Table of Contents: Introduction; 1. Potential and Limitations of Gene Editing; 2. From Regulation to Implementation of the Technique; 3. Civil Liability for Risks Arising from Gene Editing; 4. Civil liability for damages arising from the failure to use gene-editing technology; 5. Conclusion; 6. References
The manipulation of DNA sequences in human embryos ceased to be a mere prospect and became a reality in 2015. Chinese researchers, using the gene-editing technique —CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats)—successfully corrected a mutation in the HBB gene, the expression of which causes beta-thalassemia, a condition that leads to severe anemia (1).
Thus, for the first time ever, this technique—capable of enabling the specific modulation of segments of human DNA—has become a revolutionary tool in mapping serious, hereditary diseases that are, in most cases, incurable, generating positive expectations regarding preventive measures and the development of new therapeutic alternatives in humans.
In the mid-1990s, the applicability of gene editing was limited solely to the somatic cell line. Unlike the germline, the somatic cell line does not have the potential to generate gametes. Therefore, modifications made to its genetic material are not passed on to future generations, affecting only the individual themselves and never their offspring. In contrast, gene editing of germ cells can affect the individual’s entire organism as well as that of their descendants, which explains why this technique has been heavily criticized—for various reasons—in the biomedical, bioethical, and/or legal spheres. Thus, the possibility of inducing permanent changes in DNA, with potential implications for future generations, has fueled intense debates on the subject (2).
From this perspective, it is undeniable that the implementation of this technique at this time may entail future and unknown risks and could even give rise to issues related to civil liability (3). On the other hand, once the limitations of the technique are overcome—a reality that cannot be denied in light of ongoing contemporary biotechnological advances— and given the continued existence of medical indications, would not refusing to allow the use of the technique under safe conditions—or choosing not to use it in situations where preimplantation diagnosis is required—also constitute a harm eligible for compensation?
It is in this context that the need arises to discuss the harm caused by this unique form of damage, characterized by its legal significance, irreversibility, and the fact that it affects a person’s existence—which implies “being unable to act” or “having to act differently”—Damage to the Life Plan (4).
1. Potential and Limitations of Gene-Editing Technology
The CRISPR/Cas9 technique, which functions as a “genetic text editor,” enables the correction or deletion of genes carrying disease-related mutations, thereby making it possible to reverse or silence their deleterious effects. This tool features “recognition” mechanisms that enable it to bind to specific nucleotide sequences in the target DNA, as well as “cleavage” mechanisms that allow it to cut them (5).
The editing process is divided into stages. The first stage involves the recognition and cleavage of the DNA molecule, while the second stage is dedicated to its repair. Once the nucleotides have been cleaved, natural endogenous cellular DNA repair mechanisms are activated. The editing process then utilizes these mechanisms to bring about the desired modifications. Thus, repair can occur through non-homologous end joining (a mechanism useful when the goal is to silence gene expression) or can also be template-directed. In this scenario, it is possible to introduce external DNA templates into the cells along with the editing tool. Thus, external templates containing selected genes can be provided to the new DNA segment to be formed at the cleavage site.
Gene editing, when applied to basic research, offers a significant advantage, as it generates broad scientific knowledge that can contribute to human health and well-being. This includes elucidating the mechanisms underlying cell differentiation in human models, investigating the role of specific genes in the early stages of human embryonic development, understanding the origins of genetic diseases to facilitate the development of targeted drugs for these conditions, and developing important gene therapies for the treatment of various types of cancer, among other areas. These are just a few examples of the potential applications of basic research in this field. Thus, even considering the possibility that the clinical goals of gene editing may not be achieved, the relevance of basic research in this area is indisputable (6).
With regard to research with clinical applications, the importance of gene editing in human embryos for the prevention of genetic diseases is irrefutable (6% of newborns have significant genetic disorders). Using this technique, it is possible to identify the genes responsible for these conditions, which would offer hope for preventive treatment of these diseases.
The fact that both in vitro fertilization and preimplantation genetic diagnosis involve the prior selection of embryos unaffected by genetic diseases leads many to argue that gene editing would be unnecessary. However, there are a number of situations in which the possibility of selecting viable embryos is very low or close to zero. Examples of this limitation include cases in which only one viable embryo is produced during in vitro fertilization, and that embryo carries a monogenic mutation; situations in which patients are carriers of autosomal dominant genetic disorders, carrying two copies of the mutated gene; cases of autosomal recessive disorders, where even when embryo selection is performed using in vitro fertilization followed by preimplantation genetic diagnosis, there is no way to prevent the possible transmission of the mutated gene to the offspring of the healthy carrier (both parents are carriers of the mutated gene). In most of these cases, even when using in vitro fertilization and preimplantation genetic diagnosis, it would be necessary to produce a significant number of embryos to ensure the selection of a healthy embryo, which, in most cases, is not feasible. Furthermore, this would not guarantee that such an embryo would be free of the mutation and could, therefore, pass it on to its offspring (7).
The clinical indication for editing would also include cases of polygenic diseases—that is, those in which multiple genes exhibit simultaneous mutations—especially those involving the influence of various environmental factors, which significantly reduces the likelihood of selecting a viable embryo. In these situations, numerous genetic mutations combine to characterize a single disease, such as those occurring in different types of cancer in which more than two hundred different genes are involved. Thus, gene editing in research may, in the long term, become an important tool, since the technique has the potential to induce multiple genetic alterations simultaneously. It is a fact, however, that this will depend on further research to move beyond mere expectation. The pathogenesis of these diseases has not yet been fully elucidated, so there is a need to advance investigations to demonstrate the technique’s potential to reduce their incidence.
Even in the context of infectious diseases, the clinical application of gene editing is already a reality. Certain genes can enhance an individual’s resistance to infection by various pathogens. In this regard, identifying such genes to amplify their effect and increase resistance to these agents would constitute effective immunization (8).
Despite the potential of gene editing, its novelty still presents some challenges that must be overcome. Limitations regarding its effectiveness are evident when mosaicism and off-target mutations occur (9).
A mosaic embryo results from inefficient DNA cleavage by the nuclease and/or inappropriate DNA repair (10). Thus, even after editing, different cell types will coexist: the original unmutated (normal) cells; the original mutated cells; and the properly edited (unmutated) cells. Consequently, mosaic individuals have different genomes. This can have negative implications when it comes to the germline because, in this case, mosaicism—although it does not necessarily mean the individual is affected—does not prevent the transmission of mutated genes to offspring. However, despite the risk of mosaicism, promising results from unprecedented studies conducted on laboratory animals using a specialized gene-editing method (CRISPR/Cas9/sgRNA) have already demonstrated a significant increase in the preventive effectiveness against this undesirable effect (11).
With regard to off-target mutations—that is, unintended ones—recent, more refined techniques have demonstrated an effective ability to estimate the mutagenic effect (bioinformatics tools). Thus, once the editing is performed and the mutation is detected, it would be possible to select the embryo prior to implantation. In this way, the risk of harm would not be negated, but rather prevented from becoming morally significant. In this regard, another relevant aspect is the fact that therapeutic gene editing would prevent the production of excessive numbers of surplus embryos. It is true that, to reduce the risks of potential off-target mutations, researchers have been working to improve the technology by producing more specific and accurate RNA guides and Cas9 endonucleases. These technological advances have certainly contributed to greater safety and accuracy in gene-editing techniques. In fact, the development of methods that monitor the occurrence of mosaicism and off-target mutations—and that determine their frequency of occurrence—in humans is already a reality (12) (13).
Given that safety and precautionary measures regarding mosaicism and off-target mutations are making real progress, there is no reason to assume that such risks will intensify in the long term to the point of justifying a ban on gene editing in human embryos. With technological advances, the risks will certainly be outweighed by the potential benefits of gene editing for future generations. It is undeniable that all medical research entails risks of both foreseeable and unforeseeable harm to participants, which are routinely considered from an ethical standpoint. In this context, assuming zero tolerance for risk would be equivalent to preventing any clinical innovation (14).
Given that the CRISPR/Cas9 gene-editing technique is used for the sole purpose of correcting genetic defects and restoring health in future children, it is difficult to see how this could negatively impact human dignity. Thus, depending on the genetic disease one seeks to prevent, the benefit to the individual is existential, since, in such cases, the limitations are so severe that they can compromise quality of life or life itself (15).
2. From Regulation to Implementation of the Technique
Although gene-editing technologies are yielding promising advances in the field of biosciences, studies related to their clinical application remain a source of intense concern regarding their responsible and regulated use. Further studies are still needed to assess specific risks before proceeding safely with human clinical trials. The important role of regulation in preventing the indiscriminate and inappropriate use of the technique is undeniable.
However, contrary to this logic, several clinical trials, including gene editing of human embryos, have been conducted in countries such as China, where specific regulations do not yet exist, causing great consternation in the scientific community due to the disregard for the ethical principles and criteria that guide clinical trial protocols (16).
In a minority of countries, including the United Kingdom and the United States, national scientific institutions have established important guidelines to address the main ethical and biosafety issues related to gene editing (17) (18). Research conducted in this context tends to encourage basic research and emphasizes the need for precautionary measures regarding clinical research, especially when germline cells are involved. In turn, regarding the genetic modification of human embryos, there is still a consensus on its prohibition for reproductive purposes, despite evidence that gene-editing technology, based on the CRISPR/Cas9 technique, is a viable tool with great potential when applied to the medical field. However, it still lacks clear and objective regulations to ensure its safe development, which would enable a broader scope of application in the future (19).
Even in the face of so many challenges, it is undeniable that the gene-editing technique (CRISPR/Cas9) already represents a disruptive technology, as it breaks with standards previously considered the gold standard by replacing complex, costly, and time-consuming innovative technologies with a simple, effective, low-cost, and rapid technique (20).
This may be helping to drive scientists to make the technique increasingly safe and effective, while respecting the imposed ethical and legal boundaries.
Undoubtedly, the most important biotechnological advances in medicine—including hemodialysis, solid organ transplantation, assisted human reproduction, animal cloning, human genome mapping, stem cell research, among others, have followed this same path of confrontations and challenges—ethical, legal, and technical—until they were refined to the point of being recognized as viable therapeutic options.
3. Civil Liability Regarding the Risks Arising from Gene-Editing Techniques
In the field of biotechnology, it is not uncommon to see discussions surrounding potential—or even uncertain—risks when dealing with unprecedented technologies, such as the gene-editing technique CRISPR/Cas9. Thus, it is essential that, in such situations, the discussion regarding the predictability and causality of risks be explored in depth, since, although these risks may not be immediately apparent, they can represent a latent threat characterized by unknown risks or risks of “unknown cause.”
In situations involving unknown risks, there is a well-established consensus that subjective liability does not apply, since the foreseeability of the harmful event is considered a requirement for fault, and information regarding the probable risk of harm is not available. Thus, in this context, liability based on fault could only be invoked if the precautionary principle were not respected—as occurs in situations where duties of care, protection, and information are inadequate according to the “state of the art.”
In contrast, according to the objective theory, liability for damages caused by unknown risks may arise when such risks are related to uncertain causation, which affects the allocation of the burden of proof. From a pragmatic perspective—in which every risk of harm generated is treated as a factor for objective liability—it is essential to understand the activity’s risk potential. This is undoubtedly the greatest challenge (21).
Therefore, when analyzing civil liability in the context of gene editing—where the primary challenge is the possibility of unknown risks—it is necessary to strike a balance between the general guidelines established by the legislature and the updating of legal norms based on legal doctrine and case law. In recent studies (22), the scenarios for civil liability for unknown risks in the context of gene editing have been outlined, highlighting the importance of analyzing this topic both in Brazil and in comparative law (“liability for unknown risks”). In this context, the importance of the theory of objective liability was highlighted, along with the discussion of risk theories, the peculiarities surrounding the analysis of causation, as well as the controversial discussion regarding the acceptance of unknown risk as a ground for exclusion of liability (the Brazilian perspective, and in accordance with European Directive 85/374) (23).
However, at this point, the discussion goes further. A new analytical perspective is needed, given that there is no denying the foreseeable future challenges that will arise once technical hurdles are overcome and precise limits—both ethical and legal—are established, so that gene editing may, in fact, represent a viable therapeutic option.
4. Civil liability for damages arising from the failure to use gene-editing technology
In a new scenario—still hypothetical, yet irrefutable—in which gene editing for therapeutic purposes (medical indication) becomes a viable and safe option, denying, prohibiting, or failing to offer this opportunity would explicitly constitute a denial of a constitutionally enshrined right—“protection of the person.”
This gives rise to another discussion: would we be facing a new type of harm? What would be its severity and scope? Given its irreversibility and magnitude, would we be dealing with harm to the very existence of a human being?
In some situations, objecting to the use of gene-editing techniques would effectively amount to making a choice regarding another person’s life, thereby preventing that person from being the protagonist of their own existence and compromising their freedom and future prospects. From this perspective, the harm caused would undermine the ideals that enable a person’s fulfillment as a human being (their self-realization) (24), thereby preventing the realization of their “life plan” (25).
Nevertheless, we are not considering only the self-realization of a being who is yet to come. Denying, prohibiting, or failing to offer gene editing is behavior that violates this fundamental component of our sense that life is worth living. But it is not just about this. The term “transcendence” suggests the existence of a desire to help others reach their potential. It is a loyalty to a cause beyond ourselves, driving us to identify purposes external to the “self” and enabling others to maintain the value of their existence (26).
From a constitutional perspective, the fundamental right to freedom (self-realization) grants every human being a modus vivendi and a unique way of life; however, the fundamental right to solidarity opens the door to transcendence—a concept that becomes even more tangible when the “other” is not limited to the “collective” or “future generations,” but to one’s own descendants.
4.1 Protection of the Person and the Relationship to the Concept of Existential Harm
Given the growing recognition of the need to protect against situations that cause harm extending beyond an individual’s psychophysical injury and beyond non-pecuniary personality rights, it is essential to discuss the expansion of the concept of harm, particularly from a functional perspective. For the legal doctrines that justify this need, the main argument is the lack of a legal framework capable of addressing the right to compensation for harm caused to a person in relation to other fundamental values of human life.
In this regard, it is essential to identify the criteria that define the existential interest deserving of protection, thereby avoiding the indiscriminate use of the concept of existential harm, which could compromise its effective recognition and valuation. This does not mean encompassing, within the context of existential harm, any detrimental change in a person’s daily life, nor a change that is not legally relevant. Such harm must be quantitatively and qualitatively relevant from a legal perspective, since it would affect the person’s dignity and significantly compromise their integrity. It is therefore justified to demonstrate how the concept of existential harm could be applied in a specific case, specifically based on the epistemological framework proposed in this study.
Preliminary discussions recognizing the greater need to protect individuals in their life-affirming activities (27) were influenced both by Italian legal doctrine (28) and by precedents from the Inter-American Court of Human Rights (29). Thus, in an unprecedented move, it was proposed to treat harm to the person as a refined category of civil liability—that is, a specific type of non-pecuniary harm. In this context, the autonomous category of “existential harm” was established, encompassing any harmful and legally relevant alteration to the existence of the injured person. From that point onward, efforts to expand the protection afforded to a person’s existential values have intensified.
In this scenario, the protection of the person is not restricted solely to those rights expressly or explicitly provided for in the Constitution and the Civil Code (30). From this perspective, the idea that any harm to a person must be protected becomes more robust (31). Furthermore, harm to one’s life plan (32) (33) and harm to one’s social relationships (34) have been defined as constituent elements of existential harm.
Consequently, damage caused to a person’s existence has been defined as that which is capable of generating a negative and legally relevant impact on the person’s daily life, causing a harmful, total or partial, permanent or temporary alteration in their fulfilling activities, including an involuntary renunciation of a normal state of life. It should be noted that these fulfilling activities would even include those related to meeting basic needs such as food, personal hygiene, and basic education. These situations—involving the loss of the ability to perform simple acts and the objective deprivation of the ability to carry out normal, everyday activities—are even more readily evident when a person’s physical integrity is compromised (35).
Thus, the frustration arising from the individual’s unmet expectations regarding their own development as a person would represent harm of a severity and scope incomparable to the injuries caused by other types of harm. More destructively, such harm has the potential to create an existential void, affecting the freedom—albeit abstract—that each person possesses to choose their own destiny and shape their life, which would result in the erosion of any prospect of a minimally fulfilling present and future. Furthermore, it would not affect only the sphere of the person’s inner suffering, but would also manifest externally through the pain caused by the inability to engage in hedonistic activities. The consequences of existential harm would therefore extend beyond the changes brought about in the way a person projects themselves into the world, also affecting their relationships with others (36).
It should also be noted that, depending on the specific case, by hindering the performance of acts of paramount importance for personal self-realization, existential harm can transform the ordinary aspects of daily life into genuine challenges, moments of anguish, tension, and profound difficulty. Following this line of reasoning, harm to one’s life plan would constitute an aspect of existential harm related to the practical impediment to performing acts essential to the fulfillment of personal goals and aspirations capable of giving meaning to one’s existence (37).
Beyond this analysis, one must also consider that existential harm involves an aspect of “potentiality” regarding the activities that the person would have been capable of performing had they not suffered the harm. It is, therefore, in this sense that civil liability for existential harm would be justified as harm resulting from a thwarted life plan, in which the extent of the harm would be measured in relation to what can no longer be attained (38).
Another distinctive feature of existential harm is that, although it occurs at a specific point in the individual’s life, its harmful potential extends throughout the victim’s entire life, preventing them from achieving self-actualization. For this reason, those who advocate this theory are unanimous in linking existential harm to the disruption of a projected future (failure in the pursuit of one’s life plan), in which subsequent, timeless losses—which carry an essentially existential value—are taken into account. It is further understood that the disruption of this quest—which has the potential to give meaning to each person’s life—when caused by factors beyond the individual’s control (injustice, discrimination, violence) must be considered particularly grave (39).
Although this new category of harm is not yet consistently supported by Brazilian legal doctrine, there is evidence of its application in national case law (40), where it has sometimes been referred to as “existential harm,” at other times as “harm to one’s life plan,” or, more controversially, as a synonym for “moral damage.”
Existential harm was not expressly identified in the Brazilian legal system until Law No. 13.467/2017 included, in the Consolidated Labor Laws (CLT), provision 223-B in Title II-A (“Non-Pecuniary Damages”), correctly distinguishing between moral damage and existential damage as subcategories of the broader category of “non-pecuniary damages” (41). Once evidence of their applicability has been established through an analysis of case law, and given the presence of evidence of harm caused to the individual, there is no denying the right to due compensation, even if this requires the creation of a new category of protection for personal harm through an amendment to the Civil Code, as recommended in the CLT. After all, despite the commendable trend toward recognizing the multifunctionality of civil liability, there is a solid social consensus that the primary function of non-contractual liability remains the redress of damages, supported by the principle of full redress (42).
4.2 Assessing Damage to Life Plans in the Context of Gene Editing
In the event that gene editing becomes a viable therapeutic option—a situation that is still hypothetical, yet undeniable— one must question the harmful effects of not using it, especially in cases of genetically determined, incurable diseases that limit an individual’s autonomy and may even compromise their dignity. Could one conceive of intergenerational harm? The deliberate omission of gene editing appears to be an offense with long-term consequences, for what makes us human spans generations and ultimately serves as a bridge between them.
In this context, it is not difficult to see that, only through gene editing, it would be possible to prevent harm of significant magnitude—harm with permanent consequences that limit an individual’s ability to live out their own choices, compromising their destiny, subjecting them to daily sacrifices, and trapping them in an existential void.
In this situation, questions arise regarding the likelihood of harm to one’s life plan in the context of gene editing. In other words, once a genetic alteration has been diagnosed—and if it is correctable through gene editing—failing to perform the correction will result in harm that is known to have significant, decisive, prolonged, and often permanent repercussions on that individual’s life.
However, in order to consider such scenarios, it is necessary to outline a few situations:
4.2.1. Situation in which the technique is scientifically recognized but is unavailable because it lacks legal support
Even assuming that, from a scientific standpoint, gene editing has advanced sufficiently to be recognized as a therapeutic option, it must be acknowledged that its acceptance and legal framework will depend on the specific contexts of each country. Sociocultural factors, as well as economic development, can influence this process. In the absence of legal support, the possibility of performing gene-editing procedures becomes unfeasible, leaving individuals to cope with the harm resulting from this constraint.
In this situation, another important issue should be highlighted. Since the option to undergo the procedure in their country of origin does not exist, and driven by the desire to avoid the harm resulting from the genetic conditions diagnosed in the embryo, parents resort to medical tourism. Given that policies vary from country to country—with regulations ranging from more permissive to more restrictive— people travel from their place of origin, motivated by the search for health services that provide the treatment, without even considering the risks posed by poorly regulated or even illegal markets. Thus, yet another challenge arises.
4.2.2. Situation in which the technique is available but access is limited
It is undeniable that, when implemented clinically, these techniques will certainly entail high costs, which may even hinder their availability through health insurance plans. Even if gene editing, in and of itself, is not a costly technique, its clinical implementation requires combining it with assisted reproductive technologies, in vitro fertilization, and preimplantation diagnosis—which are known to be expensive.
Thus, this fact could inevitably limit access to the technology for certain social groups, thereby creating unequal opportunities. Under these circumstances, parents’ decision not to use the technique would not be a choice. Rather, this decision would result from a lack of financial resources, making it impossible to prevent the harm resulting from the genetic alteration diagnosed in the embryo.
In a discussion that goes beyond the scope of this article, it is evident that the so-called NBIC convergence—nanotechnology, biotechnology, information technology, and cognitive science (neuroscience)—blurs the lines between natural and artificial life, dissolves the boundaries between the physical sciences and biology, and leads to the enhancement of human beings. Based on the premise that “not everything that is technically possible is ethically permissible,” the greatest fear among scholars of the phenomenon of transhumanism is that a caste of “new” human beings will have exclusive access to technologies that provide extended longevity with superior physical and mental capabilities (43). The key is to establish public policies that direct CRISPR/Cas9 technology to serve humanity—as a tool for mapping serious hereditary diseases and not subverted into a utilitarian eugenic technique— especially in the context of an extremely unequal society, where the issue of access is structurally sensitive even for essential goods (education, basic health care, social assistance, housing).
4.2.3. Situation in which the technique is available but was not used due to a diagnostic error
In such cases, the failure to diagnose genetic alterations is the responsibility of the physician or laboratory tasked, respectively, with making the diagnosis and conducting the tests. This failure—which may result from negligence or even omission—is what justifies the non-use of gene-editing technology.
In addition to the potential harm to the embryo resulting from the loss of the opportunity to correct genetic alterations, there is also harm caused to the parents, whose right to make a free and informed decision regarding whether or not to continue the pregnancy has been curtailed (termination as provided for by law) (44).
In both situations, the criteria that characterize harm to one’s life plan become evident, including irreversibility, severity, the curtailment of expectations for personal development, and even resignation to one’s own fate.
4.2.4. Situation in which the technique is available but has not been chosen
Considering the reproductive reality of prospective parents at high risk of having children affected by serious genetic diseases, it can be said that gene-editing technology constitutes yet another reproductive alternative, expanding their options and thereby ensuring greater reproductive autonomy for them.
However, precisely because it is an alternative, gene editing will not always be the chosen option. From this perspective, one must consider the significant influence that cultural, intellectual, and religious factors have on parents’ decision-making capacity, as they directly affect their understanding and acceptance of the clinical indication for the technique.
It should be noted that, in situations involving assisted human reproduction techniques, where preimplantation diagnosis is essential to ensure the procedure’s effectiveness, the diagnosis of potential genetic alterations is routine. However, specifically in these situations, even when prior diagnosis of such abnormalities is possible, parents—upholding their reproductive autonomy—may decide to proceed with the birth without undergoing gene editing. In this case, they would be choosing not to make use of the available therapy, despite the diagnosis confirming the indication for gene editing. A different situation would be that of a natural pregnancy in which such investigations occur only in the face of well-founded suspicions, which considerably reduces the likelihood of a diagnosis and, therefore, the option to correct any detected mutations.
Despite the unquestionable significance of the harm to the embryo in both situations, there is a notable difference in liability for the harm when the decision is made not to proceed with gene editing despite a prior diagnosis. In such cases, the occurrence of harm is intrinsically linked to the parents’ decision; by disregarding the possible consequences of the harm, they limit this future being’s ability to exercise its freedoms of choice regarding life.
In the event that the only option is to make a choice, avoiding the infliction of extreme suffering is an ethical commitment to the community. Within pluralism, the experience of otherness and distinct ways of life is acknowledged, but not in infinitely variable forms: both freedom and equality are among the values most sought after by human beings. However, as Isaiah Berlin points out, total freedom for wolves means the death of the sheep; the total freedom of the powerful is not compatible with the rights to a decent existence for the less fortunate (45) (46).
The point here is not to question the argument that no one can file a legal claim for having been harmed simply because they were born. It is important to note that the focus on gene editing is not similar to what occurred a few years ago in France
—whether in the famous Perruche case or in other situations where doctors were sued for detecting physical or mental disabilities in fetuses, thereby preventing mothers from choosing to have an abortion. There, the debate centered on the loss of an opportunity for mothers to avoid lives of intense suffering (a dubious causal link that could encourage eugenic practices if the lawsuits were successful). In gene editing, by contrast, the central issue is potential civil liability for a tort in which the victim is not an unborn child, or even a pre-embryo, but rather a yet-to-be-conceived child (“concepturo”)—that is, one who is yet to be conceived, an “expectation of what is to come,” existing in the realm of uncertainty. The yet-to-be-conceived child does not exist in the realm of being, and the only reference to it is found in testamentary succession (Art. 1799, I, CC), in the capacity of a child not yet conceived by a person designated by the testator. The famous “potential offspring,” which may come into existence in the future (47).
The yet-to-be-conceived child is not a person, nor does it fall under the intermediate concept of a potential life to which special protection is granted (the cryopreserved surplus embryo). In testamentary succession, the yet-to-be-conceived child emerges as a legal construct, which explains why its legal protection is purely patrimonial and limited to specific instances. But what would be the legal justification for breaking through this legislative barrier to the point of supporting a claim for existential damages on behalf of the yet-to-be-conceived child? Certainly, it would be based on a contingent right to life and comprehensive protection. While live birth is the condition precedent that will determine the receipt of the inheritance, intrauterine conception is the certain future event that marks the moment when the person comes into being and the corresponding protection of their personhood begins, even if the tort was committed prior to the embryo’s implantation in the mother’s uterus and the damages are only effectively established after birth (48).
One can even construct a reverse line of reasoning, grounded in strong pragmatism. The decedent does not hold personality rights, but his or her existential attributes never fade away as belonging to no one, for they transcend the moment of death. The “memory of the deceased” is subject to two-fold protection—preventive and reparative—by their family members, acting on their own behalf, against torts committed against the honor, image, and name of the deceased person. Well then: this line of reasoning would also apply to the dawn of life. The yet-to-be-conceived child is a pure hypothesis of being; it is not yet a subject of rights, but the tort that immediately affects it transcends the stage prior to fertilization, impacting its life and existence (49).
Thus, nothing prevents children from suing their parents for risky behaviors associated with infections such as HIV, or excessive alcohol use—e.g., Fetal Alcohol Syndrome—whose harmful effects will be identified later, even during pregnancy. Going further, this may also encompass damages resulting from the transmission of genetic disorders previously known to the parents. This is not a matter of holding them liable for giving birth to children with disabilities, but rather for committing unlawful acts, on the understanding that a preventive function of civil liability requires that the fundamental duty of care be extended to justify the protection of the yet-to-be-conceived child (50).
Regardless of any controversy regarding the starting point for the acquisition of personality rights, the fundamental right to life must be realized to ensure a dignified and fulfilling life in accordance with the historical context of each society, including the lex artis, that is, the set of medical practices generally accepted as appropriate for treatment, which vary according to technical advances in medicine.
In this context, it becomes even more relevant to analyze the choice that parents impose by not opting for gene editing, the consequences of which have the potential to create a life of curtailed autonomy, restricting the existence of the other, insofar as it fails to prevent harm capable of impeding or altering an entire life plan.
5. Conclusion
In the renowned work The Open Society and Its Enemies (1945)—in a historical examination that begins in Greece and extends to the 20th century— Karl Popper addresses the transition from a closed society to an open one, resulting in the prodigious development of the sciences, human creativity, and technology, as well as the emergence of the unique individual and the foundations of a culture of freedom. The birth of the critical spirit breaks down the walls of closed society and exposes humanity to individual responsibility. The fear of change and of the unknown causes closed society to reinforce itself. However, life is a process of constant creation. The evolution of scientific knowledge cannot be predicted by rational methods; it is impossible to anticipate the future course of a history that will be determined by discoveries and technical inventions we cannot foresee. In his reformist method of “gradual engineering” (piecemeal approach), the Austrian philosopher opposes any form of historical determinism or planning and advocates for the free competition of ideas and the gradual, consensual transformation of society through the constant improvement of institutions, which are always open to criticism and scrutiny. In an open society, freedom places a heavy burden on human beings: to decide for themselves what is good for them and what is harmful. The culture of freedom carries the burden of individual responsibility (51).
Therefore, like all other scientific advances, gene editing (CRISPR/Cas9) is viewed with optimism. It is considered one of the greatest advances in medicine in the modern era. Through the manipulation of human DNA, the technique offers a vast range of possibilities, from preventive to therapeutic applications, making it a revolutionary tool for mapping serious, hereditary, and often incurable diseases. Its contribution to understanding the origins of genetic diseases and human embryonic development is unquestionable.
However, as with any biotechnological advancement, many technical, ethical, and legal challenges remain to be addressed. In an environment where skepticism is warranted and uncertainty is a fundamental condition, we must advocate for a set of rules, responsibilities, and mechanisms for redress regarding gene editing. This reinforces the need for ongoing interdisciplinary dialogue, which is essential for weighing, outlining, and establishing new paradigms aimed at promoting the necessary adjustments. Despite the limitations currently in place, there is no denying the prospect of overcoming these challenges in the future, which will certainly determine the safe and viable preventive and/or therapeutic application of the technique.
It is in this context, consequently, that new challenges arise. Every solution gives rise to a new situation that generates its own new needs and demands, which are always unpredictable. We cannot legislate for the unknown consequences of the consequences of other consequences. However, moral and legal risks cannot be avoided, and in light of this new reality of gene editing, and in the face of a diagnosis justifying its use, failing to employ the technique could result in certain legally significant harm—irreversible, permanent, and with the potential to limit that future person’s freedom of choice, subjecting them to daily sacrifices—existential harm.
Thus, in the face of existential harm, which will objectively entail a significant and detrimental change in a person’s life, and will result in both a permanent violation of that person’s life plan and significant harm to their relationships with others, the call for the inclusion of this category of harm—whose primary purpose is to expand the protection afforded to the individual—is justified. Since the law must be concerned with preventing any harm caused to individuals, as well as curbing any injuries that may arise, the inclusion of existential harm as an autonomous category among the types of non-pecuniary damages to be considered in the protection of individuals is imperative.
(1) LIANG, P.; XU, Y.; ZHANG, X.; DING, C.; HUANG. R., et al.: “CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes”, Protein Cell, vol. 6, n. 5, p. 363-372, 2015.
(2) CLEMENTE, G. T. Manipulação gênica em embriões humanos. Actualidad Jurídica Iberoamericana, v. 9, p. 202-223, Ago. 2018.
(3) CLEMENTE, G. T. Responsabilidade Civil, Edição Gênica e o CRISPR. In: ROSENVALD, N.; DRESCH, R. F. V.; WESENDONCK, T. (Org.). Responsabilidade Civil - Novos Riscos. Indaiatuba, SP: Editora Foco, 2019. p. 301-317.
(4) SESSAREGO, C.F. Derecho a la identidad personal. Buenos Aires: Astrea, 1992. p. 261-262.
(5) CRISPR/Cas9 - This is a complex formed by an endonuclease-type enzyme (Cas9) guided to the specific region of the DNA molecule (targeted gene) to be edited, via a gRNA molecule programmed to recognize the specific DNA sequence. Thus, the DNA fragment containing the mutation is replaced with a normal sequence, enabling the correction of the disorder. The gRNA molecule can be customized to recognize specific DNA sequences by altering just 20 nucleotides. In this way, specific genes can be targeted by the gRNA and, consequently, by Cas9, which allows for precise modifications of those genes. REYES, A.; LANNER, F., Towards a CRISPR view of early human development: applications, limitations and ethical concerns of genome editing human embryos, The Company of Biologists, n. 144, p. 3-7, 2017.
(6) GYNGELL, C.; FELLOW, M.; DOUGLAS, T.; SAVULESCU, J. The ethics of germline gene editing. J Appl Philos., n. 34(4), p. 498-513, 2017.
(7) CAVALIERI, G. Genome editing and assisted reproduction: curing embryos, society or prospective parents? Medicine, Health Care and Philosophy, p. 1-11, 2017.
(8) XU, L.; YANG, H.; GAO, Y., et al. CRISPR/Cas9 – mediated CCR5 ablation in human hematopoietic steam/progenitor cells confers HIV-1 resistence in vivo. American Society of Gene & Cell Therapy, v. 25, n. 8, 2017.
(9) Off-target mutations are unintended mutations that can occur in the genome as a result of the non-specific action of the Cas9 enzyme. Thus, in addition to the intended effect, mutations in other genes may also occur in an unexpected or undesired manner – BOEL, A.; STEYAERT, W.; DE ROCKER, N., et al. BATCH-GE: batch analysis of next generation sequencing data for genoma editing assessment. Sci Rep., n. 6, p. 30330, 2016.
(10) “Mosaicism is the presence in an individual or in a tissue of at least two genetically different cell lineages, both of which are derived from a single zygote. Mutations that occur in a single cell after conception, as well as during postnatal life, can give rise to cell clones that are genetically different from the original zygote because, due to the nature of DNA replication, the mutation will persist in all clonal descendants of that cell.” THOMPSON & THOMPSON. Genética Médica: Padrões de herança monogênica. Rio de Janeiro: Elsevier, p.107-132, 2016.
(11) HASHIMOTO, M.; YAMASHITA, Y.; TAKEMOTO, T. Eletroporation of Cas9 protein/sgRNA into early pronuclear zygotes generates non-mosaic mutants in the mouse. Dev Biol., n. 418, p. 1-9, 2016.
(12) KLEINSTIVER, B.; PATTANAYAK, M.; TSAI, S., et al. High fidelity CRISPR-Cas9 - nucleases with no detectable genome-wide off-target effects. Nature, n. 529, p.490-495, 2016.
(13) SLAYMAKER, I.; GAO, L.; SCOTT, D., et al. Rationally engeneered Cas9 nucleases with improved specificity. Science, n. 351, p. 84-88, 2015.
(14) DE WERT, G.; HEINDRYCKX, B.; PENNINGS, G., et al. Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE. European Society of Human Genetics, 2018.
(15) GYNGELL, C.; FELLOW, M.; DOUGLAS, T.; SAVULESCU, J. The ethics of germline gene editing. J Appl Philos., n. 34(4), p. 498-513, 2017.
(16) CYRANOSKI, D.; LEDFORD, H. Genome-edited baby claim provokes international outery. Nature, n. 563, p. 607-608, 2018.
(17) Human genome editing: science, ethics, and governance. National Academies of Sciences, Engineering and Medicine. Washington D: Academies Press, 2017.
(18) Genoma editing and Human reproduction: social and ethical issues. Nuffield Council on Bioethics, 2018.
(19) GOUSI, L.; YAO-GUANG, L.; YAANLING, C. Genome-editing Technologies: the gap between application and policy. Sci China Life, v. 62, p. 1-5, 2019.
(20) MULVIHILL, J.J.; CAPPS, B.; JOLY, Y.; LYSAGHT, T., et al. Ethical issues of CRISPR technology and gene editing trough the lens of solidarity. British Medical Bulletin, v.122, n.1, p. 17-29, 2017.
(21) “From the perspective of law and economics, this is a challenging topic because it involves a lack of information regarding the risks involved. The economic analysis of law focuses on the incentives that civil liability can provide to guide the actors involved toward adopting best practices and making decisions regarding the level of care and activity, in order to achieve a desirable distribution of risks. In this trade-off between promoting technological advancement and protecting physical and mental well-being, the question is whether, instead of civil liability, it would not be better to have public regulation capable of better addressing negative externalities, as is already the case with mandatory insurance for workplace accidents and occupational diseases.” ROSENVALD, N. – O Direito Civil em movimento – 3ª ed., Salvador: Juspodivm, 2019, p. 206.
(22) CLEMENTE, G. T. Responsabilidade Civil, Edição Gênica e o CRISPR. In: ROSENVALD, N.; DRESCH, R. F. V.; WESENDONCK, T. (Org.). Responsabilidade Civil - Novos Riscos. Indaiatuba, SP: Editora Foco, 2019. p. 301-317.
(23) “In Directive 85/374, the development risk is summarized in the following points: (a) it is based on strict civil liability; (b) it establishes the development risk as a ground for exclusion from civil liability; (c) for this exclusion to apply, the producer bears the burden of proving that, at the time the product was placed on the market, it was not possible to detect the existence of the defect; (d) the domestic legislation of each Member State may or may not incorporate the Development Risks Defense (DRD). This defense is adopted by countries such as France, Italy, and Spain; (e) the temporal criterion for assessing the state of science and technology or the state of the art is the time the product was placed on the market, not the time the damage was verified.” ROSENVALD, N. – O Direito Civil em movimento – 3ª ed., Salvador: Juspodivm, 2019, p. 206.
(24) “Self-actualization is a slow and complex process of psychological awakening, development, and maturation of all the dormant inner potentials that lie latent within the human being, such as their ethical-moral, aesthetic, religious, artistic, and cultural experiences and achievements. It is equivalent to clarifying that it is a well-directed effort toward the realization of the deep Self and not the superficiality of the ego’s passions.” FRANCO, D.P. O despertar do espírito: obra ditada pelo espírito de Joanna de Ângelis. 5. ed. Salvador: LEAL, 2003.
(25) “What characterizes individual existence is the being who authentically chooses oneself, thereby shaping one’s destiny in a dynamic process of becoming. The individual is a conscious being, capable of making free and intentional choices—that is, choices from which the meaning of their existence arises. He creates himself by choosing himself and is a combination of realities/capacities and possibilities/potentialities; he is open-ended—or rather, he is a work in progress. This is how he chooses to be-in-the-world—what he allows himself to be through his freedom.” TEIXEIRA, J. A. C. Introdução à psicoterapia existencial. Análise Psicológica, Lisboa, v. 24, n. 3, p. 294, jul. 2006. Disponível em: <http://www.scielo.oces.mctes.pt/pdf/aps/v24n3/v24n3a03.pdf>. Acesso em: 26 dez. 2019.
(26) GAWANDE, A. Mortais, Rio de Janeiro: Objetiva, 2015.
(27) Existential harm entails a sacrifice in the person’s fulfilling activities, causing a change in the person’s relationship with their surroundings. It is a “forced renunciation of happy occasions,” as Cendon and Ziviz put it, or, at the very least, of the state of normality that existed prior to the harm. This understanding is found in ZIVIZ, Patrizia; CENDON, Paolo. Il danno esistenziale. Una nuova categoria della responsabilità civile. Milano: Giuffrè, 2000. p. XXII.
(28) Decision No. 7713 of the Italian Supreme Court, dated June 7, 2000, as a landmark case recognizing existential harm.
(29) A leading figure in Latin American legal research on damage to one’s life plan, the Peruvian legal philosopher Carlos Fernández Sessarego, a professor at the centuries-old Universidad Nacional Mayor de San Marcos – UNMSN158, associates damage to one’s life plan with a psychosomatic breakdown (with consequences that persist over time) of such magnitude that it gives rise to an existential void, in the wake of the loss of meaning experienced by human existence, to the point of nullifying the individual’s decision-making capacity or seriously impairing the possibility of making free decisions and carrying out a life plan. FERNÁNDEZ SESSAREGO, Carlos. El daño al proyecto de vida. Disponível em <http://www.pucp.edu.pe/dike/bibliotecadeautor_carlos_fernandez_cesareo/articulos/ba_fs_7.P DF>. Acesso em: 26 dez. 2019.
(30) SAPONE, Natalino. BIANCHI, Angelo. Le ragioni del danno esistenziale. Roma: Aracne Editrice, 2010
(31) PERLINGIERI, P. La dottrina del diritto civile nella legalità costituzionale. Revista Trimestral de Direito Civil. Rio de Janeiro: Padma, 31, jul/set, 2007.
(32) “We all live in time, which ultimately consumes us. Precisely because we live in time, each of us seeks to chart our life plan. The term ‘plan’ embodies an entire temporal dimension. The concept of a life plan thus has an essentially existential value, tied to the idea of integral personal fulfillment. That is to say, within the context of life’s transience, it is up to each person to make the choices that seem right to them, in the exercise of full personal freedom, to achieve the realization of their ideals. The pursuit of a life plan, therefore, reveals a profound existential value, capable of giving meaning to each person’s life. [...] That is why the abrupt disruption of this pursuit—due to external factors caused by human action (such as violence, injustice, and discrimination)—which unjustly and arbitrarily alter and destroy a person’s life plan—is of particular gravity, and the law cannot remain indifferent to this. Life—at least as we know it—is unique and has a finite duration, and the destruction of a life plan almost always results in truly irreparable harm, or harm that is, at times, difficult to remedy. Cf. ORGANIZAÇÃO DOS ESTADOS AMERICANOS. Corte Interamericana de Derechos Humanos. Caso Gutiérrez Soler Vs. Colombia. Fondo, Reparaciones y Costas. Sentencia de 12 de septiembre de 2005. Serie C n. 132. Voto razonado del Juez A.A. Cançado Trindade. Disponível em <http://www.corteidh.or.cr/docs/casos/votos/vsc_cancado_132_esp.doc>. Acesso em: 26 dez. 2019, our free translation.
(33) Harm to one’s life plan refers to non-pecuniary changes in the conditions of existence, in the normal course of the victim’s and their family’s lives. It represents the recognition that human rights violations often prevent the victim from pursuing their aspirations and vocations, causing a series of frustrations that are difficult to overcome over time. Damage to one’s life plan affects the victim’s expectations for personal, professional, and family development, impinging on their freedom to choose their own destiny. It therefore constitutes a threat to the meaning the person attributes to existence—to the spiritual meaning of life. NUNES, R.P. Reparações no sistema interamericano de proteção dos direitos humanos. In: OLIVEIRA, M.L.O. (Org.). O sistema interamericano de proteção dos direitos humanos: interface com o Direito Constitucional Contemporâneo. Belo Horizonte: Del Rey, Cap. 9, 2007, p. 166.
(34) “The individual, as a human being, can—once embedded in various interpersonal relationships, in the most diverse environments and contexts, come to shape their life experience and development through the constant pursuit of success in their life plan, the enjoyment of the rights inherent to their personhood, their affinities, and their activities. The person aims for personal growth through ongoing contact, via processes of dialogue and dialectic with other members who share in social life with him or her.” BUARQUE, E. C. M. Dano existencial: para além do dano moral. 2017. Tese. (Doutorado em Direito) – Universidade Federal de Pernambuco, Recife.
(35) SOARES, F. R. Responsabilidade civil por dano existencial. Porto Alegre: Livraria do Advogado, 2009.
(36) BUARQUE, E. C. M. Dano existencial: para além do dano moral. 2017. Tese. (Doutorado em Direito) – Universidade Federal de Pernambuco, Recife.
(37) FROTA, H. A. Noções fundamentais sobre o dano existencial. Revista Jus Navigandi, ISSN 1518-4862, Teresina, ano 16, n. 3046, 3 nov. 2011. Disponível em: https://jus.com.br/artigos/20349. Acesso em: 26 dez. 2019.
(38) SESSAREGO, C. F. ¿Existe un daño al proyecto de vida? Disponível em: <http://www. revistapersona.com.ar/Persona11/11Sessarego.htm>. Acesso em: 28 ago. 2019. Sessarego gives the following example: “We have previously mentioned, by way of example, the profound existential frustration experienced by a famous pianist who loses some of the fingers on his hand, which consequently prevents him from fulfilling himself as a pianist. This damage to the ‘life project’ has no economic significance; nevertheless, it has very serious consequences that can lead—resulting in an existential void—even to suicide. This, of course, is separate from the actual damages and lost profits simultaneously caused by the perpetrator of the tort.” SESSAREGO, C.F. Derecho a la identidad personal. Buenos Aires: Astrea, 1992. p. 261-262.
(39) BUARQUE, E. C. M. Dano existencial: para além do dano moral. 2017. Tese. (Doutorado em Direito) – Universidade Federal de Pernambuco, Recife.
(40) SANTANA, A.G. O dano existencial como categoria jurídica autônoma: um aporte a partir de um diálogo com os direitos humanos. 2017. Tese (Doutorado em Direito) – Universidade Federal do Pará, Belém.
(41) Art. 223-B—CLT. [2017 Labor Reform] An act or omission that infringes upon the moral or existential sphere of a natural or legal person causes non-pecuniary damage; such persons are the exclusive holders of the right to compensation. (Added by Law No. 13.467, dated July 13, 2017).
(42) ROSENVALD, N. As funções da Responsabilidade Civil – A Reparação e a Pena Civil. 3ª ed., São Paulo: Saraiva, 2017.
(43) “There is no reason to reject technology if it serves humanity, if it contributes to a more humane world, where the solidarity advocated by personalism can be fully realized. There is no reason to reject the idea of improving human nature itself, provided that it involves a genuine improvement that corresponds to the anthropological truth of man and allows him to pursue the fundamental goods to which he aspires.” TANGUY, M. P. Transhumanismo. Madrid: Rialp, 2018, p. 17.
(44) “In cases referred to as ‘wrongful conception’ or ‘wrongful pregnancy,’ whether or not a birth occurs, there is an unwanted pregnancy resulting from medical error (in the broad sense), or a fetus with a genetic disability is conceived after the parents were not informed—or were incorrectly informed—about its genetic risks.” PINTO, M. P. Direitos de Personalidade e Direitos Fundamentais – Estudos. Coimbra: GESTLEGAL, 2018, p. 735-772.
(45) BERLIN, I.; BEZAMAT, A. Uma mensagem para o século XXI. Belo Horizonte: Ayiné, 2018.
(46) Berlin rightly points out that “the best that can be done is to maintain a precarious balance that will prevent intolerable choices from arising—this is the first requirement for a decent society; one that will always be worth fighting for.”
(47) ROSENVALD, N. – O Direito Civil em movimento – 3ª Ed., Salvador: Juspodivm, 2019, p. 178.
(48) Ibid., p. 179.
(49) Ibid., loc. cit.
(50) “In fact, in 2016, a man born in England with severe disabilities—resulting from his mother having been raped by his own father—was awarded moral damages from his grandfather. In a landmark ruling, the Upper Tribunal held that the victim—now a 28-year-old man—is entitled to compensation. The young man has epilepsy, severe learning disabilities, and serious visual and hearing impairments. According to the defense, the plaintiff did not meet the legal definition of a “person,” since if the crime had not been committed against his mother, he would not exist. Furthermore, a wrongful act committed before conception, the consequences of which become apparent after birth, cannot be treated as an injury to a living person. However, the judges found that there is no legal provision requiring the victim to be a person at the time of the crime. The decisive factor is that the genetic disorders are consequences directly attributable to the incestuous act.” ROSENVALD, N. – O Direito Civil em movimento – 3ª ed., Salvador: Juspodivm, 2019, p. 178.
(51) POPPER, K. A Sociedade aberta e seus inimigos. Belo Horizonte: Itatiaia, 1974.