This Article is written by Aqsa Mirza, a Third-year law student of Dr Panjabrao Deshmukh College of Law, Amravati

Introduction

Genetic editing is one of the advanced scientific technologies that promise nothing less than revolutions in medicine, agriculture, and biotechnology. Such technologies as CRISPR-Cas9 opened up new possibilities for precise editing of an organism's DNA to treat genetic diseases, increase agricultural yields, and even propose changes in human germline genetics. On the other hand, such advances generated debates on the legal as well as ethical ramifications.

Genetic editing is an enormously multifaceted area of law that often represents a slow-bid response to very rapid strides in technological change. The ethical ramifications also profoundly question how far human activity may extend toward altering aspects of nature. This paper delves into the legal and ethical dimensions of genetic editing, with attention paid to international regulation of the subject and its relationship to human rights as well as the potential risks and benefits of genetic modification.

Science of Genetic Editing: CRISPR and Beyond

The CRISPR-Cas9 system remains at the heart of the genetic editing revolution, gifting scientists with the ability to make very precise changes in DNA sequences.[1] Where other gene editing techniques were clumsy and imprecise, the CRISPR capability to "cut" DNA at specific locations accelerates research in both genetic therapies and agricultural biotechnology.[2]

The two categories of genetic editing include somatic cell editing and germline editing. Somatic editing is alterations to non-reproductive cells while affecting only the individual, whereas germline editing addresses the alterations to the reproductive cells, thus possibly being handed down to future generations.[3]. Such a feature of germline editing presents different kinds of ethical issues about unforeseen changes passed on to offspring.

International Legal Frameworks on Genetic Editing

International frameworks of comprehensive laws are less advanced than the edifices of technological development into genetic editing. Differences in regulations across jurisdictions abound, with some countries embracing gene editing for use in medicine and agriculture, while others limit its use strictly and are particularly reticent about human genetic modification.[4]

The Convention on Human Rights and Biomedicine[5], being one of the most important international legal instruments concerning genetic editing, bans interventions aimed at changing the human genome for purposes other than of a therapeutic or diagnostic nature[6]. The convention was taken up by the Council of Europe and Article 13 of the convention bans modification of the human germline.[7] However, the Oviedo Convention has not been ratified by several major countries including the United States and China, so its influence is limited to parts of the world.[8].

Another significant legal framework is the UNESCO Universal Declaration on the Human Genome and Human Rights 1997, which emphasizes respect for human dignity, rights, and fundamental freedoms in genetic editing.[9]. Article 11 makes clear provisions against any "practices which are contrary to human dignity, such as reproductive cloning of human beings."[10] The declaration, being nongenerative but not technically a legally binding instrument, remains a very important source for ethics guidance both to governments and researchers[11].

National Approaches: Consensus and Conflict

International instruments are minimal in terms of guidance on genetic editing, but national approaches are quite divergent in this regard. China and the United States have been more lenient on certain aspects of genetic editing, while the European Union has been more conservative, especially on human germline editing.[12].

Perhaps no government is as mild on genetic editing as the Chinese are. Thus, the controversial case of Dr. He Jiankui in 2018 made worldwide headlines after he used CRISPR to modify the germline of twin girls to make them resistant to HIV.[13]. The event elicited widespread global outrage and calls for tighter regulation. In response, the Chinese government issued stricter guidelines on gene editing, but regulation remains relatively less stringent than in other countries.[14].

Europe, on the other hand, had been a step slower. The European Union's General Data Protection Regulation has specific provisions regarding genetic data complete with safeguards against abuse.[15]. The regulatory environment in the EU on genetic editing, particularly in agriculture, is also extremely restrictive over GMOs[16]. Divergences in regulatory regimes between countries vary according to greater divergences that exist in ethics and law.

Human Rights and Genetic Editing

Genetic editing, particularly human germline modification, presents significant human rights challenges. The right to health under international law includes the right to "enjoy the benefits of scientific progress,"[17] but then also has to be balanced with the right to life, human dignity, and the rights of yet-unborn generations[18]. Human embryo modification raises very complex questions regarding autonomy and consent over the bodies of future people who cannot give their consent over modifications being made to their genetic compositions.

Human germline editing will aggravate the already existing disparities. Genetic alterations for non-therapeutic purposes of enhancing intelligence or physical features, advocates argue, will isolate a new class of well-known individuals to be "genetically enhanced, thereby excluding social and economic classes.[19]. From the standpoint of eugenics, another reason why genetic discrimination should also be excluded from human germline editing is the possibility of such discrimination.[20].

In addition, the UN Convention on the Rights of Persons with Disabilities (CRPD) has become an important element in the debate on the issue of genetic editing. While gene editing brings with it the potential of ridding humanity of certain disabilities, ethical questions are now being raised about how much value is to be placed on diversity and the right of people with disabilities to exist.[21]. The CRPD affirms the rights of persons with disabilities to be treated with dignity and respect, challenging the notion that disabilities should be "edited out" of the human genome.[22].

Ethical Concerns in Gene Editing

The ethical questions behind genetic editing reach very deep. One of the fundamental bases upon which the ethical reasons against germline modification stand is that human dignity should be upheld[23]. The desire to modify the human genome, especially for nontherapeutic reasons, is thought by many ethicists to represent a direct challenge to the intrinsic dignity of human beings.[24]. Other than this, the precautionary principle deeply intervenes in the ethical debate, since the effects of the modifications of the genome-the more so those which touch generations to come-are unknown in the long term.[25].

The other ethical concern raised by the possibility of using genetic editing for enhancement and not for therapy is that genetic editing could be applied for enhancement, not for therapies. Using these technologies to edit out dangerous life-threatening diseases makes it possible to argue for the therapeutic application of those technologies, but if the same technologies are used for enhancing human intelligence, beauty, or athleticism, then it would appear to raise concerns about fairness and possibly unequal availability of genetic advantage.[26].

Another major ethical consideration is informed consent. In the case of somatic gene therapy, humans can consent for themselves[27]. However, about germline editing, decisions made in the present will affect future generations, and they cannot, by definition, consent[28]. The issues then come down to intergenerational justice and the rights of future individuals[29].

Risks and Benefits of Genetic Editing

The benefits in medicine due to genetic editing are enormous. For example, genetic editing holds the potential to cure disorders such as cystic fibrosis, sickle-cell anemia, and Huntington's disease by altering or modifying the genes of the disorder.[30]. Some promising treatments have also come forth as a result of discovering gene therapies with CRISPR technology for certain types of cancers and blood disorders.[31].

Its potential in agriculture includes increased crop yields, improved resistance to pests and diseases, and greater nutritional value.[32]. These would go a long way in feeding the world and mitigating some effects of climate change.[33].

However, the risks involved with genetic editing are of equal importance. There is a major problem with off-target effects the intended and un-programmed changes in the genetic material may introduce unknown health effects.[34]. Moreover, germline editing is an irreversible procedure; any mistakes introduced during this editing could be transferred to future generations.[35].

The dual-use applications of genetic editing technologies also raise concerns about potential misuse. Genetic editing may be applied in the development of biological weapons or the creation of designer babies with enhanced traits, which presents a serious issue of ethical security.[36]. The lack of a global regime for dual-use technologies makes international cooperation at par critical in addressing these risks.[37].

The Future of Genetic Editing: Legal and Ethical Concerns

As genetic editing technologies are evolving, there is an ever-increasing need for a comprehensive legal and ethical framework. The present ad-hoc collection of national regulations and non-binding international agreements is not able to tackle the global nature of genetic editing technologies.[38]. A more harmonized international approach is needed so that genetic editing can go along with responsible and ethical use.

A third would be the establishment of an International Convention on Genetic Editing, a treaty-based framework for developing standards for the use of genetic editing technologies.[39]. Undoubtedly, the International Convention would build on already extant arrangements, such as the Convention on Biological Diversity (CBD), which has already addressed the regulation of genetically modified organisms.[40].

National governments must, in the interim, ensure that their law regimes keep pace with the pace of technological development in genetic editing.[41]. Policymakers should focus on developing guidelines that are human rights-friendly, which will preclude misuse while finding a way to equitably distribute the benefits of genetic editing.[42].

Conclusion

Genetic editing offers unprecedented opportunities, but also deep ethical and legal dilemmas. Of course, the potential rewards are limitless- from curing genetic diseases to improving global food security have to be weighed against hazards of unforeseen outcomes, equality in society, and questions about human dignity and the rights of future generations.

Such a fast-evolving new branch of science and technology also calls for guidance by international law that is at the same time harmonized in its approaches but infused with human rights principles, equity, and precaution to allow for the use of genetic editing technologies in favour of all humanity while minimizing the risks of their possible misuse.

References

[1] Jennifer A. Doudna and Emmanuelle Charpentier, 'The New Frontier of Genome Engineering with CRISPR-Cas9' (2014) 346 Science 1258096.

[2] Eric Lander, 'The Heroes of CRISPR' (2016) 531 Nature 9.

[3] National Academy of Sciences, 'Human Genome Editing: Science, Ethics, and Governance' (2017) https://www.nap.edu/read/24623/chapter/1.

[4] Ibid.

[5] Council of Europe, 'Convention on Human Rights and Biomedicine' (1997) ETS No 164.

[6] Ibid art 13.

[7] Ibid.

[8] Maureen Kearney, 'Genetic Editing and the Oviedo Convention: Gaps in Global Governance' (2020) 54 Journal of Medical Ethics 324.

[9] UNESCO, 'Universal Declaration on the Human Genome and Human Rights' (1997) https://unesdoc.unesco.org/ark:/48223/pf0000110220.

[10] Ibid art 11.

[11] John Harris, 'Ethics and the Future of Gene Editing' (2017) 28 Journal of Bioethics 14.

[12] China’s Ministry of Science and Technology, 'Regulations on Human Genetic Resources' (2019) https://www.most.gov.cn.

[13] David Cyranoski, 'The CRISPR Baby Scandal: What’s Next for Human Gene Editing?' (2019) 566 Nature 440.

[14] Stanley Perrin, 'China’s Revised Gene-Editing Regulations: A Step Forward or Backward?' (2020) 55 The New England Journal of Medicine 712.

[15] General Data Protection Regulation (EU) 2016/679 art 9.

[16] European Parliament, 'Regulation of GMOs in the EU' (2017) https://www.europarl.europa.eu.

[17] International Covenant on Economic, Social and Cultural Rights (adopted 16 December 1966, entered into force 3 January 1976) 993 UNTS 3 art 15.

[18] Julian Savulescu, 'Procreative Beneficence: Why We Should Select the Best Children' (2001) 28 Bioethics 413.

[19] Thomas Douglas, 'Enhancement and Inequality' (2019) 67 Philosophy and Public Affairs 323.

[20] Ibid.

[21] UN Convention on the Rights of Persons with Disabilities (2006) A/RES/61/106.

[22] Ibid art 3.

[23] Martha Nussbaum, 'Human Dignity and Political Entitlements' (2011) 23 The Journal of Human Development 1.

[24]Michael Sandel, 'The Case Against Perfection: Ethics in the Age of Genetic Engineering' (2007) 21 Bioethics 18.

[25] Ibid.

[26] Nicholas Agar, 'Liberal Eugenics: In Defence of Human Enhancement' (2004) 36 Journal of Medical Ethics 125.

[27] Henry Greely, 'The End of Sex and the Future of Human Reproduction' (2016) 45 Stanford Law Review 89.

[28] Ibid.

[29] Christine Overall, 'Genetic Editing and Intergenerational Justice' (2018) 64 The Monist 563.

[30] American Society of Human Genetics, 'Gene Editing and Human Diseases: Clinical Trials and Challenges' (2020) 56 Genetics in Medicine 1120.

[31] Ibid.

[32] The National Academies Press, 'Genetically Engineered Crops: Experiences and Prospects' (2016) https://www.nap.edu/read/23395/chapter/1.

[33] Pamela Ronald, 'Genetic Engineering and Global Food Security' (2014) 45 Annual Review of Plant Biology 499.

[34] George Church, 'CRISPR Off-Target Effects and the Future of Genetic Editing' (2020) 34 The CRISPR Journal 129.

[35] Ibid.

[36] International Committee of the Red Cross, 'The Risks of Genetic Editing in Armed Conflict' (2021) https://www.icrc.org/en/document/gene-editing-and-conflict.

[37] Jennifer Kuzma, 'Regulating Genetic Editing and Dual-Use Technologies: Challenges and Opportunities' (2019) 68 Science and Public Policy 243.

[38] Nuffield Council on Bioethics, 'Genome Editing and Human Reproduction' (2018) https://nuffieldbioethics.org/publications/genome-editing-and-human-reproduction.

[39] Nuffield Council on Bioethics, 'International Governance of Human Germline Editing' (2020) https://nuffieldbioethics.org/publications/international-governance-of-genome-editing.

[40] Convention on Biological Diversity (adopted 22 May 1992, entered into force 29 December 1993) 1760 UNTS 79.

[41] World Health Organization, 'Global Report on Human Gene Editing' (2021) https://www.who.int.

[42] Ibid.