Breaking Through the Fog: Regulation of Human Gene Editing

1. Introduction

Genome editing refers to the modification of the DNA of the organism to alter its genetic material in order to achieve desirable outcomes. This technology enables the scientists to make targeted changes to genomes, offering potential cures for genetical diseases, insights into biological functions and agricultural improvements. One of the most well-known genome-editing tools is CRISPR-Cas9, which allows the researchers to modify, cut and replace specific DNA sequences like molecular scissors.

Human Genome Editing refers to making precise modifications to the DNA of the human cells. This powerful technology enables the scientists to modify an individual’s gene to achieve desirable characteristics. It offers potential for treating diseases and preventing them too. Such modifications are of two types, Germline and Somatic Cell editing. While Germline editing alters the DNA in embryos which passes down to future generations, somatic cell editing does not alter future offspring as it is pertaining to editing of non-reproductive cells.

2. Regulatory Gaps Fuel Ambiguity

Human gene editing is a tricky and volatile field in biomedicine that has grown quickly in recent years. Its rapid development calls for a proper regulatory framework that lays down strict conditions and guidelines to be maintained, without which it can lead to serious breaches of ethical concerns. 

One such event is China’s He Jiankui genome editing scandal where they enhanced and altered the genetic code of embryos using gene editing tools in 2018. After this incident, the government of China took immediate measures to introduce better guidelines, laws, and procedures that were monitored by their National Ethics Committee for Science and Technology. However, the absence of regulation before its introduction caused complexities in accountability fixation and determination of liability.

Even with the introduction of regulations, without the framing of exact and precise laws, the legal landscape for gene editing can prove to be rather ambiguous. See for example the Bioethics and Bio Safety Act (2016) of South Korea, where the regulations can be interpreted in multiple ways of whether the prohibition is imposed on using human embryos or aimed at human embryos. This possible loophole can cause ambiguity and misuse. 

India’s own regulatory framework is marred by ambiguity and lack of enforceability. While the National Guidelines for Stem Cell Research bans human genetic editing, it has not laid down guidelines with more binding and legal implicatures in criminal laws. Uncertainty in the legal sphere can promote the misuse and breach of ethical concerns. The lack of enforceability and punishment for said breaches could further lead to rouge underground labs and research that conduct experiments unsupervised.  

Overall, a careful nuanced approach is required while framing human gene editing legislations that ensures strict and robust foundations are laid down while simultaneously regarding public opinion and safety. The governments should ensure the passing of more watertight laws that prevent ambiguity and uncertainty which can lead to misuse of the technologies.

III. Banning Genome Editing- The Right way forward?

The Assisted Human Reproduction Act (2004) of Canada, Embryo Protection Act (1990) of Germany, Bioethics and Biosafety Act of South Korea, Oviedo Convention (Council of Europe Convention on Human Rights and Biomedicine) of France, the directive on clinical research involving germline genome editing (2024)  of China, National Guidelines for Stem Cell Research (by the Indian Council of Medical Research) of India Bans human genome editing especially in the cases of hereditary changes.

The ban on human genome editing prevents inter-alia, Inequality, violation of human rights, violation of consent and the potential for misuse. It can be argued that human- genome editing alters the primary identity of the individual, one for which they have not consented which violates the fundamental rights of the individual. Here the identity of the individual is a consequence of the preferences and choices of the previous generation, violating their autonomy. Further gene-editing would create a disparity of genetic haves and have-nots, which can lead to stratification in society and breed inequality.

 A higher concern is the potential for growth of Eugenics, that is the ideology of improving the quality of genetics of the human population through selective picking of desirable traits through discouraging or encouraging reproduction based on outcomes. A ghastly memory of the most recent such instance is the holocaust.

Additionally, it raises concerns over admissibility of DNA evidence. Altered genomes would complicate the traditional matching methods of the DNA and makes space for tampering evidence. Furthermore, if a criminal claims that his behavioral changes were caused by genome editing, the determination of the validity of such evidence would become complex and demand the testimony of an expert.

The Universal Declaration on the Human Genome and Human Rights of UNESCO deemed genome modification to be against human dignity considering the human genome to be the “heritage of humanity”, this shows the importance of ethical considerations when allowing modifications to human genome.

The human genome can be said to be a living record of the history of evolution that preserves the traces of migrations, interbreeding (Denisovans and Neanderthals) and adoptions. Allowing genetic modifications would hinder scientific development in this regard, as tracing roots would become cumbersome.

IV. Regulation, Not Prohibition, for Genome Editing

With the introduction of CRISPR-Cas9, a new door to human genome editing opened in the field of biomedicine. Its ability to possibly cure diseases has brought forth a revolutionary outlook but it can pose a serious threat to various ethical, social and medical concerns. While some propose its complete ban, implementing regulations under strict conditions would be more apt and fruitful, thereby enabling scientific developments while simultaneously taming the side effects of its mechanisms. Strong regulations, that are governed by qualified authorities, can prove to utilize the full capabilities of the technology without infringing upon the integrity and ethics of humans and animals alike.    

The United States’ National Institutes of Health Guidelines (NIH) and the United Kingdom’s Human Fertilization and Embryology Act (HFEA) demonstrate the extent to which the making of detailed and restrictive policies and regulatory specifications can facilitate innovation and ensure that the line between ethics and misuse are clearly drawn, as is the case observed across several bioethics issues.

UNESCO’s Universal Declaration on the Human Genome and Human Rights (1997), has respect for limitation of technology and underscores the need to put emphasis on the ethics of technology, public trust, and transparency. It can be achieved by engaging a broad range of stakeholders in the regulatory framework and thus building public confidence in the new technologies to be developed in the area of gene editing. At the same time, the WHO’s 2018 policy on human genome editing calls for due diligence, international partnerships, and appropriate regulation in order to avoid adverse consequences and distribute the benefits fairly among the people. Such frameworks recognize that gene editing cannot be treated solely as a scientific endeavor, rather it is a moral and societal challenge as well.

A total ban on the use of a technology or the practice will only push the practice underground, where it will lack regulatory guidelines and supervision. Legislation such as China’s National Ethics Committee for Science and Technology and even European Court of Justice’s Judgment of 2018 on Genetically Modified Organisms (GMOs) offer comprehensive coverage of risks that enable processes to be better managed regarding the research and experiments. This ensures that risks of abuse of the technology are mitigated with a more nuanced approach and a safer environment is created for use in conducting research and commissioning experiments.

V. Conclusion

In conclusion, either a complete ban or regulation of human genome editing that allows partial and specific usage of genome editing is the need of the hour. Without watertight and effective legislation supported by efficient enforcement of the same, human genome editing would have grave implications on society as stated above.

Ambiguities caused by absence of effective regulation has consequences beyond control where fixation of liability and accountability is unknown. Such a scenario leads to complexities and hazardous developments as in the case of China, where the government took measures after the embryos’ genetic code was modified and it caused debates over accountability and liability fixation.