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.
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?
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.
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.
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.
Parental identification and Genetic Fingerprinting : Secret or Lies
This article was presented in the Proceedings of the International Symposium AMADE-UNESCO on Bioethics and the Rights of the Child, Monaco, 28-30 April 2000
Human Genome Analysis from ethical and legal perspectives
This article was presented in the International Conference of the Council of Europe on Ethical Issues Arising from the Application of Biotechnology, Oviedo (Spain), 16-19 May 1999
Reproductive rights in Hungarian law : a new right to assisted procreation?
Hungary has a mixed record in terms of fulfilling reproductive rights as a whole, but in the context of artificially assisted procreation, it provides reproductive health services far beyond those offered by its neighbors, beyond what is stipulated by the ICPD Programme of Action, and, arguably, beyond the internationally accepted parameters of reproductive rights. Recent legislation on assisted procreation has established important new regulations and formulated a new "right to continuation of infertility treatment" applicable to women who have been widowed or divorced. The new legislation is examined in the context of the international reproductive rights movement, with comparisons to other European countries and with reference to Hungarian attitudes and laws on abortion and surrogacy.
From Ministry Orders towards the Constitutional Debate : Lessons drawn from the Past 50 Years of Abortion Laws in Hungary.
Special issue: Legal and Ethical Aspects of Reproductive and Sexual Health in Central Eastern Europe.