Inigo Miguel

This chapter introduces the aims and objectives of this book. Books on chemical, biological, radiological, nuclear and explosive (CBRNE) crises are usually technical and scientific. This introduction highlights some of the reasons why a volume on the ethical and legal dimensions of CBRNE crises is needed. The chapter then provides a brief summary of each of the chapters and how these develop the topic more generally. It concludes by acknowledging the EU funding which made it possible to produce this volume.

CRISPR gene edition constitutes one of the most promising tools in the area of human health. However, it also involves a number of issues that require further consideration. The concerns, indeed, are twofold: the first are connected with the safety of the technology, while the second relate to some ethical issues and it is precisely those ethical issues that this chapter will deal with. To this purpose, we will focus on four main issues: the necessity of this technology and the risk issues involved; the embryo loss involved; the alteration of the human genome and human identity; and the enhancement/eugenics issue. Some of our main conclusions are the following: (1) We strongly support the idea that if further research reduces the risks involved, then the reasons for the prohibition of gene editing in human beings will vanish; (2) Embryo loss is not a key factor in terms of the ethical discussion of gene editing; (3) a general ban on human embryo editing on the grounds of the defense of the human genome is clearly unjustified, even if we really hold this approach; (4) a general ban on gene editing affecting the embryo’s germ line genetic identity is hard to understand and entails a number of questions that hinder its practical applicability; and (5) referring to eugenics can hardly justify a general ban on the use of gene editing in human embryos, considering the benefits that are at stake and the moral imperative to pursue them.

The development and implementation of Artificial Intelligence (AI) health systems represent a great power that comes with great responsibility. Their capacity to improve and transform healthcare involves inevitable risks. A major risk in this regard is the propagation of bias throughout the life cycle of the AI system, leading to harmful or discriminatory outcomes. This paper argues that the European medical device regulations may prove inadequate to address this—not only technical but also social challenge. With the advent of new regulatory remedies, it seems that the European policymakers also want to reinforce the current medical device legal framework. In this paper, we analyse different policies to mitigate bias in AI health systems included in the Artificial Intelligence Act and in the proposed European Health Data Space. As we shall see, the different remedies based on processing sensitive data for such purpose devised by the European policymakers may have very different effects both on privacy and on protection against discrimination. We find the focus on mitigation during the pre‐commercialisation stages rather weak, and believe that bias control once the system has been implemented in the real world would have merited greater ambition.

Casgevy, the world’s first approved CRISPR-based cell therapy, has been priced at $2.2 million per patient. Although this hefty price tag was widely anticipated, the extremely high cost of this and other cell and gene therapies poses a major ethical issue in terms of equitable access and global health. In this Perspective, we argue that lowering the prices of future CRISPR therapies is an urgent ethical imperative. Although we focus on Casgevy as a case study, much of our analysis can be extrapolated to the controversies over affordable access to other gene and cell therapies. First, we explain why this first-of-its-kind CRISPR therapy might be so expensive. We then analyze the ethical issues of equity and global health of early CRISPR treatments. Next, we discuss potential solutions to lower the prices of CRISPR gene therapies. We conclude that the approval of CRISPR transforms our obligations of justice and compels us to bring future gene therapies to the maximum possible number of patients with serious genetic diseases at affordable prices.

This paper analyses the arguments for and against what we have called automatic organ procurement model in relation to the organs of the deceased. For this purpose, this work provides empirical evidence to assess the potential impact of this model on donation rates and on public opinion. Specifically, we examine first the reasons supporting this model, with special reference to utilitarian and justice arguments. On the other hand, we analyse both the approaches based on the violation of pre mortem and post mortem interests opposing this theoretical model and the rejection the model would generate in the population. Finally, we point out the aspects that, in our opinion, should be exhaustively regulated if this model were implemented. In particular, we refer to the legal status of the human body, the treatments for end-of-life patients, the incentives for health professionals and the recognition of the right to conscientious objection

The notion of the human embryo is not immutable. Various scientific and technological breakthroughs in reproductive biology have compelled us to revisit the definition of the human embryo during the past 2 decades. Somatic cell nuclear transfer, oocyte haploidisation and, more recently, human stem cell-derived embryo models have challenged this scientific term, which has both ethical and legal repercussions. Here, we offer a legal perspective to identify a universally accepted definition of ‘embryo’ which could help to ease and unify the regulation of such entities in different countries.

Anna Smajdor’s proposal of whole body gestational donation (WBGD) states that female patients diagnosed as brain-dead should be considered for use as gestational donors. In this response, Smajdor’s proposal is rejected on four different accounts: (a) the debated acceptability of surrogacy despite women's autonomy, (b) the harm to dead women ́s interests, (c) the interests of the descendants, and (d) the symbolic value of the body and interests of relatives. The first part argues that WBGD rests on a particular conception of the instrumentalization of bodies that cannot be circumvented simply by the patient’s consent and relinquished autonomy. The second part argues the importance of avoiding any harm to dead women’s interests. The third part identifies the importance of the interest of the foetus in the light of Procreative-Beneficence principle that Smajdor overlooks. And finally, the fourth part considers the symbolic value of the human body and the interest of relatives. The main goal of this commentary is not to show that WBGD cannot be implemented; rather, it is to show that there are not any good arguments in favour of doing so.

The creation of human-animal chimeras involves complex ethical issues. First, they sometimes involve harming animals, which can only be justified under some special circumstances. Furthermore, the entities created might not be treated according to what their special statute demands. This would have a negative impact on their quality of life, depriving it of many of the factors that usually bring happiness to living beings. On the other hand, there are substantive concerns about the safety of the research or the allocation of resources to a practice that might not justify such expenditure. Above all, however, chimeras are extremely challenging creatures, since they defy the fundamentals of the anthropocentric ethics that still prevail in our culture. They blur the boundaries between species and introduce moral confusion due to their particular features. A superchimp able to show rational attitudes could create an impossible dilemma for an ethical paradigm based on the idea of human dignity. However, none of these reasons seems strong enough to ban all types of human-animal chimeras.

In their recent article, Brown et al analyse several ethical aspects around immunity passports and put forward some recommendations for implementing them. Although they offer a comprehensive perspective, they overlook two essential aspects. First, while the authors consider the possibility that immunological passports may appear to discriminate against those who do not possess them, the opposite viewpoint of immune people is underdeveloped. We argue that if a person has been tested positive for and recovered from COVID-19, becoming immune to it, she cannot be considered a hazard to public health and, therefore, the curtailment of her fundamental rights (eg, the right to freedom of movement) is not legitimate. Second, they omit that vaccine distribution will create similar problems related to immunity-based licenses. Vaccine certificates will de facto generate a sort of immunity passport. In the next phases of the pandemic, different immunity statuses will be at stake, because the need to identify who can spread COVID-19 is unavoidable. If a person does not pose a threat to public health because she cannot spread the infection, then her right to freedom of movement should be respected, regardless of how she acquired that immunity.

¿Existe un derecho a poseer una identidad genética propia? La respuesta a esta pregunta ha sido, tradicionalmente, afirmativa. El presente texto trata de demostrar que esta conclusión sólo es correcta cuando hablamos de seres humanos adultos. Sin embargo, en el caso de los clones, no es posible hablar de este tipo de derecho, sino de un derecho a no vivir. Esto significa que las leyes deben incluir el reconocimiento de ese derecho, si no quieren que sus prohibiciones a la clonación pierdan todo su sentido.

The recent publications reported in 2022 reveal the possibility of obtaining mouse embryos without the need for egg or sperm. These ‘artificial embryos’ can recapitulate some stages of development ex utero – from neurulation to organogenesis – without implantation. Synthetic mouse embryos might serve as a valuable model to gain further insights into early developmental stages. Indeed, it is expected for these models to be replicated by employing human cells. This promising research raises ethical issues and expands the horizon of ethics in regard to the development of the human embryo. From this point of view, we state some of the new open venues for bioethical research.

The Solidarity Clause constitutes one of the most relevant tools of the European Union legal framework on major crises management. Created by the Treaty of Lisbon, the Clause is considered to be a nice example of the advantages provided by cooperation among the EU and its Member States in so far as it is meant to guarantee an adequate division of the tasks and duties between both types of agents. However, its real utility is yet to be checked, since it has never been invoked. Therefore, some important issues related to the Clause remain still unclear, such as the concrete sense of the term “solidarity”, its relationship with the Mutual Defence Clause, the level of intensity that a crisis should reach to allow activation of the mechanism, the consequences of a violation of the Clause, etc. This chapter is intended to bring some light to these challenging issues through a careful analysis of the Solidarity Clause.

Despite the availability of safe vaccines against SARS-CoV-2, some people will remain vulnerable because they will not be vaccinated. Who are these non-vaccinated people? We can distinguish two groups: (i) persons who cannot be vaccinated for clinical reasons and who, despite having been vaccinated, have not achieved immunity; (ii) persons who voluntarily refuse to get vaccinated. These groups have in common an immune system that will make them vulnerable to COVID-19. The reasons for their vulnerability and the ethical judgment they deserve are different; the solutions offered to them are also different. In the case of those who voluntarily avoid vaccination, States are not compromised to introduce new protective policies. In the case of people who remain involuntarily vulnerable, instead, the response should be articulated on the same rules and principles that inform the social model of disability because they will live with an organic disability.

Digital COVID certificates are a novel public health policy to tackle the COVID-19 pandemic. These immunity certificates aim to incentivize vaccination and to deny international travel or access to essential spaces to those who are unable to prove that they are not infectious. In this article, we start by describing immunity certificates and highlighting their differences from vaccination certificates. Then, we focus on the ethical, legal, and social issues involved in their use, namely autonomy and consent, data protection, equity, and international mobility from a global fairness perspective. The main conclusion of our analysis is that digital COVID certificates are only acceptable if they meet certain conditions: that they should not process personal data beyond what is strictly necessary for the aimed goals, that equal access to them should be guaranteed, and that they should not restrict people’s autonomy to access places where contagion is unlikely. We conclude that, if such conditions are guaranteed, digital COVID certificates could contribute to mitigating some of the most severe socioeconomic consequences of the pandemic.

The seat belt analogy argument is aimed at furthering the success of coercive vaccination efforts on the basis that the latter is similar to compulsory use of seat belts. However, this article demonstrated that this argument does not work so well in practice due to several reasons. The possibility of saving resources in health care does not usually apply in our societies, and the paternalist mentality that contributed to the implementation of seat belt–wearing obligation was predominant 30 years ago, but it does not apply at this moment. Furthermore, the risk/benefit analysis is totally different in both scenarios. In the case of seat belts, there is no way to discriminate between the users. In the case of vaccines, individuals present with unique circumstances that may differ substantially from those of another and might be foreseen a priori. This means that an analysis must be performed individually before vaccination is imposed. Finally, one must keep in mind that seat belts are often the only way in which we can protect third parties against a tragic hit by the occupant of another vehicle and are very efficient tools for this purpose. Vaccines, in contrast, do not always create sterilising immunity and are definitely not the only way by which we can avoid spreading a virus; immunity certificates, isolation, or even confinement may also serve as viable methods to achieve this purpose.

BackgroundSome persons conceived with donor gametes react negatively when they found their birth via donor conception. They request access to information about and seek to communicate with the donor. However, some countries mandate donor anonymity. Other countries allow donor-conceived persons to access donor information, but they can only use this access if their parents have disclosed donor conception to them. We investigated a thorny issue of donor conception: whether donor conception should be shifted from an anonymous basis to a non-anonymous basis.MethodsWe review the issues and concerns regarding donor conception. We then consider the impact of direct-to-consumer genetic testing on donor conception, as well as the influence of donor conception on offspring’s identity and the potential of different types of donors. To discuss the future policy of donor conception, the policies on the anonymity of gamete donors were investigated using publicly-available documents in 15 countries.ResultsThe aim of mandating donor anonymity is to protect the privacy of the donor and intended parents. However, the diffusion of direct-to-consumer genetic testing may make it impossible to maintain anonymity. Birth via donor conception shapes the offspring’s identity, and the donor may further influence the development of offspring’s identity through communications. It remains important to disclose donor conception to donor-conceived offspring and to provide them with donor information. However, that information might be insufficient for some donor-conceived persons. Here are benefits to having open-identity donors and known donors. Such donors can make an agreement with the parents regarding future communication with the offspring, although both sides should respect privacy. Subsequent counseling for all parties involved can result in better tripartite communication agreements.ConclusionsIn sum, ethical and practical issues that complicate donor anonymity are driving a shift to non-anonymous donor conception, in which all parties come to a communication agreement. To pave the way for such a donor conception system, transitional measures can be put into place. For countries that already adopted non-anonymous donor conception, ensuring the communication agreements is important to protect the rights of parents, donor, and offspring.

Gene editing is a particularly attractive subject in the Spanish context because it was precisely a scientist of this nationality -Professor Juan Francisco Martínez Mojica, at the University of Alicante-, who was the first to name and identify the function of this region of DNA present in some bacteria and archeas that acts as an immune mechanism against viruses and which has given rise to the gene editing technique known as CRISPR-Cas9. Martínez Mojica discovered that some bacteria and archeas were able to identify and “cut” the DNA segments of the attacking viruses, incorporating them into their own genetic make-up. In this way they could recognize and degrade the specific DNA sequences of the virus against future attacks, a defense that could be inherited by the next generation of bacteria. It was this discovery that laid the foundations for the “genetic editing revolution”.

Should we be allowed to refuse any involvement of artificial intelligence technology in diagnosis and treatment planning? This is the relevant question posed by Ploug and Holm in a recent article in Medicine, Health Care and Philosophy. In this article, I adhere to their conclusions, but not necessarily to the rationale that supports them. First, I argue that the idea that we should recognize this right on the basis of a rational interest defence is not plausible, unless we are willing to judge each patient’s ideology or religion. Instead, I consider that the right must be recognized by virtue of values such as social pluralism or individual autonomy. Second, I point out that the scope of such a right should be limited at least under three circumstances: if it is against a physician’s obligation to not cause unnecessary harm to a patient or to not provide futile treatment, in cases where the costs of implementing this right are too high, or if recognizing the right would deprive other patients of their own rights to adequate health care.

This book provides a current analysis of the legal and ethical challenges in preparing for and responding to chemical, biological, radiological, nuclear and explosive crises. From past events like the Chernobyl nuclear incident in Russia or the Bhopal chemical calamity in India, to the more recent tsunami and nuclear accident in Japan or the Ebola crisis in Africa, and with the on-going threat of bioterrorism, the need to be ready to respond to CBRNE crises is uncontroversial. What is controversial is whether we are on a path that adequately prepares us for the next event. The ethical and legal scholars in this volume hold that much work remains to be done and offer this book to stimulate further reflection and dialogue around CBRNE crises. This is an indispensable book for both students and scholars of bioethics, international law, public health, as well as for regulators and administrators developing policy and legislation related to public health planning and emergency responses.

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has an EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global‐scale responsibility and governance should be fostered by promoting cross‐disciplinary thinking and multi‐level stakeholder involvement in legal and regulatory processes.

Should we use human germline genome modification (HGGM) only when serious diseases are involved? This belief is the underlying factor in the article written by Kleiderman, Ravitsky and Knoppers to which I now respond. In my opinion, the answer to this question should be negative. In this paper, I attempt to show that there are no good reasons to think that this technology should be limited to serious diseases once it is sufficiently proven to be safe and efficient. In fact, opting otherwise would negatively harm human beings’ right to the highest standard of health that unmodified embryos could promote. Therefore, the issue should not be so much to define adequately what a serious disease is, but rather to elucidate whether this concept should play any role beyond the context of preimplantation genetic testing (PGT). This paper argues that we should not accept the similarity between technologies such as PGT and HGGM because they face different challenges and offer totally different possibilities. Therefore, we are in urgent need to build a completely new ethical architecture that covers the application of germline editing in human embryos. As a part of that process, a much deeper debate on the necessity of distinguishing different disease types is required.