Re-coding the ‘corrupt’ code: CRISPR-Cas9 interventions in human germ line editing
CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
Master Thesis Tilburg University- Law and Technology 2018-19 Tilburg Institute for Law, Technology, and Society (TILT)
October 2019
Student: Srishti Tripathy Supervisors: Prof. Dr. Robin Pierce SRN: 2012391 Dr. Emre Bayamlioglu
ANR: 659785 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
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Table of Contents
CHAPTER 1: Introduction ...... 6 1.1 Introduction and Review - “I think I’m crazy enough to do it” ...... 6 1.2 Research Question and Sub Questions ...... 9 1.4 Methodology ...... 9 1.4 Thesis structure: ...... 10 1.5 Relevance and Significance ...... 11 CHAPTER 2- Understanding the ‘algorithms’: How genes are related to cognition? .. 13 2.1 Introduction ...... 13 2.2 Genetics and cognition ...... 14 2.3 Cultivating Post-Human society: Why this scare? ...... 19 2.4 Conclusion ...... 20 CHAPTER 3: Metamorphosis into a delusional state ...... 22 3.1 Introduction ...... 22 3.2 Genetic manipulation for autonomous human ...... 22 3.3 The right to mental self-determination ...... 28 3.4 Creatures of Mind: Cognitive liberty ...... 29 3.5 Conclusion ...... 31 CHAPTER 4: Human Rights and the curious case of CRISPR-Cas9 germline application 32 4.1 Introduction ...... 32 4.2 “Everyone has the right to freedom of thought, conscience and religion……..”: ...... 37 4.3 Conclusion ...... 39 CHAPTER 5: International schema...... 41 5.1 Introduction ...... 41 5.2 Universal Declaration on Human Genome and Human Rights ...... 42 5.3 Legal background ...... 44 5.4 Oviedo Convention ...... 48 5.5 Review oversight ...... 50 5.6 Lack of legal solutions in the international regulatory landscape ...... 50 5.7 Conclusion ...... 52 CONCLUSION AND AFTERWARD: predict the future: Avert the danger ...... 55 Bibliography...... 58 Books ...... 58 Articles and Journals ...... 58 Statues and legislations ...... 63 Blogs...... 64 Caselaws ...... 64
4 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
5 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
CHAPTER 1: Introduction
To defeat the evil should we become a greater evil?1
1.1 Introduction and Review - “I think I’m crazy enough to do it”2
Humanity has survived the ravages of time; it has evolved, adapted and modified itself to suit its own need and the needs of society. In order to study and chart the evolutionary course of humanity, gene plays a singular arch role in it, but does the study of it also give us the liberty to edit/ modify/ engineer it? Through biotechnology that can edit or intervene human genome, 3 is not a new phenomenon, but the grandest of them all, called Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR-Cas9) allows to cut and paste with precision into the coding sequence of basis of a single gene, the grandeur of this technology is its simplicity and applicative accuracy,4 that has the world polarized between it being a boon or a bane. 2019, ushered a new era of gene editing, germline modification, not theoretical but in practice, when He Jiankui, a genome-editing researcher at the Southern University of Science and Technology of China in Shenzhen, announced that He has successfully delivered twins from genetically modified embryo. 5 This edit was performed to make them and their future off spring HIV- resistant. 6 What followed was not just limited to international outcry in the scientific community,7 but a series of further research on the edited gene (CCR5),8 that led to exponential insights to the linkages of gene and human cognition.9 Recently a Russian researcher Denis
1 Lelouch Vi Britannia, Code Geass 2Russian Molecular biologist Denis Rebrikov, on genetically editing human embryo. 3 Energy USDof, “Biotechnology And The Human Genome Project” (Serving Science and Society in the New Millenium: DOE's Biological and Environmental Research Program. January 1, 1998)
6 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
Rebrikov head of the Kulakov National Medical Research Center for Obstetrics, is cultivating the same notion of implanting gene- edited embryos in women, and the experiment will target the same gene, i.e., CCR5 gene, the embryos will be implanted in HIV positive women.10 Thought there was an international ban on the clinical use of the technology, but it does not apply to germline editing,11 there was and has continuously been a violation of the use of the technology itself on humans genome.12 The reasons for a moratorium of use of CRISPR-Cas 9 technology are not birthed out of only ethical and societal reasons, but majorly scientific, due to the off-target effects, the unwanted mutations and a low efficiency of homologous recombination directed repair.13 As research progresses we gain knowledge of specific identified genes that mantel a vital role in control of cognitive functions in humans advances. This poses a eugenics temptation wherein one can re-write the genetic code, thereby reshaping the contents of human body and mind, and the collective identity of a person.14 The implication that this can have are varied in nature,15 but in specific the impact that the technology will have on the Human Rights of individuals are certainly being discussed.16 The incentive to edit or modify or manipulate the human gene that transgresses beyond the generation of oneself, germline, go beyond healthcare,17 it captures the wish to enhance as well. The application of CRISPR-Cas 9 for manipulation of human germline lacks efficiency and safety,18 but the prospect of refining the use of the technology is not a distant future, with the
Cognition can be defined as the processes an organism uses to organize information. This includes acquiring information (perception), selecting (attention), representing (understanding) and retaining (memory) information, and using it to guide behaviour (reasoning and coordination of motor outputs). Interventions to improve cognitive function may be directed at any one of these core faculties. 10 Cyranoski D, “Russian Biologist Plans More CRISPR-Edited Babies” (Nature News June 10, 2019)
7 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation reality of it being readily available (DIY Crispr-cas9 kits).19 The natural progression of any debacle where a human subject is involved is the legal and ethical issues surrounding it. Though the existing literature is engulfed in diverse issues, the specificity of CRIPSR-Cas9 application on human cognition is unexplored in the legal domain, due to its nascent development of the study of neurogenetics. This leads to a direct invasive intervention to alter the cognitive function, systematically and intentionally, which consequently hampers the Human Rights of individual leading to illegitimacy of its application. Especially when it has the potential to impact memory, attention, and behavioural traits of individual. This invasive anomaly of human cognition, leads to tampering of autonomy, liberty and Human Rights of individuals. Additionally, the regulation of germline gene editing is sketchy, nationally and most importantly non-existent internationally.20 The salient distinction of what amounts to legal and illegal genome intervention can only be addressed by a regulatory structure. This work is an assimilation of how the technology interacts with the facets that will contribute to illegitimate direct intervention to altering thought linked to the notion of freedom of thought;21 this will be used as an anchor to stimulate the need for a framework for regulation of germline editing. The complexity of biotechnology is not the only aspect that CRISPR-Cas9 regulators have to battle but its dual use and entry into the neurotechnology, to advance neuroscience.22 The direct control of the hardware (DNA) along with the software (brain, mind, cognition, thought) and its potential (mis)-use is looming large. The existing literature has not yet attributed a threat to freedom of thought by CRIPSR-Cas9, unlike it’s done for neurotechnology. 23 Albeit, the ethical, legal, philosophical quagmires that will sprout at various junctures in this work are analysed taking into consideration bio-ethics and social consequences due to the misuse of CRISPR-Cas9, which will violate Human Rights. Furthermore, the lacuna in the legal literature is in understanding the need for regulation as a branch of public international law, the deployment of a workable framework is inevitable,
19 You can buy it too on, https://www.amazon.com/DIY-Bacterial-Genome-Engineering- CRISPR/dp/B071ZXW1TW 20 The Regulatory Review, “Gene Editing of Human Embryos Prompts Calls For Regulation” (The Regulatory Review August 14, 2018)
8 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation this work analysis the current landscape of international legal structures that are applicable to the use of the technology. Breathing and living in what appears to be the age of dystopia, through this thesis, I will undertake a theoretical journey to project the need for an international regulatory framework in the wake of CRISPR-Cas9’s ability to re-structure the cognitive activity, thought of an individual. Lastly, by no manner will this work limit itself to only a particular field, but borrowing insights from legal philosophy, bio-ethics, euro-ethics, neuro-law, behavioural genetics, genetics and cognition.
1.2 Research Question and Sub Questions
In order to bridge the research gap that has been identified in the current literature, the following questions will be used as pointers to adequately contribute to the existing status quo:-
Main Question: Do we need an International regulatory framework on germline application of CRISPR/ Cas9 technology in the wake of it altering human cognitive processes?
Sub questions: What are the aspects of genetic engineering that are problematic to human thought? . What does autonomy have to do with germline modification by Crispr-Cas9? . What is the role of cognitive liberty in application of CRISPR-cas9? How does the application of CRISPRCas9 in human germ line editing impinge the freedom of thought? . What parts of the definition of freedom of thought by UDHR are in threat due to CRIPSR-Cas9 and its application? What is the current status of international regulatory framework regarding human germline engineering by CRISPR-Cas9?
1.4 Methodology
The spark of novelty for this thesis was ignited by the news of genetically edited twins by He along with bare readings on behavioural genetics, from which I obtained the idea to relate the threat to freedom of thought to the application of CRISPR-Cas9 which has an affect on human cognition. This accompanied with an analysis of the existing international legal structures for germline editing were the principal source for my idea to embark on this work, i.e. the need to have a regulatory framework. The lack of literature specifically related to my topic, expect one
9 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation by Andrea Lavazza, 24 which speaks above cognitive enhancement due to CRISPR-Cas9 application on single targeted gene, gave me some leads to structure my work. Subsequently, for chapter 2 and 3 my research was mostly done on academic search engines like SSRN, Google Scholar, Weily, Springler, HeinOnline, typing keywords ‘ autonomy’,‘ manipulation’, ‘genetic manipulation’, ‘cognitive liberty’ this gave me results from a neuroscitific perspective, they were thus analysed to adapt to genetic manipulation of human cognitive activities, for this the grounding experiment was the use of CRISPR-Cas on an autism gene, for deletions in the ‘ Fragile X syndrome’. The introductory section, Gene and cognition, purely scientific articles were dealt with, mainly search on Nature and other scientific journals. There had to an extrapolation of what is applicable for neurotechnology (like EEG and fMRI) to CRISPR-Cas9. To encapsulate the connection to freedom of thought in chapter 4, the existing legal statute by UDHR was foundational. Along with “Freedom of thought for the extended mind: cognitive enhancement and the constitution”, by Marc Jonathan Blitz, was instrument in understanding the concept of freedom of thought. Chapter 5, especially centred around answering the main research question, a critical review of the all the cumulative legal structures, that are existing in the international public law area were looked upon, the international committees, the reporting by Universal declaration on human genome and Human Rights, OVIEDO Convention, WHO, led to analyse the void in germline editing by CRISPR-Cas9. This assisted in formulation of arguments that will be an in- exhaustive list to think about a regulatory framework for germline editing, due to the existing and inevitable scare of structuring cognitive activities of human species.
1.4 Thesis structure:
Chapter 1 defines the object and purpose of this thesis. The introduction is a literature review of the existing patterns of CRIPSR-Cas9 technology. It showcases the current application of the technology in the realm of human germline editing. Chapter 2 shows the correlation between gene and cognition, the chapter accumulates data from scientific literature; this partially answers sub-question 1 concluding on the threats of invasive direct intervention and the consequent misuse of it. Establishing a scientific basis for the following chapters. Chapter 3 in elaborating the concepts of autonomy, self-determination and cognitive liberty that are intrinsically linked to freedom of thought, these concepts are discussed in terms of germline application of CRISPR-Cas9 that alter human cognition and thus will be an invasive intervention
24 Lavazza A, “Cognitive Enhancement through Genetic Editing: a New Frontier to Explore (and to Regulate)?” (SpringerLink October 15, 2018)
10 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation as it impinges on these concepts, to explain this there was an extrapolation of existing literature on neuro-law as the legal literature extensively talks about the application of neurotechnology that impinges freedom of thought . This chapter specifically answers sub question 1. Chapter 4 in answering the sub question 2 dismantled the Human Right of freedom of thought as explained in Article 18 OF Universal Declaration of Human Rights, and for this again varied legal literature available on neuro-legal-ethical were used. Lastly chapter 5 answers sub-question 5 and the lack of international legal structures in regulating germline editing, as the previous chapters showcase that the technology win impinging other Human rights also violates freedom of thought as it has the capacity to directly alter human cognition that is invasive and illegitimate. This ties all the threads together to answer the main research question that is the need for regulating the germline editing by this gene-editing tool.
1.5 Relevance and Significance
The proposed work has varied layers of significance, firstly, the gene editing tool CRISPR-Cas9 has been one of the most revolutionary gene editing tool that has been in the limelight in scientific, medical, social, ethical and legal literature for reasons varying from healthcare to human evolutionary scare. In theory every technological invention requires a period where the society will have the time to adapt to the invention, along with adapting to the technology to know and learn about the technology, its risks and benefits, the ethical and social implications of the technology. Secondly, thought the technology is still at its nascent stage but the diverse application of it and specifically the application of it on editing humans has attracted multiple opinions, and the one that has been repeatedly echoed by many scholars is the legal and ethical issues of gene- editing technology, this work will be an addition to the existing expression of the issues surrounding the germline application of the technology that can take the route to alter human cognition. The velocity at which technology grows and expands in today’s day and age, makes the adaptability of it non-violable. Therefore the regulators have to take into consideration the Collingridge Dilemma,25 an essential concept for responsibility and accountability in innovation, in consideration to science and technology. It is a foundational concept for governance of innovation and co-evolution between technology and society. The informational problem that
25 The Collingridge Dilemma illustrates the difficulty of regulating new technologies within two variables: information on a given technology (x) and power to control/regulate that technology (y): +x = -y (although we can understand the tech and its risks it is already entrenched in society, which means that it also is harder to regulate). -x = +y (although the tech is easy to regulate, since it is in an embrionary stage, we do not own the information necessary for an adequate judgment).
11 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation exists with a nascent innovation, and thereafter once the technology is entrenched into the society it becomes a power problem.26 Carlos Mariscal et al elucidates the importance of regulating a technology before its affects get entrenched into the society.27 This would be seen as a beneficial aspect because then there would not be the problem where the technology becomes so entrenched; regulation becomes complex and wherein cooperation’s and other actors will have interest in maintaining the status quo.28 A department dedicated to regulate CRISPR-Cas9 its permissible limits, this department could also make sure that there is just and equitable distribution of benefits resulting from CRISPR-Cas9 application, ensuring barriers and/ or restrictions on commercialisation of the technology.29 As noted by Carlos Mariscal et al and other scholars that the technology due to its revolutionary characteristics and globalised nature of science and technology warrants international approach in order to achieve international cooperation for the purpose of regulation.30 In terms of the Collingridge Dilemma as a ‘time’ concept for regulating technology, revels that CRISPR-Cas9 needs a continuous, interdisciplinary and international understanding, In a similar sense, this work this thesis will contribute to understand the legal impact, specifically on Human Rights, in an attempt to provide the need for international regulation.
Thirdly, from a regulatory perspective this work can give insights that the direct intervention in human germline that in conjunction to altering other gene interaction has ways (if specifically targeting a particular gene) will alter the cognation of a human. Thus lack of regulatory parameters internationally is hotly debated and are of urgent needed especially when China has already produced genetically and cognitively edited twin babies. This regulatory schema is essential to tame dreams of engineering the species. It is pertinent to state that this work is categorically detached from other existing legal literature that suggest issues to regulate the technology, thought this work will be an addition to the existing issues, but the possibility of altering cognition has grave consequences on the Human Right of freedom of thought, similar to neurotech tools and pharmacological drugs. These have been a great source of inspiration for a novel issue to sprout and propose a need for regulation, which has previously not been explained in state of exiting legal literature.
26 D. Collingridge: ‘’The social control of technology’’, (Francis Printer, 1980) 27 Mariscal C and Petropanagos A, “CRISPR as a Driving Force: the Model T of Biotechnology” (2016) 34 Monash Bioethics Review 101 28 Ibid 29 Ibid 30 ibid
12 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
CHAPTER 2- Understanding the ‘algorithms’31: How genes are related to cognition?
Tawny : [after Seth says it's Tawny's turn to teleport] I'm afraid. Seth Brundle : Don't be afraid. Ronnie : No. Be afraid. Be very afraid.32
2.1 Introduction
Studies on human brain and the mind have in recent years generated a flood of discoveries about the biology that underlies in our thinking.33 The more we know the more we understand how the interplay of genes is intrinsically connected to brain, and not just brain as a physical form but the functioning of it, mind, thinking, cognition, procession, formulation of thought that have a resultant affect on human behavioural traits. Scholars have established that in the coming years, 2020-2030 there would be a through discussion that will be birthed out of debate over the question to genetically engineer some behavioural traits of humans, wherein research already exists and explored about the traits with neurotechnology. 34 A world of genetically engineering humans, which was only virtually possible in Japanese anime, is not unimaginable reality, this will unleash impending havoc that is born from the neuro-genetically modified generation and not only for the current generation but for generations to come. CRISPR/Cas9, has also been a promising tool for neuroscientists for determining the molecular mechanisms of neural circuits involved in perception, cognition, memory, and behaviour and exploring therapeutic strategies for neurological and neuropsychiatric disorders35. There have already been studies underway in exploration of molecular and neural circuit basis of
31 Organisms are algorithms,” Yuval Noah Harari asserts in his provocative new book, “Homo Deus.” 32 The fly, 1986 33 Bioethicas and law by By Janet Dolgin, Lois L. Shepherd ( 2005) p- 181 34 “WILLIAM SIMS BAINBRIDGE” (SpringerLink)
13 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation cognation and memory using CRISPR- Cas9 technique.36 But the efficiency of CRISPR Cas 9 system has not been concretely proved and the off target issues have not been addressed.37 Steve Silberman in his book NeuroTribes, argues against the concept of editing or modification of genes “framing autism as a contemporary aberration,” instead suggesting it had roots in “very old genes that are shared widely in the general population while being concentrated more in certain families than in others. Whatever autism is, it is not a unique product of modern civilization, it is a strange gift from our deep past, passed down through millions of years of evolution.”38 This projects a brief introduction to the world of gene that are singularly related to human cognition, this chapter is dedicated to the scientific study of the subject, it will provide an analysis from scientific literature that is available on gene-cognition relation. The reason for doing is to establish the foundation to answer the main research question. This form the basis for the consequent chapters to flow that will funnel down to a legal issue, i.e the Human Rights. The identification of gene-cognition, the use (off target results will still remain contribute to scientific uncertainty leading to legal lacuna) and misuse of such a knowledge by person, state or private organisation due to lack of legal authority protecting its application will be reason for Human Rights to be violated continually. This will cause a web of social consequences, ethical issues, economic exploitation and legal effects, wherein a small tinker in one will cause a domino affect on the others.
2.2 Genetics and cognition
The genome wide association studies have increasingly researched on contribution of gene to cognition; there are specific genomic loci that are significantly associated with subcortical brain structures.39 “Deleting a single gene may not only alter how other genes are going to function but also may alter the overall behaviour of the cell and the phenotype of [the] organism,”40
36 Park H and others, “In Vivo Neuronal Gene Editing via CRISPR–Cas9 Amphiphilic Nanocomplexes Alleviates Deficits in Mouse Models of Alzheimer's Disease” (Nature News March 11, 2019)
14 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
Epigenetic gene regulation involves, regulation of genes that are other than to the sequence of DNA and includes changes to histones (proteins around which DNA is wrapped) and DNA methylation.41 These epigenetic changes can influence the growth of neurons in the developing brains and as well as modify activity of the neurons in the adult brain.42 Together, these epigenetic changes on neuron structure and function can have a marked influence on an organism's behaviour. 43 Though environmental factors play a very important role, but the interaction with the environment can be triggered by genetic influences. By determining the specific environmental transactions that amplify genetic influences across development and across contexts, researchers may uncover new opportunities for environmental intervention.44 Moreover, CRISPR-Cas9 is used as a novel method to achieve changes in epigenome editing, thus going even beyond genome editing, eventually rewriting our epigenetic markers. Another field that is closely linked to working of brain and genetics is neurology, which has shown critical signs link between genetics and how human brain functions.45 Thus, arguing from a foundational point of view editing genes would invariably lead to changes in cognition, as elucidated in the introductory chapter, as well as from the study of epigenetics. In a study by Lam et al. 70 independent genomic loci associated with general cognitive ability were identified, implicating 350 genes underlying cognitive ability. 46
“The mechanisms that build our brains are just a special case of the mechanisms that build the rest of our body. The initial structure of the mind, like the initial structure of the rest of the body, is a product of our genes."47 The importance of cognition in order to define mind, preliminarily, as set of cognitive faculties is that it allows us to be conscious, to remember, to perceive, to think. In understanding the underlying genetics of thinking process, cognition, a complex human trait, one has to first be introduced to the topic of heritability. A particular trait’s heritability is the variance in its
41 Epigenetics classically refers to the inheritable changes of hereditary information without perturbing DNA sequences. DNA methylation, demethylation, hydroxyl-methylation, histone modification, chromatin remodeling, gene imprinting, and noncoding RNA are the central mechanisms involved. They play important roles in diverse biological processes including gene regulation, iPSC reprogramming and maintenance, genomic imprinting, X- chromosome inactivation, aging, neurodegeneration, autoimmune modulation, and tumorigenesis. 42 Yao B and others, “Epigenetic Mechanisms in Neurogenesis” (Nature reviews. Neuroscience September 2016)
15 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation expression that can be explained by variation in genetics.48 The variance, that is the expression of a phenotype, is a combination of variance that is genetically and environmentally determined.49 Studies have shown that the complex aspects of human cognition, temperament and personality are considerate to be relatively highly heritable. 50% of the variance in these characteristics is accounted for by genetic variance.50 In addition to what was previously explained, genes account for approximately 50% to 70% of the variation in cognition at the population level. 51 This means that genetic differences between people account for 50% to 70% of the variation in performance on tests of cognitive abilities, such as reasoning, memory, processing speed, mental rotation, and knowledge. 52 Biologists have long recognized the conceptual parallels between cellular development and cognitive-behavioural memory formation. 53 The whole realm of behavioural genetics, which holds great value in understanding how the brain and Central Nervous System (CNS) work, is an established discipline analysing the personality traits and anti-social behaviour. There are genetically influenced characteristics that pay a role on one’s behaviour. This poses great risk to legal and ethical domains, and with the use of CRISPR –Cas 9 and its application in epigenetics, the ability to control and manipulate human traits is no more a production of imagination but actuality.54 Using genetic modification for autism, depression and other mental diseases show clear link and therefore show an impact on behaviour and what one thinks.55 Research conducted in the field of genetics and cognitive neuroscience have identified genes that are important for human memory, the connection of behaviour to genetics has been a long-standing study but with the study of neural markers. There are gene and genetic loci associated with intelligence. Human Psychology, that ranges from general intelligence to specific
48 (The Genetics of Cognitive Neuroscience, edited by Terry E. Goldberg, and Daniel R. Weinberger, MIT Press, 2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/uvtilburg- ebooks/detail.action?docID=3339063.) 49 Ibid, pg- 3,4 50 Plomin R, Owen MJ and McGuffin P, “The Genetic Basis of Complex Human Behaviors” (Science (New York, N.Y.)June 17, 1994)
55 “Genetic and Environmental Influences on Cognition Across ...”
16 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation personality traits are polygenic, resulting from many genes with small effects interacting with one another.56 Moreover, this link has been further researched due to the recent genetic modification of twin girls in china that altered the gene called CCR5,57 which not only makes mice smarter but also improves human brain recovery after stroke, and could be linked to greater success in school.58 A recent study that has been conducted suggest that the babies that were genetically modified using CRISPR to make the girls resistant to HIV, there is a possibility they may also have enhanced cognition and memory. 59In the central nervous system, CCR5 is expressed on neurons, astrocytes, and microglia and functions as a suppressor for cortical plasticity and hippocampal learning and memory.60Thus people who lack the gene would recover more quickly from strokes or brain injury, and furthermore people who lack one copy of the gene will perform better in their education, thus indirectly implying a role in their intelligence level. 61 Consequently, researchers have been able to discover and substitute DNA sequences with unprecedented precision and efficiency.62 A wave of single gene study associated with a specific disorder have dominated CRIPSR-Cas9 application, they have been successful in disarming single gene-neurodegenerative disorders ranging from Huntington’s disease to cystic fibrosis.63 The introduction to this work has vastly covered the experiment by He that has led to genetic cognitive modification in twins. Autism that has been labelled a common developmental disorder, the gene that when edited using CRISPR-Cas9, the researchers who performed the edit are certain that there will be significant behavioural changes. In 2018, it was discovered that intracranial injection of CRISPR–Gold, a non-viral delivery vehicle for the CRISPR–Cas9 ribonucleoprotein, edits genes in the brain of adult mice in multiple mouse models. CRISPR–Gold can deliver both Cas9 and Cpf1 ribonucleoproteins, and can edit all of the major cell types in the brain, including neurons, astrocytes and microglia,
56 Plomin R and Deary IJ, “Genetics and Intelligence Differences: Five Special Findings” (Molecular psychiatry February 2015)
17 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation with undetectable levels of toxicity at the doses used”.64 The reason this study is important is because it was targeted at the exaggerated repetitive behaviour caused by fragile X syndrome, a single gene form of autism spectrum disorder.65
“The really compelling thing about this paper is that Hye Young was able to show that if you injected CRISPR-Gold into the brain, you could knock out disease-causing genes and actually see fairly significant behavioural changes,” said CRISPR-Gold inventor Niren Murthy, a UC Berkeley professor of bioengineering. “This is the first time anyone had ever shown that with non-viral delivery.”66
In addition to above mentioned, a gene called SHANK3 that is a gene associated with autism spectrum disorder (ASD) the knockout in this gene will result in increased social dominance and other neurological functions. 67 This gene will invariably alter the cognitive function of an organism. This gene is associated with intellectual disability, sleep disturbances, lack of speech or severe language delay, etc. Stereotypy (stereotypical behaviours) are also common in ASD, also are speech and language impairments, connecting the gene to that this trait as well. The study on this gene is still at its nascent stage but the discovery is monumental and gives further understanding on how genes impact human cognition and behaviour. Moreover, research study has also shown a molecular mechanism for memory and attention, which are also closely linked to a single gene, this has been researched widely due to, Genome-Wide Association Studies (GWAS). Even the act of multi-tasking, ability to successfully complete several operations simultaneously and the ability to the same exists due to genetics, the COMT gene. 68 The variation in this gene also improves long-term memory. 69 The COMT gene is in fact an important regulator of the dopaminergic system and also of the endocannabinoid system, which are responsible for numerous metabolic functions in the nervous system, such as long-term
64 Lee B and others, “Nanoparticle Delivery of CRISPR into the Brain Rescues a Mouse Model of Fragile X Syndrome from Exaggerated Repetitive Behaviours” (Nature News June 25, 2018)
18 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation memory and multitasking itself, whose control centres reside in the prefrontal cortex.70 What essentially one can deduce from this study is that one will be able to genetically distinguish between people their differing cognitive abilities, well this has to be also taken with a pinch of salt, but the potential of gene editing, with such an information is not inevitable.71
2.3 Cultivating Post-Human society: Why this scare?
After explaining the causal link between genes and thought-cognition, there is an urgency to move towards the why this relation has been explained in such scientific detail. The grounding issue in this work is that ok misuse, the negligent use, and the illegitimate direct intervention in human germline that would disrupt the concepts of freedom of thought, if not already doing so. This section will elaborate on some known aspects where the projection of misuse can be seen, along with the ‘rouge’ scientists whose use has already
One such issue is the problem of bio hackers who have the power and tools to do anything with no liability for their actions. Therefore the fear of using it beyond clinical application or for illegitimate reasons is not unimaginable, and the same was proved right, the latest debacle by Josiah Zayner who was the first bio hacker to use the CRISPR-Cas9 technique to modify his DNA.72 The absence of International law regulating the technology or its affects would invariably lead to devastating scenarios, where the basic human rights of individuals will be impinged. This would not only lead to suppression of individuals that are considered ‘flawed’ or considered ‘unworthy’, but the difference herein is that the parents will have the will and power to change themselves and also their progeny according to their own will.73 To modify one’s own genome or the right to do so does technically fall under the brackets of ‘ liberal eugenics’, as opined by Habermas, and that is derived from the individual’s choice, without having to have any imposition from the state that would interfere or prohibit their choice.74 Habermas in his guarded approach did not consider the gravity of the situation where manipulation of your genotype that will in turn modify your phenotype (skin colour, eye colour, obesity, and even intelligence) will have the possibility of negative or positive discrimination.75
70Ibid, supra note 2 71 Ibid, supra note 25 72 Gruber K, “Biohackers” (EMBO reports May 22, 2019)
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Though the effort of national laws, like the U.S Food and Drug Administration, which strictly regulates clinical trials and the sale of do-it-yourself kits to produce gene therapies for self-administration is prohibited,76 but as seen in the case of Zayner, this regulation can easily be bypassed.77 Though the example given here is of muscle modification this work talks about modification that changes human cognition. It has been established in the chapter 2, section 2.2, that cognitive function of humans (memory, attention comprehension, control, coordination etc) are connected to genes.78 In order to reach the brain, one has to get over the blood-brain barrier to reach the neurons and edit the target gene that is expresses, and recent works in CRISPR-Cas9 has showcased that this is already being extensively researched.79 It is already a growing issue the invasive direct interventions, by CRISPR-Cas9 for cognitive alterations is easily accessible, in theory and in its practical application this is a continuing issue as physicians or medical practitioners, this is a direct intervention into the mental state of a human, a direct neurobiological intervention. There is an additional scare of enhancement80 too which has been projected by Aldous Huxely in the Brave New World where genetic manipulation would lead to a world scenario characterization by division into classes on the basis of human biological enhancement. A term that has been coined by Julian Sorrell Huxley called Transhumanism is the product of an enhanced human.81This Idea has been branded one of the most dangerous ideas in the world, as the democratic nature of humanity will be undermined.82 This issue attracts a lot of ethical issues for researchers and parents who would wish to genetically enhance the cognition of their children, and social imbalance it will cause in the society.83
2.4 Conclusion
76 “Current State of U.S. Food and Drug Administration Regulation for Cellular and Gene Therapy Products: Potential Cures on the Horizon” (Cytotherapy June 10, 2019)
20 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
The Section 2.2.which revealed the scientific grounding of gene and cognition, this was essential to point out that it is not unknown factor, the progression of science and technology has led to cellular understudying of how humans think, the direct intervention which was earlier only possible with neuro-technological device is now possible with gene editing tool. The SHANK3 gene, COMT gene and recently the CCR5 gene (the unintended consequence of it) that has been elucidated in the section will and have led to change in human cognition. This needs to be understood in the current scheme of application, the germline application of the technology makes such knowledge is scary, and shows the possible misuse of the technology. This is essential for understanding the next chapter, as this illegitimate use and misuse by not just bio- punks but also scientists will lead to direct invasive intervention. This chapter has led to the basic identification of genes that will be problematic, this is to narrow the vast existing scientific knowledge existing, but the unintended off -target results are vastly unknown. Building the base for the next chapter which will fully answer the second research sub-question, the facets that built to freedom of thought, autonomy, self determination and cognitive liberty which would be at threat due to germline application of CRISPR-Cas9.
21 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
CHAPTER 3: Metamorphosis into a delusional state
Leeloo: Everything you create, you use to destroy. Korben Dallas: Yeah, we call it human nature.84
3.1 Introduction
This section is to establish notions that lead to violation of a human right. Like DNA that is composed of 6 molecular components, the freedom or right to freedom of thought has varying components and I will use an exhaustive list of 3 to delineate the research. The reason could be called personal bias, but these were most applicable is defending freedom of thought against the invasive interventions by CRISPR-Cas9, and also taking into consideration the scope and limitations of the work, these concepts were taken into consideration.
3.2 Genetic manipulation for autonomous human
According to the Greek etymology of the word autonomy – ‘auto’ (self) and ‘nomos’ (law), it means self-governing or self-determination, this is to say that being autonomous is taking control or ownership of one’s own life with the capacity for deliberate self-transformation. In this work I will only use the concept of personal autonomy in order to stick to the relevance of the topic of this work. The development of manipulation of human germ line in the line of scientific advances constitutes a technological revolution that has led to deliberate manipulation of the genetic composition of living organisms.85 The central processing unit of this technological invention if the molecular editing tool of our genetic code but there is a difference between alienating genetic disorders, like Huntington’s disease or other neurodegenerative disorders but selecting non- disease genes that affect cognitive functions is grave. Taking the case of SHANK3 gene, associated with ASD, as previously stated in chapter 3.2, the desirability of particular personality trait, such as extroversion over introversion in terms of society its more desirable, to manipulate one’s gene resulting in manipulating the thing and personality of an individual, is an ethical and legal conundrum that, that has motivated this work.
84 The Fifth Element, 1997 85 Paul, “CRISPR GMOs” (SSRN March 8, 2017)
22 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
Taking this into consideration the knockout of specific genes that are considered socially undesirable characteristic, lets site a hypothetical scenario say introversion deriving from the fact that one would not possess social dominance, the medical practitioner, on this own will or directed by state authority, would lead to various in ones behaviour as well, and resulting in a different set of decision making. Thus altering the set directly that would have taken in their natural progression, in these terms there is a direct invasion that resulted in altering the way one would naturally think or believe. Form its inception, the Human Genome Initiative, continues its path of mapping human genome, 86 this is expected to progressively grow due to the innovations in human genome mapping and sequencing.87 George P. Smith, et. al. has pointed out that the cumulative effect of the technology and its corresponding ability to catalogue and analyse the genotype of a particular individual create the potential for abuse of information.88 The eugenic projects of the past have continued to be Achilles Heel for the Human Genome Project. The issue at hand is not just the social engineering and development of ‘superior- modified’ humans (germline modification), but rather the impending abuse based on dissemination of arch information about the genotype combined with the phenotype of an individual revealing the rick factors of that particular individual. 89 Thus the management and handling of genetic information by state or even its agents directly implicates the liberty of an individual interest derived from the fundamental rights to quality and privacy.90 A similar disposition of manipulation to via invasive technologies is neurotechnology. Marcello Ienca explains how the possibility of external control over an individual’s future behaviour by use of various neurotechnologies will conflict with the moral values and personal autonomy and also interfere with the self-determination of personal identity. It is the way of free action that is in conjunction with self-chosen plan.
86 Hood L and Rowen L, “The Human Genome Project: Big Science Transforms Biology and Medicine” (Genome medicine September 13, 2013)
23 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
Anderson and Buss, have elucidated on the concept of autonomy which can be understood as the capacity of an individual to deliberate or act on basis of one’s own desires and plans and thus not be a product of manipulative or distorting external forces. The takeaway is that the use of CRISPR-Cas 9 and its application on germline editing has the capacity to influence the cognition, decision making and the behaviour, thus dominantly undermining the individual autonomy. Individual autonomy as a facet of human dignity is one of the guiding principle of medical ethics in clinical trials, “self-rule that is free from both controlling interference by others and from limitations” 91 A fundamental requirement for protection of patients and their dignity. 92 CRISPR-Cas9 has the power to reshape out thinking process biologically, freedom of mind should be placed in our hands and not in any other entity, parental or governmental. Blitz explains the notion of freedom of thought for the extended mind in terms of where the concept of freedom of thought is an inward concept and it is out of the realm of the state or external influences. There is an intrinsic value of not the biological ways of the brain but the mental capacity, the mind that dictates the cognitive activity and thought process. Mental Autonomy is a factor where one not only uses one’s mind but also has the freedom to shape it, autonomous mind. One cannot negate the fact that the one generates thought or it would be unless one refigures the personality that moulds it. The pathological traits like personality are encoded in our DNA and they also powerfully shape our thoughts.93The factors that one associates with autism, the attributes about anxiety and low social dominance, and on the contrary the one that exert social dominance, are more susceptive to risk taking, a decision making process.94 The want to be different and desire to do so is intrinsic to human nature. In order to like an autonomous life, self-evaluation is essential and this comes with a desire to transform as well. It has to be considered is cognitive alterations genetically administered are considered as reshaping oneself, which is also an attribution of autonomy. Thus in cognitive genetic modification it does not only lead to changes the person but also the cascading change of who he/she wants to become, the resultant affect being an inauthentic substitute. 95As noted by Blitz it is not the extension of autonomy, it is categorically undermines the original state, as it is trying
93 See Warren J, “Synaptic Self: How Our Brains Become Who We Are” (Journal of the Royal Society of Medicine July 2002)
24 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation to control over ones psyche. This is intrinsically related to identity of a person and the consequent loss of it due to tools that alter it, as stated by President’s Council on Bioethics. 96 The change brought about my application of CRISPR-Cas9 would be so profound in their genetic markers that the individual would not be the same as it would have been if not genetically engineered, the analogy can be drawn from the intake of a drug called Prozac that has the ability to make people more social and confident, but leads to cognitive alteration. Thus leads to an essential question; whose autonomy are we protecting? The genetically engineered individual or is it the one that is not engineered? The fact that the efficiency of the technology has not been proved there are far more chances of unpredictable shift of the identity of an individual. This is also an unanswerable issue and to a certain degree deeply contentious of how unpredictable the change or transformation of an individual would be due to a technology that is irreversable, once used its coded, permanent for the entire subsequent gene pool. From an ethical standpoint, autonomy is followed by consent, and altering the germline without the consent of next generation, this has been elucidated in the various commentrenties that ethically critically review the technology, thus calling for a moratorium on germline application of CRISPR-Cas9.97 The protection extends to those activities that will undermine the functioning of a democratic society and more importantly the protection of humans against direct invasive interventions. The , illegitimate use it by rouge scientist and other actors like; formidable intentional government motives, a political drive, that has already been seen earlier in early 1940’s should be starting point for identification of a need for regulation. There has to be a mechanism of strict scruitny. The fact of restricting the use of this technology is due to the primary reason that it has the capacity to change he thought patterns of an individual. The safety issues concerned with this technology should be a driving motive and to restrict is not to limit freedom of choice of parents or individuals, to better their progeny or themselves, but to control or leash the ill-fitting, non-ad hoc, use ot it. In terms of deciding the parameters of interface, looking in US jurisdiction and decisions by judiciary, that the government control a person’s private thought.98 Their intrinsic act on letting a person achieve their goals through a self-motivated path rather than resort to techniques that would create a situation where there would be imbalance in the society we live in, is place where regulation will play its role in setting balance to the imbalance.
96 Strong C, “Preembryo Personhood: an Assessment of the President's Council Arguments” (Theoretical medicine and bioethics2006)
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What is scary is that the use of this technology by the government to enhance the cognitive powers of its citizens to facilitate a superior position in the world in a constant battle of world power struggle. In a place like China, which is governed by a communist authoritarian regime, it is not a fictional projection, but a reality. There has to be a risk management in order to evaluate the legitimate interest of application of this technology. In order to evaluate and manage risk, the regulatory body has to take into consideration the medial appropriateness of its application. 99 Any kind of force or coercion that is or will be used in application of this technology will recognised as an infringement of freedom of thought. This will also attribute to an illegitimate use of the technology. Self-governance is one of the most essential characteristics of personal autonomy. Autonomy as a subset to freedom of thought is the denying (external or internal) control on human activity, unless there is authorization to do so.100 It is quintessential to take it into consideration that has the agent, one who acts, has the authority to do so, one can take advice and suggestions to act in a certain manner but in the core of the action, it should be self driven and self motivated, ‘made my her own mind’. The use of CRISPR – Cas9 has its affects especially its application on neurodegenerative dieses that will eventually alter the way one thinks and the way one will form a thought process, it will be alter, the cognitive process in a manner that will not be categorized as autonomous, this can be explained also in the case of SHANK3 gene that would have the affects of social dominance, but individual that the embryo will become has no choice or autonomy to select that characteristic. As elucidated in chapter 2 section 2.2 that gene have a high interplay with cognition, the fact that one is modifying/engineering ones gene it will inevitably change their epigenetics’ characteristics, thus impinging and manipulating the gene to function or not function in a certain manner. It is essential that one has authority over one’s own actions; this is not to be taken in the context of free will, but as a judge over one’s own actions. One also has to understand that we are not devoid of influences that shape one’s action, but some of the forces that move us to act do not merely affect which actions we choose to perform, nor how we govern ourselves in making these choices. They influence us in a way that makes a mockery of our authority to determine our own actions. They undermine our autonomy. 101 The bioethical challenge to express an autonomous decision is obvious in application of CRISPR-Ca9 to the human germline.102 As
99 Sell v. United States 539 U.S. 166, 169 (2003) at 179. 100 Buss S and Westlund A, “Personal Autonomy” (Stanford Encyclopedia of Philosophy February 15, 2018)
26 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation stated in the section 3.2, it has the potential to erase memory by use of gold Nano-particles, also its application on studying one’s behaviour, like aggression, autism will have an impact on how human cognition is formed and alter the state of one’s cognitive ability. This consequently relates to foundational pillars of bio-ethics, autonomy, consent and choice. In the existing literature in ethics on CRISPR-Cas9 germline engineering have grave objections on the grounds of ambiguity in autonomy and the complete lack of informed consent, 103 with no conclusive empirical proof of a concise risk profile, it far more unknown. 104This bioethical problem trumps all not only in terms of parental autonomy but especially where technology alters one’s cognitive pathways, like neurotechology, which undermines the autonomy of an individual. Jürgen Habermas a great critique of genetic manipulation, who is dominantly concerned with an “anthropological self-understanding” of human being, which further provides for “the context in which our existing conceptions of law and morality are embedded.” His arguments are that genetic manipulation will change our ethical self-understanding of species and thus it would worsen the self-understanding of genetically programmed humans. Consequently it would “undermine the essentially symmetrical relations between free and equal human beings”. He strongly believes that by way of gene manipulation we are robbing the humans of their ability to self project themselves as authors of their own life.105 For Bernard Stiegler states that technological artefacts are the precondition for human individuality by functioning as implicit mnemonic vectors thereby granting us access to a history upon which we can build and improve.106 Stiegler and Habermas both project a scripture that is weary of the application of technology. Habermas in his critical refection of self-understanding, gave an interesting outlook in terms of the malleability of human germline to produce progeny wherein they can hold “the programmers of their genome responsible for the unwanted consequences”. This irreversible decision dissolves the deontological aspect of people and not treating them as means to an end, a product, this challenges the “the fundamental symmetry of responsibility that, exists among free and equal persons.” The genetically altered individual will be stripped of a sense of autonomous agent, as they did not have the right to choose, and thus a slave to the non-reversible decision of another individual. The application of the technology has
103 Ibid 104 “CRISPR Ethics: Moral Considerations for Applications of a Powerful Tool” (Journal of Molecular Biology June 7, 2018)
27 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation the ability to strip an individual of being autonomous as her life would be predetermined and thus leaving the individual with no autonomy over her own thoughts or action.
3.3 The right to mental self-determination
Technologies that have an effect of alteration of mind and its capacity, that the proponents of enhancements have an extremely poor understanding of human freedom, its either freedom of action or will, which seems purely binary in nature. But the freedom here at stake is that of freedom of mind.107 Though not regarded in its own right, it is seen as an extension of freedom of thought. Van Roermund notes: “self determination is dependent on self-awareness and self-awareness is, in turn, dependent on the awareness of ‘something other-than-thyself’”.108 By means of EEG109 and fMRI,110 we can monitor and modulate, predict, control neural activity of an individual, it has gone to such extents that we can decipher the neural signature of political orientation. 111 . Andera Lavzza, stresses on technological principle as a means of regulation apart from establishment of rights and laws, in order to prevent abuse. He further has the reasons to substantiate that the concern and relevance of autonomy and self- determination has exponentially grown due to the invasive biotechnologies and neurotechnologies. Also taking a more anthropological perspective, researchers have gradually come to the conclusion it is not interested in drawing outer conclusion about a group of people but rather into a very the emic perspective, capture what is on these people’s mind. 112 The concept of privacy in terms of understanding people is transitory in nature, changes with culture and society. Taking gene editing into consideration the epistemological point of view, its is nearly impossible to
107 Bublitz C, “Moral Enhancement and Mental Freedom - Bublitz - 2016 - Journal of Applied Philosophy - Wiley Online Library” (Journal of Applied Philosophy March 6, 2015)
28 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation understand the dynamics of human relationship, the facts and knowledge of it is to broad to decipher all nuances of it and therefore one would never know what is in the best interest of a person. When speaking about privacy, it pertains to a space of non-interference; a recent study by Bert-Jaap Koops on privacy provides a multifaceted picture to the concept of privacy. It gives us an analytical approach but also showcase the extreme complexity and variability of privacy.113 Additionally the application of CRISPR-Cas9 on genes that alter human cogitation, project a clear asymmetry between privacy and personal autonomy of an individual and the freedom to do so on the other hand. This directly brings us to a positive approach to freedom, the one that connects to self-determination, autonomy, the influence that one has over one’s own destiny according to their own interest. But then this can also lead to a negative consequence from the perspective of distribution of justice, as anything could be done in the name of self- realization, knowing one’s true self.114 Article 3 of EU charter of Fundamental right, elucidates on mental integrity of an individual,115 which poses great threat to humans in terms of germline application of CRISPR- cas9. Alteration of cognitive activities of an individual, precisely the invasive direct intervention to alter, which has reached the level of human experimentation, lays down pathways at the same time, however, the misuse of these techniques by malevolent actors may generate unprecedented opportunities for mental manipulation. For example, criminally motivated actors could selectively erase memories from their victims’ brains to prevent being identified by them later on or simply to cause them harm.
3.4 Creatures of Mind: Cognitive liberty
Cognitive liberty is liberty to act freely, devoid of any external intervention that will limit the liberty of an individual. Self-determination and cognitive liberty are interchangeable concepts. Cognitive liberty is the ethics and legality of safeguarding ones own though process, the sole authority to and jurisdiction to control his or her mental processes is on the individual and not on anybody else, not even on corporate and governmental interest. There are techniques that have been developed for monitoring brain activity, affecting reasoning, memory and emotion alteration and lastly enhancing cognition.116 Cognitive liberty is the right to control one’s own mind; this concept has been central in debates concerning neurotechnologies and human
113 Ibid, pg-416 114 Miller D, “Justice” (Stanford Encyclopedia of PhilosophyJune 26, 2017)
29 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation freedom.117. Defining the parameters of cognitive liberty is the most challenging part, and more so in the ‘Morden day culture’. 118 As stated by M. Sepulveda et al, cognitive liberty as an inalienable right that every person is entitled to simply because they are humans, regardless of any barrier.119The proposal made by Paolo Sommaggio at el to have cognitive liberty as a new human right is not a solution that is feasible as it is already a part of freedom of thought, and it can be seen as a subset. Though the other side of the argument will be that there is a need for it as legislators or even general society does not truly understand the semantics of cognitive liberty as it is often hidden behind the veil of Freedom of thought of an individual. The use of CRISPR- Cas9 on editing autistic traits (SHANK3 gene) or the CCR5 gene, invariably relate to cognition and behaviour of an individual. In addition, the issue of eugenics and commodification of physical and psychological traits of an individual, that are considered ‘desirable’ would be craving in to the prism of societal status that have modified to characteristics that are modified beyond the natural progression of human species. In order to delineate that the use of the technology is invasive in germline application, specifically to genes that play a role in cognition, as it pierces through the cognitive liberty of an individual. Cognitive liberty as a multi-dimensional concept can be also be seen as a double edged sword, Bublitz considers it as a right to alter and a right to refuse at the same time.120 But the core feature of it is the autonomy and independent nature, if humans use complete set of mental abilities and take part is several ways of thought. As explained by Paolo Sommaggio et al, cognitive liberty encapsulates three conceptual points of interest: Privacy, Autonomy and Choice. Therefore it ensures the possibility of controlling owns own conscious, in order to be shielded from the attacks of economic corporations or even political legislation, and at the other extreme end the production of communal cognitive standard.121 Bublitz perceives it as a precondition to every legal concept related to human, i.e., self-determination and responsibility.122 Furthermore cognitive liberty is part of consciousness, includes facets of informed consent as captured by Boire.123 Just like any form of freedom there is a positive and negative formulation to it. This came into consideration when there was acknowledgement of the integrity
117 Bublitz J-C, “My Mind Is Mine!? Cognitive Liberty as a Legal Concept” (SpringerLink January 1, 1970)
120 Ibid supra note 108 121 Ibid, Supra note 98, p. 358. 122 Ibid, Supra note 99, p. 243. 123 Boire R, “[PDF] Neurocops: the Politics of Prohibtion and the Future of Enforcing Social Policy from inside the Body. - Semantic Scholar” (undefined January 1, 1970)
30 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation of neurochemical processes, which formulate the personality of an individual. 124 Paolo Sommaggio et al clearly suggests that conative liberty should be taken as a source for emergence and if not new but understating the existing human right, especially freedom of thought from a new perspective. He concludes on the aspect that Cognitive liberty is a new kind of ‘habeas corpus’ that would mean “ my mind is free”, as this interpretation of cognitive liberty will give a legal recognition to the issues posed by technology that impact the cognitive process of a human and the tools to alter human mind.125 Therefore, CRISPR-Cas9 an technology that is directly intervenes the human mind activities, in its application for alteration or enhancement, impacts the cognitive liberty of an individual as the control of one’s mind in permanently changed from its inception, thus cannot exercise the natural control one would do in not genetically engineered.
3.5 Conclusion
The legality of the gene-editing tool is highly questionable, taking into consideration the facet of human autonomy, in section 3.2 the importance of human autonomy, which is integral to human identity, has been described. Scholars like Marcello Ienca, Anderson and Buss explain the how essential is the concept of autonomy, and what it means to protect it from external factors that will alter human thought and consequently human behaviour. Later, Stiegler and Habermas express their wryness towards genetic manipulation of humans genes which when looked from the aspect that it impedes human autonomy is particularly synonymous to the theme of this work. Section 3.3 further takes the concept of autonomy and joins hands with self-determination, which embodies the concept of mental integrity within it. This section provides the understating of self- determination, which the technology has and further will invade, thus disrupting what one projects oneself to be, CRISPR-Cas9 by altering human cognition also alter self perception of an individual and the liberty to think as an autonomous agent. Borrowing examples from the application of neurotechnology, like EEG and fMRI that modulate human thought, CRISPR- Cas9 in the same terms is a direct invasive intervention to human thought, and this has further been anchored in section 3.4 , cognitive liberty that an individual posses. Paolo Sommaggio et al explains cognitive liberty as a concept encapsulated, autonomy, privacy and self-determination, this effectuates freedom of thought of an individual that will be explained in the next chapter. As the technology impedes upon the three concepts discussed above, its application can lead to consequences that are unintended and illegal. This work is a step towards bring into light the potential of the technology is beyond the physical consequences of blue eyes or skin colour, but choosing the thinking power of individual, selecting what is desirable and what is not, and even the misuse of this power that we possess to apply it.
124Ibid, supra note 98, p-33 125 Ibid, supra note 98, p45
31 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
CHAPTER 4: Human Rights and the curious case of CRISPR-Cas9 germline application
“Thou canst not touch the freedom of my mind.”126
4.1 Introduction
It is essential to define what exactly human rights is, and in order to do the same which would fit the purpose of this work, a definition by Beitz comes closest to the concept of Human Rights as: “Requirements whose object is to protect urgent individual interests against predictable dangerous (‘standard treats’) to which they are vulnerable under typical circumstance of life in a modern world order composed of states”127
Reading the above particularly points towards that the application of CRISPR-Cas9 to alter human cognition that is invasive and tinkers the future generations on a cognitive functioning level, is a grave violation oh Human Rights. There is a fierce reason to develop models that will protect the foundational values of a person, values such as decision-making power, autonomy, self-determination, cognitive liberty, and these values are the heart of functional democracy. As argued in the Chapter 2, the use of CRISPR-Cas9 has the ability to change and manipulate cognitive process of an individual. The pertinent question that sprouts is that; in what manner does the use of CRIPSR-Cas9 in germline violate our Human rights? Additionally, what are the rights we can claim violation of? The state of legal and ethical literature has been predominantly funnelling human germline editing to human dignity, right to life (private and public). 128 Due to the current research sprouting in the field of neurogenetics, the affects of gene manipulation resulting in altered human cognition that would lead to a lack of autonomy, self-determination and a stab on cognitive liberty of an individual. Principally, what is illuminated is a collection of rights which
126 John Milton,Comus 127 Beitz CR, The Idea of Human Rights (Oxford University Press 2009) 128 Howard HC and others, “One Small Edit for Humans, One Giant Edit for Humankind? Points and Questions to Consider for a Responsible Way Forward for Gene Editing in Humans” (European journal of human genetics : EJHG January 2018)
32 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation all boil down to the freedom of thought. This garners refection from various political spectrums, as it is essentially connected to “liberty of mind”. 129 John Rawls laid down the blocks of freedom of thought in a legal document called Political Liberalism, extending it to a “fully adequate scheme of basic liberties”.130 Jointly holds the status of primary goods.131
In light if the direct intervention by CRISPR-Cas9 to our cognitive ways, it is the ways that the technology can can alter intelligence levels, or the behavioural characteristics of social dominance or even repetitive behaviour, memory, attention at its core facility or sub traits. It not a question of enhancement but the misuse and alteration of metal activities, not just for the purpose to boost ones capacity, but can also be used for negative consequesenses to subjugate a person for personal desirability or political control.
These ideas tinker down to treads and developments in international human rights. The language expressed in Article 18 of 1948 United Nations Declaration of Human Rights (UDHR), which stipulates that: Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance.132 The same ideas are echoed in various national legislations, such as, the European Charter of Fundamental Rights (ECHR), Article 9133 and 10134 of ECHR are the ones that cement the base of the legal right to freedom of thought. The United Nations provisions reiterate the language of UDHR in terms of balancing the importance of freedom of thought. Article 19 of the International Covenant on Political and Civil Rights (ICCPR) maintains that the right to freedom of thought, conscience and religion includes freedom “to manifest [one’s] belief in worship, observance, practice and teaching,” and it
129 Fried C, Modern Liberty: and the Limits of Government (WW Norton 2007) 95-123, 160, 167. 130 Rawls J, “John Rawls, Political Liberalism: Expanded Edition” (PhilPapers January 1, 1970)
33 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation provides that “no one shall be subject to coercion which would impair his freedom to have or to adopt a religion or belief of his choice.” The Declaration on the Elimination of All Forms of Intolerance and of Discrimination Based on Religion or Belief (EAFIR) follows the ICCPR. It affirms, in the second paragraph of its preamble, that the UDHR and the International Covenants on Human Rights “proclaim the principles of non-discrimination and equality before the law and the right to freedom of thought, conscience, religion or belief.” However the analysis in this thesis will be on the affirmations of freedom of thought by UDHR, as this work is to project the need for international regulatory framework for regulating CRISPR-Cas9 and its application. The approach taken by UDHR has been the main source of inspiration that has inspired and seeped into national legislations. The interpretation bought in by UDHR moulds in the conceptual framework undertaken in neurotechnologies that challenge the freedom of thought, and habituates a homogeneous scope and notion of protection to the application of gene editing by CRISPR-Cas9. As unfolded in previous chapter, freedom of thought has its structural components vested in the concept of self-determination, and a close confidante and often synonymous to it is autonomy, thus redefined to the concept of “mental-self determination”.135 Marc Jonathan Blitz has reformulated cognitive liberty, 136 his interpretation of freedom of thought entangles the environmental and institutional resources that are distinct from those encompassed in freedom of speech and religion, though they might sometimes overlap.137 Thus establishing it as a stand- alone right. He further added that, it would ultimately be in the hands of courts and constitutions to define which spaces and resources merit which protection. 138 Therefore the interpretation takes the concept of freedom of thought to a wider notion, than limiting itself to just the freedom of religion that follows after freedom of thought. There is no “straight jacket formula” that can be applied to application of CRISPR-Cas9 for germline manipulation; instead the application of multifaceted aspects of freedom of thought is interlinking various concepts that could be used for protection against the application of CRISPR-Cas9 for alteration in human cognition. Thus the various ethical and legal construct predicating the human, their rights through in absence protection. Freedom of thought, has increasingly come into the spotlight especially with the modern neurotechnological revolution, it has streamlined neuro-law into a formidable ethical and legal
135 Bublitz C and Merkel R, “Crimes Against Minds: On Mental Manipulations, Harms and a Human Right to Mental Self-Determination” (SpringerLink August 3, 2012)
34 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation structure that has pertinently contributed to complex deliberations. In recent research, we have been able to shed some light on the molecular mechanism of memory and attention, even more so the repeated behavioural anomaly connecting to the fragile X syndrome.139 The connection to cognition and ultimately the resultant affect altering human behaviour, it thus changes or altering the thought of an individual, which essentially is without consent. This brings about the models of freedom of thought to the study of CRISPR-Cas9 social and ethical implication and specifically the implication on Human rights by the application of it. Case note 1: Taking into consideration the specific case of autism and CRIPSR-Cas 9 application of on resistance for HIV virus, the editing on CCR5 gene, He’s action was flagged as a grave travesty to ethical considerations of germline editing,140 and among others the freedom of thought was also abused, as the edit has an impact on the cognitive function of the twins,141 thus altering thought, what is uncertain is the extent of the effect, which makes it even more dangerous as one does not know the resultant affect.142 Case note 2: Autism being a developmental disorder associates itself to behavioural mechanisms in a human,143 and the use of CRISPR-Cas9 specifically a non-viral delivery system known as CRISPR-Gold to edit different cell types in the brain, this intervention effectively rescued animals from exaggerated repetitive behaviour that are symptomatic of the disorder.144 This is a clear penetration into the behavioural mechanisms, the gene that is related to human behaviour, beyond healthcare, corporations, state and even private actors to alter it in the manner one favours and a distinct disdain to the one that is unwanted for the society. This is a dangerous idea and again undermines the foundational principles of a democratic institution, which is a projection of human nature. 145 The semiology of the misuse of the technology directly contradicts the terminology of the freedom of thought, as the genetic intervention is a barrier to the possibility of updating or changing one’s personality in a manner a person would wish to. By subjecting a person to a certain type of behavioural mechanism and belief, the technology impinges on the freedom to change the stature of thoughts and opinions, thus the right is severely compromised.
139 Ibid, supra note 54 140 Li J-R and others, “Experiments That Led to the First Gene-Edited Babies: the Ethical Failings and the Urgent Need for Better Governance” (Journal of Zhejiang University. Science. B 2019)
35 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
Human cognition affects on social identity of a person are complex, extensive and varied, they affect the personality traits on a human, it is an aspect of self evaluation, it is a component of behavioural genetics that play a role is formulation of one’s personality traits with cross intersection of genes with itself and genes with environment. Personality of a person is a dynamic concept and has more than few actors that play a central role. Personality is closely tied with what one believes, therefore autonomy in development of one’s personality in turn a constant update of a person’s identity, it a distinctive derivative of self-determination. 146 Personality traits are the relatively enduring patterns of thoughts, feelings, and behaviours that reflect the tendency to respond in certain ways under certain circumstances.147 This one is the supreme owner of construction of her own identity, a psychological process work that originates and mechnisms of internal processing in one’s mind. The development of this is one’s own choice again should not me moderated, controlled or augmented by technological interventions. Human germline editing has bought about its own set of rules and regulations both nationally and internationally, in terms of Human dignity after the WWII the fear of eugenics was highlighted, the reason gene editing has been so veraciously debated on an ethical front. The scare of illegitimate interventions typically that are detrimental, birthed out of negligence, that are non-consensual and pre-mediated for a destined purpose, these cumulatively induce a negative inference for freedom of thought, as it is freedom of thought, thus an alternative explication is freedom from such direct intervention that negatively impact mental –cognitive consequences. Immnuael Kant, the creator of Kantian philosophy echoed that one of the pillars of human dignity is autonomy of an individual, which forged the path for understanding personhood and identity of an individual. Thereafter, Bublitz in assimilating cognitive liberty of freedom of thought to neurotechnological advances in human mind has sketched a similar perspective. 148 A homogeneous brew of self- awareness and self-determination in order to preserve one’s identity for the sake of self-preservation, as elaborated by Bert Van Roermund. This concept of self-determination is directly linked to freedom of thought. Van Roermund extraction of self –awareness is depended on reality, reality extrapolating from society. This concept of micro (individual) to society (macro) is an objective understanding of self -awareness that is so depended on “the others”. Sewing the two concepts self-determination, a discern of
146 “if self-determination has something to do with freedom, it is not the freedom to determine oneself as one fancies, but to postpone such determinations [...] until one has considered their feasibility in the light of the grounds one truly believes (mistakenly or not) to escape from sheer projections.” - In “Legal Thought and Philosophy: What Legal Scholarship Is About”, by Bert van Roermund. 147 Roberts BW, “Back to the Future: Personality and Assessment and Personality Development” (Journal of research in personality April 1, 2009)
36 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation self knowledge and interests intertwined with self–awareness, ones identity though rooted in society, are the diving forces for an autonomous human to fundamentally exercise this freedom to determine what she wants to be. In application of CRISPR-Cas9 which changes human cognition and affects human behaviour, it has the potential to change the outlook of an individual and the interaction that individual will have the environment, changing the ways how information is processed and projected by an individual. COMP gene related to long term memory and also multitasking, the potential of use of CRISPR-Cas9 to engineer humans to alter these specific functions is the inevitable future if not monitored and regulated. In consideration to these notions and concepts the right provided by UDHR in conjunction with ICCPR will be discussed by dissecting Article 18 of UDHR in parallel to Article 18 of ICCPR:
4.2 “Everyone has the right to freedom of thought, conscience and religion……..”:
The means to invade out minds detached from harming the body, like psychological indoctrination or manipulation, which is considered illegitimate as they are undermining the liberal foundations of democracy. 149 The reasoning that is applied to such interventions are applicable to novel bio-technologies, such direct interventions will undermine the right to freedom of thought, which protects the forum internum,150 a formation of opinions and beliefs and also the freedom to entertain any thought or conviction to remain free from severe external interventions,151 as it is akin to impeding individual autonomy.152 The application has not yet been challenged in courts; even then the rationale behind is banning any intervention that severely impairs or influences thoughts, opinion and decision-making. 153 Though it is particularly difficult to suggest (in legal and judicial sense) what would actually be protected by forum internum and how it has been violated. The potential tension between freedom of thought, the right to have one’s own thought process and direct invasive interventions by illegitimate application of CRISPR-Cas9 is neither acknowledged or commented upon in Human Rights or ethical considerations around CRISPR-Cas9. In terms of freedom of thought it is a negative obligation, that one should not intervene in direct concrete ways, physically or biologically. The essential element herein is that the right to freedom of thought are inviolable; the interventions cannot be justified by an appeal to other rights, interest of common good or other
149 Bublitz, Jan Christoph. "Saving the World through Sacrificing Liberties? A Critique of Some Normative Arguments in Unfit for the Future." Neuroethics 12, no. 1 (2016): 23-34. doi:10.1007/s12152-016-9265-8. 150 “the inner realm of the mind”, 151 ibid 152 Christman J (2015) Autonomy in Moral and Political Philosophy. Stanford Encyclopedia of Philosophy. https://plato.stanford.edu/entries/autonomy-moral/. Accessed 2 May 2019. 153 Ibid
37 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation benefit and harm deductions.154 Bublitz and Merkel has explicitly maintained their ground that direct interventions that alter thoughts of individuals qualify as a crime against humanity and are a serious offence and qualify as non-consensual.155 Bublitz further emphasises that there is a moral and legal duty to respect humans in their own given mental constitutions, and taking into consideration this stand the direct interventions, by CRISPR-Cas9, appear to be highly dubious. Human thought works analogically, according to Lyotard, not just logically, and this way of thinking depends on a body and its correlation with a reality that is perceived as inexhaustible.156 As stated above the interaction with the environment will also be subsequently changed due to alteration in cognition, its pathways affected on human behaviour, and the uncertainty of the impact due to complexity of interaction of gene decreases the credibility of its application. The scope and use of the Article 18 has been severally limited to theological perspective, mostly narrowed down to the freedom to religion, but the parameters of it is certainly go beyond the scope of spiritual freedom.157 Undesired intrusion is of significant importance that this right protects, as the right is not just limited to the right to think freely. In terms of self-determination and self-preservation, an agent who is incapable of expressing or formulating her own ideas and thoughts due to interventions that are internal then these interventions tarnish the likelihood of emancipated train of thoughts, beliefs and ideas, and this is an attempt to subvert in exercising her right to freedom of thought in full capacity. 158 This right amongst all other rights that entail the essence of being autonomous human, cannot be compromised, as the agency of autonomy of a human will be hampered. In the legal structure there is this assumption that is set in default mode, which human mind is systematically and inherently free and the state of mind is beyond the reach of contact by externalities. Until now where direct and indirect interventions through an vast range of drugs and technology unravelled many mysteries of mind, this also led to birth of new branches of
154 United Nations Human Rights Commission. General Comment No. 22. And Bublitz, Jan Christoph. 2014. Freedom of thought in the age of neuroscience. Archiv fuer Rechts- & Sozialphilosophie 100: 1–28. 155 Ibid, supra note 99. 156 “'Can Thought Go on without a Body?' On the Relationship between Machines and Organisms in Media Philosophy” (Taylor & Francis)
38 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation law(neuro-law, neuro-ethics), as this a an extremely nascent development, there is still exploration and an existing dearth in coherent legislation. In summation, manipulation, engineering or modification of human genome that leads to changes in human cognition, challenging cognitive integrity of an individual, wherein the principle of self-determination is hampered due to such interventions, leads to possible and probable violation of Article 18 of UDHR.
The threat of biotechnology, the ethical social and political implications, leading to consequences where basic human rights are constantly threatened, and the last refute that is human mind is also altered to the likes of society, government or parents. Freedom of thought is considered an arch pillar is enjoyment of other forms of Human Rights and is incumbent for enjoyment of minimal decent human existence. Thought by itself is what protects our personal identity, it is not to be tampered by anyone, and if there are ways of biologically doing so, by illegitimately misusing a technology, legal scholars need to take into consideration that the potential misuse and grave abuse of the Human Rights. The reach of freedom of thought goes beyond any kind of intervention (even governmental). When speaking about Human rights one specifically mentions that it is vital to maintain such right for a democratic society to flourish, indeed, but the threat of what the technology presents and the formidable use and misuse of it by rouge sciences, radical groups and lastly by extreme governmental regime to feed their desires of control and progression of their ideas on human subjects, calls for regulation. These direct interventions are illegitimate due its invasion to autonomy, self-determination of a human and
4.3 Conclusion
The use of CRISPR-Cas9 in germline application as a means of direct intervention to human cognition is essential in conceptualisation of thought, as they generate certain mental state (such as concentration, social dominance, memory enhancing) that would otherwise be generated solely by our own will. The scientific literature in Chapter 2 has provided ways application of CRISPR-Cas9 in germline interventions can transform our mental processes permamnently, which is not just limited to the invidiual itself but also its progeny as well. It not like a taking a blood sample or a kidney transplant. It can ,will shape, and alter the individual in all its forms, it transforms the living structure of self, in a manner that implicated the “ freedom of thought” on an individual. The consequences are not just harmful on an individual level but societal as well. Legal actors have to take a cautious and responsible account to the application of the technology as it has a crime against humanity as explained by Bublitz and Merkel. Thus the next chapter analysis the exsisitng legal studtures for germline application of CRISPR-Cas 9 as pointed out in this chapter
39 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation that if not regulated in a timly manner the infringment to freedom of thought caused by misuse of the technology will be catestrophic.
40 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
CHAPTER 5: International schema
“It was a bright cold day in April, and the clocks were striking thirteen.”159
5.1 Introduction
There has been a fierce outpour of debates and discussions of imposing a ban on use of CRISPR-Cas9 on gemline editing, it has been directed to clinical use of the technology on human germline editing. The proposition of the ban is not that it will last for an infinite period (permanent ban) of time, but till a framework is established for its use. 160 .WHO, leading authority in public health, called for a ban on clinical application of human germline gene editing, but this has many scientists divided as it would lead to a huge slowdown in research, thus adding to its ineffective legislative character.161 Though the proposition of a framework has not been negated, but the time period of 5 years for a framework for regulation and a ‘temporary’ ban until then is calling for another reckless experimentation or further misuse of the technology. This work is not in favour of voluntary form of regulation, or self-regulation, as it would not be proportionate to the threats the technology projects. The risk of over regulation will exist but lack of international legal structures will lead to interventions that are invasive and illegitimate, with the power of some nations to collaborate to deploy genetic engineering on humans with no judicial responsibility. The need to regulate the invasiveness of the technology cannot be warded off by having a laissez-faire approach to genetic modification.162 In the wake of this technology breaching the right to freedom of thought, it is pertinent to move towards a regulatory platform than keeping the international area in a legal lacuna for nation states, private organisations to exploit. The lack of regulation has not only been a dire need for a while now but also it has been expressed by leading scientists.163 The direct intervention in human mind, that has the effects of
159 George Orwell, 1984 160 Lander ES and others, “Adopt a Moratorium on Heritable Genome Editing” (Nature News March 13, 2019)
41 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation altering human cognition just by a mutation in single gene, this invasive character has to be assessed in terms of existing legal literature targeted towards gene -editing. Lack of supervisory infrastucture, regulatory oversight in many countries, because the technology is inexpensive, the acess and reach of the technology is easy and it is widely available. There should be a certain level of guiding principle for nations with lax jurisdictions to predict and avert danger, though national legislations are the arch actors but a shared “code of conduct” that clearly lays does the circumstances under which it is permissible in order to limit the scope of illegitimate interventions and misuse of the technology. The legitimacy if such interventions should be established. In this section I will consider the relevance of germ line gene editing interventions in context of International law and institutions accompanied by the existing ethical and political projects. A panoramic view of the international landscape, regulating human germline editing or the possibilities of modification by it, will provide you a blank canvas, as no treaty exists on general application of it. The relevance of public international law is that once a state has signed an international treaty, the state is bound to comply with the treaty, in addition to that, states bear a positive obligation to modify its domestic legislation in order to ensure that it is in synergy with the international treaty. To add to the dynamic character of international law, they are accompanied by monitoring bodies and further by court systems (E.g- International court of Justice, European Court of Human Rights). The international court of justice has a binding effect and is also the principal judicial organ of United Nations. The international court of justice has an overarching power to hear all legal disputes regarding international law, interpretation of international treaties, actions or activities that constitute a breach of international obligation and the consequent reparations. 164 Thus legislating CRISPR-Cas9 would lead to establishing an authority where illegitimate direct interventions can be prosecuted.
5.2 Universal Declaration on Human Genome and Human Rights
The Universal Declaration on Human Genome and Human Rights, which analyses the burning issues pertaining to scientific and political scope of manipulating human genome have suggested that practices like ‘ germ line interventions’ could be contrary to Human Dignity, invoking article 24 to its defence.165 In spite of attempts by the declaration, UNESCO that is the
164 Yotova R (2017) The regulation of genome editing and human reproduction under international law, EU law and comparative law (background report for Nuffield Council on Bioethics). 165 The NCoB has suggested that an important question in relation to genome editing is who the ‘public’ is in ‘public interest’ and whether, for instance, ‘the content of … [the] interest [in genome editing can] … be determined
42 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation monitoring body for the Declaration has not taken a definitive decision on the subject matter, despite re-examination.166 The Declaration by no means is banning germline editing as seen in Article 13- “an intervention seeking to modify the human genome may only be undertaken for preventative, diagnostic, or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.”167 Banning is not a cogent startergy that can be used monitor and control the application of the technology, on the contrary it would just make matters worse as it can be seen in the case of He Jainiki’s experiment.168 In 2015 the Report of the International Bioethics committee (IBC) on updating its reflection on the human genome and Human Rights called upon states and governments for an international moratorium on germ line engineering.169 This approach was taken in extension to maintaining the integrity of human genome.170On one hand, taking the approach of preservation of heritage of humanity, but on the other hand it also acknowledges that human genome by its vary nature is subject to mutations, due to various factors that an individual is bought up with and also further experiences in her lifetime.171 These opposing standpoints lead to ambiguity in legislating technologies that manipulate human genome. There is a three dimensional link to protection of human genome: a symbolic, a genealogical and a biological one that moulds the conceptual framework of ‘ symbolic heritage’ as a way of stimulating class unity of all human beings that corresponds to identification of dignity and diversity of humans.
independently for a given political community or … [whether] it [is] coextensive with the scope of universal human rights’. NCoB (2016) (n 9) para 4.42. 166 Article 11 of the Declaration mandates that practices contrary to human dignity (it mentions human reproductive cloning explicitly) should not be permitted, and Article 24 mandates the International Bioethics Committee to make recommendations “regarding the identification of practices that could be contrary to human dignity, such as germ- line interventions.” 167 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, ETS No 164, Oviedo, 4 April 1997. The description of the Convention by the Council is at: http://www.coe.int/en/web/bioethics/oviedo-convention, last accessed 31 May 2019. 168 Beriain M, “Should Human Germ Line Editing Be Allowed? Some Suggestions on the Basis of the Existing Regulatory Framework - De Miguel Beriain - 2019 - Bioethics - Wiley Online Library” (Bioethics August 6, 2018)
43 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
5.3 Legal background
The growth of biochemical tools have advanced to a time and space where sequencing of DNA in living organisms with precision and ease that was previously unknown or more so unattainable at the level which is available currently. The power of CRISPR-Cas9 and the other told have impacted all areas of biology and raised plethora of concerns and some of it have been enumerated above. Though the safety and efficacy of the technology has not reached to a level wherein clinical trails on human embryos are ready to be being carried out, nevertheless it has unsurprisingly been carried out. In order to cater to the various questions highlighted by this “technological revolution”, the nited States (US) National Academies of Sciences, Engineering, and Medicine (NASEM), the Royal Society and Chinese Academy of Sciences participated in the first international summit in December 2015, in Washington DC. The meeting concluded on a call for moratorium on human germline genome modification for clinical use unless and until: “(1) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (2) there is broad societal consensus about the appropriateness of the proposed application.”172 The summit hosted presentations and deliberations on the scientific, ethical and governance issues associated with human gene editing. As opined by David Baltimore, chair of the summit organizing committee: “Today, we sense that we are close to being able to alter human hereditary. Now we must face the questions that arise. How, if at all, do we as a society want to use this capability? This is the question that has motivated this meeting.” For reasons that will be later bought to light, the first summit, the like second one underlined the emerging prominence of china in gene editing, 173 this was due to the April publication by Chinese researchers to use CRISPR-Cas9 to modify a gene in non-viable human embryos. 174 The most surprising aspect of the position statement issued at the end by the organisers was that the committee did not condemn the use of CRISPR-Cas9 for germline experiments, and merely suggested that the ethical and safety issues should be addressed before
172 Li J-R and others, “Experiments That Led to the First Gene-Edited Babies: the Ethical Failings and the Urgent Need for Better Governance” (Journal of Zhejiang University. Science. B 2019)
44 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation the use of the technology to modify human embryos.175 In the national arena there are countries that specifically limit the use of human embryos for research purposes. In specific case, Chinese explicitly bans the implantation of genetically modified embryos in women, but as recently seen this was clearly violated by He. Even in USA federal funding does not support research on human embryos,176 but the report by NASEM did not condemn germline modification once the safety and technical risks have been understood.177 The summit also made some revelations that scientific journals have rejected papers, articles etc. on human germline editing because of non- compliance with local regulations.178 This validates that the use of technology that does not meet ethical and social parameters are being carried out. One of the major challenges that will be confronted in international regulation is the cultural diversity that needs to be respected to obtain international consensus. In addition to the ambiguity of human hood, the status of what is being human, at what stage of reproduction varies in different nation, and thus applicability of human rights laws.179. The second summit was held in Hong Kong in November 2018, again the main topic of discussion was about the He Jiankui research and subsequent birth of genetically modified twins with the use of CRISPR-Cas9. He deleted the CCR5 gene in order to make the twin girls resistant to HIV infection, in a race to become the pioneer of application of CRISPR-Cas9 in human application. With no justifications and knowledge about the unintended consequence, i.e., the off-target results, that let to the debate and discussion of how the edit of this particular gene could have led to cognitive enhancement in the twin babies, providing a whole new perspective what was researched only on a theoretical level with non-human subjects.180 So in a place where gene editing which is already under-regulated nationally and un-regulated internationally, faces further challenges of cognitive application to change cognitive process of an individual with CRISPR-Cs9 application. An issue that was raised in the summit was that of informed consent, it was not clear if consent was obtained for the procedure, as there was no alternate procedure present except for genetic intervention to ensure that the HIV virus that the parent carried did not
175 Ibid 176 Code of Federal Regulations: Research Involving Pregnant Women or Fetuses, 45 C.F.R. Sect 46 (2017), United States Code: Institutional Review Boards; Ethics Guidance Program, 42 U.S. Code Sect 289 (2017), Consolidated Appropriations Act of 2016 [statute on the internet] c2017 [cited 2017 Nov]. Available on: https://www.congress.gov/114/bills/hr2029/BILLS-114hr2029enr.pdf 177 “Human Genome Editing” (Google Books)
45 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation infect the twins.181 This concern was followed by the use of this technology and the safety of it, which could not be established to a level of certainty that is permissible to be used in human embryos. Additionally NASEM established criteria so that application of any technology in germline editing be made ethically feasible but it was subject to political control.182 One of the major contributions of second summit was to establish a roadmap for pre- clinical in vitro and animal research that will enable regulators to evaluate proposed human clinical trials. 183 It further focused on the efficacy, fidelity and safety of the gene editing technology. Though regarding specific forms and methods of gene editing produces immense flexibility, but there is difficulty in establishing a “golden standard” in terms of efficacy and fidelity that can be used to compare in different labs and system. Buchanan proposes that one way of regulating gene editing is through direct state intervention in terms of research and funding, as in this manner the it the state would always keep a watchful eye on the on-going research and trials, the rights of humans will be safeguarded and protected by state authorities, and mainly to avoid inequalities.184 Another way to regulate gene editing that has been effective, as seen through Oviedo Convention and similarly the rise of IVF in United States, an absence of government or federal funding in the later case for any work that uses human embryo limited the research but resulted in a severely adverse effect of a detailed measure to be taken and lack of public influence in the use of the technology from a narrow to a broad application.185 Estimating the complete ignorance of responsibility by the state has led to dire consequences, which will escalate to a situation, if not already, where private actors and ‘rouge’ scientist or the DIY CRIPSR-Cas9 kit users, would use it with no underlying guideline for the protection of human and their rights, thus being treated as a end to their (private actor) means. A global consensus on moratorium is an obscure imagination, as none of the countries will benefit from it, and more so full consensus is even more difficult as no procedure can be imagined to obtain such a consensus. The second summit suggestions indicated that individual countries to use of their own political systems to reach a public consensus on banning human
181 Greenfield A, “Fearful Old World? A Commentary on the Second International Summit on Human Genome Editing” (SpringerLink January 2, 2019)
46 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation application of CRISPR-Cas9.186 The reason for a ban or a moratorium was in light of use of CRISPR-Cas9 by “rogue” scientists, thus adding fuel to the already burning state of affairs in the genome editing.187 As germline gene editing is not banned, therefore no legally enforceable prohibition, to take a liability approach in terms of criminal liability. Unfortunately what can be assessed from the existing ‘non’-regulation of germline editing is that, the discussions and the conventions scarcely touch upon gene editing, the direct intervention that will have catastrophic results if left open for societies to play with. Nevertheless, as exposed through the course of this work, the regulation of the gene editing process in germline modification, can begin its pathway of deconstruction through a framework consolidated by findings from a neuroscientific perspective too. In order to halt the practices that that will impinge the varying notions that have been laid down in this work, researchers, ethicists, and different regulatory bodies have to come together to address the issues of clinical and also non-clinical, invasive intervention of CRISPR-Cas9, suggesting a diverse perspective. The participation of society at large will be a challenging notion but a step has to be taken in order to overcome the existing barriers. A safe and sensible path needs to be ensured so that the progression and projection of the technology is not compromised as the benefits are ground-breaking both for researchers in medical field and also for individuals who are suffering from genetic disease. Consequently, in a few years the application and possibility of genetic cognitively altered humans surrounding us will not be distant reality, the use of the technology not just for clinical purpose but also enhancement, that goes beyond treatment of therapy requires immediate attention, and should be considered in the case of international regulation. I would not like to take the route of a moral standpoint that there is something special that in human nature that is coded in our genes, that will add to the complexity of regulating and one would always revert back to a ban. That is also the reason human dignity is not taken as a basis for defending ban germ line intervention, as biological analogy does not provide a functional basis for human dignity. Indicating that other technologies that do not affect the genetic sequence of a human are not a threat to human dignity. Thus taking the alteration of human thought is not feasible as dignity of human is formed beyond human germline, environment plays a role as well.
186 National Academies of Sciences, Engineering, and Medicine. On human genome editing II: statement by the organizing committee of the Second International Summit on Human Genome Editing, November 29, 2018 187 “Charo RAR, “Rogues and Regulation of Germline Editing: NEJM” (New England Journal of Medicine)
47 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
Finally, we must not forget that environmental interventions, such as modified social interaction, have epigenetic effects, modify brain development, and can be passed on to the next generation.188 In recapitulation a ban is not a justified answer to the cons of germline editing. Alterations can be passed to germline inadvertently as well. The off target results and the risk involved are really high and nobody can point it the exact consequences. Regulation has to be imposed on the physicians, investigative agency for case-to-case analysis in terms of violation. Gross negligence and illegitimate cases that cause direct intervention.
5.4 Oviedo Convention
Oviedo Convention is the only legally binding international convention that mentions explicitly about germline intervention in Article 13 of OVIEDO Convention (entitled ‘Interventions on the human genome’) “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.”189 The convention in no regard explicitly mentions Human germline. 190 There is a misconception of associating human genome to germ line editing. The convention or even the explanatory report to the convention does not in any manner define of embryo or what the term ‘decedents’ would entail. 191 So only those modifications are prohibited that would lead to creation of human as a result of reproduction. Even then research that is not directed towards preventive, diagnostic, or therapeutic purposes for the embryo involved is not banned by the Convention, as the countries that have ratified the convention, France and Spain still allow such practices. It feels that there is an alteration in imposition of general ban on germline editing.
188 (Practical Ethics)
48 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
Even a review of the the article was advised, it never happened.192 And thus its analogy sticks to no ban on germline editing. The convention is extremely debatable in its application. It is ambiguous as to whether Oviedo Convention bans genetic editing in embryos. Even the explanatory report and the preparatory report that accompanies the convention does not mention human embryo, and this can be used for research purpose. The ambiguity in understanding the clauses of the convention let to UK and Germany not being signatories to it. A bare analogy of the wordings of the convention states that where the intention is not ‘introducing modification’ then such intervention to human genome are allowed, an essential aspect that can be deduced from the article, is that only those interventions should be avoided that voluntarily introduce modification to the genome of decedents.193 The Oviedo convention has international reach and these wordings were adopted in a number of national legislation (France, Australia, Spain).194 Another issue that one can infer is that interventions in germ line are allowed as only voluntary modification in genome of decedents ‘should’ not be undertaken. This projects a weak understanding of the off-target results or involuntary modification. Nevertheless, this of the only convention that provides a good foundational basis to regulate invasive germline interventions, as it delineates negligence modification of genome of decedents and clinical research on human embryo not for the purpose of creation on humans. The overview of existing legal literature of germline modification is limited is scope and application, there needs to be some reconciliation between the invasive interventions and protection of human rights against the risk of grave violation of Human Rights is immediately needed. The proposition for a ban though its temporary seems oddly fitting, but the need for a conceptual framework is desperately needed and on a quick notice. Though the ban is based on human dignity, it should be moved to further breaches on eugenics of change of cognitive ways of human and its decedents. But the growing use of the technology, will make the ban futile, and then comes a phase where the technology in un-regulated and its invasive misuse rampant.
192 Steering Committee on Bioethics (CDBI). Convention on the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Bio Medicine (ETS n° 164). Preparatory work on the convention, Strasbourg, 28 June 2000. p. 65. Available at : https://www.coe.int/t/dg3/healthbioethic/texts_and_documents/CDBIINF(2000)1PrepConv.pdf (accessed 12 November 2018). 193 Beriain M, “Should Human Germ Line Editing Be Allowed? Some Suggestions on the Basis of the Existing Regulatory Framework - De Miguel Beriain - 2019 - Bioethics - Wiley Online Library” (Bioethics August 6, 2018)
49 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
5.5 Review oversight
In order to pave a responsible pathway for germline gene editing, the World Health Organisation (WHO) has declared an intent to from an Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Gene Editing, this precisely targets the state of science and provide advice on “its applications, its potential usages and societal attitudes towards the different uses of this technology”, propose oversight mechanism and global governance structures.195Though, this initiative is profound as it encircles the principle of inclusiveness for grater public deliberation and consensus, WHO is no regulatory body and has enforcement no authority and, it can only aid a regulatory body. That encapsulated the big issue that one is not setting an international law on it.
5.6 Lack of legal solutions in the international regulatory landscape
The analysis of the existing state of art undertaken in this work provides an array of recommendations that can be taken into consideration to forge a regulatory framework, essentially taking into consideration invasive direct intervention, rouge researchers in germline gene editing. The factors that have been put is that the technology is a illegitimate direct intervention into the thought process of an individual that is illegitimate as there is a human right that protects and the technology in its application has the
There is a complete lack of distinct regulatory framework, concerning specific legal nature of germline application of CRISPR-Cas9 at an international level. In the current state of legal literature, some recommendations have been provided concerning gene editing, which should be taken in order to provide a somewhat suitable, format for regulation.196 Through the very act of regulation, from a positivist legal theory perspective it is intrinsically connected to and to a certain degree depended on assumptions, ideas, opinions and discussions by public and/or its representatives. Therefore for a law to be effective the notions of public morals, social acceptance and a regulation through social norms have to be taken into account for a legal structure to be effective. 197 Following this, the suggestions that have been explored in the existing state of art ranging from one end of a spectrum, i.e., a ban, to another end of no regulation for the purpose of scientific progression and the inevitable nature of the enhanced/
195 “Gene Editing” (World Health Organization July 7, 2019)
196 Ibid, supra note 143 197 “Code and Other Laws of Cyberspace” (Find in a library with WorldCat February 9, 2019)
50 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation altered human being a part of normalcy in future social structures. Thus, it is complex to precisely articulate why there is a lack of international regulation on the subject matter, but one aspect that can be commented on is the general nature of regulation, and the lack or the ignorance of specific legal or regulatory framework. Considering that there are some national legislation existing that provide for some basic regulation, the legal vacuum that is existent in the international arena is gaining attention. WHO can play an arch role in this as it is already establishing multi-disciplinary expert panel to examine the scientific, ethical, social and legal challenges associated with human genome editing. As it would be a multi-disciplinary approach the expert advisory committee would take into consideration the multi-faceted impact of application of CRISPR-Cas9. In addition to the above mentioned issue, there are a few more that this work has projected in the pervious chapters, taking a brief look at the some national status of germline editing will establish a frightened need for an international regulatory framework for germline editing by CRISPR-Cas9. The Oviedo convention and both the International Summit on Human Genome editing have only taken into consideration the biomedical research for regulating gene editing, there is complete ignorance of non-clinical application of the technology, the non-ad hoc application is not taken into consideration, leaving vast invasive, non-autonomous, illegitimate manipulation of human genetics, with only a moratorium/ ban to relay upon, but to vain as it is being evidently violated. In terms of national legalisation there are countries that are ambiguous about the legal status of human germline modification.198Thus the international regulatory landscape project that human germline modification is not totally prohibited worldwide (only 29 countries prohibit it) and the ambiguity in legal structures of some countries, leave room for further investigation.199 FDA does not ban germline modification, but imposes a temporary moratorium on it under FDA vigilance and NIH (National Institute of Health) guidelines, on the contrary Israel explicitly bans germline modification, but then there are buffer exemptions that may permit it upon recommendations of advisory committee. In parallel to the first international summit of genome editing the US National Academy of Social Sciences and The national Academy of Medicine created an international committee the review the field of gene editing and make recommendations about policies and procedures governing human genome editing.200
198Araki1 M and Ishii1 T, “International Regulatory Landscape and Integration of Corrective Genome Editing into in Vitro Fertilization” (Reproductive Biology and Endocrinology November 24, 2014)
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Though, a ban on germline editing exists in most countries (Belgium, Bulgaria, Canada, Denmark, Sweden and the Czech Republic) they do not render it illegal.201 There are polarizing opinions on this as on one hand the germline correction result in wild type status that can contribute to normal embryonic development, but on the other hand it can also be regarded as grave intervention in human life.202 In regard to the above argument, I would consider the latter taking into consideration the cognitive changes that can occur or will occur due to the application of CRISPR-Cas9. One recurring theme in state of art that the projection of issues be it ethical or societal are all from a medical perspective, referring back to the topic of autonomy, the non-ad hoc application of it is where a human is disregarded for being her autonomous self, and the regulatory framework has to take that into consideration. There is an asymmetry that exists in its regulation that desperately needs urgent attention, due to the threats of human cognitive enhancement and the evolution of human to transhuman. Scrutinisation by independent parties, peer review, ethical review board, journals and the issue in publication, all data should be submitted and if they co not confirm to the regulatory guidelines they need to be assessed and followed up, not just rejected and not followed back. The scare of genetic cognitive enhancement is not helping much from a regulatory point of view. It is a naïve outlook that will only be used for purpose of healthcare if proved safe, this rosy picture of gene editing does not really encapsulate the grave challenges that leading scholars have comprehend. The inevitable use of it in future is no excuse to promote a technology that will change the face of human species like never before, and mere expectation that in some manner, once proven safe, by not providing a solution that targets the issues that the technology posses is tragic. In my opinion he proposes what one calls in behavioural psychology, operant conditioning (a basis for learned behaviour via systematic reward and punishment techniques) those rewarded for genetic cognitive alteration. Concluding the genetic cognitive enhancement is a ‘necessary evil’ like antibiotics and mass vaccination,203 and suggesting the policy makers will consider genetic cognitive enhancement as a sort of measure that is identical to mass to the ‘mass vaccination, thus the prospective of it does not seem bright for regulators.
5.7 Conclusion
The use of the technology by rogue scientists has created havoc. 204 This invasive direct intervention in absence of either lax regulation or the case of non-existent international regulation would only lead to further invasion and misuse, consequently violating Human Rights.
201 Ibid, supra note 175 202 Ibid, supra note 175 203Ibid, supra note 175 204 Cyranoski D, “First CRISPR Babies: Six Questions That Remain” (Nature News November 30, 2018)
52 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
A central agency that will deny or grant permission is what was proposed, but in terms of a international regulation its not acting as a central agency, it takes the form of an authority that lays down the rules for playing the game, for it to be a level playing field. The development of a system for early identification of research that is crossing the predefined boundaries will be the starting point for regulation. The predefined boundary markers can be set by a panel of ethicists, scientists and regulators with the existing information available, the model followed by WHO for regulating research with potential bio-security risks can be a usher to the formulating a system for germline editing.205 The system works as an open registry, this will be catapulting change from the existing system and the dominant view of scientific independence. The caveats for initiating this global system are the countries with lax gene editing regulation countries, and thus the endeavour for a international regulatory framework is to formulate a developmental and integrative legal system for prevention and significantly the penalisation of research that are unacceptable. 206 This systematically answers the third research question, this chapter has illuminated the existing legal structure, and thus concluding in the discussion in section 5.6 there is an absence of an international regulation in terms of germline editing by CRISPR-Cas9, in light of it being a direct invasive intervention that alters human cognition207 thus altering human thought. Thus maintaining a balance is essential in order to ensure that the technology is not impinging Human rights. The balance is a delicate one and the one that is extremely essential taking into consideration the trajectory of human evolution, but also sustainability of humanity that is faced with challenges of modern era, that in some ways can be brutal, devoid of basics of what it is being a human though this is a constant space of exploration and experimentation, in a perpetual flux state, what is essential is to not to underestimate the ghastly claims by the He Jiankui, and start ground working on proposing guidelines and also the penalties that will follow if not followed, recognising the progression of science, technology, healthcare and society. Before the next summit in 2021, and before we have absolutely no control and surely cannot turn back time, there is an urgent need for some grounding.
205 Ibid, supra note 143 206 Ibid, supra note 143 207 Explained in section 4.1 and 4.2
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54 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
CONCLUSION AND AFTERWARD: predict the future: Avert the danger
“Hold my hand in yours, and we will not fear what hands like ours can do.”208
There is no denying that the omnipotent progression of science of future is inevitable. The unpredictability of both the future and technology is unsettling. The possibility of shaping one’s evolution has, to know the unknown, is an infinite learning process. Using CRIPSR-Cas9 has only accelerated the knowledge of human code. The genetic manipulation on human germline, has the consequence of altering human cognition, which has been explained in by means of scientific literature in chapter 2, section 2.2. The knowledge of this and the subsequent use of it has affects on autonomy self determination and cognitive liberty of an individual, as elucidated in chapter 3, thus ultimately will have violable affects of Human Rights. This work has highlighted the threats that this technology and its application on germline will have in order to pave a path for international regulation; this was also the main research question that this work has taken upon to answer from the very inception. As explained in the relevance of this work (section 1.6) this work has been at attempt to understand the current and possible legal affects of germline application of CRISPR-Cas9 in order to pave pathways of regulation and not be caught up in dilemmas so that its seeps into a norm of the society. Therefore, in some manner, aid the inception for a regulatory framework and also its development. The definite observations from this work are that, the lack of legal structure internationally for germline editing by CRISPR-Cas9, will lead to grave prospects, as it is a direct intervention with no possibility of reversibility. Additionally, the subsequent research question that anchored the main one, have led to insights of impinging autonomy, self- determination and cognitive liberty threatening and violating freedom of thought. The concluding remarks in chapter 5 (section 5.7) analysis the international area attempting at providing a format of guidelines that are scattered and not coherent that do not amount to international regulation. In terms of adding an international framework taking into consideration the multidisciplinary nature of this work is the proposition of WHO for an interdisciplinary committee on the issue of human germline editing is a wise precautionary choice that would stir the discussion on the technology and its affects to wide intra and inter disciplinary issues that would systematically aid regulation. Identification of these issues is vital, as CRISPR-Cas9 directly intervenes into human cognition and leads to compromise the, autonomy, self- determination, liberty of mind that makes up the freedom of thought. This illegitimate
208 The Epic of Gilgamesh
55 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation interference into the minds of an individual via a technology that already has the potential to bring back the scare of eugenics, in a world where a gamut of technology are singularly and collectively infringing Human Rights is fearful. It makes the task of regulators arduous and it’s a glim reality that legal structures are invisible in times of havoc. By means of this work for a proposed regulatory framework I do not wish to convey by any means that these are the only challenges that the regulators will face but, as a nascent researcher, this is just a step towards progressing, taking into consideration the current legal, or more so the absence of international legal status quo. It has been explained in chapter 5 that public engagement is of paramount importance in the process of establishing a regulatory structure. There are various means of structuring the use and application of the technology, one way is the proposition of global observatory by Jasanoff and Hurlbut, which could play a vital role to stir public debate. Secondly, a strict supervision by an independent supervisory authority will be able to tackle the issues of bureaucracy and power play, but also the independence should not be unprecedented. Thirdly, the scientific community has to actively be involved in the process of regulation, even in the presence of opposing deliberations with ethicists and public and most significantly with the greed for political supremacy by means of technology. These observations are followed by other varying considerations that have crossed my mind during the course of this work. Firstly the use of the technology has ways to severely alter human cognition, this intervention is illegitimate as it impinges of cognitive liberty, self- determination and autonomy of an individual. Secondly the analysis of international legal sphere provides no legal solution as there is no regulation in place that has the authority to regulate the use of the technology, there are few guiding conventions like the Oviedo convention that comes close to regulating it but the ambiguity in article 13 that limits germ line interventions leaves scope for the misuse of the technology, thirdly in lieu of the direct intervention and the whole polarised opinions on banning the use of it on human germline, does not make the case of a moratorium legally strong and effective. Thus reverting back to the main research question: if we need international regulation on germline application of CRISPR-Cas9, the answer you be yes due to the reasons that have been stated above. CRISPR-Cas9, an invasive direct interventions, with no international prohibition for application, rampant usage by rouge scientist and biopunks, no clarity in law as to what will qualify as illegitimate use there are no requirement no approval procedure, all possibility of changing, controlling, manipulating human condition, is available and ready to be used, well the landscape of one from science fiction, where the anarchy by few, rules the rest. Surprisingly, or to put in in a rather cynical realm of human calamity, un-surprisingly, technology marches ahead and law crawls behind. Instead of finding loopholes in relevance of international public law or its legitimacy, it is essential to not get distracted or diffused by such questions, but in light of the
56 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation threat and contemporary challenges of manipulation, alteration, enhancement, presents a compelling call for action. This immense gene editing revolution precipitated by CRISPR-Cas9 that will, can and has alerted human cognition inaugurated a new mode of knowledge and understanding and signals a new scientific dawn of human evolution. When possibilities are endless to tinker the genetic code of humans, the intention and curiosity to test the possibilities is inescapable and in order not to make the present and future a slaughterhouse of notions that are a source to inalienable human rights, the time to act upon it, is now.
57 Re-coding the ‘corrupt’ code CRISPR-Cas9, Germline Intervention, Human Cognition, Human Rights, International Regulation
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