GENE-EDITING
Gene-Editing (also fondly known as ‘Genome Editing’) is a powerful tool that is used by scientists for the purpose of making additions, deletions and alterations to the genetic materials in an organism or known as genome. In simpler terms, it enables scientists to make changes to an organism’s DNA. This scientific tool mainly serves three purposes, which includes therapy, prevention and enhancement. It is commonly used on animals, plants and even on humans.
This article aims to give a brief but concise overview of Gene-Editing in animals, plants and even humans.
GENE-EDITING IN ANIMALS AND PLANTS
With the rise of global food insecurity crisis that is exacerbated by the war in Ukraine and the Covid-19 pandemic, it is provided that Gene-Editing in animals, particularly livestock, can be beneficial in tackling the issue of food shortage and agricultural productivity. One of the examples of Gene-Editing in animals is the production of disease-resistant pigs. The University of Edinburgh’s Roslin Institute is currently working with the animal genetics company, Genus, on creating pigs that are resistant of Porcine Reproductive and Respiratory Syndrome (‘PRRS’),1 which is one of the most costly animal disease in the world that costs USD 664 million of losses per year in the United States’ Swine Industry.2
On the other aspect of boosting food supply, the increased production of agriculture crops is arguably also one of the top priorities due to the rapid growth in population and climate change, as seen in the recent heat waves around Europe.3 In this case, Gene-editing is a great tool to make plants hardier against tough climate challenges that are continuously spiraling.
One example of Gene-Editing in plants, particularly crops, is by enhancing drought-tolerance rice, a food that is consumed by more than one billion people in the world. Gene-editing technologies such as CRISPR-Cas, have been used to disrupt the sensitivity genes (‘Se genes’) so that plants will be able to resist droughts and be more heat-resistant. This results in more hardy crops which are less susceptible to extreme weather conditions, and in turn, resulting in a more stable food supply.
GENE-EDITING IN HUMANS
In 2012, a team of scientists discovered the possibility of editing a person’s genes by a method referred to as CRISPR-Cas9. Effectively, this method is about editing an individual’s genes to, for example, prevent viral infections.
There are two things to keep in mind when it comes to Gene-Editing technologies that can be used on humans, one is somatic cells, which are cells other than egg and sperm cells, hence are not inheritable. The other is germline cells, which can be for reproduction (passing on changes to future generations) or not for reproduction.
Gene-Editing in humans is important in terms of prevention, treatment and new strategies for diagnosis of human disease. Currently there are numerous clinical and research trials on single gene disorders such as sickle cell disease and hemophilia, and also on complex diseases such as human immunodeficiency virus (HIV) infection, mental illnesses, cancer and more.
In the recent development on Gene-Editing in humans, a USD 900 million research collaboration between global biotechnology company, named Vertex, and Gene-Editing company, named CRISPR Therapeutics, was announced back in 2015. They have developed a therapy that can help patients with rare genetic blood disease, which essentially involves the process of extracting the patient’s stem cells, modifying the cells outside the body and putting the modified cells back into the patients’ body, so that healthy hemoglobin and red blood cells will be produced. They have recently announced their clinical trial results in July 2022 and indicated that a First Gene-Editing drug may reach the market sometime in 2023.4
TERRIFIC OR TERRIFIED?
From the looks of things, there is no doubt that Gene-Editing technologies are revolutionary and will provide unlimited global health benefits to human and non-human species. However, the European Group on Ethics in Science and New Technologies (‘EGE’) has stated that the high hopes on Gene-Editing are also matched by far-reaching fears.5
One of the concerns expressed by EGE is on the clinical application of Gene-Editing in humans, especially with the purpose of enhancement. This has always been the center of debates when compared clinical trials with other purposes such as therapy and prevention. Not to mention that after the scandal of the first Chinese-edited baby was released in 2018, it is clear that the ‘success story’ (as the risks are yet to be determined) of He JianKui did not help with the public’s view on Gene-Editing, as the human germline editing community was and is still faced with heavy criticisms and backlash, with some calling for a moratorium on Gene-Editing in humans.
The reason for such fear and criticisms is because of the uncertainties as to the potential risks and benefits, as there may be occurrences of unanticipated genetic mistakes and long-term risks that may be passed on to the next generations. To add, Gene-Editing in Humans also raised conceptual considerations, such as the impact on ethical principles, and long-term societal issues such as equality and diversity.
Furthermore, Gene-Editing can also be used in sports to boost the performance of athletes. The World Anti Doping Agency’s (‘WADA’) stance on Gene Doping is that it ‘represents a threat to the integrity of sport and the health of athletes’.6 As such, WADA is currently heavily involved in the process of detection of Gene Doping in Sports. We will discuss Gene-Editing in sports more heavily in another article.
GOVERNANCE ON GENE-EDITING
The governance on gene-editing relies on international and national regulations, policies and guidance.
On an international level, as of date, the most authoritative international agreement on biotechnology is perhaps the Council of Europe’s 1997 Convention on Human Rights and Biomedicine (also referred as ‘Oviedo Convention’). It is a binding human right treaty that bans inheritable human genetic modification and human reproductive cloning under Art 13 of the Oviedo Convention.
However, it is argued that the Oviedo Convention only binds 29 state parties and does not include gene-editing technology advanced states such as the United Kingdom, Russia and more, which makes it a mere international treaty of regional rather than of general application. Nevertheless, it remains an authoritative guidance as both international standards and good practices are incorporated in the area of biomedicine.7
On a national level, it should be noted that the regulatory approaches on gene-editing vary by countries. Examples can be seen in Japan, where the country regulates by determining the level of risks that may be presented with the proposed drugs and the degree of stringency that the certain regulatory process will be applied to will vary according to the risks assessed. Whereas in Brazil, the country’s regulation is done by way of accretion of general rules in the constitution and old laws. As a result, there are now approved laws specifically on genetically engineered foods, cell therapy and others in Brazil.8
Aside from that, when it comes to Gene-Editing within a country, it itself may have different attitudes and approaches when it comes to different aspects of biotechnology. One of the examples can be seen in the United States, where Gene-Editing in animals and plants in the agriculture sector are treated with a more lenient approach as compared with approach on Gene-Editing in Humans for the purpose of therapy.
As of date, there are still no uniform or consistent regulations on governing Gene-Editing, specifically Gene-Editing in Human. There is a call for international collaboration and/or harmonization of regulations of Gene-Editing. However, the reality is to have more than 100 nations to reach the same consensus on a certain subject, let alone complex subjects like Gene-Editing would be extremely difficult and time-consuming.
CONCLUSION
It is no surprise that on 22 June 2022, the Zion Market Research Analysis revealed that the CRISPR Genome Editing Market is expected to have a stark growth of 29.50%, with a market value of USD 15.84 Billion reaching by 2028.9 Making genome editing a highly profitable and competitive business in recent years.
Despite the ground-breaking speed of growth in Gene-Editing technologies, it is to be noted that the risks that it may or had entailed should not be ignored. It is also acknowledged that a proper and uniform governance on Gene-Editing in the global scale seems impossible, but it is argued that without such governance, Gene-Editing technologies may soon grow out of hand.
- University of Edinburgh, ‘Agreement targets disease-resistant pigs’ (University of Edinburgh, 16 July 2021) https://www.ed.ac.uk/news/2021/agreement-targets-disease-resistant-gene-edited-pi accessed by 15 July 2022.
- Valdes-Donoso P, Alvarez J, Jarvis LS, Morrison RB and Perez AM, ‘Production Losses From an Endemic Animal Disease: Porcine Reproductive and Respiratory Syndrome (PRRS) in Selected Midwest US Sow Farms’ [2018] 5 Front Vet Sci 102, 2.
- Ferrer B, ‘Our Food System is in trouble: Europe’s drought scorches food security amid warnings of ‘heatflation’ (FoodIngredientsFirst, 19 July 2022) https://www.foodingredientsfirst.com accessed by 20 July 2022.
- Sy Mukherjee, ‘The first CRISPR gene-editing drug is coming—possibly as soon as next year’ (Fast Company, 1 July 2022) https://www.fastcompany.com/90762983/gene-editing-drugs-are-coming accessed by 8 July 2022.
- European Commission, ‘European Group on Ethics in Science and New Technologies: Opinion on Ethics of Genome Editing’ OP (2019) 32.
- Gene Doping — World Anti Doping Agency https://www.wada-ama.org/en/gene-doping accessed on 29 July 2022.
- Dr. Rumiana Yotova, ‘Report on Regulation: The Regulation of Genome Editing and Human Reproduction Under International Law, EU Law and Comparative Law’ (2017) https://www.nuffieldbioethics.org/wp-content/uploads/Report-regulation-GEHR-for-web.pdf accessed by 24 July 2022.
- National Academies of Sciences, Engineering and Medicines, Human Genome Editing: Science, Ethics and Governance, (National Academies Press, 2017) 55.
- Zion Market Research, ‘Statistics on Global CRISPR Genome Editing Market Size & Share to Surpass USD 15.84 Billion by 2028, Exhibit a CAGR of 29.50% | CRISPR Industry Trends, Value, Analysis & Forecast Report by Zion Market Research’ (Bloomberg, 22 June 2022) https://www.bloomberg.com/press-releases/2022-06-22/statistics-on-global-crispr-genome-editing-market-size-share-to-surpass-usd-15-84-billion-by-2028-exhibit-a-cagr-of-29-50 accessed 14 July 2022.
