than previous technologies. 

On the outset, there are many benefits of this kind of technology. Dr Lau expressed that it can help with treatments for genetic conditions, sickle cell, leukemia, anaemia, and cystic fibrosis. The promise it holds is tremendous but Dr Lau then presented possible dangers and complications via human germline engineering where the changes can be heritable.

The Case of Lulu and Nana: the world’s first CRISPR genome-edited babies

In 2018, it was revealed by a Chinese scientist, He Jiankui that he secretly used CRISPR to gene edit embryos so they would have resistance to HIV. However, two years later, one of the twins developed an off site mutation which meant she was no longer resistant to HIV. Dr Lau then broached again the complexity and seriousness of genome editing where effects may only be apparent at a later time. 

Even though there is a lack of universal documentation and international regulation on gene editing, a 2015 summit in Washington declared a moratorium on heritable genome editing. For this reason, many countries strictly oppose this kind of experimentation. In this case, scientist He was imprisoned and fined for medical malpractice in China.

Ethical Legal Social Implication (ELSI) of Technology 

Dr Lau contends that this is a common term used in the scientific community to achieve a balancing process. She focused on discussions on ethics and law interpolated with regulation. 

For ethics, there are considerations in place in biotechnology such as plant biotechnology but none yet for human gene editing. Dr Lau suggests that ethical rules that should be propounded include considerations for individual freedoms, liberty, and most importantly safety. It has to be safe and of the highest standards and transparency because without it, there will be problems for the scientific community. Dr Lau also suggests a research design protocol approved by national/international ethics boards, to evaluate the meeting of requirements, any risks, and how anticipated results have to outweigh the intervention. 

In regards to the law, Mr Wee posed a question to Dr Lau on how a lawyer should go about advising on gene editing cases. In response, the speaker provided a checklist. Firstly, by asking about the informed consent of the patient and whether they know the risks involved. Secondly, by investigating the method of gene editing and whether or not it is covered under regulations or laws in place.


In the European Union, there is some regulation of gene editing but it is not via one specific law. For example, there are directives relating to patents and GMOs. There is also the Clinical Trial Regulations. The Council of Europe also formulated the Oviedo Convention in 1997 which is the only international legally binding instrument on the protection of human rights in the biomedical field.  However, the downside of these laws is that they only apply to member countries.

In Malaysia, there are no regulations in place but Dr Lau asserted that right now, the Malaysian public would benefit the most from awareness and education. She also made reference to a paper written by researchers at University Sains Malaysia called ‘Is Malaysia Ready for Human Gene Editing: A Regulatory, Biosafety and Biosecurity Perspective’ that emphasises this point as well.


In summing up the talk, Dr Lau expressed her take on governance via 3 Rs;

  1. Reframe. Legislative amendments/additions are needed to establish boundaries between science, law, the state and society. Then it can be established whether there are effects on constitutional frameworks.
  2. Redesign – There needs to be international standards for having a strategy of governance to mobilise national and international bodies together. Financial institutions should also be involved to utilise gene editing and other techniques to produce solutions.
  3. Resilience – To look at international norms and assess if they can withstand developments in technology, and if it can be implemented in countries such as Malaysia.

Undoubtedly, gene editing has potential benefits for the public via treatment. However, it is still unknown how safe it is because what happens when we cross the line from therapy and treatment, to enhancement and augmentation is still uncertain. For this reason, it is important why there needs to be rigorous research and ethical considerations. Safety is the most important factor but development should also be encouraged. As a midway point, Dr Lau suggests that it should be sufficient to work towards “safe enough” where the benefits outweigh the risks.


Published on 28 June 2021

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