Autonomy and Social Responsibility: The Post-Pandemic Challenge.

Over the last 80 years, a series of critical events has led to reconsideration of the basic premises of medical ethics. One of these events was the recognition of horrific medical experiments performed by German medical scientists in World War II concentration camps, resulting in intensified emphasis on a consent requirement, later understood as grounded in the bioethical principle of respect for autonomy, as well as on the moral accountability of the experimenter. Another important event that is forcing a reconsideration of respect for autonomy in medicine and health care is the COVID-19 pandemic. But this time the matter pulls in a different direction, from respect for autonomy to social responsibility, represented in problems as disparate as the wearing of masks, vaccination requirements, and equity in vaccine access and distribution. How can modern bioethics, in part a creature of the response to Nazi crimes, accommodate the intensified sensitivity about public health needs that has accompanied the shock of the pandemic? The responses of European medical ethics to the Nazi era provide tools for bioethics as it faces the challenge now at hand. This article uses historical context from postwar Europe to argue that, in light of the pandemic experience, respect for autonomy must systematically incorporate a commitment to social responsibility.

Genome Editing: Learning from Its Past and Envisioning Its Future.

With the technical possibility of genome editing, we have reached a new phase of transforming human beings and even altering our genetic legacy. Genome editing constitutes new responsibilities in many fields. Science and society have never been as dependent on each other as they are today. We must also learn from the past episodes of eugenics and we need to investigate fraudulent practices and cases of failure in scientific research that have often occurred due to merciless scientific competition, profit-seeking commercial interests, or individual pride. Genome editing raises numerous legal questions, such as: Would it be possible to make a legal difference between specific versions of gene editing? Who decides on what is considered a disease or an anomaly, a condition, or a variation? Which diseases are worth being corrected or treated and which ones are not? What kinds of social implications will gene editing bring about when it becomes widely available? Some normative distinctions have already been made in the case of gene therapy: separating somatic from germline interventions. But this distinction has not yet been analyzed in the light of the most recent editing practices. Genome editing also realigns the structure of ethical debates. It makes us rethink the concept of discrimination and scrutinize its cases in the field of assisted reproductive procedures. It revolutionizes the concept of medical treatment. It may increase or reduce inequalities based on health conditions. It may lead to numerous new rights in the field of genetics. Good genome editing practice can only be achieved through the close cooperation between the natural and social sciences. The present paper will endeavor to examine this new form of dialogue.

The Vaccination Cold War.

Surveying the early responses to the Covid-19 pandemic among nation states, one finds a veritable babel of responses, some predictable and some not. Would these results have been different half a century or more ago, when smallpox was eradicated and hopes were high that international cooperation would yield similar results for other infectious diseases? Is this a story about the stability provided by the bipolar postwar world, juxtaposed with the complex geopolitical repositioning that finally followed the collapse of the Soviet Union, or is that too rich an irony? A multipolar world may indeed be less prepared to cope with an international health crisis than a bipolar one. In any case, the patterns of global response are not only reminiscent of the Cold War era itself but also suggestive of a new vaccination cold war.

Bottom Up Ethics - Neuroenhancement in Education and Employment.

Neuroenhancement involves the use of neurotechnologies to improve cognitive, affective or behavioural functioning, where these are not judged to be clinically impaired. Questions about enhancement have become one of the key topics of neuroethics over the past decade. The current study draws on in-depth public engagement activities in ten European countries giving a bottom-up perspective on the ethics and desirability of enhancement. This informed the design of an online contrastive vignette experiment that was administered to representative samples of 1000 respondents in the ten countries and the United States. The experiment investigated how the gender of the protagonist, his or her level of performance, the efficacy of the enhancer and the mode of enhancement affected support for neuroenhancement in both educational and employment contexts. Of these, higher efficacy and lower performance were found to increase willingness to support enhancement. A series of commonly articulated claims about the individual and societal dimensions of neuroenhancement were derived from the public engagement activities. Underlying these claims, multivariate analysis identified two social values. The Societal/Protective highlights counter normative consequences and opposes the use enhancers. The Individual/Proactionary highlights opportunities and supports use. For most respondents these values are not mutually exclusive. This suggests that for many neuroenhancement is viewed simultaneously as a source of both promise and concern.

Genetic Testing between Private and Public Interests: Some Legal and Ethical Reflections.

In Europe, there is a wide variety of genetic tests that various private companies offer to patients or to consumers. More and more people have become curious about their genetic predisposition and susceptibility. Most public health-care systems, however, are not adequately prepared for responding to these new demands and to the results of these genetic tests as, quite often, there is no available therapy for the identified genetic condition. This discrepancy between the newly emerging expectations and the insufficient responses contributes to a further rift between the public and private sectors of health care. Individual genetic test results may also trigger the need for personalized medicine and may open up a competition between the two fields in offering further genetic tests and medical exams. Pro-active patients may need a different kind of information on genetic tests and their implications. In this context, how should the public health system deal with the challenges of private testing? Will private genetic testing transform health care from a solidarity-based system to an individualistic one? In this paper, I would like to explore the emerging legal and ethical issues related to genetic testing and the relevant legal framework that has developed so far. In the conclusion, I will examine the possibilities of further legal development.

Let us talk about eggs! Professional resistance to elective egg vitrification and gendered medical paternalism.

In this paper, by applying a feminist bioethical perspective, we identify a new form of medical paternalism that still shapes contemporary legal policies on human egg cryopreservation performed without medical reasons. The fear of negligent, careless women who opt to delay their pregnancy for mere convenience is a widely known gender biased stereotype. Nevertheless, the opinions and judgments of medical professionals on this issue have not yet been sufficiently explored by in-depth research. In this essay, therefore, first we look at the broader bioethical, legal, and social aspects of human egg cryopreservation. In the second part of the paper we discuss a unique qualitative study conducted with professionals working at Hungarian IVF clinics. We argue, based on a bioethical analysis of the collected data, that when new reproduction technologies provide opportunities for women to widen their range of reproductive choices, the traditional forms of medical paternalism can be reinforced by gendered paternalism, as well. We identify several elements of gendered paternalism that characterized the attitudes of the IVF staff and discuss the professionals' resistance to elective egg freezing and vitrification of eggs for the future. We conclude by suggesting directions for future policy. Although we focus on the Hungarian case in this paper, we are aware that similar attitudes can be observed in some other countries where this technology has become available and requested by women, but where they also face difficulties in their access to it.

Whose Biobank? Should Biobanks Serve Research Interests or the Needs for Personalized Medicine? Analysis of the Hungarian Law.

AIMS: The law has struggled to justify the unilateral use of individual genomic data, as it could never quite fit either into the narrower data protection or the broader privacy frameworks. This article aims to explore this tension by examining rights and interests of biobank participants. METHOD: This article offers a legal analysis, by looking at how the biobank model fits into a privacy rights framework. The Hungarian law is the primary focus of analysis, but reference is made to international legal norms, as well. RESULTS: The first biobanks were designed with the purpose of achieving collective goals by providing private data from the individual gene donors to scientific research and to the biotechnology industry. The main focus was on data protection. Today, more and more people, however, opt for an active biological citizenship: they want to have access to the results that are relevant to their health. The paternalistic legal attitude does not seem to fit this request to transfer data. DISCUSSION/CONCLUSION: In the long run, people should have the possibility to contact a biobank and to ask for the return of results. Practical barriers do not constitute a valid argument against the individual's need for disclosure. The law should be on people's side.

Protection of Human Beings Trafficked for the Purpose of Organ Removal: Recommendations.

This report presents a comprehensive set of recommendations for protection of human beings who are trafficked for the purpose of organ removal or are targeted for such trafficking. Developed by an interdisciplinary group of international experts under the auspices of the project Trafficking in Human Beings for the Purpose of Organ Removal (also known as the HOTT project), these recommendations are grounded in the view that an individual who parts with an organ for money within an illegal scheme is ipso facto a victim and that the crime of trafficking in human beings for the purpose of organ removal (THBOR) intersects with the crime of trafficking in organs. Consequently, the protection of victims should be a priority for all actors involved in antitrafficking activities: those combating organ-related crimes, such as health organizations and survivor support services, and those combating trafficking in human beings, such as the criminal justice sectors. Taking into account the special characteristics of THBOR, the authors identify 5 key stakeholders in the protection of human beings trafficked for organ removal or targeted for such trafficking: states, law enforcement agencies and judiciary, nongovernmental organizations working in the areas of human rights and antitrafficking, transplant centers and health professionals involved in transplant medicine, and oversight bodies. For each stakeholder, the authors identify key areas of concern and concrete measures to identify and protect the victims of THBOR. The aim of the recommendations is to contribute to the development of a nonlegislative response to THBOR, to promote the exchange of knowledge and best practices in the area of victim protection, and to facilitate the development of a policy-driven action plan for the protection of THBOR victims in the European Union and worldwide.

The case of biobank with the law: between a legal and scientific fiction.

According to estimates more than 400 biobanks currently operate across Europe. The term 'biobank' indicates a specific field of genetic study that has quietly developed without any significant critical reflection across European societies. Although scientists now routinely use this phrase, the wider public is still confused when the word 'bank' is being connected with the collection of their biological samples. There is a striking lack of knowledge of this field. In the recent Eurobarometer survey it was demonstrated that even in 2010 two-thirds of the respondents had never even heard about biobanks. The term gives the impression that a systematic collection of biological samples can constitute a 'bank' of considerable financial worth, where the biological samples, which are insignificant in isolation but are valuable as a collection, can be preserved, analysed and put to 'profitable use'. By studying the practices of the numerous already existing biobanks, the authors address the following questions: to what extent does the term 'biobank' reflect the normative concept of using biological samples for the purposes of biomedical research? Furthermore, is it in harmony with the so far agreed legal-ethical consensus in Europe or does it deliberately pull science to the territory of a new, ambiguous commercial field? In other words, do biobanks constitute a medico-legal fiction or are they substantively different from other biomedical research protocols on human tissues?

Human rights and bioethics: competitors orallies? The role of international law in shaping the contours of a new discipline.

Bioethical norms that had constituted only a rather short chapter in the medical curricula are now integrated into universal human rights. This paper seeks to demonstrate the normative convergence between the fields of bioethics and human rights by discussing the recently adopted relevant international documents and some applicable cases from international law. Human rights case law relevant in this emerging legal domain is analyzed with the aim to tackle changes that have occurred in the fields of human rights and bioethics due to the convergence and interdependence between them. Bioethics and human rights are two different systems of norms but bioethics can enrich human rights by extending the traditional catalogue of rights in certain new fields. The theory of human rights nevertheless dictates some discipline in formulating new and new rights. Therefore it offers to bioethics, as an exchange, a more sufficient enforcement mechanism and international recognition.

The Budapest Meeting 2005 intensified networking on ethics of science: the case of reproductive cloning, germline gene therapy and human dignity.

This paper reports on the meeting of the Sounding Board of the EU Reprogenetics Project that was held in Budapest, Hungary, 6-9 November 2005. The Reprogenetics Project runs from 2004 until 2007 and has a brief to study the ethical aspects of human reproductive cloning and germline gene therapy. Discussions during The Budapest Meeting are reported in depth in this paper as well as the initiatives to involve the participating groups and others in ongoing collaborations with the goal of forming an integrated network of European resources in the fields of ethics of science.