1. INTRODUCTION
Since the description of the molecular structure of DNA (J. Watson and F. Crick, 1953) (1) and following the overcoming of the challenges posed by the sequencing of the human genome (Human Genome Project, 2003) (2), scientists have been dedicated to the study and development of technologies that enable the genetic manipulation of cells and organisms, with the aim of eliminating or correcting genetic mutations, thereby undoing or silencing their deleterious effects.
The recent announcement of the 2020 Nobel Prize in Chemistry marked a historic milestone when scientists Emmanuelle Charpentier and Jennifer Doudna received the award for the discovery of the gene-editing technique —CRISPR/Cas9—which represented scientific recognition of one of the most important discoveries of the 21st century (3). This disruptive technology, now recognized in the scientific community, represents a point of no return in light of the evidence gathered, demanding paradigm shifts and creating unprecedented challenges that call for adaptations of the legal system to meet new expectations.
Charpentier and Doudna’s studies demonstrated that the Cas9 endonuclease, together with a guide RNA molecule, could be programmed to specifically cleave any DNA sequence, which expanded and generalized the applicability of the CRISPR/Cas9 system (4). Since then, it has been possible to use this tool with high efficiency, ease, and at low cost in basic research, biotechnology, and the development of new preventive and therapeutic alternatives, representing a revolution in biological research. Genome editing has become widely accessible (5).
However, even considering the preventive and therapeutic benefits demonstrated in basic and preclinical research, due to its novelty and the potential to cause permanent changes in DNA, with a potential impact on future generations, such research justifies the intense debates surrounding the applicability of this new technology—whether regarding the need for adequate regulation or the need to weigh its limitations against its potential (6).
In the context of genetic editing of human embryos or germline cells, the discussion centers not only on ethical dilemmas but also on the impact of future and unknown risks, coupled with uncertainty regarding the harmful effects arising from this new technology, within the framework of civil liability. In the field of biotechnology, it is not uncommon to discuss potential or even uncertain risks when dealing with unprecedented technologies, such as the CRISPR/Cas9 gene-editing technique. Thus, it is essential that, in such situations, the discussion regarding the predictability and causality of risks be explored in depth, since, although they may not be immediately apparent, they can represent a latent threat characterized by unknown risks or risks of unknown cause.
In this regard, as a major challenge in the effort to propose alternatives for compensating damages, building trust, and resolving and managing conflicts of interest, it is justified to address relevant issues such as: the expansion of the precautionary function of civil liability, liability for development risks, the applicability of liability exemptions, the importance of public regulation of negative externalities, and the general protection of personality rights (7).
2. POTENTIAL AND LIMITATIONS OF THE CRISPR/Cas9 GENE-EDITING TECHNIQUE
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 these sequences (8).
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 silencing gene activity is desired) 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 (9).
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. In this regard, notable examples include 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, thereby facilitating the development of important gene therapies for their treatment, among others. As for research with clinical applications, the importance of gene editing in human embryos is undeniable, as it enables the development of preventive techniques for genetic diseases (6% of newborns have significant genetic disorders) (10).
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 (cases in which only one viable embryo is produced during in vitro fertilization, and that embryo carries a monogenic mutation; in situations where patients are carriers of autosomal dominant genetic disorders and carry two copies of the mutated gene; cases of autosomal recessive disorders, where even when embryos are selected 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). 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, and even then, there would be no guarantee that such an embryo would be free from carrying the mutation and could pass it on to its offspring. Furthermore, in the long term, research involving gene editing could become an important tool in cases of polygenic diseases, 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 speculation. The pathogenesis of these diseases has not yet been fully elucidated; therefore, further investigation is needed to demonstrate the technique’s potential to reduce their incidence (11). Even in the context of infectious diseases, the clinical application of gene editing is already a reality, since certain genes can increase an individual’s resistance to infection by various pathogens (12).
However, despite the potential of gene editing, limitations regarding its effectiveness still persist, such as the occurrence of mosaicism and off-target mutations (13).
A mosaic embryo results from inefficient DNA cleavage by the nuclease and/or inappropriate DNA repair (14). 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 a negative impact 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 laboratory studies using more sensitive RNA guides (CRISPR/Cas9/sgRNA) demonstrate a significant increase in the preventive effectiveness against this undesirable effect (15).
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 tool). 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 denied, 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 possible 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 (16) (17).
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. It is undeniable that all medical research poses risks of both foreseeable and unforeseeable harm to participants, and these risks are routinely considered from an ethical standpoint. However, in this context, assuming zero tolerance for risk would be equivalent to preventing any clinical innovation (18) (19).
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 (20) (21).
3. CIVIL LIABILITY ARISING FROM UNKNOWN RISKS AND THE CRISPR/Cas9 GENE-EDITING TECHNIQUE
Given that the production of knowledge demands an increasingly rapid pace of scientific and technical development, discussions are expanding not only regarding bioethical dilemmas and potential health risks but also regarding the possibilities for redressing damages arising from these potential harmful effects.
Given the potential risks associated with techniques considered unprecedented—such as the CRISPR/Cas9 technique—it is timely to discuss the possible predictability and causality of these risks. These risks would be those considered unpredictable and of uncertain cause; that is, although not immediately apparent, they would represent a latent threat characterized as “unknown risks” or risks of unknown cause (22).
In the context of Continental Europe, the issue of civil liability for unknown risks has been widely discussed and is viewed as a drawback of the technical advances emerging from nanotechnology, software, applications, and genetic engineering (23).
In cases involving unknown risks, there is a 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—that is, it is impossible to estimate when such a risk could have been foreseen. A different situation arises when the risk is known but difficult to control or avoid. In this case, 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 not adequately fulfilled, in accordance with legis artis.
On the other hand, according to the objective theory, liability for damages caused by unknown risks may arise when such risks are related to uncertain causation, which implies a shift in the burden of proof (if causation is not proven or if it is impossible to identify the new fact that interrupted the causal link between the damage and the activity that caused it).
Viewed from a pragmatic perspective, in which every risk generated is treated as a factor for objective liability, the inevitable consequence is the undermining of any progress in free enterprise and entrepreneurship in today’s societies. Therefore, when analyzing civil liability, it is necessary to strike a balance between the general guidelines established by the legislature and the updating of the legal framework based on legal doctrine and case law. Thus, the goal is not the impossible (elimination of risk) but the mitigation of damages. Consequently, it is essential to understand the activity’s risk potential in order to justify the objective attribution of damages to the agent. This, without a doubt, is the greatest challenge (24).
According to the general provision in the sole paragraph of Article 927 of the Brazilian Civil Code, which states that the activity involves risk “by its very nature,” this means that risk is inherent to the activity, constituting a preexisting and intrinsic aspect thereof (activity-related risk). Thus, this activity, in and of itself, generates a high risk of harm, implying that the person undertaking it is objectively liable for compensation. It is, therefore, a special risk capable of causing damages that are quantitatively numerous (high probability of causing damages) and qualitatively severe (intensity of the eventual occurrence). It should be noted that an abnormal danger in the means employed is not required; rather, what is most important is verifying the statistical regularity with which the harmful event occurs as a result of the activity being carried out.
Based on this context, it can be inferred that the unknown risks arising from the CRISPR/Cas9 technique, because they are not preexisting, cannot be considered inherent to the activity. According to this understanding, for a potential risk to manifest as harm in the context of gene editing, multiple interactions with the environment may be necessary—interactions that often occur only over time and may be detectable only in future generations. This alleged harm also depends on individual differences that can either prevent or exacerbate the activity’s harmful potential and is influenced by numerous variables that even limit the possibility of estimating the activity’s risk level. This is an essential factor in determining the probability of risk manifestation. It is known that, when it comes to genetic manipulation, one of the main determinants of the harmful effect is, precisely, the frequency with which it occurs. Thus, given so many peculiarities, it is evident that it is the nature of the activity that will determine, in the specific case, its propensity to create risk.
Furthermore, in the context of objective liability, the indisputable relevance of the analysis of causation stands out. The perpetrator of the act will be held liable simply by the assignment of a certain link of attribution, such as liability for safety, warranty, or risk. Consequently, the normative concept of the causal link is adopted, adapting the theory of causation to the problems arising from the massification and depersonalization of individuals in risk societies. It is understood that, through theories of causation, the aim is, in a sense, to facilitate redress for unjust damages by replacing causal criteria—based on certainties—with probabilistic criteria that consider the reasonableness of the occurrence of the results. This probabilistic conception of civil liability is based on the legal analysis of the attribution of damages, which is carried out by classifying the activity as statistically and typically associated with the damage (research data, scientific or technical methods, expert reports). Thus, the theory of adequate causation—which allows for an abstract analysis of the probability of the harmful event—stands out as the preferred option. In this case, the judge is entrusted with the assessment of probability, in which the facts will be accepted as presumed true based on the potential and probability of the risk in relation to the harm, thereby ultimately ensuring compensation (25). Therefore, through the theory of adequate causation, it is possible to conduct an a priori analysis of the potential for harm posed by a certain activity. Thus, statistical findings regarding the risk of the activity precede the occurrence of the harm; that is, the unreasonable risk of a certain activity is identified by recognizing its capacity to cause harm.
When analyzing the scenario in which unknown risks arise from the use of the CRISPR/Cas9 technique, certain challenges regarding the applicability of the theory of adequate causation arise. Notably, there is a limitation regarding the possibility of conducting such an analysis in an abstract manner, as it is based on the ability to evaluate a multitude of similar cases. Thus, based on objective technical evidence, one can infer whether a particular harmful event is an expected or reasonable effect of a certain activity. Another relevant aspect to consider is the fact that there is very little case law regarding the CRISPR/Cas9 technique. This is due to the current limitations on the technique’s applicability, as well as its novelty and rapid evolution. Since its creation, the technique has been refined on a daily basis, which makes it difficult to apply the criteria of probability and reasonableness when establishing the causal link between the activity that gives rise to the harm and the unjustified harm in a specific case. Therefore, the idea that the legal analysis of liability for damages will be based on the classification of the activity is undermined (26).
From this same line of reasoning, beyond this discussion, the analysis of the precautionary principle recently proposed by Koplin et al. deserves special mention. It is indisputable that, with regard to decision-making in contexts where activities pose uncertain but potentially serious threats (such as in the context of germline cell gene editing), the precautionary principle plays a significant role. However, in the pioneering and innovative analysis proposed by these authors, in addition to weighing the various nuances of the precautionary principle (negative and positive), the plausibility of the “principle of sufficient precaution” is also considered. Thus, the cost-benefit analysis framework, which had been used until then, would give way to a more specific approach to addressing risks or threats. In this context, not only would the challenges of using the technique be analyzed, but also the risks arising from its non-use, particularly with regard to the genetic health of future generations (27).
Under the umbrella of objective liability, it will also be necessary to analyze the issue of unknown risk based on the debate regarding developmental risk. Even before the enactment of the Civil Code of 2002, the Consumer Protection Code (CDC) was already in force, establishing the civil liability of suppliers of products and services for so-called “consumer accidents.” Therefore, it follows from the foregoing that the CDC adopts the doctrine of strict liability with a specific focus: the theory of product or service defect—that is, an objective obligation to compensate without regard to the risk inherent in the activity, as provided for in the Civil Code of 2002 (28).
In Brazil, although the discussion on unknown risks has not been widely addressed, the debate on development risks (a subset of “unknown risks”) is quite widespread. So-called “development risks” refer to the negative side effects arising from the use of products or services that may occur after they have been provided to consumers. In light of this, the controversy arises and intensifies when it comes to risks that, although initially unknown, become known as a result of scientific advances. This eventuality would imply acceptance of the supplier’s exclusion from liability for development risk (29).
Through Directive 85/374, the European Union addressed the issue of development risk by establishing it as a ground for exclusion from strict liability. However, as a requirement for admissibility, it was established that the producer must prove that, at the time the product was placed on the market, it was not possible to detect the existence of the defect or adverse side effect of the product, that is, the temporal criterion would be the placing of the product on the market and not the occurrence of the harm. It was further determined that it would be up to the domestic legislation of each Member State to decide whether or not to incorporate the Development Risks Defense (DRD) (30)(31)(32).
Although the Brazilian legislature has not expressly imposed this defense, its silence need not necessarily be interpreted as an exclusion of it. For those who argue that such a defense should be accepted, the main argument is that requiring such a high degree of caution—assuming risks that were impossible to foresee or unavoidable at that time—would, in a sense, impede scientific progress and force the supplier to do the impossible (33). Furthermore, it is argued that Article 10 of the CDC, by prohibiting a supplier from offering products on the market that it knows or ought to know present a high degree of danger or harmfulness, excludes liability by implication, since, with regard to development risks, there is no duty to know about the defect at the time it is introduced into the market (34).
It is worth noting that, when dealing with development risks, the most significant issue is the unpredictability of these risks. These are damages whose occurrence and extent are incalculable, which is why simply attributing liability to the supplier would undermine the logic of the risk acceptance system, given the possibility of predicting and internalizing such risks as a cost of business (35)(36)(37). It should be emphasized that, in the case of an unknown risk related to unprecedented
of gene editing, there would not strictly speaking be a “defective product.” The CRISPR/Cas9 technique is, in fact, a type of activity performed—that is to say, a service rendered. The concept of a defective service implies a service provided with a lack of safety; however, for the law to intervene, this lack of safety must exceed the limits of normality, and the risk must be foreseeable. It is this fact that characterizes the defect itself. In cases involving services with acquired danger, one can speak of a defect. However, in such cases, these activities do not, by their very nature, present an inherent or excessive risk. Thus, when the defect arises (the moment the harm manifests itself), it will be considered unpredictable (38).
In this sense, and from the perspective of the CRISPR/Cas9 technique, it is understood that an activity that does not present an inherent risk—in the event that it comes to pose a hazard (a service involving acquired hazard)—will be considered an unpredictable or unknown harmful event. The possibility of excluding liability based on the risk of development (DRD), as expressly provided for in European Directive 85/374, may therefore be considered in these circumstances (39).
In light of the foregoing, questions arise regarding the effectiveness of civil liability, as traditionally conceived, in safeguarding against the harmful effects of new technologies that often entail unknown and even unpredictable risks with the potential to affect future generations as well. Thus, a broader discussion of this topic becomes essential, which necessarily involves devising other strategies to address the challenges of civil liability in the face of “new risks.” These strategies certainly include the “general right of personality” and the “internalization of negative externalities” or risk socialization (40).
Based on a comparative analysis—between the Portuguese Civil Code and the New Brazilian Civil Code (41)—personality rights correspond, for the most part, to fundamental rights that pertain to the human personality as a whole, whether they concern particular aspects or modes of being of the personality, or when they pertain to the concept of a “general right of personality,” which corresponds to the clause on human dignity and the right to the development of personality. The systematic relationships between fundamental rights and various legal statutes, as well as the Constitution, ensure their effectiveness in private legal and constitutional relations. Thus, personality rights serve as a legal instrument for the realization of fundamental rights in private legal relations.
In legal systems where a clause providing for the protection or “general protection of personality” is explicitly provided —an indeterminate concept—this not only allows for the protection of a series of unstated special personality rights but also serves as a positive basis for the right to personality or even the recognition of other forms of protection for the individual. In Brazilian law, although not explicit, the general protection clause may be considered implicit, either through the recognition of personality rights or by virtue of its correspondence with Article 5 of the 1988 Constitution.
Thus, it can be inferred that personality rights do not merely protect a particular aspect of the human person but broadly encompass the different aspects of human personality, covering new areas of relevance. In addition to addressing the person from the perspective of a static human being, the perspective of their development is also taken into account (42).
In this sense, personality rights, protected by the general protection clause, are intended to address the human personality in all its manifestations—current, future, foreseeable, and unforeseeable—and are, therefore referred to as the “general right of personality,” a concept that has been gaining ground in most legal systems. As such, it has a broader scope of protection, encompassing even situations involving new infringements that are not protected by special rights, such as the complex issues surrounding human genetic manipulation (43). Thus, the concept of a “general right of personality” ensures, through a mechanism distinct from private law and in a very specific manner, the protection of new interests and the confrontation of new threats, always grounded in respect for personality—not only from a static perspective but also from a dynamic one that simultaneously encompasses the freedom of development (44) (45) (46).
It cannot be denied that the unlimited protection of interests requires new instruments, such as general clauses and indeterminate concepts (47). It is, therefore, in this sense that the “general right of personality” is conceived as a strategy to expand protection for the individual in the face of the new risks that gene editing technology may entail.
It is well known that gene editing, as a complex activity involving a high potential for unknown risks, fits within the context of the “risk society.” In this context, where it is difficult to establish adequate causation in the face of anonymous and timeless harms, the internalization of negative externalities stands out as a preventive measure of notable ethical merit. Thus, civil liability is well-suited to fulfill the multitude of functions it currently performs (48) (49). Redress ceases to be a possibility and becomes a certainty (50).
The option of insurance—whether mandatory social or private—would be a way to guarantee compensation for damages and provide greater security for risky activities, since it minimizes the harmful consequences of the action, mitigating its effects and allowing for coverage of damages should they occur, in addition to addressing the default of the responsible party (51) (52).
In this context, it is undeniable that the securitization of civil liability becomes a viable model for the “risk society.” Rather than fault and coercion, liability finds a new moral foundation in foresight and care (53) (54).
4. FINAL CONSIDERATIONS
In light of the various aspects addressed regarding the risks inherent in new inventions and technological advances in the field of genetics, it is necessary to identify which legal duty is violated when a risk is imposed. It is well known that risk is the probability of harm. However, as discussed earlier, this is not always sufficient to give rise to an obligation to compensate. Therefore, the basis for this obligation would not be risk alone but the violation of a legal duty. Since safety is the counterpart to risk, it represents the legal duty to be protected (protection of safety).
Thus, given the current scenario of a society exposed to various risks, there is growing debate over whether civil liability is the most effective means of safeguarding against the effects of these new technologies, which often entail unpredictable risks with the potential to affect even future generations.
In this context, the precautionary principle stands out as extremely relevant in helping to address the challenges of civil liability. It thereby ensures the management of uncertainty regarding risk and establishes proactive measures to prevent harm.
The inadequate approach to the precautionary function currently in place, given the potential risks posed by advanced genetic manipulation techniques, makes a broader discussion of this topic essential, which implies the need to devise strategies to address the challenges of civil liability in the face of “new risks.”
This reinforces the need for ongoing interdisciplinary dialogue, which is indispensable for weighing, outlining, and establishing new paradigms aimed at promoting the necessary adaptations. Despite the limitations thus far imposed in the field of gene-editing techniques, 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.
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(27) We have argued that, while negative precautionary principles can be pragmatically useful in some contexts, they have little to contribute to the policy debate surrounding reproductive GGE. Positive precautionary principles are more closely relevant. Positive precautionary principles recommend placing especial weight on avoiding certain kinds of threats, such as threats we are cognitively primed to undervalue, threats that are poorly understood, threats to the achievement of a sufficient level of well- being and threats to health security. While it is difficult to derive any straightforward policy recommendations from these positive versions of the precautionary principle, plausible versions of it would endorse GGE in at least some contexts – in particular, contexts where GGE could be used to correct otherwise catastrophic genetic mutations and/or to promote the long-term robustness of human populations. Given that the pre- cautionary principle is generally deployed against GGE, we think this is an important insight.” KOPLIN, J. J.; GYNGELL, C.; SAVULESCU, J. Germline gene editing and the precautionary principle. Bioethics. p. 1-11. 2019
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(34) ULHÔA, F.C. O empresário e os direitos do consumidor. São Paulo: Saraiva, p. 86, 1994.
(35) MIRAGEM, B. N. B. Direito Civil: Responsabilidade Civil. São Paulo: Saraiva, p. 550-557, 2015.
(36) SALOMÃO, L.F.; TARTUCE, F. Direito Civil: diálogos entre a doutrina e a jurisprudência. São Paulo: Atlas, 2018, 783p.
(37) FAURE, M., VISSCHER, L., WEBER, F. Liability for Unknown Risks – A Law and Economics Perspective. JETL, v. 7, n. 2, p. 198-228, 2016.
(38) BRAGA-NETO, F.P.; FARIAS, C.C.; ROSENVALD, N. Novo tratado de responsabilidade civil. 3ª ed. São Paulo: Saraiva Educação, p.643, 2018.
(39) CLEMENTE, G.T.; ROSENVALD, N. Edição Gênica e os limites da Responsabilidade civil. In: Martins, G.M.; Rosenvald, N. (Org.). Responsabilidade Civil e Novas Tecnologias. Indaiatuba, SP: Editora Foco, 2020. p. 235-61.
(40) Ibid., p. 247.
(41) MOTA PINTO, P.: Direitos de Personalidade e Direitos Fundamentais – Estudos, 1ªed., Coimbra: GESTLEGAL, 2018. p. 332-341.
(42) CLEMENTE, G.T., 2020, loc. cit.39
(43) “The general right of personality may thus, as a provision or ‘umbrella rule,’ come to encompass new areas of relevance to personality and protect against new infringements (one need only consider, for example, the complex problems raised today by the possibilities of manipulating human genetic material), which are not protected by special rights. In this sense, it is “open” both synchronically and diachronically, allowing for the protection of new interests and against emerging threats, always with respect for personality as its guiding principle, whether from a static perspective or in terms of its dynamic realization and development.” MOTA PINTO, P.: Direitos de Personalidade e Direitos Fundamentais – Estudos, 1ªed., Coimbra: GESTLEGAL, 2018. Ibid., p. 338.
(44) PEREIRA, A. G. D. Direitos dos pacientes e responsabilidade médica. 1ª edição, Coimbra: Coimbra Editora, p.147, 2015.
(45) “(...) the general right of personality constitutes a matrix right or framework right to which certain specific manifestations—the special rights of personality—are affiliated. This dynamic conception, open to historicity, is especially relevant in the society of biotechnological risk in which we live.” SOUSA, R. C. O Direito Geral de Personalidade. Coimbra: Coimbra Editora, p.88, 1995.
(46) The General Right of Personality constitutes “the right of every person to the respect and promotion of the totality of the elements, potentialities, and expressions of their human personality, as well as the psycho-physical-socio-environmental unity of that same human personality (e.g., their human dignity, their concrete individuality, and their power of self-determination), with the consequent obligation on the part of other individuals to refrain from committing or to cease committing acts that unlawfully infringe upon or threaten to infringe upon such legal interests of another’s personality, failing which they will incur civil liability and/or be subject to appropriate civil measures to prevent the threat from being carried out or to mitigate the effects of the offense committed.” 56 Ibid., p. 88.
(47) “Given the unlimited, collective, and unknown nature of the goods inherent to human nature, it does not seem possible a priori to provide a complete and debatable enumeration of such goods.” Ibid., p. 152.
(48) BRAGA-NETO, F.P.; FARIAS, C. C.; ROSENVALD, N. Novo tratado de responsabilidade civil. 3ª ed. São Paulo: Saraiva Educação, 2018. Ibid., p.671.
(49) “Fulfilling the primary function of civil liability—the adequate redress of damages—necessarily involves the diffusion of the duty to compensate, that is, the distribution of liability throughout the entire community, thereby fostering genuine social responsibility. Civil liability is understood as a technique for the fair administration of anonymous or incidental damages; it seems fairer to distribute these damages across society as a whole than to assign them almost randomly to the nearest “culprit” or “tortfeasor.” The spreading of damages ensures protection for the victim without placing an excessive burden on the defendant. From this perspective, civil liability is presented as a renewed instrument serving not individual claims but rather aimed at resolving damages as a collective social problem. SCHREIBER, A. Novos paradigmas da responsabilidade civil. São Paulo: Atlas, p.234-235, 2013.
(50) “It eliminates the need to resort to the lottery of causation to identify a ‘payer’ and, in a sense, eliminates the antagonism between the plaintiff and the defendant in a lawsuit.” BRAGA-NETO, F.P.; FARIAS, C. C.; ROSENVALD, N., op. cit., p.672.
(51) PEREIRA, P. M. F. L. Responsabilidade civil nos ensaios clínicos. Indaiatuba, são Paulo: Editora Foco, p.158, 2019.
(52) KFOURI NETO, M. Responsabilidade Civil do Médico. 10ª ed., São Paulo: Editora Revista dos Tribunais, p.43, 2019.
(53) “In any case, we can consider this a positive experience in the sense that it makes a legal contribution to better medical practice (...) On the other hand, the socialization of such a serious risk—one with such dire consequences for the quality of life of the child and their families—proves to be a commendable and humanistic choice. PEREIRA, A. G. D., loc cit.44
(54) BRAGA-NETO, F.P.; FARIAS, C. C.; ROSENVALD, N. Novo tratado de responsabilidade civil. 3ª ed. São Paulo: Saraiva Educação, 2018. Ibid., p.674.