Publications of Sándor, J.

Sándor J. Editing human reproduction? Legal and ethical aspects of genome editing. In: Sills E, Palermo G, editors. Human Embryos and Preimplantation Genetic Technologies. Academic Press; 2019. p. 185-97.

Editing human reproduction? Legal and ethical aspects of genome editing

Genome editing has generated an unprecedented interest in both scientific circles and the community of lawyers and bioethicists. Once this technology becomes safe and can be used for clinical purposes, it might shake the existing ethical and legal consensus. Genome editing is forcing us to rethink the dichotomies between natural and artificial or therapy and enhancement, and it is going to cast in a new light the distinction between the stances of protecting life and giving priority to personal autonomy in reproductive rights. Moreover, by applying genome editing in practice, the division between germ line and somatic line will become blurred, which will require significant adjustments in regulation. As preimplantation genetic tests become increasingly widespread, embryo selection at in vitro fertilization clinics raises serious ethical concerns. Genome editing is still a new technology, but its potential implications suggest that once it can be successfully applied in medicine, we will have to reexamine a number of basic ethical principles and legal arguments that govern bioethics and biomedical law. This chapter attempts to look at these potential changes and analyze their implications.

The Concept of Human Dignity as the Foundation of Rights in the Hungarian Biomedical Law

Human dignity has a prominent role in the Hungarian Constitution. The concept of human dignity and its interpretations play an important role both in the field of bioethics and in the Hungarian law. On different levels of the Hungarian law human dignity serves as a basic pillar for the legal provisions. Reference to human dignity provides especially important arguments in the debates on euthanasia by emphasizing the right to self-determination of the terminally ill. In the debates both on the risks of emerging technologies and on the protection of vulnerable groups, such as children and psychiatric patients, human dignity plays an essential role in protecting people who are not yet or no longer fully able to exercise their right to self-determination.

Transnational Surrogacy: An Overview of Legal and Ethical Issues

Surrogacy can be of various types and the difference in arrangement may imply very different ethical and legal questions. Surrogacy may be prohibited, ignored, tolerated, restricted or permitted in different parts of the world. But this diversity of the ethical and legal norms around surrogacy becomes problematic during transnational practices when the domestic laws or understanding of families often fail to accommodate the children born out of transnational surrogacy. This chapter discusses the controversies arising out of a legal fallout during transnational surrogacy and based on the lessons drawn from legal cases argues for the need for international norms. It examines the possibility of an adequate international legal framework that would better respond to the challenges of transnational surrogacy agreements.

Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape

Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients’ rights.

Sándor J. The “Me Molecule”. In: Kakuk P, editor. Bioethics and Biopolitics . Springer; 2017. p. 77-95.

The “Me Molecule”

This volume links three different theoretical approaches that have a common focus on the relationship between biopolitics and bioethics. This collection of papers can be categorized into different domains that are representative of the contemporary usage of biopolitics as a concept. On the one hand, several chapters develop a clear and up-to-date understanding of the primary sources of the concept and related theories of Agamben, Negri or Foucault and approach the question of relevance within the field of bioethics. Another group of papers apply the philosophical concepts and theories of biopolitics (biopower, Homo Sacer, biocitizenship) on very specific currently debated bioethical issues. Some scholars rely on the more mundane understanding of (bio)politics and investigate how its relationship with bioethics could be philosophically conceptualized. Additionally, this work also contains papers that follow a more legally oriented analysis on the effects of contemporary biopolitics on human rights and European law. The authors are philosophers, legal scholars or bioethicists. The major strength of this volume is to provide the reader with major insights and orientation in these different contemporary usages of the concept and theories of biopolitics, within the context of its various ethically relevant applications.

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.

Generic or Specific? The Frames of Stem Cell Procurement Regulation in Europe

The procurement of stem cells, which is a crucial source-material in biomedical research promising the development of novel therapies in regenerative medicine, is subject to regulation using generic and technology-specific provisions throughout Europe. The relevant national regulatory regimes, while they share common regulatory frames, exhibit considerable differences as a matter of the regulatory approach followed, the biological level regulated, or of the context in which technologies for stem cell procurement are regulated. This variety indicates that legal regulation may resort to different means so as to secure a connection with the technology regulated. It is proposed that for improving “regulatory connection” states should consider engaging in regulatory borrowing from other systems covering both generic and specific instruments of technology regulation.

hose 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.

Az én molekulám. Bioetika és emberi jogok a XXI. század elején.

Az én molekulám metaforának is tekinthető, de a szerző azon többszörösen megfogalmazott, konkrét kérdésfelvetésére is utal, hogy vajon miképpen értelmezzük az emberi jogokat, alapjogokat a biotechnológia XXI. századi kihívásai fényében. Sándor Judit a molekulákra, DNS-re, ivarsejtre, biológiai szövetmintára gondol itt elsősorban, azaz a kutatóintézetekben, meddőségi centrumokban előálló, ma már mindennapos helyzetekre, amelyekben emberi ivarsejteken, embriókon, szövetmintákon, DNS-en végeznek beavatkozásokat. A könyv alapkérdése tehát, hogy mennyiben érinti, befolyásolja a molekularizálódás az eddig kialakított, emberre vonatkoztatott jogi szemléletünket. A könyv tematikus esszéket fűz össze, információt ad, elemez, töpreng, vagy, ahol már léteznek jogi megoldások, azokra reflektál. Ma már számos gyógyászati és kutatási tevékenységet nem is az emberi test egészén, hanem annak meghatározott komponensein végzik, a beavatkozás mégis kihathat nemcsak az érintett személy életére, de akár generációk sorsára is, sőt a beavatkozások nemcsak betegségek gyógyítását teszik lehetővé, de egyre inkább lehetőséget teremtenek a tökéletesítésre, az eddig átlagosnak tekintett emberi képességek túlszárnyalására. A biotechnológia jelenlegi fejlődése naponta készteti már meglévő fogalmaink átgondolására a kutatókat, társadalomtudósokat, pácienseket, orvosokat és természetesen a jogalkotókat, egészségpolitikusokat is. Az emberi test határainak, molekuláinak, a benne hordozott információnak és mindezek összességének kereskedelmi hasznosíthatósága a jogi gondolkodás és a jogpolitika számára is kihívást jelent. A könyv egyebek közt ezekre a kérdésekre is keresi a választ. Az etikai bizottságok tagjai, orvoskutatók, biológusok, reprodukcióval foglalkozó szakemberek, nőgyógyászok, genetikusok, jogászok, bioetikusok és a széles olvasóközönség egyaránt találhat a könyvben számára fontos és élvezetes részeket. A mű napjainkig követi a biotechnológia módszereinek fejlődését, és a génszerkesztési eljárással zárul. Mivel a biotechnológia eredményeit fokozatosan veszi át a napi klinikai gyakorlat is, a könyv nem a folyamatosan formálódó biotechnológiai jog összegzését nyújtja, hanem születését és kialakulását dokumentálja.

Basic pillars of legal thinking on the human body in the Hungarian medical law: dignity, self-determination and the principle of noncommodification

For many centuries, the human body has been treated as one with the person by virtue of a legal fiction. However, for some time now, biotechnological progress has enabled us to disassociate the two. Indeed, we live in an age where the body has become an object of scientific enquiry, its parts transplanted into another’s body, or considered merely as biological material for use by others. As a result, what we can do with the body and its parts has become increasingly important for society, and its protection becomes a central concern. It is this concern which is examined in this book through the study of seventeen different jurisdictions, and their respective cultures. Several issues are examined here: in all the countries studied, how is the human body distinguished from the person herself? Does the law protect the body, and if so, to what degree? Is an individual under a duty to protect her own body? What legal principles have been adopted in order to ensure that the body is protected? Do the principles reveal a common philosophical approach or are they rather the result of cultural diversity? If the principles are violated, what recourse does the individual have? At the heart of this book is the exploration of how the human body in all its states, living or dead, is confronted by biomedical progress as witnessed by the twenty-two contributions from an international and multidisciplinary perspective. Law, anthropology, philosophy, ethics and sociology all have a take on the subject. The comparative nature of the work draws together lawyers from Europe, North and South America, North Africa, Turkey and Japan. Such a legal journey, interspersed with other disciplinary analyses, will enable the reader not only to understand how different laws treat the human body, but also to appreciate the fundamental values which underpin how the human body is protected in a variety of countries and cultures.

Sándor J. La dignité humaine, fondement des droits en Hongrie. In: Feuillet-Liger B, Orfali K, editors. La dignité de la personne: quelles réalités? Brussels: Bruylant; 2016. p. 157-71.

Creating European Markets through Regulation: The Case of the Regulation on Advanced Therapy Medicinal Products

This article analyses the EU regulatory efforts to create a European market for advanced therapy medicinal products. It focuses on the pitfalls of European regulatory intervention in a difficult market which is characterised by multiple, often contradictory stakeholder expectations, rapid scientific and technological change, and ethical diversity. It contends that while the Regulation on Advanced Therapy Medicinal Products was, in principle, equipped to address these challenges, its fundamental paradigms and choices, and its treatment of some of the dilemmas of the emerging technology market, undermined its ability to establish the balanced and sustainable market desired by the EU legislator.

Életvégi döntés életről és halálról

Az intenzív terápiás ellátás eszköztárának köszönhetően számos olyan összetett életvégi döntési helyzet jelent meg, amikor nem csupán a távozóban lévő terminális állapotú haldokló kezeléséről kell dönteni, de a szempontok között szerepel a haldokló terhessége is. Miképp kell kezelni egy perzisztens vegetatív állapotú vagy már az agyhalál állapotába jutott, de várandós egyént? Ki védi meg a jogait, és mely jogok maradnak fenn ebben az állapotban? Létezik-e postumus szülői döntés, amelyet lehetőség szerint figyelembe kell venni? Szerepe van-e itt a kegyeleti jogoknak, a nők reprodukciós jogainak? És mennyiben rokonítható ez az eset a cadaver szervtranszplantációval? A kérdés megválaszolásához több egymástól elkülönülten fejlődő jogterület egymásra vetítése szükséges. Az szerző az elemzés végén megoldási javaslatot is tesz.

Sándor J. Consistency of the regulation on assisted reproduction: Is it a missing element of reproductive justice? In: Kantsa V, Zanini G, Papadopoulou L, editors. (In)Fertile Citizens Anthropological and Legal Challenges of Assisted Reproduction. University of the Aegean, (In)FERCIT; 2015. p. 23-39.
Sándor J. The Ethical and Legal Analysis of Embryo Preimplantation Testing Policies in Europe. In: Screening the Single Euploid Embryo: Molecular Genetics in Reproductive Medicine. Dordrecht: Springer; 2015. p. 353-67.

The Ethical and Legal Analysis of Embryo Preimplantation Testing Policies in Europe

Intended for readers with a background in fertility medicine as well as those less familiar with IVF, this comprehensive work presents an update on preimplantation genetic testing to enable single embryo transfer (SET). An international cast of contributors explains the treatment sequence—from ovulation induction to luteal support—aiming to transfer only one euploid embryo. Applications of molecular techniques for gamete and embryo assessment are fully detailed, with a focus on the strengths and limitations of each. In addition, expert commentary is shared across a range of regulatory challenges associated with embryo screening and cryopreservation. As access to advanced reproductive technology increases against a sharper background of healthcare reform, clinicians, economists, bioethicists and legislators alike will find this new volume relevant and highly accessible.

Sándor J. Commodified Bodies: Is It a Gender Issue? . In: Rainhorn J-D, Boudamoussi SE, editors. New Cannibal Markets. Globalization and Commodification of the Human Body. Paris: MSH; 2015.

Reconciling traditional families with in vitro assistance: The Hungarian Legal Framework on Kinship in the Light of Biomedical Intervention

“If there is no humanity without language, nor can there be a society without parenthood. But what does it mean to be a parent?” This question from Claude Levi-Strauss is at the heart of this international and multidisciplinary study analysing the upheavals to legal family ties currently being brought about by biomedicine. As a result of the heady advances in new biomedical practices, a number of questions concerning parenthood need to be addressed. Who will be the legal father and mother of a child when infertile men and women are able to procreate? Will the child still have two parents of different sexes, or could it sometimes have three, or even four? What about the emergence of the concept of parenting and of the role of DNA testing in determining parentage? Legal experts, philosophers and sociologists from twenty countries with different cultures debated these issues, among many others, during the fifth workshop of the Réseau universitaire International de Bioéthique (RUIB – International University Network on Bioethics). Stemming from these debates, the articles brought together in this collection explore the extent to which new biomedical practices have revolutionised access to parenthood in these countries. There can be no doubt that because this topic touches on sexuality, the body and reproduction – different concepts in different cultures – one conclusion stands out: although the life sciences have now won, at least in part, control of the imparting of life, the effects of biomedicine on the legal structure of the family differs considerably from one country to the next. A rapprochement between the various systems studied would be most welcome.

Concilier les familles traditionnelles avec la fécondation in vitro: le cadre jurididique hongrois de la filiation à la lumière des interventions biomédicales

« S'il n'y a pas d'humanité sans langage, il n`y a pas non plus de société sans parenté. Mais que veut dire être parent ? » L'interrogation de Claude Levi-Strauss est au coeur de cette étude internationale et pluridisciplinaire qui analyse les bouleversements apportés actuellement par la biomédecine aux liens juridiques familiaux. Suite aux progrès vertigineux des nouvelles pratiques biomédicales, de multiples questions relatives à la parenté appellent une réponse aujourd'hui. Qui sera juridiquement le père ou la mère d'un enfant tandis que des hommes et des femmes stériles deviennent susceptibles d'engendrer? L'enfant aura t-il toujours deux parents de sexe différent, en aura t-il parfois trois, voire quatre? Qu'en est-il de l'émergence de la notion de parentalité et du rôle des empreintes génétiques en matière de filiation ? De ces questions parmi bien d'autres, souvent insolites, des juristes, des philosophes et sociologues de dix sept pays de culture différente ont débattu lors du cinquième workshop du Réseau universitaire International de Bioéthique (RUIB). Fruit de ces débats, les articles regroupés dans l'ouvrage recherchent en quoi les nouvelles pratiques biomédicales admises dans ces pays révolutionnent l'accès à la parenté. Sans doute parce que ce thème touche à la sexualité, au corps, à la procréation - notions différentes selon les cultures - une conclusion s'impose : alors que les Sciences du vivant ont acquis aujourd'hui, en partie tout au moins, la maîtrise de la transmission de la vie, les effets de la biomédecine sur la construction juridique des familles divergent considérablement d'un pays à l'autre. La connaissance de cette variété des choix sociaux est un atout important pour la réflexion menée, dans beaucoup d'États, sur l'évolution de la notion de parenté.

Right to Health and the human Organ: A Right as a Consequence?

In this paper I will analyze the right to health and right to health care in a special context, in the field of organ and tissue donation. I will argue that the cases of organ and tissue transplantation provide a useful means for the discussion of the main conceptual challenges to these twin rights. Furthermore the investigation of the scope of these rights in the context of transplantation provide an important aspect to understand to what extent can right to health encompass not only the claim to have access to basic health services but also to what extent non pecuniary solidarity in the form of relying the others' altruism can shape the contours of these rights. For the purposes of concentrating on right to health I will not differentiate between cadaver and living organ donation, only when it is absolutely necessary to make such a distinction. In order to demonstrate how existing European legislation created a special field to right to health, I will start my analysis with exploring the nature and main sources of right to health then I will demonstrate how new fields might be developed, such as the right to health in the context of organ donation.

50 éves a Helsinki Nyilatkozat: Kommentár a 2013-as módosításhoz

Az Orvos Világszövetség 2013 októberiközgyûlésén elfogadta a Helsinki Nyilatkozat új módosított változatát. Az angol eredetibôl általunk magyarra átültetett módosított nyilatkozathoz fûzünk kommentárokat. Történeti visszatekintéssel szeretnénk felhívni az orvosi kutatások résztvevôi és az etikai mérlegelésben érintett szakemberek figyelmét azokra az újdonságokra és etikai szempontból kiemelkedô változtatásokra, melyek a korábbi változatokban és a 2013-as módosításban is megjelentek.

Studies in Biopolitics. Sándor J, editor. Budapest: Center for Ethics and Law in Biomedicine ; 2013.
Sándor J, Besirevic V, Demény E, Florea GT, Codreanu N. Organ Trafficking, Organ Trade. Recommendations for a More Nuanced Legal Policy. In: Ambagstsheer F, Weimar W, editors. The EULOD Project Living Organ Donation in Europe Results and Recommendations. Lengerich: Pabst Publisher; 2013. p. 147-75.
Sándor J, Frunza M, Demény E, Ioan B. To share or not to share your door status on Facebook. In: Randhawa G, Schicktanz S, editors. Public Engagement in Organ Donation and Transplantation. Lengerich: Pabst Publisher; 2013. p. 27-36.
Sándor J, Varjú M. The Multiplicity of Norms: The Bioethics and Law of Stem Cell Patents. In: Webster A, editor. The Global Dynamics of Regenerative Medicine: A Social Science Critique. Basingstoke: Palgrave Macmillan; 2013. p. 169-93.
Sándor J. Ethical and legal debates on a dignified end-of-life and the role of the family in Hungary. In: Kőmüves S, Rózsa E, Callus T, editors. Families and End–of–Life Treatment Decisions: An International Perspective. Brussels: Bruylant; 2013. p. 211-21.
Sándor J. Demographic Influences on the Regulation of the Female Body in Hungary . In: Feuillet-Liger B, Orfali K, Callus T, editors. The Female Body: A Journey Through law, Culture and Medicine . Bruylant: Brussels; 2013. p. 115-31.

Demographic Influences on the Regulation of the Female Body in Hungary

Object of fascination and fantasy, the female body can be idealized, reified or shrouded. "It is we who make women what they are worth and that is why they are worthless", proclaimed Mirabeau in the days of the Enlightenment, to which Aragon later replied: "Woman is the future of Man". The ambiguities of the female body are therein exposed. This work examines the relationship between the female body and biomedicine. Many possibilities are offered to women through biomedical techniques: from assistance to procreate (with assisted reproduction) to refusal to do so (contraception, voluntary sterilization, termination of pregnancy); to be informed of genetic predispositions (through the use of available genetic tests); or to improve their physical appearance with cosmetic surgery. But a recurrent question arises: with its rapid progress and its extreme medicalization of the body, can biomedicine liberate women? Or rather, given the risks of the commodification of the body or its parts, is it not a source of exploitation ? The authors of this work, jurists, anthropologists, philosophers, sociologists and doctors, have explored these questions. The contributions from nineteen countries in this international multidisciplinary study analyse the reality of the amazing developments of biomedicine on the female body. Numerous systems are compared for the first time; European, African, North and South American, but also Chinese and Japanese. Beyond highlighting differences, and identifying similarities in the development of "enhancement medicine", the objective of this work is ultimately to show the complexity surrounding the question of a woman's freedom over her body and the extent to which this is limited by the State.

Protecting Persons v. Protecting Humans in Biobanks

Whilst advances in biotechnology and information technology have undoubtedly resulted in better quality of life for mankind, they can also bring about global problems. The legal response to the challenges caused by the rapid progress of technological change has been slow and the question of how international human rights should be protected and promoted with respect to science and technology remains unexplored. The contributors to this book explore the political discourse and power relations of technological growth and human rights issues between the Global South and the Global North and uncover the different perspectives of both regions. They investigate the conflict between technology and human rights and the perpetuation of inequality and subjection of the South to the North. With emerging economies such as Brazil playing a major role in trade, investment and financial law, the book examines how human rights are affected in Southern countries and identifies significant challenges to reform in the areas of international law and policy.

Sándor J. Bioethics and Basic Rights: Persons, Humans, and the Boundaries of Life. In: Sajó A, Rosenfeld M, editors. The Oxford Handbook of Comparative Constitutional Law. Oxford: Oxford University Press; 2012. p. 1142-65.

Patenting Stem Cells in Europe: The Challenge of Multiplicity in European Union Law

The recent judgment by the European Court of Justice in Brüstle ended the long-standing controversy concerning the patentability of inventions involving human embryonic stem cells in European patent law as harmonized by the Biotechnology Directive (Directive 98/44/EC). The Court of Justice, in line with EPO practice, confirmed that Article 6 of the Biotechnology Directive excluding the patentability of industrial or commercial uses of human embryos prevents patenting human embryonic stem cells. The judgment is open to criticism on account of its interpretation of the relevant ethical principles laid down in the Biotechnology Directive in an environment characterized by moral pluralism and by a multiplicity of legal fora with jurisdiction to interpret those principles.

Bárd P, Sándor J. The Question of Anonymity and Privacy in Biobanking. In: Lenk C, Sándor J, Gordijn B, editors. Biobanks and Tissue Research: the public, the patient and the regulation. Dordrecht: Springer ; 2011. p. 213-30. (International library of ethics, law and technology).
Sándor J, Bárd P. Anonymisation and Pseudonymisation as Means of Privacy Protection. In: Beier K, Schnorrer S, Hoppe N, Lenk C, editors. The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe. Göttingen: Universitätsverlag Göttingen; 2011. p. 25-34.
Sándor J. Az eutanázia mint politikai kérdés. In: Filó M, editor. Párbeszéd a halálról: Eutanázia a jogrend peremén [Dialogue about Death: Euthanasia on the Peripheries of the Legal System]. Budapest: Literatura Medica Kiadó; 2011. p. 83-95.
Sándor J, Lenk C, Gordijn B. Introduction. In: Sándor J, Lenk C, Gordijn B, editors. Biobanks and Tissue Research. Dordrecht: Springer; 2011. p. 3-17.

Law, ethics and medicine 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?

Sándor J. Anonymity in Assisted Reproduction: Gender Equality and a Pronatal Reproductive Policy in Hungarian Law. In: Feuillet-Liger B, Orfali K, Callus T, editors. Who Is My Genetic Parent? Donor Anonymity and Assisted Reproduction: A Cross-Cultural Perspective. Brussels: Bruylant; 2010. p. 199-211.

Managing Access to Biobanks: How Can we Reconcile Individual Privacy and Public Interests in Genetic Research?

This article is concerned with the ultimate objectives of genetic biobanks set up to promote the public interest—being the sharing of samples and data for medical research—and the consequences for personal privacy of realising them. Our aim is to chart the values, interests and principles in play, to consider the challenges of realizing biobanking objectives on a global scale, and to propose viable ways forward that ensure, as far as possible, that access provisions remain fit for purpose throughout the entire life of a biobank, while adequately protecting the privacy interests at stake. It is argued that key features in any robust access model must include mechanisms to (a) maintain participant trust in management of the resource and to measure and respond to participants’ expectations, (b) facilitate and promote the sharing of benefits, and (c) respond timeously and effectively to new challenges.

Biobankok: Sikeres fikció a tudomány szolgálatában?

Alig pár évvel az Emberi Genome Program bejelentése után világszerte új fogalom jelent meg a biomedicinában: a biobank fogalma. A szóösszetétel már önmagában is utal arra a nemrégiben bekövetkezett szemléletváltásra, hogy biológiai alkotórészeinek gondos rendszerezése révén anyagi értékkel is bíró bankot alkothatnak, amelyben tárolhatók, összegyűjthetők, ezáltal „kamatoztathatóak” az elszigetelten bár jelentéktelen, de együttesen mégis értékes biológiai minták. Ily módon a minták levétele, összegyűjtése egyúttal befektetés is, de nemcsak üzleti értelemben, hanem olyan módon is, hogy a biobank kialakításában résztvevők további kutatásra, tudományos együttműködésre szánt mintakollekcióval is rendelkezhetnek, amelyben a biológiai szöveteket kölcsönösen cserélhetik egymással, valamint más hazai és külföldi kutatókkal.

Sándor J. Introduction. In: Perfect copy? : Law and ethics of reproductive medicine. Budapest: Celab; 2009. p. 7-18.
Sándor J. A retórica legal em torno da reproducao. In: Silva S, Voloso L, editors. Representacoes juridicas tecnologias reprodutivas : contributos para uma reflexao. Porto: UPorto Editorial; 2009. p. 21-43.
Sándor J. Adolescents and Medical Treatment. In: 3rd Meeting of the Francophone Network of Lawyers in the field of Biomedicine. Kyoto; 2009.

Adolescents and Medical Treatment

This article was presented on the 3rd Meeting of the Francophone Network of Lawyers in the field of Biomedicine, 5- 6 January 2009, in Kyoto, Japan.It was submitted in French.

Sándor J. IKT-implantátumok (az ember-számítógép kommunikáció távlatai). In: Dömölki B, editor. Égen-földön informatika : az információs társadalom technológiai távlatai. Budapest: Typotex; 2008. p. 317-33.
Sándor J. ‘Body Immortal’. In: Gunning J, editor. Ethics, law and society. Hampshire: Ashgate; 2007. p. 123-35.
Sándor J. Az emberi méltóság tiszteletéről a bioetikában és az orvosbiológiai jogban. In: Trócsányi L, editor. A mi alkotmányunk : vélemények és elemzések Magyarország Alkotmányáról. Budapest: Complex Kiadó; 2006. p. 355-7.
Sándor J. Jogi felelősség az egészségügyi tevékenységért. In: Oláh A, Gaál C, editors. Hibák és szövődmények a hasi sebészetben. Budapest: Medicina; 2006. p. 63-70.
Sándor J. Body that Matters. Journal de médecine legale, droit medical, victimiologie, dommage corporel. 2006;49(2-3.):59.

The Budapest Meeting 2005 Intensified Networking on Ethics of Science

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.

Sándor J. Research Ethics Committees in Hungary. In: Beyleveld D, Townend D, Wright J, editors. Research ethics committees, data protection, and medical research in European countries. Aldershot, England: Ashgate; 2005. p. 93-107.
Sándor J. Cells, Tissues, and Health Care Data. In: "The Budapest meeting" : EU accession and its consequences for candidate countries' health systems : yearbook 2003. Rotterdam: Erasmus University Press; 2004. p. 57-71.
Sándor J. Protection of Health Care Data in Hungarian Law. In: Beyleveld D, Townend D, Wright J, editors. Implementation of the Data Protection Directive in Relation to Medical research in Europe. Aldershot: Ashgate; 2004. p. 157-75.
Sándor J. Ombudspersons and Patients’ Rights Representatives in Hungary. In: Fallberg L, Mackenney S, editors. Protecting Patients’ Rights? A Comparative Study of the Ombudsman in Healthcare. Abingdon: Radcliffe Medical Press; 2004. p. 55-77.
Sándor J. Genetic Infromation : Science, Society, and Legal Norms. In: Society and Genetic Information: Codes and Laws in the Genetic Era. Budapest: CEU Press; 2004. p. 21-54.
Sándor J. Data Protection in Health Care. Beyond Biomedical Use. In: Sándor J, Exter A, editors. Frontiers of European health law : yearbook, 2002. Rotterdam: Erasmus University; 2003. p. 76-96.
Sándor J. A genetikai adatok védelme. Acta humana : emberi jogi közlemények. 2003;14(3):3-21.
Sándor J. Genetic Data : Old and New Challenges for Data Protection. In: Ethics in Human Genetics : Challenges of the (Post) Genomic Era. Bratislava: Charis–IMEB Foundation; 2002. p. 89-99.